Datasets:

allenai

/

cochrane_dense_mean

like 0

Follow

Ai2 1,359

[ "16394043", "6751268", "7845426", "15590951", "9600815", "20074933", "8305389", "12850623", "9284774" ]

[ "Aggressive surgical effort and improved survival in advanced-stage ovarian cancer.", "Radical pelvic surgery versus radical surgery plus radiotherapy for stage Ib carcinoma of the cervix uteri. Preliminary results of a prospective randomized clinical study.", "The effect of debulking surgery after induction chemotherapy on the prognosis in advanced epithelial ovarian cancer. Gynecological Cancer Cooperative Group of the European Organization for Research and Treatment of Cancer.", "Secondary surgical cytoreduction for advanced ovarian carcinoma.", "Complete cytoreductive surgery is feasible and maximizes survival in patients with advanced epithelial ovarian cancer: a prospective study.", "Understanding the problem of inadequately staging early ovarian cancer.", "Intervention debulking surgery in advanced epithelial ovarian cancer.", "Stages III and IV invasive epithelial ovarian carcinoma in younger versus older women: what prognostic factors are important?", "Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer." ]

[ "Residual disease after initial surgery for ovarian cancer is the strongest prognostic factor for survival. However, the extent of surgical resection required to achieve optimal cytoreduction is controversial. Our goal was to estimate the effect of aggressive surgical resection on ovarian cancer patient survival.\n A retrospective cohort study of consecutive patients with International Federation of Gynecology and Obstetrics stage IIIC ovarian cancer undergoing primary surgery was conducted between January 1, 1994, and December 31, 1998. The main outcome measures were residual disease after cytoreduction, frequency of radical surgical resection, and 5-year disease-specific survival.\n The study comprised 194 patients, including 144 with carcinomatosis. The mean patient age and follow-up time were 64.4 and 3.5 years, respectively. After surgery, 131 (67.5%) of the 194 patients had less than 1 cm of residual disease (definition of optimal cytoreduction). Considering all patients, residual disease was the only independent predictor of survival; the need to perform radical procedures to achieve optimal cytoreduction was not associated with a decrease in survival. For the subgroup of patients with carcinomatosis, residual disease and the performance of radical surgical procedures were the only independent predictors. Disease-specific survival was markedly improved for patients with carcinomatosis operated on by surgeons who most frequently used radical procedures compared with those least likely to use radical procedures (44% versus 17%, P < .001).\n Overall, residual disease was the only independent predictor of survival. Minimizing residual disease through aggressive surgical resection was beneficial, especially in patients with carcinomatosis.\n II-2.", "In a preliminary report of a prospective controlled study treatment results and therapy morbidity of 60 patients with stage pT1bNoMo carcinoma of the uterine cervix treated by radical surgery only (Wertheim-Meigs) were compared with those of 60 patients treated by radical surgery followed by a postoperative external radiotherapy. The median duration of follow-up was 44 (24--72) months. Comparing the survival probability analyzed by life-table-method up to 18 months there was a significant better result for patients treated with surgery only. However, after that the study demonstrated comparable therapeutic results with the two therapeutic regimens. There was no difference of tumor size in patients who died after surgery alone and those who died after combined therapy. The therapy morbidity was slightly greater in patients treated by combined therapy. Especially lymphedemas of the leg developed more frequent in patients treated with combined surgery and radiotherapy. Preliminary analysis of the study does not demonstrate any beneficial effect of postoperative radiotherapy followed a radical hysterectomy with pelvic lymphonodectomy in cervical cancer stage pT1bNoMo, but optimal staging, radical surgery and carefully histological examination of the removed tissue are essential needs for this approach.", "Although the value of primary cytoreductive surgery for epithelial ovarian cancer is beyond doubt, the value of debulking surgery after induction chemotherapy has not yet been defined. In this randomized study we investigated the effect on survival of debulking surgery.\n Eligible patients had residual lesions measuring more than 1 cm in diameter after primary surgery. After three cycles of cyclophosphamide and cisplatin, these patients were randomly assigned to undergo either debulking surgery or no surgery, followed by further cycles of cyclophosphamide and cisplatin. The study end points were progression-free and overall survival. At surgery 65 percent of the patients had lesions measuring more than 1 cm. In 45 percent of this group, the lesions were reduced surgically to less than 1 cm.\n Of the 319 patients who underwent randomization, 278 could be evaluated (140 patients who underwent surgery and 138 patients who did not). Progression-free and overall survival were both significantly longer in the group that underwent surgery (P = 0.01). The difference in median survival was six months. The survival rate at two years was 56 percent for the group that underwent surgery and 46 percent for the group that did not. In the multivariate analysis, debulking surgery was an independent prognostic factor (P = 0.012). Overall, after adjustment for all other prognostic factors, surgery reduced the risk of death by 33 percent (95 percent confidence interval, 10 to 50 percent; P = 0.008). Surgery was not associated with death or severe morbidity.\n Debulking surgery significantly lengthened progression-free and overall survival. The risk of death was reduced by one third, after adjustment for a variety of prognostic factors.", "We evaluated the effect of adding secondary cytoreductive surgery to postoperative chemotherapy on progression-free survival and overall survival among patients who had advanced ovarian cancer and residual tumor exceeding 1 cm in diameter after primary surgery.\n Women were enrolled within six weeks after primary surgery. If, after three cycles of postoperative paclitaxel plus cisplatin, a patient had no evidence of progressive disease, she was randomly assigned to undergo secondary cytoreductive surgery followed by three more cycles of chemotherapy or three more cycles of chemotherapy alone.\n We enrolled 550 women. After completing three cycles of postoperative chemotherapy, 216 eligible patients were randomly assigned to receive secondary surgical cytoreduction followed by chemotherapy and 208 to receive chemotherapy alone. Surgery was declined by or medically contraindicated in 15 patients who were assigned to secondary surgery (7 percent). As of March 2003, 296 patients had died and 82 had progressive disease. The likelihood of progression-free survival in the group assigned to secondary surgery plus chemotherapy, as compared with the chemotherapy-alone group, was 1.07 (95 percent confidence interval, 0.87 to 1.31; P=0.54), and the relative risk of death was 0.99 (95 percent confidence interval, 0.79 to 1.24; P=0.92).\n For patients with advanced ovarian carcinoma in whom primary cytoreductive surgery was considered to be maximal, the addition of secondary cytoreductive surgery to postoperative chemotherapy with paclitaxel plus cisplatin does not improve progression-free survival or overall survival.\n Copyright 2004 Massachusetts Medical Society.", "Despite correlation between the completeness of surgical cytoreduction and survival for patients with advanced ovarian cancer, relatively few undergo complete cytoreduction. This study was initiated to prospectively determine the ability to surgically eliminate all visible disease in patients with stage IIIC and IV epithelial ovarian cancer and the associated impact on survival.\n Between 1990 and 1996, 163 consecutive patients underwent primary cytoreduction. The goal was the excision or ablation of all visible disease prior to initiation of systemic platinum-based combination chemotherapy. A multivariate analysis determined which clinical and pathologic variables influenced the probability of achieving complete cytoreduction (logistic regression) and survival (Cox proportional hazards model).\n One hundred thirty-nine patients (85.3%) underwent removal of all visible tumor, 22 (13.5%) had cytoreduction to </=1 cm residual disease, and 2 (1.2%) had unresected bulky disease. The median and estimated 5-year survival for the entire cohort was 54 months and 48%, respectively. The probability of achieving complete cytoreduction was influenced independently by the preoperative Gynecologic Oncology Group performance status (0-1 vs 2-3, P = 0.04), the number of mesenteric and intestinal serosal implants (</=75 vs >75 implants, P = 0.005), and stage (IIIC vs IV, P = 0.006). The probability of survival was independently influenced by age (</=61 vs >61 years, P = 0.003), volume of ascites (</=1 vs >1 liter, P = 0.01), stage (IIIC vs IV, P = 0.04), histology (clear cell and mucinous vs all other, P = 0.03), and the completeness of cytoreductive operation (complete vs incomplete cytoreduction, P = 0.02).\n Complete cytoreduction is possible for the majority of patients and improves survival, even compared to operations with minimal (</=1 cm) residual disease. Unless their medical condition prohibits anesthesia and surgery, patients with advanced epithelial ovarian cancer should undergo primary cytoreductive surgery with the intention of complete tumor removal.\n Copyright 1998 Academic Press.", "Early ovarian cancer patients are often incompletely staged during initial surgery.(1-3) This omission can have serious adverse consequences for the prognosis of patients as the completeness of surgical staging has been identified as an independent prognostic parameter for survival.(4,5) The reasons for the problem of inadequate staging of early ovarian cancer are largely unknown. We have analysed the data of a large randomised trial in early ovarian cancer in which detailed information of the surgical staging procedure was monitored.(5)\n Data of the EORTC Adjuvant ChemoTherapy In Ovarian Neoplasm (ACTION) Trial were used in which 448 early ovarian cancer patients were randomised between postoperative chemotherapy in one arm and observation following surgery in the other. In this trial strict criteria for surgical staging were advised but optimal, complete staging was performed in only 1/3 of patients. Staging characteristics of the incompletely staged patients were analysed and factors that could explain the failure to perform a complete staging were studied.\n Sampling of para-aortic nodes was omitted in 78% of the incompletely staged patients, while 52% of these patients had no pelvic lymph node dissection. Taking blind biopsies from different peritoneal sites was not performed in more than 1/3 of the incompletely staged group. Omission of the staging steps ranged from 3% (infracolic omentectomy) to 55% (biopsy of the right hemi-diaphragm). A significant difference (p=0.04) between the fraction of completely staged patients was found when comparing institutes who entered less than 5 patients (21%) versus those who included more than 20 patients (37%) in the trial.\n Even in a randomised trial in which comprehensive surgical staging was strongly advised in the study protocol the majority of patients (66%) were incompletely staged. Factors relating to a lack of surgical skills attributed most to the number of incompletely staged patients, but insufficient knowledge of the tumour behaviour and routes of spread of ovarian cancer also contributed substantially to this problem. Multicentre trials recruiting patients from many institutes with small volume contribution to the study, run the risk of inadequate adherence to the study protocol.\n Copyright 2009 Elsevier Ltd. All rights reserved.", "To study whether intervention debulking surgery improves survival in patients with advanced ovarian cancer who have bulky (> 2 cm) residual disease after primary surgery.\n A prospective multicentre randomised study.\n Hospitals in the West Midlands.\n Ovarian cancer patients with bulky residual disease after primary surgery who are considered well enough to receive cis-platinum based chemotherapy and further surgery.\n Eligible patients were randomised to receive combination chemotherapy alone or combined with intervention debulking surgery.\n Survival was assessed using product limit method and log-rank test.\n Seventy-nine patients were entered into the study. Thirty-seven patients were randomised to intervention debulking surgery, 25 (67%) of whom underwent intervention debulking surgery, which was performed a median of 13 weeks after primary surgery. The median survival for the intervention debulking surgery group was 15 months (95% CI 10-20 mo) and that of those randomised to chemotherapy alone, which was 12 months (95% CI 8-16 mo), were not significantly different (hazard ratio = 0.71; 95% CI 0.44-1.13).\n Intervention debulking surgery may not improve survival in patients with advanced ovarian cancer.", "OBJECTIVE; To compare the survival rates in younger (45 years or younger) and older women (over 45) diagnosed with advanced-stage invasive epithelial ovarian cancer. Clinical and pathologic factors responsible for survival differences between the two groups were also determined.\n All younger women with advanced-stage epithelial ovarian carcinoma diagnosed between 1984 and 2001 were identified from tumor registry databases at two hospitals. Patients with borderline tumors were excluded. An older group of comparable controls was selected for comparison. Kaplan-Meier and Cox proportional hazards analyses were used to determine the predictors for survival.\n Of 104 women with advanced-stage epithelial ovarian carcinoma, 52 were 45 or younger and the rest were over 45. The 5-year survival rate and median survival in younger patients were 48% and 54 months, compared with 22% and 34 months in the older women (P =.003). Younger women had significantly better performance status than older patients, and survival remained significantly better in younger women based on Kaplan-Meier analysis stratified by performance status (0 versus 1 to 2, P =.02). Furthermore, overall survival was significantly better in younger women after stratification by stage (III versus IV, P =.002) and by cytoreductive surgery (optimal versus suboptimal, P =.003). Multivariable analysis demonstrated that all these factors remained as significant independent prognostic factors for survival.\n Younger women with advanced-stage invasive epithelial ovarian cancer have significantly improved survival rates relative to older patients. Age, performance status, stage of disease, and extent of cytoreductive surgery are important independent prognostic factors for survival.", "Stage Ib and IIa cervical carcinoma can be cured by radical surgery or radiotherapy. These two procedures are equally effective, but differ in associated morbidity and type of complications. In this prospective randomised trial of radiotherapy versus surgery, our aim was to assess the 5-year survival and the rate and pattern of complications and recurrences associated with each treatment.\n Between September, 1986, and December, 1991, 469 women with newly diagnosed stage Ib and IIa cervical carcinoma were referred to our institute. 343 eligible patients were randomised: 172 to surgery and 171 to radical radiotherapy. Adjuvant radiotherapy was delivered after surgery for women with surgical stage pT2b or greater, less than 3 mm of safe cervical stroma, cut-through, or positive nodes. The primary outcome measures were 5-year survival and the rate of complications. The analysis of survival and recurrence was by intention to treat and analysis of complications was by treatment delivered.\n 170 patients in the surgery group and 167 in the radiotherapy group were included in the intention-to-treat analysis; scheduled treatment was delivered to 169 and 158 women, respectively, 62 of 114 women with cervical diameters of 4 cm or smaller and 46 of 55 with diameters larger than 4 cm received adjuvant therapy. After a median follow-up of 87 (range 57-120) months, 5-year overall and disease-free survival were identical in the surgery and radiotherapy groups (83% and 74%, respectively, for both groups), 86 women developed recurrent disease: 42 (25%) in the surgery group and 44 (26%) in the radiotherapy group. Significant factors for survival in univariate and multivariate analyses were: cervical diameter, positive lymphangiography, and adeno-carcinomatous histotype. 48 (28%) surgery-group patients had severe morbidity compared with 19 (12%) radiotherapy-group patients (p = 0.0004).\n There is no treatment of choice for early-stage cervical carcinoma in terms of overall or disease-free survival. The combination of surgery and radiotherapy has the worst morbidity, especially urological complications. The optimum therapy for each patient should take account of clinical factors such as menopausal status, age, medical illness, histological type, and cervical diameter to yield the best cure with minimum complications." ]

[ "3174314", "3312552", "11430325", "1305392", "10228288", "3677969", "10730525", "8627434", "2231212" ]

[ "Prophylactic indomethacin for prevention of intraventricular hemorrhage in premature infants.", "Prevention of symptomatic patent ductus arteriosus with a single dose of indomethacin.", "Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants.", "[Indomethacin in the prevention of subependymal-intraventricular hemorrhage in preterm newborns with conventional mechanical ventilation].", "Short versus prolonged indomethacin therapy for patent ductus arteriosus in preterm infants.", "Failure of prophylactic indomethacin to improve the outcome of the very low birth weight infant.", "Indomethacin prophylaxis for patent ductus arteriosus (PDA) in infants with a birth weight of less than 1250 grams.", "Prophylactic indomethacin therapy in the first twenty-four hours of life for the prevention of patent ductus arteriosus in preterm infants treated prophylactically with surfactant in the delivery room.", "Prolonged indomethacin therapy for the prevention of recurrences of patent ductus arteriosus." ]

[ "The impact of early prophylactic use of intravenous indomethacin on the incidence and severity of periventricular-intraventricular hemorrhage and patent ductus arteriosus in 199 oxygen-requiring premature infants (less than or equal to 1300 g birth weight) was prospectively investigated. The trial was controlled, the infants were randomized, and the investigators were unaware of the group assignments. Patients with minimal (grade I) or no periventricular-intraventricular hemorrhage determined by prestudy echoencephalography were randomized within two birth weight subgroups (500 to 899 and 900 to 1300 g) to receive either prophylactic indomethacin (n = 99) or an equal volume of saline-vehicle placebo (n = 100). The first dose (0.2 mg/kg) was given within 12 hours of delivery and two subsequent doses (0.1 mg/kg) were administered at 12 hourly intervals. Prophylactic indomethacin significantly reduced the incidence of grades II to IV periventricular-intraventricular hemorrhage. Intraventricular hemorrhage was half as common in infants given prophylactic indomethacin as in control infants (23% v 46%, P less than .002). The reduction was manifested in both birth weight subgroups. Results of this study also confirmed a lower incidence of clinically significant patent ductus arteriosus in infants who received prophylactic indomethacin in contrast to those who received placebo (11% v 42%, P less than .001). No significant differences were found between treatment and control groups in the duration of oxygen therapy, mechanical ventilation, or hospitalization or in the incidence of pneumothorax, chronic lung disease, sepsis, necrotizing enterocolitis, retinopathy of prematurity, or death. Early prophylactic indomethacin initiated within 12 hours of delivery is effective in reducing the incidence of intraventricular hemorrhage as well as clinically significant patent ductus arteriosus in very low birth weight premature infants.", "To determine the efficacy of indomethacin to prevent the occurrence of symptomatic patent ductus arteriosus (PDA), a randomized clinical trial was conducted involving 32 preterm infants weighing 750 to 1500 g at birth who had hyaline membrane disease. By random assignment, 15 infants were given a single dose of indomethacin, 0.2 mg/kg intravenously, 24 hours after birth. Seventeen infants composed a control group for which indomethacin was reserved as treatment for symptomatic PDA. Birth weight, gestational age, male/female ratio, black/white ratio, and severity of disease were similar for both groups. Only one of the 14 survivors who received prophylactic indomethacin had symptomatic PDA, compared with nine of the 16 survivors in the control group (P = 0.007). There was no difference between the groups in development of bronchopulmonary dysplasia, duration of time endotracheal intubation, was required, duration in oxygen, duration to reach full feedings and regain birth weight, and duration of hospital stay. There was no difference between the two groups in incidence of intraventricular hemorrhage, and none developed necrotizing enterocolitis. These results indicate that the use of prophylactic indomethacin is beneficial in prevention of symptomatic PDA; the lack of differences in pulmonary sequelae or other complications may have been related to a population sample size not large enough to impart sufficient statistical power.", "The prophylactic administration of indomethacin reduces the frequency of patent ductus arteriosus and severe intraventricular hemorrhage in very-low-birth-weight infants (those with birth weights below 1500 g). Whether prophylaxis with indomethacin confers any long-term benefits that outweigh the risks of drug-induced reductions in renal, intestinal, and cerebral blood flow is not known.\n Soon after they were born, we randomly assigned 1202 infants with birth weights of 500 to 999 g (extremely low birth weight) to receive either indomethacin (0.1 mg per kilogram of body weight) or placebo intravenously once daily for three days. The primary outcome was a composite of death, cerebral palsy, cognitive delay, deafness, and blindness at a corrected age of 18 months. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly within the same time frame. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, ultrasonographic evidence of intracranial abnormalities, necrotizing enterocolitis, and retinopathy.\n Of the 574 infants with data on the primary outcome who were assigned to prophylaxis with indomethacin, 271 (47 percent) died or survived with impairments, as compared with 261 of the 569 infants (46 percent) assigned to placebo (odds ratio, 1.1; 95 percent confidence interval, 0.8 to 1.4; P=0.61). Indomethacin reduced the incidence of patent ductus arteriosus (24 percent vs. 50 percent in the placebo group; odds ratio, 0.3; P<0.001) and of severe periventricular and intraventricular hemorrhage (9 percent vs. 13 percent in the placebo group; odds ratio, 0.6; P=0.02). No other outcomes were altered by the prophylactic administration of indomethacin.\n In extremely-low-birth-weight infants, prophylaxis with indomethacin does not improve the rate of survival without neurosensory impairment at 18 months, despite the fact that it reduces the frequency of patent ductus arteriosus and severe periventricular and intraventricular hemorrhage.", "The results of a double blind study to evaluate the efficiency of prophylactic endovenous indomethacin versus placebo for prevention of intraventricular hemorrhage (IVH) in newborn infants between 28 to 36 weeks of age who were intubated at the delivery room and required mechanical ventilation in NICU are presented. Fourty six patients required mechanical ventilation, but 14 neonates had IVH evaluated by ultrasound when were admitted to the Unit. At least 32 infants were studied, 16 for each group. There were no differences between the groups in weight, gestational age, sex and delivery way. The mobility was the same in relation to hialine membrane disease, sepsis, pneumonie and pneumotorax. The placebo group had more frequency of PDA and mortality (P < 0.5). There were no differences in mean airway pressure and arterial gases, also in glucose, platelets and urinary volume. The indomethacin group had mayor urinary density and FeNa but the results were always in normal ranges. The IVH was the same in both groups. We concluded that the indomethacin at the levels used did not produced alterations, and if the IVH is not prevented, were observed lesser severity of the same and the frequency of PDA and mortality are lesser. But still is necessary more number of cases for best conclusions.", "To evaluate whether a prolonged low-dose course of indomethacin would produce an improved closure rate and have fewer side effects compared with a short standard dosage schedule in the management of patent ductus arteriosus (PDA) in preterm infants.\n Sixty-one infants of gestational ages 24 to 32 weeks with a PDA confirmed with echocardiography were randomized to receive 0.2 to 0.1 to 0.1 mg/kg indomethacin in 24 hours (short course, n = 31) or 0.1 mg/kg every 24 hours 7 times (long course, n = 30). Echocardiography was done 3, 9, and 14 days after the treatment was started, and side effects were monitored.\n Primary PDA closure occurred more often in the short course group (94% vs 67%, P =.011), but the sustained closure rates were not different (74% vs 60%). Surgical PDA ligations were less frequent in the short course group than in the long course group. The short course group had a shorter duration of oxygen supplementation, less frequent symptoms of necrotizing enterocolitis, and a lower rate of urea retention. Mortality and other neonatal morbidity rates were similar.\n A prolonged low-dosage indomethacin regimen offers no advantage compared with a standard-dosage short course in the management of a hemodynamically significant PDA in preterm infants.", "Prophylactic closure of the patent ductus arteriosus (PDA) has been recommended as a means of decreasing early respiratory distress, and thereby chronic respiratory sequelae in the very low birth weight (VLBW) neonate. This study was undertaken to evaluate some possible mechanisms for the observed failure of early indomethacin therapy to achieve such improvement. 24 VLBW infants with echocardiographic evidence of PDA were randomized to receive either indomethacin or placebo at 48 h of life; and then they were studied for clinical, metabolic and laboratory signs of ductal constriction and/or reopening. Early indomethacin conferred no improvement in respiratory sequelae. However, this was not secondary to a short-term therapeutic failure. Prophylactic indomethacin, even in the VLBW infant, was successful in decreasing dilator prostaglandin production, and probably in closing the PDA and in decreasing the number of recurrences. The implications are that even with effective ductal constriction, overall morbidity is not affected.", "Very low birth weight (VLBW, less than 1500 g) and extremely low birth weight infants (ELBW, less than 1000 g) are the premature infants that are most likely to develop symptomatic PDA. Intravenous indomethacin has proven effective in prevention of PDA in many prospective trials. This strategy will be a useful adjunctive therapy for premature infants in Thailand.\n To answer the following questions: 1. Will multiple doses of intravenous indomethacin, given to VLBW infants within the first day of life, effectively prevent the occurrence of symptomatic PDA? Are there any side effects or complications? 2. Will this strategy be more beneficial in ELBW?\n The study included thirty VLBW infants born at Ramathibodi Hospital, with birth weights ranging from 630 to 1230 g. They were randomized into 2 groups of 15 infants each. One group received 3 doses of intravenous indomethacin at the dosage of 0.2 mg/kg initially and then 0.1 mg/kg every 12 hours for 2 more doses; the second group received a placebo. The study was performed by a double blind control.\n Sixteen infants developed symptomatic PDA, 4 in the indomethacin group and 12 in the placebo group. The decrease in incidence of PDA is statistically significant. But when the data was analyzed separately for the VLBW and ELBW groups. The effects were only significantly different in ELBW but not yet significant in the VLBW group. There was a statistically significant difference in the incidence of severe intraventricular hemorrhage (IVH) (grade 3 or higher) in the ELBW infants.\n Intravenous indomethacin therapy given to VLBW infants with a birth weight of less than 1250 g decreased incidence of symptomatic PDA with no significant permanent side effects. The effect was markedly noticeable in ELBW infants. Incidence of severe IVH was also markedly decreased in the ELBW infants who received indomethacin.", "To determine whether a course of low-dose indomethacin therapy, when initiated within 24 hours of birth, would decrease ductal shunting in premature infants who received prophylactic surfactant in the delivery room.\n Ninety infants, with birth weights of 600 to 1250 gm, were entered into a prospective, randomized, controlled trial to receive either indomethacin, 0.1 mg/kg per dose, or placebo less than 24 hours and again every 24 hours for six doses. Echocardiography was performed on day 1 before treatment and on day 7, 24 hours after treatment. A hemodynamically significant patent ductus arteriosus (PDA) was confirmed with an out-of-study echocardiogram, and the nonresponders were treated with standard indomethacin or ligation.\n Forty-three infants received indomethacin (birth weight, 915 +/- 209 gm; gestational age, 26.4 +/- 1.6 weeks; 25 boys), and 47 received placebo (birth weight, 879 +/- 202 gm; gestational age, 26.4 +/- 1.8 weeks; 22 boys) (P = not significant). Of 90 infants, 77 (86%) had a PDA by echocardiogram on the first day of life before study treatment; 84% of these PDAs were moderate or large in size in the indomethacin-treated group compared with 93% in the placebo group. Nine of forty indomethacin-treated infants (21%) were study-dose nonresponders compared with 22 (47%) of 47 placebo-treated infants (p < 0.018). There were no significant differences between both groups in any of the long-term outcome variables, including intraventricular hemorrhage, duration of oxygen therapy, endotracheal intubation, duration of stay in neonatal intensive care unit, time to regain birth weight or reach full caloric intake, incidence of bronchopulmonary dysplasia, and survival. No significant differences were noted in the incidence of oliguria, elevated plasma creatinine concentration, thrombocytopenia, pulmonary hemorrhage, or necrotizing enterocolitis.\n The prophylactic use of low doses of indomethacin, when initiated in the first 24 hours of life in low birth weight infants who receive prophylactic surfactant in the delivery room, decreases the incidence of left-to-right shunting at the level of the ductus arteriosus.", "We tested the hypothesis that prolonged maintenance indomethacin therapy would allow more effective closure of patent ductus arteriosus (PDA) and thereby decrease the recurrence rate. Thirty-nine low birthweight neonates (less than 1500 gm) with confirmed PDA were randomly assigned in a double-blind fashion to receive standard indomethacin therapy (three doses), followed either by maintenance indomethacin therapy (0.2 mg/kg/day) for 5 days or by an equivalent volume of placebo for 5 days. Of the 20 infants who received maintenance indomethacin therapy, two (10%) required additional therapy and one of these required surgical ligation. Of the 19 infants who received only the first three indomethacin doses, nine (47%) required additional therapy for PDA (p less than 0.05) and seven of these had a ligation (p less than 0.05). We conclude that maintenance indomethacin therapy, in comparison with short-term indomethacin therapy, decreases the incidence of surgical PDA ligations, eliminates most PDA recurrences, and does not increase toxic effects of indomethacin in the low birth weight infant with PDA." ]

[ "2381003", "9848045", "20079572", "10626971", "6994679", "14562531", "9499605", "15993304", "16881426" ]

[ "Comparison of a hydrocolloid dressing and silver sulfadiazine cream in the outpatient management of second-degree burns.", "A matched-pair, randomized study evaluating the efficacy and safety of Acticoat silver-coated dressing for the treatment of burn wounds.", "Procutase versus 1% silver sulphadiazine in the treatment of minor burns.", "Biobrane versus 1% silver sulfadiazine in second-degree pediatric burns.", "Safety and efficacy of a new synthetic burn dressing: a multicenter study.", "A comparison of topical Phenytoin with Silverex in the treatment of superficial dermal burn wounds.", "A comparative controlled trial of intralesionally-administered zinc sulphate, hypertonic sodium chloride and pentavalent antimony compound against acute cutaneous leishmaniasis.", "Treatment of second degree facial burns with allografts--preliminary results.", "Comparison of efficacy of 1% silver sulfadiazine and Acticoat for treatment of partial-thickness burn wounds." ]

[ "The purpose of this prospective randomized study was to evaluate the use of an occlusive hydrocolloid dressing (Duoderm hydroactive, Squibb) and silver sulfadiazine (Silvadene, Marion) cream in the outpatient management of second-degree burns. The inclusion criteria consisted of burns less than 15% total body surface area that were evaluated within 24 hours of injury and did not require hospital admission. Fifty patients were randomly assigned after having been screened through a list of seven exclusion criteria. On initial evaluation the burns were photographed and screened for causative agent, location, size, depth, tetanus status, and presence of associated burns and injuries. Patients were seen in followup at least biweekly and evaluated for wound bed healing, wound margin healing, pain, number of dressing changes between visits, and ease of dressing application and removal. On final evaluation the burns were photographed and inspected for appearance of the healed burn, repigmentation, wound contraction, approximate time for dressing change, patient compliance, limitation of activity, overall impression of the treatment, and number of days for complete healing. Results were compared using a two-tailed t-test with p less than 0.01. Both groups were statistically similar in age, sex, and size. Duoderm-treated burns had statistically significantly better wound healing, repigmentation, less pain, fewer dressing changes, less time for dressing changes, and less cost. Duoderm-treated patients had statistically significantly less limitation of activity, better patient compliance, greater patient comfort, better overall acceptance, and felt the treatment was more aesthetically pleasing. The results reveal that the Duoderm Hydroactive dressings are superior to Silvadene cream in the outpatient management of second-degree burns.", "A new silver-coating technology was developed to prevent wound adhesion, limit nosocomial infection, control bacterial growth, and facilitate burn wound care through a silver-coated dressing material. For the purposes of this article, Acticoat (Westaim Biomedical Inc, Fort Saskatchawan, Alberta, Canada) silver-coated dressing was used. After in vitro and in vivo studies, a randomized, prospective clinical study was performed to assess the efficacy and ease of use of Acticoat dressing as compared with the efficacy and ease of our institution's standard burn wound care. Thirty burn patients with symmetric wounds were randomized to be treated with either 0.5% silver nitrate solution or Acticoat silver-coated dressing. The dressing was evaluated on the basis of overall patient comfort, ease of use for the wound care provider, and level of antimicrobial effectiveness. Wound pain was rated by the patient using a visual analog scale during dressing removal, application, and 2 hours after application. Ease of use was rated by the nurse providing wound care. Antimicrobial effectiveness was evaluated by quantitative burn wound biopsies performed before and at the end of treatment. Patients found dressing removal less painful with Acticoat than with silver nitrate, but they found the pain to be comparable during application and 2 hours after application. According to the nurses, there was no statistically significant difference in the ease of use. The frequency of burn wound sepsis (> 10(5) organisms per gram of tissue) was less in Acticoat-treated wounds than in those treated with silver nitrate (5 vs 16). Secondary bacteremias arising from infected burn wounds were also less frequent with Acticoat than with silver nitrate-treated wounds (1 vs 5). Acticoat dressing offers a new form of dressing for the burn wound, but it requires further investigation with greater numbers of patients in a larger number of centers and in different phases of burn wound care.", "The purpose of this randomised comparative study was to evaluate the use of silver sulphadiazine (SSD) 1% cream (Group A) with the use of Procutase (Group B) in treating burns with a TBSA <10% and a depth not greater than 2nd degree burns and thus suitable for outpatient management. The two groups were similar in age, gender, race, and extent of burn. Procutase is an ionic hydrogel composed of natural hydrophilic polymers in an active ionic solution with an inhibitor of matrix metalloproteinases MMP-1, -3 and -9 (collagenase/gelatinase). Subjects were seen in follow-up biweekly, and wounds of patients in SSD group were compared with those of Procutase group for healing time, pain score at dressing change, compliance with therapy and complication rate. The result of this study showed that Procutase treated patients had statistically significantly less pain and shorter wound healing time. Procutase can be used successfully in patients with burns that do not require hospital admission.\n 2009 Elsevier Ltd and ISBI. All rights reserved.", "Partial-thickness burns in children have been treated for many years by daily, painful tubbing, washing, and cleansing of the burn wound, followed by topical application of antimicrobial creams. Pain and impaired wound healing are the main problems. We hypothesized that the treatment of second-degree burns with Biobrane is superior to topical treatment. Twenty pediatric patients were prospectively randomized in two groups to compare the efficacy of Biobrane versus 1% silver sulfadiazine. The rest of the routine clinical protocols were followed in both groups. Demographic data, wound healing time, length of hospital stay, pain assessments and pain medication requirements, and infection were analyzed and compared. Main outcome measures included pain, pain medication requirements, wound healing time, length of hospital stay, and infection. The application of Biobrane to partial-thickness burns proved to be superior to the topical treatment. Patients included in the biosynthetic temporary cover group presented with less pain and required less pain medication. Length of hospital stay and wound healing time were also significantly shorter in the Biobrane group. None of the patients in either group presented with wound infection or needed skin autografting. In conclusion, the treatment of partial-thickness burns with Biobrane is superior to topical therapy with 1% silver sulfadiazine. Pain, pain medication requirements, wound healing time, and length of hospital stay are significantly reduced.", "A three-tiered, multicenter study evaluated the safety and efficacy of a new synthetic dressing for burn injuries. The first tier compared use of the test dressing with use of a conventional topical chemotherapeutic agent; the test dressing afforded greater patient comfort, equivalent control of bacterial growth, less frequent dressing change, and possibly faster reepithelialization. Drawbacks included difficulty of application, poor adherence during the first 24 hours after injury, frequent necessity to repair cracks and fissures, and inability to easily monitor burn wounds for bacterial growth. Subsequent tiers were noncomparative but included patients with more severe injuries. The test dressing may be useful in treating superficial and moderate second-degree burns of less than 20% of the total body surface area and possibly in treating iatrogenic \"burn\" wounds such as donor sites. Its use on third-degree burns is not recommended.", "To compare topical diphenylhydantion (Phenytoin) with silver sulphadiazine/chlorhexidine (Silverex) in terms of rate of wound healing, analgesic and antibacterial properties in small to moderate-sized (< 30% TBSA) superficial dermal (second degree) burn wounds.\n A prospective randomized controlled study.\n Surgical wards, Muhimbili National Hospital from July 2000 to February 2001.\n Sixty four patients with acute burns, 32 in each group.\n Study group treated by sprinkling Phenytoin powder and control group by sprinkling Silverex powder on the wounds for 14 days or until the wound epithelialised or was ready for skin grafting. The data collected included demographic characteristics of patients, aetiology of burn injury, circumstances of injury, site and extent of burns, pus discharge and smell from the wound, pain and discomfort from the wound, bacterial cultures of wound swabs, rate of reduction in wound size and outcome of treatment.\n The study enrolled 33 male and 31 female patients, 69% being children under five years of age. Hot liquids (80%) and open flames (20%) were the only causes of burns. In 97% of patients injury was due to domestic accidents. In half of the patients burns involved the trunk, and 52% of all patients had less than 15% total body surface burnt. Pus discharge was recorded in 59% of Phenytoin-treated and 75% in Silverex-treated patients while foul smell was noted in 19% and 31% of cases respectively. There were more negative bacterial wound cultures in Phenytoin-than Silverex-treated wounds on day five and day 10 of treatment, the difference being statistically significant (p < 0.01 and 0.001 respectively). There was also a statistically significant difference in wound pain in favour of Phenytoin (p < 0.01). There was no statistically significant difference in the rate of healing in the two groups.\n Phenytoin is a cheap and easy-to-use medicament, effective in suppressing burn wound bacteria and relieving pain thereby promoting healing, and may be advocated for the purpose in resource-scarce environments.", "A comparative clinical trial between two newly introduced intralesional treatments for acute leishmaniasis and the established treatment of intralesionally-administered pentavalent antimony compounds was performed. Treatments were allocated randomly to a total of 63 patients who received 2% zinc sulphate, 7% sodium chloride solutions or sodium stibogluconate intralesionally. A number of patients were left without treatment as controls. Patients were followed-up for 45 days, the results showing that the three treatments gave comparable cure rates by the end of the follow-up period. However, zinc sulphate gave a high cure rate (94.8%) usually with a single injection.", "Facial burns are very common and have significant clinical impact. However, the treatment regimen for superficial to deep facial burns is not well defined. The purpose of this study was to investigate the effects of cadaver skin grafting in deep partial thickness facial burns in comparison to standard care. In a prospective open study design severely injured patients with superficial and deep partial thickness burns were randomized into the group receiving open treatment with silversulfadiazine (standard n=5) or into the group receiving early superficial debridement followed by coverage with glycerolized cadaver skin (n=5). The outcome measures were time and quality of wound healing, and incidence of hypertrophic scarring at 3 and 6 months post burn. There were no significant differences in demographics between groups. In the group treated with the allogenic material time to reepithelialization was 10.5 days, while it was 12.4 days in the silversulfadiazine group (p<0.05). Scar quality was found to be significantly improved in the allogenic treatment group. Three and 6 months postburn there were no patients with significant hypertrophic scarring in the allogenic group while there were two patients who developed hypertrophic scars in the silversulfadiazine group (p<0.05). In this study, we demonstrated that glyzerolized cadaver allograft skin represents a superior biological dressing for shallow and deep partial thickness facial burns. This is in concordance with other reports on scalds. It would be worthwhile to perform more clinical studies with a larger number of patients to further evaluate the effect and function of allogenic skin for facial burns.", "Acticoat (Smith & Nephew, Hull, UK) is a silver-coated dressing reported to reduce infection and exhibit antimicrobial activity in wounds.\n The purpose of the present study was to compare the efficacy ofacticoat and 1% silver sulfadiazine (1% AgSD) for treatment of partial thickness burn wounds.\n The authors reviewed 50 patients who had partial thickness burn wounds less than 25% admitted to Siriraj Burn Unit from May 2002 to September 2005. All patients were divided into 2 groups: the acticoat treated group (25 patients) and the 1% silver sulfadiazine treated group (25 patients). The 2 groups were compared for the etiology of burn wound, demographic data including age, sex, % Total Body Surface Area burn (TBSA%), cultured organisms, wound infection and outcome of Length Of hospital Stay (LOS) and level of pain.\n The authors found no significant differences in age, TBSA (%) between both groups. 7 patients (28%) developed wound infection. There were no differences in wound infection and LOS between both groups (p > 0.05). All of the patients who developed wound infection responded well to targeted topical and systemic antibiotic treatment. The 1% AgSD treated group (6 of 25, 24%) obtained more split thickness skin graft to close the granulation defects compared to patients who were treated with acticoat (4 of 25, 16%) but no statistical significance, p = 0.32). Average pain scores in the acticoat treated groups were significantly lower than the 1% AgSD treated group (4 +/- 0.6 versus 5 +/- 0.7, respectively).\n The present study confirms the efficacy of acticoat treatment in partial thickness burn wound. The authors conclude that acticoat has an advantage of limiting the frequency of replacement of the dressing and provides a less painful alternative to wound care with 1% AgSD with comparable incidence of burn wound infection. This is due to its long wear time and the ease of application and removal." ]

[ "1159434", "7355429", "15489085", "9403477", "16129870", "11096217", "17239798", "15045129", "2233931" ]

[ "Trial of long-term anticoagulant therapy in the treatment of small stroke associated with a normal carotid arteriogram.", "Anticoagulant vs anti-platelet therapy as prophylactic against cerebral infarction in transient ischemic attacks.", "Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study.", "A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin. The Stroke Prevention in Reversible Ischemia Trial (SPIRIT) Study Group.", "Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial.", "Long-term follow-up after extracranial internal carotid artery dissection.", "Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial.", "Treatment with anticoagulants in cerebral events (TRACE).", "The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators." ]

[ "The clinical features of 49 patients who had sustained small strokes in the internal carotid artery territory, who were normotensive, free from cardiac or other relevant disease, and who each had a normal appropriate single vessel angiogram are presented. These were randomized into two groups: group A, 25 patients, who received only supportive treatment; group B, 24 patients who were treated with anticoagulants for an average period of 18 months. There was a reduced incidence of neurological episodes during the administration of anticoagulant therapy but, after treatment was discontinued, there was no significant difference between the two groups. In view of the relatively benign prognosis for this syndrome, unless special facilities exist for the personal control of anticoagulant treatment, the dangers may outweigh the benefits.", "156 patients with transient ischemic attacks (TIA) or reversible ischemic neurological deficit (RIND) were given prophylactic anticoagulant (AC) treatment against cerebral infarction in a prospective multicenter study from 5 hospitals in southern Sweden. After 2 months of AC treatment, 135 patients remained in the study and were randomized into 2 groups; one continued with AC treatment and one changed to anti-platelet therapy. The patients were followed for 12 months. No significant difference was seen between the 2 groups but 3 completed cerebral infarctions occurred during anti-platelet therapy against one during AC treatment. One cerebral hemorrhage was seen during AC treatment. All completed strokes occurred in men who initially had carotid symptoms. The number of patients with TIA/RIND was somewhat higher in the anti-platelet group whereas myocardial infarctions occurred more often during AC treatment. Compared to the natural history of untreated TIA/RIND both treatments were found to have a prophylactic effect against cerebral infarction.", "This trial evaluated the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis.\n Warfarin was more effective than aspirin in preventing stroke in these patients; combined therapy with low anticoagulant intensity was ineffective. Mitral stenosis patients were not investigated.\n We performed a multicenter randomized trial in 1,209 patients at risk. The intermediate-risk group included patients with risk factors or age >60 years: 242 received the cyclooxygenase inhibitor triflusal, 237 received acenocumarol, and 235 received a combination of both. The high-risk group included patients with prior embolism or mitral stenosis: 259 received anticoagulants and 236 received the combined therapy. Median follow-up was 2.76 years. Primary outcome was a composite of vascular death and nonfatal stroke or systemic embolism.\n Primary outcome was lower in the combined therapy than in the anticoagulant arm in both the intermediate- (hazard ratio [HR] 0.33 [95% confidence interval (CI)0.12 to 0.91]; p = 0.02) and the high-risk group (HR 0.51 [95% CI 0.27 to 0.96]; p = 0.03). Primary outcome plus severe bleeding was lower with combined therapy in the intermediate-risk group. Nonvalvular and mitral stenosis patients had similar embolic event rates during anticoagulant therapy.\n The combined antiplatelet plus moderate-intensity anticoagulation therapy significantly decreased the vascular events compared with anticoagulation alone and proved to be safe in atrial fibrillation patients.", "Aspirin is only modestly effective in the secondary prevention after cerebral ischemia. Studies in other vascular disorders suggest that anticoagulant drugs in patients with cerebral ischemia of presumed arterial (noncardiac) origin might be more effective. The aim of the Stroke Prevention in Reversible Ischemia Trial (SPIRIT) therefore was to compare the efficacy and safety of 30 mg aspirin daily and oral anticoagulation (international normalized ratio [INR] 3.0-4.5). Patients referred to a neurologist in one of 58 collaborating centers because of a transient ischemic attack or minor ischemic stroke (Rankin grade < or =3) were eligible. Randomization was concealed, treatment assignment was open, and assessment of outcome events was masked. The primary measure of outcome was the composite event \"death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction, or nonfatal major bleeding complication.\" The trial was stopped at the first interim analysis. A total of 1,316 patients participated; their mean follow-up was 14 months. There was an excess of the primary outcome event in the anticoagulated group (81 of 651) versus 36 of 665 in the aspirin group (hazard ratio, 2.3; 95% confidence interval [CI], 1.6-3.5). This excess could be attributed to 53 major bleeding complications (27 intracranial; 17 fatal) during anticoagulant therapy versus 6 on aspirin (3 intracranial; 1 fatal). The bleeding incidence increased by a factor of 1.43 (95% CI, 0.96-2.13) for each 0.5 unit increase of the achieved INR. Anticoagulant therapy with an INR range of 3.0 to 4.5 in patients after cerebral ischemia of presumed arterial origin is not safe. The efficacy of a lower intensity anticoagulation regimen remains to be determined.", "Too few patients with nonvalvular atrial fibrillation (NVAF) receive appropriate antithrombotic therapy. We tested the short-term (primary outcome) and long-term (secondary outcome) effect of a patient decision aid on the appropriateness of antithrombotic therapy among patients with NVAF.\n We conducted a cluster randomized trial with blinded outcome assessment involving 434 NVAF patients from 102 community-based primary care practices. Patients in the intervention group received a self-administered booklet and audiotape decision aid tailored to their personal stroke risk profile. Patients in the control group received usual care. The primary outcome measure was change in antithrombotic therapy at 3 months. Appropriateness of therapy was defined using the American College of Chest Physicians (ACCP) recommendations.\n The mean patient age was 72 years, and the median duration of NVAF was 5 years. In the control group, there was a 3% decrease over 3 months in the number of patients receiving therapy appropriate to their risk of stroke (40% [85/215] at baseline v. 37% [79/215] at 3 months). In the intervention group, the number of patients receiving therapy appropriate to their stroke risk increased by 9% (32% [69/219] at baseline v. 41% [89/219] at 3 months). Although the proportion of patients whose therapy met the ACCP treatment recommendations did not differ between study arms at baseline (p = 0.11) or 3 months (p = 0.44), there was a 12% absolute improvement in the number of patients receiving appropriate care in the intervention group compared with the control group at 3 months (p = 0.03). The beneficial effect of the decision aid did not persist (p = 0.44 for differences between study arms after 12 months).\n There was short-term improvement in the appropriateness of antithrombotic care among patients with NVAF who were exposed to a decision aid, but the improvement did not persist.", "To evaluate long-term outcome after extracranial internal carotid artery dissection (eICAD) in consideration of the applied antithrombotic therapy.\n Among 33 consecutive eICAD patients initially treated either with anticoagulation (n = 25) or with antiplatelets (n = 8), a standardized interview was performed after 28 +/- 22.1 months to analyze risks and benefits of both agents. Ischemic and hemorrhagic complications, occurrence of seizure and rates of arterial recanalization were compared and long-term clinical outcome was assessed using the modified Rankin Scale (mRS) and Barthel Index (BI).\n Among anticoagulated patients, 1 died due to brain herniation. In 3 patients stroke (n = 2) or TIA (n = 1) recurred. In the antiplatelet group, none died and no subsequent ischemic events happened. Hemorrhagic complications were noted in neither treatment group. Functional outcome among anticoagulated patients was BI 92 +/- 21.6 and mRS 1.48 +/- 1.50, which did not differ from patients initially treated with antiplatelets (BI 89 +/- 18.9, mRS 1.50 +/- 1.41, p > 0.05). Four anticoagulated patients developed seizures, compared to 2 patients with antiplatelets (p > 0.05). Arterial recanalization occurred in 16 of 22 antico- agulated patients with ultrasound follow-up, compared to 6 of 6 patients with antiplatelets (p > 0.05).\n In the absence of iatrogenic side effects, both anticoagulation and antiplatelets seem to be safe for eICAD. The rates for death and stroke were low and outcome ratings did not differ between both agents. These findings may indicate that a controlled randomized trial comparing anticoagulation and antiplatelets is ethically justified.\n Copyright 2000 S. Karger AG, Basel", "Oral anticoagulants are better than aspirin for secondary prevention after myocardial infarction and after cerebral ischaemia in combination with non-rheumatic atrial fibrillation. The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) aimed to determine whether oral anticoagulation with medium intensity is more effective than aspirin in preventing future vascular events in patients with transient ischaemic attack or minor stroke of presumed arterial origin.\n In this international, multicentre trial, patients were randomly assigned within 6 months after a transient ischaemic attack or minor stroke of presumed arterial origin either anticoagulants (target INR range 2.0-3.0; n=536) or aspirin (30-325 mg daily; n=532). The primary outcome was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever occurred first. In a post hoc analysis anticoagulants were compared with the combination of aspirin and dipyridamole (200 mg twice daily). Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with ClinicalTrials.gov (NCT00161070).\n The anticoagulants versus aspirin comparison of ESPRIT was prematurely ended because ESPRIT reported previously that the combination of aspirin and dipyridamole was more effective than aspirin alone. Mean follow-up was 4.6 years (SD 2.2). The mean achieved INR was 2.57 (SD 0.86). A primary outcome event occurred in 99 (19%) patients on anticoagulants and in 98 (18%) patients on aspirin (hazard ratio [HR] 1.02, 95% CI 0.77-1.35). The HR for ischaemic events was 0.73 (0.52-1.01) and for major bleeding complications 2.56 (1.48-4.43). The HR for the primary outcome event comparing anticoagulants with the combination treatment of aspirin and dipyridamole was 1.31 (0.98-1.75).\n Oral anticoagulants (target INR range 2.0-3.0) are not more effective than aspirin for secondary prevention after transient ischaemic attack or minor stroke of arterial origin. A possible protective effect against ischaemic events is offset by increased bleeding complications.", "90 patients with acute stroke and a concomitant cardiac embolism source or a symptomatic high-grade stenosis of an extra-or intracranial vessel received in a mulitcenter, randomized, controlled study either Enoxaparin 1 mg/kg BW s.c. b.i.d. or i.v. heparin aPTT-adjusted daily for 8 +/- 2 days as secondary prophylaxis. There were no significant differences between the two groups regarding cerebral and systemic embolic events, bleeding complications, length of hospital stay, number of diagnostic and therapeutic measures and outcome after three months. This suggests that Enoxaparin, which is easier to administer and monitor, is a safe drug in patients with acute cerebral events.", "Nonrheumatic atrial fibrillation increases the risk of stroke, presumably from atrial thromboemboli. There is uncertainty about the efficacy and risks of long-term warfarin therapy to prevent stroke.\n We conducted an unblinded, randomized, controlled trial of long-term, low-dose warfarin therapy (target prothrombin-time ratio, 1.2 to 1.5) in patients with nonrheumatic atrial fibrillation. The control group was not given warfarin but could choose to take aspirin.\n A total of 420 patients entered the trial (212 in the warfarin group and 208 in the control group) and were followed for an average of 2.2 years. Prothrombin times in the warfarin group were in the target range 83 percent of the time. Only 10 percent of the patients assigned to receive warfarin discontinued the drug permanently. There were 2 strokes in the warfarin group (incidence, 0.41 percent per year) as compared with 13 strokes in the control group (incidence, 2.98 percent per year), for a reduction of 86 percent in the risk of stroke (warfarin:control incidence ratio = 0.14; 95 percent confidence interval, 0.04 to 0.49; P = 0.0022). There were 37 deaths altogether. The death rate was markedly lower in the warfarin group than in the control group: 2.25 percent as compared with 5.97 percent per year, for an incidence ratio of 0.38 (95 percent confidence interval, 0.17 to 0.82; P = 0.005). There was one fatal hemorrhage in each group. The frequency of bleeding events that led to hospitalization or transfusion was essentially the same in both groups. The warfarin group had a higher rate of minor hemorrhage than the control group (38 vs. 21 patients).\n Long-term low-dose warfarin therapy is highly effective in preventing stroke in patients with non-rheumatic atrial fibrillation, and can be quite safe with careful monitoring." ]

[ "11212135", "6487909", "10780138", "8116338", "10450619", "11317951", "11777121", "8481745", "11784832" ]

[ "Neuropsychological counseling improves social behavior in cognitively-impaired multiple sclerosis patients.", "An evaluation of cognitive-behaviour therapy for depression in patients with multiple sclerosis.", "Telephone-administered cognitive-behavioral therapy for the treatment of depressive symptoms in multiple sclerosis.", "Effects of neuropsychological treatment in patients with multiple sclerosis.", "Professional and paraprofessional group treatments for depression: a comparison of cognitive-behavioral and mutual support interventions.", "A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia.", "Comparative outcomes for individual cognitive-behavior therapy, supportive-expressive group psychotherapy, and sertraline for the treatment of depression in multiple sclerosis.", "A trial of two cognitive-behavioural methods of treating drug-resistant residual psychotic symptoms in schizophrenic patients: I. Outcome.", "Evaluation of cognitive assessment and cognitive intervention for people with multiple sclerosis." ]

[ "We studied the effectiveness of a newly-developed cognitive-behavioral intervention in 15 patients with marked cognitive impairment and behavior disorder. The design was a single-blind test of a neuropsychological intervention, with pre- and post-treatment assessments of personality and social behavior. MS patients underwent neurological examination and neuropsychological testing at baseline. The patients were then randomly assigned to neuropsychological counseling or standard, non-specific supportive psychotherapy. The active 12-week treatment emphasized enhancement of insight through education, social skills training, and behavior modification. All patients were re-examined within 2 weeks of the termination of treatment. Neuropsychological technicians were blind to treatment condition. Both groups showed evidence of cognitive impairment and personality/behavior disorder prior to treatment and were well matched on demographic, disability, and cognitive measures. Patients who underwent neuropsychological counseling showed significant positive response on measures of social behavior (e.g. excessive ego-centric speech) compared to those who underwent standard counseling. We conclude that these data support the use of non-pharmacological, neuropsychological counseling in patients with acquired, MS-associated behavior disorder.", "Twenty depressed multiple sclerotic patients were randomly allocated either to cognitive-behaviour therapy or to a waiting list control condition. Assessment of depressive symptoms was conducted at pre-treatment, post-treatment, and a four-week follow-up. In comparison to the waiting list condition, cognitive-behaviour therapy was found to result in clinically and statistically significant improvement on most measures. Although the mechanism by which such treatment achieves its effects is unclear, these results clearly support the use of cognitive-behavioural treatments for depression in this population.", "This study examined the efficacy of an 8-week telephone-administered cognitive-behavioral therapy (CBT) for the treatment of depressive symptomatology in multiple sclerosis (MS) patients. The treatment, Coping with MS (CMS), included a patient workbook designed to structure the treatment, provide visual aids, and help with homework assignments. Thirty-two patients with MS, who scored at least 15 on the Profile of Mood States Depression-Dejection scale, were randomly assigned to either the telephone CMS or to a usual-care control (UCC) condition. Depressive symptomatology decreased significantly in the CMS condition compared with the UCC condition. Furthermore, adherence to interferon beta-1a, a disease-modifying medication for the treatment of MS, was significantly better at the 4-month follow-up among patients who received CMS as compared with those in the UCC condition.", "The chronic and progressive nature of multiple sclerosis (MS) often excludes patients from neuropsychological treatment. At the Multiple Sclerosis Rehabilitation Hospital, Haslev, 40 patients with mild to moderate cognitive and behavioral impairment associated with MS were randomized to either specific cognitive treatment (20 pts) by direct training, compensatory strategies and neuropsychotherapy, or to non-specific, deliberately diffuse mental stimulation (20 pts). Treatment was for a mean of 46 days. The effects of treatment were evaluated by neuropsychological tests before treatment, immediately after treatment (short-term effects) and 6 months later (long-term effects). After short-term treatment, effects on cognitive measures were not convincing, but on the Beck Depression Inventory (BDI) the specific cognitive treatment group reported significantly less depression. After 6 months only this group showed an effect, since the visuo-spatial memory was improved. However, the depression ratings (BDI) were almost maintained from the short-term level. Interestingly, the non-specific treatment group rated themselves as significantly more depressed. Conclusively, it is worth while to offer specific neuropsychological treatment to MS patients with cognitive and behavioral dysfunction.", "The relative efficacy of professional and paraprofessional therapists in providing group cognitive-behavioral therapy (CBT) and mutual support group therapy (MSG) was examined. Depressed outpatients (N = 98) were randomly assigned to CBT or MSG led by either 2 professional or 2 paraprofessional therapists. Results suggest that nonprofessionals were as effective as professionals in reducing depressive symptoms and that clients in the CBT and MSG conditions improved equally. Clinically significant improvement was demonstrated for both conditions. However, following treatment, more patients in the professionally led CBT groups were classified as nondepressed and alleviated than in the paraprofessionally led CBT groups. Additionally, therapist adherence to manual-based treatments was associated with greater improvement in clinician-rated depressive symptoms in both conditions and skills in cognitive restructuring were associated with greater improvement among clients in CBT.", "To investigate short-term effects of Multi-Sensory Stimulation (MSS) on behaviour, mood and cognition of older adults with dementia, the generalization of effects to day hospital and home environments and the endurance of any effects over time.\n A randomized controlled trial comparing MSS with a credible control of one-to-one activities.\n Fifty patients with diagnoses of moderate to severe dementia were randomized to either MSS or Activity groups. Patients participated in eight 30-minute sessions over a 4-week period. Ratings of behaviour and mood were taken before, during and after sessions to investigate immediate effects. Pre, mid, post-trial, and follow-up assessments were taken to investigate any generalization of effects on cognition, behaviour at the day hospital and behaviour and mood at home and endurance of effects once sessions had ceased.\n Immediately after MSS and Activity sessions patients talked more spontaneously, related better to others, did more from their own initiative, were less bored/inactive, and were more happy, active or alert. Both groups were more attentive to their environment than before, with a significantly greater improvement from the MSS group. At the day hospital, patients in the Activity group improved on their 'speech skills' (amount of speech; initiation of speech), whereas the MSS group remained unchanged during the trial. The MSS group showed a significant improvement in mood and behaviour at home compared to the Activity group whose behaviour deteriorated. No longer-term benefits were shown; indeed, behaviour declined sharply during the month follow-up period.\n Both MSS and Activity sessions appear to be effective and appropriate therapies for people with dementia.", "This study compared the efficacy of 3 16-week treatments for depression in 63 patients with multiple sclerosis (MS) and major depressive disorder (MDD): individual cognitive-behavioral therapy (CBT), supportive-expressive group therapy (SEG). and the antidepressant sertraline. Significant reductions were seen from pre- to posttreatment in all measures of depression. Intent-to-treat and completers analyses using the Beck Depression Inventory (BDI; A. T. Beck, C. H. Ward. M. Medelson. J. Mock, & J. Erbaugh, 1961) and MDD diagnosis found that CBT and sertraline were more effective than SEG at reducing depression. These results were largely supported by the BDI-18, which eliminates BDI items confounded with MS. However, the Hamilton Rating Scale for Depression (M. Hamilton, 1960) did not show consistent differences between treatments. Reasons for this inconsistency are discussed. These findings suggest that CBT or sertraline is more likely to be effective in treating MDD in MS compared with supportive group treatments.", "Despite neuroleptic medication, many schizophrenic patients continue to experience residual positive psychotic symptoms. These residual symptoms cause distress and disability. We report a controlled trial of two cognitive-behavioural treatments to alleviate residual hallucinations and delusions. Forty-nine patients were recruited into the trial, of whom 27 entered the trial and completed post-treatment assessment, and 23 were reassessed at six-month follow-up. Patients were randomly allocated to either coping strategy enhancement (CSE) or problem solving (PS). Half the patients were allocated to a high-expectancy positive demand condition and half to a counter-demand condition to evaluate expectation of improvement. Patients receiving either cognitive-behavioural treatment showed significant reductions in psychotic symptoms compared with those in the waiting period, who showed no improvement. There was some evidence, although equivocal, that patients receiving CSE improved more than those receiving PS. There was no evidence that improvements generalised to negative symptoms or social functioning, nor was there evidence that expectancy of treatment benefit contributed to the treatment effect.", "Cognitive problems in multiple sclerosis are common but any possible benefits of treatment remain uncertain. The aim of the study was to evaluate the benefits of providing a psychology service, including cognitive assessment and intervention, to patients with multiple sclerosis.\n The study was a single blind randomised controlled trial. A total of 240 patients with clinically definite, laboratory supported, or clinically probable multiple sclerosis were recruited from an multiple sclerosis management clinic and assessed on a brief screening battery. They were randomised into three groups. The control group received no further intervention. The assessment group received a detailed cognitive assessment, the result of which was fed back to staff involved in the patients' care. The treatment group received the same detailed cognitive assessment and a treatment programme designed to help reduce the impact of their cognitive problems. Patients were followed up 4 and 8 months later on the general health questionnaire (GHQ-28), extended activities of daily living scale, SF-36, everyday memory questionnaire, dysexecutive syndrome questionnaire, and memory aids questionnaire.\n The three groups were compared on the outcome measures at 4 and 8 months after recruitment. There were few significant differences between the groups and those that occurred favoured the control group. Overall, the results showed no effect of the interventions on mood, quality of life, subjective cognitive impairment or independence.\n The study failed to detect any significant effects of cognitive assessment or cognitive intervention in this cohort of people with multiple sclerosis." ]

[ "11554954", "16492236", "9825271", "15482357", "16618262", "8427430", "15579612", "11014413", "17563841" ]

[ "Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial.", "Rofecoxib in the acute treatment of migraine: a randomized controlled clinical trial.", "Effectiveness of ibuprofen-arginine in the treatment of acute migraine attacks.", "Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks.", "Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine: results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study.", "The efficacy of metoclopramide in the treatment of migraine headache.", "Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial.", "Ibuprofen plus caffeine in the treatment of tension-type headache.", "Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial." ]

[ "To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migraine headache.\n Migraine headache is a common illness with significant social and economic impact.\n Randomized, placebo-controlled, double-blind trial of 6 hours' treatment duration.\n Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults aged 18 to 84 years with migraine headache of moderate to severe intensity. Each patient was randomly assigned to a single dose of study medication: ibuprofen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The percentage of patients with a reduction in baseline headache intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none.\n Significantly (P < or = .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours (41.7% and 40.8%, respectively), compared with those treated with placebo (28.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < or = .001) greater for patients treated with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differences in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with severe baseline pain intensity, ibuprofen, 400 mg, was significantly (P < or = .048) superior to placebo for the primary efficacy end points, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were statistically significantly more effective than placebo for all clinically important secondary pain relief outcomes. Mean severity changes of migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < or = .03) in favor of both doses of ibuprofen over placebo, and results for the percentage of patients with symptoms reduced to none consistently, although less often statistically significant, favored ibuprofen. No statistically significant differences in adverse events were found among treatment groups.\n Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cost-effective, well-tolerated, single-ingredient nonprescription treatment for pain of migraine headache. In addition, while not always statistically significant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability.", "To investigate the efficacy, tolerability, and safety of rofecoxib and ibuprofen for acute migraine treatment.\n Rofecoxib was effective and well tolerated in a previous study of treatment of a single migraine attack. We sought to replicate these findings for a single attack and also study the clinical profile of rofecoxib in the acute treatment of multiple migraine attacks. Ibuprofen was included as a reference nonselective NSAID.\n Adult migraineurs (n = 783) treated one migraine attack with either rofecoxib (25 or 50 mg), ibuprofen 400 mg, or placebo in a randomized, double-blind study. Patients could elect to enroll in a 3-month double-blind extension phase.\n In the single-attack phase, headache relief at 2 hours postdose was reported by 59.4%, 62.2%, and 57.7% of patients who took rofecoxib 25 mg, rofecoxib 50 mg, and ibuprofen 400 mg, respectively, versus 30.5% for placebo (all P < .001 vs placebo). The active drugs were statistically superior to placebo on a variety of additional measures. In the extension phase, the mean percentage of patients' attacks with headache relief at 2 hours postdose was 61.8% for rofecoxib 25 mg, 65.4% for rofecoxib 50 mg, and 59.3% for ibuprofen 400 mg. The mean percentage of patients' attacks with 24-hour sustained headache relief was greater for rofecoxib 50 mg (52.0%) than for rofecoxib 25 mg (47.8%, P < .050) or ibuprofen (39.0%, P < .010). In the single-attack phase, the adverse event rate was higher for rofecoxib 50 mg (37.8%) than placebo (27.8%, P < .050); rates were similar to placebo for rofecoxib 25 mg (32.0%, n.s.) and ibuprofen 400 mg (28.1%, n.s.). In the extension phase, treatment groups had similar adverse event rates.\n Rofecoxib 25 and 50 mg and ibuprofen 400 mg were effective and generally well tolerated in the acute treatment of migraine.", "The purpose of this study was to evaluate the effectiveness of a new formulation of ibuprofen (ibuprofen-arginine [IA]) in the treatment of migraine attacks. This is a faster absorbed formulation as compared with ibuprofen alone. The rapidity of action is considered to be a crucial factor in the treatment of migraine attacks. Forty migraine patients participated in this multicenter, double-blind, crossover, randomized, placebo-controlled trial. Each patient was treated with a single oral dose of IA 400 mg or placebo during two consecutive migraine attacks. The results confirm the efficacy of IA, with a significant (p < 0.05) improvement in pain relief at 30 min after treatment. A statistically significant (p < 0.001) reduction in pain intensity was observed at 1, 2, 4 and 6 h after treatment with ibuprofen as compared with placebo. IA was well tolerated and our data indicate that this new formulation of ibuprofen is valuable in the treatment of acute migraine attacks.", "Acetylsalicylic acid (ASA) in combination with metoclopramide has been frequently used in clinical trials in the acute treatment of migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a triptan and a nonsteroidal anti-inflammatory drug (ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany, Italy and Spain. Effervescent ASA (1000 mg) was compared to encapsulated sumatriptan (50 mg), ibuprofen (400 mg) and placebo. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (primary endpoint) was 52.5% for ASA, 60.2% for ibuprofen, 55.8% for sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA, ibuprofen, sumatriptan or placebo, respectively. The difference between ASA and sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and ibuprofen or sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA, ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg sumatriptan and 400 mg ibuprofen in the treatment of migraine attacks regarding headache relief from moderate/severe to mild/no pain at 2 h. Regarding pain-free at 2 h sumatriptan was most effective.", "Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine.\n Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief.\n There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036).\n AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.", "By evaluating the efficacy of metoclopramide alone and in combination with ibuprofen versus placebos, this study was designed to both evaluate the efficacy of metoclopramide and elucidate its mechanism of action in the treatment of migraine headache.\n The study was conducted over a two-year period and was a randomized, double-blind, placebo-controlled study.\n An urban teaching hospital.\n Patients enrolled were at least 18 years old and had recurring headaches with one or more of the following characteristics: unilateral, preceded by neurologic symptoms, significant nausea and vomiting, or mood changes and photophobia.\n Ten milligrams of metoclopramide or an equal volume of IV normal saline was given and 600 mg of ibuprofen or identical-appearing placebo was given orally at time 0. Patients rated their pain and nausea at time 0, 30 minutes, and 60 minutes using visual-analog scales.\n The differences in pain and nausea scores for the metoclopramide + placebos group versus the other three groups were tested using exact nonparametric (Mann-Whitney) statistical procedures. The metoclopramide + placebos group had significantly better relief of pain compared with the placebos + ibuprofen and placebos + placebos groups. The metoclopramide + placebos group had significantly better relief of nausea than the ibuprofen + placebos group; nausea scores for the placebos + placebos group could not be analyzed due to excessive variance from the other groups at baseline. The differences between the metoclopramide + placebos group and the metoclopramide + ibuprofen group were not statistically significant with regard to either pain or nausea.\n Metoclopramide is efficacious in the treatment of both the pain and nausea of migraine headache. This is a direct action that is not dependent on the concomitant administration of another agent.", "Rofecoxib is a potent cyclo-oxygenase-2 inhibitor with a long duration of action. Its role in migraine has not been systematically evaluated.\n To study the efficacy of rofecoxib in migraine.\n In a randomised placebo controlled trial rofecoxib 25 mg, ibuprofen 400 mg, and placebo were compared regarding their efficacy in relieving acute migraine attack. Migraine patients with 2-6 attacks per month were recruited. Headache severity, functional disability, and severity of associated symptoms were graded on a 0-3 scale. The primary endpoint was pain relief at two hours. Relief of associated symptoms and sustained pain relief for 24 hours were also noted.\n One hundred and twenty four patients were randomised into rofecoxib (42), ibuprofen (40), and placebo (42) groups. One hundred and one patients were followed up: 33 on rofecoxib, 35 ibuprofen, and 33 placebo. Patients' ages ranged from 16-62 (mean 31.4) years, and 83 were females. Pain relief at two hours was noted in 45.5% on rofecoxib, 55.6% on ibuprofen, and 9.1% in the placebo group. The associated symptoms at two hours were reduced in 39.4% on rofecoxib, 50% on ibuprofen, and 9.1% in the placebo group. Sustained 24 hour pain relief was noted in 36.4% on rofecoxib, 41% on ibuprofen, and 6.1% in the placebo group. In the ibuprofen group, five patients had abdominal pain but there were no side effects in those on rofecoxib or in the control group. Both rofecoxib and ibuprofen were significantly effective in relieving pain, associated symptoms at two hours, and in sustained pain relief. There was no significant difference between rofecoxib and ibuprofen in aborting acute migraine attacks.\n Both ibuprofen and rofecoxib were superior to placebo in aborting an acute migraine attack, and there was no significant difference in their efficacy in an acute migraine attack.", "The effectiveness of caffeine as an adjuvant to ibuprofen has been documented in investigations of acute pain. Our objectives were to assess this agent in the treatment of tension-type headache and to establish clinical trial methods capable of assessing this agent in comparison with various tension headache treatments. Stopwatch technology was used for measurement techniques.\n A randomized, double-blind, parallel, multicenter, single-dose, placebo- and active-controlled study included 301 subjects diagnosed with tension-type headache. Treatment groups included ibuprofen and caffeine, ibuprofen alone, caffeine alone, or placebo. Subjects measured onset of relief (both time to first perceptible relief and time to meaningful relief) after taking a single oral dose of their assigned medication. Pain intensity and pain relief were rated over a 6-hour study period. Overall evaluation was made on completion of all other ratings.\n Ibuprofen and caffeine administered together provided significantly greater analgesic activity than ibuprofen alone, caffeine alone, and placebo. Ibuprofen and caffeine administered together demonstrated significantly shorter times to meaningful improvement in headache relief than ibuprofen or placebo; significantly greater total analgesia than ibuprofen alone, caffeine alone, or placebo; and significantly greater peak relief than ibuprofen alone, caffeine alone, or placebo. Significantly more subjects obtained meaningful headache relief with ibuprofen and caffeine administered together than with ibuprofen alone or placebo. More patients reported complete headache relief with ibuprofen and caffeine administered together than with ibuprofen alone, caffeine alone, or placebo. Ibuprofen and caffeine administered together was rated significantly better by patients than either ibuprofen alone, caffeine alone, or placebo. No subjects ended participation in the study early because of adverse events.\n Sensitive methods have been introduced to assess differences in analgesia among over-the-counter analgesic agents in relieving tension-type headache pain. A double-blind study with this method suggests that ibuprofen and caffeine administered together provides greater analgesic effectiveness than either component alone.", "The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with <8 attacks/months were included. One hundred and fifty-five migraine patients were randomised to rizatriptan 10 mg (53), ibuprofen 400 mg (52) and placebo (50). Efficacy was assessed by headache relief, and headache freedom at 2 h and 24 h. Two-hour headache relief, was noted in 73% in rizatriptan, 53.8% in ibuprofen and 8% in placebo groups. Headache freedom was achieved in 37.7% in rizatriptan, 30.8% in ibuprofen and 2% in placebo groups. Rizatriptan was superior to ibuprofen and placebo in relieving headache at 2 h but not at 24 h. Side effects were noted in 9 patients in rizatriptan, 8 in ibuprofen and 3 in placebo, all of which were nonsignificant. Rizatriptan and ibuprofen are superior to placebo. Rizatriptan is superior to ibuprofen in relieving headache, associated symptoms and functional disability." ]

[ "12213353", "9545126", "3520389", "12873289", "6343041", "7555472", "15523183", "18466210", "9083709" ]

[ "Insulin lispro therapy in pregnancies complicated by type 1 diabetes mellitus.", "Human insulin analogue [LYS(B28), PRO(B29)]: the ideal pump insulin?", "[Comparison of intensified traditional insulin therapy and micropump therapy in pregnant women with type 1 diabetes mellitus].", "Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with Type 1 diabetes.", "Evaluation of efficacy and safety of human insulin (Novo) in the treatment of insulin-dependent diabetes mellitus: a double-blind, multicenter clinical trial.", "Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients.", "Special management of insulin lispro in continuous subcutaneous insulin infusion in young diabetic children: a randomized cross-over study.", "Effects of insulin pump vs. injection treatment on quality of life and impact of disease in children with type 1 diabetes mellitus in a randomized, prospective comparison.", "Improved mealtime treatment of diabetes mellitus using an insulin analogue. Multicenter Insulin Lispro Study Group." ]

[ "To compare the efficacy and safety of preprandial administration of rapid-acting lispro analogue with regular short-acting insulin to pregnant women with type 1 diabetes.\n Open randomised multicentre study. Women were treated with multiple insulin injections aiming at normoglycaemia. Blood glucose was determined six times daily, HbA(1c) every 4 weeks. Diurnal profiles of blood glucose were analysed at gestational week 14 and during the study period at weeks 21, 28 and 34.\n 33 pregnant women with type 1 DM were randomised to treatment with lispro insulin (n=16) or regular insulin (n=17).\n Blood glucose was significantly lower (P<0.01) after breakfast in the lispro group, while there were no significant group differences in glycemic control during the rest of the day. Severe hypoglycaemia occurred in two patients in the regular group but biochemical hypoglycaemia (blood glucose <3.0 mmol/l) was more frequent in the lispro than in the regular group (5.5 vs. 3.9%, respectively). HbA(1c) values at inclusion were 6.5 and 6.6% in the lispro and regular group respectively. HbA(1c) values declined during the study period and were similar in both groups. There was no perinatal mortality. Complications during pregnancy, route of delivery and foetal outcome did not differ between the groups. Retinopathy progressed in both groups, one patient in the regular group developed proliferative retinopathy.\n The results suggest that it is possible to achieve at least as adequate glycemic control with lispro as with regular insulin therapy in type 1 diabetic pregnancies.", "The short-acting insulin analogue lispro ([LYS(B28), PRO(B29)] is absorbed from the subcutis more rapidly than soluble insulin (S). To compare the clinical effectiveness of lispro vs S, 11 Type 1 patients using continuous subcutaneous insulin infusion (CSII) therapy (6 F, 5 M, age 30 +/- 2.5 years, diabetes duration 14 +/- 1.0 years, BMI 24.0 +/- 0.8 kg m(-2), HbA1c 6.5 +/- 0.2%) were studied in an open, randomized, crossover study for 6 months (3 months lispro and 3 months S or vice versa). During lispro treatment mean fasting and 2 h postprandial blood glucose were lower compared to the S phase (fasting 6.5 +/- 0.4 vs 7.5 +/- 0.4 mmol l(-1) (NS), postprandial 6.8 +/- 0.3 vs 8.3 +/- 0.3 mmol l(-1), p = 0.03). In patients treated first with lispro HbA1c levels improved from 6.3 +/- 0.2% to 5.7 +/- 0.3%; On reversion to S HbA1c increased to 6.2 +/- 0.2%. In the group treated first with S, HbA1c fell (6.7 +/- 0.4% vs 6.5 +/- 0.3%) and then improved further to 6.3 +/- 0.3% with lispro. None of these changes were significant. There was no significant difference with respect to hypoglycaemic or other adverse events. It can be concluded that lispro in CSII therapy is safe and may improve postprandial glucose excursions.", "Ten pregnant women, affected by type I diabetes mellitus, observed for the first time during the II-III month of pregnancy, were examined. These patients were divided in two groups at random: group A underwent continuous subcutaneous insulin infusion with micropump CPI 9100 Lilly; group B underwent intensified insulin therapy with three daily doses of MC rapid insulin, two of which associated with MC intermediate insulin. All the patients were able to monitor their own blood glucose levels at home by means of reactive strips and reflectometer. In both the groups the mean glycemic values during fast and two hours after meals, and the eventual presence of urinary keton bodies and hypoglycemic crisis were evaluated during the course of pregnancy: these parameters turned out to be identical in the two groups. The increased need of insulin, the maternal body weight gain, the week and mode of delivery, the neonatal weight and the maternal and fetal complications also turned out to be identical in the two groups. To conclude, a good maternal metabolic control can be obtained either with the intensified conventional insulin therapy of with micropumps, if the patients, being properly instructed, are responsible for the monitoring of their own blood glucose levels at home.", "To compare quality of life (QoL) and treatment satisfaction in patients with Type 1 diabetes receiving the rapid-acting insulin analogue, insulin aspart (IAsp), with that in patients receiving soluble human insulin (HI).\n In this 6-month, multinational, randomized, open-label trial, 424 patients from German-speaking countries were subjected to psychometric assessment before and after randomization (ratio 2 : 1) to basal-bolus treatment with either IAsp (n = 283) or HI (n = 141). Patients on HI were advised to keep an injection-meal interval of 30 min, whereas patients on IAsp were advised to inject immediately before meals. Treatment satisfaction and diabetes-related QoL were assessed using validated instruments to measure the domains of patients' individual treatment goals, physical complaints, worries about the future, social relations, leisure time flexibility, daily hassles, diet restrictions, burdens and fear of hypoglycaemia, blood glucose fluctuations, self-efficacy, and fear of insulin analogues.\n After 6 months, IAsp was associated with significantly greater improvement in treatment satisfaction than HI in two different scales (P < 0.01), and in QoL with respect to diet restrictions (P < 0.01). Improved satisfaction was mainly due to increased dietary and leisure time flexibility (P < 0.0001). Twenty-three percent of the IAsp group vs. 14% of the HI group achieved small but important improvements of total QoL (between-group difference, P < 0.06). The number needed to treat (NNT) with IAsp for an important increase in QoL was calculated to be 10. Regression analyses of potential predictors of improvement in QoL highlighted patients intensely striving for physical strength (P < 0.01; NNT = 7) and patients feeling less protected against hypoglycaemia (P < 0.005; NNT = 8) as being the most likely to benefit from IAsp.\n Under these study conditions, IAsp improved treatment satisfaction and quality of life regarding diet restrictions when compared with human insulin. The 'numbers needed to treat' for important quality of life benefits indicate that the effect of IAsp in this regard is not trivial.", "The safety and efficacy of human insulin (Novo) were evaluated in a double-blind, parallel, multicenter trial in which 47 insulin-dependent diabetic patients were randomly divided into two equal groups and treated with either purified pork or human insulin (Actrapid and Monotard, Novo) for 12 wk. Mean levels of fasting plasma glucose, glycohemoglobin, and daily insulin dosages showed no statistical differences between the two groups, and there was no significant difference in the incidence of hypoglycemic reactions. The results from this clinical trial indicate that human insulin, prepared by enzymatic transpeptidation of pork insulin, appears to be as safe and efficacious as purified pork insulin in the treatment of insulin-dependent diabetes mellitus.", "Optimal insulin regimens for non-insulin-dependent diabetes mellitus (NIDDM) patients with secondary failure are controversial. We evaluated the efficacy, side effects, and quality of life of patients receiving insulin either alone or in combination with their previous oral hypoglycemic agents (OHAs).\n Fifty-three Chinese patients with NIDDM (mean age 53.9 +/- 12.6 years, duration of diabetes 9.0 +/- 4.9 years, body wt 60.4 +/- 13.3 kg with corresponding body mass index 24.2 +/- 4.3 kg/m2, receiving the maximum dose of sulfonylurea and/or metformin) were confirmed to have OHA failure. Twenty-seven patients were randomized to continue OHAs and were given additional bedtime insulin (combination group); 26 patients were randomized to insulin therapy alone with twice-daily insulin (insulin group). Insulin doses were increased incrementally, aiming at fasting plasma glucose (FPG) < 7.8 mmol/l during a stabilization period of up to 8 weeks. Insulin dosage, body weight, glycemic control, and quality of life were assessed before and at 3 and 6 months after stabilization.\n Both groups showed similar improvement of glycemic control. For the combination group, FPG decreased from 13.5 +/- 2.7 to 8.9 +/- 3.0 mmol/l at 3 months (P < 0.0001) and to 8.6 +/- 2.5 mmol/l at 6 months (P < 0.0001). For the insulin group, FPG decreased from 13.5 +/- 3.6 to 7.5 +/-3.0 mmol/l at 3 months (P < 0.0001) and to 9.8 +/- 3.5 mmol/l at 6 months (P < 0.0001). No significant differences were observed between the groups. Similarly, both groups had significant improvement of fructosamine and glycosylated hemoglobin (HbA1c). Fructosamine fell from a mean of 458 to 365 mumol/l at 3 months (P < 0.0001) and to 371 mumol/l at 6 months (P < 0.0001) and from 484 to 325 mumol/l at 3 months (P < 0.0001) and to 350 mumol/l at 6 months (P < 0.0001) for the combination and insulin groups, respectively. HbA1c decreased from 10.2 to 8.4% at 3 months (P < 0.0001) and to 8.7% at 6 months (P < 0.0001) in the combination group and from 10.7 to 7.8% at 3 months (P < 0.0001) and to 8.4% at 6 months (P < 0.0001) in the insulin group. Despite similar improvement of glycemia, insulin requirements were very different. At 3 months, the combination group was receiving a mean of 14.4 U/day compared with 57.5 U/day in the insulin group (P < 0.0001). Similar findings were observed at 6 months (15.0 vs 57.2 U/day, P < 0>0001). Both groups gained weight. However, for the combination group, weight gain was 1.6 +/- 1.8 kg at 3 months and 2.1 +/- 2.5% kg at 6 months (both P < 0.0001 vs baseline), whereas for the insulin group, weight gain was 3.5 +/- 4.3 and 5.2 +/- 4.1 kg, respectively (both P < 0.0001 vs baseline). Weight gain was significantly greater in the insulin group (P < 0.05 at 3 months, and P < 0.005 at 6 months). Fasting plasma triglyceride decreased in the insulin group (1.8 +/- 1.0 to 1.4 +/- 0.8 mmol/l at 3 months [P < 0.005] and to 1.4 +/ 0.7 mmol/l at 6 months [P < 0.02] but not in the combination group. No changes were observed in total and high-density lipoprotein cholesterol. No severe hypoglycemic reactions were recorded in either group. Mild reactions occurred with similar frequency in both groups. Well-being and quality of life improved significantly in both groups. The majority of patients (82.7%) wanted to continue insulin beyond 6 months, irrespective of the treatment group.\n In NIDDM patients with secondary OHA failure, therapy with a combination of OHAs and insulin and with insulin alone was equally effective and well tolerated. However, combination therapy was associated with a lower insulin dose and less weight gain. Combination treatment may be considered when OHA failure occurs as a potential intermediate stage before full insulin replacement.", "To compare the safety, efficacy and management of insulin lispro (LP) with regular human insulin (RH) in young diabetic children treated with continuous subcutaneous insulin infusion (CSII).\n 27 very young diabetic children (age 4.6 +/- 2.2 years) treated with CSII participated in an open-label, randomized cross-over multicenter study comparing 2 periods of 16 weeks of CSII with LP or RH.\n Mean daily basal rate was significantly higher during the LP period (p = 0.04). No differences were seen in changes in HbA1c levels, number of hypoglycemic events, cutaneous infections and catheter occlusions. There was no significant difference between the two treatments for preprandial and postprandial glucose values, although prandial glucose excursions tended to be lower with LP (significant at dinner, p = 0.01). Mean blood glucose levels were significantly higher at 0.00 and 3.00 a.m. during LP therapy (p < 0.05). No episode of ketoacidosis occurred during LP treatment. More parents indicated that LP made their own and the child's daily life easier (p = 0.02) and preferred LP (p = 0.01).\n LP in CSII therapy in children is safe, as effective as RH, improved postprandial excursions, met the needs of young children in their daily life well, and gained their parents' satisfaction and preference. However, a shorter duration of LP resulted in hyperglycemia during the first part of the night, which must be compensated for by increasing nocturnal basal rates during this time.", "Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control.\n An open, parallel, randomized controlled prospective comparative study lasting 14 months was completed by 38 type 1 children with diabetes (age 4-16 yr) following a 3.5-months run-in phase. Standardized quality-of-life Pediatric Quality of life Inventory (PedsQL) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters. Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality.\n Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment. Treatment group comparisons did not show significant improvement. Pump treatment resulted in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22% after run in.\n Within-patient comparison suggests that metabolic control, frequency of severe hypoglycaemia (a threefold decrease), quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections.", "The absorption of regular human insulin from subcutaneous injection sites is delayed due to the self-association of insulin to multimeric forms. The insulin analogue insulin lispro has a weak self-association and a fast absorption rate. We examined the safety and efficacy of insulin lispro in the premeal treatment of patients with diabetes mellitus. A 12-month study was performed in 336 patients with insulin-dependent diabetes mellitus (IDDM) and 295 patients with non-insulin-dependent diabetes mellitus (NIDDM). The patients were randomized to inject either regular human insulin 30 to 45 minutes before eating, or insulin lispro immediately before each meal, in addition to basal insulin. The postprandial rise in serum glucose was lower in patients receiving insulin lispro than in those receiving regular human insulin therapy. At end point the increment was significantly lower at 1 hour (35%) and at 2 hours (64%) after the meal in IDDM patients; in NIDDM patients, the increment was nonsignificantly lower at 1 hour (19%) and significantly lower at 2 hours (48%). IDDM patients receiving insulin lispro achieved significantly lower glycated hemoglobin (HbA1c) levels in patients receiving regular human insulin (8.1% vs 8.3%). In NIDDM patients, HbA1c levels decreased equally in both treatment groups. Due to its fast absorption rate, insulin lispro improves postprandial control in diabetes. Insulin lispro can be considered one step toward optimal insulin therapy and improved patient convenience." ]

[ "15671460", "16322168", "434277", "9917436", "1861939", "15582060", "7847110", "9002332", "18686554" ]

[ "The State Children's Health Insurance Program: a multicenter trial of outreach through the emergency department.", "A randomized, controlled trial of the effectiveness of community-based case management in insuring uninsured Latino children.", "The effect of outreach workers' educational efforts on disadvantaged preschool children's use of preventive services.", "A randomized study of tracking with outreach and provider prompting to improve immunization coverage and primary care.", "Increasing patient knowledge, satisfaction, and involvement: randomized trial of a communication intervention.", "Monetary incentives in primary health care and effects on use and coverage of preventive health care interventions in rural Honduras: cluster randomised trial.", "Improving the immunization coverage of children less than 7 years old in a family practice residency.", "Maximizing immunization coverage through home visits: a controlled trial in an urban area of Ghana.", "Training in complementary feeding counselling of healthcare workers and its influence on maternal behaviours and child growth: a cluster-randomized controlled trial in Lahore, Pakistan." ]

[ "We evaluated emergency department (ED)-based outreach for the State Children's Health Insurance Program (SCHIP).\n We conducted a multicenter trial among uninsured children (< or = 18 years) who presented to 5 EDs in 2001 and 2002. On-site staff enrolled consecutive subjects for a control period followed by an intervention period during which staff handed out SCHIP applications to the uninsured. The primary outcome was state-level confirmation of insured status at 90 days.\n We followed 223 subjects (108 control, 115 intervention) by both phone interview and state records. Compared to control subjects, those receiving a SCHIP application were more likely to have state health insurance at 90 days (42% vs 28%; P<.05; odds ratio [OR]=3.8; 95% confidence interval [CI]=1.7, 8.6). Although the intervention effect was prominent among 118 African Americans (50% insured after intervention vs 31% of controls, P<.05), lack of family enrollment in other public assistance programs was the primary predictor of intervention success (OR=3.7; 95% CI=1.6, 8.4).\n Handing out insurance applications in the ED can be an effective SCHIP enrollment strategy, particularly among minority children without connections to the social welfare system. Adopted nationwide, this simple strategy could initiate insurance coverage for more than a quarter million additional children each year.", "Lack of health insurance adversely affects children's health. Eight million US children are uninsured, with Latinos being the racial/ethnic group at greatest risk for being uninsured. A randomized, controlled trial comparing the effectiveness of various public insurance strategies for insuring uninsured children has never been conducted.\n To evaluate whether case managers are more effective than traditional methods in insuring uninsured Latino children.\n Randomized, controlled trial conducted from May 2002 to August 2004.\n A total of 275 uninsured Latino children and their parents were recruited from urban community sites in Boston.\n Uninsured children were assigned randomly to an intervention group with trained case managers or a control group that received traditional Medicaid and State Children's Health Insurance Program (SCHIP) outreach and enrollment. Case managers provided information on program eligibility, helped families complete insurance applications, acted as a family liaison with Medicaid/SCHIP, and assisted in maintaining coverage.\n Obtaining health insurance, coverage continuity, the time to obtain coverage, and parental satisfaction with the process of obtaining insurance for children were assessed. Subjects were contacted monthly for 1 year to monitor outcomes by a researcher blinded with respect to group assignment.\n One hundred thirty-nine subjects were assigned randomly to the intervention group and 136 to the control group. Intervention group children were significantly more likely to obtain health insurance (96% vs 57%) and had approximately 8 times the adjusted odds (odds ratio: 7.78; 95% confidence interval: 5.20-11.64) of obtaining insurance. Seventy-eight percent of intervention group children were insured continuously, compared with 30% of control group children. Intervention group children obtained insurance significantly faster (mean: 87.5 vs 134.8 days), and their parents were significantly more satisfied with the process of obtaining insurance.\n Community-based case managers are more effective than traditional Medicaid/SCHIP outreach and enrollment in insuring uninsured Latino children. Case management may be a useful mechanism to reduce the number of uninsured children, especially among high-risk populations.", "A special program of outreach services was implemented to assist a poverty population to appropriately use health services in the Kaiser-Permanente Medical Care Program. A study was conducted to determine the effect of outreach workers' intervention on the use of preventive services by this population. Intially, families were divided into two groups, one with and one without outreach workers. Outreach workers (neighborhood health coordinators) were trained in prevention and health education. They were then assigned to specific subgroups of the poverty population to teach the importance of preventive services and to motivate persons to use these services. This paper focuses on the effect of outreach workers' services on the use of selected preventive care services (immunizations and tine test) by preschool children from poverty families. Preschool children in families with coordinator services had higher use rates for preventive care. The sub-group for which outreach workers were specially trained to focus on preventive procedures for the pre-school group had markedly higher use rates for preventive care. The findings suggest that special intervention programs, using indigenous and nonprofessional outreach workers, can increase preventive service utilization by poverty groups.", "To compare and measure the effects and cost-effectiveness of two interventions designed to raise immunization rates.\n Nine primary care sites serving impoverished and middle-class children.\n Complete birth cohorts (ages 0 to 12 months; n = 3015) from these sites.\n Two 18-month duration interventions: 1) tracking with outreach [tracking/outreach] to bring underimmunized children to their primary care provider office, and 2) a primary care provider office policy change to identify and reduce missed immunization opportunities (prompting).\n Randomized, controlled trial, randomizing within sites using a two-by-two factorial design. Subjects were allocated to one of four study groups: control, prompting only, tracking/outreach only, and combined prompting with tracking/outreach. Outcomes were obtained by blinded chart abstraction.\n Immunization status for age; number of days of delay in immunization; primary care utilization; and rates of screening for occult disease.\n Out of 3015 subjects, 274 subjects (9%) transferred out of the participating sites or had incomplete charts and were excluded. The 2741 (91%) remaining subjects were assessed. At baseline, study groups did not differ in age, gender, insurance type, or immunization status. Of the remaining subjects, 63% received Medicaid. Final series-complete immunization coverage levels were: control, 74%; prompting-only, 76%; tracking/outreach-only 95%; and combined tracking/outreach with prompting, 95%. Analysis of variance showed that: 1) tracking/outreach increased immunization rates 20 percentage points; 2) tracking/outreach decreased mean immunization delay 63 days; 3) tracking/outreach increased mean health supervision visits 0.44 visits per child; 4) tracking/outreach increased mean anemia screening 0.17 screenings per child and mean lead screenings 0.12 screenings per child; 5) impact of tracking/outreach was greatest for uninsured and impoverished patients; and 6) the prompting intervention had no impact on the studied outcomes, and its failure was caused by inconsistent use of prompts and failure to vaccinate ill children when prompted. Using tracking/outreach, the cost per additional child fully immunized was $474. Each $1000 spent on the tracking/outreach intervention resulted in: 2.1 additional fully vaccinated children and 668 fewer child-days of delayed immunization; 4.6 additional health supervision visits and 5.9 additional other visits to the primary care provider; and 1.8 additional anemia screenings and 1.3 additional lead screenings.\n Outreach directed toward children not up-to-date on immunizations improves not only immunization status, but also health supervision visit attendance and screening rates. The cost per additional child immunized was high, but should be interpreted in view of the spillover benefits that accompanied improved immunization. Effective means to improve coverage by reducing missed immunization opportunities still need to be identified.", "A brief educational intervention to promote effective communication between physicians, children, and parents during pediatric office visits was designed and tested. A randomized clinical trial involving 141 children (5- to 15-year-olds) tested the effectiveness of the intervention to improve the process and outcome of medical care. The intervention was contained in three brief videotapes (one each for parents, physicians, and patients) and in accompanying written materials. Materials were designed to build skills and motivation for increased child competence and participation during pediatric medical visits. Control subjects saw health education videotapes and received materials comparable in length with those of experimental subjects. Postintervention medical visit process was analyzed using videotapes of visits. Visit outcomes, assessed with standardized instruments and interviews, included children's rapport with physicians, children's anxiety, children's preference for an active health role, children's recall of information, parents' satisfaction with the medical visit, and physician satisfaction. Results indicated that physicians in the intervention group, compared with their counterparts in the control group, more often included children in discussions of medical recommendations (50% vs 29%, t = 2.39, P less than .05); that children in the intervention group, compared with control children, recalled more medication recommendations (77% vs 47%, P less than .01) and reported greater satisfaction and preference for an active health role; and that the intervention and control groups did not differ in parent satisfaction, physician satisfaction, or child anxiety. The results suggest that a brief educational intervention administered during waiting room time can positively impact physician-child rapport and children's preference for an active role in health and their acquisition of medical information.", "Scaling-up of effective preventive interventions in child and maternal health is constrained in many developing countries by lack of demand. In Latin America, some governments have been trying to increase demand for health interventions by making direct payments to poor households contingent on them keeping up-to-date with preventive health services. We undertook a public health programme effectiveness trial in Honduras to assess this approach, contrasting it with a direct transfer of resources to local health teams.\n 70 municipalities were selected because they had the country's highest prevalence of malnutrition. They were allocated at random to four groups: money to households; resources to local health teams combined with a community-based nutrition intervention; both packages; and neither. Evaluation surveys of about 5600 households were undertaken at baseline and roughly 2 years later. Pregnant women and mothers of children younger than 3 years old were asked about use of health services (primary outcome) and coverage of interventions such as immunisation and growth monitoring (secondary outcome). Reports were supplemented with data from children's health cards and government service utilisation data. Analysis was by mixed effects regression, accounting for the municipality-level randomisation.\n The household-level intervention had a large impact (15-20 percentage points; p<0.01) on the reported coverage of antenatal care and well-child check-ups. Childhood immunisation series could thus be started more opportunely, and the coverage of growth monitoring was markedly increased (15-21 percentage points; p<0.01. Measles and tetanus toxoid immunisation were not affected. The transfer of resources to local health teams could not be implemented properly because of legal complications.\n Conditional payments to households increase the use and coverage of preventive health care interventions.", "This prospective cohort study was designed to evaluate the effectiveness of mail and telephone contact with parents as a means to improve the immunization coverage of children less than 7 years old in a family practice residency clinic.\n Immunization records for 519 children enrolled in an outpatient clinic were reviewed and updated. Children whose immunizations were current (55) were excluded, which left 464 children whose immunizations were more than 1 month behind for their age groups. A random sample of one-half of these children (231) were mailed a postcard listing the immunizations that they required to be up to date. The mailing was followed up with telephone contact, when necessary, to prompt compliance. The other one-half of the children were not contacted and served as the control group. Immunizations provided to the two groups were compared 6 months after the initial mailing.\n Before the initiation of the study, only 10.6 percent of the infants and children in the practice had their immunizations completed or were up to date. There were 124 immunizations given to 49 children in the intervention group compared with 84 immunizations to 33 children in the control (P < 0.047). Thirty-four children were brought up to date in the control group compared with 17 in the intervention cohort (P < 0.011).\n Direct mail reminders and telephone contact with parents of children who were behind in their immunizations were effective methods to encourage compliance. The increased number of immunizations received by the children in the intervention group was overshadowed by the poor coverage of the entire practice, a highly mobile and predominantly indigent group. Additional interventions are urgently needed to improve immunization levels in infants and children.", "A strategy of home visits to maximize children's immunization coverage was implemented in three towns in Ghana. The strategy was tested in town 1 in a controlled trial where clusters of children were allocated to the intervention and control groups. A total of 200 mothers in the intervention group were visited at home by non-health workers and their children were referred to a routine under-fives' clinic. Subsequent home visits targeted at those who failed to complete immunization schedules were made by nurses. After 6 months, coverage had risen from 60% to 85%, which was 20% higher than in the town 1 control group of 219 age-matched children (P < 0.005). A similar home-visiting strategy in a neighbouring town resulted in a rise in coverage from 38% to 91% (n = 55), mainly through home immunizations. Children were more likely to complete the schedule if their fathers were interviewed and participated in the decision to send them to the clinic. Countries with national service programmes can use a home-visiting strategy to supplement and strengthen their routine immunization programmes. A wide range of other community-based primary health care interventions could also be tested and implemented using this methodology.", "Malnutrition is common among children aged 6-24 months in developing countries. It increases the risk of mortality. Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children. A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children. Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries. The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques. The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance, improving feeding practices, and reducing growth faltering in children aged 6-24 months. A cluster-randomized controlled trial was carried out. The method used in this study was a replica of the method in a similar study in Pelotas, Brazil. Forty health centres were paired, and one centre of each pair was randomly allocated to the intervention group, and the other to the control group. The Integrated Management of Childhood Illness (IMCI) module-'Counsel the mother'-was used for training health workers in the health centres in the intervention group. Data from 36 paired health centres and 375 mothers and their children aged 6-24 months recruited from these health centres following consultation with health workers were included in analysis. Independent observers, masked to the intervention status, examined the performance of health workers within the first month after training. Mother-child pairs were visited at home within two weeks, 45 days, and 180 days after recruitment. Information was recorded on the feeding practices, recall of the recommendations of health workers, and sociodemographic variables at these home-visits. Weight and length of the child were measured at each contact. The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group. The mothers' recall of the recommendation of health workers and reported infant-feeding practices were also significantly better in the intervention group than in the control group, even 180 days after the recruitment consultation. Growth faltering was less in the intervention group, with the largest effect observed among children in the age-group of 12 + months. These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers. Improved feeding practices of counselled mothers can, in turn, reduce growth faltering in their children." ]

[ "683224", "8477163", "3794867", "671204", "3312553", "602256", "7472106", "8979185", "463541" ]

[ "Low positioning of umbilical-artery catheters increases associated complications in newborn infants.", "Randomized trial of umbilical arterial catheter position: clinical outcome.", "Efficacy of thromboresistant umbilical artery catheters in reducing aortic thrombosis and related complications.", "Umbilical artery catheters: high, low, or no.", "Effect of heparin infusates in umbilical arterial catheters on frequency of thrombotic complications.", "Prophylactic antibiotics in neonates with umbilical artery catheter placement: a prospective study of 137 patients.", "Prevention of umbilical artery catheter clots with heparinized infusates.", "Intravenous access in newborn infants: impact of extended umbilical venous catheter use on requirement for peripheral venous lines.", "Umbilical artery catheterization in newborns. I. Thrombosis in relation to catheter type and position." ]

[ "We performed a randomized prospective study of the effect of placement position of umbilical-artery catheters on complication rates in high-risk newborn infants. A higher complication rate (31 of 40 vs. 13 of 33) (P less than 0.005) occurred in the group with the catheter tip at the third to fourth lumbar segment, as compared to those with the tip at the seventh to eighth thoracic segment, owing to more episodes of blanching and cyanosis of the extremities. There was no difference between groups in the rate of complications requiring catheter removal. Aortography revealed thrombosis in 21 of 23 patients studied, but there was no clinical evidence of impaired circulation. In retrospect, we found that, independently of catheter position, administration of antibiotics through the catheter was associated with an increased rate of complications (63 vs. 20 per cent). Umbilical-artery catheterization entails potential risks regardless of the position of the catheter; placement of the catheter with its tip at the seventh to eighth thoracic segment may be associated with fewer complications than at lower positions.", "In order to determine if umbilical arterial catheter position affects the incidence of necrotizing enterocolitis, clinical outcome was analysed in 308 infants whose umbilical arterial catheter had been randomly allocated to a high (n = 162) or a low (n = 146) position. Necrotizing enterocolitis was classified as suspected or confirmed; all renal, lower limb and local catheter complications were also recorded. High umbilical arterial catheters were in place for longer than low catheters, provided more samples and were removed as an emergency less often. Lower limb blanching and cyanosis were more common with low catheters. Eleven cases of confirmed necrotizing enterocolitis occurred in the \"high\" group and nine in the \"low\" group. One case of fatal aortic thrombosis was encountered in the high group. Positioning umbilical arterial catheters in a high position allowed longer functional use and did not increase the incidence of necrotizing enterocolitis.", "Previous in vitro and in vivo reports suggest that catheters constructed of polyurethane with heparin bonded to the surface (HB-PU) are less thrombogenic than catheters made of polyvinyl chloride (PVC). A randomized trial sufficiently large (power 80%) to detect a reduction in the incidence of umbilical artery (UA) catheter complications, including aortic thrombus formation, from 45% to 20% was conducted in 125 infants. The infants were monitored for complications possibly related to the use of a UA catheter, such as systemic hypertension and abnormalities of lower extremity perfusion. The presence of aortic thrombi was assessed by ultrasound study 3.5 +/- 1.2 (SD) days and 11.1 +/- 2.3 days after insertion of the catheter. The use of HB-PU umbilical catheters did not lead to a significant reduction in the incidence of complications and aortic thrombi compared with the use of PVC catheters. The lack of reduction may have been related to the prolonged duration of catheter use in both groups. A much larger study would have been required to detect a smaller, but perhaps clinically significant, reduction in catheter-associated complications.", "nan", "We studied 111 infants requiring an umbilical artery catheter, 59 with heparin and 52 without. Thirty-four thrombi were detected, 16 in the heparin group and 18 in the control group. The numbers of thrombi in the two groups was not significantly different, but the number of clotted or nonfunctioning umbilical artery catheters was greater in the control group (P less than 0.05), as was the incidence of hypertension (P less than 0.05). There were no other significant differences between the two groups. We conclude that the use of low doses of heparin may not change the incidence of umbilical artery catheter-related thrombi, but it does appear to lower the incidence of their sequelae.", "To analyze the risk of cannula sepsis from indwelling umbilical arterial catheters and the indication for prophylactic antibiotics, 137 catheterized neonates with respiratory distress were prospectively placed into either antibiotic-treated (penicillin 50,000U/kg/day and kanamycin 15 mg./kg./day) or non-treated groups. Although bacteria were frequently isolated from blood and catheter tip cultures obtained upon removal of the catheter, especially among non-antibiotic treated infants, these isolates were predominantly non-pathogens and probably skin flora. Corresponding peripheral blood cultures were usually sterile. No cases of cannula-associated sepsis occurred among treated and non-treated newborns. The risk of bacteriologically proven sepsis resulting from an indwelling umbilical artery catheter appears insufficient to justify prophylactic antibiotics.", "49 neonates requiring umbilical artery catheters (UACs) were randomly assigned to receive standard or heparin-containing infusates. 3 of 23 (13%) of the patients receiving heparin had catheters removed because they became functionally occluded compared to 15 of 26 (58%) in the control group (p less than 0.005). 4 of 13 (31%) single injection aortograms obtained in control infants demonstrated thrombi, compared to none of 7 in the heparin group. 1 patient in the heparin group had an aortic clot demonstrated at post-mortum examination. There were neither clinical coagulopathies nor abnormalities of partial thromboplastin time attributable to the administration of heparinized fluids. Heparinization of UAC infusates appears to be a safe method of reducing the risk of catheter occlusion. Heparin effect on large vessel clot risk remains unproven.", "Central venous lines are used to care for critically ill neonates in cases of limited peripheral venous access. This prospective, randomized study evaluated the risks and benefits of the use of single- and double-lumen umbilical venous catheters for up to 14 days. Patients were randomized to one of three treatment arms: (1) single-lumen umbilical catheter, (2) double-lumen umbilical catheter, or (3) no umbilical catheter; peripheral intravenous lines only. Infants in the groups treated with an umbilical venous catheter had significantly fewer venipunctures and peripheral intravenous lines placed during their first 2 weeks of life than those in the peripheral line only group. Less time and money were spent obtaining peripheral line placement in the umbilical venous catheter groups. The incidence rates of sepsis and complications were not higher in treated patients than in control patients. The double-lumen catheter further reduced peripheral venipunctures and lines. We conclude that an umbilical venous catheter used during the first 2 weeks of life is a relatively safe, less stressful, cost-effective means of providing intravenous therapy to neonates.", "Seventy-one sick newborn infants, who had an umbilical artery catheterized, were randomized in one of four catheter groups: long end-hole-, short end-hole-, long side-hole- or short side-hole catheter. A long catheter means a high position of the catheter tip (Th6--11) and a short catheter a low position of the tip (L3--5). An angiography through the indwelling catheter in order to diagnose thrombosis was performed before the catheter was withdrawn. Dissection of the aorta and its brances was performed on infants who died. The total frequency of thromboses was 26%. There were no thromboses among infants with long end-hole catheters while infants with short end-hole catheters had thrombosis in 26%, long side-hole catheters in 33% and short side-hole catheters in 64%. Long end-hole catheters functioned better than the others. Only 6 of 16 infants with thrombosis had physical signs from the legs, while 12 infants without thrombosis had similar signs." ]

[ "21955873", "7740012", "19025276", "19822836", "14993087", "7673531", "14636795", "2246637", "11291373" ]

[ "Web-based intervention for adolescent nonsmokers to help parents stop smoking: a pilot feasibility study.", "The television, school, and family smoking prevention and cessation project. VIII. Student outcomes and mediating variables.", "Using the internet to assist smoking prevention and cessation in schools: a randomized, controlled trial.", "Group-randomized trial of a proactive, personalized telephone counseling intervention for adolescent smoking cessation.", "Effects of an advocacy intervention to reduce smoking among teenagers.", "Preventing escalation in problem behaviors with high-risk young adolescents: immediate and 1-year outcomes.", "A randomized trial of a family-based smoking prevention intervention in managed care.", "The impact of physicians' brief smoking cessation counseling: a MIRNET study.", "The influence of a family program on adolescent tobacco and alcohol use." ]

[ "A novel approach to tobacco control is to engage adolescent nonsmokers in support roles to encourage and help their parents stop smoking. This pilot study examined the feasibility and potential efficacy of a web-based support skills training (SST) intervention for adolescents to help a parent stop smoking. Forty nonsmoking adolescents 13-19 years of age (70% female, 93% White) were enrolled and randomly assigned to a health education (HE) control group (n=20) or SST (n=20). Both consisted of written materials and five weekly, 30 min, web-based, counselor-facilitated group sessions. Parents were enrolled for assessments only. Adolescents and parents completed assessments at baseline, week 6 (post-treatment), week 12 and 6-months follow-up. Both interventions were feasible based on treatment acceptability ratings, study retention and treatment compliance. The biochemically confirmed 6-month smoking abstinence rate was higher for parents linked to teens in HE (35%, 7/20) than in SST (10%, 2/20), p=0.13. About half of parents in each group reported a quit attempt since study enrollment. Teens can be engaged to help parents stop smoking. Future research is warranted on determining effective intervention approaches.\n Copyright © 2011 Elsevier Ltd. All rights reserved.", "This paper presents the student outcomes of a large-scale, social-influences-based, school and media-based tobacco use prevention and cessation project in Southern California.\n The study provided an experimental comparison of classroom delivery with television delivery and the combination of the two in a 2 x 2 plus 1 design. Schools were randomly assigned to conditions. Control groups included \"treatment as usual\" and an \"attention control\" with the same outcome expectancies as the treatment conditions. Students were surveyed twice in grade 7 and once in each of grades 8 and 9. The interventions occurred during grade 7.\n We observed significant effects on mediating variables such as knowledge and prevalence estimates, and coping effort. The knowledge and prevalence estimates effects decayed partially but remained significant up to a 2-year follow-up. The coping effort effect did not persist at follow-ups. There were significant main effects of both classroom training and TV programming on knowledge and prevalence estimates and significant interactions of classroom and TV programming on knowledge (negative), disapproval of parental smoking, and coping effort. There were no consistent program effects on refusal/self-efficacy, smoking intentions, or behavior.\n Previous reports demonstrated successful development and pilot testing of program components and measures and high acceptance of the program by students and parents. The lack of behavioral effects may have been the result of imperfect program implementation or low base rates of intentions and behavior.", "To evaluate the impact of a classroom-based, Web-assisted tobacco intervention addressing smoking prevention and cessation with adolescents.\n A two-group randomized control trial with 1,402 male and female students in grades 9 through 11 from 14 secondary schools in Toronto, Canada. Participants were randomly assigned to a tailored Web-assisted tobacco intervention or an interactive control condition task conducted during a single classroom session with e-mail follow-up. The cornerstone of the intervention was a five-stage interactive Web site called the Smoking Zine (http://www.smokingzine.org) integrated into a program that included a paper-based journal, a small group form of motivational interviewing, and tailored e-mails.\n Resistance to smoking, behavioral intentions to smoke, and cigarette use were assessed at baseline, postintervention, and three- and six-month follow-up. Multilevel logistic growth modeling was used to assess the effect of the intervention on change over time.\n The integrated Smoking Zine program helped smokers significantly reduce the likelihood of having high intentions to smoke and increased their likelihood of high resistance to continued cigarette use at 6 months. The intervention also significantly reduced the likelihood of heavy cigarette use adoption by nonsmokers during the study period.\n The Smoking Zine intervention provided cessation motivation for smokers most resistant to quitting at baseline and prevented nonsmoking adolescents from becoming heavy smokers at 6 months. By providing an accessible and attractive method of engaging young people in smoking prevention and cessation, this interactive and integrated program provides a novel vehicle for school- and population-level health promotion.", "The Hutchinson Study of High School Smoking randomized trial was designed to rigorously evaluate a proactive, personalized telephone counseling intervention for adolescent smoking cessation.\n Fifty randomly selected Washington State high schools were randomized to the experimental or control condition. High school junior smokers were proactively identified (N = 2151). Trained counselors delivered the motivational interviewing plus cognitive behavioral skills training telephone intervention to smokers in experimental schools during their senior year of high school. Participants were followed up, with 88.8% participation, to outcome ascertainment more than 1 year after random assignment. The main outcome was 6-months prolonged abstinence from smoking. All statistical tests were two-sided.\n The intervention increased the percentage who achieved 6-month prolonged smoking abstinence among all smokers (21.8% in the experimental condition vs 17.7% in the control condition, difference = 4.0%, 95% confidence interval [CI] = -0.2 to 8.1, P = .06) and in particular among daily smokers (10.1% vs 5.9%, difference = 4.1%, 95% CI = 0.8 to 7.1, P = .02). There was also generally strong evidence of intervention impact for 3-month, 1-month, and 7-day abstinence and duration since last cigarette (P = .09, .015, .01, and .03, respectively). The intervention effect was strongest among male daily smokers and among female less-than-daily smokers.\n Proactive identification and recruitment of adolescents via public high schools can produce a high level of intervention reach; a personalized motivational interviewing plus cognitive behavioral skills training counseling intervention delivered by counselor-initiated telephone calls is effective in increasing teen smoking cessation; and both daily and less-than-daily teen smokers participate in and benefit from telephone-based smoking cessation intervention.", "To test whether high school students' participation in advocacy activities related to the advertising, availability, and use of tobacco in their communities would prevent or reduce their own tobacco use.\n Ten continuation high schools in northern California, randomly assigned to a semester-long program in which students either carried out advocacy activities to counter environmental-level smoking influences in their communities (treatment) or learned about drug and alcohol abuse prevention (control).\n Eleventh and 12th grade high school students; 5 (advocacy) treatment and 5 control schools over 4 semesters from 2000 through 2002.\n Self-reported smoking defined as nonsmokers (those who had never smoked tobacco or those who were former smokers), light smokers (those who smoked <1 pack per week), or regular smokers (those who smoked >or=1 pack per week), and confirmed by carbon monoxide level readings. The following 3 constructs related to social cognitive theory- perceived incentive value, perceived self-efficacy, and outcome expectancies-were assessed.\n There was a significant net change from baseline to the end of the semester (after the intervention) between treatment and control schools for students who were regular smokers, but not for students who were nonsmokers or light smokers. Regular smoking decreased 3.8% in treatment schools and increased 1.5% in control schools (P<.001). Regular smoking continued to decrease at 6 months after the intervention in treatment schools, with a total change in prevalence from 25.1% to 20.3%. Involvement in community-advocacy activities and the 3 social constructs-perceived incentive value, perceived self-efficacy, and outcome expectancies-also showed significant net changes between treatment and control schools (all P values <.01).\n Student engagement in community-advocacy activities that addressed environmental influences of cigarette smoking resulted in significant decreases in regular smoking.", "The study tested alternative intervention strategies to reduce escalation in problem behaviors among high-risk young adolescents (11 to 14 years old). A total of 158 families with young adolescents (male and female) participated in this study. Of these, 119 families were randomly assigned to 1 of the following intervention conditions: (a) parent focus, (b) teen focus, (c) parent and teen focus, (d) self-directed change (materials only). In addition, 39 families of young adolescents were recruited as a quasi-experimental control. Parent focus and teen focus interventions resulted in immediate beneficial effects in observed and reported family conflict. The parent intervention conditions showed immediate beneficial effects on behavior problems at school. Longitudinal trends suggest that the parent focus condition may reduce subsequent tobacco use, compared with all other approaches. Interventions that aggregated high-risk youths into groups, however, showed the highest escalations in tobacco use and problem behavior at school, beginning at termination and persisting to follow-up. These findings are discussed with respect to the need to re-evaluate strategies that aggregate high-risk youths into intervention programs and focus more on strategies to engage parents in prevention.", "Each day more than 2000 youth under age 18 become daily smokers and the age of tobacco initiation has been going down. Health care settings can partner with families to encourage parent-child interactions that prevent youth tobacco use. This study evaluates a smoking prevention intervention package for parents and children (aged 10-12) provided through their managed care organization.\n A two-arm (usual care vs intervention) randomized trial was employed. The intervention included a mailed parental smoking prevention kit, outreach follow-up telephone calls to the parent by a health educator, child materials, medical record cues for physicians to deliver prevention messages, and parent newsletter. Outcome measures were susceptibility to smoking, experimentation with smoking, and smoking in the past 30 days as assessed by 20-month follow-up surveys of children.\n A total of 4,026 families enrolled in the study. The response rate to the 20-month follow-up was 88%. There were no significant effects of the intervention on any of the primary outcomes. The intervention was associated with modest but statistically significant increases in parent-child discussions of smoking related topics.\n A minimal-intensity family-based prevention program did not significantly reduce rates of susceptibility or tobacco use among youth aged 10-12 at baseline and 11 to 14 at follow-up. Development and evaluation of innovative approaches to tobacco use prevention must continue, despite our disappointing results. Parents and health care systems are too important to abandon as channels for prevention messages.", "Although many family physicians may discuss smoking cessation with their patients, few do so consistently. A common belief among many physicians is that such efforts will not deter their patients from smoking. Others believe the time commitment required for a successful intervention is excessive. The present study addressed the above issues by examining the effect of a 3- to 5-minute unstructured physician discussion encouraging smoking cessation with family practice patients. Cigarette-smoking patients of two busy family practices in southeast Michigan were randomly assigned to either a control group receiving routine care or an intervention group receiving, in addition to routine care, smoking cessation counseling from their physician. A third comparison group was drawn from smokers in practices not involved in delivering the intervention. Two hundred thirty-eight patients from the intervention group, 178 from the control group, and 47 from the comparison group were followed up with a telephone interview at 6 months. Intervention group patients made significantly more quit attempts than did those in the control group (P less than .001), which was similar to the comparison group. At the 6-month follow-up, 8% of intervention group members, and 4% of both the comparison and control groups reportedly were abstinent from smoking. Among those contacted at the 1-year follow-up, the respective percentages abstinent were 8%, 3%, and 4%. Although these differences in quit rates were not statistically significant, the findings suggest that physicians can positively affect patient smoking cessation. This intervention was feasible in busy family practices, highlighting its generalizability and applicability to other family practice settings in the United States.", "This study examined a family-directed program's effectiveness in preventing adolescent tobacco and alcohol use in a general population.\n Adolescents aged 12 to 14 years and their families were identified by random-digit dialing throughout the contiguous United States. After providing baseline data by telephone interviews, they were randomly allocated to receive or not receive a family-directed program featuring mailed booklets and telephone contacts by health educators. Follow-up telephone interviews were conducted 3 and 12 months after program completion.\n The findings suggested that smoking onset was reduced by 16.4% at 1 year, with a 25.0% reduction for non-Hispanic Whites but no statistically significant program effect for other races/ethnicities. There were no statistically significant program effects for smokeless tobacco or alcohol use onset.\n The family-directed program was associated with reduced smoking onset for non-Hispanic Whites, suggesting that it is worthy of further application, development, and evaluation." ]

[ "15671970", "9925973", "18786425", "16294597", "16210193", "16966982", "20181120", "15811544", "16186521" ]

[ "Graduated driver licensing in Utah: is it effective?", "The effectiveness of parents in promoting the development of road crossing skills in young children.", "The Iowa Graduated Driver Licensing program: effectiveness in reducing crashes of teenage drivers.", "Graduated driver licensing in Wisconsin: does it create safer drivers?", "Specific and long-term effects of Nova Scotia's graduated licensing program.", "Effectiveness of brief interventions after alcohol-related vehicular injury: A randomized controlled trial.", "Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial.", "Graduated driver licensing and teen traffic fatalities.", "Effect of simulator training on driving after stroke: a randomized controlled trial." ]

[ "We seek to examine the effectiveness of the graduated driver licensing system in Utah by determining whether crash rates of 16-year-old drivers decreased after graduated driver licensing implementation.\n We studied 16-year-old-driver crashes using statewide motor vehicle crash data probabilistically linked to emergency department (ED), hospital inpatient, and driver licensure data for 1996 to 2001. Outcomes examined included overall crash rates, nighttime crashes, crash severity indicators (eg, noninjury crash, injury crash, ED crash, inpatient crash, fatal crash), seat belt usage, licensure status, and citations. Rate ratios (RR), chi 2 tests, and interventional time series analyses were used to assess changes before and after graduated driver licensing implementation.\n There were 27,304 16-year-old-driver crashes during the study period. The overall crash rate per 1,000 licensed 16-year-old drivers decreased by 5% (RR 0.95; 95% confidence interval [CI] 0.92 to 0.97), and a time-series analysis showed a reduction of 0.8 (SD 0.39) crashes per month per 1,000 licensed drivers after graduated driver licensing implementation (1996 to 1999 versus 1999 to 2001). The nighttime crash rate did not change (RR 0.91; 95% CI 0.78 to 1.04), and there was no association between crash severity and graduated driver licensing implementation ( P =.096). Reported seat belt usage increased by 6.3%, and few graduated driver licensing citations were issued by law enforcement.\n The results suggest that graduated driver licensing may have contributed to a reduction in young driver crashes, but the effects were minimal compared with those shown in many other graduated driver licensing evaluations.", "Young children show poor judgment when asked to select a safe place to cross the road, frequently considering dangerous sites to be safe. Correspondingly, child pedestrian accidents are over-represented at such locations. Increasing the child's ability to recognise such dangers is a central challenge for road safety education.\n Practical training methods have proved effective in improving such judgments but are labour-intensive, time-consuming and therefore difficult to implement on a realistic scale. The study examined the possibility that volunteers from the local community might be capable of using such methods to promote children's pedestrian competence.\n Sixty children from the Primary 1 (Reception) classes of three Glasgow schools took part. Volunteers were ordinary parents from the same areas. None had 'formal' experience of working with children other than through being parents.\n Volunteers received experience of training children at courses organised in each school. Children learned in small groups, receiving two sessions of roadside training followed by four on a table-top model. Pre- and post-tests allowed the effectiveness of training to be assessed.\n Significant improvements relative to controls were found in all children following training. Improvements proved robust and no deterioration was observed two months after the programme ended. Comparison with a previous study in which training was undertaken by highly qualified staff showed that the volunteers were as effective as 'expert' trainers.\n Parent volunteers can significantly increase the pedestrian competence of children as young as five years. They constitute a most valuable 'resource' in road safety education. The opportunities afforded by involving the local community in educational interventions should be further explored.", "Graduated Driver Licensing (GDL) programs vary in the United States in terms of implementation and restrictions. The State of Iowa's GDL program is assessed for its effectiveness in reducing crashes among teenage drivers.\n Time series analysis was used to evaluate police documented crashes involving 16-, 17-, and 18-year-old drivers over a 10 year period, with an intervention identified at the point of GDL implementation.\n After controlling for seasonal trends and auto-correlative effects, a significant reduction in the crash rate of and 16- and 17-year-old drivers was observed due to the GDL implementation. However, there were no significant reductions in crash rates for 18-year-old drivers.\n The analyses suggest that the Iowa GDL program is effective in reducing the crash rates of 16- and 17-year-old drivers but the effects do not sustain for 18-year-old drivers.\n The results suggest that the program appears to be working, however further analysis is needed to determine what factors are preventing lasting effects for these teenage drivers.", "The purpose of this study was to measure the effectiveness of Wisconsin's graduated driver licensing law and determine whether a reduction in crash rates was due to reduced exposure, safer driving, or both.\n General population crash rates for 16 and 17 year olds were computed for years before and after graduated drivers licensing. The induced exposure method was used to measure exposure and compute the odds ratio of at-fault crash involvement.\n For 16 year olds, general crash rates declined 13.8% while injury crash rates declined 15.6%. For 17 year olds, crash rates declined 6.2% for all crashes and 5.8% for injury crashes. There was no statistically significant change in the odds ratio of at-fault crash involvement for 16- or 17-year-old drivers, relative to the reference group. After graduated drivers licensing, 16-year-old drivers were more likely to have at least 1 adult present and less likely to carry 2 or more teen passengers. There was no statistically significant effect on driving habits by time for 16 year olds.\n Graduated driver licensing in Wisconsin has resulted in a drop in the general population crash rates for 16 and 17 year olds. This decrease is the result of reduced exposure to the risk of collision rather than safer driving by teens.", "A graduated licensing (GL) program was introduced in Nova Scotia, Canada, in October 1994. Previous research has shown that it reduced collisions in the short term. The present study examined the relative contribution of each stage of the program (i.e., learner and intermediate levels) and the program's impact after beginning drivers graduated to full licensure. The research focused on teenage beginning drivers (age 16-17), but the effects on older beginners also was examined. Per-driver crash rates of two groups of novices selected from driver records in Nova Scotia were compared. One group (pre-GL) received their learner's permits during the 2 years before the program was implemented, and the second group (GL) received their learner's permits during the 2 years after implementation. The findings clearly establish that most of the collision reduction in Nova Scotia's program occurred during the first year of the program, particularly during the first 6 months when the majority of novices were driving under supervision. The collision rate for 16 to 17-year-old GL novices was 50% lower than the rate for pre-GL novices during the 6 months after they received their learner's permits, and about 10% lower during their first 2 years of licensure when unsupervised driving from midnight to 5 A.M. was prohibited. Much of this improvement for 16 to 17-year-olds occurred during restricted night hours. Collision rates also were lower during nonrestricted hours in the initial 6 months of licensure. The 3-month \"time discount\" for driver education provided no safety benefit, and GL novices with driver education had collision rates that were not lower than pre-GL novices. There was no long-term effect found for the program after 16 to 17-year-olds graduated to full licensure. For older beginning drivers, crash rates during the first year after obtaining a learner's permit showed a 31% reduction. This effect diminished rapidly. There was only a 2% reduction during the first year of licensure, and crash rates increased during the following 2 years. Overall the data indicate substantial benefits of graduated licensing for 16 to 17-year-old beginners, but no benefits beyond the learner stage for older beginners.", "Because 40% of motor vehicle fatalities in the United States are alcohol-related, interventions delivered by trauma clinicians targeted to reduce drinking are of particular importance to public health. The objective of this study was to test the effectiveness of hospital-based brief intervention strategies to reduce alcohol consumption and other health-related outcomes in the year after an alcohol-related vehicular injury. Brief interventions are clinically based strategies including assessment and direct feedback about drinking alcohol, goal setting, behavioral modification techniques, and the use of a self-help manual.\n The study was a randomized controlled trial of two types of brief intervention with a 12-month follow-up. Participants with alcohol-related vehicular injury who were admitted to Level I trauma centers were eligible for enrollment. Enrolled participants were randomized to a control, simple advice, or brief counseling condition. Primary outcome variables were alcohol consumption (standard drinks/month, binges/month), adverse driving events (driving citations, traffic crashes), and changes in health status (hospital and emergency department admissions).\n The study enrolled 187 participants at baseline and retained 100 across 12 months. Participants had a significant decrease in alcohol consumption and traffic citations at 12 months as compared with baseline. Mean standard drinks/month declined from 56.80 (SD 63.89) at baseline to 32.10 (SD 53.20) at 12 months. Mean binges/month declined from 5.79 (SD 6.98) at baseline to 3.21 (SD 6.17) at 12 months. There were no differences in alcohol consumption, adverse driving events, or health status by condition.\n Whether the reductions in alcohol consumption and traffic citations were a result of the crash, hospitalization for injury, screening for alcohol use, or combination of these factors is difficult to determine. Further work is needed to understand the mechanisms involved in reductions of health-related outcomes and the role of brief intervention in this population.", "Road traffic accidents (RTAs) are the leading health threat to children in Europe, resulting in 355,000 injuries annually. Because children can suffer significant and long-term mental health problems following RTAs, there is considerable interest in the development of early psychological interventions. To date, the research in this field is scarce, and currently no evidence-based recommendations can be made.\n To evaluate the effectiveness of a single-session early psychological intervention, 99 children age 7-16 were randomly assigned to an intervention or control group. The manualised intervention was provided to the child and at least one parent around 10 days after the child's involvement in an RTA. It included reconstruction of the accident using drawings and accident-related toys, and psychoeducation. All of the children were interviewed at 10 days, 2 months and 6 months after the accident. Parents filled in questionnaires. Standardised instruments were used to assess acute stress disorder (ASD), posttraumatic stress disorder (PTSD), depressive symptoms and behavioural problems.\n The children of the two study groups showed no significant differences concerning posttraumatic symptoms and other outcome variables at 2 or at 6 months. Interestingly, analyses showed a significant intervention x age-group effect, indicating that for preadolescent children the intervention was effective in decreasing depressive symptoms and behavioural problems.\n This study is the first to show a beneficial effect of a single-session early psychological intervention after RTA in preadolescent children. Therefore, an age-specific approach in an early stage after RTAs may be a promising way for further research. Younger children can benefit from the intervention evaluated here. However, these results have to be interpreted with caution, because of small subgroup sizes. Future studies are needed to examine specific approaches for children and adolescents. Also, the intervention evaluated here needs to be studied in other groups of traumatised children.\n Clinical Trial Registry: ClinicalTrials.gov: NCT00296842.", "Over the last 8 years, nearly every state has introduced graduated driver licensing (GDL) for teens. These new licensing procedures require teen drivers to advance through distinct stages where they are subject to a variety of restrictions (e.g., adult supervision, daytime driving, passenger limits). In this study, we present evidence on whether these restrictions have been effective in reducing traffic fatalities among teens. These evaluations are based on state-by-year panel data from 1992 to 2002. We assess the reliability of our basic inferences in several ways including an examination of contemporaneous data for older cohorts who were not directly affected by these policies. Our results indicate that GDL regulations reduced traffic fatalities among 15-17-year-olds by at least 5.6%. We also find that the life-saving benefits of these regulations were plausibly related to their restrictiveness. And we find no evidence that these benefits were attenuated by an increase in fatality risks during the full-licensure period available to older teens.", "Neurologically impaired persons seem to benefit from driving-training programs, but there is no convincing evidence to support this notion. The authors therefore investigated the effect of simulator-based training on driving after stroke.\n Eighty-three first-ever subacute stroke patients entered a 5-week 15-hour training program in which they were randomly allocated to either an experimental (simulator-based training) or control (driving-related cognitive tasks) group. Performance in off-road evaluations and an on-road test were used to assess the driving ability of subjects pre- and post-training. Outcome of an official predriving assessment administered 6 to 9 months poststroke was also considered.\n Both groups significantly improved in a visual and many neuropsychological evaluations and in the on-road test after training. There were no significant differences between both groups in improvements from pre- to post-training except in the \"road sign recognition test\" in which the experimental subjects improved more. Significant improvements in the three-class decision (\"fit to drive,\" \"temporarily unfit to drive,\" and \"unfit to drive\") were found in favor of the experimental group post-training. Academic qualification and overall disability together determined subjects that benefited most from the simulator-based driving training. Significantly more experimental subjects (73%) than control subjects (42%) passed the follow-up official predriving assessment and were legally allowed to resume driving.\n Simulator-based driving training improved driving ability, especially for well educated and less disabled stroke patients. However, the findings of the study may have been modified as a result of the large number of dropouts and the possibility of some neurologic recovery unrelated to training." ]

[ "9691103", "15017504", "8536887", "9692692", "8881815", "15709986", "12135030", "11922560", "15095852" ]

[ "A comparison of budesonide and mesalamine for active Crohn's disease. International Budesonide-Mesalamine Study Group.", "Budesonide versus mesalamine for maintaining remission in patients refusing other immunomodulators for steroid-dependent Crohn's disease.", "Oral budesonide as maintenance treatment for Crohn's disease: a placebo-controlled, dose-ranging study. Canadian Inflammatory Bowel Disease Study Group.", "Oral budesonide as maintenance therapy in Crohn's disease--results of a 12-month study. Global Budesonide Study Group.", "Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease. A placebo controlled one year study.", "Budesonide as maintenance treatment in Crohn's disease: a placebo-controlled trial.", "Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: a randomized placebo-controlled study in the United States.", "Budesonide and mesalazine in active Crohn's disease: a comparison of the effects on quality of life.", "Budesonide versus prednisolone for the treatment of active Crohn's disease in children: a randomized, double-blind, controlled, multicentre trial." ]

[ "Crohn's disease is often treated with glucocorticoids or mesalamine. We compared the efficacy and safety of controlled-ileal-release budesonide capsules and slow-release mesalamine tablets in patients with active Crohn's disease affecting the ileum, the ascending colon, or both.\n In a double-blind, multicenter trial, we enrolled 182 patients with scores of 200 to 400 on the Crohn's Disease Activity Index (with higher scores indicating greater disease activity) and randomly assigned 93 to receive 9 mg of budesonide once daily and 89 to receive 2 g of mesalamine twice daily for 16 weeks. The primary efficacy variable was clinical remission, defined as a score of 150 or less on the Crohn's Disease Activity Index.\n In the analysis of all patients who received at least one dose of study drug, the rates of remission after 8 weeks of treatment were 69 percent in the budesonide group and 45 percent in the mesalamine group (P=0.001); the respective rates after 16 weeks of treatment were 62 percent and 36 percent (P<0.001). Seventy-seven patients in the budesonide group completed the 16 weeks of treatment, as compared with 50 patients in the mesalamine group (P<0.001). The numbers of patients with adverse events were similar in the two groups, but those assigned to budesonide had fewer severe adverse events. Among patients who completed 16 weeks of treatment, the morning plasma cortisol value was normal in 67 percent of budesonide-treated patients and 83 percent of mesalamine-treated patients (P=0.06); 90 percent and 100 percent, respectively, had normal increases in cortisol in response to cosyntropin (P=0.02).\n In patients with active Crohn's disease affecting the ileum, the ascending colon, or both, a controlled-ileal-release formulation of budesonide was more effective in inducing remission than a slow-release formulation of mesalamine.", "To compare the efficacy of controlled-release budesonide capsules with that of mesalamine for maintaining remission and improving quality of life (QOL) in patients with steroid-dependent Crohn's disease.\n Fifty-seven patients (25 men; mean age, 32 +/- 10.1 yr) with quiescent steroid-dependent Crohn's ileitis, ileocolitis, or colitis (Crohn's disease activity index <150) entered a prospective, investigator-blind trial. Patients were eligible for treatment with azathioprine but had not consented or had developed side effects. Patients were randomized to receive budesonide 6 mg/day (n = 29) or mesalamine 1 g 3 times/day (n = 28). Follow-up assessments were made every 2 months for up to 1 year or until relapse. At each visit, quality of life (QOL) was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ).\n There were no significant differences in baseline clinical characteristics between the study groups. The 1-year relapse rate was significantly lower in the budesonide group than in the mesalamine group (55% vs. 82%; 95% confidence interval, 12.4%-41%; P = 0.045). Patients assigned to budesonide also remained in remission longer (241 +/- 114 days vs. 147 +/- 117 days; 95% confidence interval, 32.7-155.3 days; P = 0.003). Compared with mesalamine, budesonide treatment also was associated with a better QOL throughout the study (mean total IBDQ scores 165 +/- 36 vs. 182 +/- 28, respectively; 95% confidence interval, -0.4 to 34.4, P = 0.0001). This advantage was confirmed in patients' self-assessed QOL scores.\n Over a 1-year period, controlled-release budesonide was significantly more effective than mesalamine for maintaining remission and improving the QOL of patients with steroid-dependent Crohn's disease.", "Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism. The efficacy and safety of an oral controlled-release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease.\n In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year. The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of > 150 and a minimum increase of 60 points.\n Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3-mg and placebo groups. Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups.\n Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up.", "Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid inactivation. We have assessed the efficacy and safety of an oral controlled ileal release (CIR) preparation of budesonide for maintenance of remission in patients with ileal or ileocaecal Crohn's disease.\n In a double-blind, multicentre trial, 75 patients in clinical remission (Crohn's Disease Activity Index, CDAI, < or = 150) were randomly assigned to receive placebo, budesonide 3 mg or budesonide 6 mg daily for 12 months. Trial drugs were given at a fixed dose and without concomitant medication. The primary outcome measure was relapse, defined as a CDAI > 150 together with an increase of at least 60 units from entry. A patient was also considered to have a relapse if withdrawn from the study due to clinical deterioration, whether or not a CDAI value could be calculated at that time.\n There were no statistically significant differences in the relapse rate at any time-point throughout the study. By 12 months the proportion of patients having relapsed were 48, 46 and 60% in those patients treated with budesonide 6 mg, 3 mg and placebo, respectively (N.S.). Treatments were well tolerated, and the proportion of patients with suppressed adrenal function (according to predetermined criteria) were 50% (6 mg), 26% (3 mg) and 17% (placebo) (P = 0.096).\n In the present study, relapse rate and time to relapse were similar in the patients treated with budesonide CIR, 6 mg daily or 3 mg daily or with placebo, throughout 12 months. This is in contrast to the two previous trials with identical design, where a significant effect of budesonide CIR in prolonging the median time to relapse was found. Possible reasons for the negative results of the present study include small sample size, and the fact that there was a high placebo response.", "To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formulation for maintenance of remission in patients with ileal and ileocaecal Crohn's disease (CD).\n Out of 176 patients with active CD who had achieved remission (CD activity index score < or = 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatment of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 months in a double blind, multicentre trial. Time to symptomatic relapse was calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was performed after three months of treatment.\n Thirty two patients were allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patients in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p = 0.047). The corresponding results after 12 months was 59 per cent in the 6 mg budesonide group, 74 per cent in the 3 mg group, and 63 per cent in the placebo group (p = 0.44). The median time to relapse or discontinuation was 258 days in the 6 mg group, 139 days in the 3 mg group, and 92 days in the placebo group (p = 0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant differences at 12 months. All 13 patients remaining in the placebo group after three months had a normal corticotropin stimulation response, compared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg budesonide groups (p = 0.14). Acne and moon face were slightly more common in the budesonide groups.\n 6 mg budesonide once daily is significantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects.", "To assess the efficacy and safety of budesonide capsules 6 mg daily for prolongation of time to relapse and maintenance of remission in patients with Crohn's disease (CD) affecting the ileum and/or ascending colon.\n In a double-blind, placebo-controlled, multicentre trial, 110 patients with CD, who had previously achieved remission in a placebo-controlled trial of budesonide 9 mg daily, were randomly assigned to receive budesonide 6 mg once daily or placebo for 52 weeks. Primary outcome measure was time to relapse [CD activity index (CDAI) of >150 plus an increase of at least 60 points from study entry or withdrawal due to clinical deterioration].\n Median time to relapse was 360 days for budesonide patients; 169 days for placebo patients (P = 0.132). No significant differences were seen between groups in relapse rates at 1 year. Budesonide was safe and well tolerated, with a similar adverse events profile to placebo.\n Patients treated with budesonide 6 mg once daily had a trend towards a prolonged time to relapse and lower CDAI scores compared with patients treated with placebo, but relapse rates were not significantly different at the 1-year end point.", "Budesonide controlled ileal release (CIR) capsules deliver budesonide, a glucocorticosteroid with high topical and low systemic activity, to the distal ileum and the proximal colon. In four previous controlled trials in Crohn's disease, remission rates ranged from 51% to 69%. We sought to evaluate the efficacy and safety of this drug in a population of patients in the United States with Crohn's disease.\n In this multicenter, double blind, randomized trial, 200 patients in the United States with mild to moderate Crohn's disease (Crohn's Disease Activity Index [CDAI] between 200 and 450) involving the distal ileum and/or ascending colon received 9 mg of budesonide CIR once daily, 4.5 mg b.i.d., or placebos for 8 wk. The primary outcome was remission defined by a CDAI of 150 or less.\n Remission was achieved in 48%, 53%, and 33% with 9 mg once daily, 4.5 mg b.i.d., and placebos, respectively, after 8 wk of treatment. Differences between the groups were not significant. The differences in mean change from baseline CDAI between the combined budesonide and placebo groups was significant (p < 0.05). There was no difference in observed adverse events between treatment groups, although a modest decrease in plasma cortisol levels was observed relative to the placebo (p < 0.01).\n Treatment of symptomatic Crohn's disease with budesonide CIR capsules (9 mg daily) was safe, and remission rates were similar to those achieved in previous trials. Although the remission rate did not significantly differ from the placebo response in this study, there was a significant change in the mean CDAI from baseline in the combined treatment groups relative to the placebo.", "Controlled ileal release budesonide and slow release mesalazine are both used to treat mild to moderate active Crohn's disease, although data show that budesonide is more effective in inducing remission. When comparing different treatment options, the effects of agents on health-related quality of life must be considered as well as efficacy. In this study, we sought to compare the effects of budesonide and mesalazine on the health-related quality of life of patients with active Crohn's disease.\n The study included 182 patients with Crohn's Disease Activity Index scores between 200 and 400. Patients were randomized in a double blind, double dummy, multicenter study to receive 9 mg of budesonide, once daily (n = 93), or 2 g of mesalazine, b.i.d. (n = 89), for 16 wk. Quality of life was assessed at baseline and after 2, 4, 8, 12, and 16 wk of treatment using the Psychological General Well-Being index. In addition, a physician's global evaluation was used to assess how symptoms affected patients' normal activities.\n Patients treated with budesonide experienced significantly greater improvement in Psychological General Well-Being scores than the group treated with mesalazine after 2, 8, 12, and 16 wk. All components of this index showed greater improvements in the budesonide-treated group than in the mesalazine group at 12 and 16 wk. The physician's global evaluation showed significantly greater improvements in the budesonide group than in the mesalazine group at all visits.\n Budesonide (9 mg once daily) improves health-related quality of life to a greater extent than mesalazine (2 g b.i.d.) in patients with mild to moderate active Crohn's disease.", "Budesonide is a corticosteroid with low systemic bioavailability because of its high first-pass metabolism in the liver. In this paediatric, randomized, double-blind, double-dummy, controlled, multicentre trial, the safety and efficacy of budesonide versus prednisolone were evaluated in children with active Crohn's disease.\n Forty-eight children, aged 6-16 years, with active Crohn's disease (Crohn's Disease Activity Index > 200) involving ileum and/or ascending colon were randomized to receive budesonide (9 mg/day for 8 weeks, 6 mg/day for 4 weeks) or prednisolone (1 mg/kg/day for 4 weeks, tapering for 8 weeks).\n The groups were comparable for age, sex, pubertal stage, disease activity and disease duration. Mean morning plasma cortisol concentration was significantly higher in the budesonide group (200 nmol/l) than in the prednisolone group (98 nmol/l) after 8 weeks, reflecting less adrenal suppression by budesonide (difference -102 nmol/l; 95% CI -226, -52; P = 0.0028). Glucocorticosteroid side effects such as moon face and acne occurred significantly less frequently in the budesonide group. Remission (Crohn's Disease Activity Index < or = 150) was seen at 8 weeks in 12/22 (55%) patients treated with budesonide and in 17/24 (71%) patients receiving prednisolone (difference -16%; 95% CI -45,13; P = 0.25).\n Significantly fewer side effects and less adrenal suppression were observed in the children receiving budesonide. Remission rates were not significantly different in the two groups. However, there was a trend for prednisolone to be more effective for inducing remission." ]

[ "2498657", "3677969", "2231212", "11106052", "15745109", "3312552", "14615738", "10228288", "10730525" ]

[ "A randomized, controlled trial of very early prophylactic ligation of the ductus arteriosus in babies who weighed 1000 g or less at birth.", "Failure of prophylactic indomethacin to improve the outcome of the very low birth weight infant.", "Prolonged indomethacin therapy for the prevention of recurrences of patent ductus arteriosus.", "Prophylaxis of patent ductus arteriosus with ibuprofen in preterm infants.", "A randomized controlled trial of beta-blockers versus endoscopic band ligation for primary prophylaxis: a large sample size is required to show a difference in bleeding rates.", "Prevention of symptomatic patent ductus arteriosus with a single dose of indomethacin.", "A trial of vitamin A therapy to facilitate ductal closure in premature infants.", "Short versus prolonged indomethacin therapy for patent ductus arteriosus in preterm infants.", "Indomethacin prophylaxis for patent ductus arteriosus (PDA) in infants with a birth weight of less than 1250 grams." ]

[ "We speculated that prophylactic ligation of the ductus arteriosus would reduce mortality and morbidity in very-low-birth-weight infants. To test this hypothesis, we randomly assigned 84 babies who weighed 1000 g or less at birth and required supplemental oxygen either to receive standard treatment (n = 44) or to undergo prophylactic surgical ligation of the ductus arteriosus on the day of birth (n = 40). The ductus was ligated in babies in the control group only if the shunt was hemodynamically important. All the babies were followed for one year. The incidence of necrotizing enterocolitis was reduced in the group that underwent prophylactic ligation (3 of 40 [8 percent]) as compared with the control group (13 of 44 [30 percent]; P = 0.002). The frequency of death, bronchopulmonary dysplasia, retinopathy of prematurity, and intraventricular hemorrhage was similar in both groups. Because early enteral feeding may have increased the incidence of necrotizing enterocolitis, we analyzed separately the babies who were fed early. Among the infants who were fed within 14 days of birth, those who underwent prophylactic ligation had a lower incidence of necrotizing enterocolitis (1 of 11 [9 percent]) than those who did not (13 of 24 [54 percent]; P = 0.001). Within the control group, the infants who were fed within 14 days of birth and whose ductus was ligated for medical reasons within 5 days of birth had a lower incidence of necrotizing enterocolitis (2 of 10 [20 percent]) than those whose ductus was ligated later or not at all (11 of 14 [79 percent]; P = 0.004). We conclude that early surgical closure of the ductus arteriosus reduces the risk of necrotizing enterocolitis in infants of very low birth weight who require supplemental oxygen.", "Prophylactic closure of the patent ductus arteriosus (PDA) has been recommended as a means of decreasing early respiratory distress, and thereby chronic respiratory sequelae in the very low birth weight (VLBW) neonate. This study was undertaken to evaluate some possible mechanisms for the observed failure of early indomethacin therapy to achieve such improvement. 24 VLBW infants with echocardiographic evidence of PDA were randomized to receive either indomethacin or placebo at 48 h of life; and then they were studied for clinical, metabolic and laboratory signs of ductal constriction and/or reopening. Early indomethacin conferred no improvement in respiratory sequelae. However, this was not secondary to a short-term therapeutic failure. Prophylactic indomethacin, even in the VLBW infant, was successful in decreasing dilator prostaglandin production, and probably in closing the PDA and in decreasing the number of recurrences. The implications are that even with effective ductal constriction, overall morbidity is not affected.", "We tested the hypothesis that prolonged maintenance indomethacin therapy would allow more effective closure of patent ductus arteriosus (PDA) and thereby decrease the recurrence rate. Thirty-nine low birthweight neonates (less than 1500 gm) with confirmed PDA were randomly assigned in a double-blind fashion to receive standard indomethacin therapy (three doses), followed either by maintenance indomethacin therapy (0.2 mg/kg/day) for 5 days or by an equivalent volume of placebo for 5 days. Of the 20 infants who received maintenance indomethacin therapy, two (10%) required additional therapy and one of these required surgical ligation. Of the 19 infants who received only the first three indomethacin doses, nine (47%) required additional therapy for PDA (p less than 0.05) and seven of these had a ligation (p less than 0.05). We conclude that maintenance indomethacin therapy, in comparison with short-term indomethacin therapy, decreases the incidence of surgical PDA ligations, eliminates most PDA recurrences, and does not increase toxic effects of indomethacin in the low birth weight infant with PDA.", "The aim of our study was to evaluate whether the prophylactic use of ibuprofen would reduce the incidence of significant patent ductus arteriosus (PDA) and to confirm the effectiveness of ibuprofen as rescue treatment in closing PDA. Eighty preterm infants with gestational age less than 34 wk with infant respiratory distress syndrome (iRDS) were randomized to receive intravenous ibuprofen lysine (10 mg/kg, followed by 5 mg/kg after 24 and 48 h) either within 24 h of life (group A) or after echocardiographic diagnosis of PDA (group B). To evaluate the severity of RDS in each patient, we calculated the initial and highest values of Oxygenation Index (O.I. = mean airway pressure x FiO2 x 100/PaO2) and Ventilatory Index (V.I. = O.I. x mechanical respiratory rate). Other studied variables were ventilatory support, renal function, biochemical and haematological profiles, frequency of bronchopulmonary dysplasia (BPD), intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). On the 3rd day of life, 8% (3/40) of patients of group A and 53% of patients (21/40) of group B (p < 0.0001) developed a significant PDA. Between patients of group B who presented PDA at 3 d of life 90% (19/21) had a closure of ductus arteriosus after ibuprofen treatment. Initial and highest values of O.I. and V.I. were similar in both groups A and B. No significant differences between the groups were observed in regard to respiratory support, renal function and frequency of BPD, IVH, NEC and ROP. Ibuprofen was not associated with adverse effects. Conclusion: Prophylactic treatment with ibuprofen reduces PDA occurrence in preterm infants with iRDS at 3 d of life in comparison with rescue treatment, but both modes are effective in closing the ductus without significant adverse effects.", "Primary prophylaxis with nonselective beta-blockers in high-risk subjects has been shown to be effective in reducing both esophageal variceal bleeding and mortality. Recently it has been suggested that band ligation may be a better option for primary prophylaxis. We compared nonselective beta-blockers with band ligation in patients with large varices (F2, F3) and elevated hepatic venous wedge pressure gradient (HVWPG, > or = 12 mm Hg). All patients were prospectively followed for variceal bleeding, mortality, and treatment-related complications. Based on previous published studies, we estimated that 90 patients in each arm would be required to show a difference in bleeding rate. The study was prematurely terminated when we realized that our estimated sample size was inadequate to show a difference based on the observed bleeding rate. At the time of termination, 31 patients (Child A, 11; B, 14; C, 6), with a mean HVWPG of 19 +/- 9.1 mm Hg, were randomized to either band ligation (group A; n = 16) or beta-blockers (group B; n = 15). Baseline demographics of both groups were similar and the mean follow-up period was 27.4 +/- 12.9 months. During the follow-up, two patients in group A and one patient in group B had bleeding. Nine patients (29%; group A, six; group B, three; P = ns) died due to non-bleeding-related causes and five (16%) patients (group A, three; group B, two) underwent liver transplantation. Treatment-related complication were minimal in both groups. Despite the selection of high-risk patients, the observed bleeding rate was much lower than anticipated. Based on our observed bleeding rates, 424 patients would be required in each arm to show a difference between band ligation and beta-blocker therapy.", "To determine the efficacy of indomethacin to prevent the occurrence of symptomatic patent ductus arteriosus (PDA), a randomized clinical trial was conducted involving 32 preterm infants weighing 750 to 1500 g at birth who had hyaline membrane disease. By random assignment, 15 infants were given a single dose of indomethacin, 0.2 mg/kg intravenously, 24 hours after birth. Seventeen infants composed a control group for which indomethacin was reserved as treatment for symptomatic PDA. Birth weight, gestational age, male/female ratio, black/white ratio, and severity of disease were similar for both groups. Only one of the 14 survivors who received prophylactic indomethacin had symptomatic PDA, compared with nine of the 16 survivors in the control group (P = 0.007). There was no difference between the groups in development of bronchopulmonary dysplasia, duration of time endotracheal intubation, was required, duration in oxygen, duration to reach full feedings and regain birth weight, and duration of hospital stay. There was no difference between the two groups in incidence of intraventricular hemorrhage, and none developed necrotizing enterocolitis. These results indicate that the use of prophylactic indomethacin is beneficial in prevention of symptomatic PDA; the lack of differences in pulmonary sequelae or other complications may have been related to a population sample size not large enough to impart sufficient statistical power.", "To determine whether postnatal vitamin A therapy increased ductal closure rate in premature infants.\n This was a prospective, double-blind, placebo-controlled trial. Subjects (n=40) were recruited on day of life 1. Inclusion criteria were premature neonates weighing 500 to 1500 g with an indwelling umbilical line. Vitamin A was administered intramuscularly on days 1, 3, and 7. Blood vitamin A and retinol binding protein levels were obtained on days 1 and 3. Echocardiography was performed on days 1, 3, 7, and 14. Failure of ductal closure was defined as the presence of a moderate to large patent ductus arteriosus on day 14, indomethacin therapy, or surgical ligation.\n Comparison between the treatment and placebo groups revealed no differences in gestational age, weight, or oxygenation index. Vitamin A and retinol binding protein levels did not differ between the groups at entry but increased significantly after vitamin A treatment. Failure of ductal closure occurred in 22 of 40 babies without any difference between the groups (12/22 vs 10/18, P=NS). Four infants required surgical ligation, all in the treatment group (P=.04). Clinical outcome did not vary between groups.\n Postnatal vitamin A therapy did not improve ductal closure rates in premature infants.", "To evaluate whether a prolonged low-dose course of indomethacin would produce an improved closure rate and have fewer side effects compared with a short standard dosage schedule in the management of patent ductus arteriosus (PDA) in preterm infants.\n Sixty-one infants of gestational ages 24 to 32 weeks with a PDA confirmed with echocardiography were randomized to receive 0.2 to 0.1 to 0.1 mg/kg indomethacin in 24 hours (short course, n = 31) or 0.1 mg/kg every 24 hours 7 times (long course, n = 30). Echocardiography was done 3, 9, and 14 days after the treatment was started, and side effects were monitored.\n Primary PDA closure occurred more often in the short course group (94% vs 67%, P =.011), but the sustained closure rates were not different (74% vs 60%). Surgical PDA ligations were less frequent in the short course group than in the long course group. The short course group had a shorter duration of oxygen supplementation, less frequent symptoms of necrotizing enterocolitis, and a lower rate of urea retention. Mortality and other neonatal morbidity rates were similar.\n A prolonged low-dosage indomethacin regimen offers no advantage compared with a standard-dosage short course in the management of a hemodynamically significant PDA in preterm infants.", "Very low birth weight (VLBW, less than 1500 g) and extremely low birth weight infants (ELBW, less than 1000 g) are the premature infants that are most likely to develop symptomatic PDA. Intravenous indomethacin has proven effective in prevention of PDA in many prospective trials. This strategy will be a useful adjunctive therapy for premature infants in Thailand.\n To answer the following questions: 1. Will multiple doses of intravenous indomethacin, given to VLBW infants within the first day of life, effectively prevent the occurrence of symptomatic PDA? Are there any side effects or complications? 2. Will this strategy be more beneficial in ELBW?\n The study included thirty VLBW infants born at Ramathibodi Hospital, with birth weights ranging from 630 to 1230 g. They were randomized into 2 groups of 15 infants each. One group received 3 doses of intravenous indomethacin at the dosage of 0.2 mg/kg initially and then 0.1 mg/kg every 12 hours for 2 more doses; the second group received a placebo. The study was performed by a double blind control.\n Sixteen infants developed symptomatic PDA, 4 in the indomethacin group and 12 in the placebo group. The decrease in incidence of PDA is statistically significant. But when the data was analyzed separately for the VLBW and ELBW groups. The effects were only significantly different in ELBW but not yet significant in the VLBW group. There was a statistically significant difference in the incidence of severe intraventricular hemorrhage (IVH) (grade 3 or higher) in the ELBW infants.\n Intravenous indomethacin therapy given to VLBW infants with a birth weight of less than 1250 g decreased incidence of symptomatic PDA with no significant permanent side effects. The effect was markedly noticeable in ELBW infants. Incidence of severe IVH was also markedly decreased in the ELBW infants who received indomethacin." ]

[ "2889518", "2730380", "7501140", "7611638", "3902184", "2972270", "14759641", "10579658", "16806095" ]

[ "A randomized controlled trial of amantadine in fatigue associated with multiple sclerosis. The Canadian MS Research Group.", "Amantadine treatment of fatigue associated with multiple sclerosis.", "Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo.", "A double-blind, placebo-controlled trial of amantadine for the treatment of fatigue in patients with the post-polio syndrome.", "Amantadine therapy for fatigue in multiple sclerosis.", "Amantadine, fatigue, and multiple sclerosis.", "Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial.", "Cognitive and behavioural efficacy of amantadine in acute traumatic brain injury: an initial double-blind placebo-controlled study.", "Galantamine improves cognition in schizophrenic patients stabilized on risperidone." ]

[ "One hundred and fifteen patients with definite multiple sclerosis (M.S.) and chronic persistent fatigue were studied. This ten-week cross-over study consisted of a 2-week baseline period and two 3-week treatment periods separated by a 2-week washout. Patients received either amantadine 100 mg bid or matching placebo capsules. Fatigue, the effect of fatigue on an individually pre-selected activity and its effect on activities of daily living, were evaluated. Amantadine produced a small but statistically significant decrease in fatigue. An important placebo effect was noted. Mean fatigue during the washout period was lower than during the placebo run-in period, independently of which treatment had been given first. Side effects were numerous both on amantadine and on placebo. Only insomnia was significantly more common with amantadine.", "Fatigue is a common symptom of multiple sclerosis (MS) that is without an effective treatment. A double-blind, controlled study of fatigue treatment was conducted to evaluate the efficacy of amantadine hydrochloride in treating MS-associated fatigue. Since fatigue cannot be characterized by a single symptom or behavior, a variety of neuropsychological, behavioral, and self-report measures were used to monitor changes across different systems. According to patients' daily diary ratings, amantadine produced small but statistically significant improvements in fatigue across four of seven dimensions (overall energy level, concentration, problem solving, and sense of well-being). In addition, patients with MS who were taking amantadine performed slightly better on the Stroop Interference Test, an attentional measure of freedom from distracting information. Although retrospective reports by patients with MS did not confirm the degree of improvement recorded on a daily basis, the study's results suggested that amantadine may offer modest benefits in alleviating the day-to-day subjective experience of fatigue.", "To determine the relative efficacy of amantadine, pemoline, and placebo in treatment of multiple sclerosis (MS)-related fatigue.\n Fatigue is a complication of MS. Both pemoline and amantadine have been used to treat MS fatigue, but their relative efficacy is not known.\n Amantadine, pemoline, and placebo were compared in a randomized, double-blind, placebo-controlled study using a parallel-group design. Ninety-three ambulatory MS patients completed the study. Primary outcome measures were the fatigue severity scale (FSS); the MS-specific fatigue scale (MS-FS); and subjective response determined by verbal self-report. Secondary outcome measures consisted of assessments of sleep, depression, and vitality. Repeated-measures analysis of variance with planned post-hoc contrasts and Fisher's exact test were used to compare treatment response.\n Amantadine-treated patients showed a significantly greater reduction in fatigue, as measured by the MS-FS, than did patients treated with placebo (p = 0.04). By verbal report at the end of the study, 79% of patients treated with amantadine versus 52% treated with placebo and 32% treated with pemoline preferred drug therapy compared with no treatment (p = 0.03). No significant differences in any primary outcome measures were noted between pemoline and placebo. Neither amantadine nor pemoline affected sleep or depression relative to placebo.\n Amantadine was significantly better than placebo in treating fatigue in MS patients, whereas pemoline was not. The benefit of amantadine was not due to changes in sleep, depression, or neurologic disability.", "Because amantadine has been shown to reduce fatigue in patients with multiple sclerosis, we performed a double-blind, placebo-controlled study to assess its efficacy in the disabling symptom of post-polio fatigue. Twenty-three patients completed six weeks of therapy. Fatigue was measured by the patients using visual analogue scales (twice per day) and numerical fatigue severity scales (once per week) and by overall impression (at end of therapy). Formal neuropsychological testing and serum drug levels were performed to assess compliance. On all measures, no significant difference was found between treatment and placebo groups. Fifty-four percent of patients given amantadine and 43% given placebo reported a decrease in fatigue; however, the visual analogue scales and fatigue severity scales failed to reflect any improvement. Several patients in the treatment group elected to continue amantadine therapy after the study was completed. Our findings suggest that amantadine is not significantly better than placebo in reducing the sensation of fatigue in post-polio syndrome, and that the measures we employed were insensitive to capture the subjective response experienced by a few patients.", "We carried out a double blind control study of fatigue in 32 patients with multiple sclerosis, comparing amantadine hydrochloride 100 mg twice a day and placebo. On amantadine 31% had marked improvement; 15.6% moderate improvement; 15.6% mild improvement; and 36.5% unchanged. On placebo, none noted marked improvement; one claimed moderate improvement on either amantadine or placebo. 18.7% reported mild improvement on placebo; and most of them had similar or more response to amantadine. No patient selected placebo over amantadine at the end of the trial. Overall improvement was seen in 62.5% of patients on amantadine and 21.8% on placebo. Additional experience up to two years suggests continued benefit but common and important side-effects.", "In a double-blind placebo-controlled crossover study of ten patients with multiple sclerosis, we found amantadine hydrochloride therapy to be effective in improving fatigability in six. Administration of the drug was associated with significantly higher levels of beta-endorphin-beta-lipotropin and responders had significantly higher levels than nonresponders. Lactate levels were significantly higher and pyruvate levels lower in nonresponders. Amantadine given for fatigue to patients with multiple sclerosis is associated with measurable changes in levels of metabolites and peptides in the circulation.", "Treatment with acetyl L-carnitine (ALCAR) has been shown to improve fatigue in patients with chronic fatigue syndrome, but there have been no trials on the effect of ALCAR for treating fatigue in multiple sclerosis (MS). To compare the efficacy of ALCAR with that of amantadine, one of the drugs most widely used to treat MS-related fatigue, 36 MS patients presenting fatigue were enrolled in a randomised, double-blind, crossover study. Patients were treated for 3 months with either amantadine (100 mg twice daily) or ALCAR (1 g twice daily). After a 3-month washout period, they crossed over to the alternative treatment for 3 months. Patients were rated at baseline and every 3 months according to the Fatigue Severity Scale (FSS), the primary endpoint of the study. Secondary outcome variables were: Fatigue Impact Scale (FIS), Beck Depression Inventory (BDI) and Social Experience Checklist (SEC). Six patients withdrew from the study because of adverse reactions (five on amantadine and one on ALCAR). Statistical analysis showed significant effects of ALCAR compared with amantadine for the Fatigue Severity Scale (p = 0.039). There were no significant effects for any of the secondary outcome variables. The results of this study show that ALCAR is better tolerated and more effective than amantadine for the treatment of MS-related fatigue.", "The objective of the current study was to determine the efficacy of amantadine in improving cognitive and behavioural performance in a traumatic brain injury (TBI) rehabilitation sample. The design was a prospective, randomized, double-blind, placebo-controlled, crossover design. Subjects were 10 adult traumatic brain injury patients in an acute brain injury rehabilitation unit. Subjects received a 2-week trail of amantadine or placebo, followed by a 2-week washout, then a 2-week trail of the alternative (placebo or amantadine). Neuropsychological outcome measures included orientation, attention, executive function, memory, orientation, behaviour, and a composite variable. Results of repeated measures ANOVA and regression analysis of slope/change showed a main effect of time, but no significant difference for amantadine versus placebo. In conclusion, although patients generally improved, this initial exploratory study found no differences in rate of cognitive improvement between subjects given amantadine versus those given placebo. However, the small sample size, heterogeneous population, acute time course, and large number of dependent variables limit power and generalizability. Implications are discussed for further research to better answer questions regarding efficacy of amantadine post-TBI.", "Cognition in schizophrenia is impaired in a variety of cognitive domains. Galantamine, a cholinesterase inhibitor with putative nicotinic agonist-like effects, improves cognition in Alzheimer's patients.\n Sixteen schizophrenic or schizoaffective patients stabilized on risperidone were administered galantamine (n=8) or placebo (n=8) in a randomized, double-blind trial. The Repeatable Battery for Assessment of Neuropsychological Status (RBANS) assessed changes in cognitive performance over an eight-week treatment interval.\n Clinical symptoms improved in both groups during the trial with no evidence that galantamine exacerbated extrapyramidal symptoms. Patients treated with galantamine experienced an overall improvement in cognitive performance (RBANS Total scale score; galantamine = 12.1 +/- 12.8 SD, placebo = .5 +/- 13.5, t = 2.32, p < .04). Confidence intervals suggest that RBANS Attention and Delayed Memory subscale performance was robustly improved in galantamine patients by approximately one standard deviation, effectively normalizing cognitive performance in these domains.\n Adjunctive treatment with galantamine improves memory and attention in patients with schizophrenia who are stabilized on risperidone, providing the opportunity to improve functional outcome in these patients." ]

[ "11880065", "14970093", "11295408", "10190914", "16566424", "9892331", "2085989", "16392777", "2487304" ]

[ "Single-dose fluoroquinolone therapy of acute uncomplicated urinary tract infection in women: results from a randomized, double-blind, multicenter trial comparing single-dose to 3-day fluoroquinolone regimens.", "Optimal duration of antibiotic therapy for uncomplicated urinary tract infection in older women: a double-blind randomized controlled trial.", "Treatment of lower urinary tract infection in pregnancy.", "Comparison of a beta-lactam alone versus beta-lactam and an aminoglycoside for pulmonary exacerbation in cystic fibrosis.", "[A study of non-antibiotic versus antibiotic prophylaxis for recurrent urinary-tract infections in women (the NAPRUTI study)].", "Oral vs intravenous ciprofloxacin in the initial empirical management of severe pyelonephritis or complicated urinary tract infections: a prospective randomized clinical trial.", "Fosfomycin trometamol versus netilmicin in children's lower urinary tract infections.", "Acute uncomplicated lower urinary tract infections in general practice: clinical and microbiological cure rates after three- versus five-day treatment with trimethoprim.", "[Acute cystourethritis during pregnancy]." ]

[ "To compare the efficacy and safety of single-dose and 3-day fluoroquinolone treatment of uncomplicated urinary tract infection (UTI).\n Adult women with acute uncomplicated UTI were randomized to receive either a single dose of gatifloxacin (400 mg), 3 days of gatifloxacin (200 mg daily), or 3 days of ciprofloxacin (100 mg twice daily). Patients were assessed at four points during the study: before treatment (within 48 hours before the initiation of the study medication), at the end of treatment (by telephone contact on day 3), and twice after treatment completion (5 to 9 days after treatment [test-of-cure visit] and 29 to 42 days after treatment [only patients with a bacteriologic response of eradication at the test-of-cure visit]).\n The bacterial eradication rate for the single-dose gatifloxacin, 3-day gatifloxacin, and 3-day ciprofloxacin groups was 90%, 95%, and 89%, respectively; the clinical efficacy rate was 93%, 95%, and 93%, respectively, for microbiologically assessable patients at the test-of-cure visit. Eradication of the most common uropathogens, including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, was achieved with gatifloxacin and ciprofloxacin. Single-dose gatifloxacin was equivalent to 3-day ciprofloxacin in both microbiologic and clinical efficacy.\n Single-dose and 3-day gatifloxacin were microbiologically and clinically equivalent to 3-day ciprofloxacin for the treatment of acute UTI among women. Single-dose gatifloxacin may offer advantages over 3-day fluoroquinolone therapy for uncomplicated UTI by decreasing secondary use of medical resources and improving patient compliance.", "The optimal duration of antibiotic therapy in older patients with uncomplicated urinary tract infection (UTI) is still a matter of debate. The aim of this randomized controlled double-blind noninferiority trial was to compare the efficacy and safety of 3-day and 7-day courses of oral ciprofloxacin for uncomplicated symptomatic UTI in older women.\n A total of 183 women at least 65 years of age with acute uncomplicated UTI were recruited from ambulatory clinics and hospital acute care units. Patients with pyelonephritis, contraindications to fluoroquinolones, recent use of antibiotics, urinary tract abnormalities and diabetes mellitus were excluded. Women were randomly assigned to receive either ciprofloxacin 250 mg twice daily orally for 3 days followed by placebo for 4 days (the 3-day group, 93 patients) or ciprofloxacin 250 mg twice daily orally for 7 days (the 7-day group, 90 patients). Bacterial eradication, clinical improvement and occurrence of adverse events were determined 2 days after completion of treatment, and occurrence of reinfection or relapse were determined 6 weeks after completion of treatment. Bacterial eradication and relapse were determined by urine culture. Double-blind procedures were maintained throughout data collection.\n The proportion of patients with bacterial eradication at 2 days after treatment was 98% (91/93) in the 3-day group and 93% (83/89) in the 7-day group (p = 0.16). The frequency of adverse events, including drowsiness, headache, nausea or vomiting, and loss of appetite, was significantly lower in the 3-day group.\n These results suggest that a 3-day course of antibiotic therapy is not inferior to a 7-day course for treatment of uncomplicated symptomatic UTI in older women, and that the shorter course is better tolerated.", "Urinary tract infection (UTI) is a common complication of pregnancy. Approximately 20--40% of women with asymptomatic bacteriuria will develop pyelonephritis during pregnancy. All pregnant women, therefore, should have their urine cultured at their first visit to the clinic. In a clinical study comparing single-dose treatment with 3 g fosfomycin trometamol versus a 3-day course of 400 mg ceftibuten orally, the inclusion criteria were acute symptomatic lower UTI (acute cystitis), significant bacteriuria (> or =10(3) CFU/ml), pyuria and confirmed pregnancy. Excluded were patients with asymptomatic bacteriuria or acute pyelonephritis. Predisposing factors comprised a history of recurrent UTI, diabetes mellitus, analgesic nephropathy, hyperuricaemia or Fanconi's syndrome. Escherichia coli was the most frequently isolated pathogen in both groups. Therapeutic success (clinical cure and bacteriological eradication of uropathogens) was achieved in 95.2% of the patients treated with fosfomycin-trometamol versus 90.0% of those treated with ceftibuten (P, non-significant). The treatment of acute cystitis in pregnant women using a single-dose of fosfomycin trometamol was equally effective as the 3-day course of oral ceftibuten. Both regimens were well tolerated with only minor adverse effects. Long-term chemoprophylaxis should be suggested in patients with recurrent UTI or following acute pyelonephritis during pregnancy.", "We determined whether a beta-lactam and an aminoglycoside have efficacy greater than a beta-lactam alone in the management of a pulmonary exacerbation in patients with cystic fibrosis. Study design: Azlocillin and placebo or azlocillin and tobramycin were administered to 76 patients with a pulmonary exacerbation caused by Pseudomonas aeruginosa in a randomized double-blind, third-party monitored protocol. Improvement was assessed by standardized clinical evaluation, pulmonary function testing, sputum bacterial density, sputum DNA content, and time to the next pulmonary exacerbation requiring hospitalization.\n No significant difference was seen between the 2 treatment groups in clinical evaluation, sputum DNA concentration, forced vital capacity, forced expiratory volume in second 1, or peak expiratory flow rate at the end of treatment (33 receiving azlocillin alone and 43 both antibiotics); adverse reactions were equivalent in each group. Sputum P. aeruginosa density decreased more with combination therapy (P =.034). On follow-up evaluation, an average of 26 days after the end of treatment, all outcome indicators had worsened in both groups. Time to readmission for a new pulmonary exacerbation was significantly longer in the group receiving azlocillin plus tobramycin (P <.001). Treatment-emergent tobramycin resistance occurred in both groups and was more frequent with combination therapy.\n We conclude that the combination of a beta-lactam and an aminoglycoside produces a longer clinical remission than a beta-lactam alone and slightly better initial improvement.", "Patient enrolment in the 'Non-antibiotic versus antibiotic prophylaxis for recurrent urinary-tract infections' (NAPRUTI) study was started in September 2005. In this study of women with recurrent urinary-tract infections we aim to investigate the effect of 12 months of non-antibiotic prophylaxis in comparison with antibiotic prophylaxis on the rate of recurrence of urinary-tract infections and the development of antibiotic resistance. The study consists of two interlinked, randomised, clinical non-inferiority trials. In one trial, 280 premenopausal women will receive either cranberry capsules (twice daily 500 mg) or standardised antibiotic therapy (once daily 480 mg trimethoprim-sulfamethoxazole). In the other trial, 280 postmenopausal women will receive either oral lactobacilli (twice daily a capsule with > 10(9) colony-forming units of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) or standardised antibiotic therapy. Non-inferiority of non-antibiotic prophylaxis would be attractive given its potential to reduce the prevalence of microbial resistance to antibiotics significantly.", "There are few data on the efficacy of oral antibiotics in the initial empirical management of severe forms of urinary tract infection (UTI).\n In a multicenter, prospective, randomized trial we compared oral (500 mg twice daily) vs intravenous ciprofloxacin (200 mg twice daily) in the initial empirical management of hospitalized patients with serious forms of UTI. Exclusion criteria were severe sepsis, inability to take oral medication, or the presence of obstruction or renal foci of suppuration. The study population included 66 women with pyelonephritis, 43 patients with community-acquired UTIs, and 32 patients with hospital-acquired UTIs. The frequency of bacteremia was 28 (42%) of 66 in the patients with pyelonephritis and 25 (33%) of 75 in those with complicated UTIs. Seventy-two patients were randomized to treatment with oral and 69 to intravenous ciprofloxacin.\n There were no infection-related deaths and no patients required an early change of antibiotics because of worsening clinical status during the initial empirical phase of treatment. The mean duration of fever was 1.7 days in patients treated by the oral vs 1.9 days in patients treated by the intravenous route (P = .15). The rates of microbiological failure (3% in the oral vs 2% in the intravenous treatment group) and of unsatisfactory clinical response (4% oral vs 3% intravenous) were low. A treatment change was eventually required in 14% of the patients assigned to the oral and 7% of the patients assigned to the intravenous regimen, mainly because of the isolation of enterococci or ciprofloxacin-resistant organisms in pretherapy urine specimens.\n In the hospital setting, oral ciprofloxacin is as effective as the intravenous regimen in the initial empirical management of serious UTIs, including bacteremic forms, in patients without severe sepsis, obstruction, or renal foci of suppuration. The efficacy of the oral regimen indicates a potential use for ciprofloxacin in outpatient treatment of a subset of patients currently hospitalized on account of disease severity.", "Fosfomycin trometamol (FT), an antibiotic active against the common urinary pathogens, may be demonstrated in adequate urine concentrations up to 36-48 h after a single oral dose of 1-2 g. This pharmacokinetic peculiarity seems to indicate that this antibiotic may be used in single doses in the therapy of lower urinary tract infections (UTIs) in infants and children. The efficacy and safety of FT in single oral doses was compared with those of netilmicin (NM), an aminoglycoside antibiotic with a demonstrated efficacy in bolus doses against UTIs, shown in a multicentric study. One hundred and thirty-five children with lower UTI, diagnosed on the basis of fever (less than 38 degrees C), erythrocyte sedimentation rate (less than 25 mm/l h) and C-reactive protein (less than 20 micrograms/ml), were included in the study: 71 received 2 g of FT, 64 5 mg/kg of NM. Cure, defined as persistence of sterile urine up to 30 days after therapy, was reached in 80.2% of children in the FT group and in 81.2% of children in the NM group. Persistence of infection was demonstrated in 7 and in 3 children, respectively. Recurrence of infection was noticed in 7 patients in the FT group and in 9 in the NM group. No differences between FT- and NM-treated children are demonstrable even if the patient population is analyzed according to the higher risk of UTI because of the presence of an anatomical and/or functional abnormality of the urinary tract or due to a previous tendency to recurrent UTIs. FT is as effective as NM in the treatment of lower UTIs in infants and children.", "Epidemiological studies indicate that acute uncomplicated urinary tract infections (UTI) in women can be successfully treated with short treatment regimens. However, the findings from the literature do not match experiences in daily practice.\n A randomised, controlled trial evaluating the microbiological and clinical (self-reported) cure rates of a three-day vs. five-day treatment regimen with trimethoprim for UTI in women.\n No statistically significant difference in bacteriological cure rate was found between the three-day and five-day regimen. One day after the shorter regimen 44% of women considered themselves as 'not-recovered' due to persistence of the symptoms compared with 35% after the five-day treatment (p > 0.05). Three days after therapy these percentages were 30 and 25% respectively.\n The relatively high percentage of persistent symptoms one day after the three-day regimen might be responsible for general practitioners believing that short regimens are not successful. It is therefore advisable that if urine samples are controlled to wait at least three days after finishing treatment.", "A prospective study was carried out in 103/863 obstetric patients with cystitis characterized by urinary urgency and frequency, dysuria, pyuria and suprapubic discomfort in the absence of systemic symptoms such as fever and costovertebral angle tenderness. The association of symptomatic lower urinary tract infection with low-count bacteriuria (10(2)-10(5) UFC/mL of urine) was present in all the patients. The incidence of cystourethritis was about 12%, most of the infections occurred at the first trimester. To learn whether a multiple-dose of nitrofurantoin or ampicillin is safe and effective therapy for acute uncomplicated urinary tract infections, 103 symptomatic pregnant women were randomly grouped to receive oral nitrofurantoin (100 mg t.i.d.) or ampicillin (500 mg t.i.d.) for five days. Seventeen patient were excluded since they did not return for follow-up. Escherichia coli was isolated in 67% of infections. Overall cure varied from 87% to 89%, without any great differences between the regimens. Nine patients had asymptomatic bacteriuria in the course of pregnancy, four developed acute pyelonephritis and one of them had abnormal intravenous pyelogram." ]

[ "1751442", "8399011", "9875920", "2223682", "9141579", "12946338", "8476803", "11408301", "9141577" ]

[ "Doppler flow velocity waveform analysis in high risk pregnancies: a randomized controlled trial.", "The effect of introduction of umbilical Doppler recordings to obstetric practice.", "A randomized, controlled trial of computerized physiologic trend monitoring in an intensive care unit.", "Randomized comparison of routine vs highly selective use of Doppler ultrasound and biophysical scoring to investigate high risk pregnancies.", "Randomised controlled trial of cardiotocography versus umbilical artery Doppler in the management of small for gestational age fetuses.", "A randomised controlled trial of admission electronic fetal monitoring in normal labour.", "Randomised comparison of routine versus highly selective use of Doppler ultrasound in low risk pregnancies.", "Randomised controlled trial of cardiotocography versus Doppler auscultation of fetal heart at admission in labour in low risk obstetric population.", "A randomised controlled trial of Doppler ultrasound velocimetry of the umbilical artery in low risk pregnancies. Doppler French Study Group." ]

[ "To test whether the introduction of Doppler waveform analysis into the ultrasound department of a tertiary level hospital reduces neonatal morbidity and improves obstetric management.\n A randomized controlled trial.\n Department of Ultrasound, King Edward Memorial Hospital, Perth, Western Australia.\n 505 women with pregnancy abnormalities referred to an ultrasound department for fetal investigation during the third trimester.\n Continuous wave Doppler studies of umbilical and uteroplacental arterial circulations. Results were revealed to patients and clinicians.\n Principal end point was the duration of neonatal stay in hospital; other end points included the number and type of fetal heart rate monitoring studies, obstetric interventions, frequency of fetal distress, birthweight, Apgar scores and need for neonatal intensive care.\n There was no effect on the duration of neonatal stay in hospital. Small trends in obstetric management were observed with study group patients having fewer contraction stress tests, less likelihood of antepartum fetal distress, and more likelihood of fetal distress after induction of labour leading to emergency caesarean section. Depressed Apgar scores were more frequent in the study group.\n Introduction of Doppler waveform studies did not result in reduced neonatal morbidity but did have a small effect on obstetric management. For each institution the role of Doppler studies in late pregnancy will be influenced by the usage of other tests of fetal welfare already entrenched in clinical practice.", "To assess the effect on obstetric practice of clinician access to umbilical artery Doppler ultrasound results.\n Randomised controlled trial.\n A large teaching hospital.\n Two thousand two hundred and eighty-nine pregnancies defined as being at risk by referral for Doppler or fetal monitoring.\n Continuous wave Doppler studies of umbilical artery. Results immediately available to clinicians.\n Fetal outcome: perinatal mortality, Apgar score and admission to the neonatal unit. Obstetric intervention: admission to hospital, induction of labour and caesarean section. Use of of fetal well being: cardiotocography, biophysical profile and ultrasound biometry.\n The treatment and control groups were comparable in age, parity, gestation at point of entry and risk features. There were no overall differences in perinatal outcome, obstetric intervention or use of fetal monitoring. Examination of a subset recruited only because of hypertension or suspected intrauterine growth retardation (n = 754) similarly showed no difference attributable to group randomisation. Comparison of only those pregnancies retrospectively defined as low risk and high risk showed more use of cardiotocography in the high risk group with access to Doppler (P = 0.007) but no difference in the low risk group.\n Doppler umbilical artery recording has been shown to perform well in prediction power of antenatal fetal compromise. What has been examined in this study is the response of clinicians to the test. The results suggest that obstetricians do not use the test to modify their risk assessment, and, therefore, the need for fetal monitoring in particular pregnancies. There is a real need for accumulation of information from very large data sets, particularly in the prediction power of Doppler for antenatal fetal compromise from apparently chronic utero-placental cause to guide use of monitoring resources. If simply added to existing fetal monitoring techniques in a hospital where these are widely used, then umbilical artery Doppler recordings may at present simply involve extra resources of staff and expenses, without benefit.", "To assess whether the provision of computerized physiologic trend data could improve outcome in newborn infants requiring intensive care.\n Randomized, controlled trial, with subsidiary questionnaire studies.\n Tertiary neonatal intensive care unit with 12 intensive care cots.\n All infants admitted between January 1991 and September 1993 who were < or =32 wks gestation or >32 wks gestation, and ventilated for >4 hrs or asphyxiated.\n Randomization to one of four groups for first 7 days of life: A) no display of trend data; B) continuous display of trend data; C1) alternating 24-hr display of trend data, starting with display in first 24 hrs; and C2) alternating 24-hr display of trend data, starting with no display in first 24 hrs.\n The short-term effects of monitoring on patient outcome was judged by volume of colloid given, number of blood gases taken, and by measurement taken from cranial Doppler ultrasound. Medium-term measures included time ventilated, time given supplemental oxygen, death, time to death or discharge, and cranial ultrasound at discharge. Long-term outcome was assessed by neurodevelopmental status at age 1 to 4 yrs of age. Staff and parent questionnaires assessed their respective attitudes to the introduction of this technology. None of the patient outcome measures, short-, medium-, or long-term, demonstrated any significant benefit from the provision of computerized physiologic trend monitoring. Staff questionnaires demonstrated an acceptance of the system and an improved understanding of neonatal physiology as a result of computerized physiologic trends. Parent questionnaires demonstrated increased anxiety caused by the system in 11% of parents, although only 1% of parents continued to have concerns if the system were able to help their child.\n A randomized, controlled trial was unable to demonstrate any benefit to patients resulting from the introduction of a computerized physiologic trend monitoring system. Benefits of the system have been recognized, however, in subsidiary studies, staff education, and research studies.", "To compare routine versus highly selective use of Doppler ultrasound and biophysical scoring in higher risk pregnancy.\n A pragmatic randomized trial.\n St James's University Hospital, Leeds.\n 500 pregnant women at high risk of intrauterine growth retardation or still birth.\n Regular monitoring with biophysical profile assessment and Doppler velocity waveform recording in umbilical and uteroplacental arteries. Results immediately available to clinicians.\n Gestational age at delivery, obstetric intervention rates and short-term neonatal morbidity.\n Risk factors were distributed very evenly between the 250 patients in the study and control groups respectively. A total of 902 biophysical profile and Doppler assessments were done in the 250 study group patients and only in 12 patients in the control group. In the study group, absent end-diastolic flow was found in only 2.7% of all 902 measurements. A persistently abnormal biophysical score was always associated with absence of end-diastolic flow. The mean gestational age at induction of labour was statistically and clinically similar in the two groups and there was no overall statistically significant difference in intervention rates between the two groups. There was a statistically significant lower frequency of depressed 5-min Apgar scores in the study group. Serious neonatal morbidity was also statistically significantly more common in the control group than in the study group.\n The use of Doppler ultrasound in higher risk pregnancies does not lead to an increase in iatrogenic preterm delivery. The total rate of positive tests on Doppler ultrasound is very low and persistently abnormal biophysical scores are unlikely to be found in patients where umbilical end-diastolic blood flow is present. Surrogate measures for fetal damage seem to be improved when clinicians have access to Doppler ultrasound assessments.", "To compare the impact on use of resources in the management of small for gestational age babies using Doppler ultrasound versus cardiotocography.\n A randomised controlled trial.\n A large district general hospital delivering 5500 to 6000 infants each year, 30% to 35% of which are to women of Pakistani origin.\n One hundred and fifty women delivered of small for gestational age infants.\n Primary outcome measures were length of hospital inpatient stay and induction of labour rates. Secondary outcome measures included caesarean section rates and length of stay on neonatal unit.\n The use of Doppler reduced average hospital inpatient stay from 2.5 days to 1.1 days, compared with cardiotocography (P = 0.036). There was no effect on induction of labour rates or caesarean section rates. There was no significant difference in length of stay on the neonatal unit (P = 0.33). There was a reduction in monitoring frequency and fewer hospital antenatal clinic visits.\n The use of Doppler ultrasound to manage small for gestational age infants reduces the use of resources, compared with cardiotocography.", "To test the hypothesis that the use of admission Electronic Fetal Monitoring (EFM) for healthy pregnant women in spontaneous labour would result in an increase in continuous EFM when compared to women who have had no admission EFM.\n A randomised controlled trial.\n The Midwives Birth Unit in Glasgow Royal Maternity Hospital, a major urban teaching hospital with approximately 5000 births per year.\n Healthy pregnant women admitted in normal labour, deemed low risk based on the midwives' birth unit admission criteria.\n Women were randomly allocated either to receive a routine 20-minute period of EFM at the time of admission (control group), or to receive no routine admission EFM (study group).\n Primary study outcomes, use of continuous EFM; and use of EFM additional to the admission test. Secondary outcomes: artificial rupture of membranes, use of fetal scalp electrode, fetal blood sample, syntocinon, epidural analgesia, number of vaginal examinations, rate of transfer to labour ward, and reason for transfer.\n There was no statistically significant difference between the groups for use of continuous monitoring, but significantly more women in the control group did receive additional EFM. There was no statistically significant difference between groups for any of the interventions studied.\n The use of admission EFM did not in itself lead to a cascade of intervention. Other factors including setting of care and philosophy of caregivers may have an effect on the rate of intervention in labour.", "To help answer the question: should Doppler ultrasound of the umbilical circulation be made available to all pregnant women as part of their routine antenatal care?\n A randomised trial.\n St James's University Hospital, Leeds.\n 2025 low risk primigravid women.\n Obstetric intervention rates and short term neonatal morbidity.\n The incidence of abnormal Doppler was low (1.7%) with complete absence of end diastolic flow in only 0.3% of cases. No significant differences could be demonstrated between control and study women in any of the outcomes measured.\n This study did not demonstrate any benefit or harm from Doppler ultrasound as a routine screening test for all low risk women, whereas our previous studies have suggested that it is useful in high risk pregnancies. Any marginal returns on extending access to Doppler ultrasound from high risk to all women must be small. Since this test has excellent performance characteristics (sensitivity and specificity) for the prediction of fetal hypoxia and acidosis our results call into question the cost to benefit ratio of all tests designed to predict these outcomes in low risk women.", "To compare the effect of admission cardiotocography and Doppler auscultation of the fetal heart on neonatal outcome and levels of obstetric intervention in a low risk obstetric population.\n Randomised controlled trial.\n Obstetric unit of teaching hospital\n Pregnant women who had no obstetric complications that warranted continuous monitoring of fetal heart rate in labour.\n Women were randomised to receive either cardiotocography or Doppler auscultation of the fetal heart when they were admitted in spontaneous uncomplicated labour.\n The primary outcome measure was umbilical arterial metabolic acidosis. Secondary outcome measures included other measures of condition at birth and obstetric intervention.\n There were no significant differences in the incidence of metabolic acidosis or any other measure of neonatal outcome among women who remained at low risk when they were admitted in labour. However, compared with women who received Doppler auscultation, women who had admission cardiotocography were significantly more likely to have continuous fetal heart rate monitoring in labour (odds ratio 1.49, 95% confidence interval 1.26 to 1.76), augmentation of labour (1.26, 1.02 to 1.56), epidural analgesia (1.33, 1.10 to 1.61), and operative delivery (1.36, 1.12 to 1.65).\n Compared with Doppler auscultation of the fetal heart, admission cardiotocography does not benefit neonatal outcome in low risk women. Its use results in increased obstetric intervention, including operative delivery.", "To evaluate the effect on management and outcome of pregnancy of routine umbilical Doppler examination in low risk populations.\n Pragmatic randomised controlled trial.\n Twenty centres caring for low risk pregnant women.\n 4187 women were randomly assigned to umbilical Doppler between 28 and 34 weeks of gestation or no routine umbilical Doppler. The women included were at low risk at 28 weeks of gestation defined by a normal ultrasonographic examination at the time of randomisation and no obstetric or medical complications during the first two trimesters of the pregnancy.\n The general characteristics at inclusion were comparable for the two groups. Performance of umbilical Doppler led to a significant increase in the number of ultrasonographic and Doppler examinations subsequently conducted; there were no other effects on the management of the pregnancy. There was no significant difference in fetal distress during labour (odds ratio [OR] 0.96; 95% confidence interval [CI] 0.70-1.33). There were three times fewer perinatal deaths in the Doppler group (three versus nine), but this difference was not significant (OR 0.33; 95% CI 0.06-1.33).\n Based on this trial routine use of umbilical doppler for low risk pregnancy cannot be recommended. More data are needed to reach a definite conclusion of the value of routine Doppler." ]

[ "11251497", "2406656", "12092017", "7819846", "8924098", "2927328", "8494832", "16154062", "2406169" ]

[ "Team midwifery care in a tertiary level obstetric service: a randomized controlled trial.", "A randomized trial of nurse-midwifery prenatal care to reduce low birth weight.", "Traditional care of the perineum during birth. A prospective, randomized, multicenter study of 1,076 women.", "Midwife managed delivery unit: a randomised controlled comparison with consultant led care.", "A randomized, controlled trial of nurse-midwifery care.", "The 'Know Your Midwife' scheme--a randomised trial of continuity of care by a team of midwives.", "Simulated home delivery in hospital: a randomised controlled trial.", "Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial.", "Evaluation of the home-visiting system for women with threatened preterm labor: results of a randomized controlled trial." ]

[ "In 1996 a new model of maternity care characterized by continuity of midwifery care from early pregnancy through to the postpartum period was implemented for women attending Monash Medical Centre, a tertiary level obstetric service, in Melbourne, Australia. The objective of this study was to compare the new model of care with standard maternity care.\n In a randomized controlled trial, 1000 women who booked at the antenatal clinic and met the eligibility criteria were randomly allocated to receive continuity of midwifery care (team care) from a group of seven midwives in collaboration with obstetric staff, or care from a variety of midwives and obstetric staff (standard care). The primary outcome measures were procedures in labor, maternal outcomes, neonatal outcomes, and length of hospital stay.\n Women assigned to the team care group experienced less augmentation of labor, less electronic fetal monitoring, less use of narcotic and epidural analgesia, and fewer episiotomies but more unsutured tears. Team care women stayed in hospital 7 hours less than women in standard care. More babies of standard care mothers were admitted to the special care nurseries for more than 5 days because of preterm birth, and more babies of team care mothers were admitted to the nurseries for more than 5 days with intrauterine growth retardation. No differences occurred in perinatal mortality between the two groups.\n Continuity of midwifery care was associated with a reduction in medical procedures in labor and a shorter length of stay without compromising maternal and perinatal safety. Continuity of midwifery care is realistically achievable in a tertiary obstetric referral service.", "In a randomized, controlled trial in five regional centers with state health department clinics, 1458 women at high risk for low birth weight (LBW) outcome received either prenatal interventions provided by nurse-midwives and nurses under their supervision or the standard high-risk prenatal care provided by obstetricians. The intervention administered by the nurse-midwives included patient education to identify the signs and symptoms of preterm labor, activity counseling in response to monitoring of the cervix by frequent examinations, stress reduction by enhancing social support, nutrition counseling with emphasis on weight gain, and substance-abuse counseling. For women in the control group, care was provided by obstetricians according to local standards for the management of high-risk pregnancies. We hypothesized that the LBW rate among live births to women who had received care from nurse-midwives would be lower than that in the control group. Although the LBW rate was lower in the intervention group than in the control group, the observed difference was not statistically significant. Race was not prespecified as a possible effect modifier, but examination of the data post hoc suggested that black women at high statistical risk of giving birth to an LBW infant may have derived benefit from the program. Although the results do not suggest any striking advantage of the nurse-midwifery intervention over standard obstetric care for women at high statistical risk of having an LBW infant, neither do they suggest any disadvantage. Nurse-midwives could provide care to certain populations of high-risk women and facilitate future coverage of these presently underserved populations.", "To investigate the influence of the traditional hands-on versus the innovative hands-poised method on the risk of perineal trauma during vaginal delivery and on neonatal outcomes.\n In a prospective, randomized, multicenter study, 1,161 of 1,505 women giving birth at the Departments of Obstetrics and Gynecology of the University Hospital of Vienna and Semmelweis Women's Hospital, Vienna, between February and September 1999, were randomized into the trial. In the hands-on method, the left hand of the midwife puts pressure on the infant's head, and the right hand is placed against the perineum. In the hands-poised method, the midwife guides the parturient through the birth without touching the perineum, prepared to apply light pressure on the infant's head.\n One hundred eighty-seven of 574 women (32.5%) in the hands-on group and 180 of 502 women (35.8%) in the hands-poised group experienced perineal tears (P = .5). Sixteen women (2.7%) treated with the hands-on method developed third-degree perineal tears as compared with five women (0.9%) treated with the hands-poised method (P < .05). In the hands-on group, 103 women (17.9%) underwent episiotomy as compared with 51 cases (10.1%) in the hands-poised group (P < .01). No significant differences in neonatal outcomes were observed between the two groups.\n Our data suggest that a policy of hands-poised care is more suitable for preserving the perineum during birth and is a safe and effective birthing alternative for women.", "To examine whether intrapartum care and delivery of low risk women in a midwife managed delivery unit differs from that in a consultant led labour ward.\n Pragmatic randomised controlled trial. Subjects were randomised in a 2:1 ratio between the midwives unit and the labour ward.\n Aberdeen Maternity Hospital, Grampian.\n 2844 low risk women, as defined by existing booking criteria for general practitioner units in Grampian. 1900 women were randomised to the midwives unit and 944 to the labour ward.\n Maternal and perinatal morbidity.\n Of the women randomised to the midwives unit, 647 (34%) were transferred to the labour ward antepartum, 303 (16%) were transferred intrapartum, and 80 (4%) were lost to follow up. 870 women (46%) were delivered in the midwives unit. Primigravid women (255/596, 43%) were significantly more likely to be transferred intrapartum than multi-gravid women (48/577, 8%). Significant differences between the midwives unit and labour ward were found in monitoring, fetal distress, analgesia, mobility, and use of episiotomy. There were no significant differences in mode of delivery or fetal outcome.\n Midwife managed intrapartum care for low risk women results in more mobility and less intervention with no increase in neonatal morbidity. However, the high rate of transfer shows that antenatal criteria are unable to determine who will remain at low risk throughout pregnancy and labour.", "In 1990 a pilot nurse-midwifery program was implemented in a tertiary care hospital in a major western Canadian city. a randomized, controlled trial was conducted to determine if, when maternal and newborn patient outcomes were compared, the midwifery program was as effective as traditional, low-risk health care available in the city.\n All low-risk women who requested and qualified for nurse-midwifery care were randomly assigned to an experimental or control group.\n One hundred one women received care from nurse-midwives and 93 received standard care from either an obstetrician or family physician. The rate of cesarean delivery in the nurse-midwife group was 4 percent compared with 15.1 percent in the physician group. The episiotomy rate, excluding cesarean deliveries, for the nurse-midwife group was 15.5 percent compared with 32.9 percent in the physician group. The rates of epidural anesthesia for pain relief in labor were 12.9 percent and 23.7 percent, respectively. Statistically significant differences were found ultrasound examinations, amniotomy, intravenous drug administration during labor, dietary supplements, length of hospital stay, and admission of infants to the neonatal intensive care unit.\n The results clearly support the effectiveness of the pilot nurse-midwifery program and suggest that more extensive participation of midwives in the Canadian health care system is an appropriate use of health care dollars.", "A team of four midwives provided the majority of care during pregnancy, labour and the puerperium to 503 women at low obstetric risk, over a 2-year period. Compared with standard hospital care randomly allocated to 498 women this 'Know Your Midwife' scheme was associated with greater continuity in all phases of maternity care. The scheme appeared very acceptable to women: they spent less time in the antenatal clinic, and overall, felt more satisfied, better prepared and better able to discuss problems. The scheme was characterised by less obstetric intervention particularly in respect of augmentation of labour and intrapartum analgesia; labours tended to be longer. Neonatal outcome was generally similar in the two groups but the size of the trial did not allow a precise assessment of differential effects in these terms. The 'Know Your Midwife' scheme is feasible. It should now be introduced more widely but in a way which allows continuing evaluation.", "To compare the outcome of two methods of maternity care during the antenatal period and at delivery. One was to be midwife-led for both antenatal care and delivery, the latter taking place in rooms similar to those in one's own home to simulate home confinement. The other would be consultant-led with the mothers labouring in the delivery suite rooms with resuscitation equipment for both mother and baby in evidence, monitors present and a delivery bed on which both anaesthetic and obstetric procedures could be easily and safely carried out.\n Randomised controlled trial.\n Leicester Royal Infirmary Maternity Hospital.\n Of 3510 women who were randomised, 2304 were assigned to the midwife-led scheme and 1206 were assigned to the consultant-led scheme.\n Complications in the antenatal, intrapartum and postpartum periods were compared as was maternal morbidity and fetal mortality and morbidity. Satisfaction of the women with care over different periods of the pregnancy and birth were assessed.\n There were few significant differences in antepartum, intrapartum and postpartum events between the two groups. There was no difference in the percentage of mothers and babies discharged home alive and well. Generally higher levels of satisfaction with care antenatally and during labour and delivery were shown in those women allocated to midwife care.", "Genital tract trauma after spontaneous vaginal childbirth is common, and evidence-based prevention measures have not been identified beyond minimizing the use of episiotomy. This study randomized 1211 healthy women in midwifery care at the University of New Mexico teaching hospital to 1 of 3 care measures late in the second stage of labor: 1) warm compresses to the perineal area, 2) massage with lubricant, or 3) no touching of the perineum until crowning of the infant's head. The purpose was to assess whether any of these measures was associated with lower levels of obstetric trauma. After each birth, the clinical midwife recorded demographic, clinical care, and outcome data, including the location and extent of any genital tract trauma. The frequency distribution of genital tract trauma was equal in all three groups. Individual women and their clinicians should decide whether to use these techniques on the basis of maternal comfort and other considerations.", "We assessed the effectiveness of the home-visiting system in reducing the care provided in maternity units, especially hospitalization, and attempted to establish whether this system increases women's satisfaction with medical care. The trial involved 158 women and was conducted in four maternity units in Paris. A policy of one or two weekly visits by domiciliary midwives was compared with the usual policy of the hospitals. The study was restricted to women with moderate threatened preterm labor between 26 and 36 weeks of gestation. No decrease in the number of women hospitalized or the number of days spent in hospital was observed in the intervention group, but the number of prenatal visits to outpatient clinics was significantly smaller in the intervention than control group. Satisfaction with medical care during the episode of threatened preterm labor was much greater in the intervention group. Home visits by a midwife were considered by the women to be a better care system than numerous outpatient visits or hospitalization. Our results for medical care suggest that the introduction of the home-visiting system did not greatly alter medical practice in the maternity units, although this system had been designed to avoid or reduce hospitalization." ]

[ "7835254", "7974045", "3285637", "6866590", "11332926", "2205798", "18208636", "8632217", "16946216" ]

[ "Factors affecting the morbidity of vitamin D deficiency rickets and primary protection.", "Rickets in very-low-birth-weight infants born at Baragwanath Hospital.", "Double blind study on the need for vitamin D supplementation in prepubertal children.", "Nutrient and mineral retention and vitamin D absorption in low-birth-weight infants: effect of medium-chain triglycerides.", "A randomized controlled clinical trial of zinc, vitamin A or both in undernourished children with persistent diarrhea in Bangladesh.", "Reduced mortality among children in southern India receiving a small weekly dose of vitamin A.", "Effect of vitamin D supplementation on bone and vitamin D status among Pakistani immigrants in Denmark: a randomised double-blinded placebo-controlled intervention study.", "Zinc supplementation reduces the incidence of persistent diarrhea and dysentery among low socioeconomic children in India.", "Effects of dietary calcium intervention on adolescent mothers and newborns: A randomized controlled trial." ]

[ "Rickets was investigated in 860 children in the 3 to 36 month age group in 21 villages attached to Sinik Health Centre, in northeastern Turkey. The blood calcium, phosphorus and alkaline phosphatase levels of suspect cases were determined following examination and wrist x-rays taken. The prevalence of cross-sectional rickets was determined, in the cohort group formed by removing the rickets cases (to the first group, advice was not given; to the second, 400 IU of vitamin D) and its incidence determined. The prevalence of rickets was calculated as 9.8% with no distinction observed between males and females (P > 0.05). It is higher in children in the 3-6 month group (23.97%) (P < 0.05); exposed rarely to the sun (P < 0.001); without fish in diet (P < 0.01); born to mother under 18 years old (P < 0.001); with a mother not using contraception (P < 0.01). The prevalence of acute respiratory infections (ARI) was calculated as 47.62% and 35.70% (P < 0.05) in children with and without rickets, respectively. The prevalence of enteritis was calculated as 29.76% and 18.43% (P < 0.05) in children with rickets and without rickets, respectively. Rickets was not seen where 400 IU of vitamin D was administered, while incidence for the twelve-month period was calculated as 3.8% in the other group. Combatting rickets is important in developing countries where deaths under five years are largely due to ARI and enteritis.", "Disturbed mineral and bone metabolism has been reported to occur frequently in very-low-birth-weight infants fed breast-milk during the first 3 months of life. This study was designed to assess the prevalence of disturbed mineral homeostasis in a breast-milk-fed very-low-birth-weight population at Baragwanath Hospital and to determine whether the addition of a preterm infant formula to the feeds would reduce this prevalence and increase the rate of weight gain. Fifty-three neonates weighing less than 1 200 g at birth were monitored for weight gain, growth and biochemical and radiological evidence of metabolic bone disease at 2-weekly intervals during hospitalisation and for 18 weeks after discharge. The infants were randomised at 2 weeks of age to receive either breast-milk only, or a combination of breast-milk and a premature formula containing 550 mg calcium and 300 mg phosphorus. All infants received 800 IU vitamin D daily from day 14. Weight gain and growth were similar in both groups. Calcium and phosphorus intakes were higher in the mixed feeding group, but did not affect serum mineral levels. Radiological rickets was uncommon in both groups although periosteal reactions and osteopenia occurred frequently and with similar prevalences. Vitamin D deficiency was not found to be a problem. In conclusion, overt rickets is not a major problem in very-low-birth-weight infants born at Baragwanath Hospital, although biochemical abnormalities occur frequently.(ABSTRACT TRUNCATED AT 250 WORDS)", "Fifty-one healthy prepubertal schoolchildren were followed for 13 months in a double blind study. Twenty-four of them were supplemented with 400 IU of vitamin D2 5-7 times weekly, while 27 received a placebo. The children were examined in winter both at the beginning and at the end of the study, and in the middle of the study in autumn. Mean 25-hydroxyvitamin D levels in the supplemented group were significantly higher than those in the placebo group both in autumn and in winter, when the study ended. The vitamin D supplementation did not, however, affect other vitamin D metabolites, serum calcium, albumin, inorganic phosphorus, parathyroid hormone concentrations or alkaline phosphatase activity. Moreover, the supplementation caused no alterations in the weight or height gain or bone mineral content of the distal radius of the children, and thus subclinical rickets could not be shown.", "A randomized prospective study of the effect of medium-chain triglycerides (MCT) upon the absorption and retention of major minerals and nutrients, as well as upon 25-hydroxy vitamin D levels, was performed in low-birth-weight infants. Ten infants received a high-calcium and vitamin D-containing formula, which contained 50% of its fat as MCT, while ten other infants received a similar formula in which all the fat was in long-chain triglycerides. There was a five-day delay in reaching full oral feeding volumes, and therefore there was a delay in the onset of the balance study in the MCT group, primarily due to gastrointestinal symptoms. There was a significant improvement in the percent of fat absorption (P less than .05) with MCT, but no difference in the percent of absorption or retention of calcium, phosphorus, sodium, or nitrogen. 25-Hydroxy vitamin D levels decreased in both groups after full oral feeding volumes had been established, but all values were within normal ranges. At the high intake levels of calcium and vitamin D given to the infants, MCT did not increase major mineral or nutrient absorption.", "In a double-blind randomized controlled clinical trial, moderately malnourished Bangladeshi children (61-75% of the median weight/age) were studied for the effect of zinc and/or vitamin A supplementation on the clinical outcome of persistent diarrhea. Children 6 mo to 2 y of age with diarrhea for more than 14 d were randomly allocated into 4 groups of 24 receiving a multivitamin syrup and (i) zinc (20 mg elemental), (ii) vitamin A, (iii) both zinc and vitamin A, or (iv) neither, in 2 doses daily for 7 d. Clinical data on recovery and on stool output, consistency and frequency were recorded for 7 d, and weight change from day 1 to day 7 was assessed. The baseline characteristics of the four study groups were comparable. The mean daily stool outputs from days 2 to 7 of therapy were significantly less in the zinc and zinc plus vitamin A groups, but not in the vitamin A group, in comparison with the control group. In children receiving zinc, the cumulative stool weight in the 7 d was 39% less than in the control group (p < 0.001) and 32% less than in the vitamin A group (p = 0.006). The cumulative stool weight in the zinc plus vitamin A group was 24% less than in the control group (p < 0.001), but the 14% lower output than in the vitamin A group was not statistically different. The change in body weight over the 7 d study period was significantly different between the group receiving zinc and the control group (+111 g vs -90 g, p = 0.045). The rate of clinical recovery of children within 7 d was significantly greater in the zinc group (88%) compared with the control group (46%, p = 0.002) or vitamin A group (50%, p = 0.005), but not statistically different from the zinc plus vitamin A group (67%, p = 0.086). Conclusion: The results indicate that zinc, but not vitamin A, supplementation in persistent diarrhea reduces stool output, prevents weight loss and promotes earlier recovery.", "Clinical vitamin A deficiency affects millions of children worldwide, and subclinical deficiency is even more common. Supplemental vitamin A has been reported to reduce mortality among these children, but the results have been questioned.\n We conducted a randomized, controlled, masked clinical trial for one year in southern India involving 15,419 preschool-age children who received either 8.7 mumol (8333 IU) of vitamin A and 46 mumol (20 mg) of vitamin E (the treated group) or vitamin E alone (the control group). Vitamin supplements were delivered weekly by community health volunteers who also recorded mortality and morbidity. Weekly contact was made with at least 88 percent of the children in both study groups. The base-line characteristics of the children were similar and documented a high prevalence of vitamin A deficiency and undernutrition.\n One hundred twenty-five deaths occurred, of which 117 were not accidental. The risk of death in the group treated with vitamin A was less than half that in the control group (relative risk, 0.46; 95 percent confidence interval, 0.30 to 0.71). The risk was most reduced among children under 3 years of age (6 to 11 months--relative risk, 0.28; 95 percent confidence interval, 0.09 to 0.85; 12 to 35 months--relative risk, 0.46; 95 percent confidence interval, 0.26 to 0.81) and among those who were chronically undernourished, as manifested by stunting (relative risk, 0.11; 95 percent confidence interval, 0.03 to 0.36). The symptom-specific risk of mortality was significantly associated with diarrhea, convulsions, and other infection-related symptoms.\n The regular provision of a supplement of vitamin A to children, at a level potentially obtainable from foods, in an area where vitamin A deficiency and under-nutrition are documented public health problems contributed substantially to children's survival; mortality was reduced on average by 54 percent.", "Severe vitamin D deficiency is common among Muslim immigrants. The dose necessary to correct the deficiency and its consequence for bone health are not known for immigrants. The aim was to assess the effect of relatively low dosages of supplemental vitamin D on vitamin D and bone status in Pakistani immigrants. This 1-year-long randomised double-blinded placebo-controlled intervention with vitamin D3 (10 and 20 microg/d) included girls (10.1-14.7 years), women (18.1-52.7 years) and men (17.9-63.5 years) of Pakistani origin living in Denmark. The main endpoints were serum 25-hydroxyvitamin D (S-25OHD), parathyroid hormone, bone turnover markers and bone mass. The study showed that supplementation with 10 and 20 microg vitamin D3 per d increased S-25OHD concentrations similarly in vitamin D-deficient Pakistani women (4-fold), and that 10 microg increased S-25OHD concentrations 2-fold and 20 microg 3-fold in Pakistani men. S-25OHD concentrations increased at 6 months and were stable thereafter. Baseline S-25OHD concentrations tended to be lower in girls and women than in men; females achieved about 46 nmol/l and men 55 nmol/l after supplementation. Serum intact parathyroid hormone concentrations decreased at 6 months, but there was no significant effect of the intervention on bone turnover markers and dual-energy X-ray absorptiometry measurements of the whole body and lumbar spine.", "Persistent diarrhea (PD) and dysentery (DD) account for most diarrhea-associated deaths among children in developing countries. Zinc deficiency can cause stunting and impaired immune function, both of which are risk factors for these diarrheal illnesses. We investigated the effect of zinc supplementation on the incidence of PD and DD in a community-based, double-blind randomized trial in children 6-35 mo of age. Increase over baseline in plasma zinc concentrations in the supplemented group compared with a control group (3.61 vs. 0.009 mumol.L-1), indicated successful supplementation. The overall reductions in the zinc supplemented group of 21% in the incidence of PD (95% CI -6 to 42%) and 14% in the incidence of dysentery (95% CI -15 to 36%) were not significant. There was a significant interaction of treatment effect with baseline plasma zinc concentration and age for PD and with gender for DD. In the zinc-supplemented group compared with the control group, the incidence of PD was reduced by 73% (P < 0.05; 95% CI 34 to 91%) in children with a baseline zinc < 7.65 mumol.L-1 and by 49% (P < 0.05; 95%CI 24 to 66%) in children > 11 mo of age. Zinc supplementation resulted in a 38% (P < 0.05 95%CI 8 to 59%) reduction in the incidence of DD in boys. There was no effect on PD among children 6-11 mo old or on DD in girls. In conclusion, zinc supplementation had a significant impact on the incidence of persistent diarrhea in children > 1 y old and in children with low plasma zinc, as well as on dysentery in boys. These findings may have important implications for reducing diarrhea-related morbidity and mortality.", "To evaluate the effects of dietary calcium (Ca) intervention on adolescent pregnant mothers and their newborns.\n Seventy-two pregnant adolescent mothers were randomized into one of 3 groups: control, orange juice fortified with calcium, and dairy. The orange juice and dairy groups were required to take more than 1,200 mg Ca. Calcium tablets were added for those not able to meet required Ca. Maternal and infant weight, length, and blood pressure (BP) were recorded. Maternal dietary records were evaluated. Mother's blood was drawn for serum Ca, phosphate (P), magnesium (Mg), and vitamin 25-hydroxyvitamin D (D). Cord blood was collected for serum Ca and D. Newborn total body Ca was determined.\n All mothers were similar in weight, height, and BP. Mothers in the orange juice plus calcium and dairy groups had higher intakes of Ca (1,472 mg and 1,771 mg) than controls (862 mg). One half of the mothers in the orange juice plus calcium group required Ca tablets. Mothers in the dairy group had higher intakes of P, D, and Mg, higher serum folate and D, and higher cord D levels. Mothers in the orange juice plus calcium group had higher serum P but lower serum folate and D. Infants (3,517+/-273 g) in the dairy group were heavier than infants in the control (3,277+/-177 g) and orange juice plus calcium (3,292+/-165 g) groups. Infants in the dairy group had higher total body calcium than control infants.\n Calcium diet supplemented with dairy products during adolescent pregnancy resulted in higher maternal vitamin D and folate serum levels and higher newborn weight and bone mineralization compared with controls." ]

[ "9432077", "9738752", "3124628", "3172958", "3324594", "7282909", "11773839", "14758376", "3553455" ]

[ "Use of antibiotic prophylaxis in ear surgery.", "Prophylactic antibiotics in surgery for chronic ear disease.", "The role of prophylactic antibiotics in middle ear surgery. A study on phenoxymethylpenicillin prophylaxis.", "Antimicrobial prophylaxis in ear surgery.", "Single-dose v. short-term antibiotic therapy for prevention of wound infection in general surgery. A prospective, randomized double-blind trial.", "Effectiveness of prophylactic antibiotic treatment in mastoid surgery.", "Preoperative topical ofloxacin solution for tympanoplasty: a randomized, controlled study.", "Prophylactic ciprofloxacin drops after tympanostomy tube insertion.", "Perioperative antibiotic prophylaxis for prevention of postoperative neurosurgical infections. A randomized clinical trial." ]

[ "A prospective, double-blind, randomized, placebo-controlled study was performed to evaluate the effect of antibiotic prophylaxis in ear surgery. The present study reports on the results of 750 patients, half of whom received cefuroxime for 1 day, the other half, placebo. All postoperative infections occurring within 2 weeks after the intervention were recorded, together with several preoperative and perioperative parameters. It is concluded that exploratory tympanoplasties (including stapedotomy) and \"dry perforation\" tympanoplasties should be considered \"clean\" operations according to the American National Research Council and do not benefit from antibiotic prophylaxis. On the other hand, tympanoplasties performed on draining ears and on ears with cholesteatoma should be considered \"dirty\" operations for which antibiotic prophylaxis may decrease the postoperative infection rate by factor 3. All postoperative infections healed without sequels under proper treatment, except for three that resulted in graft necrosis--one in the placebo group and two in the cefuroxime group. In consequence, prophylaxis may not be mandatory in the dirty group, although the authors advocate its use for the sake of patient and surgeon comfort.", "The role of prophylactic antibiotics in otologic surgery continues to be debated and perhaps misused. Prior studies have provided conflicting evidence with regard to the benefit obtained from the use of prophylactic antibiotics in surgery for chronic otitis media. The current study was designed to evaluate the role of prophylactic antibiotics in the outcomes of surgery for chronic ear disease. It was the authors' impression that there was no indication for prophylactic antibiotics in such surgery.\n Randomized prospective study performed in a tertiary care facility.\n Patients who met inclusion criteria (n = 146) were randomly assigned to an antibiotic treatment group or a control group receiving no prophylactic antibiotics. Patients in the antibiotic treatment group were given preoperative intravenous antibiotics followed by oral antibiotics for 5 days after surgery. Patients were followed postoperatively and observed for clinical evidence of infection and graft failure.\n There was no statistically significant difference between the two groups with regard to the incidence of postoperative infection or graft survival.\n The use of prophylactic antibiotics in surgery for chronic ear disease cannot be recommended based on the findings of this study.", "A randomized prospective double-blind study was performed testing the value of phenoxymethylpenicillin in conjunction with middle ear surgery. The patients were evaluated for clinical signs of infection and with bacteriologic cultures both pre- and postoperatively. No difference in clinical signs of infection was noted between the pre- and postoperative evaluations. A significantly larger number of patients, however, presented with postoperative positive bacteriologic cultures as compared with the preoperative cultures. This increase was particularly evident in the placebo group. The two microorganisms that were found in increased numbers postoperatively were Staphylococcus epidermidis and Pseudomonas strains. The value of prophylactic antibiotic treatment and phenoxymethylpenicillin treatment in particular is discussed.", "The purpose of this research was to assess the efficacy of prophylactic antibiotic administration in ear surgery over a wide range of cases. Additional objectives include the assessment of the relative effect of patient age, duration of operation, preoperative condition, and the success of tympanoplasty. Prospectively, in a controlled study, 4,000 patients were studied employing cephalosporin and oxacillin as prophylactic antimicrobials. No statistically significant difference in postoperative otologic infection rates was observed. This conclusion was unaltered by the operative duration, patient age, or preoperative condition. Grafting success was not improved.", "To investigate the effectiveness of a single-dose antibiotic regimen for preventing postoperative wound infection, a prospective, randomized double-blind trial was carried out in patients undergoing \"clean-contaminated\", \"contaminated\" or \"clean\" (vascular) surgery. Both elective and emergency operations were included. Single-dose (preoperative) prophylaxis was compared with short-term prophylaxis (1 dose preoperatively and 2 doses postoperatively). The antibiotics were penicillin, tobramycin and metronidazole in various combinations, and comparisons between single-dose and short-term prophylaxis were made with all the regimens. The incidence of wound infection was 5/277 (1.8%) in the short-term group and 9/287 (3.1%) in the single-dose group. The difference was not statistically significant. Nor was statistically significant difference found when the type of operation and the degree of contamination were considered. Single-dose antibiotic prophylaxis thus gave a low incidence of postoperative wound infection, even in \"clean-contaminated\" or \"contaminated\" cases.", "This article describes a prospective study of the effectiveness of prophylactic antibiotic treatment in preventing infection following mastoid surgery. Seventy-two patients who underwent surgery for chronic middle ear disease served as the basis for this study. Bacteriologic findings from middle ear discharge, showing aerobic and anaerobic bacteria, are reported. The patients were randomly classified into two groups, one undergoing surgery with preventive antibiotic treatment with clindamycin and gentamycin and the other undergoing surgery without antibiotic therapy. The early postoperative inflammatory complications are presented. No significant differences were found in the incidence of these complications between the two groups. In view of the results, the effectiveness of preventive antibiotic treatment in mastoid surgery is questioned.", "To establish the efficacy of immediate preoperative ototopical ofloxacin eardrops in eradicating middle ear pathogens and improving operative outcome.\n Single-blind, randomized control study.\n Tertiary referral center, ambulatory clinic, and hospital setting.\n Consecutive patients with chronic suppurative otitis media for Type I tympanoplasty (myringoplasty).\n The patients were randomly assigned to 3 groups: Group A underwent 10-minute daily treatments with eardrops for 2 weeks before surgery, Group B underwent 3-minute daily treatments for 2 weeks before surgery, and Group C underwent no treatment.\n Preoperative and perioperative bacteriology and success of the surgery as defined by an intact tympanic membrane in the eighth week postsurgery.\n There were 101 patients entered in the study. The preoperative, perioperative, and postoperative observation of discharge and quantity of the discharge were compared, and no differences were found among the groups (Kruskal-Wallis test). The perioperative culture results were analyzed and 18/21 (86%) became culture negative in Group A, 23/27 (85%) became culture negative in Group B, and 3/21 (14%) became culture negative in the control group (Group C versus Group A or Group B, chi(2) tests p < 0.001). The success rates of surgery as defined by an intact tympanic membrane showed no difference: 28/33 (85%), 27/33 (82%), and 31/35 (89%) in Groups A, B, and C, respectively. The preoperative positive bacteriology rate in the surgical failures was 10/15 (67%), compared with 16/76 (21%) for the successful procedures (p < 0.001).\n Our study has shown that ofloxacin successfully eradicates most bacterial flora preoperatively. We cannot, however, confirm the benefits of its preoperative usage in improving the graft success rate.", "To evaluate the effectiveness of prophylactic ciprofloxacin drops in decreasing the incidence of post-tympanostomy otorrhea, and the relation between middle ear content and post-tympanostomy otorrhea.\n One hundred and fifty patients aged 3-14 years underwent tympanostomy and tube insertion at the Prince Rashid Ben Al-Hasan Hospital, Al-Husn, Jordan during the interval between February 2000 to January 2003. The patients were randomized into 3 groups: group 1 (control group) received no antibiotic drops, group 2 received a single dose of ciprofloxacin drops intraoperatively and group 3 received an intraoperative dose followed by 5-day postoperative course.\n Application of topical ciprofloxacin after tympanostomy tube insertion was associated with a significantly lower incidence of early post-tympanostomy otorrhea. The rate of otorrhea for the control group was 16.5% and the treatment groups were (group 1) 8.4%, (group 2) 8.2% and p=0.011. A single dose of antibiotics was effective when patient's middle ears were dry or had serous effusions. For those whose ears had mucoid or purulent content a 5-day course was indicated.\n Topical administration of a single dose of ototopical ciprofloxacin after surgery is an effective treatment for the prevention of early post-tympanostomy otorrhea, and a prolonged course (5 days) may be indicated for those whose ears had purulent or thick mucoid contents, and the content of middle ear are important in predicating postoperative otorrhea.", "The authors report the results of a randomized, prospective study to assess the effectiveness of perioperative antibiotic prophylaxis in preventing postoperative infections following clean neurosurgical operations. The study group comprised 846 patients treated between October, 1979, and June, 1984. Antibiotics, including cefazolin and gentamicin, were administered only in the immediate preoperative and intraoperative periods. Sixteen patients, none of whom developed infections, were excluded from final statistical analysis because they had inadvertently been entered into the study while failing to meet entry criteria. Fifteen wound infections (3.64%) developed in the group of 412 patients who did not receive antibiotics, whereas only four infections (0.96%) were identified among the 418 patients who received antibiotics. The difference is statistically significant (p = 0.008) and represents a 74% reduction in infection rate with antibiotics. An analysis of subgroups of surgical procedures revealed a dramatic decrease in craniotomy infections from 6.77% to 0% (p = 0.003). Of the four infections that occurred among the antibiotic-treated patients, three were in cases where foreign bodies had been implanted. No complications of antibiotic usage were identified. The rates of infection in areas of the body other than the surgical wound were no different in the antibiotic-treated and nontreated groups. All wound infections in both antibiotic-treated and nontreated patients involved similar types of Gram-positive organisms, suggesting that antibiotic prophylaxis did not produce infections with resistant or unusual organisms. This study, combined with other recently published analyses, suggests that routine perioperative antibiotic prophylaxis can significantly reduce the incidence of postoperative neurosurgical infections." ]

[ "17954514", "17954515", "14512476", "21537720", "9090331", "15231557", "8561204", "10722180", "8625628" ]

[ "Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.", "Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine.", "Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine.", "Rapid tranquilization for agitated patients in emergency psychiatric rooms: a randomized trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone.", "Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial.", "Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine.", "A double-blind trial of haloperidol, chlorpromazine, and lorazepam in the treatment of delirium in hospitalized AIDS patients.", "A multicentre, double-blind, randomized comparison of quetiapine (ICI 204,636, 'Seroquel') and haloperidol in schizophrenia.", "Therapy of alcohol withdrawal syndrome in intensive care unit patients following trauma: results of a prospective, randomized trial." ]

[ "To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.\n Pragmatic, allocation concealed, randomised controlled trial.\n Emergency services of a general hospital psychiatry department in Vellore, south India.\n 300 adults with agitated or violent behaviour as a result of mental illness; 150 randomised to intramuscular olanzapine and 150 randomised to intramuscular haloperidol plus promethazine.\n Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine.\n Primary outcome was proportion of patients who were tranquil or asleep at 15 minutes and 240 minutes. Secondary outcomes were proportion of patients who were tranquil, asleep, restrained, absconding, or clinically improved at 15, 30, 60, 120, and 240 minutes; additional medical interventions and adverse effects over four hours; and compliance with oral drugs and adverse effects over two weeks.\n Of 300 people randomised to receive either intramuscular olanzapine or intramuscular haloperidol plus promethazine, follow-up data were available for primary outcomes for 298 (99%). Both treatments resulted in similar proportions of people being tranquil or asleep at 15 minutes (olanzapine 131/150 (87%), haloperidol plus promethazine 136/150 (91%); relative risk 0.96, 95% confidence interval 0.34 to 1.47) and 240 minutes (olanzapine 144/150 (96%), haloperidol plus promethazine 145/150 (97%); relative risk 0.99, 0.95 to 1.03). However, more people given olanzapine than those given haloperidol plus promethazine required additional drugs over four hours (65/150 (43%) v 31/150 (21%); relative risk 2.07, 1.43 to 2.97). Adverse effects were uncommon with both treatments.\n Intramuscular olanzapine and intramuscular haloperidol plus promethazine were effective at rapidly tranquillising or sedating agitated or violent patients with mental illness but the combination resulted in fewer additional medical interventions within four hours of intervention.\n Clinical trials NCT00455234 [ClinicalTrials.gov].", "To determine whether haloperidol alone results in swifter and safer tranquillisation and sedation than haloperidol plus promethazine.\n Pragmatic randomised open trial (January-July 2004).\n Psychiatric emergency room, Rio de Janeiro, Brazil.\n 316 patients who needed urgent intramuscular sedation because of agitation, dangerous behaviour, or both.\n Open treatment with intramuscular haloperidol 5-10 mg or intramuscular haloperidol 5-10 mg plus intramuscular promethazine up to 50 mg; doses were at the discretion of the prescribing clinician.\n The primary outcome was proportion tranquil or asleep by 20 minutes. Secondary outcomes were asleep by 20 minutes; tranquil or asleep by 40, 60, and 120 minutes; physically restrained or given additional drugs within 2 hours; severe adverse events; another episode of agitation or aggression; additional visit from the doctor during the subsequent 24 hours; overall antipsychotic load in the first 24 hours; and still in hospital after 2 weeks.\n Primary outcome data were available for 311 (98.4%) people, 77% of whom were thought to have a psychotic illness. Patients allocated haloperidol plus promethazine were more likely to be tranquil or asleep by 20 minutes than those who received intramuscular haloperidol alone (relative risk 1.30, 95% confidence interval 1.10 to 1.55; number needed to treat 6, 95% confidence interval 4 to 16; P=0.002). No differences were found after 20 minutes. However, 10 cases of acute dystonia occurred, all in the haloperidol alone group.\n Haloperidol plus promethazine is a better option than haloperidol alone in terms of speed of onset of action and safety. Enough data are now available to change guidelines that continue to recommend treatments that leave people exposed to longer periods of aggression than necessary and patients vulnerable to distressing and unsafe adverse effects.\n Current Controlled Trials ISRCTN83261243 [controlled-trials.com].", "To compare two widely used drug treatments for people with aggression or agitation due to mental illness.\n Pragmatic, randomised clinical trial.\n Three psychiatric emergency rooms in Rio de Janeiro, Brazil.\n 301 aggressive or agitated people.\n Open treatment with intramuscular midazolam or intramuscular haloperidol plus promethazine.\n Patients tranquil or sedated at 20 minutes. Secondary outcomes: patients tranquil or asleep by 40, 60, and 120 minutes; restrained or given extra drugs within 2 hours; severe adverse events; another episode of agitation or aggression; needing extra visits from doctor during first 24 hours; overall antipsychotic load in first 24 hours; and not discharged by two weeks.\n 151 patients were randomised to midazolam, and 150 to haloperidol-promethazine mix. Follow up for the primary outcome was available for 298 (99%): 134/151 (89%) of patients given midazolam were tranquil or asleep after 20 minutes compared with 101/150 (67%) of those given haloperidol plus promethazine (relative risk 1.32 (95% confidence interval 1.16 to 1.49)). By 40 minutes, midazolam still had a statistically and clinically significant 13% relative advantage (1.13 (1.01 to 1.26)). After 1 hour, about 90% of both groups were tranquil or asleep. One important adverse event occurred in each group: a patient given midazolam had transient respiratory depression, and one given haloperidol-promethazine had a grande mal seizure.\n Both treatments were effective. Midazolam was more rapidly sedating than haloperidol-promethazine, reducing the time people are exposed to aggression. Adverse effects and resources to deal with them should be considered in the choice of the treatment.", "To compare the effectiveness of intramuscular olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone as the first medication(s) used to treat patients with agitation and aggressive behavior.\n One hundred fifty patients with agitation caused by psychotic or bipolar disorder were randomly assigned under double-blind conditions to receive olanzapine, ziprasidone, haloperidol plus midazolam, haloperidol plus promethazine or haloperidol alone. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale were applied within 12 hours after the first dosage.\n All medications produced a calming effect within one hour of administration, but only olanzapine and haloperidol reduced agitation by less than 10 points, and only olanzapine reduced aggression by less than four points in the first hour. After twelve hours, only patients treated with haloperidol plus midazolam had high levels of agitation and aggression and also more side effects. Ziprasidone, olanzapine and haloperidol alone had more stable results for agitation control, while ziprasidone, haloperidol plus promethazine and olanzapine had stable results for aggression control.\n Olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol were effective in controlling agitation and aggression caused by mental illness over 12 hours. Although all the drugs had advantages and disadvantages, haloperidol plus midazolam was associated with the worst results in all the observed parameters.", "This international, multicenter double-blind trial was designed to compare the therapeutic profile of an atypical antipsychotic, olanzapine, with that of a conventional dopamine D2 antagonist, haloperidol.\n A total of 1,996 patients at 174 sites in Europe and North America were randomly assigned to treatment with olanzapine (N = 1,336) or haloperidol (N = 660) over 6 weeks. The primary efficacy analysis involved the mean change from baseline to endpoint in total scores on the Brief Psychiatric Rating Scale (BPRS). Secondary analyses included comparisons of the mean change in positive and negative symptoms, comorbid depression, extrapyramidal symptoms, and overall drug safety.\n Olanzapine demonstrated clinical results superior to those of haloperidol on overall improvement according to the BPRS and on every secondary measure, including depression. Olanzapine was also associated with significantly fewer discontinuations of treatment due to lack of drug efficacy or adverse events. Substantially more olanzapine-treated patients (66.5%) than haloperidol-treated patients (46.8%) completed 6 weeks of therapy. Statistically significant advantages of olanzapine treatment were related to 1) change in negative symptoms, 2) extrapyramidal symptom profile, 3) effect on prolactin levels, and 4) response rate.\n Olanzapine shows a superior and broader spectrum of efficacy in the treatment of schizophrenic psychopathology, with a substantially more favorable safety profile, than haloperidol. It meets several of the criteria for a novel atypical antipsychotic agent.", "The pharmacological management of violence in people with psychiatric disorders is under-researched.\n To compare interventions commonly used for controlling agitation or violence in people with serious psychiatric disorders.\n We randomised 200 people to receive intramuscular lorazepam (4 mg) or intramuscular haloperidol (10 mg) plus promethazine (25-50 mg mix).\n At blinded assessments 4 h later (99.5% follow-up), equal numbers in both groups (96%) were tranquil or asleep. However, 76% given the haloperidol-promethazine mix were asleep compared with 45% of those allocated lorazepam (RR=2.29,95% CI 1.59-3.39; NNT=3.2,95% CI 2.3-5.4). The haloperidol-promethazine mix produced a faster onset of tranquillisation/sedation and more clinical improvement over the first 2 h. Neither intervention differed significantly in the need for additional intervention or physical restraints, numbers absconding, or adverse effects.\n Both interventions are effective for controlling violent/agitated behaviour. If speed of sedation is required, the haloperidol-promethazine combination has advantages over lorazepam.", "The purpose of this study was to examine the efficacy and side effects of haloperidol, chlorpromazine, and lorazepam for the treatment of the symptoms of delirium in adult AIDS patients in a randomized, double-blind, comparison trial.\n Nondelirious, medically hospitalized AIDS patients (N = 244) consented to participate in the study and were monitored prospectively for the development of delirium. Patients entered the treatment phase of the study if they met DSM-III-R criteria for delirium and scored 13 or greater on the Delirium Rating Scale. Thirty patients were randomly assigned to treatment with haloperidol (N = 11), chlorpromazine (N = 13), or lorazepam (N = 6). Efficacy and side effects associated with the treatment were measured with repeated assessments using the Delirium Rating Scale, the Mini-Mental State, and the Extrapyramidal Symptom Rating Scale.\n Treatment with either haloperidol or chlorpromazine in relatively low doses resulted in significant improvement in the symptoms of delirium as measured by the Delirium Rating Scale. No improvement in the symptoms of delirium was found in the lorazepam group. Cognitive function, as measured by the Mini-Mental State, improved significantly from baseline to day 2 for patients receiving chlorpromazine. Treatment with haloperidol or chlorpromazine was associated with an extremely low prevalence of extrapyramidal side effects. All patients receiving lorazepam, however, developed treatment-limiting adverse effects. Although only a small number of patients had been treated with lorazepam, the authors became sufficiently concerned with the adverse effects to terminate that arm of the protocol early.\n Symptoms of delirium in medically hospitalized AIDS patients may be treated efficaciously with few side effects by using low-dose neuroleptics (haloperidol or chlorpromazine). Lorazepam alone appears to be ineffective and associated with treatment-limiting adverse effects.", "Quetiapine (ICI 204,636, 'Seroquel') is a new atypical antipsychotic agent with a similar binding profile to the original atypical antipsychotic, clozapine. Its clinical efficacy has already been demonstrated at multiple fixed doses (150-750 mg/day) and has been suggested to be comparable with haloperidol (12 mg/day).\n This international, 6-week, multicentre, double-blind, randomized, parallel-group trial compared quetiapine with haloperidol (455 mg and 8 mg mean total daily doses, respectively) in 448 hospitalized patients with acute exacerbation of chronic or subchronic schizophrenia (DSM-III-R), in order to establish their equivalence in terms of efficacy, and the nature of their tolerability profiles, especially in terms of extrapyramidal symptoms (EPS) and serum prolactin levels.\n Both quetiapine and haloperidol produced a clear reduction in the Positive and Negative Syndrome Scale (PANSS) scores and Clinical Global Impression (CGI) Severity of Illness and Global Improvement scores. At day 42, the PANSS total score was reduced by -18.7+/-1.63 in the quetiapine group, and -22.1+/-1.63 in the haloperidol group (P = 0.13, between-treatment). Quetiapine was better tolerated than haloperidol in terms of EPS as demonstrated by the significant differences in the Simpson Scale and Abnormal Involuntary Movement Scale scores (P < 0.05). Although patients in both groups had elevated serum prolactin concentrations at baseline, mean serum prolactin concentration decreased (by 16.5 microg/l) in quetiapine-treated patients, yet increased (by 5.9 microg/l) in patients treated with haloperidol.\n Quetiapine is an effective and well tolerated antipsychotic of comparable efficacy to haloperidol and lacks the latter compound's effect on prolactin and EPS.", "To assess the effect of three different alcohol withdrawal therapy regimens in traumatized chronic alcoholic patients with respect to the duration of mechanical ventilation and the frequency of pneumonia and cardiac disorders during their intensive care unit (ICU) stay.\n A prospective, randomized, blinded, controlled clinical trial.\n A university hospital ICU.\n Multiple-injured alcohol-dependent patients (n=180) transferred to the ICU after admission to the emergency room and operative management. A total of 180 patients were included in the study; however, 21 patients were excluded from the study after assignment.\n Patients who developed actual alcohol withdrawal syndrome were randomized to one of the following treatment regimens: flunitrazepam/clonidine (n=54); chlormethiazole/haloperidol (n=50); or flunitrazepam/haloperidol (n=55). The need for administration of medication was determined, using a validated measure of the severity of alcohol withdrawal (Revised Clinical Institute Withdrawal Assessment for Alcohol Scale).\n The duration of mechanical ventilation and major intercurrent complications, such as pneumonia, sepsis, cardiac disorders, bleeding disorders, and death, were documented. Patients did not differ significantly between groups regarding age, Revised Trauma and Injury Severity Score and Acute Physiology and Chronic Health Evaluation II score on admission. In all except four patients in the flunitrazepam/clonidine group, who continued to hallucinate, the Revised Clinical Institute Withdrawal Assessment for Alcohol Scale decreased to <20 after initiation of therapy. ICU stay did not significantly differ between groups (p=.1669). However, mechanical ventilation was significantly prolonged in the chlormethiazole/haloperidol group (p=.0315) due to an increased frequency of pneumonia (p=.0414). Cardiac complications were significantly (p=.0047) increased in the flunitrazepam/clonidine group.\n There was some advantage in the flunitrazepam/clonidine regimen with respect to pneumonia and the necessity for mechanical ventilation. However, four (7%) patients had to be excluded from the study due to ongoing hallucinations during therapy. Also, cardiac complications were increased in this group. Thus, flunitrazepam/haloperidol should be preferred in patients with cardiac or pulmonary risk. Further studies are required to determine which therapy should be considered." ]

[ "10596681", "9337824", "8765628", "9192929", "1416422", "15316206", "7750335", "8977608", "11066186" ]

[ "A randomized trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease patients.", "Effect of long-term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia.", "Inhaled nitric oxide in term infants with hypoxemic respiratory failure.", "Training with supplemental oxygen in patients with COPD and hypoxaemia at peak exercise.", "Oxygen may improve dyspnea and endurance in patients with chronic obstructive pulmonary disease and only mild hypoxemia.", "Long-term oxygen therapy stops the natural decline of endurance in COPD patients with reversible hypercapnia.", "Reappraisal of continuous positive airway pressure therapy in acute cardiogenic pulmonary edema. Short-term results and long-term follow-up.", "Comparison of the acute effects on gas exchange of nasal ventilation and doxapram in exacerbations of chronic obstructive pulmonary disease.", "Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial." ]

[ "The beneficial effects of nocturnal oxygen therapy (NOT) in chronic obstructive pulmonary disease (COPD) patients with mild-to-moderate daytime hypoxaemia (arterial oxygen tension (Pa,O2) in the range 7.4-9.2 kPa (56-69 mmHg)) and exhibiting sleep-related oxygen desaturation remains controversial. The effectiveness of NOT in that category of COPD patients was studied. The end points included pulmonary haemodynamic effects after 2 yrs of follow-up, survival and requirement for long-term oxygen therapy (LTOT). Seventy-six patients could be randomized, 41 were allocated to NOT and 35 to no NOT (control). The goal of NOT was to achieve an arterial oxygen saturation of >90% throughout the night. All these patients underwent polysomnography to exclude an associated obstructive sleep apnoea syndrome. The two groups exhibited an identical meansD daytime Pa,O2 of 8.4+/-0.4 kPa (63+/-3 mmHg) at baseline. Twenty-two patients (12 in the NOT group and 10 in the control group, p=0.98) required LTOT during the whole follow-up (35+/-14 months). Sixteen patients died, nine in the NOT group and seven in the control group (p=0.84). Forty-six patients were able to undergo pulmonary haemodynamic re-evaluation after 2 yrs, 24 in the NOT and 22 in the control group. In the control group, mean resting pulmonary artery pressure increased from 19.8+/-5.6 to 20.5+6.5 mmHg, which was not different from the change in mean pulmonary artery pressure in the NOT group, from 18.3+/-4.7 to 19.5+/-5.3 mmHg (p= 0.79). Nocturnal oxygen therapy did not modify the evolution of pulmonary haemodynamics and did not allow delay in the prescription of long-term oxygen therapy. No effect of NOT on survival was observed, but the small number of deaths precluded any firm conclusion. These results suggest that the prescription of nocturnal oxygen therapy in isolation is probably not justified in chronic obstructive pulmonary disease patients.", "To date only two controlled studies have been published on the effects of domiciliary oxygen treatment on survival in patients with chronic obstructive pulmonary disease (COPD) with advanced respiratory failure. The survival in such patients despite oxygen treatment remains poor. The prescription of long term oxygen therapy (LTOT) in less severe disease remains controversial. The aim of this study was to evaluate the rationale for prescribing oxygen to patients with COPD with moderate hypoxaemia.\n One hundred and thirty five patients with COPD, with PaO2 7.4-8.7 kPa (56-65 mmHg) and advanced airflow limitation (mean (SD) forced expiratory volume in one second (FEV1) 0.83 (0.28) 1), were randomly allocated to a control (n = 67) and LTOT (n = 68) group. The patients were followed every three months for at least three years or until death.\n The cumulative survival rate was 88% at one year, 77% at two years, and 66% at three years. No significant differences were found in survival rates between patients treated with LTOT and controls, nor did longer oxygen use (over 15 hours per day) improve survival. Younger age, better spirometric values, and higher body mass index predicted better survival.\n Domiciliary oxygen treatment does not prolong survival in patients with COPD with moderate hypoxaemia. Airway limitation seems to determine survival in this group of patients.", "To determine whether inhaled nitric oxide (NO) administered during conventional mechanical ventilation could produce improvements in oxygenation and reduce the incidence of meeting extracorporeal membrane oxygenation (ECMO) criteria in infants with hypoxemia.\n Prospective, randomized, controlled trial. Enrolled infants were assigned to conventional treatment with or without adjunctive inhaled NO. Control infants meeting failure criteria (partial pressure of arterial oxygen (PaO2)<80 mm Hg (10.7 kPa)) were allowed to cross over. Caregivers were not masked to group assignment.\n Neonatal intensive care units at the University of Alabama Hospital and the Children's Hospital of Alabama, October 1993 to May 1994.\n Newborn infants, both term and near-term, with PaO2 less than 100 mm Hg (13.3 kPa) who were receiving mechanical ventilation with 100% oxygen. Exclusion criteria included major congenital anomalies, diaphragmatic hernia, profound asphyxia, and significant bleeding.\n Inhaled NO was initiated in the NO group at a dose of 20 to 40 ppm and advanced stepwise to 80 ppm if PaO2 remained less than 100 mm Hg (13.3 kPa).\n Primary outcome variables were treatment failure and meeting of ECMO criteria before crossover. Improvement in oxygenation and ultimate use of ECMO or high-frequency oscillatory ventilation were secondary outcome variables.\n Seventeen neonates with hypoxemia were enrolled; 16 had echocardiographic evidence of pulmonary hypertension, and eight had extrapulmonary shunting. At 1 hour of treatment, two infants in the NO group responded with increases in PaO2 of more than 100 mm Hg (13.3 kPa); after crossover, two had increases in PaO2 of more than 10 mm Hg (1.3 kPa) and one control infant had an increase in PaO2 of more than 10 mm Hg (1.3 kPa). All control infants met failure criteria and crossed over to receive NO; two had increases in PaO2 of more than 10 mm Hg (1.3 kPa) with NO treatment. Despite initial responses, all subjects in both groups eventually met failure criteria. There were no differences between groups in primary outcome variables.\n Although inhaled NO produced a transient improvement in oxygenation in some infants, it did not reduce the incidence of meeting ECMO criteria in this population.", "Supplemental oxygen has acute beneficial effects on exercise performance in patients with chronic obstructive pulmonary disease (COPD). The purpose of this study was to investigate whether oxygen-supplemented training enhances the effects of training while breathing room air in patients with severe COPD. A randomized controlled trial was performed in 24 patients with severe COPD who developed hypoxaemia during incremental cycle exercise (arterial oxygen saturation (Sa,O2) <90% at peak exercise). All patients participated in an in-patient pulmonary rehabilitation programme of 10 weeks duration. They were assigned either to general exercise training while breathing room air (GET/RA group: forced expiratory volume in one second (FEV1) 38% of predicted; arterial oxygen tension (Pa,O2) 10.5 kPa at rest; Pa,O2 7.3 kPa at peak exercise), or to GET while breathing supplemental oxygen (GET/O2 group: FEV1 29% pred; Pa,O2 10.2 kPa at rest; Pa,O2 7.2 kPa at peak exercise). Sa,O2 was not allowed to fall below 90% during the training. The effects on exercise performance while breathing air and oxygen, and on quality of life were compared. Maximum workload (Wmax) significantly increased in the GET/RA group (mean (SD) 17 (15) W, p<0.01), but not in the GET/O2 group (7 (25) W). Six minute walking distance (6MWD), stair-climbing, weight-lifting exercise (all while breathing room air) and quality of life significantly increased in both groups. Acute administration of oxygen improved exercise performance before and after training. Training significantly increased Wmax, peak carbon dioxide production (V'CO2) and 6MWD while breathing oxygen in both groups. Differences between groups were not significant. Pulmonary rehabilitation improved exercise performance and quality of life in both groups. Supplementation of oxygen during the training did not add to the effects of training on room air.", "Oxygen (O2) has been reported to improve exercise tolerance in some patients with chronic obstructive pulmonary disease (COPD) despite only mild resting hypoxemia (PaO2 greater than 60 mm Hg). To confirm these prior studies and evaluate potential mechanisms of benefit, we measured dyspnea scores by numeric rating scale during cycle ergometry endurance testing and correlated the severity of dyspnea with right ventricular systolic pressure (RVSP) measured by Doppler echocardiography during a separate supine incremental exercise test. Both sets of exercise were performed according to a randomized double-blind crossover protocol in which patients breathed compressed air or 40% O2. We studied 12 patients with severe COPD (FEV1 0.89 +/- 0.09 L [mean +/- SEM], FEV1/FVC 37 +/- 2%, DLCO 9.8 +/- 1.5 ml/min/mm Hg[47% of predicted], PaO2 71 +/- 2.6 mm Hg). With endurance testing on compressed air, PaO2 did not change significantly in the group as whole (postexercise PaO2 63 +/- 5.1 mm Hg, p = NS), but did fall to less than 55 mm Hg in four patients from this group. Duration of exercise increased on 40% O2 from 10.3 +/- 1.6 to 14.2 +/- 1.5 min (p = 0.005), and the rise in dyspnea scores was delayed. Oxygen delayed the rise in RVSP with incremental exercise in all patients and lowered the mean RVSP at maximum exercise from 71 +/- 8 to 64 +/- 7 mm Hg (p less than 0.03). Improvement in duration of exercise correlated with decrease in dyspnea (r2 = 0.66, p = 0.001) but not with decreases in heart rate, minute ventilation, or RVSP.(ABSTRACT TRUNCATED AT 250 WORDS)", "Respiratory muscle weakness is one of the most important causes of hypercapnia in patients with COPD. There is evidence that stable hypercapnic patients will benefit from long-term oxygen therapy (LTOT).\n The prognostic role of reversible hypercapnia in COPD is still unclear. Early implementation of LTOT in these patients may influence endurance time and mortality.\n In this pilot study, we investigated 28 patients (26 males, 49-74 years) with COPD, advanced airflow limitation [forced expiratory volume in 1 s (percentage of predicted value) 40.8 +/- 10.2] and mild hypoxaemia (pO(2) 66.5 +/- 6.3 mm Hg). All patients had developed a moderate reversible hypercapnia during an acute exacerbation or during exercise testing (peak pCO(2) 48.0 +/- 2.5 mm Hg). Patients were allocated randomly to a control group (n = 14) or an LTOT group (n = 14). The two groups were well matched in terms of physiological data. Lung function, endurance time (cycle ergometer), dyspnoea score, blood gases and LTOT compliance were measured at baseline and every 6 months over a period of 3 years.\n Endurance time increased from 6.4 +/- 2.7 min at baseline to 7.1 +/- 2.7 min after 1 year in the LTOT group and decreased from 6.1 +/- 3.0 to 4.9 +/- 3.8 min in the controls (p < 0.05). After 1 year, the end-exercise dyspnoea score was significantly lower in the LTOT group (4.5 +/- 1.5) than in the controls (5.7 +/- 1.9).\n COPD patients with reversible hypercapnia and mild hypoxaemia benefit from LTOT in terms of endurance time and a reduction of exertional dyspnoea after 1 year.\n Copyright 2004 S. Karger AG, Basel", "To investigate whether serial incremental continuous positive airway pressure (CPAP) has any short-term or long-term advantages over face-mask oxygen therapy by way of intrapulmonary shunt reduction, 100 patients admitted to the coronary care unit for the treatment of acute cardiogenic pulmonary edema were studied. All patients received Swan-Ganz catheterization. Hemodynamic and pulmonary function parameters were recorded over the next 6 h, and the patients were followed until hospital discharge. All survivors received regular follow-up at 1-month intervals in the outpatient clinic. During the first-stage investigation period (3 h) PaO2 in the CPAP group showed a significant increase, whereas the intrapulmonary shunt and alveolar-arterial oxygen tension gradient (P[A-a]O2) was significantly reduced (p < 0.005). The CPAP group had significantly lower rate-pressure product and higher stroke volume index compared with the control group. The therapeutic failure rate over 6 h was 24% in the CPAP group and 50% in the control group (p < 0.01). The CPAP group had a significantly lower incidence of tracheal intubation and ventilator therapy than the control group; however, there was no significant difference in short-term mortality and hospital stay between the two groups. In conclusion, although study size was not large enough to demonstrate a difference in mortality, CPAP therapy resulted in physiologic cardiovascular and pulmonary function improvement and significantly reduced the need for intubation; however, it did not decrease mortality in patients with acute cardiogenic pulmonary edema, and a much larger study is needed to investigate this possibility.", "Nasal intermittent positive pressure ventilation (NIPPV) is useful in exacerbations of chronic obstructive pulmonary disease (COPD) complicated by ventilatory failure. The effects of NIPPV were compared with those of the respiratory stimulant doxapram on gas exchange in patients with COPD and acute ventilatory failure.\n Patients admitted with acute exacerbations of COPD and type 2 respiratory failure (Pao2 < 8 kPa and PaCO2 > 6.7 kPa) who did not improve with conventional treatment were randomised to receive either NIPPV or intravenous doxapram. Blood gas tensions were monitored for four hours.\n In nine patients who received NIPPV the arterial PaO2 improved from a mean (SE) of 5.9 (0.4) kPa to a maximum of 8.1 (0.6) kPa which was maintained at four hours. Eight patients who received doxapram had a similar baseline Pao2 of 5.6 (0.4) kPa which rose to a maximum of 7.3 (0.5) kPa but this was not maintained at four hours. The improvement in Pao2 in patients on NIPPV was accompanied by a fall in Paco2 but, in contrast, in those who received doxapram there was no improvement in Paco2.\n NIPPV may be more effective than doxapram in the management of acute ventilatory failure complicating COPD.", "Continuous positive airway pressure (CPAP) is widely used in the belief that it may reduce the need for intubation and mechanical ventilation in patients with acute hypoxemic respiratory insufficiency.\n To compare the physiologic effects and the clinical efficacy of CPAP vs standard oxygen therapy in patients with acute hypoxemic, nonhypercapnic respiratory insufficiency.\n Randomized, concealed, and unblinded trial of 123 consecutive adult patients who were admitted to 6 intensive care units between September 1997 and January 1999 with a PaO(2)/FIO(2) ratio of 300 mm Hg or less due to bilateral pulmonary edema (n = 102 with acute lung injury and n = 21 with cardiac disease).\n Patients were randomly assigned to receive oxygen therapy alone (n = 61) or oxygen therapy plus CPAP (n = 62).\n Improvement in PaO(2)/FIO(2) ratio, rate of endotracheal intubation at any time during the study, adverse events, length of hospital stay, mortality, and duration of ventilatory assistance, compared between the CPAP and standard treatment groups.\n Among the CPAP vs standard therapy groups, respectively, causes of respiratory failure (pneumonia, 54% and 55%), presence of cardiac disease (33% and 35%), severity at admission, and hypoxemia (median [5th-95th percentile] PaO(2)/FIO(2) ratio, 140 [59-288] mm Hg vs 148 [62-283] mm Hg; P =.43) were similarly distributed. After 1 hour of treatment, subjective responses to treatment (P<.001) and median (5th-95th percentile) PaO(2)/FIO(2) ratios were greater with CPAP (203 [45-431] mm Hg vs 151 [73-482] mm Hg; P =.02). No further difference in respiratory indices was observed between the groups. Treatment with CPAP failed to reduce the endotracheal intubation rate (21 [34%] vs 24 [39%] in the standard therapy group; P =.53), hospital mortality (19 [31%] vs 18 [30%]; P =.89), or median (5th-95th percentile) intensive care unit length of stay (6.5 [1-57] days vs 6.0 [1-36] days; P =.43). A higher number of adverse events occurred with CPAP treatment (18 vs 6; P =.01).\n In this study, despite early physiologic improvement, CPAP neither reduced the need for intubation nor improved outcomes in patients with acute hypoxemic, nonhypercapnic respiratory insufficiency primarily due to acute lung injury. JAMA. 2000;284:2352-2360." ]

[ "2792672", "2194894", "16259890", "10733802", "16670131", "11466598", "15810049", "12150647", "15672051" ]

[ "A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity.", "Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon.", "Laparoscopic adjustable gastric banding versus open vertical banded gastroplasty: a prospective randomized trial.", "Surgery for Obesity- An Update of a Randomized Trial.", "Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial.", "Conceptualisation and evaluation of a cognitive-behavioural training programme for children and adolescents with obesity.", "Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity.", "A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder.", "Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up." ]

[ "We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven.", "A prolonged randomized, prospective, double-blind, crossover study, including a sham-sham-treated group, was undertaken to evaluate the efficacy and safety of a 500-mL gastric bubble (Ballobes; DOT ApS, Rödovre, Denmark) as an adjunct to diet, physical training, and behavioral modification. Only supermorbidly obese patients who fulfilled the usual criteria for surgery were admitted. A weight loss of 38 kg in the first 17 weeks and another 12 kg in the second 18 weeks could be achieved. The body mass index, the percentage of overweight and the loss in percentage of initial weight, paralleled this impressive weight loss. In the second period, a plateau effect occurred after the massive changes in the first period, and only one third of the changes in all parameters was seen. Stratification into a sham-sham, sham-balloon, balloon-sham, and balloon-balloon group did not show any statistical difference for all parameters between the four groups. The double-blind nature of the study was affirmed by the patient's correct judgment of the presence or absence of a balloon in only 21% of the balloon and 44% of the sham procedures. Gastrointestinal complications were infrequent and consisted of erosions (three patients), asymptomatic reflux oesophagitis (one patient), and asymptomatic gastric ulcer (one patient). Only the latter patient had elevated gastrin levels. One patient could not tolerate the balloon. All balloons remained airtight during both parts of the study for a mean of 123 days. This study confirmed the safety of the balloon, but no additional benefit could be ascribed to the balloon compared with a very low-calorie diet and medical and dietary support.", "Laparoscopic adjustable gastric banding (LAGB) and open vertical banded gastroplasty (VBG) are treatment modalities for morbid obesity. However, few prospective randomized clinical trials (RCT) have been performed to compare both operations.\n 100 patients (50 per group) were included in the study. Postoperative outcomes included hospital length of stay (LOS), complications, percent excess weight loss (%EWL), BMI and reduction in total comorbidities. Follow-up in all patients was 2 years.\n LOS was significantly shorter in the LAGB group. 3 LAGB were converted to open (1 to gastric bypass). Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died. After 2 years, 100% follow-up was achieved. BMI and %EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group (31.0 kg/m2 and 70.1% vs 34.6 and 54.9% respectively). Co-morbidities significantly decreased in both groups in time. 2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia.\n This RCT demonstrates that, despite the initial better weight loss in the VBG group, based on complication rates and clinical outcome, LAGB is preferred. It had a shorter LOS and less postoperative morbidity.", "BACKGROUND: A prospective, randomized trial comparing vertical banded gastroplasty (VBG) and gastric bypass (GB) was performed on 106 patients between 1987 and 1990. METHODS AND RESULTS: Failures of these two operations (manifested by failure to lose weight, late weight gain or intolerance of adequate oral intake) were treated by means of a third operation, isolated gastric bypass (IGB), in which the small gastric pouch was isolated from the gastric fundus. The latter operation was significantly better than VBG or GB and achieved a 63% success rate, i.e. body mass index (BMI) < 35 kg m(2) and less than 50% excess weight. During the year following this trial an additional 54 patients underwent IGB. When this operation was performed for morbid obesity and was the Initial procedure, 96% of the patients achieved a successful result. If IGB was performed as a revision procedure or for super obesity (BMI > 50 kg m(2)), the success rate was 63% with 100% follow-up at 40 months. Major morbidity occurred in six of the 160 patients who underwent 195 operations (the trial period and subsequent year). There were no deaths and follow-up was 98%. CONCLUSIONS: The ideal gastric operation based on this study emphasizes the following requirements: a small pouch (< 15 ml) totally separated from the stomach, a pouch not dependent on staples, placed in the dependent position to prevent stasis, constructed without foreign material and with an anastomosis which permits ingestion of solid food.", "Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this.\n To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.\n Randomized, controlled trial.\n University departments of medicine and surgery and an affiliated private hospital.\n 80 adults with mild to moderate obesity (body mass index, 30 kg/m2 to 35 kg/m2) from the general community. Interventions: Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group).\n Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.\n At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores).\n The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.\n Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program.", "Obesity is common in children and adolescents with incidence rates increasing both nationally and internationally. Its causes are complex and multifaceted, and obesity is associated with high morbidity and mortality as well as psychological distress. Multidimensional programmes are necessary in the treatment of this chronic disease in order to change eating and physical activity habits. A cognitive-behavioural training programme was developed and evaluated. In combination with diet and exercise, this special group programme that includes well established behavioural methods, was expected to result in long-term weight reduction and decrease of psychological distress in connection with obesity.\n As part of the six week in-patient rehabilitation for children and adolescents at Viktoriastift in Bad Kreuznach, the three-part programme (experimental group, EG) was compared with a programme that differed only in the psychological intervention component (instead of the specific training programme they undertook muscle relaxation training, comparison group, CG).\n In total, 197 children and adolescents between 9 and 19 y-of-age were recruited into the study.\n Somatic (eg weight status), behavioural (eg eating behaviour) and psychological (eg quality of life) outcomes were assessed at five points in time: two weeks before the intervention, at the beginning and end of the programme, as well as six months and one year post-intervention. The study started in spring 1997. Main outcomes will be presented.\n Pre- vs post-intervention-tests showed significant improvements in self-reported eating behaviours for the EG compared with the CG (F=6.38, P<0.05); these changes were independent of age and sex. The weight status measured as the percentage of overweight dependent on height was reduced in both groups immediately after the intervention and at follow-up (F=16.51, P<0.01). Reduction in the prevalence of obesity tended to be higher in the EG than in the CG (15% vs 10%). Self-reported quality of life increased from before the intervention to follow-up more in the EG than in the CG (F=3.27, P=0.08). In all, the acceptance of the behavioural patient education programme was good.\n In summary, evaluation results indicate that the cognitive-behavioural training programme is a promising approach to alter obesity-related habits and to reduce somatic and psychosocial consequences. Long-term effects after two years are expected to underscore these results.", "Laparoscopic techniques have been developed for performing Roux-en-Y gastric bypass (LRYGBP) and vertical banded gastroplasty (LVBG) in patients with morbid obesity. It is not certain, however, which is the better technique in non-superobese patients (body mass index less than 50 kg/m(2)).\n Eighty-three patients (LRYGBP 37, LVBG 46) were assessed in a randomized clinical trial. Perioperative complications were recorded together with preoperative and postoperative respiratory function and mobilization rate. Patients were monitored for 2 years after operation with regard to weight change and the need for remedial surgery.\n There were no conversions to open surgery. The mean operating time was longer for LRYGBP than LVBG (138 versus 105 min). Five early reoperations were performed after LRYGBP (three for haemorrhage, one for ileus and one suspected leak) and one after LVBG (suspected leak). There were no differences in postoperative respiratory function or mobilization. Weight reduction was greater after LRYGBP (excess weight loss 78.3 versus 62.9 per cent 1 year after surgery, P = 0.009; 84.4 versus 59.8 per cent at 2 years, P < 0.001). Remedial surgical intervention was required in eight patients after LVBG (conversion to Roux-en-Ygastric bypass) and none after LRYGBP.\n LRYGBP and LVBG were comparable in terms of operative safety and postoperative recovery, but weight reduction was better after LRYGBP.\n Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.", "Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED.\n One hundred sixty-two overweight patients meeting DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or group IPT. Assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at posttreatment, and at 4-month intervals up to 12 months following treatment.\n Binge-eating recovery rates were equivalent for CBT and IPT at posttreatment (64 [79%] of 81 vs 59 [73%] of 81) and at 1-year follow-up (48 [59%] of 81 vs 50 [62%] of 81). Binge eating increased slightly through follow-up but remained significantly below pretreatment levels. Across treatments, patients had similar significant reductions in associated eating disorders and psychiatric symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased significantly but only slightly, with the greatest reduction among patients sustaining recovery from binge eating from posttreatment to 1-year follow-up.\n Group IPT is a viable alternative to group CBT for the treatment of overweight patients with BED. Although lacking a nonspecific control condition limits conclusions about treatment specificity, both treatments showed initial and long-term efficacy for the core and related symptoms of BED.", "Prior efforts to treat obesity with intragastric balloons were thwarted by high complication rates. Therefore, fundamental requirements for optimal balloon designs were defined. The aim of the present study was to investigate the effectiveness, the safety, and the tolerance of a new intragastric balloon.\n Adults with treatment-resistant obesity and no GI contraindications to balloon placement were invited to participate in a randomized, double-blind trial of balloon or sham treatment of 3 months' duration. Patients (sham- and balloon-treated groups) in whom a preset weight-loss goal was achieved were given an additional 9 months of balloon treatment. After removal of the balloon at year 1, patients were followed for a second year without the balloon.\n Forty-three treatment-resistant patients (mean body mass index 43.3 kg/m 2) were enrolled. Five patients did not meet the preset weight-loss goal (nonresponse 11.6%). Three patients did not tolerate the balloon (7.0%), with endoscopy demonstrating severe esophagitis. Three other patients developed esophagitis that was related to use of nonsteroidal anti-inflammatory drugs, albeit prohibited (2 patients), or substantial weight loss with balloon treatment (1). In intention-to-treat analysis, sham- and balloon-treated groups had a similar mean weight loss of 11.2 kg (9.0%) and 12.9 kg (10.4%), respectively, during the first 3 months. During months 3 to 6, patients who had sham therapy in months 0 to 3 lost 8.8 kg (7.9%) during the first 3 months of balloon treatment. In contrast, patients in the balloon-treatment group lost 3.9 kg (3.5%) during months 3 to 6 (their second balloon treatment period). The overall weight loss was 20 kg (16.1%) and 16.7 kg (13.4%) after 6 months in the sham/balloon and in the balloon/balloon treated groups (not significant), respectively. After 1-year of balloon treatment, a mean weight loss of 21.3 kg (17.1%) was achieved in all patients, of which 12.6 kg (9.9%) was maintained at the end of the second balloon-free year; 47% of patients sustained a greater than 10% weight loss, with considerably reduced comorbidity. In 33 patients who completed the study per protocol, weight loss was 25.6 kg (20.5%) after 1 year and 14.6 kg (11.4%) after 2 years; 55% maintained a weight loss of greater than 10%. Interventional complications occurred in 1.6% (2/128) and balloon deflations in 2.3% (3/128).\n For patients with treatment-resistant obesity, the intragastric balloon appeared to be safe but was not a treatment option in a fifth of patients. Although an independent benefit of balloon treatment beyond diet, exercise, and behavioral therapy could not be demonstrated in the first 3 months, balloon treatment for 1 year resulted in substantial weight loss, the greater part of which was maintained during the balloon-free second year." ]

[ "2406126", "16468111", "4006888", "2044499", "8603630", "16087407", "2113015", "12027917", "3349967" ]

[ "Randomized trial of a program to enhance the competencies of children with epilepsy.", "[Education of children with epilepsy and their parents by the modular education program epilepsy for families (FAMOSES)--results of an evaluation study].", "Effects of a broad-spectrum behavior modification treatment program on children with refractory epileptic seizures.", "Impact of the Children's Epilepsy Program on parents.", "Comparison of antiepileptic drugs on cognitive function in newly diagnosed epileptic children: a psychometric and neurophysiological study.", "A structured, nurse-led intervention program improves quality of life in patients with epilepsy: a randomized, controlled trial.", "Specific cognitive dysfunction in children with epileptic mothers.", "The efficacy of an educational treatment program for patients with epilepsy (MOSES): results of a controlled, randomized study. Modular Service Package Epilepsy.", "Neuropsychological assessment of subjects with uncontrolled epilepsy: effects of EEG feedback training." ]

[ "A randomized, controlled trial was conducted in Santiago, Chile to test the impact of a child-centered, family-focused educational program for children aged 7-14 years with epilepsy and for their parents. The objectives of the program developed and pilot-tested in Los Angeles, California were to increase the children's knowledge, perceptions of competency, and skills related to dealing with seizures. Children in the experimental group (n = 123) and their parents separately attended four 1 1/2-h sessions and then met together at the end of each session to share learning experiences. Control children (n = 113) and their parents attended three 2-h sessions with a traditional lecture followed by question-and-answer format. All participants were pretested and then retested 5 months after completion of the educational intervention. Although there was some knowledge increase among children in the control group, the knowledge of children in the experimental group was significantly enhanced in a variety of areas related to management of their seizures and unnecessary restriction of their social and play activities. There was a significant increase in the self-perceptions of social competency of children in the experimental group. Children in the experimental group without serious behavioral problems also reported significantly better behavior after the intervention than did control children. There was no impact on children's disclosure of their diagnosis to friends and others.", "The aim of the study was to evaluate the efficacy of the modular educational program for children with epilepsy and their parents (FAMOSES). This program was developed by an interdisciplinary project group to improve knowledge, coping, treatment outcome, emotional and practical adaptation to the condition.\n A prospective, controlled, multi-center, pre-post study design was used to examine the efficacy of the program in the treatment group compared to the waiting group (control group). Questionnaires included epilepsy specific scales regarding knowledge, attitudes, restrictions in daily living, epilepsy related fears, coping with the chronic disease and generic instruments (quality of life, KINDL). 55 parents of the treatment group completed the questionnaires three months before the course and three months later; the corresponding waiting group included 48 parents. Respectively, 31 children, who participated in the program, completed the questionnaires immediately before the course and three months later; the corresponding waiting group included 19 children.\n Children, who attended the program, showed improvements in the domains perceived restrictions (significant, medium effect size), absence from school and seizure frequency. Not significantly greater compared to the control group were the improvements of knowledge, attitudes and fears regarding to the epilepsy. Parents of the treatment group showed significant enhancements in epilepsy specific knowledge (large effect size), attitudes toward the epilepsy, management of epileptic seizures and significant reductions of fears and restrictions of their child with epilepsy (small to medium effect sizes).", "A group of 18 children with refractory epileptic seizures was divided into three groups--behavior modification treatment, attention control, and control groups--with the purpose of investigating the effects of a learning-based broad-spectrum treatment program superimposed on a regular medical treatment program. The design consisted of a 10-week baseline, 6-week intervention, and 10-week and 1-year follow-ups. A combination of number of seizures and seizure duration--termed \"seizure index\"--was used as a dependent measure. There was a significant reduction in seizure index only for those children receiving the behavior modification treatment, at both follow-ups. The results indicate that this behavioral treatment program may be of substantial help to children with epilepsy who are resistant to conventional drug therapy.", "A randomized controlled trial was conducted in Santiago, Chile to test the efficacy of the Children's Epilepsy Program, a child-centered, family-focused intervention developed and pilot tested in Los Angeles, CA, U.S.A., using a counseling model for parents of children with seizure disorders to help them (a) deal with their anger, resentment, and grief related to the loss of a normal child; (b) increase their knowledge about caring for their child; (c) reduce anxieties related to having a child with a seizure disorder; and (d) improve their decision-making skills. All parents were pretested and then retested 5 months after the educational interventions. Parents in the experimental group (n = 185) and their children separately attended four 1 1/2-h sessions and then met together at the end of each session to share learning experiences. Comparison group parents (n = 180) and their children jointly attended three 2-h lecture sessions followed by question-and-answer periods. Although parents' overall knowledge of epilepsy was relatively high initially, it improved considerably in both comparison and experimental groups. With regard to anxiety, at the 5-month evaluation, experimental group parents and mothers in particular were more likely than control parents to state that they were less anxious (p less than 0.001), and their anxiety, as measured by the Taylor Manifest Anxiety scale, was significantly reduced (p less than 0.01).", "Using a randomized parallel group study design, we compared the cognit ive effects of carbamazepine (CBZ), phenobarbital (PB), and valproate (VPA) in children with epilepsy. Seventy-three children with newly diagnosed epilepsy were tested with the Wechsler Intelligence Scale for Children-Revised (WISC-R), Bender-Gestalt test, and auditory event-related potentials (P 300) before and 6 and 12 months after antiepileptic drug (AED) treatment. There were no significant differences in WISC-R IQs and Bender-Gestalt scores for children in any group at any of the three sessions. P 300 latencies were increased in the children receiving PB but not in children receiving CBZ and VPA. P 300 amplitudes were significantly reduced in treated children in all three groups, but amplitudes were not significantly different among the three groups. These findings suggest that PB may affect cognitive function of epileptic children and that the P 300 may be a sensitive additional procedure that can be used to assess the cognitive effect of AEDs.", "We tested the hypothesis that structured epilepsy nursing improves quality of life (QOL). One hundred fourteen adult patients with uncontrolled epilepsy were randomly assigned to either an intervention group or a control group. The intervention group was offered an interactive, 1-day group education program followed by extended nurse follow-up and counseling. The nurse was present at as many outpatient consultations as possible and performed repeated consultations by telephone. All patients completed the QOLIE-89 before randomization and after 2 years. QOL was significantly improved from inclusion to completion of study in the intervention group (P=0.019), mainly in the subitems for Health Discouragement (P=0.01), Medication Effects (P=0.035), and Physical Role Limitations (P=0.05). To our knowledge, this is the first study to demonstrate a significant effect of a structured nurse-led intervention program in QOL of patients with epilepsy.", "Specific cognitive abilities and motor function were investigated at 5.5 years in 104 children with epileptic mothers and in 105 control children, all with normal general intelligence. The majority (89 per cent) of the children of epileptic mothers had been exposed to anti-epileptic drugs during pregnancy, most commonly phenytoin (69 per cent). Maternal seizures had occurred during pregnancy in 52 per cent. A significant difference, with poorer performance in the study group, was found in block design (WPPSI) and auditory closure (ITPA). Significantly more study than control children had some type of specific cognitive dysfunction. Within the study group, increased risk was associated with maternal partial seizures, with seizures occurring during pregnancy, and with low paternal education, but not with exposure to anti-epileptic drugs. Three possible mechanisms of this effect are suggested: subtle brain-damage associated with fetal asphyxia during the mothers' generalized convulsions; genetically transmitted brain abnormalities; and psychosocial disadvantage limiting partner choice.", "To evaluate the efficacy of the educational program MOSES (Modular Service Package Epilepsy). It was developed to improve patients' knowledge and understanding about their epilepsy, its treatment, and psychosocial consequences. The program intends to improve patients' coping with the disease, to strengthen self-esteem, and to support patients to become experts in managing their epilepsy.\n A controlled, randomized study design was used to examine the efficacy of MOSES. Patients from 22 epilepsy centers in Germany, Austria, and Switzerland were randomly allocated to either MOSES group (treatment group) or waiting-list group (control group). The 242 patients were aged from 16 to 80 years. The MOSES group (n = 113) completed the questionnaires immediately before the educational course (T1) and 6 months later (T2), and the control group (n = 129), 6 months before (T1) and immediately before (T2) the course. The questionnaires included generic instruments (SF-36, Rosenberg self-esteem Scale, von Zerssen Depression Scale), and epilepsy-specific scales (Restrictions in Daily Life, Epilepsy-Related Fears, Coping with Epilepsy and Adaptation). Depression was used as a moderator variable. Seizure frequency and satisfaction with therapy also were assessed. Multivariate analysis of variance (MANOVA) with repeated measurements and univariate analyses of variance were performed.\n The MANOVA showed that participants of the educational program improved significantly. Univariate analyses revealed improvements in knowledge (p < 0.001) and coping with epilepsy (p = 0.004), whereas important effects of MOSES on other epilepsy-specific measures and on generic questionnaires (SF-36, self-esteem) were not found. Participants of the MOSES program also improved in seizure outcome (p = 0.041) and became more satisfied with the therapy [better tolerability of antiepileptic drug (AED) therapy, fewer side effects; p = 0.014]. In addition, participants expressed being highly satisfied with the program.\n The study clearly indicates the need for patient education. Even patients with a long history of epilepsy and with additional handicaps or diseases benefitted from the MOSES program.", "A battery of neuropsychological tests was administered at baseline, postcontrol period, and posttraining period to 24 drug-refractory subjects with epilepsy participating in a study of sensorimotor electroencephalographic (EEG) normalization feedback training. Results revealed the following. First, subjects exhibited significant baseline deficits in psychosocial, cognitive and motor functioning. Second, certain tests discriminated subjects before training who were subsequently above and below the median in seizure reduction following EEG training. Subjects who showed the greatest seizure reduction performed better on a test of general problem-solving ability but not on other cognitive tests and worse on tests involving strong motor components and were more intact psychosocially. These subjects also took significantly fewer medications in combination than did less successful subjects. Third, improvement on several measures occurred following participation in the study. Cognitive and motor functioning improved only in subjects with the greatest seizure reduction and only after actual training as opposed to control conditions. Psychological functioning, as measured by the Minnesota Multiphasic Personality Inventory (MMPI) improved in both outcome groups. MMPI improvement, unlike cognitive improvement, was as likely to occur after control conditions, when seizure reduction had not yet occurred, as after EEG training. Thus, MMPI changes apparently reflected the nonspecific benefits of participation in this study." ]

[ "18607963", "15072419", "16087029", "9726671", "7488373", "14653370", "8924287", "10753321", "207210" ]

[ "Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial.", "Selective vestibular ablation by intratympanic gentamicin in patients with unilateral active Ménière's disease: a prospective, double-blind, placebo-controlled, randomized clinical trial.", "Dexamethasone inner ear perfusion by intratympanic injection in unilateral Ménière's disease: a two-year prospective, placebo-controlled, double-blind, randomized trial.", "Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double-blind clinical trial.", "Treatment of chronic ear disease. Topical ciprofloxacin vs topical gentamicin.", "Treatment of idiopathic sudden sensorineural hearing loss with antiviral therapy: a prospective, randomized, double-blind clinical trial.", "[Prospective double-blind randomized study of the efficacy and tolerance of topical ciprofloxacin vs topical gentamicin in the treatment of simple chronic otitis media and diffuse external otitis].", "Idiopathic Subjective Tinnitus Treated by Amitriptyline Hydrochloride/Biofeedback.", "[Double-blind comparative study of trimethroprim-sulphacetamide-polymyxin b and gentamicin in the treatment of otorrhoea (author's transl)]." ]

[ "Intratympanic application of gentamicin is a relatively safe and efficient treatment for the reduction of complaints of vertigo attacks associated with Menière's disease. The treatment also reduces the severity of the perceived aural fullness.\n To investigate the effectiveness of intratympanic gentamicin treatment in patients with unilateral Menière's disease.\n In a prospective, double-blind, randomized, placebo-controlled clinical trial subjects scored vertigo complaints, aural fullness and tinnitus, before, during and up to 1 year after treatment. Hearing loss was monitored with pure tone audiometry.\n Gentamicin treatment resulted in a significant reduction of the score for vertigo complaints and the score for perceived aural fullness. A small increase in hearing loss (average 8 dB) was measured in the gentamicin group.", "To establish the efficacy of intratympanic gentamicin treatment in patients with unilateral Ménière's disease.\n This was a prospective, double-blind, randomized clinical trial of intratympanic gentamicin versus intratympanic buffer solution (placebo) in patients with established active Ménière's disease in the affected ear. Outcome measures included the number of vertiginous spells, degree of sensorineural hearing loss, labyrinthine function and labyrinthine asymmetry.\n Topical gentamicin provided a significant reduction in the number of vertiginous spells, although a \"placebo effect\" was also observed. Sensorineural hearing loss did not occur in the gentamicin group, although some deterioration occurred in the placebo group.\n Intratympanic gentamicin is a safe and efficient treatment for the vertiginous spells associated with Ménière's disease. When applied early in the course of the disease, it may prevent some of the sensorineural hearing deterioration associated with it.", "To investigate the efficacy of dexamethasone inner ear perfusion by intratympanic injection in hearing loss, tinnitus, aural fullness, and vertigo in the treatment of unilateral Ménière's disease and compare it with the control group.\n A prospective, randomized, double-blind study with 2-year follow-up comparing changes secondary to dexamethasone inner ear perfusion versus placebo consisting of saline solution.\n Twenty-two patients having definite Ménière's disease as outlined by the 1995 American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium. All the patients were older than 18 years of age and were not receiving any other form of treatment with steroids for their Ménière's disease.\n Five consecutive daily intratympanic injections of dexamethasone or placebo to the involved ear.\n In the dexamethasone group at 2-year follow-up, complete control of vertigo (class A) was achieved in 9 of 11 patients (82%) and substantial control of vertigo (class B) in the remaining 2 patients (18%.) In the control group only 7 of 11 patients (64%) finished the 2-year follow-up because in the other 4 patients (36%) we had to give another treatment for the continuing vertigo and thus they were classified as failure (class F.) From the 7 patients who have finished the follow-up of 2 years in the control group, 4 patients (57%) achieved class A, 2 patients (29%) achieved class C, and 1 patient (14%) class F.\n Dexamethasone (4 mg/mL) inner ear perfusion in a group of patients with unilateral Ménière's disease (Shea's stage III) showed 82% of complete control of vertigo over placebo (57%). There was also a subjective improvement in tinnitus (48%), hearing loss (35%), and aural fullness (48%) in the dexamethasone group compared with 20%, 10%, and 20% respectively in the control group.", "A subclinical viral labyrinthitis has been postulated in the literature to elicit Idiopathic Sudden Sensorineural Hearing Loss. An etiological role for the herpes virus family is assumed. Corticosteroids possess a limited beneficial effect on hearing recovery in ISSHL. In this study, the therapeutic value of the antiherpetic drug aciclovir (Zovirax) on hearing recovery in 44 ISSHL patients receiving prednisolone is evaluated in a multicentre clinical trial. The study is designed prospectively, randomized, double-blind and placebo-controlled. Subjective parameters include hearing recovery, a pressure sensation on the affected ear, disequilibrium or vertigo and tinnitus. Audiometric parameters include pure tone and speech audiometry. A one-year follow up is obtained. Both the pressure sensation and disequilibrium or vertigo have a good prognosis, but tinnitus, occurring in most patients, has a poor prognosis. Hearing recovery prognosis depends on the severity of initial hearing loss, and not on vestibular involvement. No beneficial effect from combining aciclovir with prednisolone can be established in ISSHL.", "To determine and compare the therapeutic efficiency of ciprofloxacin hydrochloride and gentamicin sulfate in the treatment of chronic ear disease.\n Prospective randomized study.\n Academic tertiary medical center.\n Consecutive referred sample of 44 patients with chronic suppurative otitis media randomized into two groups.\n Ciprofloxacin hydrochloride (200 mg/mL) was administered to the first group (composed of 24 patients), while the second group (composed of 20 patients) received gentamicin sulfate (5 mg/mL) locally, five drops three times a day for 10 days.\n In the ciprofloxacin group, 21 (88%) of the 24 patients with suppurative chronic otitis media were cured. On the other hand, only six (30%) of the patients in the gentamicin group were cured. The rest of the patients showed no clinical or bacteriological improvement.\n To our knowledge, this is the first study to compare the efficiency of two topical otic preparations in the treatment of chronic ear disease. The results show that topical ciprofloxacin preparation is more efficacious and efficient than topical gentamicin for the treatment of chronic otitis media in the acute stage.", "A subclinical viral labyrinthitis has been postulated in the literature to elicit idiopathic sudden sensorineural hearing loss (ISSHL). An etiologic role for the herpes family is assumed. Corticosteroids possess a limited beneficial effect on hearing recovery in ISSHL. In this study, we evaluated the therapeutic value of the antiherpetic drug acyclovir (Zovirax) on hearing recovery in 91 patients with ISSHL who received prednisolone in a prospective, randomized, double-blind, placebo-controlled, multicenter trial. The audiometric parameters included pure tone and speech audiometry. Subjective parameters studied included hearing recovery, a pressure sensation in the affected ear, vertigo, and tinnitus. A 1-year follow-up was obtained. Hearing recovery for the whole group averaged about 35 dB and was independent of the severity of the initial hearing loss or vestibular involvement. Speech audiometry improved from 49% to 75%. After 12 months, pressure sensation and vertigo decreased to 15.6% (acyclovir) and 10.3% (placebo) and 12.5% (acyclovir) and 10.7% (placebo), respectively. Tinnitus decreased slightly, to 46.9% (acyclovir) and 55.2% (placebo), in the same period (p > .05 for all parameters). We conclude that no beneficial effect from combining acyclovir with prednisolone can be established in patients with ISSHL.", "A prospective, randomized double-blind study was made of topical ciprofloxacillin (0.5%) compared with topical gentamicin (0.3%) in the treatment of simple chronic otitis media (COM) and diffuse external otitis (DEO). The study included 47 patients with COM and 54 patients with DEO. Success rates in the COM subgroup were 95% for ciprofloxacillin and 96% for gentamicin (p = 0.082), and in the DEO subgroup, 87% for ciprofloxacillin and 79% for gentamicin (p = 0.19). Both drugs were well tolerated and there was no significant change in audiometric measurements with either medication in either group. Therefore, ciprofloxacillin is at least as effective as gentamicin in such ear infections and has no potential ototoxic effect.", "The efficiency of two treatment modalities for subjective/idiopathic tinnitus (SIT): biofeedback (BF) and amitriptyline hydrochloride (AT) was investigated in 225 randomly selected subjects. Findings show that after 10 weeks of treatment in the BF group, 43.5% of the patients reported an improvement of tinnitus during activity. In the AT group, 27.5% of patients reported subjective improvement of tinnitus at rest although only 15.8% of the AT patients reported improvement during activity. Biofeedback during rest had a significantly better effect on tinnitus disturbance than AT. No objective diminishment of tinnitus loudness was found as a result of any of the treatment modalities. We believe that BF can help tinnitus patients especially during periods of rest and we also suggest trying tricyclic antidepressant drugs such as AT for treatment of tinnitus patients, in small doses, however, to minimize the side effects of this drug. Subjective tinnitus (ST) is one of the most common and yet most unclear of otologic symptoms.(1-4) ST can accompany any type of hearing loss including both sensorineural as well as conductive hearing loss, and may originate from any part of the auditory pathway.(1,5) Treatment of ST must be primarily directed to the basic illness diagnosed after a thorough general ear-nose-throat and neurologic evaluation.(6) Severity of ST is evaluated both objectively, by determining the pitch and intensity of the tinnitus,(7) and subjectively as described by the patient. Because of the relatively high incidence of ST and in some patients, the severe personal reaction to it, many different treatments have been suggested, but generally only small to moderate success has been achieved in reducing tinnitus and its consequences, if any at all.(8) In this study we examined the effect of two treatment modalities: amitriptyline hydro-chloride and biofeedback.", "A double-blind comparative study of the use of Garamycine (gentamicin) ear drops and TSP (trimethroprim-sulphacetamide-polomyxin B) ear drops in the treatment of 100 cases of otorrhoea due to external otitis, a recurrent otitis media accompanied by perforation of the drum, an infection of the mastoid cavity or a postoperative infection, provided evidence of the effectiveness of both medications. TSP ear drops gave positive results in 42 out of 50 cases treated, whilst for gentamicin aural solution results were positive for 46 out of 50 cases. Gentamicin gave a successful result in 5 of the 8 failures with TSP, whilst TSP cured the four original failures with gentamicin. There were no signs of ototoxicity, of excessive fungal proliferation nor of any local sensitivity to the ear drops. It would seem that these aural preparations are complementary, capable of resulting in the disappearance of the majority of bacterial agents responsible for pathogenic otorrhoea." ]

[ "18383539", "19066176", "19644849", "9920948", "15146409", "11840438", "2084236", "19560810", "1642652" ]

[ "Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study.", "Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study.", "Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis.", "A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate.", "Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial.", "Comparative assessment of leflunomide and methotrexate for the treatment of rheumatoid arthritis, by dynamic enhanced magnetic resonance imaging.", "Adverse experience with methotrexate during 176 weeks of a longterm prospective trial in patients with rheumatoid arthritis.", "Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial.", "Comparison of azathioprine, methotrexate, and the combination of both in the treatment of rheumatoid arthritis. A controlled clinical trial." ]

[ "To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX).\n Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo.\n The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P=0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P<0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group.\n Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.", "The phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate therapy.\n Patients were randomly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules (group 1, n = 133), golimumab 100 mg injections plus placebo capsules (group 2, n = 133), golimumab 50 mg injections plus methotrexate capsules (group 3, n = 89), or golimumab 100 mg injections plus methotrexate capsules (group 4, n = 89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with 20% or greater improvement in the American College of Rheumatology criteria (ACR20) at week 14 and the change from baseline in the health assessment questionnaire-disability index (HAQ-DI) score at week 24.\n The proportion of patients who achieved an ACR20 response at week 14 was 33.1% in the placebo plus methotrexate group, 44.4% (p = 0.059) in the golimumab 100 mg plus placebo group, 55.1% (p = 0.001) in the golimumab 50 mg plus methotrexate group and 56.2% (p<0.001) in the golimumab 100 mg plus methotrexate group. At week 24, median improvements from baseline in HAQ-DI scores were 0.13, 0.13 (p = 0.240), 0.38 (p<0.001) and 0.50 (p<0.001), respectively. During the placebo-controlled portion of the study (to week 16), serious adverse events occurred in 2.3%, 3.8%, 5.6% and 9.0% of patients and serious infections occurred in 0.8%, 0.8%, 2.2% and 5.6%, respectively.\n The addition of golimumab to methotrexate in patients with active RA despite methotrexate therapy significantly reduced the signs and symptoms of RA and improved physical function.", "To assess the safety and efficacy of golimumab in methotrexate (MTX)-naive patients with active rheumatoid arthritis (RA).\n MTX-naive patients with RA (n = 637) were randomized to receive placebo plus MTX (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus MTX (group 3), or golimumab 100 mg plus MTX (group 4). Subcutaneous injections of golimumab or placebo were administered every 4 weeks. The dosage of MTX/placebo capsules started at 10 mg/week and escalated to 20 mg/week. The primary end point, the proportion of patients meeting the American College of Rheumatology 50% improvement criteria (achieving an ACR50 response) at week 24, required significant differences between groups 3 and 4 combined (combined group) versus group 1 and significant differences in a pairwise comparison (group 3 or group 4 versus group 1).\n An intent-to-treat (ITT) analysis of the ACR50 response at week 24 did not show a significant difference between the combined group and group 1 (38.4% and 29.4%, respectively; P=0.053), while a post hoc modified ITT analysis (excluding 3 untreated patients) of the ACR50 response showed statistically significant differences between the combined group and group 1 (38.5% versus 29.4%; P=0.049) and between group 3 (40.5%; P=0.038) but not group 4 (36.5%; P=0.177) and group 1. Group 2 was noninferior to group 1 for the ACR50 response at week 24 (33.1%; 95% confidence interval lower bound -5.2%; predefined delta value for noninferiority -10%). The combination of golimumab plus MTX demonstrated a significantly better response compared with placebo plus MTX in most other efficacy parameters, including response/remission according to the Disease Activity Score in 28 joints. Serious adverse events occurred in 7%, 3%, 6%, and 6% of patients in groups 1, 2, 3, and 4, respectively.\n Although the primary end point was not met, the modified ITT analysis of the primary end point and other prespecified efficacy measures demonstrated that the efficacy of golimumab plus MTX is better than, and the efficacy of golimumab alone is similar to, the efficacy of MTX alone in reducing RA signs and symptoms in MTX-naive patients, with no unexpected safety concerns.", "Patients treated with methotrexate for rheumatoid arthritis often improve but continue to have active disease. This study was undertaken to determine whether the addition of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein (TNFR:Fc), to methotrexate therapy would provide additional benefit to patients who had persistent rheumatoid arthritis despite receiving methotrexate.\n In a 24-week, double-blind trial, we randomly assigned 89 patients with persistently active rheumatoid arthritis despite at least 6 months of methotrexate therapy at a stable dose of 15 to 25 mg per week (or as low as 10 mg per week for patients unable to tolerate higher doses) to receive either etanercept (25 mg) or placebo subcutaneously twice weekly while continuing to receive methotrexate. The primary measure of clinical response was the American College of Rheumatology criteria for a 20 percent improvement in measures of disease activity (ACR 20) at 24 weeks.\n The addition of etanercept to methotrexate therapy resulted in rapid and sustained improvement. At 24 weeks, 71 percent of the patients receiving etanercept plus methotrexate and 27 percent of those receiving placebo plus methotrexate met the ACR 20 criteria (P<0.001); 39 percent of the patients receiving etanercept plus methotrexate and 3 percent of those receiving placebo plus methotrexate met the ACR 50 criteria (for a 50 percent improvement) (P<0.001). Patients receiving etanercept plus methotrexate had significantly better outcomes according to all measures of disease activity. The only adverse events associated with etanercept were mild injection-site reactions, and no patient withdrew from the study because of adverse events associated with etanercept.\n In patients with persistently active rheumatoid arthritis, the combination of etanercept and methotrexate was safe and well tolerated and provided significantly greater clinical benefit than methotrexate alone.", "Tumor necrosis factor (TNF) is an important proinflammatory cytokine that mediates inflammatory synovitis and articular matrix degradation in rheumatoid arthritis (RA). We investigated the ability of adalimumab, a human anti-TNF monoclonal antibody, to inhibit the progression of structural joint damage, reduce the signs and symptoms, and improve physical function in patients with active RA receiving concomitant treatment with methotrexate (MTX).\n In this multicenter, 52-week, double-blind, placebo-controlled study, 619 patients with active RA who had an inadequate response to MTX were randomized to receive adalimumab 40 mg subcutaneously every other week (n = 207), adalimumab 20 mg subcutaneously every week (n = 212), or placebo (n = 200) plus concomitant MTX. The primary efficacy end points were radiographic progression at week 52 (total Sharp score by a modified method [TSS]), clinical response at week 24 (improvements of at least 20% in the American College of Rheumatology core criteria [ACR20]), and physical function at week 52 (disability index of the Health Assessment Questionnaire [HAQ]).\n At week 52, there was statistically significantly less radiographic progression, as measured by the change in TSS, in the patients receiving adalimumab either 40 mg every other week (mean +/- SD change 0.1 +/- 4.8) or 20 mg weekly (0.8 +/- 4.9) as compared with that in the placebo group (2.7 +/- 6.8) (P < or = 0.001 for each comparison). In addition, there were statistically significant changes in the components of the TSS. At week 24, ACR20 responses were achieved by 63% and 61% of patients in the adalimumab 40 mg every other week and 20 mg weekly groups, respectively, versus 30% of patients in the placebo group (P < or = 0.001 for each comparison). At week 52, ACR20 responses were achieved by 59% and 55% of patients taking adalimumab 40 mg every other week and 20 mg weekly, respectively, versus 24% of patients taking placebo (P < or = 0.001 for each comparison). At week 52, physical function as measured by the HAQ demonstrated statistically significant improvement with adalimumab 40 mg every other week and 20 mg weekly compared with placebo (mean change in HAQ score -0.59 and -0.61, respectively, versus -0.25; P < or = 0.001 for each comparison). A total of 467 patients (75.4%) completed 52 weeks of treatment. Adalimumab was generally well tolerated. Discontinuations occurred in 22.0% of adalimumab-treated patients and in 30.0% of placebo-treated patients. The rate of adverse events (both serious and nonserious) was comparable in the adalimumab and placebo groups, although the proportion of patients reporting serious infections was higher in patients receiving adalimumab (3.8%) than in those receiving placebo (0.5%) (P < or = 0.02), and was highest in the patients receiving 40 mg every other week.\n In this 52-week trial, adalimumab was more effective than placebo at inhibiting the progression of structural joint damage, reducing the signs and symptoms, and improving physical function in patients with active RA who had demonstrated an incomplete response to MTX.", "Ethical constraints on the conduct of placebo-controlled trials evaluating new therapies for serious chronic diseases, such as rheumatoid arthritis (RA), indicate the need for discerning methods to assess treatment effect in active-controlled clinical trials. Dynamic gadolinium-enhanced magnetic resonance imaging (DEMRI) is a sensitive technique for the detection of synovial inflammation in RA. Therefore, this investigation was undertaken to evaluate DEMRI as an efficacy assessment tool for differentiating treatment effect in a randomized, active-controlled trial comparing leflunomide and methotrexate.\n Patients with active RA (n = 39) were randomized in a 2-center, prospective, double-blind clinical trial to receive either leflunomide (n = 18) or methotrexate (n = 21) therapy for 4 months. DEMRI scans were obtained at baseline and at 4 months, and the initial rate of enhancement (IRE) and the maximal signal intensity (SI) enhancement (ME) were calculated from the SI curves. Clinical improvement was assessed by conventional outcome measures.\n Thirty-four patients (17 treated with leflunomide and 17 with methotrexate) had usable baseline and end point DEMRI scans. Leflunomide treatment was associated with a significantly greater improvement in IRE compared with methotrexate treatment (P < 0.05). Average values of ME indicated reduction of inflammation with both leflunomide and methotrexate. The improvement in clinical signs and symptoms, as measured by traditional assessments, was comparable for both active treatments.\n Results of this study validate the sensitivity of DEMRI in detecting inflammatory changes in active RA in response to treatment. Improvement in synovial inflammation as measured by IRE was significantly better with leflunomide than with methotrexate over 4 months of therapy.", "Adverse experience occurred with a high frequency in a longterm (greater than 3 years), prospective, double blind, followed by an open trial of methotrexate (MTX) therapy in 45 patients with rheumatoid arthritis (RA). Adverse experiences occurred in 96% of patients, and the discontinuation rate was 44% over 176 weeks. No hepatic or pulmonary fibrosis occurred. Unusual toxicities included weight loss (2 patients), systemic fungal infections (2 patients), and transient noncirrhotic ascites (1 patient). Baseline white blood cell counts and creatinine may help predict adverse experiences. The full dose-toxicity spectrum of MTX RA is not yet fully defined.", "Tumour necrosis factor alpha (TNFalpha) inhibitors are frequently used to treat rheumatoid arthritis, but whether use of a different TNFalpha inhibitor can improve patient response is unknown. We assess the efficacy and safety of the TNFalpha inhibitor golimumab in patients with active rheumatoid arthritis who had previously received one or more TNFalpha inhibitors.\n 461 patients with active rheumatoid arthritis from 82 sites in 10 countries were randomly allocated by interactive voice response system, stratified by study site and methotrexate use, to receive subcutaneous injections of placebo (n=155), 50 mg golimumab (n=153), or 100 mg golimumab (n=153) every 4 weeks between Feb 21, 2006, and Sept 26, 2007. Allocation was double-blind. Eligible patients had been treated with at least one dose of a TNFalpha inhibitor previously. Patients continued stable doses of methotrexate, sulfasalazine, hydroxychloroquine, oral corticosteroids, and non-steroidal anti-inflammatory drugs. The primary endpoint was achievement at week 14 of 20% or higher improvement in American College of Rheumatology criteria for assessment of rheumatoid arthritis (ACR20). At week 16, patients who had less than 20% improvement in tender and swollen joint counts were given rescue therapy and changed treatment from placebo to 50 mg golimumab, or from 50 mg to 100 mg golimumab. Drug efficacy was assessed by intention to treat and safety was assessed according to the study drug given. This study is registered with ClinicalTrials.gov, number NCT00299546.\n Patients had discontinued previous TNFalpha inhibitors because of lack of effectiveness (269 [58%] patients) or reasons unrelated to effectiveness (246 [53%] patients), such as intolerance and accessibility issues. Patients had active disease, which was indicated by a median of 14.0 (IQR 9.0-22.0) swollen and 26.0 (16.0-41.0) tender joints for the whole group. 28 (18%) patients on placebo, 54 (35%) patients on 50 mg golimumab (odds ratio 2.5 [95% CI 1.5-4.2], p=0.0006), and 58 (38%) patients on 100 mg golimumab (2.8 [1.6-4.7], p=0.0001) achieved ACR20 at week 14. Two patients were never treated, and 57 patients did not complete the study because of adverse events, unsatisfactory treatment effect, loss to follow-up, death, or other reasons. 155 patients on placebo, 153 on 50 mg golimumab, and 153 on 100 mg golimumab were assessed for drug efficacy. For weeks 1-16, serious adverse events were recorded in 11 (7%) patients on placebo, 8 (5%) on 50 mg golimumab, and 4 (3%) on 100 mg golimumab. For weeks 1-24, after some patients were given rescue therapy, serious adverse events were recorded in 15 (10%) patients on placebo, 14 (5%) on 50 mg golimumab, and 8 (4%) on 100 mg golimumab.\n Golimumab reduced the signs and symptoms of rheumatoid arthritis in patients with active disease who had previously received one or more TNFalpha inhibitors.\n Centocor Research and Development and Schering-Plough Research Institute.", "To compare the relative safety and efficacy of azathioprine (AZA), methotrexate (MTX), and the combination of both in the treatment of active rheumatoid arthritis (RA).\n Two hundred twelve patients with active RA were entered into a 24-week prospective, controlled, double-blind, multicenter trial and were randomly assigned to 1 of 3 treatment groups.\n One hundred fifty-eight patients finished 24 weeks of the study. There were no remissions seen but response rates were greater than 30% for all outcome measures. Combination therapy was not statistically superior to MTX therapy alone, but both combination therapy and MTX alone were superior to AZA alone when patients were analyzed by intent-to-treat and with withdrawals treated as therapy failures. If only patients who continued taking the therapy were analyzed, the mean improvement was greater for AZA therapy than for MTX, while the combination remained the most active. Adverse effects on the gastrointestinal tract and elevations of liver enzyme levels were the most frequent causes for discontinuations.\n Both combination therapy and MTX alone were superior to therapy with AZA alone for active RA but were not statistically different in their effect on outcome assessment." ]

[ "3679106", "11260571", "17077429", "14606735", "21515905", "17332444", "9803707", "10616135", "12435467" ]

[ "Group art therapy as an adjunct to treatment for chronic outpatients.", "Art therapy as support for children with leukemia during painful procedures.", "Music therapy for in-patients with schizophrenia: exploratory randomised controlled trial.", "A randomized controlled trial of an education and counselling intervention for families after stroke.", "Mental practice with motor imagery in stroke recovery: randomized controlled trial of efficacy.", "Mental practice in chronic stroke: results of a randomized, placebo-controlled trial.", "Treatment of acute stress disorder: a comparison of cognitive-behavioral therapy and supportive counseling.", "Identifying randomized controlled trials of cognitive therapy for depression: comparing the efficiency of Embase, Medline and PsycINFO bibliographic databases.", "Tailored cognitive-behavioral therapy in early rheumatoid arthritis for patients at risk: a randomized controlled trial." ]

[ "Art therapy has lagged behind other therapeutic modalities in being subjected to rigorous evaluation of its effectiveness. This study examines psychosocial outcome for a group of chronic psychiatric outpatients. Half the patients were randomly assigned to a ten-week supportive art therapy group as an adjunct to treatment; the other patients served as a control group. Patients who remained in the art therapy group for the full ten weeks reported a significant improvement in their attitudes toward themselves as measured by the Progress Evaluation Scales, and their therapists rated them as significantly better able to get along with others. The authors believe the study demonstrates the potential of supportive art therapy to enhance functioning of chronic psychiatric patients in the short run. Empirical attention to long-term gains and to the efficacy of specific forms of art therapy is needed in the future.", "Children with leukemia undergo painful procedures such as lumbar puncture and bone marrow aspiration. To overcome pain, certain units offer total anesthesia; others offer generic support; others offer no preparation at all. Since September, 1997, we have provided leukemic children with art therapy (AT), a nonverbal and creative modality that develops coping skills. Our goal is to prevent anxiety and fear during painful interventions as well as prolonged emotional distress.\n We treated 32 children aged 2-14 years. The modes of AT before, during, and after the punctures were as follows: clinical dialogue to calm children and help them cope with painful procedures; visual imagination to activate alternative thought processes and decrease the attention towards overwhelming reality and raise the peripheral sensitivity gate; medical play to clarify illness, eliminate doubts, and offer control over threatening reality; structured drawing to contain anxiety by offering a structured, predictable reality (the drawing) that was controllable by children; free drawing to allow children to externalize confusion and fears; and dramatization to help children accept and reconcile themselves to body changes.\n Children hospitalized before September, 1997, exhibited resistance and anxiety during and after painful procedures. By contrast, children provided with AT from the first hospitalization exhibited collaborative behavior. They or their parents asked for AT when the intervention had to be repeated. Parents declared themselves better able to manage the painful procedures when AT was offered.\n AT was shown to be a useful intervention that can prevent permanent trauma and support children and parents during intrusive interventions.\n Copyright 2001 Wiley-Liss, Inc.", "Music therapy may provide a means of improving mental health among people with schizophrenia, but its effects in acute psychoses have not been explored.\n To examine the feasibility of a randomised trial of music therapy for inpatients with schizophrenia, and explore its effects on mental health.\n Up to 12 weeks of individual music therapy plus standard care were compared with standard care alone. Masked assessments of mental health, global functioning and satisfaction with care were conducted at 3 months.\n Of 115 eligible patients 81 (70%) were randomised. Two-thirds of those randomised to music therapy attended at least four sessions (median attendance, eight sessions). Multivariate analysis demonstrated a trend towards improved symptom scores among those randomised to music therapy, especially in general symptoms of schizophrenia.\n A randomised trial of music therapy for in-patients with schizophrenia is feasible. The effects and cost-effectiveness of music therapy for acute psychosis should be further explored in an explanatory randomised trial.", "To determine whether education and counselling after stroke leads to improved family functioning and psychosocial outcomes for stroke patients and their spouses, and better functional and social outcomes for patients.\n Two-group randomized controlled trial. Data were collected on admission to and discharge from rehabilitation, and again six months later.\n Rehabilitation units at Repatriation General Hospital and Griffith Hospital, in Adelaide, South Australia.\n Sixty-two stroke patients and their spouses, 32 in the intervention group and 30 in the control group.\n Stroke information package and three visits from a social worker trained in family counselling.\n Family functioning: McMaster Family Assessment Device (FAD); functional status: Barthel Index (BI); social recovery: Adelaide Activities Profile (AAP); depression: Geriatric Depression Scale (GDS); anxiety: Hospital Anxiety and Depression Scale (HADS); mastery: Mastery Scale (MS); health status: SF-36.\n At six months the intervention group had better family functioning for both patients (mean FAD difference 0.19) and spouses (mean difference 0.09). A modest benefit in functional status for intervention patients (mean BI difference 1.3) was related to improved family functioning. Intervention patients reported better social recovery (mean AAP differences: domestic chores 5.7, household maintenance 4.6, social activities 11.5), but there were no significant effects on depression, anxiety, mastery or health status.\n An education and counselling intervention maintained family functioning, and in turn led to improved functional and social patient outcomes. This approach helps patients and their spouses to make the optimal adjustment to living with stroke.", "This randomized controlled trial evaluated the therapeutic benefit of mental practice with motor imagery in stroke patients with persistent upper limb motor weakness. There is evidence to suggest that mental rehearsal of movement can produce effects normally attributed to practising the actual movements. Imagining hand movements could stimulate restitution and redistribution of brain activity, which accompanies recovery of hand function, thus resulting in a reduced motor deficit. Current efficacy evidence for mental practice with motor imagery in stroke is insufficient due to methodological limitations. This randomized controlled sequential cohort study included 121 stroke patients with a residual upper limb weakness within 6 months following stroke (on average <3 months post-stroke). Randomization was performed using an automated statistical minimizing procedure. The primary outcome measure was a blinded rating on the Action Research Arm test. The study analysed the outcome of 39 patients involved in 4 weeks of mental rehearsal of upper limb movements during 45-min supervised sessions three times a week and structured independent sessions twice a week, compared to 31 patients who performed equally intensive non-motor mental rehearsal, and 32 patients receiving normal care without additional training. No differences between the treatment groups were found at baseline or outcome on the Action Research Arm Test (ANCOVA statistical P=0.77, and effect size partial η2=0.005) or any of the secondary outcome measures. Results suggest that mental practice with motor imagery does not enhance motor recovery in patients early post-stroke. In light of the evidence, it remains to be seen whether mental practice with motor imagery is a valid rehabilitation technique in its own right.", "Mental practice (MP) of a particular motor skill has repeatedly been shown to activate the same musculature and neural areas as physical practice of the skill. Pilot study results suggest that a rehabilitation program incorporating MP of valued motor skills in chronic stroke patients provides sufficient repetitive practice to increase affected arm use and function. This Phase 2 study compared efficacy of a rehabilitation program incorporating MP of specific arm movements to a placebo condition using randomized controlled methods and an appropriate sample size. Method- Thirty-two chronic stroke patients (mean=3.6 years) with moderate motor deficits received 30-minute therapy sessions occurring 2 days/week for 6 weeks, and emphasizing activities of daily living. Subjects randomly assigned to the experimental condition also received 30-minute MP sessions provided directly after therapy requiring daily MP of the activities of daily living; subjects assigned to the control group received the same amount of therapist interaction as the experimental group, and a sham intervention directly after therapy, consisting of relaxation. Outcomes were evaluated by a blinded rater using the Action Research Arm test and the upper extremity section of the Fugl-Meyer Assessment.\n No pre-existing group differences were found on any demographic variable or movement scale. Subjects receiving MP showed significant reductions in affected arm impairment and significant increases in daily arm function (both at the P<0.0001 level). Only patients in the group receiving MP exhibited new ability to perform valued activities.\n The results support the efficacy of programs incorporating mental practice for rehabilitating affected arm motor function in patients with chronic stroke. These changes are clinically significant.", "Acute stress disorder (ASD) is a precursor of chronic posttraumatic stress disorder (PTSD). Twenty-four participants with ASD following civilian trauma were given 5 sessions of either cognitive-behavioral therapy (CBT) or supportive counseling (SC) within 2 weeks of their trauma. Fewer participants in CBT (8%) than in SC (83%) met criteria for PTSD at posttreatment. There were also fewer cases of PTSD in the CBT condition (17%) than in the SC condition (67%) 6 months posttrauma. There were greater statistically and clinically significant reductions in intrusive, avoidance, and depressive symptomatology among the CBT participants than among the SC participants. This study represents the 1st demonstration of successful treatment of ASD with CBT and its efficacy in preventing chronic PTSD.", "This study sought to compare the sensitivity and precision of Embase, Medline and PsycINFO bibliographic database searches for randomized controlled trials of cognitive therapy for depression. Searches in each database combined with a hand search in five selected journals formed the total pool against which each search was assessed. Sensitivities of standard searches (index terms only) were 68%, 84% and 38% in Embase, Medline and PsycINFO respectively. Sensitivities of expert searches (index and free text terms) were 76%, 97% and 65% for Embase, Medline and PsycINFO respectively. Medline appears to be the most efficient at identifying articles describing psychological treatment evaluation.", "Recent developments in chronic pain research suggest that effectiveness of cognitive-behavioral therapy (CBT) may be optimized when applying early, customized treatments to patients at risk. For this purpose, a randomized, controlled trial with tailor-made treatment modules was conducted among patients with relatively early rheumatoid arthritis (RA disease duration of <8 years), who had been screened for psychosocial risk profiles. All participants received standard medical care from a rheumatologist and rheumatology nurse consultant. Patients in the CBT condition additionally received an individual CBT treatment with two out of four possible treatment modules. Choice of treatment modules was determined on the basis of patient priorities, which resulted in most frequent application of the fatigue module, followed by the negative mood, social relationships and pain and functional disability modules. Analyses of completers and of intention-to-treat revealed beneficial effects of CBT on physical, psychological and social functioning. Specifically, fatigue and depression were significantly reduced at post-treatment and at the 6-month follow-up in the CBT condition in comparison to the control condition, while perceived support increased at follow-up assessment. In addition, helplessness decreased at post-treatment and follow-up assessment, active coping with stress increased at post-treatment, and compliance with medication increased at follow-up assessment in the CBT condition in comparison to the control condition. Results indicate the effectiveness of tailor-made CBT for patients at risk in relatively early RA, and supply preliminary support for the idea that customizing treatments to patient characteristics may be a way to optimize CBT effectiveness in RA patients." ]

[ "17462166", "19758364", "15482502", "16740868", "15832550", "17700083", "11473908", "16271570", "17076751" ]

[ "Additional therapy for young children with spastic cerebral palsy: a randomised controlled trial.", "Intensive speech and language therapy for older children with cerebral palsy: a systems approach.", "A new social communication intervention for children with autism: pilot randomised controlled treatment study suggesting effectiveness.", "Quality of reporting of randomized, controlled trials in cerebral palsy.", "Effects of constraint-induced movement therapy in young children with hemiplegic cerebral palsy: an adapted model.", "A randomized, controlled trial of a home-based intervention program for children with autism and developmental delay.", "Multicentre controlled trial of parenting groups for childhood antisocial behaviour in clinical practice.", "Efficacy of forced-use therapy in hemiplegic cerebral palsy.", "Randomised controlled trial of a parenting intervention in the voluntary sector for reducing child conduct problems: outcomes and mechanisms of change." ]

[ "To investigate whether, in the short and medium term, additional support by (a) a physiotherapy assistant improved physical function in young children with spastic cerebral palsy and (b) a family support worker improved family functioning.\n This was a multi-centre randomised controlled trial (RCT) with blinded assessments and a cost-effectiveness analysis. The children studied had spastic cerebral palsy that was the consequence of perinatal adversity. All were less than 4 years old on entry to the study.\n In the child development centre and in the home.\n Seventy-six families completed the intervention period. Forty-three families were reassessed 6 months after the end of the intervention and 34 of these after a further 6-month period.\n Randomisation was to: (a) a group who received extra physiotherapy from a physiotherapy assistant; (b) a group who received standard physiotherapy; and (c) a group where the child received standard physiotherapy and the family was also visited by a family support worker. Children in all groups continued to receive standard physiotherapy in addition to the study interventions.\n The child outcome measures were motor functioning, developmental status and adaptive functioning. The family outcome measures were self-reported maternal stress, level of family needs and parental satisfaction.\n There was no evidence that additional physical therapy for 1 hour per week for 6 months by a physiotherapy assistant improved any child outcome measure in the short or medium term. Intervention by a family support worker did not have a clinically significant effect on parental stress or family needs. Over the 6-month period the total cost of services for each child ranged from 250 pounds to 6750 pounds, with higher costs associated with children with more severe impairments. No significant relationship was found between measures of intensity of services received by the children and families and the main outcome measures. Low-functioning children, in terms of both motor and cognitive function, were more likely to receive more services in terms of range and frequency. Parents generally reported high satisfaction ratings after all interventions and some stated that the interventions had benefited the child and/or the family. There was therefore a discrepancy between the perceptions of these parents and the objective, quantitative measurements. The family support workers identified a small number of families who were experiencing considerable family problems, but who had not been referred for appropriate support by any other agency.\n The findings of this study provide support for the current literature that there was no evidence that additional intervention (in this case by a physiotherapy assistant or family support worker) helped the motor or general development of young children with spastic cerebral palsy. Nor was there any quantitative evidence that providing extra family support helped levels of parental stress and family needs. The implication was that the provision of extra physical therapy does not necessarily improve the motor function of a young child with cerebral palsy and additional family support should not automatically be assumed to be beneficial. In addition, no significant association was found between the intensity of the local services provided and any outcome measure, other than a slight association with lowered family needs. The provision of local services was related to the severity of the child's impairments and not to family difficulties. A small group of families with complex family problems needed more service input. There was a wide range in the costs of services. Research is needed to examine what 'sufficient' levels of provision or therapy might be for which children and which families. A time series of different levels of input and outcomes would provide valuable information for practitioners. It is also recommended that future assessments of therapies of this type adopt a similar multifaceted approach, which is likely to be more suitable than a simple RCT for the evaluation of clinical interventions where the effects are complex. The most appropriate measures of outcome should be used, including assessment of provision of information and emotional support for families.", "To investigate whether speech therapy using a speech systems approach to controlling breath support, phonation, and speech rate can increase the speech intelligibility of children with dysarthria and cerebral palsy (CP).\n Sixteen children with dysarthria and CP participated in a modified time series design. Group characteristics were as follows: seven males, nine females; age range 12 to 18 years (mean 14y, SD 2); CP type: nine spastic, two dyskinetic, four mixed, one Worster-Drought; Gross Motor Function Classification System levels range I to V (median IV). Children received three 30- to 45-minute sessions of individual therapy per week for 6 weeks. Intelligibility in single words and connected speech was compared across four points: 1 week and 6 weeks before therapy, and 1 week and 6 weeks after its completion. Three familiar listeners and three unfamiliar listeners scored each recording. Mean percentage intelligibility was compared using general linear modelling techniques.\n After treatment, familiar listeners understood 14.7% more single words and 12.1% more words in connected speech. Unfamiliar listeners understood 15% more single words and 15.9% more words in connected speech after therapy.\n Therapy was associated with increases in speech intelligibility. Effects of the therapy should be investigated further, in an exploratory trial with younger children and in a randomized controlled trial.", "Psychosocial treatments are the mainstay of management of autism in the UK but there is a notable lack of a systematic evidence base for their effectiveness. Randomised controlled trial (RCT) studies in this area have been rare but are essential because of the developmental heterogeneity of the disorder. We aimed to test a new theoretically based social communication intervention targeting parental communication in a randomised design against routine care alone.\n The intervention was given in addition to existing care and involved regular monthly therapist contact for 6 months with a further 6 months of 2-monthly consolidation sessions. It aimed to educate parents and train them in adapted communication tailored to their child's individual competencies. Twenty-eight children with autism were randomised between this treatment and routine care alone, stratified for age and baseline severity. Outcome was measured at 12 months from commencement of intervention, using standardised instruments.\n All cases studied met full Autism Diagnostic Interview (ADI) criteria for classical autism. Treatment and controls had similar routine care during the study period and there were no study dropouts after treatment had started. The active treatment group showed significant improvement compared with controls on the primary outcome measure--Autism Diagnostic Observation Schedule (ADOS) total score, particularly in reciprocal social interaction--and on secondary measures of expressive language, communicative initiation and parent-child interaction. Suggestive but non-significant results were found in Vineland Adaptive Behaviour Scales (Communication Sub-domain) and ADOS stereotyped and restricted behaviour domain.\n A Randomised Treatment Trial design of this kind in classical autism is feasible and acceptable to patients. This pilot study suggests significant additional treatment benefits following a targeted (but relatively non-intensive) dyadic social communication treatment, when compared with routine care. The study needs replication on larger and independent samples. It should encourage further RCT designs in this area.", "In conducting reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy, the assessment of trials can be hampered by problems in reporting. Therefore, we set out to evaluate trial reporting by using the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations.\n Randomized, controlled trials published in 1990 or later were identified in literature searches for reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy. Two independent reviewers evaluated the trial reporting by using a modified 33-item Consolidated Standards of Reporting Trials checklist.\n We identified 15 randomized, controlled trials. Almost half (48%) of the applicable items were reported adequately. Inadequate reporting was found in the following items: outcome measures, sample-size determination, details of the sequence generation, allocation concealment and implementation of the randomization, success of assessor blinding, recruitment and follow-up dates, intention-to-treat analysis, precision of the effect size, co-interventions, and adverse events.\n Only a small number of sufficiently reported trials were found. Because nearly all items had been described in at least 1 article, high-quality reporting seems feasible. Assessment of trials depends on appropriate reporting, and poor reporting jeopardizes judgments on the clinical implications. Authors of randomized, controlled trials are encouraged to follow the Consolidated Standards of Reporting Trials criteria. There is a clear need to improve the quality of reporting of trials in this field.", "The aim of this study was to evaluate the effects of a modified version of constraint-induced (CI) movement therapy on bimanual hand-use in children with hemiplegic cerebral palsy (CP; age range 18 mo to 4 y) and to make a comparison with conventional paediatric treatment. Twenty-one children (13 females, eight males) completed the CI therapy programme and 20 children (12 males, eight females) served as a control group. Children in the CI therapy group were expected to wear a restraint glove for 2 hours each day over a period of 2 months. The training was based on principles of motor learning used in play and in motivational settings. To evaluate the effect of treatment, the Assisting Hand Assessment (AHA) was used. Assessments took place on three occasions: at onset, after 2 months, and 6 months after the first assessment. A significant interaction was found between group and AHA measure (ANOVA, F(2,74) = 5.64, p = 0.005). The children who received CI therapy improved their ability to use their hemiplegic hand significantly more than the children in the control group after 2 months, i.e. after treatment. Effect size was high after treatment and remained medium at 6 months. As the treatment was tailored to each child's capacity and interests, little frustration was experienced by the children.", "This study aimed to (1) investigate whether provision of a home-based program in addition to a center-based program improves development in young children with disabilities and coping abilities of their families and (2) describe the characteristics of children and families who benefit most from the intervention.\n Fifty-nine children, aged 3-5 years, with no cerebral palsy, participated in the study. Half of the group was randomized to receive an additional program in their homes. A special education teacher provided 40 visits over 12 months working with the families to help generalize skills to the home environment and assist with their concerns. All children were assessed before and after the intervention, and families completed questionnaires assessing family stress, support, and empowerment on both occasions. Differences in change over time and between the intervention and control group were analyzed by repeated measures and the association between characteristics of children and families with improved outcome by multivariate analysis of variance.\n Change in cognitive development and behavior (in the centers) over time favored the children who received the extra intervention (p = .007 and p = .007, respectively). The groups did not differ on any of the family measures of change. Multivariate analysis of variance revealed more improvement for children in the intervention group from higher than lower stressed families.\n Results suggest the need for daily reinforcement of skills learned at the center-based program and the importance of involving families, especially those with few resources and relatively high stress.", "To see whether a behaviourally based group parenting programme, delivered in regular clinical practice, is an effective treatment for antisocial behaviour in children.\n Controlled trial with permuted block design with allocation by date of referral.\n Four local child and adolescent mental health services.\n 141 children aged 3-8 years referred with antisocial behaviour and allocated to parenting groups (90) or waiting list control (51).\n Webster-Stratton basic videotape programme administered to parents of six to eight children over 13-16 weeks. This programme emphasises engagement with parental emotions, rehearsal of behavioural strategies, and parental understanding of its scientific rationale.\n Semistructured parent interview and questionnaires about antisocial behaviour in children administered 5-7 months after entering trial; direct observation of parent-child interaction.\n Referred children were highly antisocial (above the 97th centile on interview measure). Children in the intervention group showed a large reduction in antisocial behaviour; those in the waiting list group did not change (effect size between groups 1.06 SD (95% confidence interval 0.71 to 1.41), P<0.001). Parents in the intervention group increased the proportion of praise to ineffective commands they gave their children threefold, while control parents reduced it by a third (effect size between groups 0.76 (0.16 to 1.36), P=0.018). If the 31 children lost to follow up were included in an intention to treat analysis the effect size on antisocial behaviour was reduced by 16%.\n Parenting groups effectively reduce serious antisocial behaviour in children in real life conditions. Follow up is needed to see if the children's poor prognosis is improved and criminality prevented.", "To determine the efficacy of forced-use therapy (FUT) on the improvement of upper-extremity function in children with hemiplegic cerebral palsy (CP).\n Prospective case series.\n Outpatient ambulatory clinic in South Korea.\n Thirty-one patients with hemiplegic CP were assigned to the FUT group (n=18) or to the control group (n=13). The mean age of the patients in the FUT group was 33.2 months and in the control group it was 43.2 months.\n The FUT group wore a short-arm Scotchcast on the unaffected arm for 6 weeks and also participated in a conventional rehabilitation program that included stretching exercises and functional occupational therapy for the upper extremity. The control group underwent the conventional rehabilitation program only.\n Hand function tests, including the box and block test (BBT), Erhardt Developmental Prehension Assessment (EDPA), and WeeFIM instrument taken before and after 6 weeks of treatment.\n Before treatment, there was no significant difference between groups in the BBT, EDPA, and WeeFIM scores. After 6 weeks of treatment, however, the FUT group showed significant improvement in the affected arm in the BBT and EDPA scores, compared with the control group (P<.05). The self-care score on the WeeFIM was also significantly improved in the FUT group (P<.05).\n FUT combined with a conventional rehabilitation program appears to be more effective than a rehabilitation program alone in improving affected hand function in children with hemiplegic CP.", "To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children.\n Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems, aged 2-9, primarily low-income families, randomised to treatment vs. 6-month wait-list group. Retention was 93% at 6 months, 90% at 18 months. Interventions--Webster-Stratton Incredible Years video-based 14-week group programme, teaches cognitive-behavioural principles for managing behaviour, using a collaborative, practical, problem-solving approach. Primary outcomes--child problem behaviour by parent-report (Eyberg) and home-based direct observation; secondary outcomes--observed positive and negative parenting; parent-reported parenting skill, confidence and depression.\n Post-treatment improvements were found in child problem behaviour, by parent-report (effect size (ES) .48, p = .05) and direct observation (ES .78, p = .02); child independent play (ES .77, p = .003); observed negative (ES .74, p = .003) and positive (ES .38, p = .04) parenting; parent-reported confidence (ES .40, p = .03) and skill (ES .65, p =.01), using ANCOVA to control for baseline scores. Maternal depression did not change. Consumer satisfaction was high. At 18-month follow-up, although no randomised comparison was possible, changes appeared to maintain, with no significant change toward baseline level on any measure. Change in observed positive parenting appeared to mediate change in child problem behaviour (p < .025).\n Findings suggest that a group-based cognitive-behavioural parenting programme, delivered by well-trained and supervised staff, can be effective in a community voluntary-sector setting, for reducing conduct problems and enhancing parenting skills. Change in parenting skill appears to be a key mechanism for change in child behaviour. Findings have implications for feasibility of translating evidence-based programmes, even for clinically-referred conduct problems, into less specialised community settings, likely to have lower costs and be more accessible for families." ]

[ "10213547", "6791596", "413493", "11379805", "7573849", "3133964", "3929698", "8387933", "2167369" ]

[ "Randomised placebo-controlled trial of inhaled sodium cromoglycate in 1-4-year-old children with moderate asthma.", "Nebulised cromoglycate, theophylline, and placebo in preschool asthmatic children.", "Nebulized sodium cromoglycate in young asthmatic children. Double-blind trial.", "Comparison of the cost-effectiveness of budesonide and sodium cromoglycate in the management of childhood asthma in everyday clinical practice.", "A double-blind, placebo-controlled comparison of sodium cromoglycate and ketotifen in the treatment of childhood asthma.", "Double-blind crossover study comparing sodium cromoglycate, reproterol, reproterol plus sodium cromoglycate, and placebo in exercise-induced asthma.", "Nebulised sodium cromoglycate in recurrently wheezy preschool children.", "Comparison of nedocromil sodium and sodium cromoglycate administered by pressurized aerosol, with and without a spacer device in exercise-induced asthma in children.", "Attenuation of exercise induced asthma by nedocromil sodium and sodium cromoglycate." ]

[ "Inhalation therapy with sodium cromoglycate is recommended as the first-line prophylactic treatment for moderate asthma in children. The availability of spacer devices with face-masks has extended the applicability of metered-dose inhalers to younger children. We studied the feasibility and effects of this therapy compared with placebo in children aged 1-4 years.\n 218 children aged 1-4 years with moderate asthma were recruited through 151 general practitioners between March, 1995, and March, 1996. They were randomly assigned sodium cromoglycate (10 mg three times daily) or placebo, given by inhaler with spacer device and face-mask for 5 months. Rescue medication (ipratropium plus fenoterol aerosol) was available during the baseline period of 1 month and the intervention period. Parents completed a daily symptom-score list. The primary outcome measure was the proportion of symptom-free days in months 2 to 5. Analysis was by both intention to treat and on treatment.\n 167 (77%) children completed the trial. 131 (78%) of these children used at least 80% of the recommended dose. Of the 51 children who stopped prematurely, 23 had difficulties with inhaled treatment. The mean proportion of symptom-free days for both groups was greater for the treatment period than for the baseline period (95% CI for mean difference 5.1 to 17.5 cromoglycate, 11.9 to 23.3 placebo). However there were no differences between the sodium cromoglycate and placebo groups in the proportion of symptom-free days (mean 65.7 [SD 25.3] vs 64.3 [24.5]%; 95% CI for difference -8.46 to 5.70) or in any other outcome measure.\n Our study in a general practice setting shows that inhalation therapy with a spacer device and face-mask is feasible in a majority of children below the age of 4 years. However, long-term prophylactic therapy with inhaled sodium cromoglycate is not more effective than placebo in this age-group.", "Sixteen children aged under 5 years with chronic asthma completed a double-blind crossover trial of treatment with oral choline theophyllinate (6.7 mg/kg four times daily) and nebulised sodium cromoglycate (20 mg four times daily). The trial comprised three 8-week treatment periods during which active sodium cromoglycate, active choline theophyllinate, and placebo were given in random order. Symptom scores for sleep disturbance, cough, wheeze, and daily activities were similar during the three treatment periods if results were analysed using Friedman's non-parametric analysis of variance. However the Mantel-Haenszel test showed that sodium cromoglycate was superior to placebo (P less than 0.05) in maintaining normal daily activities. Either regimen is safe and well tolerated by young children.", "Seventeen asthmatic children under 5 years of age took part in a double-blind controlled trial of nebulized sodium cromoglycate solution. Daily symptom scores kept by the parents showed improvement in 11 children during active treatment, and a significant improvement in scores for cough by day and night was obtained for the group as a whole.", "Budesonide and sodium cromoglycate are both recommended as maintenance therapy for childhood asthma.\n To compare the cost-effectiveness of these two treatment strategies in clinical practice, in an open-label, pharmacoeconomic clinical trial.\n Health economics were evaluated in 138 children, ages 5 to 11 years, with unstable asthma not previously treated with corticosteroids or cromones. The asthma was stabilized during 4 to 6 weeks with budesonide 200 to 400 microg twice daily. The children were then randomly allocated to one of the two treatment strategies aiming at maintaining asthma control for 12 months; budesonide 400 microg/day (N = 69) or sodium cromoglycate 60 mg/day (N = 69). If asthma control was judged unsatisfactory, the doses were increased or the children were switched to the alternate treatment.\n In children continuing on the same treatment, the degree of asthma control was similar in the two groups at study end. To maintain asthma control, 42% of cromoglycate children switched to budesonide, and then experienced a 14% increase in symptom-free days. No budesonide patient had to switch therapy because of lack of asthma control. Although not statistically significant, total annual cost per patient was 24% (Swedish kronor 4195; US $487; Euro 485) lower in the budesonide than the cromoglycate group, mainly due to a lower cost for asthma medication.\n A budesonide strategy for continued maintenance treatment, after an initial period of stabilizing treatment with budesonide, resulted in lower costs and less drug switches than did a strategy with sodium cromoglycate.", "We compared three treatments: sodium cromoglycate 5 mg aerosol and placebo syrup (39 patients), placebo aerosol and ketotifen syrup (39 patients), and placebo aerosol and syrup (36 patients). The patients (mean age 11.7 years) had mostly allergic, moderately severe asthma. Treatments were added to current therapy (mostly bronchodilators only) for 3 months. Aerosols were taken four times daily and syrups twice daily. The following results were significant at a level of 5%. At the final clinic visit, the changes from baseline in lung function favored sodium cromoglycate over the other treatments. During month 3, sodium cromoglycate was superior to ketotifen for night symptoms, morning tightness, daytime symptoms, and cough. Bronchodilator use decreased more with sodium cromoglycate than ketotifen. Patients' and clinicians' overall opinions of treatment effectiveness favored sodium cromoglycate over ketotifen and placebo. In these patients, sodium cromoglycate was both effective and superior to ketotifen.", "Sixteen patients were included in the analysis of this double-blind crossover study comparing the effect of sodium cromoglycate, reproterol, sodium cromoglycate plus reproterol, and placebo in exercise-induced asthma. Both the sodium cromoglycate and the reproterol-containing treatment significantly inhibited exercise-induced asthma. The best protection is effected by the combination of sodium cromoglycate and reproterol. A synergistic effect of both medications could not be confirmed statistically so that their combined effect is simply additive.", "A double blind crossover study of nebulised sodium cromoglycate in 27 asthmatic preschool children was carried out over a one year period. All subjects had sufficiently severe asthma to have had at least one admission to hospital. The active treatment was sodium cromoglycate 20 mg (in 2 ml) administered by a nebuliser four times daily. Assessment was made by a diary card and clinical examination. Results were analysed in 24 subjects who completed the study. Statistical analysis allowed for order of treatment and seasonal effects. Significant results in favour of treatment with sodium cromoglycate were obtained for night cough, day activity, percentage of symptom free days, and overall severity of asthma. During active treatment there was no reduction in the rate of admissions to hospital or intravenous drugs used. The wheeze score during the week after an upper respiratory tract infection was not reduced during treatment with sodium cromoglycate. Nebulised sodium cromoglycate is a tedious prophylactic treatment for the young asthmatic child but is useful when other treatments have failed.", "To compare the effectiveness of nedocromil sodium (NS) and sodium cromoglycate (SCG) administered by metered dose inhaler (MDI) in preventing exercise-induced asthma (EIA), 12 asthmatic children with EIA were studied in a randomized, double-blind, cross-over, placebo-controlled study. NS and SCG were given by MDI alone, and by MDI with a 700 ml spacer device (Fisonair, Fisons, UK), in order to assess the benefit of using such a device. Following a baseline exercise challenge, the protective effect of NS, SCG or placebo was evaluated in each subject. The percentage fall in forced expiratory volume in one second, and percentage protection were measured. NS and SCG provided a significant and comparable protection from EIA, and both were better than placebo. No further improvement was observed after drug administration via the spacer. Both NS and SCG are effective in preventing EIA in children, when administered at the recommended clinical dose, and the use of a spacer for administering the drug provides no advantage if the technique of inhalation is good.", "A randomized double blind cross over trial to compare nedocromil sodium and sodium cromoglycate with placebo in the prevention of exercise induced asthma was conducted. Twenty asthmatics received nedocromil sodium, sodium cromoglycate or placebo via metered dose inhalers on successive days 30 minutes before exercise in a randomized order. Nedocromil sodium and sodium cromoglycate gave sufficient protection (P less than 0.05) compared to placebo as assessed by the reduction in the maximum percentage fall in the forced expiratory volume in 1 second (FEV1). The protective effect of nedocromil sodium and sodium cromoglycate varied in individuals." ]

[ "2267922", "7359263", "3089439", "2188543", "9802368", "7638372", "2201941", "12969999", "9722255" ]

[ "Placebo controlled trial of systemic corticosteroids in acute childhood asthma.", "Corticosteroids in status asthmaticus.", "Short course of steroids in home treatment of children with acute asthma.", "Early administration of corticosteroids in emergency room treatment of acute asthma.", "Effectiveness and safety of inhaled corticosteroids in controlling acute asthma attacks in children who were treated in the emergency department: a controlled comparative study with oral prednisolone.", "Comparison of fluticasone propionate and sodium cromoglycate for the treatment of childhood asthma (an open parallel group study).", "Methylprednisolone therapy for acute asthma in infants and toddlers: a controlled clinical trial.", "A randomized controlled trial of inhaled flunisolide in the management of acute asthma in children.", "Efficacy of sequential early systemic and inhaled corticosteroid therapy in the prevention of chronic lung disease of prematurity." ]

[ "In a randomised controlled trial 38 asthmatic children aged 2-11 yr who had not received regular oral or inhaled steroids during the previous year, were treated with a standard regime of nebulised salbutamol and intravenous aminophylline plus either hydrocortisone and oral prednisolone for 5 days, or placebo. The children were observed throughout their hospital stay and for 3 months afterwards. There was a greater fall in heart rates in the steroid treated group on the second day of treatment (mean diff. 16 beats/min) and at discharge (mean diff. 13 beats/min); p less than 0.025. Peak Expiratory Flow Rates recorded in 26 children, 13 in each group, showed more improvement on day 2 in those given steroids (mean diff 16% predicted); p less than 0.05. This difference was not apparent at discharge but 9 children treated with steroids were clinically wheeze-free when they left hospital compared with 3 in the placebo group, p less than 0.05. There were no differences in respiratory rate, pulsus paradoxus and arterial oxygen saturation. Trends in duration of hospital stay and relapse rate during the succeeding 3 months favoured active treatment. These findings support the use of systemic corticosteroids in addition to high dose bronchodilators to treat 'non steroid dependent' children hospitalised with acute severe asthma.", "Nineteen children who were not steroid dependent and were hospitalized in status asthmaticus were studied to evaluate the effect of corticosteroids. They were randomized into two groups. Each group received salbutamol inhalations and intravenous aminophylline therapy. One group received 7 mg/kg hydrocortisone intravenously every six hours; the other group served as a control. Each group showed significant improvement in clinical score and peak expiratory flow rate after 36 hours; there was no statistical difference in the degree of improvement. Six of ten steroid-treated children and six of nine controls achieved a PEFR of 50% predicted by 36 hours. The response to inhaled salbutamol was similar in each group. The results show that in the first 36 hours of therapy, corticosteroids have no additive effect on the bronchodilator response of aminophylline and salbutamol and do not hasten the recovery of nonsteroid-dependent children in status asthmaticus. Although the results show that an inhaled sympathomimetic drug is beneficial in status asthmaticus, corticosteroid therapy does not increase the responsiveness of the airways to these agents.", "A double blind, randomised, placebo controlled study of the treatment of children with acute asthma at home showed that a three day course of prednisolone hastened improvement of both asthmatic symptoms and peak expiratory flow rates. Thus all asthmatic children who present with an acute attack should be considered for treatment with corticosteroids in addition to bronchodilators not only to prevent possible deterioration but also to speed recovery.", "To determine the effect of early administration of high-dose intravenous corticosteroids on duration of emergency room treatment and hospital admission rate in patients with acute asthma.\n Randomized, double-blind, placebo-controlled trial.\n The emergency room of a large, urban hospital with primary and referral care responsibilities.\n Eighty-one patients from 18 to 45 years of age with acute bronchial asthma and without pneumonitis or other serious underlying illnesses were studied on 91 occasions and were randomly assigned to control or experimental groups.\n The steroid group received 125 mg of intravenous methylprednisolone whereas the control group received intravenous normal saline 30 minutes after initial treatment. Additional treatment included aerosolized metaproterenol and oral theophylline therapy. Six hours after study entry, remaining patients were treated with 40 mg of intravenous methylprednisolone. Hospitalization was mandatory if total treatment time was greater than 12 hours.\n Age, sex, peak expiratory flow at entry, and prevalence of recent corticosteroids use were similar in both groups. Duration of emergency room treatment was 6.7 +/- 4.2 (SD) hours in the steroid group and 6.3 +/- 4.1 hours in the control group (P = 0.66). Hospitalization was necessary in 18% (95% CI, 7% to 30%) of the steroid group and in 13% (CI, 3% to 22%) of the control group. Frequency of return visits for acute asthma 2 days after emergency room discharge was 11% (CI, -1% to 22%) in the steroid group and 13% (CI, 2% to 23%) in the control group.\n These results fail to show any benefit for early administration of corticosteroids in patients with acute asthma. Routine administration of corticosteroids on initial presentation in such patients may not be warranted.", "Inhaled corticosteroids have a greater antiinflammatory potency and fewer systemic effects than intravenous, intramuscular, or oral corticosteroids. However, their role in acute asthma has not been established. We prospectively investigated the efficacy and safety of inhaled corticosteroids in controlling moderately severe acute asthma attacks in children who were treated in the emergency department.\n Children who were treated in the emergency department with moderately severe asthma attacks after receiving treatment with inhaled terbutaline were allocated by double-blind design to receive 1 dose of either 1600 micro(g) budesonide turbohaler or 2 mg/kg prednisolone. The pulmonary index score and peak expiratory flow rate were measured hourly for the first 4 hours. After discharge the children were treated with the same initial doses given 4 times daily, followed by a 25% reduction in dose every second day for 1 week. Parents recorded asthma symptoms and use of beta-2 agonists on a daily diary card. Serum cortisol concentration was measured at the end of weeks 1 and 3.\n Twenty-two children (11 in each group) with similar baseline parameters completed the study. There was a similar improvement in pulmonary index score and peak expiratory flow rate in the 2 groups. Children treated with budesonide showed an earlier clinical response than those given prednisolone, who also showed a decrease in serum cortisol concentration.\n In children with moderately severe asthma attacks who were treated in the emergency department, a short-term dose schedule of inhaled budesonide turbohaler, starting with a high dose and followed by a decrease over 1 week, is at least as effective as oral prednisolone, without suppressing serum cortisol concentration.", "Inhaled corticosteroids are highly effective in the treatment of asthma at all ages and their use in younger children is increasing. As concerns exist about the long-term systemic side-effects of high dose inhaled corticosteroids, current guidelines continue to recommend sodium cromoglycate (SCG) as first line regular medication for children with frequent symptoms. Few published studies have compared the safety and efficacy of inhaled corticosteroids with SCG in children. This study compares SCG with the new inhaled corticosteroid, fluticasone propionate (FP), which has theoretical advantages over other currently available corticosteroids due to its negligible oral bioavailability. This was a randomized, open, multi-centre, parallel group comparison of 50 micrograms FP twice daily and 20 mg SCG four times daily over 8 weeks, preceded by a 2-week baseline period. Sixty-two general practices and two hospital centres enrolled 225 asthmatic children aged 4-12 years (110 received FP; 115 received SCG). Outcome measures improved in both groups, with a significant difference in favour of FP for the key variables of mean morning and evening % predicted PEFR and % of symptom-free days and nights. No significant difference was observed for FEV1, or relief medication use. Two children taking FP and 10 children taking SCG withdrew because of adverse events. This study showed that low dose FP was effective and superior to SCG in young children with mild-moderate asthma. Safety studies of longer duration are needed before changing the current recommendations for inhaled corticosteroid therapy.", "A controlled double-blind trial was carried out to assess the effect of the early introduction of combined corticosteroid and beta-adrenergic drugs for the treatment of acute asthma in infants and toddlers. Seventy-four emergency room patients (aged 7 to 54 months) who were treated for acute asthma were studied. Treatment included, in addition to salbutamol inhalations, a single dose of intramuscular methylprednisolone (4 mg/kg) or normal saline as placebo. The patients were reevaluated 3 hours after initiation of treatment. At that time, patients were either admitted or discharged based on a clinical decision. Only 8 (20%) of 39 patients treated with steroids were admitted, compared with 15 (43%) of 35 in the placebo group (P less than .05). Sequential analysis of 33 pairs, matched by age and severity of symptoms, revealed statistically significant reduced admission rates in patients treated with steroids. In the younger patients (6 to 24 months), admission rate was significantly lower for those treated with steroids (18%) as compared with those treated without steroids (50%) (P less than .05). In the older group (24 to 54 months), the trend was similar but not statistically significant: 23% vs 31% in the steroid and placebo groups, respectively. These data indicate that corticosteroid treatment combined with an adrenergic agent, given early during an acute asthmatic episode, significantly reduces the hospital admission rate of infants and toddlers.", "Inhaled corticosteroids (ICS) may provide benefit in the therapy of acute asthma. The purpose of this study was to test the hypothesis that ICS are as effective as oral corticosteroids (OCS) in the management of acute childhood asthma.\n A randomized, masked, placebo-controlled study was conducted in children aged 6 to 16 years seeking emergent care for an acute exacerbation of asthma. Patients were randomized into one of two groups: group 1 (OCS), oral prednisone, 2 mg/kg (maximum of 60 mg/d) for 7 days, and placebo pressurized metered-dose inhaler with valved holding chamber, four inhalations bid; and group 2 (ICS), flunisolide, four inhalations (1 mg) bid for 7 days, and daily placebo tablets. Spirometry (FEV(1)) was performed at baseline, day 3, and day 7 of the study. A symptom diary and twice-daily peak expiratory flow were recorded.\n A total of 58 subjects receiving ICS (n = 27) or OCS (n = 28) were enrolled. Baseline asthma severity, race, gender, and age were balanced between the two groups. chi(2) showed no significant difference in symptom severity between the two groups at any time during the study. FEV(1) percentage of predicted was lower in the ICS group on day 3 (65% vs 78%, p = 0.03) and on day 7 (77% vs 95%, p = 0.002).\n ICS were found to be useful in the management of acute asthma in children; however, spirometry data suggested a more rapid resolution of asthma with OCS.", "In order to assess the efficacy of a combination of systemic and nebulized corticosteroids in reducing the incidence and severity of chronic lung disease (CLD) in very low birthweight (VLBW) infants, 60 ventilator-dependent infants < or = 1500 g were randomly assigned to receive either steroids or placebo as of 7 d. The steroid group (n = 30, GA = 25.8 +/- 1.6 weeks, BW = 731 +/- 147 g) received systemic dexamethasone for 3 d, followed by nebulized budesonide for 18 d. Control infants (n = 30, GA = 25.9 +/- 1.8 weeks, BW = 796 +/- 199 g) received systemic and inhaled saline. Steroid-treated infants required less ventilatory support between 9 and 17 d (p < 0.01), and had greater lung compliance at 10 d (p = 0.01), but not subsequently. CLD incidence at 36 weeks was 45.5% vs 56.0% in controls, and fewer steroid-treated infants required dexamethasone rescue (23.3% vs 56.7%, p = 0.017). Survival to discharge was similar (73.3% vs 83.3%), as were the durations of mechanical ventilation, supplemental oxygen use, and hospitalization. Tracheal effluent elastase/albumin ratios and serum cortisol values did not differ between groups, and no adverse effects were noted. We conclude that early dexamethasone administration was associated with improved pulmonary function, which was not sustained with nebulized budesonide. However, the steroid regimen studied reduced the need for dexamethasone rescue in infants with CLD." ]

[ "11078836", "20675729", "7945822", "8708952", "15803166", "15284215", "12870339", "1547173", "15522021" ]

[ "Amniotic membrane transplantation for repair of leaking glaucoma filtering blebs.", "Amniotic membrane transplantation as an adjunct to medical therapy in acute ocular burns.", "Honey-impregnated gauze versus amniotic membrane in the treatment of burns.", "Periodontal regeneration of human intrabony defects with bioresorbable membranes. A controlled clinical trial.", "Long-term intraocular pressure control of eyes that developed encapsulated blebs following trabeculectomy.", "A European multicentre prospective randomized study to assess the use of assisted hatching with a diode laser and the benefit of an immunosuppressive/antibiotic treatment in different patient populations.", "[Long-term follow-up study on Hunan aqueous drainage implantation combined with mitomycin C for refractory glaucoma].", "Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage.", "Comparison of melanocytes transplantation methods for the treatment of vitiligo." ]

[ "To compare the safety and efficacy of human preserved amniotic membrane transplant with conjunctival advancement for repair of late-onset glaucoma filtering bleb leaks.\n A prospective, randomized clinical trial compared amniotic membrane transplant with conjunctival advancement in patients with leaking glaucoma filtering blebs. Intraocular pressure, number of glaucoma medications, and reoperation for glaucoma or persistent or recurrent bleb-leak were compared in the two groups. Patients were followed for a minimum of 1 year.\n Mean intraocular pressure was the same at 6 (amniotic membrane transplant, 15.4 +/- 4.4, conjunctival advancement 14.1 +/- 6.4, P = 0.6), 12 (amniotic membrane transplant, 15.0 +/- 6.3, conjunctival advancement, 13.2 +/- 6.6, P = 0.5), and 24 (amniotic membrane transplant, 17.2 +/- 7.1, conjunctival advancement, 15.0 +/- 6.3, P = 0.6) months. The mean number of glaucoma medications in use was the same in the two groups at all time intervals. After an average follow-up of 19 months, there were seven failures in the amniotic membrane transplant group (two with persistent leaks that were unresponsive to further suturing, two with late-onset leaks, and three who required repeat glaucoma surgery) and none in the conjunctival advancement group. The cumulative survival rate for amniotic membrane transplant was 81% at 6 months, 74% at 1 year, and 46% at 2 years. The cumulative survival rate was 100% for conjunctival advancement throughout follow-up.\n Amniotic membrane transplantation does not offer an effective alternative to conjunctival advancement for repair of leaking glaucoma filtering blebs.", "To evaluate the role of amniotic membrane transplantation in patients with acute ocular burns.\n In a prospective, randomised, controlled clinical trial, 100 patients with grade II to IV acute ocular burns (Roper Hall Classification) were recruited. 50 patients with grade II-III burns were graded as moderate burns, and 50 patients with grade IV burns were graded as severe burns. Both groups were individually randomised into control group (n=25) and study group (n=25). The corresponding grade of ocular surface burn by Dua classification was noted. The eyes in the study group underwent amniotic membrane transplantation in addition to conventional medical therapy. In the control group, conventional medical therapy along with mechanical release of early adhesions as and when necessary was instituted. Rate of healing of corneal epithelial defect, visual acuity, extent of corneal vascularisation, corneal clarity and formation of symblepharon were compared in both groups.\n In patients with moderate ocular burns treated with amniotic membrane transplantation, the rate of epithelial healing was significantly better than the group treated with standard medical therapy alone (p=0.0004). There was no overall difference in the final visual outcome, symblepharon formation, corneal clarity and vascularisation with or without amniotic membrane transplantation.\n Amniotic membrane transplantation in eyes with acute ocular burns promotes faster healing of epithelial defect in patients with moderate grade burns. There seems to be no definite long-term advantage of amniotic membrane transplantation over medical therapy and mechanical release of adhesions in terms of final visual outcome, appearance of symblepharon and corneal vascularisation when compared in a controlled clinical setting.", "A prospective randomized clinical study to compare honey-impregnated gauze with amniotic membrane dressing in partial thickness burns was carried out. Sixty-four patients were studied. Forty of them were treated with honey-impregnated gauze and 24 were treated with amniotic membrane. The burns treated with honey healed earlier as compared to the amniotic membrane (mean 9.4 vs 17.5 days) (P < 0.001). Residual scars were noted in 8 per cent of patients treated with honey-impregnated gauze and in 16.6 per cent of cases treated with amniotic membrane (P < 0.001).", "The purpose of this controlled clinical trial was to compare the clinical efficacy of 3 treatment modalities in the treatment of deep interproximal intrabony defects. Thirty-six (36) defects in 36 patients were randomly assigned to 1 of 3 treatment groups by blocking to prognostic variables. The test was treated with bioresorbable membranes positioned coronal to the interproximal bone crest; the second group (membrane control) was treated with conventional non-resorbable (ePTFE) barrier membranes applied coronal to the alveolar crest; the third group (flap Control) was treated with an access flap procedure (MWF). No differences were observed in terms of baseline oral hygiene and defect characteristics among the 3 groups, indicating that the blocking approach was effective. A stringent infection control program was enforced for 1 year. The results indicated that: 1) at 1 year all treatment modalities resulted in clinically significant improvements in clinical attachment levels (CAL) and reductions in probing depths; 2) a statistically significant treatment effect (P < 0.0001, ANOVA) was observed comparing the test (4.6 +/- 1.2 mm), the membrane control (5.2 +/- 1.4 mm), and the flap control groups (2.3 +/- 0.8 mm) in terms of CAL gain; 3) differences in terms of CAL gain between the test (bioresorbable) and the membrane control (ePTFE) groups were not statistically significant (P = 0.19, t-test); 4) both the test and the membrane control groups gained significantly more CAL at 1 year than the MWF group (P < 0.0001, t-test). CAL gains > or = 4 mm were observed in 83.3% of cases in both GTR groups, while CAL gains of this magnitude were not detected in the MWF group. We concluded that clinically significant CAL gains can be obtained with GTR procedures using both bioresorbable and non-resorbable membranes. Patients' morbidity, however, was lower in the group treated with bioresorbable membranes.", "To evaluate the long-term intraocular pressure (IOP) control of eyes that developed an encapsulated bleb (EB) following trabeculectomy.\n Between 1994 and 1995, 25 eyes developed EBs and were randomized to medical treatment or needling without adjunct antimetabolites. Among the 25 patients who developed an EB, 21 were followed for at least 6 months. A control group of 21 consecutive eyes, which underwent trabeculectomy during the same period and that did not develop EBs was retrospectively selected. Success was defined as IOP <21 mmHg with or without medications. Kaplan-Meier survival analysis was performed to compare the groups.\n Among the 21 eyes that developed EBs, 12 (57%) had undergone transconjunctival needling and nine (43%) had received medical treatment. Mean follow-ups were 30.0 +/- 14.0 months, 33.3 +/- 18.5 months, and 37.4 +/- 2.6 months for the needling, medical treatment, and control groups, respectively (P = 0.19). Kaplan-Meier survival curves demonstrated that the control group showed a significantly lower chance of failure than both the needling and the medical treatment groups (P < 0.0001).\n Encapsulated blebs may be associated with an increased risk for surgical failure.", "Assisted hatching (AH) techniques, designed for facilitating the embryo escape out of the zona pellucida (ZP) have been used in IVF centres since 1992. The initial indications for AH were patient's age, ZP thickness, high basal FSH and repeated IVF failures. Several retrospective and prospective studies assessing AH in these indications have given disparate results. Our aims were to evaluate the benefits of AH and immunosuppressive/antibiotic treatment (IA) in patients with either a poor prognosis of success, previous implantation failures or transfers of cryopreserved embryos.\n Four IVF centres allocated 426 patients, randomized for AH and IA, into four groups of AH indications between 1997 and 1999. AH was performed with a diode laser. ZP thickness, opening size and embryo score were recorded. Outcome measures were implantation and delivery rates.\n Patients coming for a first or third transfer of cryopreserved embryos and poor prognosis patients admitted for a first trial did not benefit from AH. Even patients with repeated implantation failures of fresh embryos did not gain significantly from AH.\n Among AH indications, absence of implantation after several transfers of good quality embryos remains the strongest patient selection criterion. Prescription of an immunosuppressive/antibiotic treatment is essential.", "To investigate the long-term therapeutic effect of Hunan aqueous drainage (HAD) implantation with and without adjunctive intraoperative mitomycin C (MMC) for refractory glaucoma.\n 154 cases (159 eyes) with refractory glaucoma underwent Hunan aqueous drainage (HAD) implantation from July 1995 to July 2001. Sixty-five eyes were combined with MMC (0.4 mg/ml, 1 to 5 mins). With success defined as the introcular pressure (IOP) greater than 6 mmHg but no greater than 21 mmHg at the last visit.\n The mean period of postoperative follow-up was 54.6 (range, 12-72) months. The IOP was lowered from preoperative (46.8 +/- 14.5) mmHg to postoperative (16.8 +/- 11.3) mmHg at the 1st year after surgery. The success rate with MMC and without MMC were 90.0%, 77.3% (P < 0.05) at the 1st year, 87.1%, 67.3% (P < 0.05) at the 2nd year, 83.3%, 61.1% (P < 0.05) at the 3rd year, 81.3%, 56.7% (P < 0.05) at the 4th year, and 75.0%, 50.0% (P < 0.05) at the 5th year using Kaplan-Meier life-table analysis. The height of the posterior bleb underwent standardized ocular echography at the 1st year was (3.8 +/- 0.9) mm and (2.1 +/- 1.4) mm, respectively. Ninty-five eyes (81.9%) with visual acuity remained or improved after the surgery (P > 0.05). The most frequent complications for long-term follow-up included elevated IOP (IOP > 22 mmHg) (19.8%), the iris adherent to the proximal orifice of the tube (15.5%), developed cataract formation (12.9%) and so on (P > 0.05). We didn't find any severe complications after using MMC.\n This study suggests that HAD implantation is an effective method in the management of refractory glaucoma in spite of its unneligible complications and combined with MMC can improve the prognosis.", "To compare by randomized prospective clinical trial the outcome of labours which are managed with the intention to leave the membranes intact, compared with the practice of elective artificial rupture of the membranes (ARM) in early established labour.\n Prospective randomized controlled trial of low risk women admitted in spontaneous labour, with intact membranes.\n The labour ward of St. James's University Hospital, Leeds, UK.\n 362 women in spontaneous labour with intact membranes and no evidence of fetal distress, between 37 and 42 weeks gestation. During the course of the trial it was found that some randomization cards could not be accounted for and a system of daily checks was instituted. The results were analysed for all recorded women (n = 362) and after institution of the more rigorous system (n = 120).\n The duration of each phase of labour, epidural rate, prevalence of an abnormal cardiotocograph (CTG) (assessed blind), method of delivery and neonatal outcome.\n 178 of the 183 women (97%) in the ARM group had their membranes ruptured in early labour, and 83 (46%) of the 179 women allocated to non-intervention had ARM performed at some stage. A significant decrease in the duration of labour (mean 8.3, SD 4.1 h vs mean 9.7, SD 4.8 h, n = 156; P = 0.05) was found amongst primigravidae allocated to ARM when compared with non intervention. The duration of the second stage of labour was unaffected. In the ARM group the epidural rate was higher and labour was more often complicated by CTG abnormalities. There were no differences in the method of delivery, fetal condition at birth (cord blood lactate, Apgar score) or postpartum pyrexia between the ARM and non-intervention groups. The same trends were observed when analysis was confined to women entered into the trial after the system of rigour was instituted.\n Routine ARM results in labour that is slightly shorter than if the membranes are allowed to rupture spontaneously but more epidurals are used suggesting that labour is more painful. There are fewer fetal heart rate abnormalities if the membranes are left intact but amniotomy has no effect on fetal condition at birth.", "Surgical therapy of vitiligo is indicated when depigmented macules are localized in areas that are known to respond poorly.\n The objective was to compare the results of treatment of vitiliginous macules localized in the dorsum of the hands and lower limbs by transplantation of cultured autologous melanocytes plus PUVA therapy (CMP), suction blister transplantation plus PUVA therapy (SBP), cryotherapy plus PUVA therapy (CP), and only PUVA therapy (OP).\n Twenty patients qualified for the study. The patients were split into two groups of 10 patients. In the first group, the CMP procedure was performed on one limb and OP on the other. In the second group, SBP and CP were used, respectively.\n The CMP procedure was successfully performed on only 6 of 10 patients, whereas SBP was carried out on all 10 patients. No significant difference was found between the number of successful transplants in both groups of patients. A total lack of effectiveness was found in CP and OP methods.\n This study demonstrated the advantage of the suction blister transplantation method over the autologous cultured melanocytes transplantation method because of the difficulties in cell culture establishment in some cases." ]

[ "15479682", "9354192", "21453880", "18240282", "15647189", "16696804", "2202199", "20049950", "16670529" ]

[ "Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine.", "Double-blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis.", "A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis.", "Probiotic administration in patients with ileal pouch-anal anastomosis for ulcerative colitis is associated with expansion of mucosal regulatory cells.", "Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: a randomised controlled pilot trial.", "Efficacy of Lactobacillus GG in maintaining remission of ulcerative colitis.", "5-Aminosalicylic acid suppositories in the maintenance of remission in idiopathic proctitis or proctosigmoiditis: a double-blind placebo-controlled clinical trial.", "Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis: a double-blind, randomized study.", "Probiotic treatment of collagenous colitis: a randomized, double-blind, placebo-controlled trial with Lactobacillus acidophilus and Bifidobacterium animalis subsp. Lactis." ]

[ "Evidence exists for the pathogenic role of the enteric flora in inflammatory bowel disease. Probiotics contain living microorganisms which exert health effects on the host. We compared the efficacy in maintaining remission of the probiotic preparation Escherichia coli Nissle 1917 and established therapy with mesalazine in patients with ulcerative colitis.\n In total, 327 patients were recruited and assigned to a double blind, double dummy trial to receive either the probiotic drug 200 mg once daily (n = 162) or mesalazine 500 mg three times daily (n = 165). The study lasted for 12 months and patients were assessed by clinical and endoscopic activity indices (Rachmilewitz) as well as by histology. The primary aim of the study was to confirm equivalent efficacy of the two drugs in the prevention of relapses.\n The per protocol analysis revealed relapses in 40/110 (36.4%) patients in the E coli Nissle 1917 group and 38/112 (33.9%) in the mesalazine group (significant equivalence p = 0.003). Subgroup analyses showed no differences between the treatment groups in terms of duration and localisation of disease or pretrial treatment. Safety profile and tolerability were very good for both groups and were not different.\n The probiotic drug E coli Nissle 1917 shows efficacy and safety in maintaining remission equivalent to the gold standard mesalazine in patients with ulcerative colitis. The effectiveness of probiotic treatment further underlines the pathogenetic significance of the enteric flora.", "Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis. As yet, there is no other existing alternative with proven efficacy. In light of the hypothesis that the intestinal environment may contribute to the pathophysiology of ulcerative colitis, a trial was conducted to test the effects of probiotic treatment with an oral preparation of non-pathogenic E. coli.\n A total of 120 patients with inactive ulcerative colitis were included in a double-blind, double-dummy study comparing mesalazine 500 mg t.d.s. to an oral preparation of viable E. coli strain Nissle (Serotype 06: K5: H1) for 12 weeks with regard to their efficacy in preventing a relapse of the disease. Study objectives were to assess the equivalence of the clinical activity index (CAI) under the two treatment modalities and to compare relapse rates, relapse-free times and global assessment.\n The start and end scores of the CAI demonstrated no significant difference (P = 0.12) between the two treatment groups. Relapse rates were 11.3% under mesalazine and 16.0% under E. coli Nissle 1917 (N.S.). Life table analysis showed a relapse-free time of 103 +/- 4 days for mesalazine and 106 +/- 5 days for E. coli Nissle 1917 (N.S.). Global assessment was similar for both groups. Tolerability to the treatment was excellent and did not differ. No serious adverse events were reported.\n From the results of this preliminary study, probiotic treatment appears to offer another option for maintenance therapy of ulcerative colitis. Additional support is provided for the hypothesis of a pathophysiological role for the intestinal environment in ulcerative colitis.", "To investigate the clinical effect of treatment with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 (Probio-Tec AB-25) to maintain remission in patients with ulcerative colitis.\n Patients with left-sided ulcerative colitis in remission - including proctitis and at least one relapse within the last year were randomised (2:1) in a double-blind placebo-controlled study to Probio-Tec AB-25 or placebo for 52 weeks. The patients were evaluated clinically, endoscopically and histologically at entry and if relapsing. No other medication for ulcerative colitis than the study drug was allowed during the study. Primary endpoint was maintenance of clinical remission, secondary endpoints comparisons of days to relapse, and safety and tolerability of the study drug. The concentrations of the probiotic bacterial strains in stool were analysed in a subset of patients.\n Thirty-two patients were randomised. Twenty patients received Probio-Tec AB-25 and twelve patients received placebo. Five patients (25%) in the Probio-Tec AB-25 group and one patient (8%) in the placebo group maintained remission after 1 year of treatment (p=0.37). The median time to relapse was 125.5days (range 11-391 days) in the probiotic group and 104 days (range 28-369 days) in the placebo group respectively, (p=0.683). Probio-Tec AB-25 was overall well tolerated.\n In this small randomised placebo-controlled trial no significant clinical benefit of Probio-Tec AB-25 could be demonstrated in comparison with placebo for maintaining remission in patients with left-sided ulcerative colitis. A difference may be achieved in larger studies, but the clinical significance of this would be questionable. This study was registered in ClinicalTrial.gov (NCT00268164).\n Copyright © 2010 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.", "Probiotics have anti-inflammatory effects in patients with inflammatory bowel disease and appear to regulate mucosal immune response through reductions in proinflammatory cytokines. The probiotic VSL#3 prevents pouchitis if started within a week of ileostomy closure and maintains remission following antibacterial treatment in patients with refractory or recurrent pouchitis. However, the efficacy of probiotics and their effects on regulatory cells if started at a greater time after surgery in patients undergoing ileal pouch anal anastomosis (IPAA) for ulcerative colitis are unknown.\n We conducted an open-label study in which 31 patients at different periods from surgery without signs and symptoms of pouchitis were randomized to 2 sachets of VSL#3 once daily or no treatment for 12 months. Pouchitis disease activity index (PDAI) was evaluated at baseline and after 3, 6, and 12 months. The percentage of CD4+ T lymphocytes expressing CD25 and the inactive form of transforming growth factor-beta [latency-associated peptide (LAP)] were evaluated at baseline and after 3 and 6 months in peripheral-blood mononuclear cells and mucosal biopsies. Variation in tissue interleukin-1beta and Foxp3 mRNA expression was also evaluated.\n During the study period, VSL#3-treated patients showed a significant reduction in PDAI score and a significant increase in the percentage of mucosal CD4+CD25(high) and CD4+ LAP-positive cells compared with baseline values. Tissue samples at different points showed a significant reduction in IL-1beta mRNA expression, and a significant increase in Foxp3 mRNA expression.\n We conclude that VSL#3 administration in patients with IPAA modulates the PDAI and expands the number of mucosal regulatory T cells.", "Ulcerative colitis (UC) is an acute and chronic inflammatory disease of the large bowel with unknown aetiology. The immune response against normal commensal microorganisms is believed to drive inflammatory processes associated with UC. Therefore, modulation of bacterial communities on the gut mucosa, through the use of probiotics and prebiotics, may be used to modify the disease state.\n A synbiotic was developed for use in UC patients combining a probiotic, Bifidobacterium longum, isolated from healthy rectal epithelium, and a prebiotic (Synergy 1), a preferential inulin-oligofructose growth substrate for the probiotic strain. Treatment was employed in a double blinded randomised controlled trial using 18 patients with active UC for a period of one month. Clinical status was scored and rectal biopsies were collected before and after treatment, and transcription levels of epithelium related immune markers were measured.\n Sigmoidoscopy scores (scale 0-6) were reduced in the test group (start 4.5 (1.4), end 3.1 (2.5)) compared with placebo (start 2.6 (2.1), end 3.2 (2.2)) (p=0.06). mRNA levels for human beta defensins 2, 3, and 4, which are strongly upregulated in active UC, were significantly reduced in the test group after treatment (p=0.016, 0.038, and 0.008, respectively). Tumour necrosis factor alpha and interleukin 1alpha, which are inflammatory cytokines that drive inflammation and induce defensin expression, were also significantly reduced after treatment (p=0.018 and 0.023, respectively). Biopsies in the test group had reduced inflammation and regeneration of epithelial tissue.\n Short term synbiotic treatment of active UC resulted in improvement of the full clinical appearance of chronic inflammation in patients receiving this therapy.", "Aminosalicylates are the mainstay of therapy to prevent relapse of quiescent ulcerative colitis. The rationale for using probiotics is based on the evidence implicating intestinal bacteria in the pathogenesis of this disorder.\n To evaluate the efficacy of Lactobacillus GG alone or in combination with mesalazine vs. mesalazine as maintenance treatment in ulcerative colitis.\n 187 ulcerative colitis patients with quiescent disease were randomized to receive Lactobacillus GG 18 x 10(9) viable bacteria/day (65 patients), mesalazine 2400 mg/day (60 patients) or Lactobacillus GG + mesalazine (62 patients). Disease activity index, endoscopic and histological scores were determined at 0, 6 and 12 months and in case of relapse. The primary end point was to evaluate sustained remission.\n Overall analysis showed no difference in relapse rate at 6 (P = 0.44) and 12 months (P = 0.77) among the three treatment groups. However, the treatment with Lactobacillus GG seems to be more effective than standard treatment with mesalazine in prolonging the relapse-free time (P < 0.05).\n Lactobacillus GG seems to be effective and safe for maintaining remission in patients with ulcerative colitis, and it could represent a good therapeutic option for preventing relapse in this group of patients.", "Thirty patients with distal ulcerative colitis in remission (17 proctitis, 13 proctosigmoiditis) were randomly given either 5-aminosalicylic acid (5-ASA) or placebo suppositories, 400 mg bid. During the 1-yr follow-up, patients were assessed clinically every month, and flexible sigmoidoscopy with a rectal pinch biopsy specimen and laboratory data were carried out every 3 months. Two patients in the 5-ASA group chose to withdraw from the study, one relapsed, and 12 remained in remission. In the placebo group, one patient chose to withdraw, 11 relapsed, and three remained in remission. The cumulative remission rate at the 12th month was 92% in the 5-ASA group and 21% in the placebo group. Log rank test showed a significant difference in the relapse rate between the two groups (chi 2 = 14.26, p less than 0.001). No side effects were observed. We conclude that 5-ASA in suppository form (800 mg/day), administered for 1 yr, is safe and effective in maintaining remission of distal ulcerative colitis.", "Mesalamine is the first-line drug for the treatment of ulcerative colitis (UC). We directly compared the efficacy and safety of two mesalamine formulations for the induction of remission in patients with UC.\n In a multicenter, double-blind, randomized study, 229 patients with mild-to-moderate active UC were assigned to 4 groups: 66 and 65 received a pH-dependent release formulation of 2.4 g/day (pH-2.4 g) or 3.6 g/day (pH-3.6 g), respectively; 65 received a time-dependent release formulation of 2.25 g/day (Time-2.25 g), and 33 received placebo (Placebo). The drugs were administered three times daily for eight weeks. The primary endpoint was a decrease in the UC disease activity index (UC-DAI).\n In the full analysis set (n = 225) the decrease in UC-DAI in each group was 1.5 in pH-2.4 g, 2.9 in pH-3.6 g, 1.3 in Time-2.25 g and 0.3 in Placebo, respectively. These results demonstrate the superiority of pH-3.6 g over Time-2.25 g (P = 0.003) and the noninferiority of pH-2.4 g to Time-2.25 g. Among the patients with proctitis-type UC, a significant decrease in UC-DAI was observed in pH-2.4 g and pH-3.6 g as compared to Placebo, but not in Time-2.25 g. No differences were observed in the safety profiles.\n Higher dose of the pH-dependent release formulation was more effective for induction of remission in patients with mild-to-moderate active UC. Additionally, the pH-dependent release formulation was preferable to the time-dependent release formulation for patients with proctitis-type UC (UMIN Clinical Trials Registry, no. C000000288).", "Probiotic treatment may be effective in diseases involving gut microflora and intestinal inflammation. In collagenous colitis (CC), a potential pathogenic role of the gut microflora has been proposed. The effect of probiotic treatment in CC is unknown. Our aim was to investigate the clinical effect of treatment with Lactobacillus acidophilus LA-5 and Bifidobacterium animalis subsp. lactis BB-12 (AB-Cap-10) in patients with CC.\n Patients with CC and diarrhea were in a double-blind placebo-controlled study randomized (2:1) to AB-Cap-10 or placebo for 12 weeks. The primary end point was reduction in bowel frequency per week of >or=50%. Secondary end points were changes in bowel frequencies, stool consistency, stool weight, histopathology, and abdominal bloating and pain.\n Twenty-nine patients were randomized: 21 to probiotics and 8 to placebo. Reduction in bowel frequency per week of >or=50% occurred in 6 of 21 (29%) and in 1 of 8 (13%) patients receiving probiotic and placebo, respectively (P = 0.635). No differences between treatments were observed regarding the secondary end points. Post hoc analysis showed a median reduction in bowel frequency per week from 32 (range 18-84) to 23 (range 11-56; P < 0.005), a reduction in number of days with liquid stools per week from 6 days (range 0-7 days) to 1 day (range 0-7 days; P < 0.005), and an increase in number of days with solid stools per week (P < 0.05) in the AB-Cap-10 group.\n AB-Cap-10 had no significant effect on the chosen end points. Post hoc analysis demonstrated amelioration of clinical symptoms in the AB-Cap-10 group, indicating that probiotic treatment may potentially influence the disease course of CC." ]

[ "10819344", "9821420", "21829969", "16138795", "12243918", "12655535", "1095132", "11930093", "8925987" ]

[ "Five vs. ten days of antibiotic therapy for acute otitis media in young children.", "A multicenter, randomized, double-blind trial of 5 versus 10 days of antibiotic therapy for acute otitis media in young children.", "Antibiotic treatment schemes for very severe community-acquired pneumonia in children: a randomized clinical study.", "Home management of mild to moderately severe community-acquired pneumonia: a randomised controlled trial.", "Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial.", "Outpatient, sequential, parenteral-oral antibiotic therapy for lower risk febrile neutropenia in children with malignant disease: a single-center, randomized, controlled trial in Argentina.", "Duration of treatment for urinary tract infections in children.", "Treatment of childhood encopresis: a randomized trial comparing three treatment protocols.", "[Short-term antibiotic therapy of post-cesarean-section endometritis]." ]

[ "Many publications in recent years have argued in favor of shortened therapy for acute otitis media. However, doubt persists regarding children younger than 2 years, and some authors therefore restrict short course therapy to children older than 2 years.\n In a prospective, comparative, double blind, randomized, multicenter trial we compared cefpodoxime-proxetil, 8 mg/kg/day in two divided doses for 10 days, with an identical 5-day regimen followed by a 5-day placebo period.\n Between October, 1996, and April, 1997, 450 children (mean age, 14.3 months) were enrolled, 227 in the 5-day group and 223 in the 10-day group. In the per protocol analysis clinical success was obtained on Days 12 to 14 after the beginning of treatment (main analysis) in 175 (84.1%) of the 208 children receiving the 5-day regimen and 194 (92.4%) of the 210 children receiving the 10-day regimen (P = 0.009). The superiority of the standard regimen was more marked among children cared for outside their homes (92.5% vs. 81.5%). Clinical success persisted on Days 28 to 42 among 134 (85.4%) of the 157 assessable patients in the 5-day group and 144 (83.7%) of the 172 assessable patients in the 10-day group (P = 0.68).\n The 10-day regimen resulted in a higher success rate at the conclusion of therapy, but there were no differences between the two study groups 4 to 6 weeks after enrollment in the study protocol.", "All but 2 of the 15 published trials have failed to show a difference in efficacy between short (3 to 5 days) and standard (7 to 10 days) antibiotic regimens for acute otitis media (AOM). These studies involved relatively few patients under 2 years of age, who are at a higher risk for treatment failure.\n In a prospective, comparative, double-blind, randomized, multicenter trial, we compared amoxicillin/clavulanate in 3 divided doses for 10 days with an identical 5-day regimen, followed by a 5-day placebo period.\n Between February 1995 and May 1996, 385 children (mean age, 13.3 months) were enrolled, 194 in the 5-day treatment group and 191 in the 10-day treatment group. In the per protocol analysis, clinical success was obtained on days 12 to 14 after the beginning of treatment (main analysis) in 125 (76.7%) of the 163 children receiving the 5-day regimen and 148 (88.1%) of the 168 receiving the 10-day regimen (P = .006). Clinical success persisted on days 28 to 42 among 57 (40.4%) of the 141 assessable patients in the 5-day group and 64 (46%) of the 139 assessable patients in the 10-day group. (P = .34). Multivariate analysis showed that the 10-day course was statistically superior only among children cared for outside their homes (86.8% vs 70.8%; P = .008).\n When assessed on days 12 to 14 after the outset of treatment, a 5-day regimen is not equivalent to a 10-day regimen among young children with AOM.", "To compare clinical response to initial empiric treatment with oxacillin plus ceftriaxone and amoxicillin plus clavulanic acid in hospitalized children diagnosed with very severe community-acquired pneumonia (CAP).\n A prospective randomized clinical study was conducted among children 2 months to 5 years old with a diagnosis of very severe CAP in the pediatric ward of São Paulo State University Hospital in Botucatu, São Paulo, Brazil, from April 2007 to May 2008. Patients were randomly divided into two groups by type of treatment: an oxacillin/ceftriaxone group (OCG, n = 48) and an amoxicillin/clavulanic acid group (ACG, n = 56). Analyzed outcomes were: time to clinical improvement (fever and tachypnea), time on oxygen therapy, length of stay in hospital, need to widen antimicrobial spectrum, and complications (including pleural effusion).\n The two groups did not differ statistically for age, sex, symptom duration before admission, or previous antibiotic treatment. Time to improve tachypnea was less among ACG patients than OCG patients (4.8 ± 2.2 versus 5.8 ± 2.4 days respectively; P = 0.028), as was length of hospital stay (11.0 ± 6.2 versus 14.4 ± 4.5 days respectively; P = 0.002). There were no statistically significant differences between the two groups for fever improvement time, time on oxygen therapy, need to widen antimicrobial spectrum, or frequency of pleural effusion.\n Both treatment plans are effective in treating very severe CAP in 2-month-to 5-year-old hospitalized children. The only analyzed outcome that favored amoxicillin/clavulanic acid treatment was time required to improve tachypnea.\n ClinicalTrials.gov ID: NCT01166932.", "To determine whether community management of mild to moderate community-acquired pneumonia (CAP) is as effective and acceptable as standard hospital management of CAP.\n Randomised controlled trial.\n Christchurch, New Zealand, primary and secondary care.\n 55 patients presenting or referred to the emergency department at Christchurch Hospital with mild to moderately severe pneumonia, assessed using a validated pneumonia severity assessment score, from July 2002 to October 2003.\n Hospital treatment as usual or comprehensive care in the home delivered by primary care teams.\n Primary: days to discharge, days on intravenous (IV) antibiotics, patient-rated symptom scores. Secondary: health status measured using level of functioning at 2 and 6 weeks, patient satisfaction.\n The median number of days to discharge was higher in the home care group (4 days; range, 1-14) than in the hospital groups (2 days; range, 0-10; P = 0.004). There was no difference in the number of days on IV antibiotics or on subsequent oral antibiotics. Patient-rated symptom scores at 2 and 6 weeks, median change in symptom severity from baseline to 6 weeks, and general functioning at 2 and 6 weeks did not differ between the groups. Patients in both groups were satisfied with their treatment, with a clear preference for community treatment (P < 0.001).\n Mild to moderately severe CAP can be managed effectively in the community by primary care teams. This model of comprehensive care at home can be implemented by primary care teams with suitable funding structures.", "For most infections, especially acute respiratory infections (ARIs), the recommended duration of therapy is not based on strong scientific or clinical criteria. Shorter courses of antibiotics for non-severe pneumonia would result in lower costs, enhance patient compliance, and might help to contain antimicrobial resistance. We aimed to compare the clinical efficacy of 3-day and 5-day courses of amoxicillin in children with non-severe pneumonia.\n We recruited 2000 children, aged 2-59 months, with non-severe pneumonia (WHO criteria) diagnosed in the outpatient departments of seven hospitals. Patients were randomly assigned to 3 days or 5 days of treatment with oral amoxicillin. The primary outcome was treatment failure. Analyses were by intention to treat.\n We allocated 1000 children to 3 days of treatment and 1000 to 5 days. Treatment failed in 209 (21%) patients in the 3-day group, and in 202 (20%) in the 5-day group (difference 0.7%; 95% CI -1.8 to 3.2). In 12 (1%) children in the 3-day group and in 13 (1%) in the 5-day group the disease relapsed (difference 0.1%; -0.6 to 0.8). Treatment was more likely to fail in children who did not adhere to treatment (p<0.0001), in those younger than 12 months (p<0.0001), in those whose illness lasted for 3 days or longer (p=0.004), in those whose respiratory rate was more than 10 breaths/min above the age-specific cut-off (p=0.004), and in those with vomiting (p=0.009). Non-adherence was also associated with failure of treatment in the 5-day group (p<0.0001).\n Treatment with oral amoxicillin for 3-days was equally as effective as treatment for 5 days in children with non-severe pneumonia. The most important risk factor for treatment failure was non-compliance, which was also associated with longer duration of therapy.", "Recent reports and previous randomized trials conducted at the authors' institution suggested that children with lower risk febrile neutropenic (LRFN) may benefit from substitution of oral antibiotic therapy for parenteral therapy. The objective of this study was to determine the efficacy of parenteral-oral outpatient therapy in the management of children with LRFN who were receiving treatment for malignant disease.\n From August 2000 to April 2002, 135 children with a median age of 7.5 years (range, 1.6-15.8 years) who had a total of 177 episodes of LRFN were included in a prospective, randomized, single-institution trial. Children with LRFN received a single dose of ceftriaxone and amikacin and completed a risk-assessment work-up. All patients were discharged immediately and, at 24 hours, were allocated randomly to two groups: Group A (89 episodes) received oral ciprofloxacin, and Group B (88 episodes) received intravenous ceftriaxone.\n Most patients (61% in Group A and 51% in Group B) were receiving treatment for leukemia (P value not significant [NS]). Twenty-eight children (31%) in Group A and 22 children (25%) in Group B displayed unexplained fever (P value NS). No significant differences in sites of initial infection were found between the two groups. The median duration of neutropenia was 4.2 days and 4.7 days for Group A and Group B, respectively (P value NS); the median duration of fever was 2.3 days and 2.6 days, respectively (P value NS); and the median duration of antibiotic treatment was 4.5 days and 4.8 days, respectively (P value NS). The overall results of the study were excellent. Only four treatment failures in Group A (5%) and 6 treatment failures in Group B (7%) were observed. These patients were readmitted to the hospital and did well with appropriate treatment.\n In children with LRFN who are receiving treatment for malignant disease, outpatient oral ciprofloxacin after 24 hours of a single dose of intravenous ceftriaxone and amikacin was as safe and efficacious as parenteral ceftriaxone. Outpatient management and early antibiotic withdrawal were safe for both groups.\n Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11251", "In a double-blind trial 45 children aged 6 months to 14 years with Escherichia coli infections of the urinary tract were given co-trimoxazole for two weeks and then allotted at random to one of two treatment groups for the remainder of six months; one continued with the active drug and the other with dummy tablets of identical appearance. Of the 24 children who took co-trimoxazole for two weeks and the 21 who took it for six months, 11 and 10, respectively, remained without further infections for at least a year. Over 90% of the reinfections occurred within five months of stopping the antibiotics, and the longer treatment did not cause any delay in their appearance. Thus probably a six-month course of treatment is no more likely to achieve a cure than a two-week course; nevertheless, no infection occurred during treatment, and there may be an advantage in continuing with antibiotics in small dosage.", "To compare short- and long-term effectiveness of three additive treatment protocols in children experiencing chronic encopresis.\n Children, 6 to 15 years of age, who experienced at least weekly fecal soiling for 6 months or longer were eligible for the study. Children were randomly assigned to a group that received intensive medical therapy (IMT), a group that received intensive medical therapy plus a behavior management program called enhanced toilet training (ETT), or a group that received intensive medical therapy with enhanced toilet training and external anal sphincter electromyographic biofeedback (BF). Data concerning toileting habits were collected for 14 consecutive days before an initial visit, and at 3, 6, and 12 months after initiation of therapy. All data were collected using a computerized voice-mail system that telephoned the families each day. At 12 months, children were classified as significantly improved (reduction in soiling, P < 0.001) or cured (<one fecal accident in 2 weeks).\n Eighty-seven children participated in the study, 72 boys and 15 girls. Mean age at enrollment was 8.6 +/- 2.0 years, and mean duration of symptoms was 58.2 +/- 38.5 months. At 12 months, the cure rates for the IMM, ETT, and BF groups were 36, 48, and 39, respectively (not significant). The improvement rates for these three groups were 45, 78, and 54, respectively (P < 0.05). These results were very stable over time (r > 0.90, P < 0.001 in each case). Response to treatment during the first 2 weeks of therapy was highly predictive of outcome at 3, 6, and 12 months (P < 0.0001). Children in the ETT group used less laxative medication (P < 0.04) and required fewer treatment contacts (P = 0.08) than children in the IMM group. All three treatments resulted in significant increases in daily bowel movements passed in the toilet and self-initiated toileting, and resulted in decreases in average daily soiling at 3, 6, and 12 months (P < 0.05).\n Enhanced toilet training is somewhat more effective in treating childhood encopresis than either intensive medical therapy or anal sphincter biofeedback therapy. Although similar total cure rates at 1 year can be expected with these three forms of therapy, enhanced toilet training results in statistically significant decreases in the daily frequency of soiling for the greatest number of children.", "Post-cesarean-section endometritis therapy usually combines an intravenous administered antibiotic followed, once fever has remitted, by an oral or intramuscular course of 7-10 days of the same antibiotic. From November 1993 to May 1994 and trying to reduce the length of the treatment we conducted a randomized, comparative study between the conventional post-C-section endometritis treatment used at the Hospital Central Militar (long course) and a short parenteral treatment with the same antibiotics. Thirty one patients were randomized in the short course group and 32 in the long course group. Only in the long course group there was a patient with persistence of infection after ten days of antibiotic treatment (p > 0.05). The short course regimen brought additional advantages as reduction in treatment days as well as discomfort for the intramuscular administration of antibiotics. This observation suggests that a short course of antibiotics based on the patient's clinical response is a safe and less expensive alternative in the treatment of post-C-section endometritis." ]

[ "786665", "15741443", "2403903", "1745841", "1615177", "15562142", "7741782", "9730996", "10464834" ]

[ "A controlled trial of intermittent oral acetylcysteine in the long-term treatment of chronic bronchitis.", "Inhaled fluticasone in bronchiectasis: a 12 month study.", "The National Mucolytic Study. Results of a randomized, double-blind, placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis.", "Role of bromhexine in exacerbations of bronchiectasis. Double-blind randomized multicenter study versus placebo.", "Inhaled steroids in patients with bronchiectasis.", "Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa.", "Clinical effectiveness of a combination of bromhexine and amoxicillin in lower respiratory tract infection. A randomized controlled trial.", "Inhaled fluticasone reduces sputum inflammatory indices in severe bronchiectasis.", "Inhaled antibiotic therapy in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection by Pseudomonas aeruginosa." ]

[ "In 69 out-patients with chronic bronchitis in 6 centres the effects of acetylcysteine 600 mg daily, 3 days a week for 6 months, and a placebo have been compared in a double-blind controlled trial. Thirty-five patients were treated with the mucolytic and 34 with the dummy preparation. In the former the clinical course of the chronic bronchitis improved to a greater extent and a significantly lower number of exacerbations was observed. The advantages of long-term oral treatment with the mucolytic in chronic bronchitis suggest that it may be useful as an alternative to long-term antibiotic prophylaxis, or to complement brief courses of antibiotics, in addition to the usual physiotherapy.", "The clinical efficacy of inhaled corticosteroid (ICS) treatment has not been evaluated in bronchiectasis, despite the presence of chronic airway inflammation.\n After three consecutive weekly visits, 86 patients were randomised to receive either fluticasone 500 mug twice daily (n = 43, 23F, mean (SD) age 57.7 (14.4) years) or matched placebo (n = 43, 34F, 59.2 (14.2) years) and reviewed regularly for 52 weeks in a double blind fashion.\n 35 and 38 patients in the fluticasone and placebo groups completed the study. Significantly more patients on ICS than on placebo showed improvement in 24 hour sputum volume (OR 2.5, 95% CI 1.1 to 6.0, p = 0.03) but not in exacerbation frequency, forced expiratory volume in 1 second, forced vital capacity, or sputum purulence score. Significantly more patients with Pseudomonas aeruginosa infection receiving fluticasone showed improvement in 24 hour sputum volume (OR 13.5, 95% CI 1.8 to 100.2, p = 0.03) and exacerbation frequency (OR 13.3, 95% CI 1.8 to 100.2, p = 0.01) than those given placebo. Logistic regression models revealed a significantly better response in sputum volume with fluticasone treatment than with placebo among subgroups of patients with 24 hour sputum volume <30 ml (p = 0.04), exacerbation frequency </=2/year (p = 0.04), and sputum purulence score >5 (p = 0.03).\n ICS treatment is beneficial to patients with bronchiectasis, particularly those with P. aerurginosa infection.", "Seventy-four pulmonologists and one allergist were recruited to assess the efficacy and safety of iodinated glycerol (Organidin), 60 mg qid, vs placebo in patients with stable chronic obstructive bronchitis in a randomized, double-blind, placebo-controlled, parallel design. A total of 361 patients (180 to iodinated glycerol and 181 to placebo) who complained of cough and difficulty bringing up sputum entered the eight-week study. Evaluations were based upon eight primary symptom efficacy parameters (cough frequency, cough severity, chest discomfort, dyspnea, ease in bringing up sputum, patient and physician global assessments, and a derived patients' global assessment), and six secondary parameters (frequency of aerosol bronchodilator use, incidence and duration of acute exacerbations, frequency of concomitant medication use, incidences of adverse experiences and dropouts). Cough frequency, cough severity, chest discomfort, patients' ease in bringing up sputum, patients' overall condition, and a derived subject global assessment were significantly (p less than 0.05) improved by iodinated glycerol as compared with placebo within eight weeks of treatment. Dyspnea showed a trend toward improvement and the physicians' global evaluation showed no significant difference between groups. Similar findings were noted in a subgroup analysis of moderately-to-severely affected patients. The mean duration (days) of acute exacerbations and number of dropouts attributable to adverse experiences were significantly less (p less than 0.05) in the iodinated glycerol group.(ABSTRACT TRUNCATED AT 250 WORDS)", "The effectiveness of bromhexine in the treatment of patients with bronchiectasis, in a stage of clinical exacerbation, was assessed in a double-blind, placebo-controlled trial involving 88 in-patients. Bronchiectasis was diagnosed by bronchography and/or CT scan. Bromhexine or matched placebo was administered as 30-mg capsules three times daily per os. Ceftazidine, 1 g i.m., was given to all patients once a day for the first week only. Bromhexine seemed to improve the clinical picture, with significantly positive trends for expectoration, quantity of sputum and auscultatory findings. It also increased the FEV1 and was well-tolerated. Both patients and investigators judged it efficacious.", "The effect of inhaled beclomethasone diproprionate (1500 micrograms day-1) on symptoms, pulmonary function and sputum production was examined in a double-blind, placebo-controlled, cross-over study in 20 patients with bronchiectasis. An 18% reduction in daily sputum production (P less than 0.003) was observed on treatment with inhaled steroid compared to placebo. A small, significant, improvement in morning peak expiratory flow rate (P less than 0.03) and forced expiratory volume in 1 s (P less than 0.03) was seen but the absolute changes are unlikely to be of clinical importance. Symptom scores for cough improved significantly (P less than 0.02). Inhaled steroids may have a role in the management of bronchiectasis by reducing cough and sputum production.", "Non-cystic fibrosis (CF) patients with bronchiectasis usually develop chronic bronchial infection with Pseudomonas aeruginosa (PA) that is related to worsening lung function and increased morbidity and mortality.\n To determine whether direct aerosol delivery of tobramycin to the lower airways may control infection and produce only low systemic toxicity.\n A double-blind, placebo-controlled crossover trial involving 30 patients was conducted to determine the clinical effectiveness and safety of 6-month tobramycin inhalation therapy. Patients received 300 mg of aerosolized tobramycin or placebo twice daily in 2 cycles, each for 6 months, with a one-month washout period. The number of exacerbations, number of hospital admissions, number of hospital admission days, antibiotic use, pulmonary function, quality of life, tobramycin toxicity, density of PA in sputum, emergence of bacterial resistance, and emergence of other opportunistic bacteria were recorded.\n The number of admissions and days of admission (mean +/- SD) during the tobramycin period (0.15 +/- 0.37 and 2.05 +/- 5.03) were lower than those during the placebo period (0.75 +/-1.16 and 12.65 +/- 21.8) (p < 0.047). A decrease in PA density in sputum was associated with tobramycin administration in the analysis of the first 6-month cycle (p = 0.038). No significant differences were observed in the number of exacerbations, antibiotic use, pulmonary function, and quality of life. The emergence of bacterial resistance and other bacteria did not differ between the 2 periods of study. Inhaled tobramycin was associated with bronchospasm in 3 patients, but not with detectable ototoxicity or nephrotoxicity.\n Aerosol administration of high-dose tobramycin in non-CF bronchiectatic patients for endobronchial infection with PA appears to be safe and decreases the risk of hospitalization and PA density in sputum. Nevertheless, pulmonary function and quality of life are not improved, and the risk of bronchospasm is appreciable.", "A multicenter double-blind randomized trial was performed in 22 teaching hospitals to compare the clinical effectiveness of the combination of amoxicillin (CAS 26787-78-0) plus bromhexine (CAS 3572-43-8) versus amoxicillin alone given 4 times a day for 5 to 7 days in the treatment of clinically diagnosed community-acquired bacterial lower respiratory tract infections. 392 adult patients diagnosed clinically to have acute bronchitis or pneumonia of bacterial etiology were recruited for the study with 192 subjects given amoxicillin (250 mg) plus bromhexine (8 mg) (Drug AB) and 200 receiving amoxicillin (250 mg) (Drug AA) alone 4 times a day for 5 to 7 days. Clinical response, improvement in symptom scores using a visual analogue scale, and bacteriologic response were monitored at Days 3, 5 and 7 of treatment. Results showed that although 180/192 (94%) given Drug AB and 185/200 (93%) given Drug AA had favorable clinical response at the end of treatment, the infection was completely resolved for 89/192 (46%) among the Drug AB group and in 67/200 (34%) of patients on Drug AA (p = 0.022). Also, patients given Drug AB had significantly greater reduction of their symptom scores at Day 3 for symptoms of cough discomfort, cough frequency, ease of expectoration and sputum volume. Among the subset of patients with pneumonia, the cure rates for Drug AB and Drug AA were 24/50 (47%) and 11/50 (22%), respectively (p = 0.008). A respiratory pathogen was cultured in only 72/392 (18%) of subjects.(ABSTRACT TRUNCATED AT 250 WORDS)", "Although corticosteroid therapy might be clinically beneficial for bronchiectasis, very little is known of its effects on the inflammatory and infective markers in bronchiectasis. We have therefore performed a double-blind, placebo-controlled study to evaluate the effects of a 4-wk administration of inhaled fluticasone in bronchiectasis. Twenty-four patients (12 female; mean age 51 yr) were randomized into receiving either inhaled fluticasone (500 microgram twice daily) via the Accuhaler device (n = 12) or placebo. At each visit, spirometry, 24-h sputum volume, sputum leukocyte density, bacterial densities, and concentrations of interleukin (IL)-1beta, IL-8, tumor necrosis factor-alpha (TNF-alpha), and leukotriene B4 (LTB4) were determined. There was a significant (p < 0.05) decrease in sputum leukocyte density and IL-1beta, IL-8, and LTB4 after fluticasone treatment. The fluticasone group had one and the placebo group three episodes of exacerbation. There were no significant changes in spirometry (p > 0.05) or any reported adverse reactions in either group. The results of this study show that high-dose fluticasone is effective in reducing the sputum inflammatory indices in bronchiectasis. Large-scale and long-term studies are indicated to evaluate the effects of inhaled steroid therapy on the inflammatory components in bronchiectasis.", "The aim of this study was to investigate the long-term effectiveness and safety of inhaled antibiotic treatment in non-cystic fibrosis patients with bronchiectasis and chronic infection by Pseudomonas aeruginosa, after standard endovenous and oral therapy for long-term control of the infection had failed. After completing a 2-week endovenous antibiotic treatment to stabilize respiratory status, 17 patients were randomly allocated to a 12-month treatment either with inhaled ceftazidime and tobramycin (group A) or a symptomatic treatment (group B). One patient from group A abandoned inhaled treatment because of bronchospasm and another from group B died before the end of the study. The remaining 15 patients, seven from group A and eight from group B, completed the study. Both groups had similar previous characteristics. The number of admissions and days of admission (mean +/- SEM) of group A [0.6 (1.5) and 13.1 (34.8)] were lower than those of group B [2.5 (2.1) and 57.9 (41.8)] (P < 0.05). Forced vital capacity (FVC), forced expiratory volume in 1 sec (FEV1), PAO2 and PACO2 were similar in the two groups at the end of follow-up, showing a comparable decline in these parameters. There were no significant differences either in the use of oral antibiotics or in the frequency of emergence of antibiotic-resistant bacteria between groups. Microbiological studies suggested that several patients had different Pseudomonas aeruginosa strains. None of the patients presented impaired renal or auditory function at the end of the study. This study suggests that long-term inhaled antibiotic therapy may be safe and lessen disease severity in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection by Pseudomonas aeruginosa which do not respond satisfactorily to antibiotics administered via other routes." ]

[ "15479896", "1985618", "11678298", "9855212", "3890159", "14962967", "19969160", "1562888", "14760802" ]

[ "Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial.", "Corticosteroid injections in adhesive capsulitis: investigation of their value and site.", "Comparison of the efficacy of local corticosteroid injection and physical therapy for the treatment of adhesive capsulitis.", "Treatment of \"frozen shoulder\" with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial.", "A placebo-controlled trial of steroid injections in the treatment of supraspinatus tendonitis.", "Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial.", "Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique.", "[Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension].", "A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder." ]

[ "To determine whether a short course of prednisolone is superior to placebo for improving pain, function, and range of motion in adhesive capsulitis.\n Double blind, randomised, placebo controlled trial.\n Community based rheumatology practice in Australia.\n 50 participants (24 active, 26 placebo); 46 completed the 12 week protocol. Entry criteria were age > or =18 years, pain and stiffness in predominantly one shoulder for > or =3 weeks, and restriction of passive motion by >30 degrees in two or more planes.Interventions: 30 mg oral prednisolone/day for three weeks or placebo.\n Overall, night, and activity related pain, SPADI, Croft shoulder disability questionnaire, DASH, HAQ, SF-36, participant rated improvement, and range of active motion measured at baseline and at 3, 6, and 12 weeks.\n At 3 weeks, there was greater improvement in overall pain in the prednisolone group than in the placebo group (mean (SD) change from baseline, 4.1 (2.3) v 1.4 (2.3); adjusted difference in mean change between the two groups, 2.4 (95% CI, 1.1 to 3.8)). There was also greater improvement in disability, range of active motion, and participant rated improvement (marked or moderate overall improvement in 22/23 v 11/23; RR = 2 (1.3 to 3.1), p = 0.001). At 6 weeks the analysis favoured the prednisolone group for most outcomes but none of the differences was significant. At 12 weeks, the analysis tended to favour the placebo group.\n A three week course of 30 mg prednisolone daily is of significant short term benefit in adhesive capsulitis but benefits are not maintained beyond six weeks.", "Forty-eight patients with frozen shoulder for less than six months were assigned at random to receive three shoulder injections into the subacromial bursa or glenohumeral joint at weekly intervals. The treatment groups were (1) intra-articular methylprednisolone and lidocaine, (2) intrabursal methylprednisolone and lidocaine, (3) intra-articular lidocaine, (4) intrabursal lidocaine. The same physical therapy program was carried out for all patients. Assessments of pain and range of motion were performed by a physical therapist who was uninformed about the nature of the injection therapy. There was no significant difference in outcome between intrabursal injection and intra-articular injection. Injection of steroid with lidocaine had no advantage over lidocaine alone in restoring shoulder motion, but partial, transient pain relief occurred in two thirds of the steroid-treated patients.", "Adhesive capsulitis is a common musculoskeletal disorder mainly affecting middle aged adults. It is associated with generalized pain and tenderness in the shoulder joint with severe loss of active and passive ranges of motion in all planes. The aim of this study was to compare the efficacy of local steroid injection and physical therapy measures for treating this disorder. Ten male and 10 female patients were enrolled in the study. The patients were divided randomly into two groups and treated with either 40 mg methylprednisolone acetate injection with local anesthetic (group A) or physical therapy measures plus nonsteroidal anti-inflammatory drugs (group B). The mean ages of the patients were 55.6+/-12.2 years in group A and 56.4+/-7.1 years in group B. Clinical assessment was performed on initial visit and at the 2nd and 12th weeks. Active and passive range of motion was recorded and the visual analogue scale was used to evaluate pain intensity. At initial visit, these data in both groups of patients were not statistically different. Although both treatment regimens resulted in significant improvement in range of motion, the differences between mean external rotation at the 2nd and 12th weeks were not statistically significant in either group. The improvement in range of motion at the end of the study was similar in both groups (P>0.05). All patients reported improvement during the study. The differences between mean VAS scores at the 2nd and 12th weeks were statistically significant in both groups. In conclusion, local steroid injection therapy was found to be as effective as physical therapy for the treatment of adhesive capsulitis.", "This study is a comparison of treatments of idiopathic \"Frozen Shoulder\" (adhesive capsulitis), distension combined with steroid is compared with steroid alone. Evaluation was based on pain scales, analgesic usage, and range of motion outcome scales. Out of one-hundred twenty patients (age, mean 51, range 21-70) that were referred under the diagnosis FS, twenty-six fulfilled the criteria for inclusion in the study, but four patients did not want to participate in the trial, giving a total of 22 patients (age, mean 53, range 40-65) in the study. Patients were randomised by the envelope method. Two patients dropped-out, one in each treatment group thus leaving the study with 20 patients for the final statistical analysis. Eight were treated with steroid alone and 12 with distension combined with steroid. Patients received one treatment per week for a six weeks period with a follow-up at 12 weeks. They were evaluated by pain VAS on function and at rest within the study period, the different ranges of motion (ROM) were measured at inclusion time and subsequent afterwards at 3, 6, and 12 weeks. The VAS outcomes showed no difference between the treatments (VAS-function p=0,1; VAS-rest p=0.1), while in the distension group ROM showed significant improvement in all directions except extension (external p=0.0007, flexion p=0.03, extension p=0,01). The analgesic usage was significantly lower in the group treated with distension at the end of the study (p=0.008). A blinded clinical assessment of ROM also showed significant improvement (p=0.002). It is concluded that distension with steroid can seem to help in management of \"Frozen Shoulder\". Other studies seems to support the conclusion.", "In this report of a double-blind placebo-controlled trial of steroid injections for supraspinatus tendonitis, there was no statistical difference in the improvement in pain score between the two groups at 2 and 8 weeks of follow-up or in analgesic consumption. This trial casts further doubt on the efficacy of such treatment in soft tissue lesions around the shoulder.", "To determine whether arthrographic distension with a mixture of saline and steroid, in patients with painful stiff shoulder for at least 3 months, is better than placebo in improving function, pain, and range of motion at 3, 6, and 12 weeks.\n A randomised, placebo controlled trial with participant and outcome assessor blinding in which shoulder joint distension with normal saline and corticosteroid was compared with placebo (arthrogram). Outcome measures, assessed at 3, 6, and 12 weeks, included a shoulder-specific disability measure (SPADI), a patient preference measure (Problem Elicitation Technique (PET)), pain, and range of active motion.\n From 96 potential participants, 48 were recruited. Four withdrew from the placebo group after the 3 week assessment and three subsequently received arthrographic distension with saline and steroid. At 3 weeks, significantly greater improvement in SPADI (p = 0.005), PET, overall pain, active total shoulder abduction, and hand behind back was found in participants in the joint distension and steroid group than in the placebo group. At 6 weeks the results of the intention to treat analysis favoured joint distension, although the between-group differences were only significant for improvement in PET (difference in mean change in PET between groups = 45.9 (95% CI 3.2 to 88.7). Excluding the four withdrawals, the between-group differences for the disability and pain measures significantly favoured distension over placebo. At 12 weeks, both the intention to treat analysis and an analysis excluding the four withdrawals demonstrated a significantly greater improvement in PET score for the distension group.\n Short term efficacy of arthrographic distension with normal saline and corticosteroid over placebo was demonstrated in patients with painful stiff shoulder.", "Lee H-J, Lim K-B, Kim D-Y, Lee K-T. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique.\n To evaluate the clinical effect of ultrasonography (US)-guided intra-articular injections compared with a blind (unguided) technique for the treatment of adhesive capsulitis.\n Randomized controlled trial.\n Outpatient rehabilitation clinic.\n Patients (N=43) diagnosed as having adhesive capsulitis after clinical examinations and radiologic and ultrasonographic study.\n Under either US-guided or a blind technique, patients received a 20-mg intra-articular injection of triamcinolone mixed with 1.5mL 2% lidocaine and 4mL normal saline in the first week followed by 5 weekly injections of sodium hyaluronate.\n A visual analog scale for pain intensity, range of motion (ROM) of the shoulder (flexion, abduction, external rotation, and internal rotation), and general shoulder function during daily activities at preinjection as a baseline and then every week after injection for 6 weeks for each patient.\n Twenty patients out of 22 in the blind injection group and 20 out of 21 in the US-guided group finished the entire 6-week study period. The improvement in pain intensity, ROM, and shoulder function score was significantly greater in the US-guided injection group than in the blind injection group by the second week postinjection (P<.05). However, there were no further significant differences in the improvement between the 2 groups beyond the third week.\n US-guided intra-articular injections may offer advantages over a blind technique for the treatment of adhesive capsulitis and may deliver clinical benefits during the first few weeks of treatment. This finding suggests that the improved targeting to the intra-articular space by using US can result in better treatment of adhesive capsulitis.", "A double-blind, prospective study of 45 patients with adhesive capsulitis of the shoulder compared the therapeutic efficacy of distensive and nondistensive arthrography in combination with the intra-articular injection of corticosteroids. After 1 and 3 months there was no significant difference between the two treatments in the degree of pain or of limitation of movement experienced by the patients. More than 80% of the patients who experienced pain at rest and nocturnal pain improved under both treatment regimens. Scapulohumeral mobility increased significantly but only partially within the first month of treatment. Articular capacity and the duration of symptoms before treatment were of no prognostic value.", "Local corticosteroid injections, commonly accepted by rheumatologists to be effective treating painful shoulder, have shown controversial results. High frequency ultrasonography is an accurate and safe imaging modality for guiding musculoskeletal injections. We prospectively compared the short term response to randomized blind injection versus sonographic-guided injection of local corticosteroid in patients with painful shoulder.\n We studied 41 consecutive patients with painful shoulder. Patients with previous trauma or chronic inflammatory arthritis were excluded. No patient had received previous physiotherapy or local steroid injection in the shoulder. Patients were randomized to receive either a blind subacromial injection of 20 mg triamcinolone (Group 1, n = 20) or a sonographic guided injection of 20 mg triamcinolone (Group 2, n = 21) by the same rheumatologist blinded to the clinical evaluation. In both groups we recorded shoulder abnormalities and the location of the steroid postinjection by ultrasound. Each patient was clinically assessed within 5 days before injection and 6 weeks after injection by another rheumatologist without knowledge of the injection technique performed. Clinical assessment included demographic and clinical data, a visual analog scale (VAS) for pain (0-100), the Shoulder Function Assessment (SFA) scale (0-70), and postinjection adverse effects. No patient received physical therapy during the followup period. Initially, demographic, clinical, and ultrasonographic findings in both groups showed no significant differences.\n Six weeks after injection, the VAS and the SFA score showed a significantly greater improvement in Group 2 compared with Group 1 (mean VAS score change 34.9 for Group 2 vs 7.1 for Group 1, p < 0.001; and mean SFA score change 15 for Group 2 vs 5.6 for Group 1, p = 0.012). One patient in Group 1 reported mild postinjection adverse effects.\n We suggest that sonographic-guided corticosteroid injections should be indicated, at least, in patients with poor response to previous blind injection to ensure accurate medication placement in order to improve therapeutic effectiveness." ]

[ "19948625", "19797985", "16810506", "16483745", "16648324", "14628980", "12610718", "12860772", "12363115" ]

[ "Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.", "A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder.", "The neurocognitive effects of aripiprazole: an open-label comparison with olanzapine.", "A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA).", "Aripiprazole in the treatment of patients with borderline personality disorder: a double-blind, placebo-controlled study.", "Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study.", "Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study.", "Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder.", "Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder." ]

[ "The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.\n This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed.\n Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8.\n Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.", "To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.\n Two hundred eighteen children and adolescents (aged 6-17 years) with a diagnosis of autistic disorder, and with behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these symptoms, were randomized 1:1:1:1 to aripiprazole (5, 10, or 15 mg/day) or placebo in this 8-week double-blind, randomized, placebo-controlled, parallel-group study. Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale (primary efficacy measure) and the clinician-rated Clinical Global Impressions-Improvement score. Safety and tolerability were also assessed.\n At week 8, all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores (5 mg/day, -12.4; 10 mg/day, -13.2; 15 mg/day, -14.4; versus placebo, -8.4; all p < .05). All aripiprazole doses demonstrated significantly greater improvements in mean Clinical Global Impressions-Improvement score than placebo at week 8. Discontinuation rates due to adverse events were as follows: placebo 7.7%, aripiprazole 5 mg/day 9.4%, 10 mg/day 13.6%, and 15 mg/day 7.4%. The most common adverse event leading to discontinuation was sedation. There were two serious adverse events: presyncope (5 mg/day) and aggression (10 mg/day). At week 8, mean weight change (last observation carried forward) was as follows: placebo +0.3 kg, aripiprazole 5 mg/day +1.3 kg, 10 mg/day +1.3 kg, and 15 mg/day +1.5 kg; all p < .05 versus placebo.\n Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder.", "Cognitive deficits are a core feature of schizophrenia. As a target of intervention, improvements in cognition may lead to improvements in functional outcome.\n The present paper is the first report, to our knowledge, on the neurocognitive effects of aripiprazole. Unlike other second-generation antipsychotics, aripiprazole is a D(2) and D(3) receptor partial agonist. It is unknown what effects this unusual pharmacological profile may yield on neurocognition.\n The present open-label study included data on 169 patients with schizophrenia or schizoaffective disorder who were randomly treated with aripiprazole or olanzapine. Subjects received a neurocognitive battery at baseline, week 8, and 26.\n The aripiprazole group had a significantly greater dropout rate than the olanzapine group. Neurocognitive data were reduced through a principal components analysis that yielded a three-factor solution. The factors were general cognitive functioning, executive functioning, and verbal learning. For general cognitive functioning, both groups improved from baseline and the effects were relatively stable over the 26-week protocol. There were no differential treatment effects. For executive functioning, neither group improved significantly from baseline. For verbal learning, the aripiprazole group improved significantly from baseline to the 8th and 26th week of assessment, and there was a between-group effect favoring aripiprazole over olanzapine that was largely attributable to the differences in performance within the 8th week. Separate analyses were conducted for a measure of sustained attention (Continuous Performance Test-Identical Pairs). There were no differential treatment effects on this measure.\n The findings from this open-label study suggest that the neurocognitive effects of aripiprazole are at least as good as those of olanzapine.", "BETA was designed to evaluate the overall effectiveness of aripiprazole in patients with schizophrenia or schizoaffective disorder treated in a general psychiatry outpatient practice setting.\n In this 8-week, multicenter, open-label study, 1,599 outpatients with schizophrenia or schizoaffective disorder were randomly assigned to receive either aripiprazole (n=1,295) or another antipsychotic medication (safety control [SC] group; n=304). Aripiprazole was initiated at 15 mg/d with the option to adjust between 10-30 mg/d. The SC medication was specifically selected for each patient by the clinician and dosed according to prescribing guidelines for that medication. The primary effectiveness measure was the Clinical Global Impression-Improvement (CGI-I) score of the aripiprazole group at study end point. Secondary measures included response rates and preference of medicine (POM) ratings by patients and caregivers.\n Sixty-five percent of aripiprazole patients completed the study. The mean aripiprazole dose at end point was 19.9 mg/d, with approximately 39% of patients starting and remaining at 15 mg/d. At end point, the mean CGI-I score of 2.77 demonstrated that aripiprazole was minimally to moderately effective; the mean CGI-I score for the SC group was 3.59 indicating minimally effective to no change. Fifty-three percent of aripiprazole patients responded to treatment (CGI-I score of 1 or 2; last-observation-carried-forward [LOCF]), and approximately 71% of patients and caregivers rated aripiprazole as better than the prestudy medication on the POM (LOCF). Incidence and severity of adverse events (AEs) were similar to those reported in double-blind, randomized, placebo-controlled aripiprazole clinical trials. The most frequent AE in the aripiprazole group was insomnia (24%).\n Aripiprazole was effective for the treatment of schizophrenia and schizoaffective disorder in a general psychiatry outpatient practice setting. Overall, aripiprazole was found to be effective by the treating clinician and well accepted by patients and caregivers over the 8-week treatment course.", "Aripiprazole is a relatively new atypical antipsychotic agent that has been successfully employed in therapy for schizophrenia and schizoaffective disorders. A few neuroleptics have been used in therapy for patients with borderline personality disorder, which is associated with severe psychopathological symptoms. Aripiprazole, however, has not yet been tested for this disorder, and the goal of this study was to determine whether aripiprazole is effective in the treatment of several domains of symptoms of borderline personality disorder.\n Subjects meeting criteria for the Structured Clinical Interview for DSM-III-R Personality Disorders for borderline personality disorder (43 women and 9 men) were randomly assigned in a 1:1 ratio to 15 mg/day of aripiprazole (N=26) or placebo (N=26) for 8 weeks. Primary outcome measures were changes in scores on the symptom checklist (SCL-90-R), the Hamilton Depression Rating Scale (HAM-D), the Hamilton Anxiety Rating Scale (HAM-A), and the State-Trait Anger Expression Inventory and were assessed weekly. Side effects and self-injury were assessed with a nonvalidated questionnaire.\n According to the intent-to-treat principle, significant changes in scores on most scales of the SCL-90-R, the HAM-D, the HAM-A, and all scales of the State-Trait Anger Expression Inventory were observed in the subjects treated with aripiprazole after 8 weeks. Self-injury occurred in the groups. The reported side effects were headache, insomnia, nausea, numbness, constipation, and anxiety.\n Aripiprazole appears to be a safe and effective agent in the treatment of patients with borderline personality disorder.", "Aripiprazole is a novel antipsychotic for the management of schizophrenia. This study investigated the efficacy, safety, and tolerability of aripiprazole in preventing relapse in adult chronic schizophrenia patients experiencing ongoing stable symptomatology.\n In this 26-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, 310 patients with DSM-IV schizophrenia (mean Positive and Negative Syndrome Scale [PANSS] total score = 82) were randomly assigned to receive a once-daily fixed dose of aripiprazole, 15 mg, or placebo. The primary outcome measure was time to relapse following randomization. Secondary objectives were to assess the efficacy, safety, and tolerability of aripiprazole, 15 mg, compared with placebo, in the study population. The study was conducted between Dec. 21, 2000, and Aug. 20, 2001.\n The time to relapse following randomization was significantly (p < .001) longer for aripiprazole compared with placebo. More patients relapsed with placebo (N = 85; 57%) than aripiprazole (N = 50; 34%); the relative risk of relapse for the aripiprazole group was 0.59 (p < .001). Aripiprazole was significantly superior to placebo from baseline to endpoint in PANSS total, PANSS positive, PANSS-derived Brief Psychiatric Rating Scale, and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores and demonstrated significantly better mean Clinical Global Impressions-Global Improvement scale scores (p < or = .01 for all comparisons except CGI-S: .01 < p < or = .05). Aripiprazole was well tolerated, with no evidence of marked sedation and no evidence of hyperprolactinemia or prolonged heart rate-corrected QT interval (QTc). Extrapyramidal symptoms were comparable in the aripiprazole and placebo groups. Modest mean weight loss at endpoint was evident in both groups.\n Aripiprazole, 15 mg once daily, is an effective, well-tolerated treatment for prevention of relapse in patients with chronic, stable schizophrenia.", "Switching patients from one antipsychotic to another can lead to tolerability problems or transient symptom exacerbations. It is important to compare switching strategies to determine which methods produce the best possible patient outcomes.\n To investigate the efficacy, safety and tolerability of three dosing strategies for switching chronic, stable patients with schizophrenia from current oral antipsychotic monotherapy to once-daily oral aripiprazole monotherapy.\n Patients in this 8-week, open-label, outpatient study were randomized to: 1). immediate initiation of 30 mg/day aripiprazole with simultaneous immediate discontinuation of current antipsychotic; 2). immediate initiation of 30 mg/day aripiprazole while tapering off current antipsychotic over 2 weeks; or 3). up-titrating aripiprazole to 30 mg/day over 2 weeks, while simultaneously tapering off current antipsychotic. Efficacy assessments included PANSS, CGI-S, and CGI-I scores. Safety assessments included: adverse events (AEs) recording, evaluation of extrapyramidal symptoms (EPS), vital signs, ECG, and clinical laboratory tests.\n Efficacy with aripiprazole was maintained during the study with numerical improvements compared with baseline in all three groups. The overall incidence of AEs was broadly comparable across all groups, and AEs were generally mild to moderate in severity and time-limited. Discontinuations due to AEs were comparable across the groups. No deterioration in EPS occurred in any group. The reduction in body weight and plasma prolactin levels following switch to aripiprazole were comparable across the three groups.\n Any of the three strategies evaluated can be used safely for switching patients to aripiprazole from antipsychotic monotherapy. Furthermore, patients' symptoms may continue to improve after switching to aripiprazole.", "Aripiprazole is a dopamine D2 receptor partial agonist with partial agonist activity at serotonin 5HT1A receptors and antagonist activity at 5HT2A receptors. This multicenter trial examined the efficacy, safety, and tolerability of aripiprazole in patients with acute exacerbation of schizophrenia or schizoaffective disorder.\n In this 4-week double-blind study, 404 patients were randomized to 20 mg/d (n = 101) or 30 mg/d (n = 101) of aripiprazole, placebo (n = 103), or 6 mg/d of risperidone (n = 99). Efficacy assessments included Positive and Negative Syndrome Scale (PANSS) scores and Clinical Global Impression scores. Safety and tolerability evaluations included extrapyramidal symptoms and effects on weight, prolactin, and corrected QT (QTc) interval.\n Aripiprazole (20 and 30 mg/d) and risperidone (6 mg/d) were significantly better than placebo on all efficacy measures. Separation from placebo occurred at week 1 for PANSS total and positive scores with aripiprazole and risperidone and for PANSS negative scores with aripiprazole. There were no significant differences between aripiprazole and placebo in mean change from baseline in the extrapyramidal symptom rating scales. Mean prolactin levels decreased with aripiprazole but significantly increased 5-fold with risperidone. Mean change in QTc interval did not differ significantly from placebo with any active treatment group. Aripiprazole and risperidone groups showed a similar low incidence of clinically significant weight gain.\n Aripiprazole is effective, safe, and well tolerated for the positive and negative symptoms in schizophrenia and schizoaffective disorder. It is the first non-D2 receptor antagonist with clear antipsychotic effects and represents a novel treatment development for psychotic disorders.", "Aripiprazole is an investigational agent for treating schizophrenia that has a novel pharmacologic profile. The present study investigated the efficacy, safety, and tolerability of aripiprazole and haloperidol compared with placebo.\n A 4-week, double-blind, randomized study, conducted at 36 U.S. centers between July 1997 and June 1998, compared aripiprazole (15 mg/day, 30 mg/day) to placebo, with haloperidol (10 mg/day) as an active control. Fixed doses of each agent were administered from day 1 throughout the study. A total of 414 patients with a primary DSM-IV diagnosis of schizophrenia or schizoaffective disorder were randomized. Efficacy measures included the Positive and Negative Syndrome Scale (PANSS) total, PANSS positive, PANSS negative, PANSS-derived Brief Psychiatric Rating Scale (BPRS) core, Clinical Global Impressions (CGI)-Severity of Illness, and mean CGI-Improvement scores. Safety and tolerability evaluations included extrapyramidal symptoms (EPS), weight gain, serum prolactin level, and QTc interval.\n Both doses of aripiprazole and haloperidol, 10 mg, produced statistically significant (p < or = .05) improvements from baseline in PANSS total, PANSS positive, PANSS-derived BPRS core, and CGI-Severity scores and significantly lower CGI-Improvement scores at endpoint, compared with placebo. Aripiprazole, 15 mg, and haloperidol, 10 mg, significantly improved PANSS negative score compared with placebo. Both aripiprazole doses and haloperidol separated from placebo for PANSS total scores at week 2. Unlike haloperidol, aripiprazole was not associated with significant EPS or prolactin elevation at endpoint compared with placebo. There were no statistically significant differences in mean changes in body weight across the treatment groups versus placebo, and no patients receiving aripiprazole experienced clinically significant increases in QTc interval.\n Aripiprazole, effective against positive and negative symptoms, is a safe and well-tolerated potential treatment for schizophrenia and schizoaffective disorder." ]

[ "16291160", "8688396", "48000", "15925045", "9442160", "8760703", "9359441", "11767219", "15294856" ]

[ "A randomized controlled trial of elective preterm delivery of fetuses with gastroschisis.", "A multicentre randomised controlled trial comparing elective and selective caesarean section for the delivery of the preterm breech infant.", "Elective induction of labour. A randomised prospective trial.", "Induction of labor with three different techniques at 41 weeks of gestation or spontaneous follow-up until 42 weeks in women with definitely unfavorable cervical scores.", "Sweeping of the membranes at 39 weeks in nulliparous women: a randomised controlled trial.", "A randomised trial of two expectant managements of prelabour rupture of the membranes at 34 to 42 weeks.", "Pregnancy outcome beyond 41 weeks gestation.", "Management of prolonged pregnancy: a randomized trial of induction of labour and antepartum foetal monitoring.", "Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery." ]

[ "Elective preterm delivery of the fetus with gastroschisis may help to limit injury to the extruded fetal gut and thus promote faster recovery of neonatal gut function and earlier hospital discharge. This hypothesis has not previously been tested in a prospective randomized controlled trial.\n Between May 1995 and September 1999, all women referred to a single tertiary center before 34 weeks' gestation with a sonographically diagnosed fetal gastroschisis were invited to participate in a randomized controlled trial. Eligible patients were randomized to elective delivery at 36 weeks or to await the onset of spontaneous labor. The method of delivery was not prescribed by the trial. Primary outcome measures in the neonate were the time taken to tolerate full enteral feeding (150 mL/kg per day) and duration of hospital stay.\n Of 44 eligible women, 42 were randomized, 21 to elective delivery and 21 to await spontaneous labor. There were 20 liveborn infants in each group. Four babies in the elective group and 4 in the spontaneous group delivered before 36 weeks' gestation but were included in the analysis on an intention-to-treat basis. Mean gestational age at delivery was 35.8 weeks in the elective group and 36.7 weeks in the spontaneous group. Primary closure of the gastroschisis was achieved in a similar proportion (80%-85%) of infants in both groups. Two babies in the elective group died from short gut complications. In the survivors, there was a trend in favor of a shorter median time to achieve full enteral feeding (30.5 vs 37.5 days) and a shorter median duration of hospital stay (47.5 vs 53 days) in the elective group, but this was not statistically significant. These findings remained unaltered when the data were reanalyzed after (a) excluding infants with intestinal atresia or (b) excluding infants born before 36 weeks' gestation.\n Although limited by the small number of patients, this randomized controlled trial demonstrates no significant benefit from elective preterm delivery of fetuses with gastroschisis.", "To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks.\n A multicentre randomised controlled trial.\n Twenty-six hospitals in England, UK.\n Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation, with no clear indication for a caesarean section or vaginal breech delivery.\n Random allocation to either \"intention to delivery vaginally' or \"intention to deliver by caesarean section'.\n Perinatal mortality, neonatal morbidity, maternal morbidity and gestation at delivery.\n The trial was closed after 17 months because of low recruitment, by which time substantial numbers of women had been in the eligible gestation period. Thirteen women from six hospitals were recruited. One infant, randomised to and delivered vaginally, was stillborn. Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry. No formal statistical analysis was performed due to the small numbers.\n No conclusions about the optimum mode of delivery for women in preterm labour with a fetus presenting by the breech can be drawn from this trial. The low accrual rate was due to clinicians' reluctance to randomise eligible women, reflecting the circumstances and nature of the trial.", "In a prospective, randomised trial, 111 obstetrically normal pregnant women, who had elective induction of labour performed between 39 and 40 weeks, were compared with 117 controls who were managed expectantly until 41 weeks. Compared with the controls, the patients who had elective induction of labour had significantly less meconium staining in labour and a smaller blood-loss after delivery. The mean length of labour, the amount of pethidine used, and the Apgar scores at 1 minute were similar in the two groups. In the electively induced group, the caesarean-section rate was lower and the use of epidural analgesia more common than in the controls, but the differences were mot statistically signficant. The hour of delivery was similar in the two groups, suggesting that convenience to medical and nursing staff would not be greatly changed by elective induction of labour. There was no evidence that the hazards to mother and child were increased by elective induction, and its use might improve perinatal mortality by reducing the number of unexplained mature stillbirths.", "To compare the obstetric outcome of induction of labor at 41 weeks and of follow-up until 42 weeks and induction if the patient has still not given birth at 42 weeks.\n Six hundred women at 287+/-1 days of gestation with definitely unfavorable cervical scores were randomized to labor induction (N=300) or spontaneous follow-up (N=300) with twice-weekly nonstress testing and amniotic fluid measurement and once-weekly biophysical scoring. The treatments used in the induction group were (1) vaginal administration of 50 microg misoprostol (n=100), (2) oxytocin induction (n=100), and (3) transcervical insertion of a Foley balloon (n=100). The primary outcome measures were the cesarean delivery rate, whether or not the normal hospital stay had to be extended, and the neonatal outcomes. Secondary outcome measure included number of emergency cesarean deliveries performed for abnormalities of the fetal heart rate (FHR).\n The abdominal delivery rate was 19.3% in the induction group and 22% in the follow-up group (p=0.4). The mean length of hospital stay in the two main groups was 1.4+/-0.8 days and 1.3+/-1 days, respectively (p=0.1). Significantly higher rates of macrosomia and shoulder dystocia were seen in the follow-up group (24.6 and 2.3%) than in the induction group (7.6%, p<0.001; 0.3%, p=0.03). Meconium-stained amniotic fluid and meconium aspiration syndrome were observed significantly less frequently in the induction group (9.3 and 1.3%) than in the follow-up group (20.3%, p<0.001; 4%, p=0.03). Rates of emergency abdominal delivery in response to worrying FHR traces, neonatal intensive care unit admission, and low umblical artery pH were similar in the two groups. There was one intrauterine fetal death in the follow-up group.\n Induction of labor at 41 weeks of gestation does not increase the cesarean delivery rate or cause a longer stay in hospital than follow-up until 42 weeks, and neonatal morbidity is also lower after induction.", "To determine whether weekly sweeping of the membranes from 39 weeks of gestation results in a reduction in the number of women reaching 41 completed weeks and subsequently in a reduction of the number of women who will need induction of labour.\n Randomised controlled trial.\n Two hundred and seventy-eight nulliparous women, who were seen at the antenatal clinic of a university teaching hospital, were randomly allocated at 39 weeks of gestation to receive on a weekly basis either sweeping of the membranes (n = 140) or a routine pelvic examination (n = 138).\n The time interval between randomisation and delivery, the incidence of prolonged pregnancy (i.e. > 41 completed weeks), and the incidence of induction of labour.\n In 24 women (17%) sweeping of the membranes was not possible. Fifty-three women (38%) in the sweeping group and 50 women (36%) in the control group were delivered within one week after randomisation. Women allocated to sweeping showed a trend towards having a shorter randomisation-delivery interval: 9.4 days versus 10.6 days in the controls (P = 0.087). Sweeping had no statistically significant effect on the mean duration of pregnancy (282.8 days in the sweeping group versus 283.8 days in the control group, P = 0.127). The need for induction of labour was significantly reduced in those women who underwent sweeping (11% versus 26%, P = 0.004), merely as a result of a decrease in the number of women that exceeded 41 weeks (19% versus 33%, P = 0.016).\n Sweeping of the membranes weekly from 39 weeks does not increase the number of women who will deliver within the first week but significantly decreases the number that will reach 41 weeks. Induction of labour then becomes less necessary.", "To compare obstetric and perinatal outcome between two different expectant managements in women with prelabour rupture of the membranes (PROM).\n A randomised study.\n One thousand three hundred and eighty-five women with rupture of the membranes at 34 to 42 weeks without contractions.\n Women without contractions 2 h after admission were randomised to early induction the following morning after PROM (early induction group) or induction two days later (late induction group). Women with contractions starting within 2 h after admission were included in the calculations as a short latency group. Digital examinations of the cervix were avoided until onset of active labour. Labour was induced with oxytocin in both groups if no spontaneous contractions occurred or if chorioamnionitis or fetal distress was detected.\n The frequency of spontaneous deliveries, operative deliveries, maternal and neonatal infections.\n In nulliparous women, a higher rate of spontaneous deliveries was found in the late induction group (89%) compared with the early induction group (81%) (P < 0.05). The ventouse extraction rate was 7% and 14% respectively (P < 0.05). A low (2-4%) caesarean section rate was recorded and did not differ between the groups. Endometritis was detected in six women after delivery. Sixty-one children were treated with antibiotics, and no difference could be detected between the groups.\n A higher rate of spontaneous deliveries was found among nulliparous women with prolonged latency as compared with brief latency prior to induction. A protocol of no digital examination before labour was associated with infrequent maternal and fetal morbidity, regardless of latency.", "To determine maternal and perinatal morbidity and the spontaneous labor rate beyond 41 weeks of gestation.\n Patients with uncomplicated pregnancy were recruited at 41 weeks and screened for fetal or maternal well-being. Following observation between 41 and 42 weeks, patients were randomized to either serial monitoring by cardiotocography and measurement of amniotic fluid index, or to immediate induction. Comparisons were made using the chi(2) test. Results after 42 weeks were analyzed according to intention at randomization.\n Morbidity was not increased before 42 weeks. After 42 weeks, the cesarean section rate and incidence of meconium below the vocal cords were increased in monitored patients. The median gestational age in patients who were monitored was 298.5 (294-321) days. In patients observed from 41 weeks, 91.6% labored spontaneously.\n It is reasonable to observe uncomplicated pregnancy until 42 weeks with adequate monitoring. After 42 weeks, induction of labor is preferred.", "The two methods of management of prolonged pregnancy, induction of labour and expectant management with foetal surveillance, have pros and cons. Therefore, we compared the induction of labour with serial antenatal foetal monitoring in the management of post-term pregnancy.\n Seventy-four women with uncomplicated pregnancy at 41 weeks (287 days) of gestation were randomly assigned to undergo either induction of labour or serial antenatal foetal monitoring. Labour was induced in the latter group whenever there was evidence of foetal compromise. Antenatal monitoring consisted of the foetal kick count, non-stress test and biophysical profile.\n Fifty-seven per cent of women went into spontaneous labour by 41 weeks and 4 days (291 days) of gestation and only 14% developed foetal compromise before that. However, when the gestational age was more than 41 weeks and 4 days (291 days), the incidence of meconium staining of amniotic fluid and evidence of uteroplacental insufficiency increased significantly. The rate of caesarean section, instrumental delivery, foetal distress and duration of labour did not differ significantly between the two groups.\n The policy of inducing labour at 41 weeks and 4 days (291 days of gestation) in uncomplicated pregnancies is justified in our population. However, foetal monitoring should begin at 41 weeks of gestation.", "To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women.\n Multicentre, prospective, randomised controlled trial.\n Non-hospital based antenatal clinics.\n 4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers.\n The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage.\n Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and <or= 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group.\n Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women." ]

[ "9143888", "7691775", "8953976", "1718250", "6184769", "11024412", "1718253", "9111254", "1693496" ]

[ "Indirect scatter laser photocoagulation to subfoveal choroidal neovascularization in age-related macular degeneration.", "Grid laser treatment of occult choroidal neovascularization in age related macular degeneration.", "Macular scatter ('grid') laser treatment of poorly demarcated subfoveal choroidal neovascularization in age-related macular degeneration. Results of a randomized pilot trial.", "Laser photocoagulation of subfoveal neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group.", "Treatment of neovascular senile maculopathy at the foveal capillary free zone with red krypton laser.", "Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: I. Ophthalmic outcomes submacular surgery trials pilot study report number 1.", "Perifoveal laser treatment for subfoveal choroidal new vessels in age-related macular degeneration. Results of a randomized clinical trial.", "A pilot randomized controlled study on the effect of laser photocoagulation of confluent soft macular drusen.", "Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group." ]

[ "Occult choroidal neovascularization (CNV), poorly defined on fluorescein angiography, is present in the majority of patients with exudative complications of age-related macular degeneration. For patients who present with this type of subfoveal CNV but who have useful visual acuity, no form of treatment is of proven benefit. Accordingly, a pilot randomized trial of indirect laser treatment was performed. The rationale of this treatment was to inhibit the CNV through laser-induced effects on the retinal pigment epithelium.\n Patients with occult subfoveal CNV without retinal pigment epithelial detachment and with visual acuity of 20/200 or better were randomized to treatment or control groups. A grid of laser burns was applied to the macula beyond the area of serous retinal detachment and of angiographically defined occult CNV.\n After an average follow-up of 38 months, there was no difference in mean final visual acuity (0.12 treated, 0.14 control) or clinical outcome between treated and untreated groups. Fluorescein angiography showed gradual enlargement in the occult CNV in 58% of eyes in both groups. A decrease in visual acuity to worse than 20/200 (54% of treated, 50% of control eyes) was associated with ingrowth of well-delineated CNV (6 treated, 7 control eyes) or progression to a fibroglial or atrophic scar (11 treated, 8 control eyes).\n No benefit was demonstrated for scatter photocoagulation of the macula in patients with age-related macular degeneration and occult subfoveal CNV with initially good visual acuity. There were, however, no complications related to treatment.", "Laser photocoagulation treatment of occult choroidal neovascularization (CNV) in age related macular degeneration has been up to now discouraging. We report a randomized clinical trial comparing 'grid' laser treatment versus the natural course in 24 eyes with this kind of neovascularization. In 12 eyes a low energy scatter photocoagulation was applied to the areas of presumed CNV and abnormal retinal pigment epithelium, sparing the fovea. The follow-up ranged from 1 to 3 years. At the three months follow-up visit, the subretinal exudation appeared reduced in 40% of the treated eyes and in none of the control eyes. During the period of follow-up the occult CNV turned to classic CNV in 4 treated and in 4 untreated eyes. At the last examination (average follow-up 18 months), anatomical and functional conditions were not significantly different in the two groups. Our data fail to show a beneficial long-term effect of grid laser treatment for occult CNV; no iatrogenic complications were seen in our series.", "To determine the effects of macular scatter (\"grid\") laser photocoagulation compared with observation on the visual function of eyes with subfoveal choroidal neovascularization (CNV) that has poorly demarcated boundaries and to provide preliminary data for the evaluation of the feasibility and design of a larger, definitive trial.\n Randomized pilot clinical trial.\n Two tertiary care retinal referral practices.\n Symptomatic individuals with subfoveal CNV secondary to age-related macular degeneration in whom fluorescein angiography showed occult CNV with poorly demarcated boundaries; classic CNV was allowed but did not need to be present for entry into the study.\n Change in visual acuity from baseline to specified time periods.\n Fifty-two eyes were assigned to observation. Fifty-one eyes were assigned randomly to treatment consisting of macular scatter (\"grid\") laser photocoagulation to the area of CNV. The treatment protocol for 8 of these eyes also included confluent laser photocoagulation to areas of classic CNV. The average visual acuity decrease from baseline was greater in the treated than in the observed group. The difference between these groups was greatest within the first year after study enrollment. At 24 months, slightly more than 40% of the eyes in each group had lost 6 or more lines of visual acuity. Similar results were noted for the subgroup of eyes initially with angiographic features of occult CNV but no classic CNV.\n These short-term study results suggest that macular scatter (\"grid\") laser treatment is not beneficial and is possibly harmful compared with observation for symptomatic subfoveal CNV with poorly demarcated boundaries in age-related macular degeneration. With or without treatment, a significant proportion of these patients are at risk of severe visual loss within 2 years of seeking treatment, even when the eye initially has occult CNV and no classic CNV.", "A clinical trial has been conducted to evaluate the effect on vision of laser treatment (argon green or krypton red lasers, assigned randomly) compared with no treatment of eyes with subfoveal choroidal neovascularization associated with age-related macular degeneration. Three months after enrollment, the visual acuity of 37 (20%) of 184 laser-treated eyes had decreased 6 or more lines from the baseline level, while only 19 (11%) of 178 untreated eyes had suffered such large decreases (P = .01, chi 2 test). However, 24 months after enrollment, the visual acuity of only 23 (20%) of 114 laser-treated eyes had decreased by 6 or more lines from baseline compared with 41 (37%) of 112 untreated eyes (P less than .01, chi 2 test). On average, after 24 months, visual acuity of laser-treated eyes had decreased 3 lines from baseline, and visual acuity of untreated eyes had decreased 4 lines (P = .003, t test). Laser-treated eyes retained contrast threshold for large letters at or near baseline levels through 36 months of follow-up examinations, while the contrast threshold of untreated eyes worsened. Persistent or recurrent neovascularization was observed in 51% of the laser-treated eyes by 24 months after initial treatment but was not associated with decreased visual acuity. None of the findings suggested a reason to favor either the argon green or krypton red wavelength. Laser treatment of subfoveal neovascular lesions that meet the eligibility criteria for this study is recommended if both the patient and the ophthalmologist are prepared for a large decrease in visual acuity immediately after treatment.", "Sixty-eight eyes with neovascular senile maculopathy involving the capillary free zone that were assigned randomly for red krypton laser photocoagulation were followed for two years and compared to 55 eyes with the same disease that were not treated. In the majority of the studied eyes there was a decline of visual acuity during the follow-up period. However, an increase in visual acuity was encountered in one third of treated eyes, but no increase in the untreated eyes. The extent of visual acuity deterioration was greater in the nontreated than in the treated eyes. Eyes that were treated when visual acuity was between 6/9-6/60 generally belonged to a better final visual acuity group than those eyes that were treated when visual acuity was less than 6/60. The technique of red krypton laser photocoagulation is described, the rationale for this treatment is discussed, and the results of the treatment are evaluated.", "To report complications and changes in vision during 2 years of follow-up of patients with age-related macular degeneration assigned randomly to surgical removal or to laser photocoagulation of subfoveal recurrent neovascular lesions in a pilot trial designed to test methods, to refine estimates of outcome rates, and to project patient accrual rates for a larger multicenter randomized trial to evaluate submacular surgery.\n Eligible patients with previous laser photocoagulation of extrafoveal or juxtafoveal choroidal neovascularization secondary to age-related macular degeneration were enrolled at 15 collaborating clinical centers. Assignments to treatment arm were made by personnel at a central coordinating center. Adherence to eligibility criteria and treatment assignment was assessed centrally at a photograph reading center. Patients were examined at 3, 6, 12, and 24 months after treatment for data collection purposes. Outcome measures reported include treatment complications, adverse events, requirements for additional treatment, and 2-year changes in visual acuity from baseline.\n Of 70 patients enrolled, 36 were assigned to laser photocoagulation and 34 to submacular surgery; all were treated as assigned. One patient in each group died before the 2-year examination. Visual acuity was measured at the 2-year examination for 31 of the surviving patients (89%) in the laser arm and for 28 of the surviving patients (85%) in the surgery arm. The 2-year measurements for 36 of the 59 patients (61%) were made by an examiner masked to treatment assignment and to the identity of the study eye. Improvements and losses of visual acuity were observed in both treatment arms; 20 of 31 study eyes (65%) in the laser arm and 14 of 28 study eyes (50%) in the surgery arm had visual acuity 2 years after enrollment that was better than or no more than 1 line worse than the baseline level. Changes in visual acuity and the size of the central macular lesions from baseline to the 2-year examination were similar in the treatment arms. Few serious complications were observed in either arm at the time of initial treatment; serious adverse events were rare. During follow-up, 11 laser-treated eyes and 18 surgically treated eyes had additional intraocular procedures.\n The data from this pilot trial suggest no reason to prefer submacular surgery over laser photocoagulation for treatment of patients with age-related macular degeneration who have lesions similar to those studied in this pilot trial. Any clinical trial designed to compare submacular surgery with laser photocoagulation in eyes with age-related macular degeneration and subfoveal recurrent neovascular lesions must enroll several hundred patients in order to reach a statistically valid conclusion regarding differences between these two methods of treatment with respect to either changes in visual acuity or complication rates.", "In a controlled clinical trial, 160 eyes underwent \"perifoveal\" laser photocoagulation. All patients had age-related macular degeneration and subfoveal neovascularization (0.5 to 2.5 disc diameters), without detectable fibrous tissue, and visual acuity from 20/100 to 20/1000. At least 1 year of follow-up has been completed in 127 eyes. Visual acuity was maintained or improved in 12 (20.3%) of 59 untreated eyes vs 28 (41.1%) of 68 treated eyes (P = .04). Reading visual acuity (J4) with the use of low-vision aids was retained in 28 untreated eyes (47.4%) vs 50 treated eyes (73.5%) (P less than .01). Automated static perimetry showed an increased scotomatous area and/or depth with eccentric fixation in all but four patients. A flat atrophic scar was achieved in 53 of 68 treated eyes. Statistical analysis indicated that perifoveal photocoagulation has been effective in the short-term preservation of visual acuity.", "The authors determined the effect of photocoagulation of drusen on visual acuity and progression to subretinal neovascular membranes (SRNV).\n One of paired eyes was randomized to photocoagulation with other eye to control in 27 patients having symmetrical maculopathy and visual acuities, aged 46 to 81 years (mean, 69.7 years); follow-up 1 to 6 years (mean, 3.2 years).\n Final visual acuity was improved in treated eye or decreased in control eye in 12 patients, equal in 13 patients, and decreased in treated eye in 2 patients (P < 0.006). Progression to SRNV was less with treatment.\n Laser photocoagulation of confluent soft macular drusen may improve long-term visual prognosis.", "The Age-Related Macular Degeneration Study-Krypton Laser (AMDS-K) is a multicenter controlled clinical trial designed to determine whether krypton red laser photocoagulation is of value in preventing visual acuity loss in eyes with macular degeneration that have either choroidal neovascularization 1 to 199 microns from the center of the foveal avascular zone or choroidal neovascularization 200 microns or farther from the foveal avascular zone center with blood and/or blocked fluorescence extending within 200 microns of the foveal avascular zone center. Recruitment ended in December 1987 after 247 patients had been assigned to photocoagulation and 249 patients had been assigned to no treatment. At 3 years after randomization, 49% (86/174) of treated eyes, in contrast to 58% (98/169) of untreated eyes, had lost six or more lines of visual acuity. The average visual acuity of treated and untreated eyes at that time was 20/200 and 20/250, respectively. The benefit of laser treatment was largest among patients without evidence of hypertension and diminished to no apparent benefit among patients who had highly elevated blood pressure and/or used antihypertensive medication. Treatment of lesions meeting the AMDS-K eligibility criteria in eyes of patients with no hypertension is recommended. However, treatment cannot be recommended uniformly for patients with definite hypertension having lesions similar to those of patients enrolled in the AMDS-K." ]

[ "11087881", "14530224", "10979111", "10566565", "10096266", "9751091", "10500058", "17039120", "10609815" ]

[ "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group.", "Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial.", "Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study.", "The safety profile, tolerability, and effective dose range of rofecoxib in the treatment of rheumatoid arthritis. Phase II Rofecoxib Rheumatoid Arthritis Study Group.", "Characterization of rofecoxib as a cyclooxygenase-2 isoform inhibitor and demonstration of analgesia in the dental pain model.", "Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor: efficacy and safety in two placebo-controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects.", "A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Rofecoxib Osteoarthritis Endoscopy Study Group.", "COX-2 specific inhibitors in the management of osteoarthritis of the knee: a placebo-controlled, randomized, double-blind study.", "Celecoxib versus diclofenac in long-term management of rheumatoid arthritis: randomised double-blind comparison." ]

[ "Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis.\n We randomly assigned 8076 patients who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis to receive either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily. The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers).\n Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis. During a median follow-up of 9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6; P<0.001). The respective rates of complicated confirmed events (perforation, obstruction, and severe upper gastrointestinal bleeding) were 0.6 per 100 patient-years and 1.4 per 100 patient-years (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.005). The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7); the overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups.\n In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor.", "Gastrointestinal (GI) toxicity mediated by dual cyclooxygenase (COX)-1 and COX-2 inhibition of nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious alterations of mucosal integrity or, more commonly, intolerable GI symptoms that may necessitate discontinuation of therapy. Unlike NSAIDs, rofecoxib targets only the COX-2 isoform.\n To assess the tolerability of rofecoxib compared with naproxen for treatment of osteoarthritis.\n Randomized, controlled trial.\n 600 office and clinical research sites.\n 5557 patients (mean age, 63 years) with a baseline diagnosis of osteoarthritis of the knee, hip, hand, or spine.\n Rofecoxib, 25 mg/d, or naproxen, 500 mg twice daily. Use of routine medications, including aspirin, was permitted.\n Discontinuation due to GI adverse events (primary end point) and use of concomitant medication to treat GI symptoms (secondary end point). Efficacy was determined by patient-reported global assessment of disease status and the Australian/Canadian Osteoarthritis Hand Index, as well as discontinuations due to lack of efficacy. Patients were evaluated at baseline and at weeks 6 and 12.\n Rates of cumulative discontinuation due to GI adverse events were statistically significantly lower in the rofecoxib group than in the naproxen group (5.9% vs. 8.1%; relative risk, 0.74 [95% CI, 0.60 to 0.92]; P = 0.005), as were rates of cumulative use of medication to treat GI symptoms (9.1% vs. 11.2%; relative risk, 0.79 [CI, 0.66 to 0.96]; P = 0.014]). Subgroup analysis of patients who used low-dose aspirin (13%) and those who previously discontinued using arthritis medication because of GI symptoms (15%) demonstrated a relative risk similar to the overall sample for discontinuation due to GI adverse events (relative risk, 0.56 [CI, 0.31 to 1.01] and 0.53 [CI, 0.34 to 0.84], respectively). No statistically significant difference was observed between treatments for efficacy in treating osteoarthritis or for occurrence of other adverse events.\n In patients with osteoarthritis treated for 12 weeks, rofecoxib, 25 mg/d, was as effective as naproxen, 500 mg twice daily, but had statistically significantly superior GI tolerability and led to less use of concomitant GI medications. Benefits of rofecoxib in subgroup analyses were consistent with findings in the overall sample.", "Conventional nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with a spectrum of toxic effects, notably gastrointestinal (GI) effects, because of inhibition of cyclooxygenase (COX)-1. Whether COX-2-specific inhibitors are associated with fewer clinical GI toxic effects is unknown.\n To determine whether celecoxib, a COX-2-specific inhibitor, is associated with a lower incidence of significant upper GI toxic effects and other adverse effects compared with conventional NSAIDs.\n The Celecoxib Long-term Arthritis Safety Study (CLASS), a double-blind, randomized controlled trial conducted from September 1998 to March 2000.\n Three hundred eighty-six clinical sites in the United States and Canada.\n A total of 8059 patients (>/=18 years old) with osteoarthritis (OA) or rheumatoid arthritis (RA) were enrolled in the study, and 7968 received at least 1 dose of study drug. A total of 4573 patients (57%) received treatment for 6 months.\n Patients were randomly assigned to receive celecoxib, 400 mg twice per day (2 and 4 times the maximum RA and OA dosages, respectively; n = 3987); ibuprofen, 800 mg 3 times per day (n = 1985); or diclofenac, 75 mg twice per day (n = 1996). Aspirin use for cardiovascular prophylaxis (</=325 mg/d) was permitted.\n Incidence of prospectively defined symptomatic upper GI ulcers and ulcer complications (bleeding, perforation, and obstruction) and other adverse effects during the 6-month treatment period.\n For all patients, the annualized incidence rates of upper GI ulcer complications alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 0.76% vs 1.45% (P =.09) and 2. 08% vs 3.54% (P =.02), respectively. For patients not taking aspirin, the annualized incidence rates of upper GI ulcer complications alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 0.44% vs 1.27% (P =.04) and 1.40% vs 2.91% (P =.02). For patients taking aspirin, the annualized incidence rates of upper GI ulcer complications alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 2.01% vs 2.12% (P =.92) and 4.70% vs 6.00% (P =.49). Fewer celecoxib-treated patients than NSAID-treated patients experienced chronic GI blood loss, GI intolerance, hepatotoxicity, or renal toxicity. No difference was noted in the incidence of cardiovascular events between celecoxib and NSAIDs, irrespective of aspirin use.\n In this study, celecoxib, at dosages greater than those indicated clinically, was associated with a lower incidence of symptomatic ulcers and ulcer complications combined, as well as other clinically important toxic effects, compared with NSAIDs at standard dosages. The decrease in upper GI toxicity was strongest among patients not taking aspirin concomitantly. JAMA. 2000;284:1247-1255", "Nonsteroidal anti-inflammatory drugs. (NSAIDs) inhibit both cyclooxygenase (COX)-1 and COX-2 isoenzymes and are effective in the treatment of inflammatory disorders. This 8-week, double-masked, placebo-controlled trial was undertaken to assess the safety profile, tolerability, and effective dose range of once-daily rofecoxib, a COX-2-specific inhibitor, in the treatment of rheumatoid arthritis (RA). After a 3- to 15-day washout of prior NSAID therapy, 658 patients were randomly allocated to receive placebo or rofecoxib 5 mg, 25 mg, or 50 mg once daily. Safety profile, tolerability, and efficacy were evaluated after 2, 4, and 8 weeks of therapy. Six hundred fifty-eight patients (168, 158, 171, and 161 in the placebo and 5-mg, 25-mg, and 50-mg rofecoxib groups, respectively) were enrolled at 79 clinical centers in the United States. Mean age was 55 years, mean duration of RA was 10 years, and 506 (77%) of the 658 patients were female. All groups had similar baseline demographic characteristics. Patients taking rofecoxib 25 and 50 mg showed significant clinical improvement compared with those taking placebo; 43.9% in the rofecoxib 25-mg group and 49.7% in the rofecoxib 50-mg group completed the treatment period and achieved an American College of Rheumatology 20 response (P = 0.025 and 0.001 vs. placebo, respectively). The 5-mg dose of rofecoxib did not differ significantly from placebo. Patients in the rofecoxib 25- and 50-mg groups showed significant improvement in key individual efficacy measurements, including patient global assessment of pain, patient and investigator global assessment of disease activity, and Stanford Health Assessment Questionnaire Disability Index (P<0.05 vs placebo). Compared with placebo, significantly fewer patients in the 25-mg and 50-mg rofecoxib groups discontinued therapy because of lack of efficacy (P = 0.02 and P = 0.032, respectively). Our results show that rofecoxib 25 and 50 mg once daily was effective and generally well-tolerated in patients with RA.", "Nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, and indomethacin (INN, indometacin) inhibit both the constitutive (COX-1) and inducible (COX-2) isoforms of cyclooxygenase. The induction of COX-2 after inflammatory stimuli has led to the hypothesis that COX-2 inhibition primarily accounts for the therapeutic properties of NSAIDs.\n Chinese hamster ovary (CHO) cell lines that express each COX isoform were used to characterize the in vitro selectivity of rofecoxib. Single oral doses of rofecoxib and indomethacin were then assessed in subjects with use of ex vivo COX-isoform specific assays (serum thromboxane B2 [TXB2] and lipopolysaccharide [LPS]-stimulated whole blood prostaglandin E2 and assays of COX-1 and COX-2 activity, respectively). A double-blind, parallel-group study compared the analgesic efficacy of rofecoxib to placebo and ibuprofen in 102 patients with dental pain.\n Rofecoxib showed a >800-fold COX-2 selectivity with use of CHO cells that express human COX-1 and COX-2. In subjects, dose- and concentration-dependent inhibition of LPS-stimulated prostaglandin E2 was observed with both rofecoxib (IC50 [the concentration estimated to produce 50% inhibition], 0.77 micromol/L) and indomethacin (IC50, 0.33 micromol/L). Whereas indomethacin inhibited TXB2, (IC50, 0.14 micromol/L), no inhibition was observed with rofecoxib even at doses of up to 1000 mg. In the dental pain study, total pain relief (TOTPAR) over the 6 hours after dosing was similar between 50 mg and 500 mg rofecoxib and 400 mg ibuprofen (P > .20). All active treatments showed greater improvement than placebo (P < .001)\n Rofecoxib inhibited COX-2 without evidence of COX-1 inhibition, even at oral doses of up to 1000 mg. Nonetheless, rofecoxib showed analgesic activity indistinguishable from that observed with ibuprofen, a nonisoform-selective COX inhibitor. These results support the hypothesis that the analgesic effects of NSAIDs primarily derive from inhibition of COX-2.", "To investigate the efficacy and safety of SC-58635 (celecoxib), an antiinflammatory and analgesic agent that acts by selective cyclooxygenase 2 (COX-2) inhibition and is not expected to cause the typical gastrointestinal (GI), renal, and platelet-related side effects associated with inhibition of the COX-1 enzyme.\n Four phase II trials were performed: a 2-week osteoarthritis efficacy trial, a 4-week rheumatoid arthritis efficacy trial, a 1-week endoscopic study of GI mucosal effects, and a 1-week study of effects on platelet function.\n The 2 arthritis trials identified SC-58635 dosage levels that were consistently effective in treating the signs and symptoms of arthritis and were distinguished from placebo on standard arthritis scales. In the upper GI endoscopy study, 19% of subjects receiving naproxen (6 of 32) developed gastric ulcers, whereas no ulcers occurred in subjects receiving SC-58635 or placebo. The study of platelet effects revealed no meaningful effect of SC-58635 on platelet aggregation or thromboxane B2 levels, whereas aspirin caused significant decreases in 2 of 3 platelet aggregation measures and thromboxane B2 levels. In all 4 trials, SC-58635 was well tolerated, with a safety profile similar to that of placebo.\n SC-58635 achieves analgesic and antiinflammatory efficacy in arthritis through selective COX-2 inhibition, without showing any evidence of 2 of the toxic effects of COX-1 inhibition associated with nonsteroidal antiinflammatory drugs.", "Prostaglandin production in the normal gastrointestinal tract, believed to be critical for mucosal integrity, is mediated by cyclooxygenase (COX)-1, whereas prostaglandin production at inflammatory sites seems to occur via induction of COX-2. We hypothesized that COX-2-specific inhibition with rofecoxib (25 mg once daily) in the treatment of patients with osteoarthritis would cause fewer gastroduodenal ulcers than an equally effective dose of ibuprofen (800 mg 3 times a day), a nonspecific COX inhibitor.\n A total of 742 osteoarthritis patients without ulcers on baseline endoscopy were randomly assigned to receive rofecoxib (25 or 50 mg once daily), ibuprofen (800 mg 3 times daily), or placebo. Endoscopy was repeated at 6, 12, and 24 weeks. At 16 weeks, by study design, 95% of the placebo group and 5% of the other groups were discontinued.\n The cumulative incidence of gastroduodenal ulcers >/=3 mm with rofecoxib (25 or 50 mg once daily) was significantly (P < 0.001) lower than with ibuprofen and was statistically equivalent to placebo at week 12 (placebo, 9.9%; 25 mg rofecoxib, 4.1%; 50 mg rofecoxib, 7.3%; and ibuprofen, 27.7%). At 24 weeks, ulcer rates were 25 mg rofecoxib, 9. 6%; 50 mg rofecoxib, 14.7%; and ibuprofen, 45.8% (P < 0.001, ibuprofen vs. 25 and 50 mg rofecoxib).\n Rofecoxib, at doses 2-4 times the dose demonstrated to relieve symptoms of osteoarthritis, caused significantly less gastroduodenal ulceration than ibuprofen, with ulcer rates comparable to placebo.", "COX-2 specific inhibitors have demonstrated significant safety advantages and comparable efficacy in osteoarthritis (OA) compared with conventional nonsteroidal anti-inflammatory drugs (NSAIDs), but no direct comparative trials between COX-2 specific inhibitors have been published. In this double-blind, placebo-controlled, parallel group, multicenter study, 182 patients (> or =40 years old) with OA of the knee were randomly assigned to treatment with celecoxib 200 mg q.d. (n = 63), rofecoxib 25 mg q.d. (n = 59), or placebo (n = 60) for 6 weeks. Arthritis assessments were performed at baseline and Weeks 3 and 6, or at early termination. At Week 6, celecoxib and rofecoxib treatment resulted in similar mean changes from baseline (p > 0.55) in arthritis pain visual analogue scale, patient's global assessment, and total score for WOMAC; all changes were superior to placebo (p < 0.05). In the patient's global assessment of arthritis pain at Week 6, 79% of celecoxib-treated and 78% of rofecoxib-treated patients improved by > or =1 grade, compared with 50% of placebo patients (celecoxib, p = 0.025; rofecoxib, p = 0.020). Adverse event incidences were similar among the active comparators; however, celecoxib-treated patients had significantly fewer adverse gastrointestinal symptoms compared with rofecoxib-treated patients, which suggests that celecoxib may have a better gastrointestinal tolerability profile than rofecoxib at these doses. Adverse events that prompted withdrawal occurred in fewer than 7% of patients, and the overall incidences were similar between the active agents. Once-daily doses of celecoxib 200 mg and rofecoxib 25 mg offer comparable efficacy and are an effective alternative to conventional NSAIDs in the management of OA.", "Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit cyclo-oxygenase (COX), which leads to suppression of COX-1-mediated production of gastrointestinal-protective prostaglandins. Gastrointestinal injury is a common outcome. We compared the efficacy, safety, and tolerability of long-term therapy with celecoxib, a COX-1 sparing inhibitor of COX-2, with diclofenac, a non-specific COX inhibitor.\n 655 patients with adult-onset rheumatoid arthritis of at least 6 months' duration were randomly assigned oral celecoxib 200 mg twice daily or diclofenac SR 75 mg twice daily for 24 weeks. Anti-inflammatory and analgesic activity and tolerability were assessed at baseline, every 4 weeks, and at week 24. We assessed gastrointestinal safety by upper-gastrointestinal endoscopy within 7 days of the last treatment dose at centres where the procedure was available. Analysis was by intention-to-treat.\n 430 patients underwent endoscopy (celecoxib n=212, diclofenac n=218). The two drugs were similar in management of rheumatoid arthritis pain and inflammation. Gastroduodenal ulcers were detected endoscopically in 33 (15%) patients treated with diclofenac and in eight (4%) in the celecoxib group (p<0.001). The rate of withdrawal for any gastrointestinal-related adverse event, most commonly abdominal pain, diarrhoea, and dyspepsia, was nearly three times higher in the diclofenac-treated group than in the celecoxib group (16 vs 6%; p<0.001).\n Celecoxib showed sustained anti-inflammatory and analgesic activity similar to diclofenac, with a lower frequency of upper gastrointestinal ulceration or gastrointestinal adverse events, and tolerability was better." ]

[ "18853562", "16435703", "15530927", "18074710", "19171828", "15713204", "8907444", "20390477", "21700922" ]

[ "Highlighting human form and motion information enhances the conspicuity of pedestrians at night.", "Limitations in drivers' ability to recognize pedestrians at night.", "High visibility safety apparel and nighttime conspicuity of pedestrians in work zones.", "Effects of age and illumination on night driving: a road test.", "Comparing explorative saccade and flicker training in hemianopia: a randomized controlled study.", "Use of prisms for navigation and driving in hemianopic patients.", "Effect of a walking aid on disability, oxygenation, and breathlessness in patients with chronic airflow limitation.", "A randomized controlled trial to evaluate the relative efficacy of adding voluntary counseling and testing (VCT) to information dissemination in reducing HIV-related risk behaviors among Hong Kong male cross-border truck drivers.", "Prism adaptation therapy enhances rehabilitation of stroke patients with unilateral spatial neglect: a randomized, controlled trial." ]

[ "Exploring how biological motion can make pedestrians more conspicuous to drivers at night, one-hundred-and-twenty participants were driven along an open-road route at night and pressed a button whenever they recognized that a pedestrian was present. A test pedestrian wearing black clothing alone or with 302 cm2 of retroreflective markings in one of four configurations either stood still or walked in place on an unilluminated sidewalk. Participants' response distances were maximal for the full biological-motion configuration and remained surprisingly long when convenient subsets of reflective markers were positioned on the pedestrian's ankles and wrists. When the pedestrian wore a reflective vest, the responses were no better than when he wore no reflective markings. The biological-motion advantage actually results from interacting form-perception and motion-perception mechanisms. These results confirm that basic perceptual phenomena-observers' sensitivity to human form and motion can be harnessed to reduce an important problem of traffic safety.", "This study quantified drivers' ability to recognize pedestrians at night. Ten young and 10 older participants drove around a closed road circuit and responded when they first recognized a pedestrian. Four pedestrian clothing and two beam conditions were tested. Results demonstrate that driver age, clothing configuration, headlamp beam, and glare all significantly affect performance. Drivers recognized only 5% of pedestrians in the most challenging condition (low beams, black clothing, glare), whereas drivers recognized 100% of the pedestrians who wore retroreflective clothing configured to depict biological motion (no glare). In the absence of glare, mean recognition distances varied from 0.0 m (older drivers, low beam, black clothing) to 220 m (722 feet; younger drivers, high beam, retroreflective biomotion). These data provide new motivation to minimize interactions between vehicular and pedestrian traffic at night and suggest garment designs to maximize pedestrian conspicuity when these interactions are unavoidable.", "Every year numerous occupational fatalities result from pedestrians being struck by motor vehicles intruding into work zones.\n Attributes of retroreflective personal safety garments on pedestrian conspicuity at night were assessed in a field study. Using instrumented vehicles on a closed track, participants drove through simulated work zones attempting to detect pedestrians located in the work zones.\n Configuration of the retroreflective trim, trim color, placement in the work zone, and driver age significantly affected pedestrian conspicuity. Intensity and the amount of retroreflective trim did not.\n Personal safety garments incorporating retroreflective trim significantly improve pedestrian conspicuity in work zones.\n The results emphasize the importance of retroreflective trim on personal safety garments, particularly if the trim is located on garment sleeves.\n We examine the design attributes that contribute to making a personal safety garment conspicuous. The results have implications regarding preferred garment designs, industry standards, and service life of personal safety garments.", "This study investigated the effects of drivers' age and low light on speed, lane keeping, and visual recognition of typical roadway stimuli.\n Poor visibility, which is exacerbated by age-related changes in vision, is a leading contributor to fatal nighttime crashes. There is little evidence, however, concerning the extent to which drivers recognize and compensate for their visual limitations at night.\n Young, middle-aged, and elder participants drove on a closed road course in day and night conditions at a \"comfortable\" speed without speedometer information. During night tests, headlight intensity was varied over a range of 1.5 log units using neutral density filters.\n Average speed and recognition of road signs decreased significantly as functions of increased age and reduced illumination. Recognition of pedestrians at night was significantly enhanced by retroreflective markings of limb joints as compared with markings of the torso, and this benefit was greater for middle-aged and elder drivers. Lane keeping showed nonlinear effects of lighting, which interacted with task conditions and drivers' lateral bias, indicating that older drivers drove more cautiously in low light.\n Consistent with the hypothesis that drivers misjudge their visual abilities at night, participants of all age groups failed to compensate fully for diminished visual recognition abilities in low light, although older drivers behaved more cautiously than the younger groups.\n These findings highlight the importance of educating all road users about the limitations of night vision and provide new evidence that retroreflective markings of the limbs can be of great benefit to pedestrians' safety at night.", "Patients with homonymous hemianopia are disabled on everyday exploratory activities. We examined whether explorative saccade training (EST), compared with flicker-stimulation training (FT), would selectively improve saccadic behavior on the patients' blind side and benefit performance on natural exploratory tasks.\n Twenty-eight hemianopic patients were randomly assigned to distinct groups performing for 6 weeks either EST (a digit-search task) or FT (blind-hemifield stimulation by flickering letters). Outcome variables (response times [RTs] during natural search, number of fixations during natural scene exploration, fixation stability, visual fields, and quality-of-life scores) were collected before, directly after, and 6 weeks after training.\n EST yielded a reduced (post/pre, 47%) digit-search RT for the blind side. Natural search RT decreased (post/pre, 23%) on the blind side but not on the seeing side. After FT, both sides' RT remained unchanged. Only with EST did the number of fixations during natural scene exploration increase toward the blind and decrease on the seeing side (follow-up/pre difference, 238%). Even with the target located on the seeing side, after EST more fixations occurred toward the blind side. The EST group showed decreased (post/pre, 43%) fixation stability and increased (post/pre, 482%) asymmetry of fixations toward the blind side. Visual field size remained constant after both treatments. EST patients reported improvements in social domain.\n Explorative saccade training selectively improves saccadic behavior, natural search, and scene exploration on the blind side. Flicker-stimulation training does not improve saccadic behavior or visual fields. The findings show substantial benefits of compensatory exploration training, including subjective improvements in mastering daily-life activities, in a randomized controlled trial.", "(1) To compare the outcomes of orientation and mobility and driving training with Fresnel prisms and the Gottlieb Visual Field Awareness System for patients with homonymous hemianopsia, and (2) To determine whether the patients continue to use the optical enhancement devices at a 2-year follow-up point.\n Patients with homonymous hemianopsia were provided with a rehabilitation program where they were fitted with prism lenses and trained to use them for navigation and driving. Telephone interviews were used to obtain information about device usage 2 years following the completion of the training program.\n Patients' performance was compared with a test-retest criterion in the visual skills areas of recognition, mobility, peripheral detection, scanning, tracking, and visual memory. Patients with hemianopic loss showed improvements in all of the visual skills categories, ranging from the highest improvements of 26% of tasks improved in the mobility category to 13% in the recognition category. The majority of the hemianopic patients reported using the devices at the 2-year follow-up interview.\n The patients with homonymous hemianopsia showed improvements in visual functioning using prism lenses, although these improvements were smaller than those found in previous studies with central or bilateral peripheral vision loss groups who were trained to use other optical enhancement devices for navigation and driving using a similar curriculum. However, given the evidence of increased risk of accidents for patients with peripheral vision loss, the safety of peripheral enhancement devices for driving must be thoroughly evaluated before their impact on public safety is known.", "This study assessed the effect of a wheeled walking aid on disability, oxygenation, and breathlessness in patients with severe disability secondary to chronic irreversible airflow limitation.\n Eleven subjects with chronic irreversible airflow limitation, mean forced expired volume in 1 second (FEV1) 0.71 L +/- .33 L, were studied. Subjects performed four 6-minute walk tests, two on each of two study days, twice unaided and twice with the assistance of a wheeled walking aid. A randomized cross-over design was used. All subjects were oriented to 6-minute walk tests, use of bronchodilators was controlled, and standard encouragement was given during each walk test. Outcome measures were the distance walked in 6 minutes, change in oxyhemoglobin saturation during the walk, and breathlessness using a modified Borg Scale.\n The use of a wheeled walker resulted in a significant increase in 6-minute walking distance, a significant reduction in hypoxemia with walking and a significant reduction in breathlessness during the walk test.\n The use of a wheeled walker resulted in significant decreases in disability, hypoxemia, and breathlessness during a 6-minute walk test. By reducing disability and breathlessness, a wheeled walker may improve quality of life in individuals with severe impairment in lung function.", "Mobile populations are vulnerable to contracting HIV. The present study aims to evaluate the relative efficacy of the voluntary counseling and testing plus information dissemination (VCT-ID) approach versus the information dissemination (ID) approach for promoting HIV preventive behaviors in a mobile population, cross-border truck drivers. A total of 301 adult male cross-border truck drivers who self-reported having had sex with female sex workers (FSW) or non-regular sex partners (NRPs) in mainland China in the last 12 months were recruited and randomized into the VCT-ID intervention group (Group I) or ID control group (Group C). Anonymous structured questionnaires, administered through a computer-assisted method, were used to collect data. At the follow-up survey (about 8-9 weeks since the baseline survey), Group I participants, as compared to Group C participants, were more likely to be consistent condom users when having sex with FSW (85.5% versus 68.5%, p<0.05) and with NRP (54.8% versus 36.4%, p<0.1), more knowledgeable about HIV, and were less likely to have contracted sexually transmitted diseases (STD) in the last two months. The VCT-ID approach is shown to be more efficacious than the ID approach in promoting safer sex and HIV-related knowledge among local cross-border truck drivers. Feasibility of providing voluntary counseling and testing (VCT) services at locations which are convenient to the target population is demonstrated. It also shows that VCT services can be used as a means of HIV prevention. The findings of this study resulted in up-scaled VCT services for the local target population.", "and objective. Unilateral spatial neglect (USN) can interfere with rehabilitation processes and lead to poor functional outcome. The purpose of this study was to determine whether prism adaptation (PA) therapy improves USN and functional outcomes in stroke patients in the subacute stage.\n . A multicenter, double-masked, randomized, controlled trial was conducted to evaluate the effects of a 2-week PA therapy on USN assessed with the Behavioral Inattention Test (BIT), the Catherine Bergego Scale (CBS), and activities of daily living (ADL) as evaluated with the Functional Independence Measure (FIM). A total of 38 USN patients with right-brain damage were divided into prism (n = 20) and control (n = 18) groups. Patients were divided into mild and severe USN groups according to BIT behavioral test (mild ≥ 55 and severe<55). The prism group performed repetitive pointing with prism glasses that induce rightward optical shift twice daily, 5 days per week, for 2 weeks, whereas the control group performed similar pointing training with neutral glasses.\n . The FIM improved significantly more in the prism group. In mild USN patients, there was significantly greater improvement of BIT and FIM in the prism group.\n . PA therapy can significantly improve ADL in patients with subacute stroke." ]

[ "16084925", "18237352", "15823886", "11242721", "15113492", "18838727", "15249520", "22032247", "16602835" ]

[ "Can a facilitated programme promote effective multidisciplinary audit in secondary care teams? An exploratory trial.", "Strategies for improving the quality of health care in maternal and child health in low- and middle-income countries: an overview of systematic reviews.", "Interdisciplinary collaboration between primary care, social insurance and social services in the rehabilitation of people with musculoskeletal disorder: effects on self-rated health and physical performance.", "Comparison of an enhanced versus a written feedback model on the management of Medicare inpatients with venous thrombosis.", "Exploratory cluster randomised controlled trial of shared care development for long-term mental illness.", "The effect of a quality improvement collaborative to improve antimicrobial prophylaxis in surgical patients: a randomized trial.", "Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.", "Implementing collaborative care for depression treatment in primary care: a cluster randomized evaluation of a quality improvement practice redesign.", "Participatory supervision model: building health promotion capacity among health officers and the community." ]

[ "This 24-month exploratory study evaluated whether a 6-month programme supported by a trained external facilitator was feasible, acceptable and led to the adoption of a multidisciplinary approach to audit by secondary care staff. Undertaken in five acute hospital sites in the East Midlands UK, 22 multidisciplinary teams were randomised to either an intervention or control arm. Employing mixed methods, a range of outcomes, including collaborative behaviour, was measured. The intervention was feasible and acceptable to staff. Involvement in the facilitated programme had a positive impact on self-reported knowledge (P=0.000 post-intervention and at 4-months follow-up), skills (P=0.000 post-intervention and P=0.02 at 4-months follow-up) and attitudes (P<0.01 post-intervention), appeared to have some influence on improving self-reported (P<0.05 post-intervention) and observed collaborative behaviour (P=0.01) and led to better quality audit resulting in measurable improvements to care. Improved collaborative behaviour may have resulted from an increase in assertive behaviour by nurses. Research to test approaches to support teams to work effectively together is currently hampered by a lack of suitable research instruments and needs addressing before main (phase 111) trials are undertaken.", "There are many systematic reviews of continuing education programmes and educational strategies for quality improvement in health care. Most of the reviewed studies are one-off evaluations rather than impact evaluations with long-term follow-up. There are few systematic reviews of organisational, financial and regulatory interventions, and few high-quality studies. These interventions are probably as or more important than educational strategies, although they are less well evaluated. Few studies have been undertaken in low- and middle-income countries (LMIC) or that address maternal and child health (MCH). Thus, the results of the available studies and reviews need to be interpreted cautiously when applied to LMIC. Interactive workshops, reminders and multifaceted interventions can improve professional practice, and they generally have moderate effects. Educational outreach visits consistently improve prescribing but have variable effects on other behaviours. Audit and feedback interventions have variable effects on professional practice, but most often these are small to moderate effects. Mass-media and patient-mediated interventions may change professional practice. Multifaceted interventions that combine several quality-improvement strategies are also effective but may not be more so than single interventions. While all of these strategies are applicable to MCH in LMIC, the applicability of the results to rural settings, in particular, may be limited. Use of these strategies could exacerbate inequalities, and this should be taken into consideration when planning implementation. Scaling up and sustainability may be difficult to achieve in LMIC contexts and need careful consideration. The use of financial interventions has not been well studied; financial incentives and disincentives may be difficult to use effectively and efficiently, although their impact on practice needs to be considered. Organisational interventions are likely to be important, given that there are often underlying organisational or system problems. Regulatory interventions have not been well evaluated, but may sometimes be both inexpensive and effective. There are no 'magic bullets' or simple solutions for ensuring the quality of health care services. Interventions should be selected or tailored to address the underlying reasons for a failure to deliver effective services. Decision-makers should select the most appropriate interventions for specific problems. This requires a governance structure that clearly assigns responsibility for quality-improvement activities, priority setting, selection and design of interventions, and evaluation.", "Previous research shows there can be good results from co-financing between welfare sectors on the perceived quality of interprofessional collaboration. However, little is known about the impact on patient outcome of such schemes. This study aimed to assess whether co-financed teams with personnel from primary care, social insurance and social services have any effect on patients' health status. A comparative study of patients attending health care centres with and without a co-financed collaboration model was carried out. Although research has shown positive results from co-financed collaboration on staff and organization, we could not find that this new interdisciplinary team structure gave a better patient health outcome than conventional care.", "A multistate randomized study conducted under the Health Care Financing Administration's (HCFA's) Health Care Quality Improvement Program (HCQIP) offered the opportunity to compare the effect of a written feedback intervention (WFI) with that of an enhanced feedback intervention (EFI) on improving the anticoagulant management of Medicare beneficiaries who present to the hospital with venous thromboembolic disease.\n Twenty-nine hospitals in five states were randomly assigned to receive written hospital-specific feedback (WFI) of feedback enhanced by the participation of a trained physician, quality improvement tools, and an Anticoagulant Management of Venous Thrombosis (AMVT) project liaison (EFI). Differences in the performance of five quality indicators between baseline and remeasurement were assessed. Quality managers were interviewed to determine perceptions of project implementation.\n No significant differences in the change from baseline to remeasurement were found between the two intervention groups. Significant improvement in one indicator and significant decline in two indicators were found for one or both groups. Yet 59% of all quality managers perceived the AMVT project as being successful to very successful, and more EFI quality managers perceived success than did WFI managers (71% versus 40%). In the majority of EFI hospitals, physician liaisons played an important role in project implementation.\n Study results indicated that the addition of a physician liaison, quality improvement tools, and a project liaison did not provide incremental value to hospital-specific feedback for improving quality of care. Future studies with larger sample sizes, lengthier follow-up periods, and interventions that include more of the elements shown to affect practice behavior change are needed to identify an optimal feedback model for use by external quality management organizations.", "Primary care clinicians have a considerable amount of contact with patients suffering from long-term mental illness. The United Kingdom's National Health Service now requires general practices to contribute more systematically to care for this group of patients.\n To determine the effects of Mental Health Link, a facilitation-based quality improvement programme designed to improve communication between the teams and systems of care within general practice. Design of study: Exploratory cluster randomised controlled trial.\n Twenty-three urban general practices and associated community mental health teams.\n Practices were randomised to service development as usual or to the Mental Health Link programme. Questionnaires and an audit of notes assessed 335 patients' satisfaction, unmet need, mental health status, processes of mental and physical care, and general practitioners' satisfaction with services and beliefs about service development. Service use and intervention costs were also measured.\n There were no significant differences in patients' perception of their unmet need, satisfaction or general health. Intervention patients had fewer psychiatric relapses than control patients (mean = 0.39 versus 0.71, respectively, P = 0.02) but there were no differences in documented processes of care. Intervention practitioners were more satisfied and services improved significantly for intervention practices. There was an additional mean direct cost of pound 63 per patient with long-term mental illness for the intervention compared with the control.\n Significant differences were seen in relapse rates and practitioner satisfaction. Improvements in service development did not translate into documented improvements in care. This could be explained by the intervention working via the improvements in informal shared care developed through better link working. This type of facilitated intervention tailored to context has the potential to improve care and interface working.", "Quality improvement collaboratives are used to improve health care quality, but their efficacy remains controversial.\n To assess the effects of a quality improvement collaborative on preoperative antimicrobial prophylaxis.\n Longitudinal cluster randomized trial, with the quality improvement collaborative as the intervention.\n United States.\n 44 acute care hospitals, each of which randomly sampled approximately 100 selected surgical cases (cardiac, hip or knee replacement, and hysterectomy) at both the baseline and remeasurement phases.\n All hospitals received a comparative feedback report. Hospitals randomly assigned to the intervention group (n = 22) participated in a quality improvement collaborative comprising 2 in-person meetings led by experts, monthly teleconferences, and receipt of supplemental materials over 9 months.\n Change in the proportion of patients receiving at least 1 antibiotic dose within 60 minutes of surgery (primary outcome) and change in the proportions of patients given any antibiotics, given antibiotics for 24 hours or less, given an appropriate drug, and given a single preoperative dose and receipt of any of the 5 measures (secondary outcome).\n The groups did not differ in the change in proportion of patients who received a properly timed antimicrobial prophylaxis dose (-3.8 percentage points [95% CI, -13.9 to 6.2 percentage points]) after adjustment for region, hospital size, and surgery type. Similarly, the groups did not differ in individual measures of antibiotic duration; use of appropriate drug; receipt of a single preoperative dose; or an all-or-none measure combining timing, duration, and selection.\n Hospitals volunteered for the effort, thereby resulting in selection for participants who were motivated to change. Implementation of the surgical infection prevention measure reporting requirements by the Centers for Medicare & Medicaid Services and The Joint Commission may have motivated improvement in prophylaxis performance.\n At a time of heightened national attention toward measures of antimicrobial prophylaxis performance, the trial did not demonstrate a benefit of participation in a quality improvement collaborative over performance feedback for improvement of these measures.", "A consulting method known as 'shared decision making' (SDM) has been described and operationalized in terms of several 'competences'. One of these competences concerns the discussion of the risks and benefits of treatment or care options-'risk communication'. Few data exist on clinicians' ability to acquire skills and implement the competences of SDM or risk communication in consultations with patients.\n The aims of this study were to evaluate the effects of skill development workshops for SDM and the use of risk communication aids on the process of consultations.\n A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. Half the consultations were randomly selected for audio-taping, of which 352 patients attended and were audio-taped successfully. After baseline, participating doctors were randomized to receive training in (i) SDM skills or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were allocated randomly to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations were audio-taped from each phase. Raters (independent, trained and blinded to study phase) assessed the audio-tapes using a validated scale to assess levels of patient involvement (OPTION: observing patient involvement), and to analyse the nature of risk information discussed. Clinicians completed questionnaires after each consultation, assessing perceived clinician-patient agreement and level of patient involvement in decisions. Multilevel modelling was carried out with the OPTION score as the dependent variable, and rater, consultation and clinician levels of data, standardized by rater within clinician.\n Following each of the interventions, the clinicians significantly increased their involvement of patients in decision making (OPTION score increased by 10.6 following risk communication training [95% confidence interval (CI) 7.9 -13.3; P < 0.001] and by 12.9 after SDM skill development (95% CI 10 -15.8, P < 0.001), a moderate effect size. The level of involvement achieved by the risk communication aids was significantly increased by the subsequent introduction of the skill development workshops (7.7 increase in OPTION score, 95% CI 3.4-12; P < 0.001). The alternative sequence (skills followed by risk communication aids) did not achieve this effect. The use of most risk information formats increased after the provision of specific risk communication aids (P < 0.001). Clinicians using the risk communication tools perceived significantly higher patient and clinician agreement on treatment (P < 0.001), patient satisfaction with information (P < 0.01), clinician satisfaction with decision (P < 0.01) and general overall satisfaction with the consultation (P < 0.001) than those who were exposed to SDM skill development workshops.\n These clinicians were able to acquire the skills to implement SDM competences and to use risk communication aids. Each intervention provided independent effects. Further progress towards greater patient involvement in health care decision making is possible, and skill development in this area should be incorporated into postgraduate professional development programmes.", "Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness.\n The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM.For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months.\n Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003).\n Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed.\n ClinicalTrials.gov: NCT00105820.", "The Thai traditional health supervision model has been developed since 1991. However, many supervisors lack supervisory knowledge and skills. This study aimed to compare and identify the strengths and challenges of two different supervision models, in order to determine their effects on enhancing the health promotion capacity of health officers in two primary care units (PCU) in Chiang Mai Province, northern Thailand.\n The two models were implemented at two PCU in one semi-district, Chiang Mai Province, over a six-month period. The first model involved supervisors from the district level, with the full participation of health officers at the sub-district level. The second model was designed with the addition of community involvement in the supervision process. Before implementing the models, the district supervisors attended a retraining course to enhance their supervisory knowledge and ability. Questionnaires were used to assess health officers' job satisfaction, clients' perceived service quality and care satisfaction. Semi-structured interviews and qualitative observations were used to explore the involvement of health officers and the community, and to determine the strengths and challenges of each supervisory model.\n Both before and after the intervention, the PCU health officers appeared to have good and comparable job satisfaction levels. Bivariate analysis indicated that after the intervention, both supervisory models appeared effective in terms of clients' perceived service quality and satisfaction with care, among those who utilized the PCU. However, the second model, which allowed the community to participate in the supervision process, achieved better results. The qualitative findings suggested that the involvement of health officers caused a rapid change and improvement after the supervision. The involvement of the community helped the community itself to identify problems and formulate alternatives to meet the community's needs.\n This study shows positive outcomes for two forms of participatory supervision in a rural setting. There appear to be additional positive outcomes for the model that involved community participation. To ensure successful implementation, several issues, such as the supervisor's knowledge and ability, health officer workload and supervisory communication skills, need to be improved." ]

[ "20233384", "15294856", "18450604", "1751431", "6988006", "17156466", "1303639", "9572206", "11097068" ]

[ "Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions.", "Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery.", "A behavioral intervention to improve obstetrical care.", "Randomized controlled trial of antenatal social support to prevent preterm birth.", "The influence of betamethasone and orciprenaline on the incidence of respiratory distress syndrome in the newborn after preterm labour.", "Aiming to increase birth weight: a randomised trial of pre-pregnancy information, advice and counselling in inner-urban Melbourne.", "A randomized trial of psychosocial support during high-risk pregnancies. The Latin American Network for Perinatal and Reproductive Research.", "A randomized trial of nurse intervention to reduce preterm and low birth weight births.", "Pragmatic randomized trial of antenatal intervention to prevent post-natal depression by reducing psychosocial risk factors." ]

[ "Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).\n Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.\n Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs: Two interventions prevent preterm births--smoking cessation and progesterone. Eight interventions prevent stillbirths--balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery. Eleven interventions improve survival of preterm newborns--prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome\n The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions.", "To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women.\n Multicentre, prospective, randomised controlled trial.\n Non-hospital based antenatal clinics.\n 4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers.\n The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage.\n Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and <or= 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group.\n Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women.", "Implementation of evidence-based obstetrical practices remains a significant challenge. Effective strategies to disseminate and implement such practices are needed.\n We randomly assigned 19 hospitals in Argentina and Uruguay to receive a multifaceted behavioral intervention (including selection of opinion leaders, interactive workshops, training of manual skills, one-on-one academic detailing visits with hospital birth attendants, reminders, and feedback) to develop and implement guidelines for the use of episiotomy and management of the third stage of labor or to receive no intervention. The primary outcomes were the rates of prophylactic use of oxytocin during the third stage of labor and of episiotomy. The main secondary outcomes were postpartum hemorrhage and birth attendants' readiness to change their behavior with regard to episiotomies and management of the third stage of labor. The outcomes were measured at baseline, at the end of the 18-month intervention, and 12 months after the end of the intervention.\n The rate of use of prophylactic oxytocin increased from 2.1% at baseline to 83.6% after the end of the intervention at hospitals that received the intervention and from 2.6% to 12.3% at control hospitals (P=0.01 for the difference in changes). The rate of use of episiotomy decreased from 41.1% to 29.9% at hospitals receiving the intervention but remained stable at control hospitals, with preintervention and postintervention values of 43.5% and 44.5%, respectively (P<0.001 for the difference in changes). The intervention was also associated with reductions in the rate of postpartum hemorrhage of 500 ml or more (relative rate reduction, 45%; 95% confidence interval [CI], 9 to 71) and of 1000 ml or more (relative rate reduction, 70%; 95% CI, 16 to 78). Birth attendants' readiness to change also increased in the hospitals receiving the intervention. The effects on the use of episiotomy and prophylactic oxytocin were sustained 12 months after the end of the intervention.\n A multifaceted behavioral intervention increased the prophylactic use of oxytocin during the third stage of labor and reduced the use of episiotomy. (ClinicalTrials.gov number, NCT00070720 [ClinicalTrials.gov]; Current Controlled Trials number, ISRCTN82417627 [controlled-trials.com].).\n Copyright 2008 Massachusetts Medical Society.", "To test the effect of a programme of additional antenatal social support on the occurrence of preterm birth (a birth from 20 to 36 weeks gestation) in women at risk of preterm birth.\n A prospective randomized controlled trial. The design was one of randomization before consent for a new treatment.\n Three public hospital antenatal clinics in Perth and the offices of 87 obstetricians and general practitioners in Western Australia.\n 1970 pregnant women with poor obstetric histories entered the trial; 983 of these were randomly allocated to the programme group and 987 to the control group.\n Normal antenatal care was provided for both groups. In addition, members of the programme group were offered an intervention aimed at providing expressive (emotional) social support, consisting of antenatal home visits and telephone calls by midwives. Of the women allocated to the programme group, 24 refused consent and 69 were not traced before completion of their pregnancies, the remaining 890 women (90.5%) agreed to enter the programme, and each received at least one intervention.\n Gestational age at completion of the pregnancy. A pregnancy ending before 20 weeks was labelled a miscarriage.\n There were 126/981 (12.8%) preterm births in the programme group and 147/986 (14.9%) in the control group. The outcome data for two women in the programme group and one in the control group could not be found. The unadjusted odds ratio for preterm birth in the programme was 0.84 (95% CI 0.65-1.09). The observed relative reduction in preterm births associated with the programme was 13.8% (95% CI -8.2% to +31.5%) and the trial had a 60% power to exclude a true relative reduction of 25%.\n The results of this trial and those of other controlled clinical trials provide little evidence for the effectiveness of social support interventions in the prevention of preterm birth in women with poor obstetric histories.", "In a randomized double-blind trial on antenatal corticosteroid treatment for the prevention of respiratory distress syndrome (RDS) a corticosteroid related beneficial effect was found. Possibly of more significance was the finding that the children born within 12 hours of their mother's admission to hospital showed a higher incidence of RDS than those born between 12 hours and one week after admission even in the placebo and untreated groups. Bèta-adrenergic drugs seemed to exert no other influence on the occurrence of RDS than can be explained by the delay of delivery. Prolonged ruptured membranes appeared to decrease the incidence of RDS to the same extent as other symptoms of threatened preterm labour.", "In the 1980s there was substantial interest in early pregnancy and pre-pregnancy interventions to increase birth weight and reduce preterm birth. We developed an inter-pregnancy intervention, implemented in a randomised controlled trial, to be provided by midwives at home soon after women's first birth.\n MCH nurses invited women to take part during their home visit to new mothers. Women's contact details, with their permission, were passed to the study midwife. She had a randomisation schedule to which women's names were added before she met the women or their partners. All women recruited had a home visit from the study midwife with a discussion of their first pregnancy, labour and birth and the postpartum experience. Women in the intervention arm received in addition a pre-pregnancy intervention with discussion of social, health or lifestyle problems, preparation and timing for pregnancy, family history, rubella immunisation, referrals for health problems, and a reminder card. The primary outcome was defined as a birth weight difference in the second birth of 100 g (one-sided) in favour of the intervention. Additional data collected were gestational age, perinatal deaths and birth defects. Analyses used EPI-INFO and STATA.\n Intervention and comparison groups were comparable on socioeconomic factors, prior reproductive history and first birth outcomes. Infant birth weight in the second birth was lower (-97.4 g,)) among infants in the intervention arm. There were no significant differences between intervention and comparison arms in the proportion of women having a preterm birth, an infant with low birthweight, or an infant with a birth weight <10th percentile. There were more adverse outcomes in the intervention arm: ten births <32 weeks), compared with one in standard care, and more infants with a birth weight <2000 g, 16 compared with two in standard care\n As the primary outcome was envisaged to be either improved birth weight or no effect, the study was not designed to identify the alternative outcome with confidence. Despite widespread support for pre-pregnancy interventions to improve maternal and perinatal health, this first randomised controlled trial of a multi-component intervention provided at home, did not have a beneficial outcome.", "It is often suggested that psychological and social support and health education for women at high risk for delivering a low-birth-weight infant can improve the outcomes of pregnancy, but the evidence is inconclusive. We undertook this prospective trial to evaluate a program of home visits designed to provide psychosocial support during pregnancy.\n At four centers in Latin America, 2235 women at higher-than-average risk for delivering a low-birth-weight infant were recruited before the 20th week of pregnancy. The women were randomly assigned either to an intervention group (n = 1115) that received four to six home visits from a nurse or social worker in addition to routine prenatal care or to a control group (n = 1120) that received only routine prenatal care (with a mean of eight prenatal visits). The principal measures of outcome were low birth weight (< 2500 g), preterm delivery (< 37 weeks of gestation), and specified categories of maternal and neonatal morbidity.\n The women who received the home visits as well as routine prenatal care had outcomes that differed little from those of the women who received only routine care. The risks of low birth weight (odds ratio for the intervention group as compared with the control group, 0.93; 95 percent confidence interval, 0.68 to 1.28), preterm delivery (odds ratio, 0.88; 95 percent confidence interval, 0.67 to 1.16), and intrauterine growth retardation (odds ratio, 1.08; 95 percent confidence interval, 0.83 to 1.40) were similar in the two groups. There was no evidence that the intervention had any significant effect on the type of delivery, the length of hospital stay, perinatal mortality, or neonatal morbidity in the first 40 days. There was no protective effect of the psychosocial-support program even among the mothers at highest risk.\n Interventions designed to provide psychosocial support and health education during high-risk pregnancies are unlikely to improve maternal health or to reduce the incidence of low birth weight among infants.", "To test the effect of telephone calls from registered nurses to low-income pregnant women on the rates of low birth weight (LBW) and preterm births.\n A total of 1554 women receiving prenatal care in a public clinic who met study criteria and who consented were assigned randomly to intervention and control groups. Women in the intervention group received telephone calls from a registered nurse, one or two times weekly from 24 weeks' through 37 weeks' gestation. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated.\n Low birth weight rates were 10.9% in the intervention group and 14.0% in the control group (RR 0.75; 95% CI 0.55, 1.03; P = .072). For gestational age less than 37 weeks, rates were 9.7 in the intervention group and 11.0 in the control group (RR .87; 95% CI 0.62, 1.22; P = .415). In the subgroup of low-income black women 19 years of age and older, a statistically significant difference was found in preterm birth rates before 37 weeks (8.7% in the intervention group versus 15.4% in the controls [RR 0.56; 95% CI 0.38, 0.84; P = .004]).\n There was no difference in LBW or preterm births between intervention and control groups in the total sample. In a secondary analysis of black subjects 19 years of age and older, there was a significant difference in preterm birth rates.", "Social support theory and observational risk factor studies suggest that increased antenatal psychosocial support could prevent post-natal depression. We used empirical knowledge of risk and protective factors for post-natal depression not employed previously in order to develop and evaluate an antenatal preventive intervention.\n We conducted a pragmatic randomized controlled trial in antenatal clinics. We screened 1300 primiparous women and 400 screened positive, 69 screen-positive women were untraceable or not eligible. Of 292 women who completed baseline assessment, 209 consented to randomization, of these 190 provided outcome data 3 months post-natally. 'Preparing for Parenthood', a structured antenatal risk factor reducing intervention designed to increase social support and problem-solving skills, was compared with routine antenatal care only. We compared the percentage depressed at 3 months after childbirth using the self-completion General Health Questionnaire Depression scale and Edinburgh Post-natal Depression Scale (EPDS), and the Schedules for Clinical Assessment in Neuropsychiatry a systematic clinical interview.\n Assignment to the intervention group did not significantly impact on post-natal depression (odds ratio for GHQ-Depression 1.22 (95% CI 0.63-2.39), P = 0.55) or on risk factors for depression. Forty-five per cent of the intervention group women attended sufficient sessions to be likely to benefit from intervention if effective. Attenders benefited no more than non-attenders.\n Prevention services targeting post-natal depression should not implement antenatal support programmes on these lines until further research has demonstrated the feasibility and effectiveness of such methods. The development of novel, low cost interventions effective in reducing risk factors should be completed before further trial evaluation." ]

[ "15684225", "12411847", "14718327", "9168368", "7893564", "15800328", "17267931", "7532501", "19050085" ]

[ "Association between hydration volume and symptoms in terminally ill cancer patients with abdominal malignancies.", "Hypodermoclysis for control of dehydration in terminal-stage cancer.", "The comprehensive care team: a controlled trial of outpatient palliative medicine consultation.", "A double-blind randomized trial comparing outpatient parenteral nutrition with intravenous hydration: effect on resumption of oral intake after marrow transplantation.", "The effect of intravenous fluid infusion on blood and urine parameters of hydration and on state of consciousness in terminal cancer patients.", "Effects of parenteral hydration in terminally ill cancer patients: a preliminary study.", "Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomised trial.", "Evaluation of a palliative care service: problems and pitfalls.", "Fluid resuscitation in the management of early septic shock (FINESS): a randomized controlled feasibility trial." ]

[ "To explore the association between hydration volume and symptoms during the last 3 weeks of life in terminally ill cancer patients.\n This was a multicenter, prospective, observational study of 226 consecutive terminally ill patients with abdominal malignancies. Primary responsible physicians and nurses evaluated the severity of membranous dehydration (dehydration score calculated from three physical findings), peripheral edema (edema score calculated from seven physical findings), ascites and pleural effusion (rated as physically undetectable to symptomatic), bronchial secretion, hyperactive delirium (Memorial Delirium Assessment Scale), communication capacity (Communication Capacity Scale), agitation (Agitation Distress Scale), myoclonus and bedsores.\n Patients were classified into two groups: the hydration group (n=59) who received 1 l or more of artificial hydration per day, 1 and 3 weeks before death, and the non-hydration group (n=167). The percentage of patients with deterioration in dehydration score in the final 3 weeks was significantly higher in the non-hydration group than the hydration group (35% versus 14%; P=0.002), while the percentages of patients whose symptom scores for edema, ascites and pleural effusion increased were significantly higher in the hydration group than the non-hydration group (44% versus 29%, P=0.039; 29% versus 8.4%, P <0.001; 15% versus 5.4%, P=0.016; respectively). After controlling for multiple covariates and treatment settings, the association between hydration group and dehydration/ascites score was statistically significant. Subgroup analysis of patients with peritoneal metastases identified statistically significant interaction between hydration group and dehydration/pleural effusion score. There were no significant differences in the degree of bronchial secretion, hyperactive delirium, communication capacity, agitation, myoclonus or bedsores.\n Artificial hydration therapy could alleviate membranous dehydration signs, but could worsen peripheral edema, ascites and pleural effusions. It is suggested that the potential benefits of artificial hydration therapy should be balanced with the risk of worsening fluid retention symptoms. Further clinical studies are strongly needed to identify the effects of artificial hydration therapy on overall patient well-being, and an individualized treatment and close monitoring of dehydration and fluid retention symptoms is strongly recommended.", "Many of those involved in palliative care have justifiable objections to the introduction of intravenous hydration in patients with dehydration-associated symptoms and advanced cancer. Researchers from the University of Buenos Aires carried out a randomized, comparative and prospective trail to determine the usefulness of hypodermoclysis in the control of thirst, chronic nausea and delirium. Forty-two patients were randomized into two groups. Both groups received drugs subcutaneously (haloperidol 2.5 mg every 4 hours to control delirium and/or metoclopramide 10 mg every 4 hours to control chronic nausea). The study group also received 1000 ml 5% dextrose in water infusion plus 140 milliequivalent per litre (mEq/L) sodium chloride, at a rate of 42 ml/hour per day. Both groups showed significant and equal improvements in relief of thirst and chronic nausea at 24 hours. After 48 hours, this improvement was maintained in the group that received hydration, but only for the relief of chronic nausea. Delirium did not improve significantly in either group during the 48-hour trial period. Current data suggest that decisions on rehydration of patients with terminal-phase cancer should be based more on the patient's comfort than on providing optimal hydration.", "Little is known about the use of palliative care for outpatients who continue to pursue treatment of their underlying disease or whether outpatient palliative medicine consultation teams improve clinical outcomes.\n We conducted a year-long controlled trial involving 50 intervention patients and 40 control patients in a general medicine outpatient clinic. Primary care physicians referred patients with advanced congestive heart failure, chronic obstructive pulmonary disease, or cancer who had a prognosis ranging from 1 to 5 years. In the intervention group, the primary care physicians received multiple palliative care team consultations, and patients received advance care planning, psychosocial support, and family caregiver training. Clinical and health care utilization outcomes were assessed at 6 and 12 months.\n Groups were similar at baseline. Similar numbers of patients died during the study year (P =.63). After the intervention, intervention group patients had less dyspnea (P =.01) and anxiety (P =.05) and improved sleep quality (P =.05) and spiritual well-being (P =.007), but no change in pain (P =.41), depression (P =.28), quality of life (P =.43), or satisfaction with care (P =.26). Few patients received recommended analgesic or antidepressant medications. Intervention patients had decreased primary care (P =.03) and urgent care visits (P =.04) without an increase in emergency department visits, specialty clinic visits, hospitalizations, or number of days in the hospital. There were no differences in charges (P =.80).\n Consultation by a palliative medicine team led to improved patient outcomes in dyspnea, anxiety, and spiritual well-being, but failed to improve pain or depression. Palliative care for seriously ill outpatients can be effective, but barriers to implementation must be explored.", "Outpatient parenteral nutrition (PN) is often given to marrow transplant recipients after high-dose chemoradiotherapy until the resumption of adequate oral intake; however, it may adversely prolong resumption or oral calorie intake by contributing to early satiety.\n A double-blind, randomized study compared standard PN (final concentration 25% dextrose, 5% amino acids) with a hydration solution (5% dextrose) during the first 28 days of outpatient treatment. Patients were eligible for the study if they were > or = 2 years of age, < 65 days posttransplant, had < 70% oral caloric intake at hospital discharge, and required < or = 10 U insulin/L PN. Solutions were provided until the patient's oral intake met > or = 85% caloric requirements for 3 consecutive days.\n Two hundred fifty-eight marrow transplant recipients (128, PN and 130, hydration solution) were studied. Age, donor type, and diagnoses were similar in the two groups. Time to resumption of > or = 85% oral caloric intake was 6 days sooner in the hydration group than in the PN group (median 10 vs 16 days, respectively; p = .049). When adjusting for sex, age, donor type, total body irradiation, previous oral intake, acute graft-versus-host disease, and prednisone therapy, the hydration group resumed oral intake sooner than the PN group (relative risk = 1.51; 95% confidence interval [CI] 1.04 to 2.19; p = .029). The percentage of weight change from pretransplant values, adjusted for the above covariates and the number of weeks of treatment, indicated that the hydration solution group lost weight (4.63%) compared with the PN group (1.27%) after 4 weeks of therapy (p = .004). Rates of hospital readmissions, relapse of malignancy, and survival did not differ between the two treatment groups.\n We conclude that outpatient PN delays resumption of oral intake and that its replacement with hydration solution does not result in adverse patient outcome.", "This prospective study was undertaken to assess the state of hydration in terminal cancer patients with and without intravenous fluids during the last 48 hours of their lives and to correlate various measures of hydration with their state of consciousness. We examined indicators of hydration in the plasma and urine of 68 consecutive patients for whom data were available at 48 hours or less before death. Thirteen of the patients were being treated with intravenous (IV) fluids. Nearly all of the patients studied were found to be dehydrated, as determined by laboratory measurements. State of consciousness correlated inversely with serum sodium (p < 0.001) and urine osmolality (p < 0.02). Patients receiving intravenous fluids were not better hydrated than those without IV therapy, nor was their state of consciousness improved. In light of these findings, which suggest there is no clinical benefit from intravenous infusions, decisions regarding intravenous fluid therapy during the last hours of life should be guided by the preferences of the dying patient and his family.", "Most patients with cancer develop decreased oral intake and dehydration before death. This study aimed to determine the effect of parenteral hydration on overall symptom control in terminally ill cancer patients with dehydration.\n Patients with clinical evidence of mild to moderate dehydration and a liquid oral intake less than 1,000 mL/day were randomly assigned to receive either parenteral hydration with 1,000 mL (treatment group) or placebo with 100 mL normal saline administered over 4 hours for 2 days. Patients were evaluated for target symptoms (hallucinations, myoclonus, fatigue, and sedation), global well-being, and overall benefit.\n Twenty-seven patients randomly assigned to the treatment group had improvement in 53 (73%) of their 73 target symptoms versus 33 (49%) of 67 target symptoms in the placebo group (n=22; P = .005). Fifteen (83%) of 18 and 15 (83%) of 18 patients had improved myoclonus and sedation after hydration versus eight (47%) of 17 and five (33%) of 15 patients after placebo (P = .035 and P = .005, respectively). There were no significant differences of improvement in hallucinations or fatigue between groups. When blinded to treatment, patients (17 [63%] of 77) and investigators (20 [74%] of 27) perceived hydration as effective compared with placebo in nine (41%) of 22 patients (P = .78) and 12 (54%) of 22 investigators (P = .15), respectively. The intensity of pain and swelling at the injection site were not significantly different between groups.\n Parenteral hydration decreased symptoms of dehydration in terminally ill cancer patients who had decreased fluid intake. Hydration was well tolerated, and a placebo effect was observed. Studies with larger samples and a longer follow-up period are justified.", "Caring for relatives with advanced cancer may cause psychological and physical ill health.\n To evaluate the effectiveness of increased support for distressed, informal carers of patients receiving palliative care.\n The sample was composed of 271 informal carers who scored over 5 on the 28-item General Health Questionnaire (GHQ-28). The intervention comprised six weekly visits by a trained advisor. Primary outcome was carer distress (GHQ-28) at 4-week, 9-week and 12-week follow-up. Secondary outcomes were carer strain and quality of life, satisfaction with care, and bereavement outcome.\n Scores on the GHQ-28 fell below the threshold of 5/6 in a third of participants in each trial arm at any follow-up point. Mean scores in the intervention group were lower at all time points but these differences were not significant. No difference was observed in secondary outcomes. Carers receiving the intervention reported qualitative benefit.\n The intervention might have been too brief, and ongoing help might have had accruing benefits. Alternatively, informal carers of patients with cancer may already receive considerable input and the advisor's help gave little additional advantage; or caring for a dying relative is extremely stressful and no amount of support is going to make it much better.", "To evaluate a palliative care home support team based on an inpatient unit.\n Randomised controlled trial with waiting list. Patients in the study group received the service immediately, those in the control group received it after one month. Main comparison point was at one month.\n A city of 300,000 people with a publicly funded home care service and about 200 general practitioners, most of whom provide home care.\n Pain and nausea levels were measured at entry to trial and at one month, as were quality of life for patients and care givers' health.\n Because of early deaths, problems with recruitment, and a low compliance rate for completion of questionnaires, the required sample size was not attained.\n In designing evaluations of palliative care services, investigators should be prepared to deal with the following issues: attrition due to early death, opposition to randomisation by patients and referral sources, ethical problems raised by randomisation of dying patients, the appropriate timing of comparison points, and difficulties of collecting data from sick or exhausted patients and care givers. Investigators may choose to evaluate a service from various perspectives using different methods: controlled trials, qualitative studies, surveys, and audits. Randomised trials may prove to be impracticable for evaluation of palliative care.", "It is unknown whether fluid resuscitation with colloid or crystalloid in patients with severe sepsis or septic shock is associated with an improvement in clinical outcome. This randomized controlled trial determined the feasibility of conducting a large trial testing resuscitation with pentastarch vs normal saline in early septic shock, powered for a difference in mortality.\n At three Canadian and one New Zealand academic centre, 40 patients with early septic shock defined by at least two systemic inflammatory response syndrome criteria, infectious source, and persistent hypotension after >or= 1 L of crystalloid fluid were recruited. Feasibility measures were patient recruitment, blinding of the study fluids, and acceptability of the goal directed algorithms. Boluses of blinded normal saline or pentastarch (500 mL - maximum 3 L or 28 mL x kg(-1)) were administered within goal directed care for the first 12 hr.\n Of 161 patients screened, 121 were excluded and 40 patients were enrolled, for a recruitment rate of 0.75 patients/site/month. Only 57% of physicians and 54% of nurses correctly guessed the study fluid (P = 0.46 and P = 0.67, respectively). The goal directed algorithms were acceptable to 97% of physicians.\n The ability to recruit patients in this pilot randomized controlled trial was below expectations. Blinding of study fluids was adequate, and resuscitation algorithms were acceptable to most physicians. Methods to improve recruitment are required to enhance the feasibility of conducting a multicentre fluid resuscitation trial in early septic shock." ]

[ "12444816", "9809861", "19907043", "17984403", "17683328", "17382827", "14643092", "10676820", "15364042" ]

[ "Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study.", "A multicentre double-blind comparison of hydroxyzine, buspirone and placebo in patients with generalized anxiety disorder.", "Outcome reporting in industry-sponsored trials of gabapentin for off-label use.", "A randomized controlled trial of fluoxetine and cognitive behavioral therapy in adolescents with major depression, behavior problems, and substance use disorders.", "Comparison of two different dosages of hydroxyzine for sedation in the paediatric dental patient.", "The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial.", "Lamotrigine in treatment-resistant schizophrenia: a randomized placebo-controlled crossover trial.", "Efficacy and safety of lesopitron in outpatients with generalized anxiety disorder.", "Placebo-controlled trial of lamotrigine added to conventional and atypical antipsychotics in schizophrenia." ]

[ "The prevalence of generalized anxiety disorder (GAD) represents an important public health issue. Hydroxyzine, an antagonist of histamine receptors, showed both efficacy and safety in previous short-term double-blind studies over placebo in this pathology. The aim of the current study was to confirm those positive results over a 3-month period in adult outpatients.\n This multicenter, parallel (hydroxyzine [50 mg/day]; bromazepam [6 mg/day]), randomized, double-blind, placebo-controlled trial included 2 weeks of single-blind run-in placebo, 12 weeks of double-blind randomized treatment, and 4 weeks of single-blind run-out placebo. Three hundred thirty-four of 369 selected outpatients with a diagnosis of GAD according to DSM-IV criteria and a Hamilton Rating Scale for Anxiety (HAM-A) total score >/= 20 were randomized before entering the double-blind period. The primary outcome criterion was the change in the HAM-A score from baseline to 12 weeks of double-blind treatment with hydroxyzine compared with placebo.\n In the intent-to-treat analysis, the mean +/- SD change in HAM-A scores from baseline to endpoint was -12.16 +/- 7.74 for hydroxyzine and -9.64 +/- 7.74 for placebo (p =.019). Results at endpoint for percentage of responders (p =.003) and remission rates (p =.028), Clinical Global Impressions-Severity scale score (p =.001), maintenance of efficacy (p =.022), and Hospital Anxiety and Depression scale score on day 84 (p =.008) also confirmed the efficacy of hydroxyzine over placebo. The study showed no statistically significant difference between hydroxyzine and bromazepam. Except for drowsiness, which was more frequent with bromazepam, safety results were comparable in the 3 groups.\n Hydroxyzine showed both efficacy and safety in the treatment of GAD and appears to be an effective alternative treatment to benzodiazepine prescription.", "The efficacy of hydroxyzine and buspirone, controlled by placebo, was investigated in a double-blind, parallel group, multicentre study conducted in France and the UK. A total of 244 patients with generalised anxiety disorder in primary care was allocated randomly to treatments with hydroxyzine (12.5 mg morning and mid-day, 25 mg evening), buspirone (5 mg morning and mid-day, 10 mg evening) or placebo (three capsules/day) for 4 weeks, preceded by a 1-week single-blind placebo run-in and followed by 1-week single-blind placebo administration. Rating scales were applied on days -7,0,7,14, 12,28 and 35. Seventy percent of the patients were female, the average age was 41 +/- 11 years, and the mean Hamilton Anxiety Score at day 0 was 26.5 +/- 4.2. Only 31 of the 244 patients dropped out, but equally in the three groups. Intention-to-treat LOCF analyses on the primary variable showed a significant difference only between hydroxyzine and placebo with respect to improvement on the Hamilton Anxiety Scale (10.75 versus 7.23 points, respectively). Secondary variables such as CGI and self-ratings (HAD scale) showed both hydroxyzine and buspirone to be more efficacious than placebo. Thus, hydroxyzine is a useful treatment for GAD.", "There is good evidence of selective outcome reporting in published reports of randomized trials.\n We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports.\n We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. Sources of disagreement included the introduction of a new primary outcome (in the case of 6 trials), failure to distinguish between primary and secondary outcomes (2 trials), relegation of primary outcomes to secondary outcomes (2 trials), and failure to report one or more protocol-defined primary outcomes (5 trials). Trials that presented findings that were not significant (P > or = 0.05) for the protocol-defined primary outcome in the internal documents either were not reported in full or were reported with a changed primary outcome. The primary outcome was changed in the case of 5 of 8 published trials for which statistically significant differences favoring gabapentin were reported. Of the 21 primary outcomes described in the protocols of the published trials, 6 were not reported at all and 4 were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced.\n We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.\n 2009 Massachusetts Medical Society", "To evaluate the effect of fluoxetine hydrochloride vs placebo on major depressive disorder, substance use disorder (SUD), and conduct disorder (CD) in adolescents receiving cognitive behavioral therapy (CBT) for SUD.\n Randomized controlled trial.\n A single-site study conducted between May 2001 and August 2004.\n One hundred twenty-six adolescents aged 13 to 19 years recruited from the community and meeting Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) diagnostic criteria for current major depressive disorder, lifetime CD, and at least 1 nontobacco SUD.\n Sixteen weeks of fluoxetine hydrochloride, 20 mg/d, or placebo, with CBT.\n For depression, Childhood Depression Rating Scale-Revised and Clinical Global Impression Improvement; for SUD, self-reported nontobacco substance use and urine substance use screen results in the past 30 days; and for CD, self-reported symptoms in the past 30 days.\n Fluoxetine combined with CBT had greater efficacy than did placebo and CBT according to changes on the Childhood Depression Rating Scale-Revised (effect size, 0.78) but not on the Clinical Global Impression Improvement treatment response (76% and 67%, respectively; relative risk, 1.08). There was an overall decrease in self-reported substance use (4.31 days; 95% confidence interval, 2.12-6.50) and CD symptoms (relative risk, 1.20; 95% confidence interval, 0.82-1.59), but neither difference between groups was statistically significant. The proportion of substance-free weekly urine screen results was higher in the placebo-CBT group than in the fluoxetine-CBT group (mean difference, 2.10; 95% confidence interval, 0.37-4.15).\n Fluoxetine and CBT had greater efficacy than did placebo and CBT on one but not both depression measures and was not associated with greater decline in self-reported substance use or CD symptoms. The CBT may have contributed to higher-than-expected treatment response and mixed efficacy findings, despite its focus on SUD.", "This study compared the effect of two different dosages of hydroxyzine supported by 50% nitrous oxide inhalation sedation in child patients.\n Thirty uncooperative healthy children with an age range of 31-120 months were included in this study. Patients were randomly assigned into two groups. The patients in group 1 were given 20 mg of hydroxyzine (Atarax) 24 h preoperatively and on the operation day, 3.7 mg/kg hydroxyzine was administered orally. The patients in group 2 received 3.7 mg/kg hydroxyzine orally only on the operation day. All patients also received 50% nitrous oxide inhalation sedation. The child's behaviour was evaluated every 5 min by using Houpt Sedation Rating Scale. The oxygen saturation and heart rates were also followed.\n The mean age of the children in the study was 61.9 months (SD 11.9) for group 1 and 53.7 months (SD 12.8) for group 2. Evaluation of the results showed that there were no significant differences (P < 0.05) between behavioural attitudes and sedation degree of the patients.\n Twenty milligrams of hydroxyzine administered 24 h preoperatively has no significant benefit on sedation of the child.", "Carbamazepine is widely accepted as a drug of first choice for patients with partial onset seizures. Several newer drugs possess efficacy against these seizure types but previous randomised controlled trials have failed to inform a choice between these drugs. We aimed to assess efficacy with regards to longer-term outcomes, quality of life, and health economic outcomes.\n SANAD was an unblinded randomised controlled trial in hospital-based outpatient clinics in the UK. Arm A recruited 1721 patients for whom carbamazepine was deemed to be standard treatment, and they were randomly assigned to receive carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate. Primary outcomes were time to treatment failure, and time to 12-months remission, and assessment was by both intention to treat and per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748.\n For time to treatment failure, lamotrigine was significantly better than carbamazepine (hazard ratio [HR] 0.78 [95% CI 0.63-0.97]), gabapentin (0.65 [0.52-0.80]), and topiramate (0.64 [0.52-0.79]), and had a non-significant advantage compared with oxcarbazepine (1.15 [0.86-1.54]). For time to 12-month remission carbamazepine was significantly better than gabapentin (0.75 [0.63-0.90]), and estimates suggest a non-significant advantage for carbamazepine against lamotrigine (0.91 [0.77-1.09]), topiramate (0.86 [0.72-1.03]), and oxcarbazepine (0.92 [0.73-1.18]). In a per-protocol analysis, at 2 and 4 years the difference (95% CI) in the proportion achieving a 12-month remission (lamotrigine-carbamazepine) is 0 (-8 to 7) and 5 (-3 to 12), suggesting non-inferiority of lamotrigine compared with carbamazepine.\n Lamotrigine is clinically better than carbamazepine, the standard drug treatment, for time to treatment failure outcomes and is therefore a cost-effective alternative for patients diagnosed with partial onset seizures.", "There is no evidence from randomized, controlled trials that demonstrate effectiveness for any pharmacological treatment in clozapine-resistant schizophrenia. Since the introduction of chlorpromazine, all antipsychotics with proven efficacy on positive symptoms have been dopamine antagonists, but recent experimental data suggest that ketamine-induced positive schizophreniform symptoms in healthy subjects can be controlled by a glutamate antagonist lamotrigine. The hypothesis tested was that lamotrigine is more effective than placebo in the treatment of positive schizophrenic symptoms when combined with clozapine.\n Thirty-four hospitalized treatment-resistant patients having chronic schizophrenia participated in a double-blind, placebo-controlled, 14-week, crossover trial where 200 mg/day lamotrigine was gradually added to their ongoing clozapine treatment. Clinical assessments were made by the Positive and Negative Syndrome Scale at the beginning and end of each treatment period.\n In intention-to-treat analysis, lamotrigine treatment was more effective in reducing positive (effect size.7, p =.009) and general psychopathological (effect size.6, p =.030) symptoms, whereas no improvement was observed in negative symptoms.\n These results provide the first evidence from a randomized controlled trial of an effective pharmacological treatment with an anticonvulsant agent in treatment-resistant schizophrenia and indicate that both positive and general psychopathological symptoms in patients with schizophrenia can be controlled by a drug that is not a dopamine antagonist. The results are in line with previous experimental data suggesting that excessive glutamate neurotransmission contributes to the positive symptoms of schizophrenia.", "To compare the relative efficacy and safety of lesopitron 4-80 mg/d versus lorazepam 2-4 mg/d and placebo in a subgroup of patients with anxiety history taken from a larger study of patients with a primary diagnosis of generalized anxiety disorder (GAD).\n Six-week, randomized, double-blind, parallel, placebo and lorazepam-controlled, Phase II, single-center, outpatient study.\n Outpatient clinic.\n One hundred sixty-one patients with GAD were randomized in the main study; 68 with a documented history of GAD or anxiety disorder not otherwise specified were included in the subgroup.\n After a one-week placebo lead-in, patients were randomized to receive placebo, lesopitron, or lorazepam twice daily for six weeks, followed by a one-week taper period. Efficacy was assessed using the Hamilton Rating Scale for Anxiety (HAM-A) and the Clinical Global Impressions scale. Safety was assessed through physical examinations, monitoring of vital signs, 12-lead electrocardiograms, laboratory analyses, and adverse event monitoring.\n An overall mean improvement in the HAM-A total score between baseline and end point for all three treatment groups was seen, with mean changes of 3.4 (95% CI 2.0 to 4.8), 6.1 (95% CI 4.1 to 8.1), and 6.1 (95% CI 4.6 to 7.6) for the placebo, lesopitron, and lorazepam groups, respectively (omnibus p = 0.044, uncorrected). Positive treatment effects were also observed in the subgroup population on several other measures and suggest that additional therapeutic trials may be warranted. Future trials could be stratified on the basis of referral status (symptomatic volunteer vs. clinical patient with preexisting illness) or previous exposure to anxiolytics, and use a fixed-dose rather than flexible-fixed-dose design.\n The subgroup analysis represents a comparison of treatment outcome in GAD patients presenting with a history of previous episodes of GAD or anxiety disorder not otherwise specified compared with those who were experiencing their first episode of GAD and reported no anxiety history. Although the overall study analysis was equivocal, for the approximately 40% of patients with recurrent anxiety disorder, beneficial effects for both lesopitron and lorazepam are suggested.", "Lamotrigine, a novel anticonvulsant drug having modulatory effects on glutamatergic neurotransmission, improves mood and cognition parameters in bipolar disorder. Recent studies suggest that when added to clozapine, lamotrigine treatment may result in significant positive symptoms reductions in schizophrenia. Similar effects were not observed in an open trial in which lamotrigine was used as adjuvant to nonclozapine antipsychotics.\n Thirty-eight treatment-resistant schizophrenia inpatients receiving conventional and atypical antipsychotics enrolled in a 10-week, double-blind, placebo-controlled study, in which they were randomized in a 2:1 ratio to receive adjuvant treatment with lamotrigine, gradually titrated to a 400 mg/day dose, or placebo. Of these, 31 completed the trial. Measures of clinical efficacy and side effects were determined every other week. Serum levels of amino acids were assessed at the beginning and end of the study.\n In primary last observation carried forward analysis, no statistically significant between-group differences were observed; however, the completers' analyses revealed that lamotrigine treatment resulted in significant (p < or = .05) reductions in positive and general psychopathology symptoms, as measured by the Positive and Negative Syndrome Scale. No significant differences in lamotrigine effects were noted between conventional versus atypical antipsychotics. Lamotrigine treatment was well tolerated, and glutamate serum levels remained stable throughout the study.\n These preliminary findings 1) support the hypothesis that lamotrigine adjuvant treatment may improve positive symptoms and general psychopathology in schizophrenia, 2) suggest that beneficial effects may be achieved when lamotrigine is added to both conventional and atypical antipsychotics, and 3) warrant additional, larger scale trials." ]

[ "16467702", "8323451", "12665269", "8703248", "359091", "8760776", "18415831", "2862819", "20678306" ]

[ "A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis.", "[Effects of high doses of beclomethasone dipropionate in bronchial asthma].", "The clinical efficacy of fluticasone propionate (Fluvent) compared with beclomethasone dipropionates (Becotide) in patients with mild to moderate brochial asthma at the University College Hospital, Ibadan, Nigeria.", "Effect of inhaled corticosteroids on bronchial hyperresponsiveness in patients with mild asthma.", "Beclomethasone dipropionate dry-powder inhalation compared with conventional aerosol in chronic asthma.", "Fluticasone propionate compared with theophylline for mild-to-moderate asthma.", "Effect of feedback letters to physicians and pharmacists on the appropriate use of medication in the treatment of asthma.", "Aminophylline increases the toxicity but not the efficacy of an inhaled beta-adrenergic agonist in the treatment of acute exacerbations of asthma.", "Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids." ]

[ "The antiinflammatory effect of macrolide antibiotics has been well-established, as has their role in the treatment of certain disorders of chronic airway inflammation. Several studies have suggested that long-term, low-dose macrolides may be efficacious in the treatment of chronic rhinosinusitis; however, these studies have lacked a control group. To date, this effect has not been tested in a randomized, placebo-controlled study.\n The authors conducted a double-blind, randomized, placebo-controlled clinical trial on 64 patients with chronic rhinosinusitis. Subjects received either 150 mg roxithromycin daily for 3 months or placebo. Outcome measures included the Sinonasal Outcome Test-20 (SNOT-20), measurements of peak nasal inspiratory flow, saccharine transit time, olfactory function, nasal endoscopic scoring, and nasal lavage assays for interleukin-8, fucose, and a2-macroglobulin.\n There were statistically significant improvements in SNOT-20 score, nasal endoscopy, saccharine transit time, and IL-8 levels in lavage fluid (P<.05) in the macrolide group. A correlation was noted between improved outcome measures and low IgE levels. No significant improvements were noted for olfactory function, peak nasal inspiratory flow, or lavage levels for fucose and a2-macroglobulin. No improvement in any outcome was noted in the placebo-treated patients.\n These findings suggest that macrolides may have a beneficial role in the treatment of chronic rhinosinusitis, particularly in patients with low levels of IgE, and supports the in vitro evidence of their antiinflammatory activity. Additional studies are required to assess their place in clinical practice.", "To evaluate the clinical efficacy of high dose inhaled steroids, we examined the effects of standard doses (400 micrograms/day) and high doses (800 micrograms/day) of inhaled beclomethasone dipropionate (BDP, Becotide Inhaler), and the dose for regular use (800 micrograms/day) of salbutamol (Salb. Asmidon Air) on pulmonary function, bronchial hyperresponsiveness and asthma attack score. The subjects were 17 out-patients with mild or moderate bronchial asthma who were not receiving any anti-allergics or steroids. The patients were randomly allocated into three groups i.e., Group I: BDP 400 micrograms/day, Group II: BDP 800 micrograms/day and Group III: Salb. 800 micrograms/day. The administration period was 8 weeks. Pulmonary function test were performed and bronchial hyperresponsiveness was examined before and after the 8 weeks of treatment and attack scores were recorded during this period. It was found that inhalations of 400 micrograms/day and 800 micrograms/day BDP improved FEV1.0% value, peak flow, F-V curve, Dmin. and SGrs/Grs cont. Particularly, inhalation of 800 micrograms/day of BDP significantly improved these values and reduced attack scores in the early stages of the 8 week treatment. In contrast, there was a trend for inhalation of Salbutamol to enhance bronchial hyperresponsiveness and not to improve pulmonary function and asthma attack score. In conclusion, 800 micrograms/day of inhaled BDP is considered to be useful in the treatment of mild or moderate bronchial asthma.", "This open, randomized trial was conducted at the Medical Out patient Department of University College Hospital, Nigeria to compare the clinical efficacy of Beclomethasome dipropionate (Becotide) with Fluticasone propionate (Fluvent) in patients with mild to moderate bronchial asthma. The study was performed as a week screening, 8-weeks open comparative clinical trial involving Fluticasone propionate (Fluvent) at a daily dose of 22 microg and Beclomethasone Dipropionate (Becotide) at a dose of 400 microg daily delivered through pressurized metered-dose inhaler (pMDI). The main objective of this study is to assess the efficacy of Fluvent in patients with mild to moderate asthma compared to Becotide. At the second visit (end of 1 week), 10 patients were given either Becotide of Fluvent but all were maintained on as needed beta2agonist (Salbutamol inhaler) therapy throughout the study. Efficacy was assessed by changes in symptoms, number of times beta2-agonist was used and results of pulmonary function tests (PEFR and FEV1) while safety was assessed by adverse event experiences. The baseline characteristics of the patients randomized into the two drug groups were comparable and of no statistical significance. The changes in the pulmonary function tests as well as the reduction in the asthma symptoms suggest a statistically significant improvement in the asthma status of the patients. However, these changes were more rapid among the patients using Fluvent. Also, there was higher percentage decline in the episodes of asthma symptoms either in the morning, day or night in the Fluvent group than Becotide group. The drugs were well tolerated and no adverse event was noticed on any of the patients. We therefore concluded that Fluvent would be more efficacious than Becotide in the treatment of Asthma.", "We studied the effect of inhaled budesonide on bronchial hyperresponsiveness (BHR) in twenty mild asthmatic patients. The study was conducted as a randomized, double-blind, placebo-controlled study. Before entering the study, the patients performed methacholine inhalation challenge (MIC) using a reservoir method to assess BHR. Then, they were randomly allocated to receive budesonide turbuhaler (200 micrograms/dose) or placebo turbuhaler two inhalations, twice daily for eight weeks. During the study, each patient recorded daily asthma score and daily number of puffs of beta 2 agonist and they were assessed at weeks 4 and 8. At the end of the treatment, MIC was repeated again. Patients receiving budesonide showed a significant improvement in airway responsiveness compared with those receiving placebo (p < 0.05). They also showed a significant improvement in asthma severity score and a significant decrease in beta 2 agonist bronchodilator use. This study also suggested that inhaled corticosteroids may be the primary treatment in patients, even with mild asthmatic and well-controlled symptoms.", "In a double-blind study beclomethasone dipropionate inhaled as a dry powder in doses of 100 microgram four times daily and 150 microgram four times daily was compared with the conventional aerosol dose of 100 microgram four times daily in 20 outpatients with chronic asthma. Each of the three treatments was given for four weeks. The dry powder in a dose of 150 microgram four times daily had advantages over the other two treatments in terms of FEV1 and the number of exacerbations of asthma during the study. There were no adverse reactions to inhaling dry-powder beclomethasone. It was concluded that this new way of administering the drug was effective in chronic asthma, and should allow most patients with chronic asthma who cannot use conventional pressurised aerosols efficiently to benefit from inhaled corticosteroid treatment.", "The inhaled corticosteroid, fluticasone propionate, was compared with the oral bronchodilator theophylline in the maintenance treatment of asthma.\n The objective of the present study was to compare the efficacy and safety of twice-daily inhaled fluticasone propionate, 50 micrograms, and fluticasone propionate, 100 micrograms, with that of theophylline in the maintenance treatment of mild-to-moderate asthma.\n In this randomized, double-blind, placebo-controlled, parallel-group study, 353 adult and adolescent patients with asthma inadequately controlled with inhaled beta-agonist therapy alone received fluticasone propionate, 50 micrograms, or fluticasone propionate, 100 micrograms, by metered-dose inhaler; theophylline capsules; or placebo twice daily for 12 weeks. Only inhaled albuterol was permitted as needed for acute symptoms.\n Both fluticasone propionate groups had a significantly greater probability of remaining in the study (ie, meeting asthma stability criteria) than did either the theophylline or placebo group (P < or = .008); 39% and 51% in the theophylline and placebo groups, respectively, were withdrawn due to lack of treatment efficacy compared with 14% and 21% in the fluticasone propionate, 50 micrograms, and fluticasone propionate, 100 micrograms, groups. Both fluticasone propionate groups experienced significantly greater improvement in FEV1 and PEF compared with patients in the theophylline or placebo group (P < or = .004). The incidence of potentially drug-related adverse events was significantly greater in the theophylline group (25%) than in the placebo group (11%) (P = .031), while there were no differences between placebo and fluticasone propionate, 50 micrograms, (18%) or fluticasone propionate 100 micrograms, (22%).\n Twice daily treatment with inhaled fluticasone propionate 50 micrograms or 100 micrograms was significantly more effective than theophylline in the treatment of mild-to-moderate asthma.", "Suboptimal medication treatment of asthma has been reported. More specifically, short-acting beta 2-agonists are overused, while inhaled corticosteroids are underused. This can be related in part to poor adherence by patients to the prescribed regimen and to professionals' failure to comply with practice guidelines. Feedback seems to have an effect on professional practices related to medication use.\n To assess the impact of feedback letters to physicians and pharmacists on their patients' appropriate use of asthma medication.\n Two randomized trials were set up in the province of Quebec, Canada: one with physicians and another with pharmacists. A sample of voluntary physicians and pharmacists was randomly assigned to either the experimental group or to the control group. Those in the experimental groups received three consecutive feedback letters over a 9-month period summarizing the asthma medications acquired by their patients over the preceding year. The feedback focused on short-acting beta 2-agonists, long-acting beta 2-agonists and antileukotrienes and provided information on compliance with five appropriate-use criteria. Pharmacists received aggregate profiles and individual profiles with patients' names, while most physicians received aggregate profiles for all their eligible patients. Each mailing also included a pamphlet that summarized practice guidelines on asthma treatment.\n Seventy-one physicians and 60 pharmacists participated in the study. Physicians who received the feedback letters did not differ from those in the control group in terms of their proportion of prescriptions compliant with the criteria, either before the feedback or after it (p > 0.05). The before-after difference was also similar between groups. The same was true for pharmacists. However, although the before-after difference for criteria 1 (frequency of use of short-acting beta 2-agonists) and 2 (frequency of use of long-acting beta 2-agonists) did not reach the usual statistical significance threshold of 0.05, the p value was under 0.10.\n As designed in this study, feedback provided to physicians did not improve the appropriate use of asthma medication. However, feedback to pharmacists is promising, especially when including patients' names so that pharmacists can intervene more specifically.", "We studied 40 patients with acute exacerbations of asthma to determine the efficacy of a 3-h intravenous infusion of aminophylline in patients who were already being treated with an inhaled beta-adrenergic agonist (metaproterenol). Each patient was treated with inhaled metaproterenol at hourly intervals for 3 h. In addition, patients were randomly assigned to therapy with either intravenous aminophylline or placebo. Neither the patient nor the house officers and nurses caring for the patient knew whether aminophylline or placebo was given. The FEV1 improved continually throughout the study to a similar extent in both treatment groups, but the patients treated with aminophylline had significantly more adverse effects (p less than 0.025, Mann-Whitney). There was no apparent benefit from aminophylline even in patients who presented to the emergency room with severe airway obstruction (FEV1 less than 0.8L) or with plasma theophylline levels less than 10 mg/L. We conclude that intravenous aminophylline adds to the toxicity but not the efficacy of inhaled metaproterenol in the treatment of acute exacerbations of asthma.", "Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (>or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p < 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p < 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p < 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma." ]

[ "11115031", "18410212", "12038883", "11434842", "12456542", "17076751", "17068074", "18237352", "10404442" ]

[ "Promoting secure attachment, maternal mood and child health in a vulnerable population: a randomized controlled trial.", "Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations.", "A randomized, controlled trial of a community-based support program for families of children with chronic illness: pediatric outcomes.", "Maternal outcomes of a randomized controlled trial of a community-based support program for families of children with chronic illnesses.", "Improving mental health through parenting programmes: block randomised controlled trial.", "Randomised controlled trial of a parenting intervention in the voluntary sector for reducing child conduct problems: outcomes and mechanisms of change.", "Role of home visiting in improving parenting and health in families at risk of abuse and neglect: results of a multicentre randomised controlled trial and economic evaluation.", "Strategies for improving the quality of health care in maternal and child health in low- and middle-income countries: an overview of systematic reviews.", "A randomized, controlled trial of nurse home visiting to vulnerable families with newborns." ]

[ "To evaluate the efficacy of an early home-based intervention on the quality of maternal-infant attachment, maternal mood and child health parameters in a cohort of vulnerable families.\n A total of 181 families were recruited to the study in the immediate postnatal period on the basis of a self report questionnaire relating to known family vulnerability factors. Families were assigned randomly to intervention (90), or control (91) groups. The intervention group received a series of home visits from a child health nurse (weekly to 6 weeks, fortnightly to 3 months), with a subgroup receiving home based short-term dynamic therapy from a social worker. Parent/family function was assessed at inception and at 4 months by the Parenting Stress Index and the Edinburgh Post Natal Depression Scale. At 4 months the quality of the home environment was assessed, utilizing the Home Observation for Measurement of the Environment Inventory, as were child and family health parameters and satisfaction with the community child health service.\n At 4 month follow-up, 160 families (80 intervention, 80 control) were available for assessment. The intervention improved family functioning at 4 months. All aspects of the home environment, including the quality of maternal-infant attachment and mothers' relationship with their child, were significantly enhanced. In particular, significant and positive differences were found in parenting with the intervention group feeling less restrictions imposed by the parenting role, greater sense of competence in parenting, greater acceptability of the child, and the child being more likely to provide positive reinforcement to the parent. Early differences in maternal mood were not maintained at 4 months. Various child health parameters were enhanced including immunization status, fewer parent-reported injuries and bruising, and researcher confirmed lack of smoking in the house or around the infant. The families were consistently more satisfied with their community health service.\n This form of early home based intervention targeted to vulnerable families promotes an environment conducive for infant mental and general health and hence long-term psychological and physical well-being, and is highly valued by the families who receive it.", "This study investigated the ability of a theoretically driven, psychosocial prevention program implemented through childbirth education programs to enhance the coparental relationship, parental mental health, the parent-child relationship, and infant emotional and physiological regulation. A sample of 169 heterosexual, adult couples who were expecting their 1st child was randomized to intervention and control conditions. The intervention families participated in Family Foundations, a series of 8 classes, delivered before and after birth, that was designed as a universal prevention program (i.e., it was applicable to all couples, not just those at high risk). Intent-to-treat analyses indicated significant program effects on coparental support, maternal depression and anxiety, distress in the parent-child relationship, and several indicators of infant regulation. Intervention effects were not moderated by income, but greater positive impact of the program was found for lower educated parents and for families with a father who reported higher levels of insecure attachment in close relationships. These findings support the view that coparenting is a potentially malleable intervention target that may influence family relationships as well as parent and child well-being.\n (c) 2008 APA, all rights reserved.", "Children with chronic illnesses have a heightened risk for mental health problems.\n To develop, implement, and evaluate child outcomes of a 15-month, community-based, family-support intervention designed to reduce risk for poor adjustment and mental health problems in children with 1 of 4 chronic illnesses (diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma) and their mothers.\n Randomized, controlled clinical trial design with multiple measures of mental health based on both child and parent reports taken 1 year apart.\n Community-based intervention linked to subspecialty and general pediatric clinics and practices in Baltimore, Md.\n One hundred thirty-six mothers and children aged 7 to 11 years with diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma.\n The program, provided by \"experienced mothers\" and child life specialists, included telephone contacts, face-to-face visits, and special family events.\n Outcomes were measured using the following instruments: the Personal Adjustment and Role Skills Scale III, the Children's Depression Inventory, the Revised Children's Manifest Anxiety Scale, and the Self-Perception Profile for Children.\n The experimental group's mean adjustment score increased over the intervention period while the control group's mean adjustment score decreased. Analysis of variance demonstrated that the intervention had a significant main effect on postintervention adjustment controlling for baseline scores (P =.01). Using a cutoff score indicating maladjustment, the percentage of experimental group children in the maladjustment range fell from 19% at baseline to 10% after the intervention; the percentage of control group children in the maladjustment range rose from 15% at baseline to 21% after the intervention. The effect of the intervention was more pronounced for children who had low physical self-esteem than for those who had moderate to high physical self-esteem at the beginning of the program.\n Our results demonstrate modest positive effects of a family support intervention in promoting the adjustment of children with selective chronic health conditions. Including child life specialists in a community-based intervention may be especially salient for children with chronic illnesses who have low physical self-esteem. The intervention had a similar outcome for all diagnostic groups, suggesting that it could be effective for children with any chronic illness and implemented in a variety of pediatric settings.", "Parents of children with chronic illnesses are at high risk for secondary mental health problems, such as anxiety and depression.\n To evaluate maternal outcomes of a support intervention for families of children with selected chronic illnesses.\n A randomized controlled clinical trial design with repeated measures 1 year apart.\n A community-based family support intervention linked to subspecialty and general pediatric clinics and practices in a metropolitan area.\n A population-based sample of 193 mothers of children aged 7 to 11 years; the children were diagnosed as having diabetes, sickle cell anemia, cystic fibrosis, or moderate to severe asthma. About 15% of the persons contacted refused to participate in the research, and 14% of the families were lost to follow-up.\n The 15-month intervention, the Family-to-Family Network, was designed to enhance mothers' mental health by linking mothers of school-aged children with selected chronic illnesses with mothers of older children with the same condition. The program included telephone contacts, face-to-face visits, and special family events.\n Beck Depression Inventory score and the Psychiatric Symptom Index.\n Maternal anxiety scores for participants in the experimental group decreased during the intervention period for all diagnostic groups and for the total group; scores for the control group increased (F = 5.07, P =.03). In multiple regression analyses, the intervention group was a significant predictor of posttest anxiety scores (P =.03). Effects were greater for mothers with high baseline anxiety (P<.001) and for those who were themselves in poor health (P<.01).\n A family support intervention can have beneficial effects on the mental health status of mothers of children with chronic illnesses. This type of intervention can be implemented in diverse pediatric settings.", "To assess the effectiveness of a parenting programme, delivered by health visitors in primary care, in improving the mental health of children and their parents among a representative general practice population.\n Parents of children aged 2-8 years who scored in the upper 50% on a behaviour inventory were randomised to the Webster-Stratton 10 week parenting programme delivered by trained health visitors, or no intervention. Main outcome measures were the Eyberg Child Behaviour Inventory and the Goodman Strengths and Difficulties Questionnaire to measure child behaviour, and the General Health Questionnaire, Abidin's Parenting Stress Index, and Rosenberg's Self Esteem Scale to measure parents' mental health. These outcomes were measured before and immediately after the intervention, and at six months follow up.\n The intervention was more effective at improving some aspects of the children's mental health, notably conduct problems, than the no intervention control condition. The Goodman conduct problem score was reduced at immediate and six month follow up, and the Eyberg Child Behaviour Inventory was reduced at six months. The intervention also had a short term impact on social dysfunction among parents. These benefits were seen among families with children scoring in the clinical range for behaviour problems and also among children scoring in the non-clinical (normal) range.\n This intervention could make a useful contribution to the prevention of child behaviour problems and to mental health promotion in primary care.", "To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children.\n Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems, aged 2-9, primarily low-income families, randomised to treatment vs. 6-month wait-list group. Retention was 93% at 6 months, 90% at 18 months. Interventions--Webster-Stratton Incredible Years video-based 14-week group programme, teaches cognitive-behavioural principles for managing behaviour, using a collaborative, practical, problem-solving approach. Primary outcomes--child problem behaviour by parent-report (Eyberg) and home-based direct observation; secondary outcomes--observed positive and negative parenting; parent-reported parenting skill, confidence and depression.\n Post-treatment improvements were found in child problem behaviour, by parent-report (effect size (ES) .48, p = .05) and direct observation (ES .78, p = .02); child independent play (ES .77, p = .003); observed negative (ES .74, p = .003) and positive (ES .38, p = .04) parenting; parent-reported confidence (ES .40, p = .03) and skill (ES .65, p =.01), using ANCOVA to control for baseline scores. Maternal depression did not change. Consumer satisfaction was high. At 18-month follow-up, although no randomised comparison was possible, changes appeared to maintain, with no significant change toward baseline level on any measure. Change in observed positive parenting appeared to mediate change in child problem behaviour (p < .025).\n Findings suggest that a group-based cognitive-behavioural parenting programme, delivered by well-trained and supervised staff, can be effective in a community voluntary-sector setting, for reducing conduct problems and enhancing parenting skills. Change in parenting skill appears to be a key mechanism for change in child behaviour. Findings have implications for feasibility of translating evidence-based programmes, even for clinically-referred conduct problems, into less specialised community settings, likely to have lower costs and be more accessible for families.", "To evaluate the effectiveness and cost effectiveness of an intensive home visiting programme in improving outcomes for vulnerable families.\n Multicentre randomised controlled trial in which eligible women were allocated to receive home visiting (n = 67) or standard services (n = 64). Incremental cost analysis.\n 40 general practitioner practices across 2 counties in the UK.\n 131 vulnerable pregnant women.\n Selected health visitors were trained in the Family Partnership Model to provide a weekly home visiting service from 6 months antenatally to 12 months postnatally.\n Mother-child interaction, maternal psychological health attitudes and behaviour, infant functioning and development, and risk of neglect or abuse.\n At 12 months, differences favouring the home-visited group were observed on an independent assessment of maternal sensitivity (p<0.04) and infant cooperativeness (p<0.02). No differences were identified on any other measures. A non-significant increase in the likelihood of intervention group infants being the subject of child protection proceedings, or being removed from the home, and one death in the control group were found. The mean incremental cost per infant of the home visiting intervention was 3246 pounds sterling (bootstrapped 95% CI for the difference 1645-4803 pounds sterling).\n This intervention may have the potential to improve parenting and increase the identification of infants at risk of abuse and neglect in vulnerable families. Further investigation is needed, along with long-term follow-up to assess possible sleeper effects.", "There are many systematic reviews of continuing education programmes and educational strategies for quality improvement in health care. Most of the reviewed studies are one-off evaluations rather than impact evaluations with long-term follow-up. There are few systematic reviews of organisational, financial and regulatory interventions, and few high-quality studies. These interventions are probably as or more important than educational strategies, although they are less well evaluated. Few studies have been undertaken in low- and middle-income countries (LMIC) or that address maternal and child health (MCH). Thus, the results of the available studies and reviews need to be interpreted cautiously when applied to LMIC. Interactive workshops, reminders and multifaceted interventions can improve professional practice, and they generally have moderate effects. Educational outreach visits consistently improve prescribing but have variable effects on other behaviours. Audit and feedback interventions have variable effects on professional practice, but most often these are small to moderate effects. Mass-media and patient-mediated interventions may change professional practice. Multifaceted interventions that combine several quality-improvement strategies are also effective but may not be more so than single interventions. While all of these strategies are applicable to MCH in LMIC, the applicability of the results to rural settings, in particular, may be limited. Use of these strategies could exacerbate inequalities, and this should be taken into consideration when planning implementation. Scaling up and sustainability may be difficult to achieve in LMIC contexts and need careful consideration. The use of financial interventions has not been well studied; financial incentives and disincentives may be difficult to use effectively and efficiently, although their impact on practice needs to be considered. Organisational interventions are likely to be important, given that there are often underlying organisational or system problems. Regulatory interventions have not been well evaluated, but may sometimes be both inexpensive and effective. There are no 'magic bullets' or simple solutions for ensuring the quality of health care services. Interventions should be selected or tailored to address the underlying reasons for a failure to deliver effective services. Decision-makers should select the most appropriate interventions for specific problems. This requires a governance structure that clearly assigns responsibility for quality-improvement activities, priority setting, selection and design of interventions, and evaluation.", "This project aimed to evaluate the impact of a home visiting programme that targeted families where the child, for environmental reasons, was at great risk of poor health and developmental outcomes.\n Women in the immediate postpartum period were recruited to a randomized double-blind controlled trial on the basis of self-reported vulnerability factors and were randomly assigned to receive either a structured programme of nurse home visiting, supported by a social worker and paediatrician (n = 90), or assigned to a comparison group receiving standard community child health services (n = 91). Parenting stress and maternal depression were measured at enrollment and at 6 weeks. Preventive health behaviour, service satisfaction and home environment outcomes were tested at 6 weeks, as were child health outcomes.\n At six weeks, women receiving the home-based programme had significant reductions in postnatal depression screening scores as well as improvements in their experience of the parental role and improvement in the ability to maintain their own identity. Maternal-infant interactions were more likely to be positive, with significantly higher (better) scores in aspects of the home environment related to optimal development in children, particularly maternal-infant secure attachment. Intervention group mothers were significantly more satisfied with the community child health service.\n This form of intervention for families is effective in promoting secure maternal-infant attachment, preventing maternal mood disorder and is welcomed by the families receiving it. These findings may predict long-term benefits for the healthy development of children otherwise at risk of a range of poor health and development outcomes." ]

[ "12559133", "3962941", "15123970", "15350708", "3351688", "12732859", "9313829", "6472970", "3940358" ]

[ "The effects of the shallow and the deep endotracheal suctioning on oxygen saturation and heart rate in high-risk infants.", "Partially ventilated endotracheal suction. Use in newborns with respiratory distress syndrome.", "The efficacy of facilitated tucking for relieving procedural pain of endotracheal suctioning in very low birthweight infants.", "Comparison of the effect of closed versus open endotracheal suction systems on the development of ventilator-associated pneumonia.", "Need for endotracheal intubation and suction in meconium-stained neonates.", "Closed suctioning of intubated neonates maintains better physiologic stability: a randomized trial.", "Closed versus open endotracheal suctioning in preterm infants: effects on cerebral oxygenation and blood volume.", "An investigation into the benefits of resiting nasoenteric feeding tubes.", "Benefits of orotracheal and nasotracheal intubation in neonates requiring ventilatory assistance." ]

[ "An experimental study involving repeated-measures within subjects was conducted to examine the effects of shallow and deep endotracheal suctioning (ETS) on the SpO(2) and HR in 27 ventilated high-risks infants. The order in which subjects received the ETS protocol was randomly assigned. The results showed no significant changes in both the SpO(2) and HR responses before, during and after ETS between the two ETS protocols. It is concluded that when there is no beneficial effect of performing deep ETS, it should not be carried out due to the potential hazard of direct irritation with more negative pressure on the airways in high-risk infants.", "Ventilator adapters that permit endotracheal suction without disconnection from mechanical ventilation may overcome several of the theoretical contributors to the hypoxia and bradycardia associated with neonatal endotracheal suction. Such an adapter allows for partially ventilated endotracheal suction (PVETS) as opposed to traditional, nonventilated endotracheal suction. To test the clinical value of PVETS using an endhole adapter, changes in transcutaneous partial pressure of oxygen and heart rate were compared during paired PVETS and nonventilated endotracheal suction events on 32 occasions in 11 premature neonates with respiratory distress syndrome. Partially ventilated endotracheal suction was associated with a significant decrease in the incidence and severity of hypoxic events. Partially ventilated endotracheal suction, however, did not affect the incidence of bradycardic events; PVETS had a small but statistically significant effect on reducing the severity of bradycardia. No clear relationship between bradycardic and hypoxic events was evident.", "This study compared the efficacy of a behavioral pain reducing intervention (facilitated tucking) with standard neonatal intensive care unit (NICU) care for decreasing procedural pain (endotracheal suctioning) in very low birthweight (VLBW) infants.\n A prospective randomized crossover design with infants as their own controls were used. The sample consisted of 40 VLBW infants, 23-32 weeks gestation, and weighing 560-1498 g with tracheal intubation. The infants were observed twice during each endotracheal suctioning experience; one suctioning was done according to normal nursery routine; another was done using facilitated tucking (the caregiver \"hand-swaddling\" the infant by placing a hand on the infant's head and feet while providing flexion and containment). The Premature Infant Pain Profile (PIPP) measured the infant's pain response, and severity of illness of each infant was measured by the Score for Neonatal Acute Physiology (SNAP) and the NTISS (Neonatal Therapeutic Intervention Scoring System). Repeated measures analysis of variance (RMANOVA) determined the efficacy of facilitated tucking for reducing procedural pain (PIPP) and the effects of order of intervention vs. control. Regression analyses examined the relationship of gestational age, severity of illness, and number of painful procedures to the pain response.\n There was a significant difference between the PIPP scores for tucking and nontucking positions (p = 0.001) and a nonsignificant interaction with order (p = 0.64) as well as a nonsignificant main effect for order (p = 0.46). In the regression analyses, all predictors taken together did not significantly predict PIPP scores in the tucked position (p = 0.11) or nontucked position (p = 0.57).\n Facilitated tucking is a developmentally sensitive, nonpharmacological comfort measure that can relieve procedural pain in VLBW infants. Nurses need to be increasingly aware of infant pain during daily care taking, and to use validated pain assessment instruments. Further clinical research on individual pain assessment is needed for better understanding of the quality and significance of pain for each infant, and the factors that affect pain expression.", "The aim of this study was to compare the effect of closed versus open endotracheal suction systems on the development of ventilator-associated pneumonia (VAP). A prospective, randomized, controlled trial was performed in a medical intensive care unit (MICU) of a university hospital in patients who received mechanical ventilation for more than 48 h. Patients were randomized to receive endotracheal suction with either closed catheters (closed suction group; N-41) or single-use catheters (open suction group; N=37). Cultures were taken from the ventilator tubing of 42 patients to determine the rate of colonization. There was no difference between the groups in terms of the frequency of development of VAP, mortality in the MICU, length of MICU stay and duration of mechanical ventilation. Thirteen patients in the open suction group and 16 patients in the closed suction group became colonized (P=0.14). The colonization rates by Acinetobacter spp. and Pseudomonas aeruginosa were more frequent in the closed suction group than in the open suction group (P<0.01 and P=0.04, respectively). In conclusion, closed endotracheal suction resulted in increased colonization rates of ventilator tubing with multi drug-resistant micro-organisms but did not increase the development of VAP and MICU outcome compared with open endotracheal suction.", "In a prospective study, we determined whether routine immediate tracheal aspiration at birth is necessary in meconium-stained but otherwise normal infants delivered vaginally and having a 1-minute Apgar score greater than 8. A total of 572 newborn infants who met these criteria were randomly allocated to one of two groups. All infants underwent oropharyngeal suctioning with a DeLee catheter while the head was still on the perineum. In group I (n = 308) suctioning of the trachea under direct vision was performed instantly at birth; in group II (n = 264) this procedure was not done. There was no mortality among infants in the study, but morbidity, mainly pulmonary and laryngeal disorders, occurred in six of 308 group I infants and in none of the group II infants (P less than 0.025). Immediate tracheal suction is not a harmless intervention, and should be considered superfluous in a vigorous term neonate born with meconium-stained amniotic fluid.", "To evaluate the physiological variance in a closed (CS) vs an open suction (OS) protocol in intubated infants.\n Infants were stratified into three weight groups in a randomized crossover trial. Heart rate, respiratory rate, blood pressure, oxygen saturation, transcutaneous oxygen and carbon dioxide, and end-tidal carbon dioxide were recorded prior to suctioning, during suctioning, and recovery to baseline. Following the procedures, recovery time to baseline parameters was measured. Data were analyzed using repeated measures ANOVA.\n Overall, there was significantly less deviation from baseline physiological parameters with CS. Infants <1000 g had clinically significant decreases in heart rate with the OS method (-18% OS vs -6% CS; p=0.016). Recovery time in the OS group was twice that of the CS cohort (4 vs 2 minutes; p<0.001).\n CS maintains better physiologic stability in intubated infants.", "The aim of our study was to compare, using near-infrared spectroscopy (NIRS), the effects on cerebral intracellular oxygenation and cerebral blood volume (CBV) of closed endotracheal suctioning (CS), which permits continuous ventilation of the patient, with open endotracheal suctioning (OS), which requires disconnection from the ventilator. Eleven preterm infants were studied. Each patient underwent one CS, followed, after 60 min, by one OS, or vice versa, three times during the same day. Modifications in CBV and oxidized cytochrome oxidase (CytO2) were continuously detected by NIRS; arterial oxygen saturation (SaO2) heart rate (HR), transcutaneous carbon dioxide tension and mean arterial blood pressure were simultaneously recorded. Significant reductions in HR and SaO2 were observed following OS; the magnitude and duration of these negative effects of suctioning were significantly reduced with CS. In addition, the decrease in CBV was more pronounced than following CS. No changes in CytO2 concentration were seen.", "Partial nasal obstruction in preterm infants increases the airway resistance. In spite of this, nasal feeding tubes are often used, if only because oral tubes are difficult to secure. A palatal appliance has been devised that maintains the position of oroenteric feeding tube(s) and is not associated with local complications. In order to assess the effects of resiting feeding tubes, two related studies were carried out. The first study, a trial, included respiratory monitoring of 29 infants on the third and/or seventh day after either the appliance and oroenteric tubes had been inserted, or, in the control group, after the nasoenteric tubes had been passed. After seven days, the infants using the palatal appliance had significantly less periodic breathing, central apnea, and movement than the control group. The second study showed that the removal of feeding tubes that had been in situ for several days reduced apnea rates and produced a significant increase in transcutaneous PO2.", "To investigate differences in orotracheal (OT) and nasotracheal (NT) intubation for ventilatory assistance, we randomly assigned 91 neonates to be intubated via either of the two routes: 46 infants were assigned to the OT group and 45 infants were assigned to the NT group. Inability to intubate the nostril in three neonates, and respiratory or cardiac instability during attempted NT intubation in three neonates, resulted in the assignment of 52 infants to the OT group and 39 infants to the NT group; patients in both groups were of comparable size, sex, and clinical problems. Initial malposition of the endotracheal tube and need to retape, reposition, or replace the tube during the mean duration of intubation of 247 +/- 42 hours for the OT group and 273 +/- 57 hours for the NT group were similar. Daily Gram stains of tracheal aspirates showed that inflammation (greater than or equal to ten polymorphonuclear cells per 400 power fields) was common (51% OT group, 53% NT group). Cultures grew potential pathogens in 37% of the patients from the OT group and 31% of the NT group. There was no difference in the clinical or radiologic incidence of pneumonia. Postextubation problems were comparable: atelectasis, 48% OT and 59% NT; stridor, 15% OT and 26% NT. OT intubation may be preferred for prolonged ventilatory assistance in neonates because of the relative ease of initial intubation." ]

[ "14682412", "19138505", "10421835", "10630654", "12149529", "11243949", "17463412", "15866309", "12564609" ]

[ "Short- and long-term efficacy of fluticasone propionate in subjects with early signs and symptoms of chronic obstructive pulmonary disease. Results of the DIMCA study.", "Fluticasone and N-acetylcysteine in primary care patients with COPD or chronic bronchitis.", "A double-blind placebo-controlled study of the effect of inhaled beclomethasone dipropionate for 2 years in patients with nonasthmatic chronic obstructive pulmonary disease.", "The effect of a respiratory home nurse intervention in patients with chronic obstructive pulmonary disease (COPD).", "Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness.", "Systemic glucocorticoids in severe exacerbations of COPD.", "Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease.", "Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease (Bronchitis Randomized on NAC Cost-Utility Study, BRONCUS): a randomised placebo-controlled trial.", "Symptoms are an important outcome in chronic obstructive pulmonary disease clinical trials: results of a 3-month comparative study using the Breathlessness, Cough and Sputum Scale (BCSS)." ]

[ "Early treatment with inhaled corticosteroids may prevent progression of irreversible obstruction in COPD, especially in patients with bronchial hyperresponsiveness. We investigated the clinical effects of early introduction of inhaled steroids in subjects showing early signs and symptoms of COPD without a prior clinical diagnosis.\n Study subjects were detected in a general population screening and monitoring program. Those with a moderately accelerated annual FEV1 decline and persistent respiratory symptoms were invited to participate in a 2-year randomized controlled trial comparing fluticasone propionate DPI 250 microg b.i.d. with placebo. Pre- and post-bronchodilator (BD) FEV1, PC20 histamine, functional status (COOP/WONCA charts) and occurrence of exacerbations were periodically assessed. Subjects recorded respiratory symptoms. Post-BD FEV1 decline served as the main outcome. Multivariable repeated measurements analysis techniques were applied.\n 48 subjects were randomized (24 fluticasone, 24 placebo). After 3 months, the post-BD FEV1 had increased with 125 ml (SE = 68, P = 0.075) and the pre-BD FEV1 with 174 ml (SE 90, P = 0.059) in the fluticasone relative to the placebo group. The subsequent post-BD and pre-BD FEV1 decline were not beneficially modified by fluticasone treatment. There were no statistically significant differences in respiratory symptoms, functional status, or exacerbations favoring fluticasone. Subgroup analysis indicated that the presence of bronchial hyperresponsiveness modified the initial FEV1 response on fluticasone, but not the subsequent annual FEV1 decline.\n Early initiation of inhaled steroid treatment does not seem to affect the progressive deterioration of lung function or other respiratory health outcomes in subjects with early signs and symptoms of COPD. In subjects at risk for, or in an early stage of COPD, long-term inhaled steroid treatment should not be based on a single spirometric evaluation after 3 months.", "Increased oxidative stress and bronchial inflammation are important mechanisms in the pathophysiology of COPD.\n To investigate whether treatment with the inhaled corticosteroid fluticasone propionate (FP) or the anti-oxidative agent N-acetylcysteine (NAC) are effective in primary care patients.\n The study was a 3-year placebo-controlled randomised controlled trial preceded by a 3-month washout and 2-week prednisolone pre-treatment. Patients were (ex-)smokers with chronic bronchitis or COPD. Interventions were inhaled FP 500microg b.i.d., oral NAC 600mg o.d., or placebo. Exacerbation rate and quality of life measured with the Chronic Respiratory Questionnaire (CRQ) were the primary outcomes, FEV(1) decline and respiratory symptoms secondary outcomes.\n 286 patients recruited from 44 general practices were randomised. Exacerbation rate was 1.35 times higher for NAC (p=0.054) and 1.30 times higher for FP (p=0.095) compared with placebo. CRQ total scores did not differ between NAC (p=0.306) or FP (p=0.581) treatment compared to placebo. Annual postbronchodilator FEV(1) decline was 64mL [SD 5.4] for NAC [p=0.569 versus placebo], 59mL [SD 5.7] for FP [p=0.935], and 60mL [SD 5.4] for placebo.\n No beneficial treatment effects for either high-dosed inhaled fluticasone propionate or oral N-acetylcysteine were observed in our study population of patients with COPD or chronic bronchitis.", "Treatment of chronic obstructive pulmonary disease (COPD) with inhaled and oral corticosteroids is common, although their exact role is unclear. Previous studies suggest these drugs may reduce decline in lung function in this group of patients. We report a study investigating the effect of inhaled beclomethasone diproprionate (BDP) on lung function and symptoms in a group of patients with COPD. Treatment was given for 2 years, and the decline in FEV1 in individual patients calculated over this period. Ninety-eight patients were randomized for the study, 59 completing 2 years of treatment. Patients withdrawn had more severe airflow obstruction. Decline in FEV1, measured both prior to and after bronchodilator, was less in patients receiving inhaled BDP, although the differences failed to reach statistical significance except in a subgroup of patients with more severe airflow obstruction. Exacerbation rates were also reduced by inhaled BDP, but again the differences failed to reach conventional levels of statistical significance. The results of this study are consistent with previous published work, but further insight into the long-term role of corticosteroids in COPD await the publication of large studies which have recently been completed. Although the changes seen in this study and others are numerically small, the rate of decline in FEV1 returned to normal levels expected from age-related decline, and hence such treatment combined with other strategies may well have a significant role in the long-term treatment of this condition.", "Chronic obstructive pulmomary disease (COPD) is associated with substantial mortality, morbidity, and costs to the health care system. With the increasing interest in outreach care programmes it is important to evaluate their impact upon patients and health services, for conditions such as COPD.\n To determine the effectiveness of an outreach respiratory nurse in a shared care approach, with collaboration between general practitioners and hospital services, in the management of patients with severe COPD.\n Patients with severe COPD attending The Queen Elizabeth Hospital, Adelaide participated in a randomised controlled trial of a home based nursing intervention (HBNI) over 12 months with outcome measures including mortality rate, hospital service utilisation, FEV1 and health related quality of life (HRQL) using a modified Dartmouth Primary Care Co-operative Quality of Life questionnaire.\n There were 48 subjects in each study arm, with no differences in mortality rate (eight deaths in the HBNI group and seven in the control group), hospital admissions, length of stay, number of outpatient and Emergency Service visits. The study had inadequate follow-up of FEV1 and HRQL within the control group. Within the HBNI group, a small improvement in HRQL (in three of ten indices measured) was demonstrated, despite a deterioration in FEV1 (11% reduction, p=0.04) compared to baseline. Quality of life of HBNI subjects' carers did not change.\n An increased level of care given by an outreach respiratory nurse in a shared care approach for patients with severe COPD produced small improvements in HRQL but did not result in the prevention of deaths or reduced health care utilisation.", "Treatment of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroids does not appear to be as effective as similar treatment of asthma. It seems that only certain subgroups of patients with COPD benefit from steroid treatment. A study was undertaken to examine whether inhaled fluticasone propionate (FP) had an effect on lung function and on indices of inflammation in a subgroup of COPD patients with bronchial hyperresponsiveness (BHR).\n Twenty three patients with COPD were studied. Patients had to be persistent current smokers between 40 and 70 years of age. Non-specific BHR was defined as a PC(20) for histamine of <or=8 mg/ml. Patients received either 2 x 500 microg FP or placebo for 6 months. Expiratory volumes were measured at monthly visits, BHR was determined at the start of the study and after 3 and 6 months, and bronchial biopsy specimens were taken at the start and after 6 months of treatment. Biopsy specimens from asymptomatic smokers served as controls.\n In contrast to asthma, indices of BHR were not significantly influenced by treatment with FP. Forced expiratory volume in 1 second (FEV(1)) showed a steep decline in the placebo group but remained stable in patients treated with FP. FEV(1)/FVC, and maximal expiratory flows at 50% and 25% FVC (MEF(50), MEF(25)) were significantly increased in the FP treated patients compared with the placebo group. Biopsy specimens were analysed for the presence of CD3+, CD4+, CD8+, MBP+, CD15+, CD68+, CD1a, and tryptase cells. FP treatment resulted in marginal reductions in these indices of inflammation.\n In patients with COPD and BHR, FP has a positive effect on indices of lung function compared with placebo. Bronchial inflammation analysed in bronchial biopsy specimens is only marginally reduced.", "This study aimed to compare the efficacies of 3-day and 10-day courses of methylprednisolone (MP) treatment in severe COPD exacerbations necessitating hospitalization for respiratory failure.\n Prospective, randomized, single-blind study.\n Tertiary-care center.\n Thirty-six patients were included in the study and randomized into two groups: group 1 received MP, 0.5 mg/kg q6h for 3 days, and group 2 was administered the same dosage of MP for the first 3 days, after which it was tapered and terminated on the tenth day. There was no difference between the groups for age, baseline FEV(1), PaO(2), PaCO(2), and pH levels. One patient in group 1 who developed pneumothorax and one patient in group 2 who had steroid-related psychosis could not complete the study.\n Both groups showed significant improvements in PaO(2) and FEV(1) levels, but these were more marked in group 2 (p = 0.012 and p = 0.019, respectively). There was a significant increase in FVC levels in group 2 only (p = 0.003). Group 2 also had a more marked improvement in dyspnea on exertion. There was no difference between the two groups with regards to other parameters, including pH, PaCO(2) levels, and other symptom scores. Six patients in group 1 and five patients in group 2 developed new exacerbations within the following 6 months. Hyperglycemia occurred in two patients in each group.\n In severe COPD exacerbations, a 10-day course of steroid treatment is more effective than a 3-day course in improving the outcome, but has no benefit in reducing exacerbation rates.", "The oral phosphodiesterase-4 (PDE4) inhibitor, roflumilast, can improve lung function in moderate chronic obstructive pulmonary disease (COPD). Whether treatment is effective in more severe COPD (GOLD [Global Initiative for Chronic Obstructive Lung Disease] stages III and IV) over a longer period is unknown.\n To determine whether roflumilast improves lung function and decreases exacerbation frequency over 1 year in patients with stable COPD.\n We conducted a randomized, placebo-controlled, double-blind, parallel-group trial for 1 year. We recruited 1,513 patients (mean post-bronchodilator FEV1 41% predicted), 760 receiving oral 500 microg roflumilast and 753 receiving placebo once daily.\n We recorded post-bronchodilator FEV1, exacerbation rate, St. George's Respiratory Questionnaire total score at the study end point, and number and type of reported adverse events during treatment. Post-bronchodilator FEV1 increased by 39 ml with roflumilast compared with placebo by 52 weeks (p=0.001). The mean exacerbation rate was low and comparable in both treatment groups (0.86 vs. 0.92 exacerbations/patient/yr for roflumilast and placebo, respectively). In a retrospective analysis, the exacerbation rate in patients in GOLD stage IV disease was 36% lower in patients treated with roflumilast than in those treated with placebo (1.01 vs. 1.59 exacerbations/patient/year, respectively; p=0.024). The St. George's Respiratory Questionnaire total score did not differ between treatments. The commonest adverse events related to roflumilast treatment were diarrhea, nausea, and headache, which usually subsided during continued treatment. However, roflumilast resulted in more withdrawals within the first 3 to 4 weeks of administration.\n In severe, stable COPD, PDE4 inhibition with roflumilast produced a modest but significant improvement in lung function without changing the exacerbation rate or health status. However, patients with very severe disease experienced fewer exacerbations with roflumilast.", "Increased oxidative stress is important in the pathogenesis of chronic obstructive pulmonary disease (COPD). We postulated that treatment with the antioxidant N-acetylcysteine would reduce the rate of lung-function decline, reduce yearly exacerbation rate, and improve outcomes.\n In a randomised placebo-controlled study in 50 centres, 523 patients with COPD were randomly assigned to 600 mg daily N-acetylcysteine or placebo. Patients were followed for 3 years. Primary outcomes were yearly reduction in forced expiratory volume in 1 s (FEV1) and the number of exacerbations per year. Analysis was by intention to treat.\n The yearly rate of decline in FEV1 did not differ between patients assigned N-acetylcysteine and those assigned placebo (54 mL [SE 6] vs 47 mL [6]; difference in slope between groups 8 mL [9]; 95% CI -25 to 10). The number of exacerbations per year did not differ between groups (1.25 [SD 1.35] vs 1.29 [SD 1.46]; hazard ratio 0.99 [95% CI 0.89-1.10, p=0.85]). Subgroup analysis suggested that the exacerbation rate might be reduced with N acetylcysteine in patients not treated with inhaled corticosteroids and secondary analysis was suggestive of an effect on hyperinflation.\n N-acetylcysteine is ineffective at prevention of deterioration in lung function and prevention of exacerbations in patients with COPD.", "The need to manage the key symptoms of chronic obstructive pulmonary disease (COPD) (breathlessness, cough and sputum) is an important treatment objective. Viozan (sibenadet HCl, AR-C68397AA) is a novel dual D2 dopamine receptor, beta2-adrenoceptor agonist, which combines conventional bronchodilatory activity with the sensory nerve modulation afforded by dopamine agonism. The efficacy of this agent in relieving patient symptoms has been determined in a series of large-scale clinical studies; the results of a 3-month, placebo-controlled multi-centre study are reported. Effect on patient symptoms was determined using a novel patient-reported assessment instrument, the Breathlessness, Cough and Sputum Scale (BCSS). Patients with smoking-related COPD were required to complete a 2-week baseline period before being randomized to one of three treatment groups; sibenadet (500 microg three times daily) plus placebo (twice daily); salmeterol (50 microg twice daily) plus placebo (three times daily); placebo (twice daily) plus a second placebo (three times daily). All treatments were delivered via pressurized metered dose inhaler (pMDI) for 12 weeks. From enrolment, patients were required to complete daily diary cards to record symptoms of breathlessness, cough and sputum, medication use and adverse events. The primary outcome measure was the difference between the mean BCSS total score measured over the baseline period and the mean BCSS total score in the final 4 weeks of the treatment period. Secondary measures included assessment of lung function, rescue medication use, exacerbations, health-related quality of life, opinion of efficacy and safety. Although an initial reduction in BCSS total score (indicating symptom improvement) was seen with sibenadet therapy, this effect was not maintained for the study duration. Salmeterol therapy, however, resulted in a sustained reduction in BCSS total score. No notable benefit over placebo was seen in lung function, exacerbations or health-related quality of life with either active treatment. While the results of this study failed to demonstrate sustained efficacy with sibenadet therapy, they do indicate the value of symptom assessment in the clinical evaluation of new drugs for the treatment of COPD." ]

[ "21714641", "1991274", "6734291", "2776873", "15013579", "9428212", "2166020", "5345935", "8226143" ]

[ "Reduced lung-cancer mortality with low-dose computed tomographic screening.", "Screening for lung cancer. A critique of the Mayo Lung Project.", "Screening for early lung cancer. Results of the Memorial Sloan-Kettering study in New York.", "A 10 year follow-up of semi-annual screening for early detection of lung cancer in the Erfurt County, GDR.", "Effectiveness of smoking cessation self-help materials in a lung cancer screening population.", "Yearly colonoscopy, liver CT, and chest radiography do not influence 5-year survival of colorectal cancer patients.", "The influence of tumor size and pre-treatment staging on outcome following radiation therapy alone for stage I non-small cell lung cancer.", "Earlier diagnosis and survival in lung cancer.", "Radiation therapy alone for stage I non-small cell lung cancer." ]

[ "The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening. The advent of low-dose helical computed tomography (CT) altered the landscape of lung-cancer screening, with studies indicating that low-dose CT detects many tumors at early stages. The National Lung Screening Trial (NLST) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer.\n From August 2002 through April 2004, we enrolled 53,454 persons at high risk for lung cancer at 33 U.S. medical centers. Participants were randomly assigned to undergo three annual screenings with either low-dose CT (26,722 participants) or single-view posteroanterior chest radiography (26,732). Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31, 2009.\n The rate of adherence to screening was more than 90%. The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all three rounds. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The incidence of lung cancer was 645 cases per 100,000 person-years (1060 cancers) in the low-dose CT group, as compared with 572 cases per 100,000 person-years (941 cancers) in the radiography group (rate ratio, 1.13; 95% confidence interval [CI], 1.03 to 1.23). There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95% CI, 6.8 to 26.7; P=0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7% (95% CI, 1.2 to 13.6; P=0.02).\n Screening with the use of low-dose CT reduces mortality from lung cancer. (Funded by the National Cancer Institute; National Lung Screening Trial ClinicalTrials.gov number, NCT00047385.).", "The National Cancer Institute of the United States recently sponsored three large-scale, randomized controlled trials of screening for early lung cancer. The trials were conducted at the Johns Hopkins Medical Institutions, the Memorial Sloan-Kettering Cancer Center, and the Mayo Clinic. Participants were middle-aged and older men who were chronic heavy cigarette smokers and thus at high risk of developing lung cancer. Screening procedures were chest radiography and sputum cytology, the only screening tests of established value for detecting early stage, asymptomatic lung cancer. In the Hopkins and Memorial trials the study population was offered yearly chest radiography plus sputum cytology every 4 months. The control population was offered yearly chest radiography only. In these trials the addition of sputum cytology appeared to confer no lung cancer mortality rate advantage. The Mayo Clinic trial compared offering chest radiography and sputum cytology every 4 months to offering advice that the two tests be obtained once a year. This trial demonstrated significantly increased lung cancer detection, resectability, and survivorship in the group offered screening every 4 months compared with the control group. However, there was no significant difference in lung cancer mortality rate between the two groups. The statistical power of these trials was somewhat limited. Nevertheless, results do not justify recommending large-scale radiologic or cytologic screening for early lung cancer at this time.", "The Memorial Sloan-Kettering lung cancer screening program was begun in 1974 to evaluate sputum cytology as a supplement to the annual chest x-ray examination for early detection and diagnosis. The 10,040 adult, male cigarette smokers who enrolled were randomly assigned to receive annual chest x-ray examinations only or a dual screen with annual chest x-ray examination and four monthly sputum cytology evaluation. Over 40 percent of the 288 who developed lung cancer were diagnosed in stage I, and their survival was 76 percent at five years; overall survival was 35 percent. Nearly one third of the lung cancers detected on first examination on the dual screen, and 14 percent of those on subsequent examinations were found by cytologic examination. The same number of cancers developed in the x-ray screen only group, and were diagnosed at a later date. Despite the delay, survival and mortality were the same, suggesting that the squamous carcinomas detected by cytologic examination alone are very slow growing and tend to remain localized until detectable by x-ray examination.", "A prospective and controlled study for early detection of lung cancer in the county of Erfurt with a follow-up of 10 years is presented. A collective of 41,532 males born between 1907 and 1932 was screened by chest fluorography at 6 month intervals and compared with a control group consisting of 102,348 males of the same age, who were screened at intervals of about 18 months. No significant reduction of overall mortality and of lung cancer mortality was achieved. Semi-annual screening brought about a higher detection rate (9%/6.5%), an increase in the resection rate (28%/19%) and higher 5 and 10 year survival rates (52%; 27%/39%; 19%) of resected patients than screening in 18 month intervals. Among those patients who refused resection or were surgically untreatable, the difference in survival rates between the two investigation groups lasted only up to the 12 months barrier. This is regarded as the effect of the lead-time bias. Fluorographic screening is effective only in patients with peripheral cancers. Patients resected for central lung cancers did not show differences in the survival rates. In both investigation groups considered together surgical therapy was possible mainly in those patients who had been detected by screening (resection rate: 48%; 5 yr survival rate: 26.9%). The resection rate of all the others amounted to 9%, the 5 yr survival rate to 1.4%. Therefore we consider fluorography to time as the only chance for lung cancer control of high risk groups in spite of the absence of reduction of lung cancer mortality.", "Randomized controlled trials of smoking interventions have not been well-documented for lung cancer screening populations. In this study, we randomly assigned 171 current smokers who were undergoing low-dose fast spiral chest CT (SCTS) for lung cancer screening to receive either standard written self-help materials or a written list of Internet resources for smoking cessation. At the 1-year follow-up, more of the subjects receiving Internet-based resources reported making a stop attempt (68% versus 48%, P=0.011). However, there were no statistically significant differences in 7-day point prevalence quit rates (5% versus 10%) or advancement in motivational readiness to stop smoking (27% versus 30%), respectively, between the groups. Clearly, more investigation is warranted into how to tailor smoking interventions for cancer screening participants.", "Guidelines on the type and frequency of follow-up of patients after curative surgery for colorectal cancer are unclear. The aim of this study was to determine the survival benefit of a planned follow-up program.\n Three hundred twenty-five patients who underwent curative resection of colorectal cancer were prospectively randomized to either intensive or standard follow-up. After stratification according to Dukes' stage and site in the colon or rectum, patients were randomized to intensive follow-up of yearly colonoscopy, computerized tomography (CT) of the liver, and chest radiography and clinical review and simple screening vs. structured clinical review and simple screening tests only.\n On completion of 5-year follow-up, there was no significant difference in survival between the two groups. Yearly colonoscopy failed to detect any asymptomatic local recurrences. Only one asymptomatic curable metachronous colon tumor was detected. Liver CT resulted in earlier detection of hepatic metastases but did not increase the number of curative hepatectomies. Only 1 patient had an asymptomatic CT-detected liver metastasis, and another had an asymptomatic chest radiography-detected lung metastasis. Both had curative resections.\n Yearly colonoscopy, liver CT, and chest radiography will not improve survival from colorectal cancer when added to symptom and simple screening review.", "From 1970 through 1987, 77 patients with Stage I lung cancer were treated with definitive radiation therapy (RT) alone at the Fox Chase Cancer Center or the Hospital of The University of Pennsylvania. All patients had a pathologic diagnosis of non-small cell lung cancer and were not candidates for surgical resection because of premorbid medical problems or patient refusal. The median age was 72 years, although 10 patients were over 80. The histologic cell type was squamous in 44, adenocarcinoma in 15, large cell in 3, adenosquamous in 1, non-small cell in 11, and bronchioli-alveolar in 3. Tumor size was retrievable in 75 patients and 25 were less than or equal to 3 cm, 41 from 3-6 cm, and 9 greater than 6 cm. Diagnostic staging varied during the study period. Twelve patients, evaluated with a CT scan of the chest, including the liver, and a bone scan were classified as having \"excellent\" staging, 24 patients with conventional tomography, liver-spleen scan and a bone scan had \"good\" staging, and 41 patients were staged less rigorously. The RT was of megavoltage energy in all patients. The median dose was 60 Gy. The mediastinum was treated in all but eight patients who had poor pulmonary function. Survival was measured from the date of pathologic diagnosis. The actuarial 3-year survival rate of the entire group of patients is 17% with a median survival time of 20 months. Of the 61 deaths, 51 were due to disease and 10 were due to intercurrent disease without evidence of tumor recurrence. The actuarial 3-year disease-specific survival (DSS) was 22%. The 3-year disease-specific survival for patients with tumors less than 3 cm and from 3-6 cm was 30% and 17%, respectively. All nine patients with tumors greater than 6 cm were dead of disease. Local progression occurred in 33 patients, resulting in a 44%, 3-year actuarial freedom from local progression. The median time to local failure was 28 months and there were no local failures after 3 years in the 18 patients eligible for observation beyond this point. Of the patients with \"excellent\" staging, only 2 of 12 were dead of disease compared with 22 of 24 with \"good\" staging and 30 of 41 of the remainder. In this large group of Stage I non-small cell lung cancer, thorough pre-treatment staging and smaller tumor size are associated with a more favorable outcome.", "In a controlled investigation the survival prospects of lung cancer in a population of men aged 40 and over who had been offered six-monthly chest radiographs over a period of three years were compared with lung cancer in a similar population without such x-ray facilities. The five-year survival rate of lung cancer in the study series was 15%, and in cases discovered by six-monthly examination 23%, compared with 6% in the control series. The average expectation of life after diagnosis was 2.5 years for the test cases and 1.2 for the control cases. Survival declined with age. Of resected lung cancer, 32% survived five years in the test series and 23% in the control series. The five-year survival rate for squamous carcinoma and adenocarcinoma in the test series was 28% and 25% respectively, compared with 15% and nil in the control series.On the basis of these results it is concluded that through earlier radiological detection a modest improvement in the prognosis of lung cancer can be achieved.", "This paper is a retrospective analysis of patients with clinical Stage I non-small cell carcinoma of the lung treated with definitive radiation therapy alone. The results of therapy, patterns of failure and the relationship of technical aspects of the delivery of radiotherapy to outcome are presented.\n From 1980 through 1990, 53 patients with Stage I non-small cell lung cancer were treated with definitive radiation therapy alone at the Radiation Oncology Center of the Mallinckrodt Institute of Radiology and its affiliated hospitals. All patients had a pathologic diagnosis of non-small cell lung cancer and were not candidates for surgical resection because of either patient refusal (10 patients), poor performance status (5 patients), or premorbid medical problems (38 patients). The median age was 73 years. Histologic cell type included squamous (32), adenocarcinoma (11), large cell (4), and unclassified non-small cell (6). Initial tumor size was < or = 3 cm in 23 patients, between 3 and 5 cm in 13 patients and > or = 5 cm in 17 patients. Diagnostic staging varied during the study period. All patients had chest X-rays and computed tomography scans of the chest. A majority had liver and bone scans, but only four underwent mediastinoscopy. The radiation therapy was of megavoltage energy in all patients, with a median primary prescription tumor dose of 63.2 Gy. Survival was measured from the date radiation therapy was initiated.\n The actuarial overall survival rate for the entire group was 19% at 3 years and 6% at 5 years, with a median survival time of 20.9 months. Of the 49 deaths, 35 died of lung cancer; 13 died of intercurrent illness, and one died of pancreatic cancer, which made the actuarial cause-specific survival 33% at 3 years and 13% at 5 years. The actuarial 3-year disease-free survival was 33%. Local primary tumor progression occurred in 22 patients, resulting in a 51% 3-year actuarial freedom from local progression. An additional four patients failed in regional lymph nodes that were included in the original treatment portals. Multivariate analysis found only T stage to be associated with overall survival (p = .02). However multivariate analysis showed age as a prognostic factor to be approaching statistical significance (p = .07). Patients under 70 years of age showed an increased survival rate compared to patients over 70 years. Radiation therapy doses > or = 65 Gy appeared to result in a decreased proportion of patients dying of lung cancer with no apparent increase in either acute or long-term complication rates.\n Results of definitive radiation therapy for inoperable Stage I non-small cell lung remain inferior to surgical therapy. Potential methods to improve local control with radiotherapy are discussed." ]

[ "2064291", "8492040", "7857145", "9738217", "3896372", "17394048", "3510704", "7006425", "18156032" ]

[ "[The best anastomoses after colonic resection].", "Ileocolonic anastomosis after right hemicolectomy for carcinoma: stapled or hand-sewn? A prospective, multicenter, randomized trial.", "Comparison of manually constructed and stapled anastomoses in colorectal surgery. West of Scotland and Highland Anastomosis Study Group.", "[Is the stapled suture in visceral surgery still justified? A prospective controlled, randomized study of cost effectiveness of manual and stapler suture].", "Staples or sutures for low colorectal anastomoses: a prospective randomized trial.", "Mechanical bowel preparation for elective colorectal surgery with primary intraperitoneal anastomosis by a single surgeon: interim analysis of a prospective single-blinded randomized trial.", "A prospective randomized study of sutured versus stapled bowel anastomoses in patients with cancer.", "Randomized prospective evaluation of the EEA stapler for colorectal anastomoses.", "Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial." ]

[ "Among the numerous anastomotic techniques after colonic resection, the mechanical sutures using staplers have been credited with a lower incidence of anastomotic leakage than hand-sewn anastomoses. This hypothesis has been tested in two multicentre, prospective, randomized trials after right hemicolectomy for carcinoma and after left colectomy with colorectal anastomosis. After right hemicolectomy, the stapled anastomosis using the GIA and TA staplers appeared to be superior to all hand-sewn anastomoses. This superiority was not apparent after left colectomy followed by colorectal anastomosis. Although the leakage rate of stapled anastomoses was similar to hand-sewn anastomoses, they carry a high rate of intra-operative mishaps. Furthermore, the stapler does not permit a lower anastomosis in this study. Finally, the overall cost of a stapled anastomosis is superior to the cost of an hand-sewn anastomosis.", "440 patients were prospectively enrolled in a randomized, multicenter trial to compare 4 types of manual (84 interrupted end-to-end, 77 continuous end-to-end, 82 interrupted end-to-side, and 91 continuous end-to-side) (polyglycolic derived suture) and 1 type of stapled (106 side-to-side with GIA+TA devices) ileocolonic anastomosis after right hemicolectomy for carcinoma. The trial was designed according to Schwartz' pragmatic formulation. All 5 groups were well-matched, except for a lower rate of intraoperative sepsis in the stapled group (P < 0.02). The main end point was anastomotic leakage detected clinically or by routine sodium diatrizoate enema on the 8-10th postoperative day. Results showed that stapled ileocolonic anastomosis was associated with less anastomotic leakages (2.8%) than all the other techniques combined (8.3%). In spite of the fact that staples are approximately ten times more expensive, our results suggest performing side-to-side (GIA+TA) mechanical anastomosis after right resection for carcinoma.", "The authors compared both the initial and the long-term outcomes of patients undergoing stapled and sutured colorectal anastomoses.\n Sutured and stapled large bowel anastomoses are perceived to be equally safe, but concern has been raised about increased rates of tumor recurrence with the use of stapling instruments.\n The outcome of patients with sutured and stapled colorectal anastomoses were compared in a prospective, multicenter, randomized study. Factors affecting long-term outcomes were assessed by both univariate and multivariate analysis.\n Seven hundred thirty-two patients were recruited. There was a significant increase in radiologic leakage in the sutured group (14.4% vs. 5.2%, p < 0.05), but there was no difference in clinical anastomotic leak rates, morbidity, or postoperative mortality. Tumor recurrence and cancer-specific mortality were higher in the sutured patients (7.5% and 6.7%, respectively) and in patients with anastomotic leaks.\n This study shows that suturing or stapling are equally safe in large bowel surgery. However, it also shows a long-term benefit of stapling in colorectal cancer patients.", "Hospitals are facing increasing economic pressure. It therefore seems necessary to evaluate the efficiency and effectiveness of medical or surgical interventions. In this study 324 anastomoses (167 stapled and 157 hand-sewn) were performed after randomization during 200 elective operations [20.5% gastrectomies, 14% gastric resections (Billroth II), 15% Whipple's procedures, 4% segmental colonic resections, 18% right-sided hemicolectomies, 4% left-sided hemicolectomies, 22% sigmoid- or anterior rectal resections, 2.5% total colectomies with pouch-anal anastomoses] in 200 patients. Postoperative motility (time to full oral diet, time with naso-gastric tube) and hospitalization were comparable in both groups. Anastomotic insufficiency was observed in 2.1% of all patients, five after stapled and two after hand-sewn anastomoses. Hospital mortality was 1.5%. All stapled anastomoses were performed significantly (P < 0.001) faster. However, the cost of material for these anastomoses was significantly (P < 0.001) higher, resulting in significantly higher total costs for reconstruction. The time saving for the reconstruction did not influence the total operative time (except for stapled gastrectomy). Therefore, all operations with stapled reconstruction were more expensive than those with sutured reconstruction. The difference was significant for the gastrectomy (P < 0.01), colonic resection (P < 0.01) and sigmoid and rectal resection (P < 0.001) groups. Stapled and sutured anastomoses are equally effective. Stapled anastomoses are not efficient, however, and should be reserved for individual indications.", "One hundred and eighteen patients undergoing low colorectal anastomoses were randomly allocated to reconstitution by either single layer interrupted extramucosal sutures or circular staple gun. In the 60 patients undergoing sutured anastomosis there were 2 (3 per cent) clinical leaks and 4 (7 per cent) radiological leaks, and no failures. Of the 58 patients who underwent stapled anastomosis there were 4 failures, 7 (12 per cent) clinical leaks, 14 (24 per cent) radiological leaks and 1 death. Stapled anastomoses were more than ten times as expensive as sutured anastomoses and there were no savings in time or numbers of associated colostomies. An interrupted extramucosal suture technique remains the ultimate standard for low colorectal anastomosis.", "We report an interim analysis of a prospective single-blinded randomized trial designed to investigate whether preoperative mechanical bowel preparation influences the rate of surgical-site infection and anastomotic failure after elective colorectal surgery with primary intraperitoneal anastomosis performed by a single surgeon. Patients scheduled to undergo an elective colorectal procedure with a primary intraperitoneal anastomosis were randomized to receive either oral polyethylene glycol lavage solution and enemas (group A) or no preparation (group B). Surgical-site infection and anastomotic failure were investigated. Of 97 patients included, 48 were assigned to group A and 49 to group B. Twelve (12.4%) developed wound infections, six in each group (12.5 vs. 12.2%; NS). Intra-abdominal sepsis was only seen in group A (n = 3, 6.3%). Anastomotic failure occurred in four patients in group A (8.3%) vs. two patients in group B (4.1%) (NS). The overall complication rate in group A was 27.1%, vs. 16.3% in group B. The number needed to harm was 9.3. Our interim analysis of a prospective single-blinded randomized trial suggests that a surgeon may have the same or even worse outcomes when mechanical bowel preparation is routinely used for colorectal surgery with primary intraperitoneal anastomosis.", "Eighty-eight cancer patients with the presence of one or more adverse factors for healing (carcinomatosis, adhesions, prior chemotherapy and radiation therapy, bowel obstruction, anemia, and low leukocyte count or albumin value) were prospectively randomized to undergo conventional two-layer hand suturing (45 patients) or mechanical stapling with a GIA/TA instrument (U.S. Surgical Corp., Norwalk, CT) (43 patients) of the large or small bowel anastomosis. Age, sex, complete blood count findings, and all biochemical plasma values were comparable in both groups. The anastomosis took an average of 19 minutes for the sutured and 9 minutes for the stapled technique (P = 0.0001), but the average length of operation, postoperative return of bowel function, and hospital stay were comparable in both groups. Bowel fistula was seen in one case of stapled anastomosis (P = not significant). The pulmonary and wound complication rates were the same in both groups. Of the four deaths (4.5%) due to causes unrelated to bowel anastomosis, three occurred in the stapled and one in the sutured group. It was concluded that a stapled anastomosis is as safe as a sutured one in patients with advanced-stage cancer. It saves time in anastomosis, but does not save time in postoperative return of the bowel function and hospital stay.", "A randomized, prospective study should be done to evaluate any new procedure or instrument. Our experience with the end-to-end anastomosis (EEA) stapler suggests that an anastomosis can be created in a shorter time than is required for the traditional hand-sewn technique. This difference is even greater when the anastomosis is technically difficult and located deep within the pelvis. There appears to be little difference in the security of a hand-sewn anastomosis compared with that of stapled anastomosis. Postoperative complications appear similar. With the stapler, however, there is an increased risk of intraoperative complications that are not apparent with the traditional hand-sewn technique. These include rectal tears and anastomotic defects. It appears that the EEA stapler can save as many as 12 percent of rectums that otherwise might have to be removed because of technical inability to perform an anastomosis.", "Mechanical bowel preparation is a common practice before elective colorectal surgery. We aimed to compare the rate of anastomotic leakage after elective colorectal resections and primary anastomoses between patients who did or did not have mechanical bowel preparation.\n We did a multicentre randomised non-inferiority study at 13 hospitals. We randomly assigned 1431 patients who were going to have elective colorectal surgery to either receive mechanical bowel preparation or not. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with either polyethylene glycol or sodium phosphate. The primary endpoint was anastomotic leakage, and the study was designed to test the hypothesis that patients who are given mechanical bowel preparation before colorectal surgery do not have a lower risk of anastomotic leakage than those who are not. The median follow-up was 24 days (IQR 17-34). We analysed patients who were treated as per protocol. This study is registered with ClinicalTrials.gov, number NCT00288496.\n 77 patients were excluded: 46 who did not have a bowel resection; 21 because of missing outcome data; and 10 who withdrew, cancelled, or were excluded for other reasons. The rate of anastomotic leakage did not differ between both groups: 32/670 (4.8%) patients who had mechanical bowel preparation and 37/684 (5.4%) in those who did not (difference 0.6%, 95% CI -1.7% to 2.9%, p=0.69). Patients who had mechanical bowel preparation had fewer abscesses after anastomotic leakage than those who did not (2/670 [0.3%] vs 17/684 [2.5%], p=0.001). Other septic complications, fascia dehiscence, and mortality did not differ between groups.\n We advise that mechanical bowel preparation before elective colorectal surgery can safely be abandoned." ]

[ "1748145", "18426821", "17391168", "15334791", "17392540", "11678974", "10063324", "11772907", "12453948" ]

[ "Prospective comparative study in NIDDM patients of metformin and glibenclamide with special reference to lipid profiles.", "Impact of metformin versus repaglinide on non-glycaemic cardiovascular risk markers related to inflammation and endothelial dysfunction in non-obese patients with type 2 diabetes.", "Targeting hyperglycaemia with either metformin or repaglinide in non-obese patients with type 2 diabetes: results from a randomized crossover trial.", "Metabolic variations with oral antidiabetic drugs in patients with Type 2 diabetes: comparison between glimepiride and metformin.", "Glimepiride versus metformin as monotherapy in pediatric patients with type 2 diabetes: a randomized, single-blind comparative study.", "Improved glycaemic control by addition of glimepiride to metformin monotherapy in type 2 diabetic patients.", "[Gliclazide and metformin combination in patients with type 2 diabetes. Preliminary data].", "Effect of metformin in pediatric patients with type 2 diabetes: a randomized controlled trial.", "Effect of combination glipizide GITS/metformin on fibrinolytic and metabolic parameters in poorly controlled type 2 diabetic subjects." ]

[ "Twenty-two NIDDM patients completed an open randomized cross-over study comparing metformin and glibenclamide over 1 year. The drugs had an equivalent effect on glycaemic control, but, in contrast to glibenclamide, metformin reduced body weight. Neither drug affected triglycerides, total- and LDL-cholesterol or C-peptide. Metformin caused a slight elevation of HDL-cholesterol (P less than 0.05). No serious adverse effects were observed. The results show that oral hypoglycaemic agents are not associated with undesirable effects on lipids and lipoproteins.", "In patients with type 2 diabetes mellitus (T2DM), biomarkers reflecting inflammation and endothelial dysfunction have been linked to cardiovascular disease (CVD biomarkers) and metabolic regulation. In T2DM patients, metformin and insulin secretagogues have demonstrated equal anti-hyperglycaemic potency. Here, we report the effect of metformin versus an insulin secretagogue, repaglinide, on CVD biomarkers in non-obese T2DM patients.\n Single-centre, double-masked, double-dummy, crossover study during 2x4 months involving 96 non-obese (body mass index< or =27 kg/m(2)) insulin-naïve T2DM patients. At enrolment, previous oral hypoglycaemic agents were stopped and the patients entered a 1-month run-in on diet-only treatment. Hereafter, patients were randomized to either 2 mg repaglinide thrice daily followed by 1 g metformin twice daily or vice versa each during 4 months with a 1-month washout between interventions.\n Levels of tumour necrosis factor-alpha, plasminogen activator inhibitor-1 antigen, tissue-type plasminogen activator antigen, von Willebrand factor, soluble intercellular adhesion molecule-1 and soluble E-selectin were significantly lower during metformin versus repaglinide treatments. In contrast, Amadori albumin and heart rate were higher during metformin versus repaglinide. Levels of interleukin-6, fibrinogen, soluble vascular cell adhesion molecule-1, asymmetric dimethylarginine and advanced glycation end products as well as glycaemic levels (previously reported) and 24-h blood pressure were similar between treatments. Adjustment for known macrovascular disease did not affect the between-treatment effects.\n In non-obese T2DM patients, metformin was more effective in reducing selected biomarkers reflecting inflammation and endothelial dysfunction compared with repaglinide despite similar glycaemic levels between treatments.", "Metformin is the 'drug-of-first-choice' in obese patients with type 2 diabetes mellitus (T2DM) due to its antihyperglycaemic and cardiovascular protective potentials. In non-obese patients with T2DM, insulin secretagogues are empirically used as first choice. In this investigator-initiated trial, we evaluated the effect of metformin vs. an insulin secretagogue, repaglinide on glycaemic regulation and markers of inflammation and insulin sensitivity in non-obese patients with T2DM.\n A single-centre, double-masked, double-dummy, crossover study during 2 x 4 months involved 96 non-obese (body mass index < or = 27 kg/m(2)) insulin-naïve patients with T2DM. At enrolment, previous oral hypoglycaemic agents (OHA) were stopped and patients entered a 1-month run-in on diet-only treatment. Hereafter, patients were randomized to either repaglinide 2 mg thrice daily followed by metformin 1 g twice daily or vice versa each during 4 months with 1-month washout between interventions.\n End-of-treatment levels of haemoglobin A(1c) (HbA(1c)), fasting plasma glucose, mean of seven-point home-monitored plasma glucose and fasting levels of high-sensitivity C-reactive protein and adiponectin were not significantly different between treatments. However, body weight, waist circumference, fasting serum levels of insulin and C-peptide were lower and less number of patients experienced hypoglycaemia during treatment with metformin vs. repaglinide. Both drugs were well tolerated.\n In non-obese patients with T2DM, overall glycaemic regulation was equivalent with less hypoglycaemia during metformin vs. repaglinide treatment for 2 x 4 months. Metformin was more effective targeting non-glycaemic cardiovascular risk markers related to total and abdominal body fat stores as well as fasting insulinaemia. These findings may suggest the use of metformin as the preferred OHA also in non-obese patients with T2DM.", "Patients with Type 2 diabetes (T2DM) are at high risk of morbidity and mortality from cardiovascular complications, and hypoglycaemia increases this risk. Furthermore, other metabolic parameters exacerbate cardiovascular risk in these patients. The aim of the study was to compare the metabolic effects of glimepiride and metformin in patients with T2DM. We evaluated 164 patients with T2DM (80 males, 84 females) in a multicentre, randomised, controlled, open, parallel group study comparing glimepiride with metformin. Eighty-one patients (aged 56+/-10 yr) received glimepiride (3+/-1 mg/d); 83 patients (aged 58+/-9 yr) received metformin (2500+/-500 mg/d). Patients had been diagnosed for < or = 6 months; they were non-smokers; had no hypertension or coronary heart disease; were not taking hypolipidaemic drugs, diuretics, beta-blockers or thyroxin; and had normal renal function. Metabolic parameters were measured after 6 and 12 months of treatment. Glimepiride significantly lowered lipoprotein(a) [Lp(a)] and homocysteine levels (HCT) at 6 and 12 months. Both glimepiride and metformin lowered plasminogen activator inhibitor Type 1 (PAI-1) at 12 months and significantly improved levels of glycosylated haemoglobin, fasting plasma glucose and post-prandial plasma glucose after 6 and 12 months. Metformin significantly lowered fasting plasma insulin and postprandial plasma insulin. Glimepiride and metformin also reduced levels of other metabolic parameters in patients with T2DM. In particular, glimepiride significantly reduced HCT, Lp(a), and PAI-1 levels, important metabolic risk factors for atherosclerotic vascular disease. These reductions may be owing to improved glucose metabolism, but it cannot be excluded that these drugs have a direct effect on additional metabolic parameters.", "To compare the efficacy and safety of glimepiride versus metformin in pediatric subjects with type 2 diabetes inadequately controlled with diet and exercise alone or oral monotherapy.\n This 26-week, single-blind, active-controlled, multinational study randomized 285 subjects to receive glimepiride (1-8 mg once daily) or metformin (500-1000 mg twice daily) for 24 weeks. The primary end point was mean change in A1C from baseline to week 24. Safety was assessed by incidence of hypoglycemia and other adverse events.\n Significant reductions from baseline A1C were seen in both the glimepiride (-0.54%, P = 0.001) and metformin (-0.71%, P = 0.0002) groups. A total of 42.4% (56 of 132) and 48.1% (63 of 131) of subjects in the glimepiride and metformin groups, respectively, in the intent-to-treat population achieved A1C <7.0% at week 24. No significant differences were observed between groups in reductions in A1C and self-monitored blood glucose levels, changes in serum lipid concentrations, or hypoglycemia incidence. Significant differences were observed in mean changes from baseline in BMI between groups (0.26 kg/m(2) for glimepiride and -0.33 kg/m(2) for metformin; P = 0.003). The adjusted mean body weight increase was 1.97 kg for glimepiride and 0.55 kg for metformin (P = 0.005). A hypoglycemic episode with blood glucose <50 mg/dl (<2.8 mmol/l) was experienced by 4.9 and 4.2% of glimepiride- and metformin-treated subjects, respectively. A single severe hypoglycemic event occurred in each group.\n Glimepiride reduced A1C similarly to metformin with greater weight gain, and there was comparable safety over 24 weeks in the treatment of pediatric subjects with type 2 diabetes.", "To compare the effect of glimepiride in combination with metformin with monotherapy of each drug on glycaemic control in Type 2 diabetic patients.\n Randomized, double-blind, double-dummy, parallel-group multicentre study conducted in France. Type 2 diabetic patients aged 35-70 years inadequately controlled by metformin monotherapy 2550 mg daily for at least 4 weeks were randomized to either metformin, glimepiride or metformin and glimepiride.\n Three hundred and seventy-two patients aged 56 +/- 8 years were treated for 5 months. Combination treatment was significantly more efficient in controlling HbA1c (% change + 0.07 +/- 1.20 for metformin, + 0.27 +/- 1.10 for glimepiride, -0.74 +/- 0.96 for combination treatment, P < 0.001), fasting blood glucose (FBG) (mmol/l change + 0.8 +/- 0.4 for metformin, + 0.7 +/- 3.1 for glimepiride and -1.8 +/- 2.2 for combination treatment, P < 0.001) and post-prandial blood glucose (PPBG) (mmol/l change + 1.1 +/- 5.9 for metformin, + 0.1 +/- 5.1 for glimepiride and -2.6 +/- 3.9 for combination treatment, P < 0.001) than either glimepiride or metformin alone. There was no significant difference between metformin or glimepiride monotherapy with respect to the change in HbA1c or FBG; however, glimepiride was significantly more effective than metformin in reducing PPBG. The incidence of symptomatic hypoglycaemia was higher in the combination group than in either monotherapy group (P = 0.039).\n Addition of glimepiride to metformin in Type 2 diabetic patients inadequately controlled by metformin alone resulted in superior glycaemic control compared with glimepiride or metformin monotherapy.", "This preliminary study is aimed at the evaluation of the efficacy and tolerability of combined therapy with gliclazide and metformin in the treatment of patients with type 2 diabetes mellitus inadequately controlled with maximal doses of gliclazide.\n A prospective, uncontrolled study, with a follow-up of 3 months, was performed in two Outpatient Diabetes Care Units. Fifty-seven patients affected by type 2 diabetes for at least 5 years, aged 61.0 +/- 3.4 years, with a duration of diabetes of 9.2 +/- 3.9 years, Body Mass Index (BMI) 30.5 +/- 3.7 kg/m2, previously treated with gliclazide 240 mg/day, and with HbA1c > 8.5%, were studied. The patients were treated with gliclazide 120 mg/day and metformin 1500 mg/day for 3 months; HbA1c, 24-hour glycosuria, and fasting and post-prandial glycaemia, were determined at the beginning and at the end of the study.\n After a 3-month treatment, a reduction of fasting and post-prandial glycaemia, glycosuria (15.0 +/- 5.3 versus 5.7 +/- 4.0 g/l, p < 0.01), and HbA1c (9.9 +/- 1.1 versus 8.4 +/- 1.0%, p < 0.01) was observed, while no significant changes occurred in body weight. The treatment was generally well tolerated.\n In conclusion, the combination of gliclazide and metformin, which could theoretically show some advantages over the association of glibenclamide and metformin with regards to lipid and haemorheologic profiles, resulted to be effective and well tolerated in patients with type 2 diabetes inadequately controlled with sulphonylurea monotherapy.", "Metformin is the most commonly prescribed oral antidiabetic agent in the U.S. for adults with type 2 diabetes. The incidence of type 2 diabetes in children has increased dramatically over the past 10 years, and yet, metformin has never been formally studied in children with type 2 diabetes.\n This study evaluated the safety and efficacy of metformin at doses up to 1,000 mg twice daily in 82 subjects aged 10-16 years for up to 16 weeks in a randomized double-blind placebo-controlled trial from September 1998 to November 1999. Subjects with type 2 diabetes were enrolled if they had a fasting plasma glucose (FPG) levels > or =7.0 and < or =13.3 mmol/l (> or =126 and < or =240 mg/dl), HbA(1c) > or =7.0%, stimulated C-peptide > or =0.5 nmol/l (> or =1.5 ng/ml), and a BMI > 50th percentile for age.\n Metformin significantly improved glycemic control. At the last double-blind visit, the adjusted mean change from baseline in FPG was -2.4 mmol/l (-42.9 mg/dl) for metformin compared with +1.2 mmol/l (+21.4 mg/dl) for placebo (P < 0.001). Mean HbA(1c) values, adjusted for baseline levels, were also significantly lower for metformin compared with placebo (7.5 vs. 8.6%, respectively; P < 0.001). Improvement in FPG was seen in both sexes and in all race subgroups. Metformin did not have a negative impact on body weight or lipid profile. Adverse events were similar to those reported in adults treated with metformin.\n Metformin was shown to be safe and effective for treatment of type 2 diabetes in pediatric patients.", "Epidemiological studies have implicated increased plasminogen-activated inhibitor 1 (PAI-1) as a marker or predictor of accelerated coronary atherosclerotic disease in type 2 diabetes. We sought to determine whether metabolic control, independent of its oral mode of implementation, affects PAI-1 in patients with marked hyperglycemia.\n A total of 91 subjects were screened, subjected to a 4-week drug washout, and randomized to daily treatment with glipizide GITS (maximum 20 mg, n = 46) or metformin (maximum 2,550 mg, n = 45) as monotherapy. After monotherapy, combination therapy was initiated by adding the second agent to the regimen. Plasma glucose (fasting and postprandial), HbA(1c), fructosamine, and PAI-1 were assayed before and after randomization and sequentially thereafter in all subjects; hepatic glucose output (HGO) and abdominal fat distribution were each measured in a subset of subjects.\n Glycemic control was markedly impaired at baseline (mean HbA(1c) 10.4 +/- 0.2% glipizide GITS; 10.0 +/- 0.2% metformin) but improved comparably with each agent as monotherapy and in combination (P < 0.0001 vs. baseline), as assessed with meal tolerance studies, fructosamine values, and HGO. Body weight and abdominal fat distribution did not change significantly in either group. PAI-1 concentrations were extraordinarily high (5- to 10-fold more than normal) at baseline (202 +/- 12 ng/ml glipizide GITS; 201 +/- 13 ng/ml metformin) but declined comparably, and significantly, after treatment with either agent as monotherapy and decreased further with combination therapy.\n When hyperglycemia is profound, increases in PAI-1 are also profound. Control of hyperglycemia with either glipizide GITS, an insulin secretagogue, or metformin as monotherapy comparably ameliorates elevated PAI-1." ]

[ "2963054", "7592505", "3076905", "2236455", "9585655", "8824057", "375679", "395129", "3897204" ]

[ "Predictors of therapeutic benefit from amitriptyline in mild depression: a general practice placebo-controlled trial.", "A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression.", "Double-blind placebo-controlled trial of amitriptyline among depressed patients in general practice.", "Mirtazapine vs. amitriptyline vs. placebo in the treatment of major depressive disorder.", "Randomized, controlled trial of amitriptyline versus placebo for adolescents with \"treatment-resistant\" major depression.", "A randomized, controlled trial of amitriptyline in the acute treatment of adolescent major depression.", "[Lofepramine: a comparative clinical study with amitriptyline].", "A double-blind trial with amitriptyline and lofepramine in the treatment of endogenous depression.", "A comparative trial of fluoxetine and amitriptyline in patients with major depressive disorder." ]

[ "General practice depressives were treated for 6 weeks with amitriptyline or placebo in a controlled trial. Overall, drug was found strongly superior to placebo. Interactions were examined between drug effects and a number of variables, principally reflecting demographic characteristics, history of illness, severity of illness, and endogenous depression separately in symptoms and stress. Only in the area of severity were significant interactions found. Amitriptyline was superior to placebo in probable or definite major depression on the Research Diagnostic Criteria, but not in minor depression. It was also superior to placebo in subjects with initial scores on the Hamilton Depression Scale of 13-15, and 16 or more, but not with lower scores. Findings indicate that tricyclic antidepressants are of considerable benefit in relatively mild depressions, except in the mildest range.", "A 6-week, double-blind, dose titration study was performed to evaluate efficacy and safety of the new antidepressant Org 3770 in comparison with amitriptyline and placebo.\n One hundred fifty outpatients of both sexes, 18 years and older, with a DSM-III diagnosis of major depressive episode, were randomly assigned to 6 weeks of treatment with Org 3770, amitriptyline, or placebo.\n At baseline, mean 17-item Hamilton Rating Scale for Depression (HAM-D) scores of all treatment groups were higher than 25, thus indicating that a large proportion of severely depressed patients entered the study. The overall mean daily doses were 22 mg/day for Org 3770, 133 mg/day for amitriptyline, and 4.9 capsules/day for placebo. The majority of times assessments were made, both active drugs produced significantly greater improvements than placebo on all efficacy variables (17-item HAM-D, Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions, and Zung Self-Rating Depression Scale). After 6 weeks of treatment, significantly greater (p < or = .05) proportions of patients in both active treatment groups (70% in the Org 3770- and 58% in the amitriptyline-treatment groups) than in the placebo-treatment group (33%) were HAM-D responders. Org 3770 was well tolerated in this study; dry mouth and somnolence were the only adverse experiences that occurred significantly more frequently with Org 3770- than with placebo-treated patients. By contrast, treatment with amitriptyline was related to significantly higher rates of dry mouth, constipation, and dyspepsia as compared with both Org 3770 and placebo, and significantly higher rates of somnolence as compared with placebo.\n In this study, Org 3770 was as effective as amitriptyline in the treatment of major depression, with advantages regarding improvements of depressed mood (HAM-D Item 1), responder rates, and safety.", "Depressed patients in general practice were included in a double-blind placebo-controlled six-week trial of amitriptyline (median dose 125 mg). The patients were relatively mildly ill and satisfied diagnostic criteria for depression and treatment with antidepressants in routine practice. Amitriptyline was found to be considerably superior to placebo after six weeks and significantly so as early as two weeks after the start of treatment. The effects of the antidepressant were on the core symptoms of depression, and were apparent in all but the most mildly ill patients. The findings suggest that tricyclic antidepressants are of considerable therapeutic benefit to depressed patients in general practice.", "Patients (n = 150) were randomized to a 6-week, double-blind study to evaluate the relative efficacy and safety of mirtazapine, amitriptyline, and placebo in the treatment of major depressive disorder symptoms. Average daily modal doses were mirtazapine, 18 mg; amitriptyline, 111 mg; and placebo, 4.6 capsules. Mirtazapine- and amitriptyline-treated patients had statistically significantly greater mean Hamilton Rating Scale for Depression (HAM-D) score reductions (weekly visits 1, 2, 4, and endpoint) compared to placebo. These findings were supported by the Montgomery-Asberg Depression Rating Scale (MADRS); the Zung Self-rating Depression Scale (SDS); and the Clinical Global Impressions (CGI) scales. Somnolence and weight gain were the only adverse clinical experiences (ACEs) reported substantially more often by mirtazapine-treated patients than by those in the placebo group. However, more amitriptyline-treated patients reported decreased visual accommodation, dry mouth, dyspepsia, constipation, tachycardia, hypertension, hypotension, discoordination, dizziness, and tremor than mirtazapine- or placebo-treated patients. Results of this study indicate that mirtazapine is more effective than placebo in the treatment of these patients, and superior to amitriptyline in respect to anticholinergic and cardiovascular effects.", "To assess the response to a serotonergic/noradrenergic tricyclic antidepressant, amitriptyline (AMI), in a group of adolescents with treatment-resistant major depressive disorder (MDD).\n Twenty-seven depressed adolescents admitted to a state hospital underwent a 10-week randomized, controlled trial with a flexible dose of AMI or placebo.\n There were no differences between patients taking AMI (n = 13) and placebo (n = 14). Both treatment groups showed approximately 70% to 80% improvement on the clinical outcome measurements, and 65% to 70% showed functional improvement. At the end of the protocol, 30% of patients still fulfilled criteria for MDD and had impaired functioning. Patients taking AMI experienced significantly more dry mouth and tachycardia. The final AMI dose was 173.1 mg/day +/- 56.3 mg/day; blood levels were 226.2 ng/mL +/- 80.8 ng/mL.\n No significant differences were found between AMI and placebo, in part because of the high placebo response rate. Although both treatment groups showed substantial response, at the end of treatment a substantial proportion of patients still had MDD of subsyndromal symptoms of depression. This and other studies of tricyclic antidepressants question the use of this medication as first-line treatment for youths with MDD.", "To determine amitriptyline's (AMI) efficacy in the acute treatment of adolescent major depressive disorder (MDD).\n Subjects aged 12 through 17 years meeting Research Diagnostic Criteria for MDD, diagnosed with the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS), participated in a 2-week placebo-washout followed by an 8-week, randomized, double-blind, parallel-design, placebo-controlled trial of AMI, 5 mg/kg per day. The K-SADS nine-item scale, the Hamilton Depression Rating Scale, and the Clinical Global Impressions rating scale were used as outcome measures.\n Thirty-one subjects were randomized (18 AMI, 13 placebo). Twenty-two subjects were study completers (12 AMI, 10 placebo). AMI's efficacy was suggested by the Clinical Global Impressions but not the K-SADS-derived data. Perhaps the primary limitation of the current study is its small sample size.\n No definitive recommendation can be made regarding the efficacy of tricyclic antidepressants in the treatment of adolescent MDD.", "Lofepramine, a new tricycle antidepressant, is compared with amitriptyline in a double-blind study. A brief pharmacological description of the drug is made emphasizing its low toxicity and anticholinergic peripheral effects, high plasmatic concentration levels and good tolerance and elimination in comparison with some other known tricycle antidepressants. Sixty depressive outpatients of a Mental Health Service in Lima, 5 male and 55 female, aging 16 to 65, 29 endogenous and 31 neurotic were studied with both drugs in a equimolar dosage. Through the chi square test, no statistical significance was found in maximal therapeutic response, Hamilton Depression Rating Scale scores, type of depression, and side-effects xerostomy which is lesser with lofepramine. A discussion of these results is made and it is concluded that in the present study lofepramine compared with amitriptyline has a similar therapeutic effect. Though not statistically significant, lofepramine seems to be better for neurotic depression and patients sensitive to anticholinergic side-effects.", "A double-blind trial was undertaken to compare the antidepressant efficacy and the side effects of Lofepramine with those of Amitriptyline in the treatment of endogenous depression. The study involves 22 acutely ill endogenously depressive patients. 11 patients were treated with Lofepramine and the remaining 11 with Amitriptyline. The results demonstrate that both substances are effective in the treatment of depression. However, the therapeutical efficacy of Lofepramine is significantly greater than that of Amitriptyline. Furthermore, the tolerance of Lofepramine is better than that of Amitriptyline, and the side effects of Amitriptyline, especially in blood pressure dysregulation, are greater than those of Lofepramine.", "The efficacy and safety of fluoxetine, a new antidepressant agent, were assessed in a double-blind, parallel, randomized study of 44 outpatients with major depressive disorder. Following a 1-week placebo period, patients were randomly assigned to either fluoxetine or amitriptyline for a period of 5 weeks. The mean maintenance dosages were 55 mg/day for fluoxetine and 159 mg/day for amitriptyline. Both drugs were effective in relieving the symptoms of depression. The most frequently reported side effects were nausea and nervousness for fluoxetine, and dry mouth, dizziness, and drowsiness for amitriptyline." ]

[ "15499601", "11843249", "11697833", "17374742", "12243809", "3528055", "7844608", "12506176", "11955734" ]

[ "Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer.", "Randomised trial of SIR-Spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer.", "Randomized comparison of early versus late hyperfractionated thoracic irradiation concurrently with chemotherapy in limited disease small-cell lung cancer: a randomized phase II study of the Hellenic Cooperative Oncology Group (HeCOG).", "A randomized study with or without intensified maintenance chemotherapy in patients with acute promyelocytic leukemia who have become negative for PML-RARalpha transcript after consolidation therapy: the Japan Adult Leukemia Study Group (JALSG) APL97 study.", "Phase III study comparing chemotherapy and radiotherapy with preoperative chemotherapy and surgical resection in patients with non-small-cell lung cancer with spread to mediastinal lymph nodes (N2); final report of RTOG 89-01. Radiation Therapy Oncology Group.", "Survival results from a phase III study of simultaneous versus 1-hour sequential methotrexate-5-fluorouracil chemotherapy in head and neck cancer.", "Randomized trial of hyperfractionated radiation therapy with or without concurrent chemotherapy for stage III non-small-cell lung cancer.", "An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer.", "A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients." ]

[ "Selective internal radiation therapy (SIRT) with SIR-Spheres(R) is a new technique for selectively targeting high doses of radiation to tumours within the liver. The primary objectives of this randomised trial were to compare the response rate, time to progressive disease (PD), and toxicity of a regimen of systemic fluorouracil/leucovorin chemotherapy versus the same chemotherapy plus a single administration of SIR-Spheres in patients with advanced colorectal liver metastases. The trial was designed to presage a larger trial that would have survival as the primary outcome.\n Twenty-one patients with previously untreated advanced colorectal liver metastases, with or without extrahepatic metastases, were randomised into the study.\n Using RECIST criteria, the response rate for 11 patients receiving the combination treatment was significantly greater than for 10 patients receiving chemotherapy alone (First Integrated Response; 10 PR, 1 SD vs. 0 PR, 6 SD, 4 PD, P < 0.001 and Best Confirmed Response; 8 PR, 3 SD vs. 0 PR, 6 SD, 4 PD P < 0.001). The time to PD was greater for patients receiving the combination treatment (18.6 months vs. 3.6 months, P < 0.0005). Median survival was significantly longer for patients receiving the combination treatment (29.4 months vs. 12.8 months, P = 0.02). One patient in the combination arm died from chemotherapy induced neutropenic sepsis after the fourth chemotherapy cycle. There were more Grade 3 and 4 toxicity events in patients receiving the combination treatment. There was no difference in quality-of-life over a 3 month period between the two treatments when rated by patients (P = 0.96) or physicians (P = 0.98).\n This small phase 2 randomised trial demonstrated that the addition of a single administration of SIR-Spheres to a regimen of systemic fluorouracil/leucovorin chemotherapy significantly increased both treatment related response, time to PD, and survival with acceptable toxicity. The combination of SIR-Spheres plus systemic chemotherapy is now the subject of ongoing trials to further define patient benefit.\n (c) 2004 Wiley-Liss, Inc.", "SIR-Spheres are radioactive yttrium90 microspheres (SIR-Spheres, Sirtex Medical Limited, Australia) used to selectively target high levels of ionising radiation to tumors within the liver. This trial was designed to measure any increased patient benefit by adding a single administration of SIR-Spheres to a regimen of regional hepatic artery chemotherapy (HAC) administered as a 12 day infusion of floxuridine and repeated at monthly intervals, vs. the same chemotherapy alone.\n A phase III randomised clinical trial entering 74 patients was undertaken on patients with bi-lobar non-resectable liver metastases from primary adenocarcinoma of the large bowel. Patient benefit criteria assessed in the trial were tumor response, time to disease progression in the liver, overall survival, quality of life, and treatment related toxicity. Tumor response was measured by serial changes in both cross-sectional tumor areas and total tumor volumes, provided any response lasted not less than three months as well as changes in serum carcino-embryonic antigen (CEA).\n The partial and complete response rate (PR + CR) was significantly greater for patients receiving SIR-Spheres when measured by tumor areas (44%) vs. 17.6%, P = 0.01) tumor volumes (50% vs. 24%, P = 0.03) and CEA (72% vs. 47%, P = 0.004). The median time to disease progression in the liver was significantly longer for patients receiving SIR-Spheres in comparison to patients receiving HAC alone when measured by either tumor areas (9.7 vs. 15.9 months, P = 0.001), tumor volumes (7.6 vs. 12.0 months, P = 0.04) or CEA (5.7 vs. 6.7 months, P = 0.06). The one, two, three and five-year survival for patients receiving SIR-Spheres was 72%, 39%, 17% and 3.5%, compared to 68%, 29%, 6.5% and 0% for HAC alone. Cox regression analysis suggests an improvement in survival for patients treated with SIR-Spheres who survive more than 15 months (P = 0.06). There was no increase in grade 3-4 treatment related toxicity and no loss of quality of life for patients receiving SIR-Spheres in comparison to patients receiving HAC alone.\n The combination of a single injection of SIR-Spheres plus HAC is substantially more effective in increasing tumor responses and progression free survival than the same regimen of HAC alone.", "Concurrent platinum etoposide chemotherapy given in combination with hyperfractionated thoracic radiation therapy (HTRT) in limited disease (LD) small cell lung cancer (SCLC) is associated with a high response rate and significant prolongation of survival. Given these results, the Hellenic Cooperative Oncology Group (HeCOG) performed a multicenter randomized phase II study in patients with LD SCLC to evaluate the timing of HTRT (early vs. late) when given concurrently with chemotherapy.\n To be eligible for the study, patients were required to have histologically or cytologically proven LD SCLC, confined to one hemithorax and/or ipsilateral mediastinal or supraclavicular lymphnodes and absence of pleural effusion or controlateral supraclavicular lymphnode involvement. Moreover, patients had to have a good performance status and adequate haematological, liver and renal function. Patients with LD SCLC were randomized to receive HTRT either concurrently with the first (Group A) or with the fourth (Group B) cycle of chemotherapy. Chemotherapy consisted of carboplatin administered at an AUC of six given as an i.v. 1-hour-infusion immediately followed by etoposide at a dose of 100 mg/m2 i.v. as a two-hour infusion for three consecutive days every three weeks up to a total of six cycles. Prophylactic cranial irradiation was also given to patients achieving a complete response.\n 42 and 39 patients, were eligible for efficacy evaluation in group A and B respectively. The overall response rate was 76% in group A and 92.5% in group B (P = 0.07) with a complete response rate of 40.5% and 56.5%, respectively. After a median follow-up of 35 months, time to progression was 9.5 months in group A and 10.5 in group B (NS) while overall median survival was 17.5 and 17 months respectively (NS). The 2-year survival was 36% in group A and 29% in group B (NS) and the 3-year survival 22% and 13%, respectively (NS). The distant relapse rate was 38% in group A and 61% in group B (P = 0.046). Severe grade 3 4 anemia was recorded in 19% of group A and 12.5% of group B (NS), while severe leucopenia was recorded in 35.5% and 20.5% (P = 0.09) and neutropenic fever in 5% and 2.5% (NS), respectively. Severe thrombocytopenia did not differ significantly between the two treatment groups being 21.5% and 23%, respectively. Severe grade 2-3 esophageal toxicity was 19% in group A and 23% in group B (NS), while grade 3 lung toxicity was 5% and 7.5% (NS), respectively. No toxicity-related deaths were recorded.\n Concurrent administration of HTRT with carboplatin etoposide is associated with a high response and survival rate. Although a trend for higher response rate was recorded in the group of patients who received late HTRT, the overall median, 2-year and 3-year survival rates did not differ significantly between the two treatment groups. The toxicity of this promising therapeutic approach was acceptable. Comparative phase III studies with an adequate number of patients are recommended in order to answer this question.", "To examine the efficacy of intensified maintenance chemotherapy, we conducted a prospective multicenter trial in adult patients with newly diagnosed acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy. Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission. Predicted 6-year overall survival in all assessable patients and disease-free survival in patients who achieved complete remission were 83.9% and 68.5%, respectively. A total of 175 patients negative for PML-RARalpha at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86). Predicted 6-year disease-free survival was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the 2 groups (P = .20). Predicted 6-year survival of patients assigned to the observation was 98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = .014). These results indicate that the intensified maintenance chemotherapy did not improve disease-free survival, but rather conferred a significantly poorer chance of survival in acute promyelocytic leukemia patients who have become negative for the PML-RARalpha fusion transcript after 3 courses of intensive consolidation therapy.", "To compare the outcome of treatment of mediastinoscopy-verified N2 non-small-cell lung cancer treated with induction chemotherapy followed by either surgery or radiotherapy (RT), with both options followed by consolidation chemotherapy.\n A randomized Phase III trial for Stage IIIA (T1-T3N2M0) non-small cell lung cancer was conducted by the Radiation Therapy Oncology Group (RTOG) and Eastern Cooperative Oncology Group between April 1990 and April 1994. After documentation of N2 disease by mediastinoscopy or anterior mediastinotomy, patients received induction chemotherapy with cisplatin, vinblastine, and mitomycin-C. Mitomycin-C was later dropped from the induction regimen. Patients were then randomized to surgery or RT (64 Gy in 7 weeks) followed by cisplatin and vinblastine.\n RTOG 89-01 accrued 75 patients, of whom 73 were eligible and analyzable. Twelve patients received induction chemotherapy but were not randomized to RT or surgery thereafter. Forty-five patients were randomized to postinduction RT or surgery. Of the analyzable patients, 90% had a Karnofsky performance score of 90-100, 18% had weight loss >5%, 37% had squamous cell histologic features, and 54% had bulky N2 disease. The distribution of bulky N2 disease was uniform among the treatment arms. The incidence of Grade 4 toxicity was 56% in patients receiving mitomycin-C and 29% in those who did not. Only 1 patient in each group had acute nonhematologic toxicity greater than Grade 3 (nausea and vomiting). No acute Grade 4 radiation toxicity developed. The incidences of long-term toxicity were equivalent across the arms. Three treatment-related deaths occurred: 2 patients in the surgical arms (one late pulmonary toxicity and one pulmonary embolus), and 1 patient in the radiation arm (radiation pneumonitis). Induction chemotherapy was completed in 78% of the patients. Complete resection was performed in 73% of 26 patients undergoing thoracotomy. Consolidation chemotherapy was completed in 75% of the patients. No statistically significant difference was found among the treatment arms. The overall progression-free survival rate was 53% at 1 year and 17% at 3 years. The median progression-free survival was 14 months. No difference in the 1-year survival rate (70% vs. 66%) or median survival time (19.4 vs. 17.4 months) between the surgery and RT arms. The median survival in the patients receiving induction chemotherapy only was 8.9 months. Mitomycin-C had no impact on survival (p = 0.75). No statistically significant difference was noted in the time to local failure between the surgical and RT arms.\n The patient accrual to this trial made its results inconclusive, but several observations are notable. In this trial, histologic confirmation of N2 disease in the surgical and nonsurgical arms eliminated the usual biases from clinical staging. In this setting, local control and survival were essentially equal between the surgical and RT arms. The 3- and 5-year survival rates of nonsurgical therapy were comparable to published surgical trials of N2 disease.", "There were 79 patients with squamous cell head and neck cancer randomized to receive simultaneous or 1 hour sequential methotrexate-5 fluorouracil (MTX--5-FU) chemotherapy: 47 patients were previously untreated and 32 patients had recurrent disease. The treatment groups were comparable for important prognostic features. The median survival for the 47 newly presenting patients was 22 months and for recurrent disease patients was 14 months. No difference could be detected in the survival of patients who received simultaneous versus sequential chemotherapy. When only chemotherapy responders were compared, no difference in survival was detected for those who received sequential versus simultaneous therapy. Subsequently, 19 chemotherapy responders received radical radiation therapy, and 15 were rendered disease-free whereas only 4 of 17 chemotherapy nonresponders were rendered disease-free by subsequent radiation (P = .002). The survival of the 19 chemotherapy responders was 34 months compared with 16 months for the 17 chemotherapy nonresponders treated with radiation. We conclude that there is no therapeutic advantage for 1 hour sequential MTX-5 FU chemotherapy compared with simultaneous use of these drugs in squamous cell head and neck cancer. Chemotherapy responders are more likely to respond to radiation therapy.", "To investigate the efficacy of combined hyperfractionated radiation therapy (HFX RT) and concurrent chemotherapy (CHT) in stage IIIA or IIIB non-small-cell lung cancer (NSCLC) compared with that of HFX RT alone.\n Between January 1988 and December 1989, 169 patients were divided randomly into the following groups: group I, HFX RT with 1.2 Gy twice daily to a total dose of 64.8 Gy (n = 61); group II, same HFX RT with CHT consisting of 100 mg of carboplatin (CBDCA) on days 1 and 2 and 100 mg of etoposide (VP-16) on days 1 to 3 of each week during the RT course (n = 52); and group III, same HFX RT with CHT consisting of 200 mg of CBDCA on days 1 and 2 and 100 mg of VP-16 on days 1 to 5 of the first, third, and fifth weeks of the RT course (n = 56).\n The median survival time (MST) was 8 months for group I, 18 months for group II, and 13 months for group III. The 3-year survival rates were 6.6%, 23%, and 16%, respectively. There was a significant difference in the survival rate between groups I and II (P = .0027, log-rank test), but not between groups I and III (P = .17) or between groups II and III (P = .14). The relapse-free survival rate in group II was also higher than that in group I (P = .0024), which was largely due to improved local control in group II patients. Patients in groups II and III showed a higher incidence of acute and/or late high-grade toxicity compared with group I patients, but no patient died of treatment-related toxicity.\n The combination of HFX RT and continuous CBDCA/VP-16 CHT was tolerable and substantially increased the survival rate.", "The Head and Neck Intergroup conducted a phase III randomized trial to test the benefit of adding chemotherapy to radiation in patients with unresectable squamous cell head and neck cancer.\n Eligible patients were randomly assigned between arm A (the control), single daily fractionated radiation (70 Gy at 2 Gy/d); arm B, identical radiation therapy with concurrent bolus cisplatin, given on days 1, 22, and 43; and arm C, a split course of single daily fractionated radiation and three cycles of concurrent infusional fluorouracil and bolus cisplatin chemotherapy, 30 Gy given with the first cycle and 30 to 40 Gy given with the third cycle. Surgical resection was encouraged if possible after the second chemotherapy cycle on arm C and, if necessary, as salvage therapy on all three treatment arms. Survival data were compared between each experimental arm and the control arm using a one-sided log-rank test.\n Between 1992 and 1999, 295 patients were entered on this trial. This did not meet the accrual goal of 362 patients and resulted in premature study closure. Grade 3 or worse toxicity occurred in 52% of patients enrolled in arm A, compared with 89% enrolled in arm B (P <.0001) and 77% enrolled in arm C (P <.001). With a median follow-up of 41 months, the 3-year projected overall survival for patients enrolled in arm A is 23%, compared with 37% for arm B (P =.014) and 27% for arm C (P = not significant).\n The addition of concurrent high-dose, single-agent cisplatin to conventional single daily fractionated radiation significantly improves survival, although it also increases toxicity. The loss of efficacy resulting from split-course radiation was not offset by either multiagent chemotherapy or the possibility of midcourse surgery.", "To evaluate the role of adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma (NPC) patients, we conducted a randomized Phase III trial comparing radiotherapy (RT) followed by adjuvant chemotherapy to RT alone in patients with advanced NPC.\n Between November 1994 and March 1999, 157 patients with Stage IV, M(0) (UICC/AJCC, 1992) advanced NPC disease were randomized to receive standard radiotherapy, as follows: 35-40 fractions, 1.8-2.0 Gy/fraction/day, 5 days/week, to a total dose 70-72 Gy with or without 9 weekly cycles of 24-h infusional chemotherapy (20 mg/m(2) cisplatin, 2,200 mg/m(2) 5-fluorouracil, and 120 mg/m(2) leucovorin) after RT. Of 157 patients enrolled, 154 (77 radiotherapy, 77 combined therapy) were evaluable for survival and toxicity analysis.\n With a median follow-up of 49.5 months, the 5-year overall survival and relapse-free survival rates were 60.5% vs. 54.5% (p = 0.5) and 49.5% vs. 54.4% (p = 0.38) for the radiotherapy-alone group and the combined radiotherapy and adjuvant chemotherapy group, respectively. The Cox regression showed that the hazard rates ratio of combined treatment to RT alone was 0.673 (p value = 0.232); the 95% confidence interval was 0.352 and 1.288, respectively. Patients who received combined treatment had a lower systemic relapse rate than radiotherapy-alone patients, according to relapse pattern analysis. The incidence of leukopenia (>or= Grade 3) occurred in 17 out of 819 (2.1%) cycles of weekly chemotherapy. No patient developed moderate to severe mucositis (>or= Grade 3).\n We conclude that adjuvant chemotherapy after RT for patients with advanced NPC has no benefit for overall survival or relapse-free survival." ]

[ "20375190", "12052800", "15158629", "9651405", "16168782", "20882421", "11433046", "21829969", "20619853" ]

[ "A randomized controlled trial of the effect of zinc as adjuvant therapy in children 2-35 mo of age with severe or nonsevere pneumonia in Bhaktapur, Nepal.", "Effect of routine zinc supplementation on pneumonia in children aged 6 months to 3 years: randomised controlled trial in an urban slum.", "Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial.", "Zinc supplementation reduces the incidence of acute lower respiratory infections in infants and preschool children: a double-blind, controlled trial.", "Effect of weekly zinc supplements on incidence of pneumonia and diarrhoea in children younger than 2 years in an urban, low-income population in Bangladesh: randomised controlled trial.", "Zinc supplementation in severe acute lower respiratory tract infection in children: a triple-blind randomized placebo controlled trial.", "Reducing antibiotic use in children: a randomized trial in 12 practices.", "Antibiotic treatment schemes for very severe community-acquired pneumonia in children: a randomized clinical study.", "Oral zinc for the treatment of acute gastroenteritis in Polish children: a randomized, double-blind, placebo-controlled trial." ]

[ "Pneumonia is a leading cause of illness and death in young children. Interventions to improve case management of pneumonia are needed.\n Our objective was to measure the effect of zinc supplementation in children with pneumonia in a population in which zinc deficiency is common.\n In a double-blind, placebo-controlled clinical trial, children aged 2-35 mo with severe (n = 149) or nonsevere (n = 2479) pneumonia defined according to criteria established by the World Health Organization were randomly assigned to receive zinc (10 mg for children aged 2-11 mo, 20 mg for children aged > or =12 mo) or placebo daily for 14 d as an adjuvant to antibiotics. The primary outcomes were treatment failure, defined as a need for change in antibiotics or hospitalization, and time to recovery from pneumonia.\n One of 5 children did not respond adequately to antibiotic treatment; the odds ratios between zinc and placebo groups for treatment failure were 0.95 (95% CI: 0.78, 1.2) for nonsevere pneumonia and 0.97 (95% CI: 0.42, 2.2) for severe pneumonia. There was no difference in time to recovery between zinc and placebo groups for nonsevere (median: 2 d; hazard ratio: 1.0; 95% CI: 0.96, 1.1) or severe (median: 4 d; hazard ratio: 1.1; 95% CI: 0.79, 1.5) pneumonia. Regurgitation or vomiting < or =15 min after supplementation was observed more frequently among children in the zinc group than among those in the placebo group during the supplementation period (37% compared with 13%; odds ratio: 0.25; 95% CI: 0.20, 0.30).\n Adjuvant treatment with zinc neither reduced the risk of treatment failure nor accelerated recovery in episodes of nonsevere or severe pneumonia. This trial was registered at clinicaltrials.gov as NCT00148733.", "To evaluate the effect of daily zinc supplementation in children on the incidence of acute lower respiratory tract infections and pneumonia.\n Double masked, randomised placebo controlled trial.\n A slum community in New Delhi, India.\n 2482 children aged 6 to 30 months.\n Daily elemental zinc, 10 mg to infants and 20 mg to older children or placebo for four months. Both groups received single massive dose of vitamin A (100 000 IU for infants and 200 000 IU for older children) at enrollment.\n All households were visited weekly. Any children with cough and lower chest indrawing or respiratory rate 5 breaths per minute less than the World Health Organization criteria for fast breathing were brought to study physicians.\n At four months the mean plasma zinc concentration was higher in the zinc group (19.8 (SD 10.1) v 9.3 (2.1) micromol/l, P<0.001). The proportion of children who had acute lower respiratory tract infection during follow up was no different in the two groups (absolute risk reduction -0.2%, 95% confidence interval -3.9% to 3.6%). Zinc supplementation resulted in a lower incidence of pneumonia than placebo (absolute risk reduction 2.5%, 95% confidence interval 0.4% to 4.6%). After correction for multiple episodes in the same child by generalised estimating equations analysis the odds ratio was 0.74, 95% confidence interval 0.56 to 0.99.\n Zinc supplementation substantially reduced the incidence of pneumonia in children who had received vitamin A.", "Pneumonia is a leading cause of morbidity and mortality in young children. Early reversal of severity signs--chest indrawing, hypoxia, and tachypnoea--improves outcome. We postulated that zinc, an acute phase reactant, would shorten duration of severe pneumonia and time in hospital.\n In a double-blind placebo-controlled clinical trial in Matlab Hospital, Bangladesh, 270 children aged 2-23 months were randomised to receive elemental zinc (20 mg per day) or placebo, plus the hospital's standard antimicrobial management, until discharge. The outcomes were time to cessation of severe pneumonia (no chest indrawing, respiratory rate 50 per min or less, oxygen saturation at least 95% on room air) and discharge from hospital. Discharge was allowed when respiratory rate was 40 per minute or less for 24 consecutive hours while patients were maintained only on oral antibiotics.\n The group receiving zinc had reduced duration of severe pneumonia (relative hazard [RH]=0.70, 95% CI 0.51-0.98), including duration of chest indrawing (0.80, 0.61-1.05), respiratory rate more than 50 per min (0.74, 0.57-0.98), and hypoxia (0.79, 0.61-1.04), and overall hospital duration (0.75, 0.57-0.99). The mean reduction is equivalent to 1 hospital day for both severe pneumonia and time in hospital. All effects were greater when children with wheezing were omitted from the analysis.\n Adjuvant treatment with 20 mg zinc per day accelerates recovery from severe pneumonia in children, and could help reduce antimicrobial resistance by decreasing multiple antibiotic exposures, and lessen complications and deaths where second line drugs are unavailable.", "Increased acute lower respiratory infection incidence, severity, and mortality are associated with malnutrition, and reduced immunological competence may be a mechanism for this association. Because zinc deficiency results in impaired immunocompetence and zinc supplementation improves immune status, we hypothesized that zinc deficiency is associated with increased incidence and severity of acute lower respiratory infection.\n We evaluated the effect of daily supplementation with 10 mg of elemental zinc on the incidence and prevalence of acute lower respiratory infection in a double-blind, randomized, controlled trial in 609 children (zinc, n = 298; control, n = 311) 6 to 35 months of age. Supplementation and morbidity surveillance were done for 6 months.\n After 120 days of supplementation, the percentage of children with plasma zinc concentrations <60 microg/dL decreased from 35.6% to 11.6% in the zinc group, whereas in the control group it increased from 36.8% to 43.6%. Zinc-supplemented children had 0.19 acute lower respiratory infection episodes/child/year compared with 0.35 episodes/child/year in the control children. After correction for correlation of data using generalized estimating equation regression methods, there was a reduction of 45% (95% confidence interval, 10% to 67%) in the incidence of acute lower respiratory infections in zinc-supplemented children.\n A dietary zinc supplement resulted in a significant reduction in respiratory morbidity in preschool children. These findings suggest that interventions to improve zinc intake will improve the health and survival of children in developing countries.", "Pneumonia and diarrhoea cause much morbidity and mortality in children younger than 5 years. Most deaths occur during infancy and in developing countries. Daily regimens of zinc have been reported to prevent acute lower respiratory tract infection and diarrhoea, and to reduce child mortality. We aimed to examine whether giving zinc weekly could prevent clinical pneumonia and diarrhoea in children younger than 2 years.\n 1665 poor, urban children aged 60 days to 12 months were randomly assigned zinc (70 mg) or placebo orally once weekly for 12 months. Children were assessed every week by field research assistants. Our primary outcomes were the rate of pneumonia and diarrhoea. The rates of other respiratory tract infections were the secondary outcomes. Growth, final serum copper, and final haemoglobin were also measured. Analysis was by intention to treat.\n 34 children were excluded before random assignment to treatment group because they had tuberculosis. 809 children were assigned zinc, and 812 placebo. After treatment assignment, 103 children in the treatment group and 44 in the control group withdrew. There were significantly fewer incidents of pneumonia in the zinc group than the control group (199 vs 286; relative risk 0.83, 95% CI 0.73-0.95), and a small but significant effect on incidence of diarrhoea (1881 cases vs 2407; 0.94, 0.88-0.99). There were two deaths in the zinc group and 14 in the placebo group (p=0.013). There were no pneumonia-related deaths in the zinc group, but ten in the placebo group (p=0.013). The zinc group had a small gain in height, but not weight at 10 months compared with the placebo group. Serum copper and haemoglobin concentrations were not adversely affected after 10 months of zinc supplementation.\n 70 mg of zinc weekly reduces pneumonia and mortality in young children. However, compliance with weekly intake might be problematic outside a research programme.", "To evaluate the efficacy of zinc supplementation on duration of illness in children with severe acute lower respiratory tract infection (ALRTI).\n This randomized triple-blind placebo-controlled trial was conducted in pediatric emergency of a teaching referral hospital. Children in the age group of 2-24 months presenting to pediatric emergency with severe ALRTI were included. Eligible children were randomly allocated to zinc (n=53) or control (n=53) groups. Zinc group received 20 mg of elemental zinc per day (5 ml syrup per day) as a single daily dose for 5 days. Control group received an equal amount of placebo which was appropriately modified to give the taste, smell, color and consistency similar to zinc mixture. Primary outcome was 'time to be asymptomatic', a composite outcome defined as resolution of all four of the following: danger signs, respiratory distress, tachypnea and hypoxia in room air.\n Age, gender, nutritional status, pretreatment zinc levels and other demographic and clinical variables were similar in the two groups. 'Time to be asymptomatic' was comparable in the two groups (h; median (IQR): 60 (24-78) vs. 54 (30-72), P=0.98]. At any time point a similar proportion of children were symptomatic in both the groups. Time to resolution of respiratory distress, tachypnea, dangers signs and hypoxia were also similar in two groups. Duration of hospital stay was shorter by 9 h in the zinc group but the difference was statistically insignificant.\n Zinc supplementation did not reduce recovery time and duration of hospital stay in children with ALRTI. Larger randomized controlled trials are needed to evaluate role of zinc in ALRTI.", "To test whether an educational outreach intervention for families and physicians, based on the Centers for Disease Control and Prevention (CDC) principles of judicious antibiotic use, decreases antimicrobial drug prescribing for children younger than 6 years old. Setting. Twelve practices affiliated with 2 managed care organizations (MCOs) in eastern Massachusetts and northwest Washington State. Patients. All enrolled children younger than 6 years old.\n Practices stratified by MCO and size were randomized to intervention or control groups. The intervention included 2 meetings of the practice with a physician peer leader, using CDC-endorsed summaries of judicious prescribing recommendations; feedback on previous prescribing rates were also provided. Parents were mailed a CDC brochure on antibiotic use, and supporting materials were displayed in waiting rooms. Automated enrollment, ambulatory visit, and pharmacy claims were used to determine rates of antibiotic courses dispensed (antibiotics/person-year) during baseline (1996-1997) and intervention (1997-1998) years. The primary analysis (for children 3 to <36 months and 36 to <72 months) assessed the impact of the intervention among children during the intervention year, controlling for covariates including patient age and baseline prescription rate. Confirmatory analyses at the practice level were also performed.\n The practices cared for 14 468 and 13 460 children in the 2 study years, respectively; 8815 children contributed data in both years. Sixty-two percent of antibiotic courses were dispensed for otitis media, 6.5% for pharyngitis, 6.3% for sinusitis, and 9.2% for colds and bronchitis. Antibiotic dispensing for children 3 to <36 months old decreased 0.41 antibiotics per person-year (18.6%) in intervention compared with 0.33 (11.5%) in control practices. Among children 36 to <72 months old, the rate decreased by 0.21 antibiotics per person-year (15%) in intervention and 0.17 (9.8%) in control practices. Multivariate analysis showed an adjusted intervention effect of 16% in the younger and 12% in the older age groups. The direction and approximate magnitude of effect were confirmed in practice-level analyses.\n A limited simultaneous educational outreach intervention for parents and providers reduced antibiotic use among children in primary care practices, even in the setting of substantial secular trends toward decreased prescribing. Future efforts to promote judicious prescribing should continue to build on growing public awareness of antibiotic overuse.", "To compare clinical response to initial empiric treatment with oxacillin plus ceftriaxone and amoxicillin plus clavulanic acid in hospitalized children diagnosed with very severe community-acquired pneumonia (CAP).\n A prospective randomized clinical study was conducted among children 2 months to 5 years old with a diagnosis of very severe CAP in the pediatric ward of São Paulo State University Hospital in Botucatu, São Paulo, Brazil, from April 2007 to May 2008. Patients were randomly divided into two groups by type of treatment: an oxacillin/ceftriaxone group (OCG, n = 48) and an amoxicillin/clavulanic acid group (ACG, n = 56). Analyzed outcomes were: time to clinical improvement (fever and tachypnea), time on oxygen therapy, length of stay in hospital, need to widen antimicrobial spectrum, and complications (including pleural effusion).\n The two groups did not differ statistically for age, sex, symptom duration before admission, or previous antibiotic treatment. Time to improve tachypnea was less among ACG patients than OCG patients (4.8 ± 2.2 versus 5.8 ± 2.4 days respectively; P = 0.028), as was length of hospital stay (11.0 ± 6.2 versus 14.4 ± 4.5 days respectively; P = 0.002). There were no statistically significant differences between the two groups for fever improvement time, time on oxygen therapy, need to widen antimicrobial spectrum, or frequency of pleural effusion.\n Both treatment plans are effective in treating very severe CAP in 2-month-to 5-year-old hospitalized children. The only analyzed outcome that favored amoxicillin/clavulanic acid treatment was time required to improve tachypnea.\n ClinicalTrials.gov ID: NCT01166932.", "To evaluate the efficacy and safety of zinc in the treatment of acute gastroenteritis (AGE) in children in Poland.\n Children aged 3 to 48 months with AGE were enrolled in a randomized, double-blind, placebo-controlled trial in which they received zinc sulfate (10 or 20 mg/day depending on age) or placebo for 10 days. A total of 141 of 160 children recruited were available for intention-to-treat analysis. The primary outcome was the duration of diarrhea.\n In the experimental group (n = 69) compared with the control group (n = 72), there was no significant difference in the duration of diarrhea (P > .05). Similarly, there was no significant difference in the groups in secondary outcome measures such as stool frequency on days 1, 2, and 3, vomiting frequency, intravenous fluid intake, and the number of children with diarrhea lasting >7 days.\n Children living in a country where zinc deficiency is rare do not appear to benefit from the use of zinc in the treatment of AGE.\n Copyright © 2010 Mosby, Inc. All rights reserved." ]

[ "10988090", "9462190", "17015530", "8951252", "8948561", "9142019", "12386574", "9310511", "9347370" ]

[ "Continuous tracheal gas insufflation in preterm infants with hyaline membrane disease. A prospective randomized trial.", "Randomised trial of volume controlled versus time cycled, pressure limited ventilation in preterm infants with respiratory distress syndrome.", "Randomized, controlled trial comparing synchronized intermittent mandatory ventilation and synchronized intermittent mandatory ventilation plus pressure support in preterm infants.", "The Provo multicenter early high-frequency oscillatory ventilation trial: improved pulmonary and clinical outcome in respiratory distress syndrome.", "Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously.", "A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation.", "Optimization of mechanical ventilation support following cardiac surgery.", "Multicenter controlled clinical trial of high-frequency jet ventilation in preterm infants with uncomplicated respiratory distress syndrome.", "Patient-initiated, pressure-regulated, volume-controlled ventilation compared with intermittent mandatory ventilation in neonates: a prospective, randomised study." ]

[ "In mechanically ventilated neonates, the instrumental dead space is a major determinant of total minute ventilation. By flushing this dead space, continuous tracheal gas insufflation (CTGI) may allow reduction of the risk of overinflation. We conducted a randomized trial to evaluate the efficacy of CTGI in reducing airway pressure over the entire period of mechanical ventilation while maintaining oxygenation. A total of 34 preterm newborns, ventilated in conventional pressure-limited mode, were enrolled in two study arms, to receive or not receive CTGI. Transcutaneous Pa(CO(2)) (tcPa(CO(2))) was maintained at 40 to 46 mm Hg in both groups to ensure comparable alveolar ventilation. Respiratory data were collected several times during the first day and daily until Day 28. Both groups were similar at the time of inclusion. During the first 4 d of the study, the difference between peak pressure and positive end-expiratory pressure was significantly lower in the CTGI group by 18% to 35%, with the same tcPa(CO(2)) level and with no difference in the ratio of tcPa(O(2)) to fraction of inspired oxygen (245 +/- 29 versus 261 +/- 46 mm Hg [mean +/- SD] over the first 4 d). Extubation occurred sooner in the CTGI group (p < 0.05), and the duration of mechanical ventilation was shorter (median: 3.6 d; 25th to 75th quartiles: 1.5 to 12.0 d; versus median: 15.6 d; 25th to 75th quartiles: 7.9 to 22.2; p < 0.05) than in the non-CTGI group. CTGI allows the use of low-volume ventilation over a prolonged period and reduces the duration of mechanical ventilation.", "Fifty preterm infants weighing 1200 g or more with clinical and radiographic evidence of respiratory distress syndrome, requiring both mechanical ventilation and exogenous surfactant replacement, were randomly allocated to receive either volume controlled ventilation or time cycled, pressure limited ventilation. Tidal volume delivery in each group was deliberately controlled at 5-8 ml/kg so that the only difference between the two groups was the ventilatory modality, the manner in which tidal volume was delivered. The rest of the ventilatory management and clinical care was done according to protocol. The two modes of ventilation were compared by determining the time required to achieve pre-determined success criteria, based on either the alveolar-arterial oxygen gradient or the mean airway pressure as a standard against which the speed of weaning could be objectively assessed. Infants randomised to volume controlled ventilation met success criteria sooner and had a shorter duration of mechanical ventilation. These babies also had a significantly lower incidence of intraventricular haemorrhages and abnormal periventricular echodensities on ultrasound scans. Volume controlled ventilation seems to be both safe and effective in this group of patients.", "Prolonged mechanical ventilation is associated with lung injury in preterm infants. In these infants, weaning from synchronized intermittent mandatory ventilation may be delayed by their inability to cope with increased respiratory loads. The addition of pressure support to synchronized intermittent mandatory ventilation can offset these loads and may facilitate weaning.\n The purpose of this work was to compare synchronized intermittent mandatory ventilation and synchronized intermittent mandatory ventilation plus pressure support in weaning from mechanical ventilation and the duration of supplemental oxygen dependency in preterm infants with respiratory failure.\n Preterm infants weighing 500 to 1000 g at birth who required mechanical ventilation during the first postnatal week were randomly assigned to synchronized intermittent mandatory ventilation or synchronized intermittent mandatory ventilation plus pressure support. In both groups, weaning followed a set protocol during the first 28 days. Outcomes were assessed during the first 28 days and until discharge or death.\n There were 107 infants enrolled (53 synchronized intermittent mandatory ventilation plus pressure support and 54 synchronized intermittent mandatory ventilation). Demographic and perinatal data, mortality, and morbidity did not differ between groups. During the first 28 days, infants in the synchronized intermittent mandatory ventilation plus pressure support group reached minimal ventilator settings and were extubated earlier than infants in the synchronized intermittent mandatory ventilation group. Total duration of mechanical ventilation, duration of oxygen dependency, and oxygen need at 36 weeks' postmenstrual age alone or combined with death did not differ between groups. However, infants in synchronized intermittent mandatory ventilation plus pressure support within the 700- to 1000-g birth weight strata had a shorter oxygen dependency.\n The results of this study suggest that the addition of pressure support as a supplement to synchronized intermittent mandatory ventilation during the first 28 days may play a role in reducing the duration of mechanical ventilation in extremely low birth-weight infants, and it may lead to a reduced oxygen dependency in the 700- to 1000-g birth weight strata.", "To compare the hospital course and clinical outcome of preterm infants with respiratory distress syndrome treated with surfactant and managed with high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CV) as their primary mode of ventilator support.\n A prospective randomized clinical trial.\n Three community-based level III neonatal intensive care units.\n A total of 125 neonates who were 35 weeks or less estimated gestation requiring intubation and assisted ventilation for respiratory distress syndrome with arterial to alveolar oxygen ratio less than .50.\n Patients were randomized to continue CV (61 patients) or be changed to HFOV (64 patients) after exogenous surfactant administration (100 mg/kg). HFOV was used in a strategy to promote lung recruitment and maintain lung volume. Protocol respiratory care guidelines were followed; otherwise routine care was provided by each neonatal intensive care unit.\n No differences were noted in demographic features between the two study groups. The study population birth weight was 1.51 +/- .47 kg (mean +/- SD), gestational age was 30.9 +/- 2.5 weeks, and study entry age was 2 to 3 hours. Patients randomized to HFOV demonstrated the following significant findings compared with CV-treated patients: vasopressor support was less intensive; surfactant redosing was not as frequent; oxygenation improved more rapidly and remained higher during the first 7 days; fewer infants required prolonged supplemental oxygen or ventilator support; treatment failure was reduced; more patients survived without chronic lung disease at 30 days; need for continuous supplemental oxygen at discharge was less; frequency of necrotizing enterocolitis illness was lower; there were fewer abnormal hearing tests; and hospital costs were decreased. No differences were seen between the two study groups in the frequency or severity of patent ductus arteriosus, air leak, retinopathy of prematurity, or intraventricular hemorrhage. Length of hospital stay and survival to discharge were similar for HFOV- and CV-treated infants.\n When used early with a lung recruitment strategy, HFOV after surfactant replacement resulted in clinical outcomes consistent with a reduction in both acute and chronic lung injury. Benefit was evident for preterm infants both less than or equal to 1 kg and more than 1 kg. In addition, early HFOV treatment may have had a more global effect on patient health throughout the hospitalization, resulting in reduced morbidity and decreased health care cost.", "Prompt recognition of the reversal of respiratory failure may permit earlier discontinuation of mechanical ventilation, without harm to the patient.\n We conducted a randomized, controlled trial in 300 adult patients receiving mechanical ventilation in medical and coronary intensive care units. In the intervention group, patients underwent daily screening of respiratory function by physicians, respiratory therapists, and nurses to identify those possibly capable of breathing spontaneously; successful tests were followed by two-hour trials of spontaneous breathing in those who met the criteria. Physicians were notified when their patients successfully completed the trials of spontaneous breathing. The control subjects had daily screening but no other interventions. In both groups, all clinical decisions, including the decision to discontinue mechanical ventilation, were made by the attending physicians.\n Although the 149 patients randomly assigned to the intervention group had more severe disease, they received mechanical ventilation for a median of 4.5 days, as compared with 6 days in the 151 patients in the control group (P=0.003). The median interval between the time a patient met the screening criteria and the discontinuation of mechanical ventilation was one day in the intervention group and three days in the control group (P<0.001). Complications -- removal of the breathing tube by the patient, reintubation, tracheostomy, and mechanical ventilation for more than 21 days -- occurred in 20 percent of the intervention group and 41 percent of the control group (P=0.001). The number of days of intensive care and hospital care was similar in the two groups. Total costs for the intensive care unit were lower in the intervention group (median, $15,740, vs. $20,890 in the controls, P=0.03); hospital costs were lower, though not significantly so (median, $26,229 and $29,048, respectively; P=0.3).\n Daily screening of the respiratory function of adults receiving mechanical ventilation, followed by trials of spontaneous breathing in appropriate patients and notification of their physicians when the trials were successful, can reduce the duration of mechanical ventilation and the cost of intensive care and is associated with fewer complications than usual care.", "To compare a practice of protocol-directed weaning from mechanical ventilation implemented by nurses and respiratory therapists with traditional physician-directed weaning.\n Randomized, controlled trial.\n Medical and surgical intensive care units in two university-affiliated teaching hospitals.\n Patients requiring mechanical ventilation (n = 357).\n Patients were randomly assigned to receive either protocol-directed (n = 179) or physician-directed (n = 178) weaning from mechanical ventilation.\n The primary outcome measure was the duration of mechanical ventilation from tracheal intubation until discontinuation of mechanical ventilation. Other outcome measures included need for reintubation, length of hospital stay, hospital mortality rate, and hospital costs. The median duration of mechanical ventilation was 35 hrs for the protocol-directed group (first quartile 15 hrs; third quartile 114 hrs) compared with 44 hrs for the physician-directed group (first quartile 21 hrs; third quartile 209 hrs). Kaplan-Meier analysis demonstrated that patients randomized to protocol-directed weaning had significantly shorter durations of mechanical ventilation compared with patients randomized to physician-directed weaning (chi 2 = 3.62, p = .057, log-rank test; chi 2 = 5.12, p = .024, Wilcoxon test). Cox proportional-hazards regression analysis, adjusting for other covariates, showed that the rate of successful weaning was significantly greater for patients receiving protocol-directed weaning compared with patients receiving physician-directed weaning (risk ratio 1.31; 95% confidence interval 1.15 to 1.50; p = .039). The hospital mortality rates for the two treatment groups were similar (protocol-directed 22.3% vs. physician-directed 23.6%; p = .779). Hospital cost savings for patients in the protocol-directed group were $42,960 compared with hospital costs for patients in the physician-directed group.\n Protocol-guided weaning of mechanical ventilation, as performed by nurses and respiratory therapists, is safe and led to extubation more rapidly than physician-directed weaning.", "Mechanical ventilation (MV) is essential in the management of patients that underwent cardiac surgery and cardiopulmonary bypass. It has been demonstrated that MV dependence is directly related to morbidity incidence and ICU length of stay, with a strong impact on economic cost. Therefore identification of measures that can reduce MV interval, may reduce the incidence of respiratory complications and length of hospitalization. The aim of this study was to identify weaning indexes and adopt a weaning algorithm in order to optimize ventilatory support after cardiac surgery.\n Forty-nine patients with low and medium Higgins risk score, who underwent, between February and November 1999, elective surgery at our Institution, were enrolled in this study. All patients were randomized into 2 groups: Group I (weaning group - 24 patients), extubated with the aid of a weaning protocol, and Group II (control group - 25 patients), extubated with conservative weaning, dependent on the physician's subjective clinical judgment. All patients were successfully weaned from mechanical support.\n Intubation time was significantly lower in Group I than Group II and \"Fast Track Recovery\" group (p=0.05). ICU length of stay was also significantly lower in Group I (p=0.03). Analysis of weaning indexes did not show cut-off points predictive of successful weaning, except for PaO2/FiO2 ratio, which was higher in Group I (p=0.02).\n These results confirm that the use of a weaning algorithm enables the MV interval and hospital length of stay to be shortened, suggesting that it should be used in the management following cardiac surgery.", "To test the hypothesis that high-frequency jet ventilation (HFJV) will reduce the incidence and/or severity of bronchopulmonary dysplasia (BPD) and acute airleak in premature infants who, despite surfactant administration, require mechanical ventilation for respiratory distress syndrome.\n Multicenter, randomized, controlled clinical trial of HFJV and conventional ventilation (CV). Patients were to remain on assigned therapy for 14 days or until extubation, whichever came first. Crossover from CV to HFJV was allowed if bilateral pulmonary interstitial emphysema or bronchopleural fistula developed. Patients could cross over to the other ventilatory mode if failure criteria were met. The optimal lung volume strategy was mandated for HFJV by protocol to provide alveolar recruitment and optimize lung volume and ventilation/perfusion matching, while minimizing pressure amplitude and O2 requirements. CV management was not controlled by protocol.\n Eight tertiary neonatal intensive care units.\n Preterm infants with birth weights between 700 and 1500 g and gestational age <36 weeks who required mechanical ventilation with FIO2 >0.30 at 2 to 12 hours after surfactant administration, received surfactant by 8 hours of age, were <20 hours old, and had been ventilated for <12 hours. Outcome Measures. Primary outcome variables were BPD at 28 days and 36 weeks of postconceptional age. Secondary outcome variables were survival, gas exchange, airway pressures, airleak, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and other nonpulmonary complications.\n A total of 130 patients were included in the final analysis; 65 were randomized to HFJV and 65 to CV. The groups were of comparable birth weight, gestational age, severity of illness, postnatal age, and other demographics. The incidence of BPD at 36 weeks of postconceptional age was significantly lower in babies randomized to HFJV compared with CV (20.0% vs 40.4%). The need for home oxygen was also significantly lower in infants receiving HFJV compared with CV (5.5% vs 23.1%). Survival, incidence of BPD at 28 days, retinopathy of prematurity, airleak, pulmonary hemorrhage, grade I-II IVH, and other complications were similar. In retrospect, it was noted that the traditional HFJV strategy emphasizing low airway pressures (HF-LO) rather than the prescribed optimal volume strategy (HF-OPT) was used in 29/65 HFJV infants. This presented a unique opportunity to examine the effects of different HFJV strategies on gas exchange, airway pressures, and outcomes. HF-OPT was defined as increase in positive end-expiratory pressure (PEEP) by >/=1 cm H2O from pre-HFJV baseline and/or use of PEEP of >/=7 cm H2O. Severe neuroimaging abnormalities (PVL and/or grade III-IV IVH) were not different between the CV and HFJV infants. However, there was a significantly lower incidence of severe IVH/PVL in HFJV infants treated with HF-OPT compared with CV and HF-LO. Oxygenation was similar between CV and HFJV groups as a whole, but HF-OPT infants had better oxygenation compared with the other two groups. There were no differences in PaCO2 between CV and HFJV, but the PaCO2 was lower for HF-LO compared with the other two groups. The peak inspiratory pressure and DeltaP (peak inspiratory pressure-PEEP) were lower for HFJV infants compared with CV infants.\n HFJV reduces the incidence of BPD at 36 weeks and the need for home oxygen in premature infants with uncomplicated RDS, but does not reduce the risk of acute airleak. There is no increase in adverse outcomes compared with CV. HF-OPT improves oxygenation, decreases exposure to hypocarbia, and reduces the risk of grade III-IV IVH and/or PVL.", "To compare the effects of patient-initiated, pressure-regulated, volume-controlled ventilation (PRVC) with pressure-preset intermittent mandatory ventilation (IMV) in neonates with respiratory failure.\n Randomised, prospective study.\n Intensive care unit (14 beds) in a 300-bed paediatric teaching hospital.\n 60 neonates with respiratory distress syndrome (RDS) or congenital pneumonia, weighing < 2500 g and requiring mechanical ventilation.\n Ventilatory support until extubation via either IMV (n = 30) or PRVC (n = 27). In PRVC, the tidal volume (VT) was preset and pressure-controlled breaths delivered with peak inspiratory pressure values adapted to achieve the preset VT.\n Main outcome measures were duration of ventilation and incidence of bronchopulmonary dysplasia (BPD). Pulmonary air leaks and intraventricular haemorrhage (IVH) were considered major adverse effects. Demographic data, ventilation parameters and arterial/alveolar oxygen tension ratio were similar at randomisation. Duration of ventilation and incidence of BPD were not decreased by the use of PRVC. Air leaks occurred in 3 neonates in the PRVC group and in 7 babies treated with IMV (NS). The incidence of IVH grade > II was lower in babies treated with PRVC (p < 0.05). In a subgroup of neonates weighing < 1000 g, the duration of ventilation and incidence of hypotension were reduced in the PRVC group (p < 0.05).\n Patient-initiated, pressure-regulated, volume-controlled ventilation can be safely used in neonates and may contribute to a lower incidence of complications." ]

[ "15184205", "8296253", "7842191", "11405516", "9476870", "2148702", "17603828", "14514935", "8609098" ]

[ "Peak flow monitoring for guided self-management in childhood asthma: a randomized controlled trial.", "Controlled trial evaluation of an asthma education programme for adults.", "Asthma self-management education program by home monitoring of peak expiratory flow.", "Benefit from the inclusion of self-treatment guidelines to a self-management programme for adults with asthma.", "A randomized trial comparing peak expiratory flow and symptom self-management plans for patients with asthma attending a primary care clinic.", "Evaluation of peak flow and symptoms only self management plans for control of asthma in general practice.", "An internet-based interactive telemonitoring system for improving childhood asthma outcomes in Taiwan.", "Can a self-management programme delivered by a community pharmacist improve asthma control? A randomised trial.", "Evaluation of individualized asthma self-management programs." ]

[ "We asked whether the addition of PEF recordings to a symptom-based self-management plan improved outcome in school children with asthma. In an open-randomized, parallel-group, controlled trial, we studied children aged 7-14 years with moderate asthma. After a 4-week run-in, 90 children were randomized to receive either PEF plus symptom-based management or symptom-based management alone for 12 weeks. Thresholds for action based on PEF were 70% of best (for increasing inhaled steroids) and 50% of best (for commencing prednisolone). Children were asked to perform twice-daily spirometry at home (using an electronic recording spirometer that revealed only PEF to the study group alone) and to record a symptom diary. The mean daily symptom score was the main outcome. There were no differences between groups in mean symptom score or in spirometric lung function, PEF, quality of life score, or reported use of health services over 12 weeks. During acute episodes, children responded to changes in symptoms by increasing their inhaled steroids at a mean value of PEF of greater than 70% of best so that overall PEF did not contribute to this important self-management decision. Knowledge of PEF did not enhance self-management even during acute exacerbations.", "To improve asthma control and reduce readmission rates through increased knowledge and the development of self management skills, a brief (three hour) adult education programme was developed.\n The course was designed to improve inhaler skills and to teach how to adjust drug doses according to peak flow (PEF) measurements and a treatment plan. It was evaluated in a randomised controlled trial in 76 patients admitted to hospital for asthma by using questionnaires, spirometry, and home monitoring of PEF at entry and at five and 10 months after intervention. The questionnaire provided measures of knowledge about asthma, self management behaviour appropriate to asthma control, asthma symptom frequency and severity, and psychosocial disturbance attributable to asthma.\n During the 10 months observation period the readmission rate for the educated group was one seventh that of the control group and attendance at accident and emergency departments also decreased. No consistent differential improvements were observed in spirometric results, average PEF, or mean daily variability of PEF. Both groups showed improvements in measures of asthma knowledge, behaviour, symptoms, and psychosocial disturbances. However, the intervention group showed a significantly greater improvement in some measures of asthma knowledge and self management skills.\n Despite minimal effect on measures of airway function, substantial changes in illness behaviour and use of health care facilities can be achieved by a brief asthma education programme.", "A prospective controlled trial of home monitoring of peak expiratory flow rate (PEFR) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma. Thirty-five patients managed themselves, using peak flow readings as the basis for the therapeutic plan coupled with educational intervention, whereas 35 control patients used symptoms and spirometric data for following physicians' treatment plans. After a 6-mo study period, patients in the experimental group showed statistically significant improvements in morbidity parameters (days lost from work, acute asthma attacks, days on antibiotic therapy, physician consultations, and emergency room admissions for asthma), increases in FVC, FEV1, and FEV1/FVC, mean PEFR and mean morning PEFR, decrease in percentage of the mean PEFR amplitude, and a reduction in the use of inhaled beta-agonists, oral theophylline, and oral prednisone. Although improvements in some of these parameters were also found in the control group, they did not reach the levels of significance obtained in the experimental group. The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient's condition.", "This study assessed the long-term efficacy of adding self-treatment guidelines to a self-management programme for adults with asthma. In this prospective randomized controlled trial, 245 patients with stable, moderate to severe asthma were included. They were randomized into a self-treatment group (group S) and a control group (group C). Both groups received self-management education. Additionally, group S received self-treatment guidelines based on peak expiratory flow (PEF) and symptoms. Outcome parameters included: asthma symptoms, quality of life, pulmonary function, and exacerbation rate. The 2-yr study was completed by 174 patients. Both groups showed an improvement in the quality of life of 7%. PEF variability decreased by 32% and 29%, and the number of outpatient visits by 25% and 18% in groups S and C, respectively. No significant differences in these parameters were found between the two groups. After 1 yr, patients in both groups perceived better control of asthma and had more self-confidence regarding their asthma. The latter improvements were significantly greater in group S as compared to group C. There were no other differences in outcome parameters between the groups. Individual self-treatment guidelines for exacerbations on top of a general self-management programme does not seem to be of additional benefit in terms of improvements in the clinical outcome of asthma. However, patients in the self-treatment group had better scores in subjective outcome measures such as perceived control of asthma and self-confidence than patients in the control group.", "Great emphasis is placed on educating asthmatics to use action plans to achieve better control of symptoms. The use of peak flow meters (PFM) has been recommended as an important part of self-management plans. We studied 92 (47 F) adult patients with asthma in a primary care setting to compare the effectiveness of action plans using either peak flow monitoring or symptoms to guide self-management. Each patient was instructed in the use of the action plan in the context of a 6-mo asthma education program taught by a nurse. Patients were already using inhaled corticosteroids or were newly prescribed corticosteroids by their family physician. Forty-four patients were randomized to the PFM group and 48 to the symptoms group. Spirometry, symptom scores, quality of life, medication use, and measures of health care utilization and morbidity (emergency department visits, hospitalizations, unscheduled doctor visits, and days lost from work or school) were recorded at baseline and throughout the study period. PC20 methacholine was measured at the first and at the final visits. There were significant improvements within groups for FEV1, symptoms score, PC20 methacholine, and quality of life, but no between-group differences. A significant shift from higher to lower daily use of beta-agonists (p < 0.008 for both groups) and significant shifts to higher daily doses of inhaled steroids (p < 0.001) occurred in each group. Adherence to the self-management plans was only 65% in the PFM group and 52% in the symptoms group. Outcomes for health care utilization were similar except for fewer patients making unscheduled doctor visits within the PFM group. Our findings show that education, regular follow-up, and an action plan are effective in improving asthma control and quality of life, but the routine use of PFM to guide interventions is not the only way to accomplish these objectives.", "To compare a peak flow self management plan for asthma with a symptoms only plan.\n Randomisation to one of the self management plans and follow up for a year.\n Four partner, rural training practice in Norfolk.\n 115 Patients (46 children and 69 adults) with asthma who were having prophylactic treatment for asthma and attending a nurse run asthma clinic.\n The number of doctor consultations, courses of oral steroids, and short term nebulised salbutamol treatments and the number of patients who required doctor consultations, courses of oral steroids, and short term nebulised salbutamol.\n Both self management plans produced significant reductions in the outcome measures but there were no significant differences in the degree of improvement between the groups. The results were similar for children and adults. The proportions of patients requiring a doctor consultation fell from 98% (50/51) to 66% (34/51) in the peak flow group and from 97% (62/64) to 53% (34/64) in the symptoms only group and the proportions requiring oral steroids from 73% (34/46) to 47% (21/46) and 52% (31/60) to 12% (7/60). The median number of doctor consultations was reduced from 8.0 to 2.0 in the peak flow group and from 4.5 to 1.0 in the symptoms only group.\n The peak flow meter was not the crucial ingredient in the improved illness of the two groups. Teaching patients the importance of their symptoms and the appropriate action to take when their asthma deteriorates is the key to effective management of asthma. Simply prescribing peak flow meters without a system of self management and regular review will be unlikely to improve patient care.", "A randomized, controlled trial was conducted to assess the effectiveness of Blue Angel for Asthma Kids, an Internet-based interactive asthma educational and monitoring program, used in the management of asthmatic children. One hundred sixty-four (n = 164) pediatric patients with persistent asthma were enrolled and randomized into two study groups for a 12-week controlled trial. The intervention group had 88 participants who were taught to monitor their peak expiratory flows (PEF) and asthma symptoms daily on the Internet. They also received an interactive response consisting of a self-management plan from the Blue Angel monitoring program. The control group had 76 participants who received a traditional asthma care plan consisting of a written asthma diary supplemented with instructions for self-management. Disease control was assessed by weekly averaged PEF values, symptom scores, and asthma control tests. Adherence measures were assessed by therapeutic and diagnostic monitoring. Outcome was assessed by examining quality of life and retention of asthma knowledge. The data were analyzed by comparing results before and after the trial. At the end of trial, the intervention group decreased nighttime (-0.08 +/- 0.33 vs. 0.00 +/- 0.20, p = 0.028) and daytime symptoms (-0.08 +/- 0.33 vs. 0.01 +/- 0.18, p =0.009); improved morning (241.9 +/- 81.4 vs. 223.1 +/- 55.5, p =0.017) and night PEF (255.6 +/- 86.7 vs. 232.5 +/- 55.3, p =0.010); increased adherence rates (p < 0.05); improved well-controlled rates (70.4% vs. 55.3%, p < 0.05); improved knowledge regarding self-management (93.2% vs. 70.3%, p < 0.05); and improved quality of life (6.5 +/- 0.5 vs. 4.3 +/- 1.2 on a 7-point scale, p < 0.05) when compared with conventional management. The Internet-based asthma telemonitoring program increases selfmanagement skills, improves asthma outcomes, and appears to be an effective and well-accepted technology for the care of children with asthma and their caregivers.", "No randomised studies have addressed whether self-management for asthma can be successfully delivered by community pharmacists. Most randomised trials of asthma self-management have recruited participants from secondary care; there is uncertainty regarding its effectiveness in primary care. A randomised controlled study was undertaken to determine whether a community pharmacist could improve asthma control using self-management advice for individuals recruited during attendance at a community pharmacy.\n Twenty four adults attending a community pharmacy in Tower Hamlets, east London for routine asthma medication were randomised into two groups: the intervention group received self-management advice from the pharmacist with weekly telephone follow up for 3 months and the control group received no input from the pharmacist. Participants self-completed the North of England asthma symptom scale at baseline and 3 months later.\n The groups were well matched at baseline for demographic characteristics and mean (SD) symptom scores (26.3 (4.8) and 27.8 (3.7) in the intervention and control groups, respectively). Symptom scores improved in the intervention group and marginally worsened in the control group to 20.3 (4.2) and 28.1 (3.5), respectively (p<0.001; difference adjusted for baseline scores=7.0 (95% CI 4.4 to 9.5).\n A self-management programme delivered by a community pharmacist can improve asthma control in individuals recruited at a community pharmacy. Further studies should attempt to confirm these findings using larger samples and a wider range of outcome measures.", "We compared the effectiveness of personalized asthma self-management recommendations with that of a group self-management program. We assigned each of 34 asthma patients randomly to one of three conditions: individualized asthma self-management, group asthma self-management, and control. We derived individualized self-management recommendations from patient recordings of asthma occurrence, asthma precipitants, and peak expiratory flow rate made during a 3-month period. The group program we used was the Wheezers Anonymous program. As compared to a control group of patients who received no self-management training, the patients in both the individualized and group condition evidenced improvement of pulmonary function, as measured daily with a home peak flow meter. The improvement was equivalent for patients in the two conditions. Patients in the individualized condition also exhibited a drop in frequency of asthma attacks, but patients in the group condition did not. We concluded that individualized asthma self-management is effective in reducing symptoms of asthma." ]

[ "9228354", "10027430", "9850359", "3282826", "2669554", "8323451", "10983616", "2844548", "2236929" ]

[ "A comparison of double-strength beclomethasone dipropionate (84 microg) MDI with beclomethasone dipropionate (42 microg) MDI in the treatment of asthma.", "Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma.", "Efficacy of chlorofluorocarbon-free beclomethasone dipropionate 400 micrograms day-1 delivered as an extrafine aerosol in adults with moderate asthma.", "Six-month double-blind, controlled trial of high dose, concentrated beclomethasone dipropionate in the treatment of severe chronic asthma.", "Comparison of dose-response effects of inhaled beclomethasone dipropionate and budesonide in the management of asthma.", "[Effects of high doses of beclomethasone dipropionate in bronchial asthma].", "Effectiveness of low doses (50 and 100 microg b.i.d) of beclomethasone dipropionate delivered as a CFC-free extrafine aerosol in adults with mild to moderate asthma. Study Group.", "Effects of inhaled beclomethasone dipropionate on beta 2-receptor function in the airways and adrenal responsiveness in bronchial asthma.", "Dose-related effect of beclomethasone dipropionate on airway responsiveness in asthma." ]

[ "To compare the efficacy and safety of a double-strength formulation of beclomethasone dipropionate (BDP 84) metered-dose inhaler (MDI) with that of beclomethasone dipropionate (BDP 42) MDI in the treatment of chronic asthma.\n A 28-day, randomized, double-blind, double-dummy, placebo-controlled, multicenter study.\n Outpatient.\n A total of 423 patients aged 12 to 65 years (mean range, 34 to 36 years) with moderate asthma (FEV1, 50 to 80% of predicted) who required long-term inhaled corticosteroids were enrolled.\n Patients were randomized to receive BDP 84, two oral inhalations bid (336 microg/d), BDP 42, four oral inhalations bid (336 microg/d), or placebo. A fourth treatment arm administering BDP 84, eight oral inhalations bid (HD BDP 84; 1,344 microg/d) was also included to determine whether a dose-response relationship could be demonstrated.\n Spirometry, clinical observations.\n The three active treatments were significantly more effective (p < or = 0.01) than placebo at all time points in improving FEV1, the primary efficacy parameter; BDP 42 and BDP 84 were comparable to each other at every time point. Secondary pulmonary function tests (FVC, forced expiratory flow at 25 to 75% of FVC, and peak expiratory flow rate) showed similar results. All three active treatments were well tolerated. A dose response between 336 microg/d and 1,344 microg/d was demonstrated.\n In this well-controlled 28-day study, BDP 42 and BDP 84 were shown to be comparable in efficacy and safety on a microgram-for-microgram basis.", "The improved lung deposition of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extrafine aerosol compared with chlorofluorocarbon beclomethasone dipropionate (CFC-BDP) suggests that lower doses of HFA-BDP may be required to provide equivalent asthma control. The present study was undertaken to test this hypothesis.\n A 10- to 12-day run-in period confirmed that patients met established criteria of at least moderate asthma and the asthma was inadequately controlled by current therapy (inhaled beta-agonist and CFC-BDP [< or = 400 microg/d]). A short course of oral prednisone, 30 mg/d for 7 to 12 days, was followed to establish the patients were steroid responsive and to provide an \"in-study\" baseline of \"optimal\" asthma control.\n A total of 347 patients were then randomized to HFA-BDP 400 microg/d, CFC-BDP 800 microg/d, or HFA-placebo for 12 weeks.\n Morning peak expiratory flow (AM PEF) measurements showed that HFA-BDP 400 microg/d achieved equivalent control of asthma to CFC-BDP 800 microg/d at all time intervals after oral steroid treatment. All other efficacy variables supported the AM PEF results and both active treatments were more effective than placebo. The safety profile of HFA-BDP compared favorably with that of CFC-BDP with no unexpected adverse events reported.\n These findings demonstrate that HFA-BDP provides equivalent control of moderate or moderately severe asthma as CFC-BDP in the population studied, but at half the total daily dose.", "Beclomethasone dipropionate (BDP) has been reformulated in a chlorofluorocarbon-free propellant, hydrofluoroalkane-134a (HFA), resulting in an extrafine aerosol which gives improved drug delivery to the airways. The objective of this 6 week, placebo-controlled study was to evaluate the clinical efficacy of HFA-BDP 400 micrograms day-1 in 256 adult patients with moderate asthma. This is a lower daily dose than that recommended for existing BDP inhalers in current treatment guidelines for moderate asthma (NIH publication 95-3659). Another objective was to evaluate whether delivering the 400 micrograms dose as four actuations of 50 micrograms twice daily (HFA-BDP 50 micrograms) provided equivalent asthma control to delivering the dose as two actuations of 100 micrograms twice daily (HFA-BDP 100 micrograms) without the use of a spacer or holding chamber. Both active treatments produced a significant change from baseline in morning peak expiratory flow (PEF), which was significantly larger than that in the placebo group (P < or = 0.017) throughout the study. The mean changes from baseline in morning PEF at weeks 5-6 were 47.0 l min-1 in the combined HFA-BDP group and 16.5 l min-1 in the HFA-placebo group. The two dose strengths were statistically equivalent (P = 0.017 for equivalence testing). The active treatments also produced significant improvements compared with placebo in evening PEF, forced expiratory volume in the first second, forced expiratory flow over 25-75% of vital capacity, sleep disturbance scores and daily beta-agonist use. The study medication was well tolerated, with a low incidence of adverse events. The results from this study demonstrate that a daily dose of 400 micrograms HFA-BDP (given in 50 micrograms and 100 micrograms strengths) provides dose proportionality and effective control in patients with moderate asthma.", "A six-month double-blind controlled trial compared a 2,000 microgram per day dose of beclomethasone dipropionate aerosol (BDP), with current upper level doses of 800 micrograms per day of the standard BDP, in asthmatics requiring oral corticosteroids in addition to BDP and bronchodilators. Both groups showed a significant reduction in their oral steroid requirements during the study, with a 34 percent reduction in the lower dose group and a 57 percent reduction in the high dose BDP group while maintaining good symptomatic control of asthma; there was an associated improvement in baseline serum cortisol levels. Over the same period, the pulmonary function of the lower dose group showed significant worsening relative to that of the group receiving the high dose BDP which improved. There was no increase in dysphonia or oropharyngeal candidiasis among those using the concentrated BDP. We conclude that high dose concentrated BDP appears to be a safe medication in long-term steroid-dependent asthma, and is effective in reducing dependence on the use of oral corticosteroid with associated improvement both in pulmonary and adrenal function.", "The dose-response effects of inhaled beclomethasone dipropionate (BDP) and budesonide (BUD) administered b.i.d. with the aid of metered dose aerosols were studied in 128 patients (67 men and 61 women, mean age 53 years) suffering from asthma bronchiale. The study was designed as a multi-centre, double-blind, four-period cross-over study, followed by a single-blind double placebo period. BDP was administered in doses of 400 and 1000 micrograms, and BUD in doses of 400 and 800 micrograms. The results in terms of peak expiratory flow (PEF) in the morning and evening, daily symptoms score and use of inhaled beta 2-agonists did not reveal any clinically significant differences between the drugs or between high (800 micrograms BUD, 1000 micrograms BDP) and low (400 micrograms BUD/BDP) doses. However, statistically significant differences were recorded for the corresponding parameters when comparing the placebo with preceding steroid periods. Adverse effects consisting mainly of oropharyngeal candidiasis, hoarseness and cough occurred in 54 of 468 treatment months (12%). The carry-over effects of inhaled steroids are longer lasting than was previously assumed.", "To evaluate the clinical efficacy of high dose inhaled steroids, we examined the effects of standard doses (400 micrograms/day) and high doses (800 micrograms/day) of inhaled beclomethasone dipropionate (BDP, Becotide Inhaler), and the dose for regular use (800 micrograms/day) of salbutamol (Salb. Asmidon Air) on pulmonary function, bronchial hyperresponsiveness and asthma attack score. The subjects were 17 out-patients with mild or moderate bronchial asthma who were not receiving any anti-allergics or steroids. The patients were randomly allocated into three groups i.e., Group I: BDP 400 micrograms/day, Group II: BDP 800 micrograms/day and Group III: Salb. 800 micrograms/day. The administration period was 8 weeks. Pulmonary function test were performed and bronchial hyperresponsiveness was examined before and after the 8 weeks of treatment and attack scores were recorded during this period. It was found that inhalations of 400 micrograms/day and 800 micrograms/day BDP improved FEV1.0% value, peak flow, F-V curve, Dmin. and SGrs/Grs cont. Particularly, inhalation of 800 micrograms/day of BDP significantly improved these values and reduced attack scores in the early stages of the 8 week treatment. In contrast, there was a trend for inhalation of Salbutamol to enhance bronchial hyperresponsiveness and not to improve pulmonary function and asthma attack score. In conclusion, 800 micrograms/day of inhaled BDP is considered to be useful in the treatment of mild or moderate bronchial asthma.", "The objective of this study was to evaluate the efficacy and safety of low doses (50 and 100 microg b.i.d.) of hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP) extrafine aerosol in improving asthma control. Reformulation of BDP in a new chlorofluorocarbon (CFC)-free propellant (HFA) has produced an extrafine aerosol with increased delivery of the drug to the airways of the lung. The study population comprised 270 steroid-naive patients with mild to moderate asthma (mean baseline forced expiratory volume in 1 sec [FEV1] as a percentage of predicted normal of 65%-85%). This was a 6-week, blinded, placebo-controlled, multicenter study. Patients were randomized to receive 50 or 100 microg b.i.d. HFA-BDP or HFA-placebo. Treatment with either 50 or 100 microg b.i.d. HFA-BDP resulted in a significantly greater improvement compared with placebo in FEV1 (mean change from baseline as percentage of predicted normal of 6.7%, 8.6%, and 0.4%, respectively; p < or = 0.01 active treatment groups vs. placebo), with a significant trend toward increasing improvement with increasing doses (p < or = 0.0001). Treatment also resulted in significantly greater mean changes from baseline in morning peak expiratory flow compared with placebo (29.5, 33.8, and 5.0 L/min, respectively; p < or = 0.01 active treatment groups vs. placebo). All other pulmonary function and asthma symptom measures supported these data. The study treatments were well tolerated. These results show that low doses of HFA-BDP extrafine aerosol effectively improve asthma control in adult patients with mild to moderate asthma. However, it is important that inhaled corticosteroid therapy is still given at a dose high enough to control airway inflammation as well as asthma symptoms.", "Sixteen patients suffering from bronchial asthma, with or without chronic bronchitis, sufficiently severe to be treated with inhaled corticosteroids, were studied in a single-blind trial (blind observer) of beclomethasone dipropionate (BDP) given in three randomized dosage regimens: 500, 1000 and 2000 micrograms per day, each for 4 weeks. The beta 2-adrenergic agonist response curve showed a dose-dependent increase in FEV1 which was not affected by different doses of BDP. A small but significant reduction in basal cortisol levels was observed after BDP 500 micrograms/day. There was no significant difference between the various doses of BDP in reducing cortisol level and stimulation with tetracosactide remained unchanged. The study showed a gradual, dose-dependent improvement in lung function, statistically significant for morning peak expiratory flow rate at BDP 2000 micrograms/day. Dyspnoea score and beta 2-agonist use decreased, reflecting the anti-asthmatic effects. An increase in total leukocyte count was observed, together with a decrease in the eosinophil count. Oral candidiasis was seen in 2 out of 16 patients. It is concluded that the clinical anti-asthmatic effects of corticosteroid treatment by inhalation are not due to modulation of beta 2-receptor function in the airways.", "The effects of twice daily inhaled beclomethasone dipropionate (BDP) at two dose levels (500 and 1,000 micrograms daily) on the airway responsiveness to inhaled histamine was evaluated by a randomized, single-blind, cross-over study in 10 patients with stable asthma. The 12-week study began with a 3-week run-in period of baseline treatment, which was continued unchanged throughout the study, and the two treatment periods were separated by a 3-week placebo period. Patients attended the laboratory every 3 weeks for spirometry and histamine inhalation tests to determine the provocative concentration of histamine causing a 20% fall in forced expiratory volume in 1 s (PC20 of FEV1). There was a similar significant improvement (p less than 0.05) in mean FEV1 after both treatments. There was no significant change in PC20 after treatment with 500 micrograms daily, the geometric mean being 0.587 mg/ml after the placebo period and 0.860 mg/ml after BDP treatment. There was a significant improvement in PC20 (1.930 mg/ml) after treatment with 1,000 micrograms BDP daily in comparison with the placebo and treatment periods with 500 micrograms BDP daily (p less than 0.001). These results suggest that higher doses than usual of inhaled BDP must be used to control airway responsiveness in asthmatics." ]

[ "17436825", "1981436", "138560", "9649660", "6216858", "11586012", "17436826", "21269305", "12695127" ]

[ "Dose-ranging efficacy of new once-daily extended-release minocycline for acne vulgaris.", "A double-blind comparison of topical clindamycin and oral minocycline in the treatment of acne vulgaris.", "Minocycline therapy in acne vulgaris.", "A comparison of the efficacy and safety of lymecycline and minocycline in patients with moderately severe acne vulgaris.", "Efficacy of minocycline compared with tetracycline in treatment of acne vulgaris.", "Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris.", "Safety and efficacy of a new extended-release formulation of minocycline.", "Efficacy of oral antibiotics on acne vulgaris and their effects on quality of life: a multicenter randomized controlled trial using minocycline, roxithromycin and faropenem.", "Lymecycline in the treatment of acne: an efficacious, safe and cost-effective alternative to minocycline." ]

[ "A multicenter, 12-week, randomized, double-blinded, placebo-controlled, dose-ranging study was conducted in 233 subjects with moderate to severe facial acne vulgaris to determine the lowest effective once-daily oral dose of a new extended-release (ER) minocycline hydrochloride formulation with the safest adverse effect profile. Subjects randomly were assigned to treatment with daily dosages of ER-minocycline 1-, 2-, or 3-mg/kg tablets, or daily placebo tablets, for 84 days. At the end of the 12 weeks, the number of inflammatory lesions decreased approximately 50% from baseline levels in the dose groups. No dose-dependent effect was observed, with the percentage decrease in the number of inflammatory lesions in the 1-mg/kg treatment group being equal to or greater than higher doses. The pairwise difference between the ER-minocycline 1 mg/kg and placebo groups in the percentage decrease in inflammatory lesions was statistically significant (P = .015). Acute vestibular adverse events (AVAEs) appeared to be dose proportional, with the incidence being similar in the lowest (1 mg/kg) dosing group (24%) and in the placebo group (26%). Higher-dose regimens were associated with a higher incidence of central nervous system side effects and AVAEs. A 1-mg/kg daily dosage of the new ER-minocycline formulation is the lowest effective dose with the safest side effect profile, with higher-dose regimens offering no substantial therapeutic advantages.", "Sixty-six patients with moderate to severe facial acne vulgaris were entered in a 12-week double-blind study to compare the efficacy of topical clindamycin phosphate 1% twice daily and oral minocycline 50 mg twice daily. Both treatments gave significant overall improvements from baseline observations in acne grade and inflamed lesion counts, but not in noninflamed lesion counts. There were no significant differences between the two treatment groups in respect of acne grade, inflamed or non-inflamed lesion counts. Both treatment regimes were well tolerated. This study has shown that topical clindamycin twice daily is an effective alternative to oral minocycline 50 mg twice daily in the treatment of moderate to severe facial acne vulgaris.", "A double-blind, random distribution study showed that a lower than recommended dose of minocycline--50 mg twice daily--was as effective as a dose of 250 mg twice daily of tetracycline for treatment of acne vulgaris in comparable patient groups, and that minocycline produced no vestibular side effects at the lower dosage. Like tetracycline, minocycline did not produce the phototoxicity associated with demeclocycline or the life-threatening colitis associated with clindamycin. Patients in this study did not develop a resistance either to minocycline or to tetracycline. Studies of the use of minocycline in patients who have developed tetracycline resistance and long-range studies of patients on the new lower dose of minocycline are now underway.", "A multicentre, randomised, double-blind and double-dummy study was conducted to compare the efficacy and safety of lymecycline (n = 71) with that of minocycline (n = 73) in 144 patients with moderately severe acne vulgaris. Patients with an acne score of 1-5 on the Leeds scale received oral lymecycline, 300 mg/day for 2 weeks, then 150 mg/day for 10 weeks or oral minocycline, 100 mg/day for 2 weeks then 100 mg every other day for 10 weeks. Inflammatory, non-inflammatory and total lesion counts were determined at baseline (week 0) and after 4, 8 and 12 weeks' treatment, and global efficacy and safety assessments were made by the patient and investigator at the end of the study. Both treatments were equally effective at reducing differential lesion counts and improving acne condition and severity, with no significant differences between treatments. Inflammatory lesions were reduced by 50.6% and 52.2% with lymecycline and minocycline, respectively, and non-inflammatory lesions by 40.6% and 32.2%. Acne severity was reduced by 42.4% with lymecycline and by 47.9% with minocycline. A total of 4.3% of lymecycline recipients and 4.1% of minocycline recipients experienced treatment-related adverse events, the majority of which were mild in nature. Lymecycline was as effective as minocycline for the treatment of moderately severe acne vulgaris. Both treatments were well tolerated, although there were slightly fewer adverse gastrointestinal and dermatological effects with lymecycline.", "A double-blind evaluation of the efficacy and safety of minocycline hydrochloride and tetracycline hydrochloride was conducted and completed using 49 patients with Pillsbury grade 2 or grade 3 acne. For six months, half of the patients received minocycline and half received tetracycline. Although the differences between treatment groups were not statistically significant at any evaluation, more patients treated with minocycline reached and maintained a noninflammatory acne status in less time than did patients treated with tetracycline. After six weeks, twice as many patients in the group treated with minocycline had reached noninflammatory status. Side effects reported by 7 patients were equally distributed between treatment groups. No notable abnormalities were observed in the results of blood chemistry studies, hematologic tests, quantitative serum immunoglobulin determinations, or thyroid function tests in 20 of the patients examined.", "In addition to tetracyclines, zinc may constitute an alternative treatment in inflammatory lesions of acne.\n To evaluate the place of zinc gluconate in relation to antibiotics in the treatment of acne vulgaris.\n Zinc was compared to minocycline in a multicenter randomized double-blind trial. 332 patients received either 30 mg elemental zinc or 100 mg minocycline over 3 months. The primary endpoint was defined as the percentage of the clinical success rate on day 90 (i.e. more than 2/3 decrease in inflammatory lesions, i.e. papules and pustules).\n This clinical success rate was 31.2% for zinc and 63.4% for minocycline. Minocycline nevertheless showed a 9% superiority in action at 1 month and one of 17% at 3 months, with respect to the mean change in lesion count. Regarding safety, the majority of the adverse effects of zinc gluconate and of minocycline concerned the gastrointestinal system and were moderate (5 dropouts with zinc gluconate and 4 with minocycline).\n Minocycline and zinc gluconate are both effective in the treatment of inflammatory acne, but minocycline has a superior effect evaluated to be 17% in our study.\n Copyright 2001 S. Karger AG, Basel", "The complete safety and efficacy of a new extended-release (ER) minocycline hydrochloride formulation were assessed in an analysis of a phase 2 dose-finding study and 2 phase 3 safety and efficacy studies. The studies were similar in design, subject populations, and shared common dose groups of subjects given ER minocycline 1 mg/kg daily or placebo over 12 weeks. The similar designs were prospective, multicenter, randomized, double-blinded, and placebo-controlled. A total of 1038 subjects with moderate to severe acne were available for the pooled analysis. Independently, each study showed that treatment with ER-minocycline significantly reduced (P < .001) the number of inflammatory lesions and significantly improved (P < .001) their Evaluator's Global Severity Assessment (EGSA) scores (phase 3 studies). Analysis of the pooled population confirmed the results of the individual studies. The percentage of subjects reporting acute vestibular adverse events (AVAEs) was comparable between those receiving the ER-minocycline 1-mg/kg dose and placebo (approximately 10% of subjects in each group) for both the individual studies and the pooled population. It was concluded that a novel ER-minocycline formulation that delivers consistent levels of drug at a 1-mg/kg dose reduces dose-dependent AVAEs while reducing inflammatory lesions and improving the overall appearance of patients with acne vulgaris.", "There are few clinical studies which compare the efficacy and patient satisfaction for oral antibiotics to treat inflammatory acne. To clarify the difference between oral antibiotics, acne patients with moderate to severe inflammatory eruptions were randomized into three groups, and each patient was given minocycline (MINO), roxithromycin (RXM) or faropenem (FRPM) for 4 weeks, followed by 4 weeks of observation without any oral antibiotics. We estimated the reduction rate of inflammatory lesion counts, the scale of Skindex-16 which represents patient quality of life (QOL), and minimum inhibitory concentrations required to inhibit the growth of 90% of Propionibacterium acnes isolated from acne patients (MIC(90) ). In all three groups, inflammatory lesion counts, and emotional and total score of Skindex-16 were significantly improved (P<0.05) after 4 weeks treatment, and these effects were maintained for the following 4 weeks. Dizziness/nausea in two patients (4.1%) of the MINO group and diarrhea in three patients (5.9%) of the FRPM group were observed. There was no significant difference of percentage reduction in inflammatory lesion counts and incident rates of side-effects between these three oral antibiotics. MIC(90) of MINO was 0.25 μg/mL before and after treatment, but MIC(90) of RXM had increased from 0.25 μg/mL to more than 32 μg/mL after treatment. MIC(90) of FRPM was 0.06 μg/mL or less for all strains before and after treatment. Our randomized controlled clinical trial suggested that MINO, RXM and FRPM were efficient to improve inflammatory acne and patient QOL, and there was no significant difference between them.\n © 2010 Japanese Dermatological Association.", "A comparison of efficacy, safety and cost-effectiveness of lymecycline and minocycline in the treatment of acne vulgaris has been addressed. This was a multicenter, randomized, investigator-masked, parallel group trial involving patients with moderate to moderately severe acne vulgaris, receiving either lymecycline or minocycline for 12 weeks. Efficacy and safety evaluation was performed at baseline and at weeks 4, 8, and 12 and completed by a pharmacoeconomic analysis including week 12 data. One hundred and thirty-six patients were enrolled. At week 12, the mean percent reductions in inflammatory count were 63 % and 65 %, and for total lesions counts 58 % and 56 % for lymecycline and for minocycline respectively. Median percent reduction in non-inflammatory count were 54 % and 47 % for lymecycline and for minocycline respectively. Eighty-seven per cent of all patients tolerated the treatments well. Treatment with lymecycline was found to be 4 times more cost-effective than with minocycline. Results showed that lymecycline has a comparable efficacy and safety profile to minocycline while being 4 times more cost-effective." ]

[ "14770380", "10434220", "11984383", "9378876", "17304779", "19731848", "12657991", "10758471", "3578726" ]

[ "Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea.", "An alternative method to alleviate postoperative nausea and vomiting in children.", "Isopropyl alcohol inhalation: alternative treatment of postoperative nausea and vomiting.", "Peppermint oil: a treatment for postoperative nausea.", "A comparative analysis of isopropyl alcohol and ondansetron in the treatment of postoperative nausea and vomiting from the hospital setting to the home.", "Comparison of inhalation of isopropyl alcohol vs promethazine in the treatment of postoperative nausea and vomiting (PONV) in patients identified as at high risk for developing PONV.", "Randomized, double-blinded comparison of tropisetron and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy.", "Postoperative nausea and vomiting after breast surgery: efficacy of prophylactic ondansetron and droperidol in a randomized placebo-controlled study.", "Vomiting after ophthalmic surgery. Effects of intra-operative antiemetics and postoperative oral fluid restriction." ]

[ "To determine whether aromatherapy can reduce postoperative nausea, the investigators studied 33 ambulatory surgery patients who complained of nausea in the PACU. After indicating the severity of nausea on a 100-mm visual analogue scale (VAS), subjects received randomized aromatherapy with isopropyl alcohol, oil of peppermint, or saline (placebo). The vapors were inhaled deeply through the nose from scented gauze pads held directly beneath the patients' nostrils and exhaled slowly through the mouth. Two and 5 minutes later, the subjects rated their nausea on the VAS. Overall nausea scores decreased from 60.6 +/- 4.3 mm (mean +/- SE) before aromatherapy to 43.1 +/- 4.9 mm 2 minutes after aromatherapy (P <.005), and to 28.0 +/- 4.6 mm 5 minutes after aromatherapy (P < 10(-6)). Nausea scores did not differ between the treatments at any time. Only 52% of the patients required conventional intravenous (IV) antiemetic therapy during their PACU stay. Overall satisfaction with postoperative nausea management was 86.9 +/- 4.1 mm and was independent of the treatment group. Aromatherapy effectively reduced the perceived severity of postoperative nausea. The fact that a saline \"placebo\" was as effective as alcohol or peppermint suggests that the beneficial effect may be related more to controlled breathing patterns than to the actual aroma inhaled.", "To evaluate whether isopropyl alcohol vapor is an effective treatment for postoperative nausea and vomiting.\n Double-blind, randomized, controlled study.\n Pediatric surgery center.\n 91 ASA physical status I and II children age 6-16 years, scheduled to undergo general anesthesia and elective outpatient surgery.\n Subjects were randomized to inhale isopropyl alcohol or saline. The intervention was repeated up to three times. If postoperative nausea or vomiting persisted after three sequences, intravenous ondansetron was administered as rescue therapy.\n Improvement in nausea was assessed using a visual analog scale, and improvement in vomiting was assessed using categorical analysis. After three treatment sequences, 65% of the children in the treatment group and 26% of the children in the control group had a significant reduction in the severity of either nausea or vomiting (p = 0.03). However, 54% of subjects in the treatment group and 80% of subjects in the control group had recurrent nausea or vomiting within 20 to 60 minutes.\n Under the conditions of this study, repetitive inhaled isopropyl alcohol only achieved a transient antiemetic effect in children with established postoperative nausea or vomiting following general anesthesia and surgery.", "The mechanisms for postoperative nausea and vomiting are numerous and pathways not well elucidated. Although many medications have been developed to help prevent postoperative nausea and vomiting, the search for better approaches to recovery treatment continues.\n The purpose of this study was to evaluate the effectiveness of isopropyl alcohol (IPA) inhalation for treatment of postoperative nausea and vomiting for patients who have general anesthesia for a surgical procedure.\n Participants were recruited from an urban hospital on the East Coast of the United States. Participants were assigned to an experimental or control group and IPA inhalation was compared to the standard anti-emetic treatment for rescue treatment in the immediate postoperative period. Postoperative nausea and vomiting was rated using a descriptive ordinal scale.\n The results of this study show IPA to be effective and that there was no significant difference between the standard treatment protocol and treatment with IPA. Treatment with IPA was significantly more cost effective than standard drug treatment.\n Further research is recommended to evaluate the length of effectiveness, standard dose needed, most effective mode of inhalation, and factors blocking IPA effectiveness.", "This paper describes a research study to investigate the efficacy of peppermint oil as a treatment for postoperative nausea. It uses a three-condition experimental design using statistical analysis to compare groups. The Kruskal-Wallis test was used to establish significance and the Mann-Whitney test to differentiate significance between the groups. The control, placebo and experimental groups of gynaecological patients were compared, using variables known to affect postoperative nausea. They were found to be homogeneous for the purposes of the study. A statistically significant differences was demonstrated on the day of operation, using the Kruskal-Wallis test, P = 0.0487. Using the Mann-Whitney test the difference was shown to be between the placebo and experimental group (U = 3; P = 0.02). The experimental group also required less traditional antiemetics and received more opioid analgesia postoperatively. The total cost of the treatment was 48 pence per person.", "We compared the efficacy of inhaled isopropyl alcohol (IPA) with ondansetron for the control of postoperative nausea and vomiting (PONV) during a 24-hour period in 100 ASA class I-III women undergoing laparoscopic surgery. Nausea was measured postoperatively using a 0 to 10 verbal numeric rating scale (VNRS). The control group received ondansetron, 4 mg intravenously, and the experimental group inhaled IPA vapors. Breakthrough PONV was treated with 25-mg promethazine suppositories. Demographic and anesthesia characteristics were similar between groups. There was a significant difference between groups in mean +/- SD time to alleviation of PONV symptoms: for a 50% reduction in VNRS scores, 15.00 +/- 10.6 vs. 33.88 +/- 23.2 minutes was required in the experimental vs. the control group (P = .001). A total of 21 subjects (10 control; 11 experimental) reported PONV symptoms following discharge to home. The IPA treatment was successful in alleviating PONV symptoms in the home in 91% of the experimental group. We determined that using IPA after discharge from the postanesthesia care unit is a valuable method to control PONV in the hospital and at home. The results of this study suggest that IPA is much faster than ondansetron for 50% relief of nausea.", "Frequently, patients identified as high risk for postoperative nausea and vomiting (PONV) are treated prophylactically with intravenous (IV) ondansetron and postoperatively with IV promethazine. The purpose of this study was to determine if using an aromatic therapy of 70% isopropyl alcohol (IPA) would be more effective than promethazine in resolution of breakthrough PONV symptoms in groups of high-risk patients administered prophylactic ondansetron. All subjects enrolled were identified as high risk for PONV, administered general anesthesia and a prophylactic antiemetic of 4 mg of IV ondansetron, and randomized to receive IPA or promethazine for treatment of breakthrough PONV Demographics, verbal numeric rating scale (VNRS) scores for nausea, time to 50% reduction in VNRS scores, and overall antiemetic and incidence of PONV were measured. The data for 85 subjects were included in analysis; no differences in demographic variables or baseline measurements were noted between groups. The IPA group reported a faster time to 50% reduction in VNRS scores and decreased overall antiemetic requirements. A similar incidence in PONV was noted between groups. Based on these findings, we recommend that inhalation of 70% IPA is an option for treatment of PONV in high-risk patients who have received prophylactic ondansetron.", "This prospective, randomized, placebo-controlled, double-blinded study was designed to evaluate the efficacy of tropisetron in preventing postoperative nausea and vomiting after elective supratentorial craniotomy in adult patients. We studied 65 ASA physical status I-III patients aged 18 to 76 years who were undergoing elective craniotomy for resection of various supratentorial tumors. Patients were divided into two groups and received either 2 mg of tropisetron (group T) or saline placebo (group P) intravenously at the time of dural closure. A standard general anesthetic technique was used. Episodes of nausea and vomiting and the need for rescue antiemetic medication were recorded during 24 hours postoperatively. Demographic data, duration of surgery and anesthesia, and sedation scores were comparable in both groups. Nausea occurred in 30% of group T patients and in 46.7% of group P patients (P >.05). The incidence of emetic episodes was 26.7% and 56.7% in the two groups (P <.05). Rescue antiemetic medication was needed in 26.7% and 60% of the patients (P <.05). Administration of a single dose of tropisetron (2 mg intravenously) given at the time of dural closure was effective in reducing postoperative nausea and vomiting after elective craniotomy for supratentorial tumor resection in adult patients.", "Postoperative nausea and vomiting (PONV) is a common adverse phenomenon following breast surgery. The efficacy of ondansetron and droperidol in preventing post-operative nausea and vomiting in women undergoing breast surgery was compared in this randomized, double-blind, placebo-controlled study. Altogether 207 women were randomly assigned to receive either a single intravenous dose of droperidol (1.25 mg) (n = 69), ondansetron (8 mg) (n = 67) or saline (n = 71) immediately after induction of general anaesthesia with thiopental, fentanyl, atracurium, nitrous oxide in oxygen and isoflurane. Complaints of nausea, vomiting and requests for rescue antiemetics were recorded during a 24-h period postoperatively. During the initial 2 h in the postanaesthesia care unit, the incidence of postoperative nausea and vomiting was 15%, 6% and 12% in the placebo, droperidol and ondansetron groups, respectively (NS). The incidence of post-operative nausea and vomiting during the first 24 h was 61%, 48% and 45% in the placebo, droperidol and ondansetron treatment groups, respectively (NS). Postoperative analgesic requirements and the length of stay in the post-anaesthesia care unit were equal in all three treatment groups. It is concluded that the intravenous pretreatment with single doses of ondansetron or droperidol did not substantially prevent postoperative nausea and vomiting after breast surgery.", "The usefulness of intra-operative antiemetics and postoperative oral fluid restriction in the prevention of vomiting following anaesthesia for ophthalmic surgery, was studied in 200 patients. They were allocated into four groups of 50 and given either saline (as control), droperidol, metoclopramide or prochlorperazine. Oral intake was restricted postoperatively in half of the patients of each group. Anaesthesia comprised morphine and atropine premedication and a halothane, nitrous oxide and oxygen spontaneous breathing technique. No significant beneficial effects resulted from intra-operative antiemetics; vomiting incidences of 26% after saline and droperidol, 28% after metoclopramide and 14% after prochlorperazine were observed. Younger patients and females vomited most frequently. Restriction of oral fluids did not decrease the incidence of vomiting but demonstrated that approximately half of those patients who vomit do so with their first postoperative oral intake. Vomiting was observed more frequently after non intra-ocular surgery than after intra-ocular surgery (37% cf. 16%, p less than 0.01) and postoperative analgesics were required by more non intra-ocular patients than by intra-ocular patients (25% cf. 5%, p less than 0.001). Squint patients vomited most frequently (48%) and most frequently required postoperative analgesia (35%)." ]

[ "21149743", "21636633", "19418107", "15749130", "10564627", "10632830", "9734786", "18573775", "18308500" ]

[ "Electronic patient messages to promote colorectal cancer screening: a randomized controlled trial.", "Effect of evidence based risk information on \"informed choice\" in colorectal cancer screening: randomised controlled trial.", "A randomized trial of generic versus tailored interventions to increase colorectal cancer screening among intermediate risk siblings.", "Increasing colorectal cancer screening among individuals in the carpentry trade: test of risk communication interventions.", "Tailored risk notification for women with a family history of breast cancer.", "Does informed consent alter elderly patients' preferences for colorectal cancer screening? Results of a randomized trial.", "Using an office system intervention to increase breast cancer screening.", "Randomized trial of a self-administered decision aid for colorectal cancer screening.", "A randomized trial of two print interventions to increase colon cancer screening among first-degree relatives." ]

[ "Colorectal cancer is a leading cause of cancer mortality, yet effective screening tests are often underused. Electronic patient messages and personalized risk assessments delivered via an electronic personal health record could increase screening rates.\n We conducted a randomized controlled trial in 14 ambulatory health centers involving 1103 patients ranging in age from 50 to 75 years with an active electronic personal health record who were overdue for colorectal cancer screening. Patients were randomly assigned to receive a single electronic message highlighting overdue screening status with a link to a Web-based tool to assess their personal risk of colorectal cancer. The outcomes included colorectal cancer screening rates at 1 and 4 months.\n Screening rates were higher at 1 month for patients who received electronic messages than for those who did not (8.3% vs 0.2%, P < .001), but this difference was no longer significant at 4 months (15.8% vs 13.1%, P = .18). Of 552 patients randomized to receive the intervention, 296 (54%) viewed the message, and 47 (9%) used the Web-based risk assessment tool. Among 296 intervention patients who viewed the electronic message, risk tool users were more likely than nonusers to request screening examinations (17% vs 4%, P = .04) and to be screened (30% vs 15%, P = .06). One-fifth of patients (19%) using the risk assessment tool were estimated to have an above-average risk for colorectal cancer.\n Electronic messages to patients produce an initial increase in colorectal cancer screening rates, but this effect is not sustained over time.\n clinicaltrials.gov Identifier: NCT01032746.", "To compare the effect of evidence based information on risk with that of standard information on informed choice in screening for colorectal cancer.\n Randomised controlled trial with 6 months' follow-up.\n German statutory health insurance scheme.\n 1577 insured people who were members of the target group for colorectal cancer screening (age 50-75, no history of colorectal cancer).\n Brochure with evidence based risk information on colorectal cancer screening and two optional interactive internet modules on risk and diagnostic tests; official information leaflet of the German colorectal cancer screening programme (control).\n The primary end point was \"informed choice,\" comprising \"knowledge,\" \"attitude,\" and \"combination of actual and planned uptake.\" Secondary outcomes were \"knowledge\" and \"combination of actual and planned uptake.\" Knowledge and attitude were assessed after 6 weeks and combination of actual and planned uptake of screening after 6 months.\n The response rate for return of both questionnaires was 92.4% (n = 1457). 345/785 (44.0%) participants in the intervention group made an informed choice, compared with 101/792 (12.8%) in the control group (difference 31.2%, 99% confidence interval 25.7% to 36.7%; P < 0.001). More intervention group participants had \"good knowledge\" (59.6% (n = 468) v 16.2% (128); difference 43.5%, 37.8% to 49.1%; P < 0.001). A \"positive attitude\" towards colorectal screening prevailed in both groups but was significantly lower in the intervention group (93.4% (733) v 96.5% (764); difference -3.1%, -5.9% to -0.3%; P<0.01). The intervention had no effect on the combination of actual and planned uptake (72.4% (568) v 72.9% (577); P = 0.87).\n Evidence based risk information on colorectal cancer screening increased informed choices and improved knowledge, with little change in attitudes. The intervention did not affect the combination of actual and planned uptake of screening. Trial registration Current Controlled Trials ISRCTN47105521.", "Individuals with a sibling who has had colorectal cancer diagnosed before age 61 are at increased risk for colorectal cancer and may derive particular benefit from screening. Tailored interventions may increase participation in appropriate colorectal cancer screening.\n This study evaluated the efficacy of two tailored interventions and a generic print intervention.\n Participant siblings (N = 412) who were not up-to-date with colorectal cancer screening were randomly assigned to receive either a generic print pamphlet, a tailored print pamphlet, or a tailored print pamphlet and tailored counseling call. Colorectal cancer screening 6 months after the baseline interview was the outcome measure.\n Results indicated that colorectal cancer screening adherence increased among intermediate risk siblings enrolled in all three intervention groups. Participants in both tailored intervention groups reported having colorectal cancer screening at significantly higher rates than participants in the generic print group. The increase in colorectal cancer screening in the tailored print and counseling call group was not significantly higher than that achieved by the tailored print alone. Decisional balance partially mediated treatment effects. Tailored behavioral interventions are effective methods for increasing screening adherence but telephone counseling did not add significantly to treatment effects.", "Individuals in the carpentry trade, due to lifestyle habits and occupational exposures, may be at above-average risk for colorectal cancer (CRC). Based on the literature which suggests that increasing perceived risk motivates behavior change, we report on the effectiveness of four risk-communication interventions targeted to increase initial, yearly and repeat fecal occult screening (FOBT) among carpenters (N = 860) over a 3-year period.\n Our 2 x 2 factorial design intervention study varied two dimensions of providing CRC risk factor information: (1) type of risk factor-one set of interventions emphasized three basic risk factors (age, family history and polyps); the other set emphasized a comprehensive set of risk factors including basic, lifestyle, and occupational factors, and (2) tailoring/not tailoring risk factor information. Participants were provided FOBTs. Outcomes were the proportion of returned FOBTs.\n Varying the amount and intensity of delivering CRC risk factors information affected neither risk perceptions nor initial, yearly, or repeat screening. However, yearly and repeat screening rates were greater among participants who received interventions addressing comprehensive set of risk factors, especially with increasing age.\n Tailoring on several CRC risk factors appears insufficient to increase and sustain elevated perceptions of CRC risks to promote screening.", "Evidence indicates that although first-degree relatives of breast cancer cases are at increased risk of developing the disease themselves, they may be underutilizing screening mammography. Therefore, interventions to increase the use of mammography in this group are urgently needed.\n A randomized two-group design was used to evaluate an intervention to increase mammography use among women (N = 901) with at least one first-degree relative with breast cancer. A statewide cancer registry was used to obtain a random sample of breast cancer cases who identified eligible relatives. The mailed intervention consisted of personalized risk notification and other theoretically driven materials tailored for high-risk women.\n An overall significant intervention effect was observed (8% intervention group advantage) in mammography at post-test. There was an interaction of the intervention with age such that there was no effect among women <50 years of age and a fairly large (20% advantage) effect among women 50+ and 65+. Health insurance, education, and having had a mammogram in the year before baseline assessment were positive predictors of mammography at post-test. Perceived risk, calculated risk, and relationship to index cancer case were not associated with mammography receipt.\n The intervention was successful in increasing mammography rates among high-risk women 50+ years of age. Further work is needed to determine why it was ineffective among younger women.\n Copyright 1999 American Health Foundation and Academic Press.", "To assess the impact of informed consent on elderly patients' colorectal cancer (CRC) screening preferences.\n Randomized, controlled trial.\n Four general internal medicine practices.\n We studied 399 elderly patients visiting their primary care provider for routine office visits.\n Patients were randomized to receive either a scripted control message briefly describing CRC screening methods or one of two informational interventions simulating an informed consent presentation about CRC screening. One intervention described CRC mortality risk reduction in relative terms; the other, in absolute terms.\n The main outcome measure was intent to begin or continue fecal occult blood testing (FOBT), flexible sigmoidoscopy, or both. There was no difference in screening interest between the control group and the two information groups (p =.8). The majority (63%) of patients intended to begin or continue CRC screening. Informed patients were able to gauge more accurately the positive predictive value of screening (p =.0009). Control patients rated the efficacy of screening higher than did patients receiving relative risk reduction information, who rated it higher than did patients receiving absolute risk reduction information (p =.0002).\n Elderly patients appeared to understand CRC screening information and use it to gauge the efficacy of screening, but provision of information had no impact on their preferences for screening. In view of the large proportion who preferred not to be screened, we conclude that elderly patients should be involved in the screening decision. However, factors other than provision of information must determine their CRC screening preferences.", "To evaluate an innovative approach to continuing medical education, an outreach intervention designed to improve performance rates of breast cancer screening through implementation of office systems in community primary care practices.\n Randomized, controlled trial with primary care practices assigned to either the intervention group or control group, with the practice as the unit of analysis.\n Twenty mostly rural counties in North Carolina.\n Physicians and staff of 62 randomly selected family medicine and general internal medicine practices, primarily fee-for-service, half group practices and half solo practitioners.\n Physician investigators and facilitators met with practice physicians and staff over a period of 12 to 18 months to provide feedback on breast cancer screening performance, and to assist these primary care practices in developing office systems tailored to increase breast cancer screening.\n Physician questionnaires were obtained at baseline and follow-up to assess the presence of five indicators of an office system. Three of the five indicators of office systems increased significantly more in intervention practices than in control practices, but the mean number of indicators in intervention practices at followup was only 2.8 out of 5. Cross-sectional reviews of randomly chosen medical records of eligible women patients aged 50 years and over were done at baseline (n = 2,887) and follow-up (n = 2,874) to determine whether clinical breast examinations and mammography, were performed. Results for mammography were recorded in two ways, mention of the test in the visit note and actual report of the test in the medical record. These reviews showed an increase from 39% to 51% in mention of mammography in intervention practices, compared with an increase from 41% to 44% in control practices (p = .01). There was no significant difference, however, between the two groups in change in mammograms reported (intervention group increased from 28% to 32.7%; control group increased from 30.6% to 34.0%, p = .56). There was a nonsignificant trend (p = .06) toward a greater increase in performance of clinical breast examination in intervention versus control practices.\n A moderately intensive outreach intervention to increase rates of breast cancer screening through the development of office systems was modestly successful in increasing indicators of office systems and in documenting mention of mammography, but had little impact on actual performance of breast cancer screening. At follow-up, few practices had a complete office system for breast cancer screening. Outreach approaches to assist primary care practices implement office systems are promising but need further development.", "Previous studies have not assessed whether evidence-based information about the outcomes of colorectal cancer screening increases informed choice among people from a range of socioeconomic backgrounds nor have they assessed whether this can be administered away from a health-care provider.\n Randomized controlled trial in six primary care locations. Three hundred and fourteen people aged 50-74 years received a self-administered decision aid (DA) booklet about outcomes of biennial faecal occult blood testing (FOBT) screening or government consumer guidelines (G).\n Significantly more DA recipients (20.9%) were 'informed' compared with G recipients (5.8%) (P = 0.0001, OR 4.32; 95% CI 2.49 to 7.52); the DA did not affect values clarity (61.9% clear after DA versus 59.1% after G) nor screening decisions overall (87.3% would screen after DA versus 90.5% after G). Test uptake at one month was uniformly low (5.2% DA versus 6.6% G); mostly due to being 'too busy'. DA recipients were more likely to make decisions 'integrating' knowledge with values (10.4% DA versus 1.5% G). Decisions not to screen were equally uncommon in both groups but more likely to be uninformed in G (P = 0.03). More DA recipients from all education levels were 'informed' (P = 0.02), particularly in lower education (50.0% DA versus 17.8% G) and university-educated groups (79.4% DA versus 32.1% G).\n Detailed absolute risk and benefit information about FOBT screening can be effectively used at home by people to increase informed choice. The DA was effective in people with lower education levels.\n Unique Protocol ID 211705 ClinicalTrials.gov ID NCT 00148226.", "First-degree relatives (FDRs) of people diagnosed with colorectal cancer (CRC) have a two- to threefold increased risk of developing the same disease. Tailored print interventions based on behavior change theories have demonstrated considerable promise in facilitating health-promoting behaviors. This study compared the impact of two mailed print interventions on CRC screening outcomes among FDRs.\n This randomized trial compared effects of two mailed print interventions--one tailored and one nontailored--on participation in CRC screening among FDRs of CRC survivors. Data collected via phone interviews from 140 FDRs at baseline, 1 week post-intervention, and 3 months post-intervention.\n At 3 months, both the tailored and nontailored interventions yielded modest but statistically insignificant increases in adherence to any CRC screening test (14% vs. 21%, respectively; p=0.30). While there were no main effects for tailored versus nontailored interventions, there were significant interactions that showed that the tailored print intervention had significantly greater effects on forward stage movement for CRC screening depending on stage of adoption at baseline, race, and objective CRC risk. Receipt of the tailored intervention was 2.5 times more likely to move baseline precontemplators and contemplators forward in stage of adoption for colonoscopy (95% CI: 1.10-5.68) and was three times more likely to move Caucasians forward in stage of adoption for FOBT (95% CI: 1.00-9.07). In addition, the tailored intervention was 7.7 times more likely to move people at average risk forward in stage of adoption for colonoscopy (95% CI: 1.25-47.75).\n The tailored print intervention was more effective at moving Caucasians, those in precontemplation and contemplation at baseline, and those at average risk forward in their stage of adoption for CRC screening.\n Both tailored and nontailored print interventions showed moderate effects for increasing CRC screening participation. Tailored print interventions may be more effective for certain subgroups." ]

[ "15998750", "16770975", "1477566", "18758677", "11246937", "8912507", "19501658", "17133529", "11932074" ]

[ "A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia.", "Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial.", "Electroacupuncture in fibromyalgia: results of a controlled trial.", "A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia.", "Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial.", "A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia.", "Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs).", "A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia.", "Acupuncture treatment of chronic low-back pain -- a randomized, blinded, placebo-controlled trial with 9-month follow-up." ]

[ "Fibromyalgia is a common chronic pain condition for which patients frequently use acupuncture.\n To determine whether acupuncture relieves pain in fibromyalgia.\n Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group.\n Private acupuncture offices in the greater Seattle, Washington, metropolitan area.\n 100 adults with fibromyalgia.\n Twice-weekly treatment for 12 weeks with an acupuncture program that was specifically designed to treat fibromyalgia, or 1 of 3 sham acupuncture treatments: acupuncture for an unrelated condition, needle insertion at nonacupoint locations, or noninsertive simulated acupuncture.\n The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia.\n The mean subjective pain rating among patients who received acupuncture for fibromyalgia did not differ from that in the pooled sham acupuncture group (mean between-group difference, 0.5 cm [95% CI, -0.3 cm to 1.2 cm]). Participant blinding was adequate throughout the trial, and no serious adverse effects were noted.\n A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures. A usual-care comparison group was not studied.\n Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia.", "To test the hypothesis that acupuncture improves symptoms of fibromyalgia.\n We conducted a prospective, partially blinded, controlled, randomized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture. All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture. We measured symptoms with the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 month and 7 months after treatment. The trial was conducted from May 28, 2002, to August 18, 2003.\n Fifty patients participated in the study: 25 in the acupuncture group and 25 in the control group. Total fibromyalgia symptoms, as measured by the FIQ, were significantly improved in the acupuncture group compared with the control group during the study period (P = .01). The largest difference in mean FIQ total scores was observed at 1 month (42.2 vs 34.8 in the control and acupuncture groups, respectively; P = .007). Fatigue and anxiety were the most significantly improved symptoms during the follow-up period. However, activity and physical function levels did not change. Acupuncture was well tolerated, with minimal adverse effects.\n This study paradigm allows for controlled and blinded clinical trials of acupuncture. We found that acupuncture significantly improved symptoms of fibromyalgia. Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety.", "To determine the efficacy of electroacupuncture in patients with fibromyalgia, a syndrome of unknown origin causing diffuse musculoskeletal pain.\n Three weeks' randomised study with blinded patients and evaluating physician.\n University divisions of physical medicine and rehabilitation and rheumatology, Geneva.\n 70 patients (54 women) referred to the division for fibromyalgia as defined by the American College of Rheumatology.\n Patients were randomised to electroacupuncture (n = 36) or a sham procedure (n = 34) by means of an electronic numbers generator.\n Pain threshold, number of analgesic tablets used, regional pain score, pain recorded on visual analogue scale, sleep quality, morning stiffness, and patient's and evaluating physician's appreciation.\n Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group. Differences between the groups were significant for five of the eight outcome measures after treatment.\n Electroacupuncture is effective in relieving symptoms of fibromyalgia. Its potential in long term management should now be studied.", "To evaluate the effectiveness of acupuncture for fibromyalgia.\n Fifty-eight women with fibromyalgia were allocated randomly to receive either acupuncture together with tricyclic antidepressants and exercise (n=34), or tricyclic antidepressants and exercise only (n=24). Patients rated their pain on a visual analogue scale. A blinded assessor evaluated both the mean pressure pain threshold value over all 18 fibromyalgia points and quality of life using SF-36.\n At the end of 20 sessions, patients who received acupuncture were significantly better than the control group in all measures of pain and in 5 of the SF-36 subscales. After 6 months, the acupuncture group was significantly better than the control group in numbers of tender points, mean pressure pain threshold at the 18 tender points and 3 subscales of SF-36. After one year, the acupuncture group showed significance in one subscale of the SF-36; at 2 years there were no significant differences in any outcome measures.\n Addition of acupuncture to usual treatments for fibromyalgia may be beneficial for pain and quality of life for 3 months after the end of treatment. Future research is needed to evaluate the specific effects of acupuncture for fibromyalgia.", "To test effectiveness of static magnetic fields of two different configurations, produced by magnetic sleep pads, as adjunctive therapies in decreasing patient pain perception and improving functional status in individuals with fibromyalgia.\n Randomized, placebo-controlled, 6-month trial conducted from November 1997 through December 1998.\n Adults who met the 1990 American College of Rheumatology criteria for fibromyalgia were recruited through clinical referral and media announcements and evaluated at a university-based clinic.\n Subjects in Functional Pad A group used a pad for 6 months that provided whole-body exposure to a low, uniform static magnetic field of negative polarity. Subjects in the Functional Pad B group used a pad for 6 months that exposed them to a low static magnetic field that varied spatially and in polarity. Subjects in two Sham groups used pads that were identical in appearance and texture to the functional pads but contained inactive magnets; these groups were combined for analysis. Subjects in the Usual Care group continued with their established treatment regimens.\n Primary outcomes were the change scores at 6 months in the following measures: functional status (Fibromyalgia Impact Questionnaire), pain intensity ratings, tender point count, and a tender point pain intensity score.\n There was a significant difference among groups in pain intensity ratings (p = 0.03), with Functional Pad A group showing the greatest reduction from baseline at 6 months. All four groups showed a decline in number of tender points, but differences among the groups were not significant (p = 0.72). The functional pad groups showed the largest decline in total tender point pain intensity, but overall differences were not significant (p = 0.25). Improvement in functional status was greatest in the functional pad groups, but differences among groups were not significant (p = 0.23).\n Although the functional pad groups showed improvements in functional status, pain intensity level, tender point count, and tender point intensity after 6 months of treatment, with the exception of pain intensity level these improvements did not differ significantly from changes in the Sham group or in the Usual Care group.", "To study the effect of fluoxetine (FL) and amitriptyline (AM), alone and in combination, in patients with fibromyalgia (FM).\n Nineteen patients with FM completed a randomized, double-blind crossover study, which consisted of 4 6-week trials of FL (20 mg), AM (25 mg), a combination of FL and AM, or placebo. Patients were evaluated on the first and last day of each trial period. Outcome measures included a tender point score, the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI) scale, and visual analog scales (VAS) for global well-being (1 completed by the physician and 1 by the patient), pain, sleep trouble, fatigue, and feeling refreshed upon awakening.\n Both FL and AM were associated with significantly improved scores on the FIQ and on the VAS for pain, global well-being, and sleep disturbances. When combined, the 2 treatments worked better than either medication alone. Similar, but nonsignificant, improvement occurred in the BDI scale, the physician global VAS, and the VAS for fatigue and feeling refreshed upon awakening. Trends were less clear for the tender point score.\n Both FL and AM are effective treatments for FM, and they work better in combination than either medication alone.", "Controversy remains regarding the mechanisms of acupuncture analgesia. A prevailing theory, largely unproven in humans, is that it involves the activation of endogenous opioid antinociceptive systems and mu-opioid receptors (MORs). This is also a neurotransmitter system that mediates the effects of placebo-induced analgesia. This overlap in potential mechanisms may explain the lack of differentiation between traditional acupuncture and either non-traditional or sham acupuncture in multiple controlled clinical trials. We compared both short- and long-term effects of traditional Chinese acupuncture (TA) versus sham acupuncture (SA) treatment on in vivo MOR binding availability in chronic pain patients diagnosed with fibromyalgia (FM). Patients were randomized to receive either TA or SA treatment over the course of 4 weeks. Positron emission tomography (PET) with (11)C-carfentanil was performed once during the first treatment session and then repeated a month later following the eighth treatment. Acupuncture therapy evoked short-term increases in MOR binding potential, in multiple pain and sensory processing regions including the cingulate (dorsal and subgenual), insula, caudate, thalamus, and amygdala. Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate (dorsal and perigenual), caudate, and amygdala. These short- and long-term effects were absent in the sham group where small reductions were observed, an effect more consistent with previous placebo PET studies. Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain. These findings suggest that divergent MOR processes may mediate clinically relevant analgesic effects for acupuncture and sham acupuncture.", "Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity. Because transcranial direct current stimulation (tDCS) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain, we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia.\n Thirty-two patients were randomized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC) (2 mA for 20 minutes on 5 consecutive days). A blinded evaluator rated the patient's pain, using the visual analog scale for pain, the clinician's global impression, the patient's global assessment, and the number of tender points. Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Questionnaire and the Short Form 36 Health Survey. Safety was assessed with a battery of neuropsychological tests. To assess potential confounders, we measured mood and anxiety changes throughout the trial.\n Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC (P < 0.0001). Although this effect decreased after treatment ended, it was still significant after 3 weeks of followup (P = 0.004). A small positive impact on quality of life was observed among patients who received anodal M1 stimulation. This treatment was associated with a few mild adverse events, but the frequency of these events in the active-treatment groups was similar to that in the sham group. Cognitive changes were similar in all 3 treatment groups.\n Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia, thus encouraging further trials.", "There is some evidence for the efficacy of acupuncture in chronic low-back pain (LBP), but it remains unclear whether acupuncture is superior to placebo. In a randomized, blinded, placebo-controlled trial, we evaluated the effect of traditional acupuncture in chronic LBP. A total of 131 consecutive out-patients of the Department of Orthopaedics, University Goettingen, Germany, (age=48.1 years, 58.5% female, duration of pain: 9.6 years) with non-radiating LBP for at least 6 months and a normal neurological examination were randomized to one of three groups over 12 weeks. Each group received active physiotherapy over 12 weeks. The control group (n=46) received no further treatment, the acupuncture group (n=40) received 20 sessions of traditional acupuncture and the sham-acupuncture group (n=45) 20 sessions of minimal acupuncture. Changes from baseline to the end of treatment and to 9-month follow-up were assessed in pain intensity and in pain disability, and secondary in psychological distress and in spine flexion, compared by intervention groups. Acupuncture was superior to the control condition (physiotherapy) regarding pain intensity (P=0.000), pain disability (P=0.000), and psychological distress (P=0.020) at the end of treatment. Compared to sham-acupuncture, acupuncture reduced psychological distress (P=0.040) only. At 9-month follow-up, the superiority of acupuncture compared to the control condition became less and acupuncture was not different to sham-acupuncture. We found a significant improvement by traditional acupuncture in chronic LBP compared to routine care (physiotherapy) but not compared to sham-acupuncture. The trial demonstrated a placebo effect of traditional acupuncture in chronic LBP." ]

[ "7498892", "8353699", "7953031", "475542", "9545998", "7953033", "10560218", "3899049", "9366661" ]

[ "Toward managed care for persons with severe mental illness: implications from a cost-effectiveness study.", "A controlled trial of home-based acute psychiatric services. I: Clinical and social outcome.", "Home-based versus hospital-based care for people with serious mental illness.", "A comparative trial of home and hospital psychiatric care. One-year follow-up.", "Randomized trial of general hospital and residential alternative care for patients with severe and persistent mental illness.", "Home-based versus out-patient/in-patient care for people with serious mental illness. Phase II of a controlled study.", "Home-based multisystemic therapy as an alternative to the hospitalization of youths in psychiatric crisis: clinical outcomes.", "A controlled evaluation of inpatient family intervention. I. Preliminary results of the six-month follow-up.", "A randomized trial of assertive community treatment for homeless persons with severe mental illness." ]

[ "Over the past two decades various models of community-based care for persons with severe mental illness have been developed. This study, which represents the first comparison of the most successful care approach (Program of Assertive Community Treatment or PACT adaptation model) with other, less intensive approaches (clinical team and intensive broker models) in a community service system, indicates that client outcomes were more positive in the PACT adaptation model in terms of enhanced psychosocial functioning and reduced acute and subacute care costs. The PACT model was not significantly more expensive in terms of the costs of providing supportive services compared with the clinical team approach and the intensive broker model of care.", "While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).", "A controlled study tested whether the superior outcome of community care for serious mental illness (SMI) in Madison and in Sydney would also be found in inner London.\n Patients from an inner London catchment area who faced emergency admission for SMI (many were violent or suicidal) were randomised to 20 months or more of either home-based care (Daily Living Programme, DLP; n = 92), or standard in-patient and later out-patient care (controls, n = 97). Most DLP patients had brief in-patient stays at some time. Measures included number and duration of in-patient admissions, independent ratings of clinical and social function, and patients' and relatives' satisfaction.\n Outcome was superior with home-based care. Until month 20, DLP care improved symptoms and social adjustment slightly more, and enhanced patients' and relatives' satisfaction. From 3 to 18 months DLP care greatly reduced the number of in-patient bed days as long as the DLP team was responsible for any in-patient phase its patients had. Cost was less. DLP care did not reduce the number of admissions, nor of deaths from self-harm (3 DLP, 2 control). One DLP patient killed a child. Even at 20 months many DLP and control patients still had severe symptoms, poor social adjustment, no job, and need for assertive follow-up and heavy staff input. (Beyond 20 months most gains were lost apart from satisfaction.)\n It is unclear how much the gain until 20 months from home-based care was due to its site of care, its being problem-centred, its teaching of daily living skills, its assertive follow-up, the home care team's keeping responsibility for any in-patient phase, its coordination of total care (case management), or to other care components. Home-based care is hard to organise and vulnerable to many factors, and needs careful training and clinical audit if gains are to be sustained.", "The effectiveness of community-based treatment stressing home care was compared with hospital-based psychiatric care. One hundred and fifty-five patients destined for inpatient psychiatric care were randomly assigned to Home Care (76 patients) and to Hospital Care (79 patients). Symptoms, role functioning, and psychosocial burden on the family were similar at admission, one month, three months, six months, and one year. The mean in-hospital stay of Hospital Care patients was 41.7 days compared with a mean stay of 14.5 days for Home Care patients. The difference in the amount of ambulatory care received by patients in the two groups was not significant. The evidence is consistent: community-based psychiatric care is an effective alternative to hospital-based care for many but not all severely disabled patients. The active ingredients of successful community treatment are known, yet the lag in implementing these programs persists.", "Severe and persistent mental illnesses are often lifelong and characterized by intermittent exacerbations requiring hospitalization. Providing needed care within budgetary constraints to this largely publicly subsidized population requires technologies that reduce costly inpatient episodes. The authors report a prospective randomized trial to test the clinical effectiveness of a model of acute residential alternative treatment for patients with persistent mental illness requiring hospital-level care.\n Patients enrolled in the Montgomery County, Md., public mental health system who experienced an illness exacerbation and were willing to accept voluntary treatment were randomly assigned to the acute psychiatric ward of a general hospital or a community residential alternative. There were no psychopathology-based exclusion criteria. Treatment episode symptom improvement, satisfaction, discharge status, and 6-month pre- and postepisode acute care utilization, psychosocial functioning, and patient satisfaction were assessed.\n Of 185 patients, 119 (64%) were successfully placed at their assigned treatment site. Case mix data indicated that patients treated in the hospital (N = 50) and the alternative (N = 69) were comparably ill. Treatment episode symptom reduction and patient satisfaction were comparable for the two settings. Nine (13%) of 69 patients randomly assigned to the alternative required transfer to a hospital unit; two (4%) of 50 patients randomly assigned to the hospital could not be stabilized and required transfer to another facility. Psychosocial functioning, satisfaction, and acute care use in the 6 months following admission were comparable for patients treated in the two settings and did not differ significantly from functioning before the acute episode.\n Hospitalization is a frequent and high-cost consequence of severe mental illness. For patients who do not require intensive general medical intervention and are willing to accept voluntary treatment, the alternative program model studied provides outcomes comparable to those of hospital care.", "The effect of a randomised controlled withdrawal of home-based care was studied for half of a sample of seriously mentally ill (SMI) patients from an inner London catchment area, compared with the effects of continuing home-based care.\n Patients, aged 18-64, had entered the trial at month 0 when facing emergency admission for SMI. After at least 20 months home-based care (Phase I), patients were randomised at month 30 into Phase II (months 30-45) to have either further home-based care (DLPII, n = 33) or be transferred to out-/in-patient care (DLP-control, n = 33). They were assessed at 30, 34, and 45 months. Phase I control patients (n = 70) were assessed again at month 45. Measures used were number and duration of in-patient admissions, independent ratings of clinical and social function, and patients' and relatives' satisfaction.\n The slim clinical and social gains from home-based v. out-/in-patient care during Phase I were largely lost in Phase II. Duration of crisis admissions increased from Phase I to Phase II in both DLPII and DLP-control patients. During Phase II, patients' and relatives' satisfaction remained greater for home-based than out-/in-patient care patients. At 45 months, compared with the Phase I controls, DLPII patients and relatives were more satisfied with care. Such satisfaction was independent of clinical/social gains.\n The loss of Phase I gains were perhaps due to attenuation of home-based care quality and to benefits of Phase I home-based care lingering into Phase II in DLP-controls. The Phase II home-based care team suffered from low morale.", "The primary purpose of this study was to determine whether multisystemic therapy (MST), modified for use with youths presenting psychiatric emergencies, can serve as a clinically viable alternative to inpatient psychiatric hospitalization.\n One hundred sixteen children and adolescents approved for emergency psychiatric hospitalization were randomly assigned to home-based MST or inpatient hospitalization. Assessments examining symptomatology, antisocial behavior, self-esteem, family relations, peer relations, school attendance, and consumer satisfaction were conducted at 3 times: within 24 hours of recruitment into the project, shortly after the hospitalized youth was released from the hospital (1-2 weeks after recruitment), and at the completion of MST home-based services (average of 4 months postrecruitment).\n MST was more effective than emergency hospitalization at decreasing youths' externalizing symptoms and improving their family functioning and school attendance. Hospitalization was more effective than MST at improving youths' self-esteem. Consumer satisfaction scores were higher in the MST condition.\n The findings support the view that an intensive, well-specified, and empirically supported treatment model, with judicious access to placement, can effectively serve as a family- and community-based alternative to the emergency psychiatric hospitalization of children and adolescents.", "Although family intervention is practiced in most psychiatric hospitals, there are no adequately controlled studies of its efficacy. This study was designed to answer, in part, the following question: What is the relative efficacy of hospitalization with family intervention as compared with hospitalization without family intervention for patients with major psychiatric disorders who are in need of hospital treatment and for whom both treatments are judged clinically feasible? This is our first report, presenting preliminary data on six-month follow-up for the first three quarters of the total sample of 144 patients (80 with schizophrenic disorder and 64 with major affective disorder).", "This experiment evaluated the effectiveness of an innovative program of assertive community treatment (ACT) for homeless persons with severe and persistent mental illnesses.\n One hundred fifty-two homeless persons with severe and persistent mental illness were randomized to either the experimental ACT program or to usual community services. Baseline assessments included the Structured Clinical Interview for DSM-III-R, Quality-of-Life Interview, Colorado Symptom Index, and the Medical Outcomes Study 36-Item Short Form Health Survey. All assessments (except the Structured Clinical Interview) were repeated at the 2-, 6-, and 12-month follow-up evaluations.\n Subjects in the ACT program used significantly fewer psychiatric inpatient days, fewer emergency department visits, and more psychiatric outpatient visits than the comparison subjects. The ACT subjects also spent significantly more days in stable community housing, and they experienced significantly greater improvements in symptoms, life satisfaction, and perceived health status.\n Relative to usual community care, the ACT program for homeless persons with severe and persistent mental illness shifts the locus of care from crisis-oriented services to ongoing outpatient care and produces better housing, clinical, and life satisfaction outcomes." ]

[ "8688397", "9492730", "8623871", "2030849", "9740522", "11423890", "1988896", "15515998", "15983684" ]

[ "Nonclosure of the visceral and parietal peritoneum at caesarean section: a randomised controlled trial.", "Randomized study of non-closure of peritoneum in lower segment cesarean section.", "Closure or nonclosure of the visceral peritoneum at cesarean delivery.", "A randomized study of closure of the peritoneum at cesarean delivery.", "Closure versus non-closure of peritoneum at cesarean section--evaluation of pain. A randomized study.", "A randomized controlled study of peritoneal closure at cesarean section.", "Peritoneal closure or non-closure at cesarean.", "Closure vs non-closure of the visceral and parietal peritoneum at cesarean delivery: 16 year study.", "Closure or nonclosure of the peritoneum at gynecological operations. Effect on postoperative pain." ]

[ "To assess the short term morbidity of nonclosure of the peritoneum at caesarean section.\n Women undergoing a lower segment caesarean section were randomly allocated to either closure or nonclosure of the visceral and parietal peritoneum.\n Tertiary Care University Hospital of Geneva.\n Length of post-operative hospital stay. Other outcomes include maternal pain as assessed by both a visual analogue scale and the amount of post-operative analgesics administered, post-operative ileus, and febrile morbidity. Operative time was recorded.\n We allocated 137 women to the nonclosure group and 143 to the closure group. Population characteristics were similar between groups. The mean length of hospital stay was 6.5 (SD 1.9) days for the nonclosure group and 6.8 (SD 2.2) days for the closure group (P = 0.21). No differences were found in the level of post-operative pain, the number of analgesic doses given, nor in the proportion with febrile morbidity. Post-operative ileus resolved later in the closure group (P = 0.006). The mean operative time was shorter by 6 min (P = 0.006) in the nonclosure group.\n Short term post-operative morbidity and maternal pain are not increased by a shorter and more simple surgical procedure in which the peritoneum is left unsutured.", "The advantages of non-closure of the visceral and parietal peritoneum at lower segment cesarean section seems to be evident but in the reports published so far, the number of patients studied has been relatively small and the follow-up periods short. It is obviously of value to reconfirm such important observation in several institutions and therefore, in 1991, we decided to study non-closure of the peritoneum in lower segment cesarean section in a large series of patients with long-term follow-up of at least one year.\n A prospective randomized study of 361 patients undergoing lower segment cesarean section in a University Affiliated Hospital, Al-Ain, United Arab Emirates. The operative technique was randomized to include either non-closure of both visceral and parietal peritoneum (study group, n = 179) or closure of both layers (control group, n = 182). Patients were followed up according to a study protocol. The nursing staff and the obstetricians responsible for data collection were unaware as to which of the two groups the patients belonged to. Student-t test and Chi-square test were used for statistical analysis of the results, where appropriate, with a p < 0.05 considered probability level to reflect significant differences.\n Postoperative febrile morbidity and wound infection were significantly lower in the study group as compared to the control group (p < 0.001 and p < 0.05 respectively). The incidence of wound dehiscence, urinary tract infection and the time to opening of the bowels postoperatively were similar in the two groups. In the non-closure group, the average operating time was significantly shorter by 7.9 minutes (p < 0.01) and the hospital stay was one day less (p < 0.01). There were no patients with late postoperative complications or readmissions during 2-5 years of follow-up that could be attributed to complications associated with lower segment cesarean section.\n Non-closure of the visceral and parietal peritoneum at lower segment cesarean section is associated with fewer postoperative complications, is more cost effective and is simpler than the traditional operative technique of closing both peritoneal layers.", "Our purpose was to determine whether nonclosure of the visceral peritoneum at low transverse cesarean delivery has advantages over suture peritonization with regard to postoperative morbidity.\n A prospective randomized trial of 549 women undergoing cesarean section was carried out; 262 were randomized to nonclosure and 287 to closure of the visceral peritoneum. Perioperative, intraoperative, and postoperative management decisions were made without reference to treatment groups. Statistical analysis compared intraoperative and postoperative outcome between the two groups.\n Operating and anesthesia times were significantly shorter in patients receiving nonclosure. The incidence of febrile morbidity and cystitis and the need for antibiotics and narcotics were all significantly greater when the peritoneum was closed. Hospital stay was significantly shorter after nonclosure.\n Nonclosure of the visceral peritoneum is associated with lower febrile and infectious morbidity. Routine closure of the visceral peritoneum should be abandoned at cesarean delivery.", "This study was conducted to test the hypothesis that nonclosure of the visceral and parietal peritoneum during low transverse cervical cesarean delivery is not associated with increased intraoperative or immediate postoperative complications. One hundred thirteen patients scheduled for low transverse cervical cesarean were randomized to either closure of both the visceral and parietal peritoneum with absorbable suture (N = 59) or no peritoneal closure (N = 54). Patients were cared for in the usual postoperative manner without reference to treatment group. There were no demographic differences between the groups and no differences in method(s) of anesthesia, operative indication(s), or use of peripartum epidural narcotics. The incidence of fever, endometritis, or wound infection was similar between groups. There were no differences in the number of patients requiring parenteral narcotic analgesia or in the number of doses per patient. The number of oral analgesic doses was significantly greater with closure than without (P = .014). The frequency with which postoperative ileus was diagnosed in each group was similar, and there was no difference regarding the day on which patients were advanced to liquid or select diets. Bowel stimulants were administered more frequently to the closure than to non-closure patients (P = .03). The average operating time was shorter for the open group than for the closure group (P less than .005). We conclude that non-closure of the visceral and parietal peritoneum at low transverse cervical cesarean delivery appears to have no adverse effect on immediate postoperative recovery, may decrease postoperative narcotic requirements, allows less complicated return of bowel function, and provides a simplified and shorter surgical procedure.", "To evaluate the effects of leaving the parietal peritoneum open at lower segment cesarean section (LSCS) measured by postoperative pain.\n A randomized, prospective and double-blind study.\n Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark.\n Forty women referred for an elective cesarean section were assigned to one of two groups: peritoneum open (n=21) or peritoneum closed (n=19).\n Pain was evaluated twice a day from the first to the fifth postoperative day by Visual Analog Scales.\n Postoperative pain. Other outcomes include usage of analgesics, bowel function, postoperative complications, and hospital stay.\n We found no overall difference in postoperative pain. A tendency to less pain was found in the non-closure group from the third postoperative day to the fifth postoperative day. No differences were found either in the incidence of postoperative complications, or the time to return of bowel function. Concerning opiate analgesics the non-closure group had a significantly higher use in the second postoperative 24-hour period, but in the remains of the registration period it was significantly lower. For oral analgesics no difference was found in the first 24-hour period, but in the remains of the period the non-closure group had a significantly lower use.\n The VAS-scales showed no difference in postoperative pain comparing closure to non-closure of the parietal peritoneum. However, the use of analgesics is lower in the non-closure group. We suggest leaving the parietal peritoneum open when performing LSCS.", "To assess the benefits or problems that may be associated with peritoneal closure at cesarean section.\n A randomized-controlled study of women undergoing cesarean section in Sultan Qaboos University Hospital Maternity Unit. After the decision is taken for cesarean section, women were randomized to either repair of peritoneum using standard technique or non-repair of peritoneum. Duration of operation, maternal morbidity, blood loss assessed by post-operative hemoglobin change and requirement of transfusion, post operative infection, thromboembolic disease, and length of hospital stay were analyzed in 2 groups of patients. Sixty women were randomized into the study, 30 group A, had peritoneal closure and 30, group B, and had non-closure.\n The average duration of operation for group A was 61.9+/-12.734, and for group B was 53.56 +/-11.209 (p< 0.01 statistically significant). There was no statistically significant difference in the length of stay, estimated blood loss, the mean drop in hemoglobin, postoperative pyrexia, and wound infection rate between the 2 groups.\n Our study has confirmed the previous study findings, and has shown that there are no advantages in suturing of the peritoneum in terms of blood loss, blood transfusion, operation duration, postoperative pyrexia and wound infection. In fact non-suturing of the peritoneum was associated with shorter operation duration (p< 0.01 significant), and reduced cost.", "The value of peritoneal closure at the time of cesarean birth was evaluated prospectively. Two hundred forty-eight women undergoing low transverse cesarean through a Pfannenstiel skin incision were assigned to one of two groups: peritoneum open (N = 127) or peritoneum closed (N = 121). The mean (+/- SEM) surgical time in the open group (48.1 +/- 1.2 minutes) was significantly less than for the closed group (53.2 +/- 1.4 minutes) (P less than .005). There were no postoperative differences between the groups in the incidence of wound infection, dehiscence, endometritis, ileus, and length of hospital stay. Our study suggests that leaving the parietal peritoneum unsutured is an acceptable way to manage patients at cesarean delivery.", "To determine whether non-closure of visceral and parietal peritoneum at LSCS has advantages over peritoneal closure with regard to postoperative complication and adhesions.\n Prospective randomized controlled trial.\n Paholpolpayuhasena Hospital, Kanchanaburi province, Thailand\n Three hundred and sixty full-term pregnant women undergoing first cesarean section were divided into 3 groups (N = 120). Group A: non-closure of both visceral and parietal peritoneum. Group B. non-closure of only visceral peritoneum. Group C: closure of both visceral and parietal peritoneum. Postoperative complications were compared. Adhesions were evaluated in 65 patients returning for a second LSCS and compared for severity of adhesions. The three groups were compared using statistical analysis.\n There was no significant statistical difference between group A and C, group B and C for postoperative complications or number of adhesion formation. However, adhesions in the closure group were more severe.\n Closure of visceral and parietal peritoneum has no benefit over non-closure of visceral peritoneum and non-closure of both visceral and parietal peritoneum at LSCS.", "To compare the analgesic requirement and pain scores in the postoperative period between closure and nonclosure of the peritoneum in women undergoing gynecological abdominal surgery.\n We conducted this study as a 2 parallel grouped, double blind, randomized, controlled trial between February 2002 and March 2003. The current study consists of 79 eligible women who were enrolled and completed baseline assessments. We carried out this study at the Cumhuriyet University Hospital, Sivas, Turkey.\n When the age, gravidity, parity, body mass index, type of surgery, operative time and length of hospital stay were compared, between the 2 groups, no statistically significant difference was found (p>0.05). The postoperative pain was found higher in the closure group than the nonclosure group (p<0.05) when the pain with visual analogue scale (VAS) scores compared.\n There was no significant difference in analgesic requirements between the 2 groups in the postoperative period. However, less pain and low VAS scores were evident especially after postoperative 2nd and 48th hours in the nonclosure group. We recommend non-closure of peritoneum at abdominal gynecologic procedure as the method of choice." ]

[ "16454975", "1537131", "17202203", "11666130", "8114181", "9922309", "9159691", "2526993", "14769686" ]

[ "XS0601 reduces the incidence of restenosis: a prospective study of 335 patients undergoing percutaneous coronary intervention in China.", "Double-blind, randomized, controlled trial of fish oil supplements in prevention of recurrence of stenosis after coronary angioplasty.", "Long-term results of sealed capsule irrigation using distilled water to prevent posterior capsule opacification: a prospective clinical randomised trial.", "Potential use of a low-molecular-weight heparin to prevent restenosis in patients with extensive wall damage following peripheral angioplasty.", "Long-term follow-up for recurrent stenosis: a prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy.", "Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. The IOIBD Budesonide Study Group.", "Heparin eyedrops to prevent posterior capsule opacification.", "Usefulness of fish oil supplements in preventing clinical evidence of restenosis after percutaneous transluminal coronary angioplasty.", "Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis." ]

[ "XS0601, consisting of active ingredients (Chuangxiongol and paeoniflorin), has been shown to inhibit arterial neointimal hyperplasia in animal models and in preliminary human studies. The objective of this study was to evaluate the safety and efficacy of XS0601 in preventing restenosis following percutaneous coronary intervention (PCI).\n A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 patients were randomized into treatment with the oral administration of XS0601, or a placebo for 6 months after successful PCI. Angiographic follow-up was scheduled at 6 months, and clinical follow-ups performed at 1, 3 and 6 months after PCI. The primary end point was angiographic restenosis. The secondary end points were the combined incidence of death, target lesion nonfatal myocardial infarction, repeat angioplasty, and coronary artery bypass graft surgery.\n A total of 308 patients (91.9%) completed the study and 145 cases (47.1%) received angiographic follow-up. The restenosis rates were significantly reduced in the XS0601 group as compared with the placebo group (26.0% vs. 47.2%, P < 0.05), and the minimum lumen diameter (MLD) was greater [(2.08 +/- 0.89) mm for XS0601 vs. (1.73 +/- 0.94) mm for placebo, P < 0.05]. XS0601 also significantly reduced the combined incidence of major adverse cardiac event (10.4% in the XS0601 group vs. 22.7% in the placebo group, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in XS0601 group (7.1% and 11.0%) as compared with those in placebo group (19.5% and 42.9%) (P < 0.05). No significant side effects occurred within the 6-month follow-up period in the XS0601 group.\n Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients.", "Previous studies suggest that recurrence of coronary stenosis after percutaneous transluminal coronary angioplasty (PTCA) might be prevented with dietary supplements rich in omega-3 fatty acids. The purpose of the present study was to evaluate this hypothesis. In addition, the relation between usual dietary consumption of omega-3 fatty acids and restenosis was assessed.\n A double-blind, randomized, controlled trial was conducted in which 205 patients undergoing a first PTCA received 15 capsules per day containing 1 g of either fish oil (2.7 g/day of eicosapentaenoic acid, 1.8 g/day of docosahexaenoic acid) or olive oil. The treatment was started 3 weeks before PTCA and continued for 6 months thereafter. Dietary intake was assessed by food frequency questionnaire. At 6 months after PTCA, patients underwent a control angiography. All angiographic lesions were measured by quantitative computer analysis. Four criteria were used to define restenosis. Restenosis occurred less often in the fish oil group (22.0-35.6% depending on the definition) than in the control group (40.0-53.3%). After controlling for other risk factors of restenosis, the association of fish oil supplementation with a lower frequency of restenosis was statistically significant (p = 0.03) for three of four definitions. After adjustment, a dietary intake of omega-3 fatty acids of more than 0.15 g/day was also associated with a lower frequency of restenosis (p less than or equal to 0.03).\n This trial documented the protective effect of fish oil supplements on the recurrence of coronary stenosis 6 months after PTCA. The study results suggest that a dietary intervention could be useful in preventing restenosis.", "We investigated long-term safety and efficacy of sealed capsule irrigation (SCI) during cataract surgery to prevent posterior capsule opacification (PCO).\n One eye of each of 17 patients (mean age: 70.1+/-9.7 years) who presented with bilateral cataracts was randomly chosen for SCI treatment. After phacoemulsification, the capsular bag was vacuum sealed with the PerfectCapsule device (Milvella) followed by SCI using distilled water for two minutes. No vacuum loss occurred during irrigation. Each patient's fellow eye served as a control. One hydrophilic acrylic intraocular lens model was implanted in all eyes. Five patients had to be excluded due to deep anterior chamber, small pupil or unilateral surgery. Follow-up examinations took place one day and one, three, six, 12 and 24 months after surgery. We evaluated safety parameters, anterior capsule (AC) overlapping and PCO.\n Postoperatively, mean best corrected visual acuity, pachymetry, endothelial cell count, intraocular pressure, AC overlapping and PCO showed no statistically significant difference between SCI and the control group (p>0.05, Wilcoxon test).\n SCI is a safe procedure and enables the specific pharmacological targeting of lens epithelial cells inside the capsular bag. Using distilled water, however, it is not possible to reduce PCO development significantly. Thus, alternative substances should be evaluated.", "The long-term outcome of primary successful percutaneous transluminal angioplasty (PTA) for patients with peripheral occlusive arterial disease (POAD) is frequently compromised by the development of restenosis, especially when extensive dissections result from the angioplastic procedure. Unfortunately, prevention of the occlusive process by means of drugs such as antithrombotics, anticoagulants, thrombolytics, corticosteroids, lipid reducers, or cytostatics has not been demonstrated convincingly. The authors sought to clarify whether such patients could benefit from the postsurgical administration of low-molecular-weight heparin. A total of 172 POAD patients with extensive dissections after PTA in the pelvic or upper leg regions were randomized for 7-day post-PTA intravenous treatment with either full heparinization or nadroparin calcium followed by adjunctive oral aspirin for 6 months. The primary outcome measure was the degree of stenosis (normal findings; stenosis < 50%, > 50%, > 80%, occlusion) before and after angioplasty, as well as 3 weeks and 3 and 6 months after dilation; secondary efficacy criteria included changes in the Fontaine stage and in the crurobrachial ratio. No significant treatment-related differences were found at the 3 post-PTA follow-up examinations with regard to the degree of stenosis. This was also the case for the subgroup of patients (n = 62) who had undergone angioplasty in the pelvic region. By contrast, when angioplasty was performed in the superficial femoral artery (n = 110), the degree of restenosis was significantly lower (p<0.01) among patients receiving nadroparin calcium compared to those given heparin at week 3, month 3, and month 6. No intergroup differences emerged for secondary outcome measures in the long term or for safety parameters. These preliminary results indicate that patients with extensive dissections after PTA treatment for POAD in the upper leg region might benefit from a reduction in the rate of restenosis by administration of 7-day weight-adjusted nadroparin calcium.", "To determine the effect of primary closure (PC) versus expanded polytetrafluoroethylene patch graft angioplasty (PGA) on the incidence of recurrent stenosis (> 50% lumen diameter narrowing) after carotid endarterectomy (CEA), 87 patients undergoing 100 consecutive CEA were prospectively randomized into two groups.\n Forty-four patients underwent 51 PC, and 43 patients underwent 49 PGA. All patients were evaluated after operation by duplex scanning at 1.5, 12, 24, and 36 months. There were no significant differences in the demographic characteristics or operative indications for CEA between the two patient groups. Complete follow-up was achieved in 86% (75/87) of the patients during the 36-month surveillance period.\n The perioperative permanent neurologic morbidity in the PC and PGA groups was noted to be 4% and 2%, respectively (PC = 2/51 vs PGA = 1/49, p = 0.58). Three additional reversible cerebral ischemic events occurred in the postoperative period (PC = 2/51 vs PGA = 1/49, p = 0.58). Other morbidity included immediate postoperative hemorrhage requiring reexploration (1/51) in the PC group and an infected expanded polytetrafluoroethylene patch requiring removal and replacement with autogenous vein (1/49). Long-term follow-up detected a single patient with significant bilateral restenoses of his primarily closed carotid arteries. None of the patients in the PGA group had restenoses (PC = 2/51 vs 0/49, p = 0.50). In addition, no postoperative dilation of the common or internal carotid arteries or perioperative death was observed.\n In patients undergoing CEA, these data demonstrate no significant difference in the perioperative morbidity or mortality between PC and PGA. Use of the patch did not engender patients to patch rupture or aneurysmal degeneration as previously described with vein patch angioplasty procedures. This series supports effective use of either technique to achieve minimal rates of restenosis.", "Prevention of postoperative recurrence after resection for Crohn's disease (CD) would be of great clinical benefit. The efficacy of oral budesonide for prevention of endoscopic recurrence was evaluated in patients undergoing resection for ileal or ileocecal CD.\n Sixty-three patients received budesonide and 66 received placebo in a double-blind, randomized trial with parallel groups. Ileocolonoscopy, including biopsy, was performed after 3 and 12 months. Indications for surgery were fibrostenosis (78 patients), disease activity (41), and other reasons (10).\n The frequency of endoscopic recurrence did not differ between the groups at 3 and 12 months. In patients with disease activity as indication for surgery, the endoscopic recurrence rate at the anastomosis was lower in the budesonide group at 3 months, although not significantly (21% vs. 47%; P = 0.11), and at 12 months (32% vs. 65%; P = 0.047). There was no such difference with respect to fibrostenosis as indication for surgery. No differences in adverse event patterns were found between the two groups.\n Oral budesonide, 6 mg daily, offered no benefit in prevention of endoscopic recurrence after surgery for ileal/ileocecal fibrostenotic CD but decreased the recurrence rate in patients who had undergone surgery for disease activity.", "To evaluate whether heparin eyedrops prevent or reduce posterior capsule opacification (PCO) after extracapsular cataract extraction (ECCE) with intraocular lens (IOL) implantation.\n Institute of Ophthalmology, University G. d'Annunzio, Chieti, Italy.\n This 4 year, prospective, case-controlled study evaluated 200 patients who had ECCE and implantation of the same type of posterior chamber IOL. Patients were randomly assigned to receive topical heparin eyedrops postoperatively (heparin group, n = 100) or not to receive the eyedrops (control group, n = 100). Postoperative cell response, cellular precipitates on the IOL, and presence of PCO were evaluated.\n There were no significant differences between groups in postoperative inflammation. The incidence of cellular precipitates was significantly lower in the heparin group than in the control group (P < .001). A neodymium:YAG (Nd:YAG) posterior capsulotomy was done in 7 patients in the heparin group and 14 in the control group (P = .15). During the first 24 months after surgery, the heparin group had a significantly lower incidence of Nd:YAG capsulotomy (P < .05) and fibrotic PCO (P = .02).\n Topical heparin eyedrops were effective in reducing fibrotic PCO in the long term, indicating their usefulness in the postoperative management of ECCE.", "This study assesses the effect of dietary supplements with high dose omega-3 fatty acid (N3FA) on the frequency of clinical restenosis during the 6 months after successful percutaneous transluminal coronary angioplasty (PTCA). One hundred ninety-four patients (214 significant coronary narrowings) were randomized after successful PTCA to receive conventional medical therapy or to an identical regimen supplemented by high dose N3FA (4.5 g/day). Enrollment required angina pectoris and successful dilatation of all significant coronary narrowings. The subjects were randomly assigned to either no N3FA (control, n = 99) or N3FA supplementation (n = 95). After a 1-week trial period, 11 (group 2) declined further treatment because of side effects. The remaining 84 subjects (group 1) continued N3FA throughout the 6-month period. Monthly clinical follow-up was obtained in all patients. Ninety-two percent of patients had cardiac testing for evaluation of recurrent ischemia. Except for a greater percentage of women in the group refusing N3FA supplementation (group 2), the 3 groups were similar in demographic data, medical history, dietary habits, history of previous PTCA and angiographic characteristics. Of the 194 subjects, 56 had clinical restenosis (45 by cardiac catheterization, 8 by exercise testing and 3 by symptoms alone [refused further clinical testing]). Reocclusion rates were: group 1 19%, group 2 46%, and control 35%. Analysis both in accordance with the principle of intention to treat and for subjects who actually received N3FA revealed a significant effect of N3FA on preventing clinical restenosis (p less than 0.04 and p = 0.008, respectively). These data suggest that high dose N3FA supplements reduce the clinical restenosis rate after successful PTCA.", "This study evaluated a large group of patients enrolled in a double-blind randomized trial of the sirolimus-eluting stent to document whether the initial clinical improvement seen in previous smaller series is maintained out to 12 months and to study the potential treatment effect in patient subsets known to be at increased risk of restenosis.\n A total of 1058 patients with de novo native coronary stenosis undergoing clinically indicated percutaneous coronary intervention were randomly assigned to sirolimus-eluting stent (533) or control bare stent (525). Procedural success and in-hospital outcomes were excellent and did not differ between the 2 groups. At 9 months, clinical restenosis, defined as target-lesion revascularization, was 4.1% in the sirolimus limb versus 16.6% in the control limb (P<0.001). At 12 months, the absolute difference in target-lesion revascularization continued to increase and was 4.9% versus 20% (P<0.001). There were no differences in death or myocardial infarction rates. In high-risk patient subsets, defined by vessel size, lesion length, and presence of diabetes mellitus, there was a 70% to 80% reduction in clinical restenosis at 1 year.\n Placement of the sirolimus-eluting stent results in continued clinical improvement at 1 year after initial implantation, with significant reduction in clinical restenosis as defined by target-lesion revascularization. Between 9 and 12 months, the absolute reduction of clinical restenosis continues to increase. Even in high-risk subsets of patients, there is a 70% to 80% relative reduction in clinical restenosis at 12 months with this drug-eluting stent." ]

[ "7413719", "1839644", "8964276", "12617376", "9578044", "1920391", "8404750", "8764816", "12011290" ]

[ "Chronic administration of cannabidiol to healthy volunteers and epileptic patients.", "Controlled clinical trial of cannabidiol in Huntington's disease.", "A randomised open multicentre comparative trial of lamotrigine and carbamazepine as monotherapy in patients with newly diagnosed or recurrent epilepsy.", "A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms.", "Pharmacokinetic evaluation of twice-daily extended-release carbamazepine (CBZ) and four-times-daily immediate-release CBZ in patients with epilepsy.", "Treatment of epilepsy in mentally retarded patients with a slow-release carbamazepine preparation.", "Adjuvant vigabatrin in refractory epilepsy: a ceiling to effective dosage in individual patients?", "Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy.", "Safety, tolerability, and efficacy of orally administered cannabinoids in MS." ]

[ "In phase 1 of the study, 3 mg/kg daily of cannabidiol (CBD) was given for 30 days to 8 health human volunteers. Another 8 volunteers received the same number of identical capsules containing glucose as placebo in a double-blind setting. Neurological and physical examinations, blood and urine analysis, ECG and EEG were performed at weekly intervals. In phase 2 of the study, 15 patients suffering from secondary generalized epilepsy with temporal focus were randomly divided into two groups. Each patient received, in a double-blind procedure, 200-300 mg daily of CBD or placebo. The drugs were administered for along as 4 1/2 months. Clinical and laboratory examinations, EEG and ECG were performed at 15- or 30-day intervals. Throughout the experiment the patients continued to take the antiepileptic drugs prescribed before the experiment, although these drugs no longer controlled the signs of the disease. All patients and volunteers tolerated CBD very well and no signs of toxicity or serious side effects were detected on examination. 4 of the 8 CBD subjects remained almost free of convulsive crises throughout the experiment and 3 other patients demonstrated partial improvement in their clinical condition. CBD was ineffective in 1 patient. The clinical condition of 7 placebo patients remained unchanged whereas the condition of 1 patient clearly improved. The potential use of CBD as an antiepileptic drug and its possible potentiating effect on other antiepileptic drugs are discussed.", "Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.", "The efficacy and safety of lamotrigine and carbamazepine as monotherapy in patients with untreated, newly diagnosed or recurrent partial and/or generalised tonic-clonic seizures, were compared in a randomised, open, multicentre study. Patients received 24 weeks' treatment with oral lamotrigine 100 mg (LTG 100, n = 115) or 200 mg (LTG 200, n = 111) or carbamazepine 600 mg (CBZ 600, n = 117). Efficacy measurements were comparable between the three treatment groups, although the higher lamotrigine dose was possibly most effective, with 60.4% completing seizure free compared with 51.3% (LTG 100) and 54.7% (CBZ 600). Both dosage regimens of lamotrigine were well tolerated. More patients on CBZ 600 reported adverse experiences, 66% versus 53% (LTG 100) and 58% (LTG 200), and of these a greater proportion were attributed to CBZ 600 treatment, 53% versus 23% (LTG 100) and 28% (LTG 200). Similarly, a greater proportion of the CBZ 600 group required a change in dose, 47% versus 20% (LTG 100) and 17% (LTG 200) or withdrew completely due to adverse experiences, 10.3% versus 4.3% (LTG 100) and 4.5% (LTG 200). The most common adverse experience leading to withdrawal was rash, with approximately double the proportion of reports occurring in patients on CBZ 600 (5.1%) compared with lamotrigine (1.7% on LTG 100 and 2.7% on LTG 200). Overall lamotrigine appeared equally effective but better tolerated compared with carbamazepine.", "To determine whether plant-derived cannabis medicinal extracts (CME) can alleviate neurogenic symptoms unresponsive to standard treatment, and to quantify adverse effects.\n A consecutive series of double-blind, randomized, placebo-controlled single-patient cross-over trials with two-week treatment periods.\n Patients attended as outpatients, but took the CME at home.\n Twenty-four patients with multiple sclerosis (18), spinal cord injury (4), brachial plexus damage (1), and limb amputation due to neurofibromatosis (1).\n Whole-plant extracts of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), 1:1 CBD:THC, or matched placebo were self-administered by sublingual spray at doses determined by titration against symptom relief or unwanted effects within the range of 2.5-120 mg/24 hours. Measures used: Patients recorded symptom, well-being and intoxication scores on a daily basis using visual analogue scales. At the end of each two-week period an observer rated severity and frequency of symptoms on numerical rating scales, administered standard measures of disability (Barthel Index), mood and cognition, and recorded adverse events.\n Pain relief associated with both THC and CBD was significantly superior to placebo. Impaired bladder control, muscle spasms and spasticity were improved by CME in some patients with these symptoms. Three patients had transient hypotension and intoxication with rapid initial dosing of THC-containing CME.\n Cannabis medicinal extracts can improve neurogenic symptoms unresponsive to standard treatments. Unwanted effects are predictable and generally well tolerated. Larger scale studies are warranted to confirm these findings.", "A new capsule dosage form of carbamazepine (CBZ) has been developed, consisting of three different types of beads (immediate-release, extended-release, and enteric-release) that may be taken sprinkled on food or swallowed for easy administration. We compared the pharmacokinetics of the extended-release dosage form of CBZ (Carbatrol capsules) twice daily with the conventional immediate-release formulation of CBZ four times daily.\n The randomized, double-blind, two-way, cross-over study was conducted at two sites, with a planned sample size of 24 adult patients with epilepsy. Each treatment was administered for 2 weeks. At the end of the 2-week period, blood samples were obtained hourly for a 24-h period.\n The 90% confidence intervals (CI) of the ratio of the means of the extended-release formulation twice daily to the immediate-release formulation four times daily were within the range of 0.80-1.25 for each of the pharmacokinetic parameters for CBZ and for the summation of CBZ and CBZ-epoxide (CBZ-E). There was no difference in the frequency of seizures between treatment (p = 0.103).\n Our results demonstrate that extended-release CBZ twice daily was bioequivalent to immediate-release CBZ four times daily, with regard to CBZ levels and summation of CBZ and CBZ-E levels, based on the pharmacokinetic parameters evaluated. Substituting one formulation for the other did not cause patients to have a significant change in seizure frequency.", "Pharmacokinetic properties and efficacy of a conventional (C) carbamazepine (CBZ) preparation divided into three daily doses and a slow-release CBZ preparation (SR) divided into two daily doses were evaluated in a randomized, double-blind, cross-over study. The trial started with a 8-week baseline period followed by the two treatment periods each 10 weeks long. At the end of each period, a 24-h blood sample series for determination of serum CBZ and carbamazepine-10,11-epoxide (CBZE) was collected. The occurrence of seizures was monitored day and night during the whole study period by experienced nurses. The mean age of the 20 evaluable patients was 24.9 and the duration of epilepsy 19.2 and carbamazepine treatment 7.0 years. The bioavailability of CBZ from the two preparations was similar. The mean fluctuation of serum CBZ concentration (Cmax-Cmin/Css) was 16% smaller during SR. The mean serum CBZ concentration in the morning samples was significantly (P less than 0.001) higher during SR treatment. The mean total number of seizures was approximately four per week and did not differ between the two treatments, but during the last 2 weeks of the study period the occurrence of seizures was significantly smaller during SR (P = 0.02).", "A double-blind, randomized, cross-over study of additional vigabatrin (gamma-vinyl-GABA, VGB, 1.0 g twice daily for 6 weeks, followed by 1.5 g twice daily for 6 weeks) and matched placebo was undertaken in 24 patients with refractory epilepsy. Nineteen completed the trial satisfactorily. Fewer seizure days were reported during VGB treatment [placebo 41, VGB 23, p < 0.05, 95% confidence interval (CI) -1.5 to -14]. An overall reduction in median seizure numbers failed to reach statistical significance (n = 19; placebo 52, VGB 32, NS, 95% CI -18 to +24). Subgroup analysis, however, showed a significant reduction in partial seizures (n = 17) with 2 g VGB daily (placebo 22, VGB 13, p < 0.05, 95% CI -0.5 to -16.5), but not with higher dosage (placebo 28, VGB 22, NS, 95% CI -18 to +11). A deterioration in control of partial seizures as compared with the equivalent placebo phase was observed when patients were changed from 2 to 3 g/day VGB (2 g VGB 13, 3 g VGB 22, p = 0.05, 95% CI 0 to +20). Loss of efficacy was noted in 3 patients, and seizure control worsened slightly in 5 others. One previously resistant patient developed a therapeutic response, and 2 other patients reported an additional useful reduction in seizures. In the remaining 8 patients, seizure frequency did not change. VGB did not appear to benefit tonic-clonic seizures. Serum VGB concentrations were higher during treatment with 3 g (15.5 +/- 8.9 mg/L) daily than with 2 g (13.5 +/- 11.2 mg/L). No important alterations were noted in the concentrations of concomitantly administered antiepileptic drugs (AEDs) throughout the trial. VGB is useful adjuvant therapy for treatment of partial seizures. There may be a ceiling to effective dosage. This demands individual dose titration for each patient.", "We wished to evaluate adjunctive therapy for partial-onset seizures with topiramate (TPM) for efficacy and safety in a double-blind, placebo-controlled, randomized, parallel-group study.\n Sixty outpatients with epilepsy (47 men and 13 women, mean age 32.9 years) were studied. All had a documented history of partial-onset seizures with or without secondarily generalized seizures. After an 8-week baseline during which patients had at least one seizure per week, 30 patients each were randomized to TPM 300 mg twice daily (b.i.d.) or placebo for 12 weeks.\n TPM was significantly superior to placebo, as indicated by all efficacy assessments: greater median percent reduction from baseline in the average monthly seizure rate (46 vs. -12%, p = 0.004); greater number of treatment responders (patients with > or = 50% reduction in seizure rate) (47 vs. 10%, p = 0.001), and better investigator (p = 0.002) and patient (p = 0.010) global assessments of treatment. Among TPM-treated patients, the most commonly reported adverse events (AE) were headache, somnolence, fatigue, dizziness, and abnormal thinking. Most AE were mild or moderate in severity.\n The results of the present trial indicate that TPM 600 mg/day is effective in the treatment of refractory partial-onset seizures with or without secondarily generalized seizures.", "The authors conducted a randomized, double-blind, placebo-controlled, twofold crossover study in 16 patients with MS who presented with severe spasticity to investigate safety, tolerability, and efficacy of oral Delta(9)-Tetrahydrocannabinol (THC) and Cannabis sativa plant extract. Both drugs were safe, but adverse events were more common with plant-extract treatment. Compared with placebo, neither THC nor plant-extract treatment reduced spasticity. Both THC and plant-extract treatment worsened the participant's global impression." ]

[ "6853785", "1809589", "20889234", "8219661", "1757612", "14732659", "8286257", "20513160", "11234559" ]

[ "Once-daily treatment of psoriasis with topical glucocorticosteroid ointments.", "Intermittent corticosteroid maintenance treatment of psoriasis: a double-blind multicenter trial of augmented betamethasone dipropionate ointment in a pulse dose treatment regimen.", "A phase II placebo-controlled study of photodynamic therapy with topical hypericin and visible light irradiation in the treatment of cutaneous T-cell lymphoma and psoriasis.", "A double-blind, randomized, placebo-controlled trial of n-3 fatty acid based lipid infusion in acute, extended guttate psoriasis. Rapid improvement of clinical manifestations and changes in neutrophil leukotriene profile.", "Evaluation of halobetasol propionate ointment in the treatment of plaque psoriasis: report on two double-blind, vehicle-controlled studies.", "Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials.", "Highly purified omega-3-polyunsaturated fatty acids for topical treatment of psoriasis. Results of a double-blind, placebo-controlled multicentre study.", "Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream.", "Double-blind, placebo-controlled, randomized, right-left study comparing calcipotriol monotherapy with a combined treatment of calcipotriol and diflucortolone valerate in chronic plaque psoriasis." ]

[ "A double-blind, vehicle-controlled comparison of two glucocorticosteroid ointments demonstrated that once-daily therapy for psoriasis was effective. After 3 weeks of once-daily therapy, psoriasis subjects treated with betamethasone dipropionate (BD) ointment or diflorasone diacetate (DD) ointment showed statistically significant (p less than 0.01) improvement compared to subjects using vehicle alone.", "Ninety psoriasis patients, who were either completely cleared of or manifested only a minimal presence of disease signs following 3-4 weeks of twice daily treatment with augmented betamethasone dipropionate (ABD) ointment 0.05%, were enrolled in this multicenter, double-blind, placebo-controlled study. The study was designed to determine if an intermittent pulse dose regimen of ABD ointment could safely and effectively maintain a remission disease status when treatment was applied in three consecutive applications 12 h apart, once a week for a maximum treatment period of 6 months. The disease of 60% of the patients in the active treatment group was successfully controlled for 6 months, while 80% of the placebo-treated patients experienced exacerbation of disease signs. No serious local or systemic treatment-related adverse experiences were reported. ABD ointment 0.05%, when applied using the intermittent treatment regimen described here, was shown to be a clinically beneficial and well-tolerated method of long-term (up to 6 months) maintenance therapy for psoriasis patients.", "Hypericin is a known photodynamic agent that has been demonstrated to induce apoptosis in normal and malignant B and T lymphocytes, and has potential to treat benign and malignant disorders of the skin, including psoriasis and cutaneous T-cell lymphoma.\n We wished to test whether topical hypericin was an effective, safe, and well-tolerated therapy for patch or plaque phase mycosis fungoides and for plaque psoriasis.\n We conducted a phase II placebo-controlled clinical study in patients who had either patch or plaque phase mycosis fungoides or plaque type psoriasis vulgaris. Representative lesions were treated twice weekly for 6 weeks with topically applied hypericin or placebo followed 24 hours later by exposure to visible light at 8 to 20 J/cm(2).\n After 6 weeks of twice-weekly therapy, several concentrations of hypericin resulted in the significant improvement of treated skin lesions among the majority of patients with cutaneous T-cell lymphoma and psoriasis whereas the placebo vehicle was ineffective.\n The clinical trial involved a small number of patients.\n Overall, the data from this study support the conclusion that topical hypericin/visible light photodynamic therapy is an effective and well-tolerated alternative to standard psoralen plus ultraviolet A treatment of these disorders.\n Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.", "Twenty patients hospitalized for acute psoriasis guttata with a minimum 10% of body surface area involvement (range 10-90%) completed a 10-day trial in which they were randomly allocated to receive daily infusions with either an n-3 fatty acid based lipid emulsion [100 ml/day with 2.1 g eicosapentaenoic (EPA) and 21 g docosahexaenoic acid (DHA)] or a conventional n-6 lipid emulsion (EPA + DHA < 0.1 g/100 ml). The severity of disease was evaluated by scoring daily erythema, infiltration, and desquamation and by a subjective scoring of clinical manifestations offered by the patients. Leukotriene (LT) and platelet-activating factor (PAF) generation were investigated in ionophore-stimulated neutrophils obtained on days 0, 1, 3, 5, 10, and 40. Moderate improvement in clinical manifestations was noted in the n-6 group (changes in score systems between 16-25% from baseline within 10 days). In contrast, the severity of disease markedly decreased in all patients of the n-3 group, with improvements in all score systems ranging between 45% and 76% within 10 days (P < 0.05 for each variable). The difference in response to the two regimens was evident within 4-7 days after onset of lipid infusion. A more than ten fold increase in neutrophil EPA-derived 5-lipoxygenase product formation (LTB5, its omega-oxidation products, non-enzymatic degradation products of LTA5 and 5-hydroxyeicosapentaenoic acid) was noted in the n-3 group but not in the n-6 group. Neutrophil PAF generation increased in the n-6 group but decreased in the n-3 group. In conclusion, modulation of eicosanoid metabolism by intravenous n-3 fatty acid supplementation appears to exert a rapid beneficial effect on inflammatory skin lesions in acute guttate psoriasis.", "The results of two studies are presented that reveal the efficacy and safety of 0.05% halobetasol ointment in the treatment of patients with plaque psoriasis of at least moderate severity. Both multicenter studies were randomized, double-blind, and vehicle controlled, and study medications were applied twice daily for 2 weeks. One study was a paired-comparison (PC); the other study was of parallel-group (PG) design. Both studies called for evaluations at entry (week 0) and after 1 and 2 weeks of treatment. The PC study enrolled 100 patients; the PG study enrolled 110 patients; 204 patients provided efficacy data over both studies. In the PC study, plaque elevation, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistical (p less than or equal to 0.0003) and clinical significance (all greater than 1-unit difference on the rating scale) favoring 0.05% halobetasol ointment over vehicle. Pruritus (initially mild) and total score also showed statistically significant treatment differences favoring halobetasol at the final evaluation. Patient global responses for \"effectiveness\" and \"overall rating\" favored 0.05% halobetasol ointment over vehicle. In the PG study, induration, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistically and clinically significant differences favoring 0.05% halobetasol ointment over vehicle. Physician's global evaluation favored 0.05% halobetasol ointment over vehicle after 2 weeks of use. No patients were released from either study because of adverse events. No systemic adverse events or findings of skin atrophy were reported in these studies. Reports of \"stings\" or \"burns\" were equally divided between halobetasol and its vehicle.(ABSTRACT TRUNCATED AT 250 WORDS)", "To determine the safety and efficacy of photodynamic therapy (PDT) using 20% wt/vol aminolevulinic acid hydrochloride (hereinafter \"ALA\") and visible blue light for the treatment of multiple actinic keratoses of the face and scalp.\n Randomized, placebo-controlled, uneven parallel-group study.\n Patients (N = 243) were randomized to receive vehicle or ALA followed within 14 to 18 hours by PDT. Follow-up visits occurred 24 hours and 1, 4, 8, and 12 weeks following PDT. Target lesions remaining at week 8 were re-treated.\n Clinical response based on lesion clearing by week 8.\n Most patients in both groups had 4 to 7 lesions. Complete response rates for patients with 75% or more of the treated lesions clearing at weeks 8 and 12 were 77% (128/166) and 89% (133/149), respectively, for the drug group and 18% (10/55) and 13% (7/52), respectively, for the vehicle group (P<.001, Cochran-Mantel-Haenszel general association test). The 95% confidence interval for the difference in response rates at week 8 was 46.9% to 71.0% and at week 12, 65.3% to 86.3%. The week 12 response rate includes 30% of patients who received a second treatment. Most patients experienced erythema and edema at the treated sites, which resolved or improved within 1 to 4 weeks after therapy, and stinging or burning during light treatment, which decreased or resolved by 24 hours after light treatment.\n Findings indicate that topical ALA PDT is an effective and safe treatment for multiple actinic keratoses of the face and scalp.", "We report the results of a multicentre, double-blind, placebo-controlled study of topical therapy with omega-3-polyunsaturated fatty acids (omega-3-PUFA) in 52 patients suffering from moderate plaque-type psoriasis. In each patient, two similar stable psoriatic plaques served as indicator lesions for the study. One indicator lesion was randomly assigned to treatment with topical preparations of highly purified omega-3-PUFA in one of two concentrations (1 or 10%), and the other was treated with placebo. Efficacy assessment was based on changes in local psoriasis severity index, area involved, erythema, desquamation, induration and pruritus. After 8 weeks of treatment, all indicator lesions had improved significantly, compared with baseline. However, no statistically or clinically relevant differences between the omega-3-PUFA-treated and the placebo-treated lesions were found. Therapy was well tolerated and, apart from one patient who developed perilesional eczema, no clinically relevant adverse events occurred. In conclusion, topical omega-3-PUFA were not effective in a randomized, placebo-controlled, double-blind setting. Results of non-blind trials should be (re-)considered with caution.", "Topical coal tar is a well known and effective treatment for psoriasis, but the messiness, staining, odor, and inconvenience associated with its use make patient satisfaction and compliance a challenge.\n To determine the efficacy, patient tolerability, and cosmetic acceptability of a new topical liquor carbonis distillate (LCD) 15% solution compared with calcipotriene (calcipotriol) cream in patients with moderate, chronic plaque psoriasis.\n A randomized, single-blind, active-controlled, parallel-group, clinical trial consisting of a 12-week treatment phase and a 6-week post-treatment follow-up phase.\n Outpatient dermatology research unit in an academic hospital.\n Sixty adults with moderate, chronic plaque psoriasis (3-15% body surface area affected) not receiving other psoriasis therapies.\n Patients were randomized to apply either an LCD 15% solution (Psorent) or a commercially available calcipotriene 0.005% cream (Dovonex) to their psoriasis areas (excluding the head) twice daily at home for 12 weeks.\n A blinded investigator evaluated the patients' psoriasis using a modified Psoriasis Area and Severity Index (PASI) that excluded the head, and a Physician's Global Assessment (PGA) scale at weeks 0 (baseline), 2, 4, 8, and 12 (end of treatment), and 18 (6 weeks after treatment was withdrawn). Patients assessed their psoriasis symptoms and quality of life and completed a cosmetic acceptability survey about their medication.\n The changes in the baseline PASI scores after 12 weeks of treatment were compared between LCD and calcipotriene groups. Additional comparisons were performed for success rates during treatment (PASI 75 and PASI 50), changes in PGA scores, patient-reported psoriasis symptom scores, patients' quality-of-life scores, and recurrence rates during post-treatment follow-up.\n Both treatment groups showed improvement in psoriasis severity and quality of life. However, the LCD group had greater mean reductions in PASI scores: 58% vs 37% in the calcipotriene group (p < 0.05) at week 12. Additionally, the LCD group had more patients (14/27) with absent or minimal psoriasis on the PGA scale than the calcipotriene group (6/28) by the end of treatment (p < 0.05). LCD-treated patients also maintained their improvement better than calcipotriene-treated patients through week 18 after treatment was withdrawn for 6 weeks. Both treatments were well tolerated and cosmetically acceptable to patients.\n The newly formulated LCD solution, applied twice daily at home for 12 weeks, was more effective and as well tolerated and cosmetically acceptable as the calcipotriene cream over 12 weeks of treatment and 6 weeks of follow-up. The LCD solution is a patient-accepted and effective corticosteroid-sparing treatment alternative for psoriasis patients.", "A double-blind, randomized clinical study was conducted to compare the efficacy and tolerability of twice-daily topical calcipotriol treatment with a combination treatment of calcipotriol once a day in the morning and diflucortolone valerate in the evening. Sixty-three patients with a clinical diagnosis of chronic plaque psoriasis and comparable psoriatic lesions on both sides of the body were included. After a washout phase of 1 week, psoriatic lesions were treated for 4 weeks with calcipotriol ointment twice daily on one side of the body and a combination of calcipotriol and diflucortolone valerate ointment on the other side. The treatment period was followed by a period of 4 weeks without any treatment. The psoriasis area and severity index (PASI) was used to compare the 2 groups. Furthermore, the overall therapeutic results were assessed independently by the investigators and by the patients. Both treatment regimens showed a significant, nearly identical, reduction in PASI. The mean PASI for calcipotriol alone was 5.7 at baseline, 1.9 after 4 weeks of treatment and 3.8 at the end of the follow-up period. For combination therapy, these values were 5.7, 1.8 and 3.8, respectively. There was a statistically significant advantage in favor of combined calcipotriol and diflucortolone valerate treatment at weeks 1 and 2 (p < 0.05); however, at the end of the treatment phase the difference between the 2 therapies was not significant. Subjective evaluation of efficacy by both the investigators and the patients revealed no difference between the 2 treatments. The frequency of side effects (e.g. irritation) was low in both groups. In conclusion, both therapies were effective for the treatment of chronic plaque-type psoriatic lesions. The combination of calcipotriol and a topical steroid appeared to produce a more rapid clinical response and was shown to be as effective as calcipotriol therapy alone." ]

[ "15585539", "15377573", "18417560", "15089956", "17055767", "7041850", "1532760", "17678655", "9549021" ]

[ "Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference.", "Randomised controlled trial of physiotherapy compared with advice for low back pain.", "A randomised controlled trial on whether a participatory ergonomics intervention could prevent musculoskeletal disorders.", "Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design?", "Effectiveness of physiotherapy in Parkinson's disease: the feasibility of a randomised controlled trial.", "Electromyographic feedback in the remobilization of stroke patients: a controlled trial.", "Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up.", "Circuit class therapy versus individual physiotherapy sessions during inpatient stroke rehabilitation: a controlled trial.", "Electromyographic biofeedback for gait training after stroke." ]

[ "Firstly, to compare the effectiveness of a brief physiotherapy intervention with \"usual\" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome.\n Non-inferiority randomised controlled trial eliciting preferences independently of randomisation.\n Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire.\n 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned.\n The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement.\n At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy.\n Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.", "To measure the effectiveness of routine physiotherapy compared with an assessment session and advice from a physiotherapist for patients with low back pain.\n Pragmatic, multicentre, randomised controlled trial.\n Seven British NHS physiotherapy departments.\n 286 patients with low back pain of more than six weeks' duration.\n Routine physiotherapy or advice on remaining active from a physiotherapist. Both groups received an advice book.\n Primary outcome was scores on the Oswestry disability index at 12 months. Secondary outcomes were scores on the Oswestry disability index (two and six months), scores on the Roland and Morris disability questionnaire and SF-36 (2, 6 and 12 months), and patient perceived benefit from treatment (2, 6, and 12 months).\n 200 of 286 patients (70%) provided follow up information at 12 months. Patients in the therapy group reported enhanced perceptions of benefit, but there was no evidence of a long term effect of physiotherapy in either disease specific or generic outcome measures (mean difference in change in Oswestry disability index scores at 12 months -1.0%, 95% confidence interval -3.7% to 1.6%). The most common treatments were low velocity spinal joint mobilisation techniques (72%, 104 of 144 patients) and lumbar spine mobility and abdominal strengthening exercises (94%, 136 patients).\n Routine physiotherapy seemed to be no more effective than one session of assessment and advice from a physiotherapist.", "To examine the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders among kitchen workers. Participatory ergonomics is commonly recommended to reduce musculoskeletal disorders, but evidence for its effectiveness is sparse.\n A cluster randomised controlled trial among the 504 workers of 119 kitchens in Finland was conducted during 2002-2005. Kitchens were randomised to an intervention (n = 59) and control (n = 60) group. The duration of the intervention that guided the workers to identify strenuous work tasks and to seek solutions for decreasing physical and mental workload, was 11 to 14 months. In total, 402 ergonomic changes were implemented. The main outcome measures were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites, local fatigue after work, and sick leave due to musculoskeletal disorders. Individual level data were collected by a questionnaire at baseline and every 3 months during the intervention and 1-year follow-up period. All response rates exceeded 92%.\n No systematic differences in any outcome variable were found between the intervention and control groups during the intervention or during the 1-year follow-up.\n The intervention did not reduce perceived physical work load and no evidence was found for the efficacy of the intervention in preventing musculoskeletal disorders among kitchen workers. It may be that a more comprehensive redesign of work organisation and processes is needed, taking more account of workers' physical and mental resources.", "There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered.", "To study the feasibility of a large randomised controlled trial (RCT) evaluating the effectiveness of physiotherapy in Parkinson's disease (PD), 173 patients were asked to participate in a study with random allocation to best practice physiotherapy, or to no physiotherapy. The primary outcome measures were the Parkinson's disease questionnaire-39, the Parkinson activity scale, and a patient preference outcome scale (PPOS). Only 14% of the patients could be included in the study. The PPOS showed the largest effect size (0.74) with a significant group effect (p<0.05). Specific alterations to the study design to ensure successful RCTs in this field are recommended.", "Electromyographic biofeedback was compared with simple exercise therapy as to its effectiveness in improving foot-drop in 22 stroke patients. The study was designed to be a rigorous trial of biofeedback and the patients tested were aged and had stroke of long duration. One group of 11 patients underwent 6 weeks of exercise therapy 2 sessions per week for 15 minutes per session; the 2nd group of 11 patients underwent similar therapy with EMG feedback. All therapy was conducted by a research assistant who was not a trained therapist. The groups were assessed blind before treatment, after treatment and a 6-week follow-up. The significantly greater improvements in the biofeedback group in terms of muscle strength at the end of treatment were maintained at follow-up. On the range of movement and gait analysis measures, both groups showed some improvement after treatment. However, at follow-up this improvement had relapsed for the exercise group while for the biofeedback group it had been maintained. It is argued that controlled trials are possible in biofeedback and that using patients as their own controls is not justified in view of the present findings and the previously reported literature.", "To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints.\n Randomised clinical trial.\n Primary health care in the Netherlands.\n 256 patients with non-specific back and neck complaints of at least six weeks' duration who had not received physiotherapy or manipulative therapy in the past two years.\n At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes).\n Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients.\n Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months' follow up was similar for both treatments.\n Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.", "To compare the effectiveness of circuit class therapy and individual physiotherapy (PT) sessions in improving walking ability and functional balance for people recovering from stroke.\n Nonrandomized, single-blind controlled trial.\n Medical rehabilitation ward of a rehabilitation hospital.\n Sixty-eight persons receiving inpatient rehabilitation after a stroke.\n Subjects received group circuit class therapy or individual treatment sessions as the sole method of PT service delivery for the duration of their inpatient stay.\n Five-meter walk test (5MWT), two-minute walk test (2MWT), and the Berg Balance Scale (BBS) measured 4 weeks after admission. Secondary outcome measures included the Iowa Level of Assistance Scale, Motor Assessment Scale upper-limb items, and patient satisfaction. Measures were taken on admission and 4 weeks later.\n Subjects in both groups showed significant improvements between admission and week 4 in all primary outcome measures. There were no significant between group differences in the primary outcome measures at week 4 (5MWT mean difference, .07m/s; 2MWT mean difference, 1.8m; BBS mean difference, 3.9 points). A significantly higher proportion of subjects in the circuit class therapy group were able to walk independently at discharge (P=.01) and were satisfied with the amount of therapy received (P=.007).\n Circuit class therapy appeared as effective as individual PT sessions for this sample of subjects receiving inpatient rehabilitation poststroke. Favorable results for circuit classes in terms of increased walking independence and patient satisfaction suggest this model of service delivery warrants further investigation.", "To examine the effects of electromyographic (EMG) biofeedback training on the recovery of gait in the acute phase post stroke.\n Patients were randomly assigned to EMG biofeedback or control groups. They received treatment three times a week for six weeks. All patients were assessed prior to treatment, after 18 treatment sessions, and at three months follow-up.\n The study was carried out at Scunthorpe General Hospital in North Lincolnshire. The subjects were acute stroke patients who had been admitted on to the medical and elderly wards.\n The EMG biofeedback group were treated using EMG as an adjunct to physiotherapy. The patients were encouraged to facilitate or inhibit abnormal muscle tone via auditory or visual signals transmitted from electrodes placed over the appropriate muscles. The control group were treated using the same techniques, electrodes were used with this group of patients, but the EMG machine was turned off and faced away from the patient and the therapist to control the placebo effect.\n A large battery of outcome measures was used for physical and psychological assessment. The physical measures consisted of active movement, muscle tone, sensation, proprioception, mobility and activities of daily living (ADL). The psychological measures included orientation, memory, spatial performance, language and IQ.\n Twenty-one patients were included in the study. Scores were combined into four groups: mild EMG, severe EMG, mild control and severe control. Results showed that there was an improvement in physical scores for active movement, mobility and ADL over time, but there was no significant difference between the EMG and control groups. Scores on the psychological tests were within normal limits, and there was no difference in performance between the EMG and control groups.\n This study showed no significant differences in the rate of improvement after stroke between the two groups. Although EMG biofeedback was used as an adjunct to physiotherapy and represented clinical practice, the results provide little evidence to support the clinical significance of using EMG biofeedback to improve gait in the acute phase after stroke." ]

[ "11273219", "12181464", "17031321", "18213382", "20851460", "20024738", "15385901", "18176319", "19996048" ]

[ "Vaginal lavage with chlorhexidine during labour to reduce mother-to-child HIV transmission: clinical trial in Mombasa, Kenya.", "15 Month follow up of African children following vaginal cleansing with benzalkonium chloride of their HIV infected mothers during late pregnancy and delivery.", "Integration of antiretroviral treatment within antenatal care in Gauteng Province, South Africa.", "SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria.", "PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial.", "Condom use promotion among isiXhosa speaking women living with HIV in the Western Cape Province, South Africa: a pilot study.", "A randomized controlled trial to reduce HIV transmission risk behaviors and sexually transmitted diseases among women living with HIV: The WiLLOW Program.", "Effects of a coping intervention on transmission risk behavior among people living with HIV/AIDS and a history of childhood sexual abuse.", "Efficacy of sexually transmitted disease/human immunodeficiency virus sexual risk-reduction intervention for african american adolescent females seeking sexual health services: a randomized controlled trial." ]

[ "To evaluate the effect of vaginal lavage with diluted chlorhexidine on mother-to child transmission of HIV (MTCT) in a breastfeeding population.\n This prospective clinical trial was conducted in a governmental hospital in Mombasa, Kenya. On alternating weeks, women were allocated to non-intervention or to intervention consisting of vaginal lavage with 120 ml 0.2% chlorhexidine, later increased to 0.4%, repeated every 3 h from admission to delivery. Infants were tested for HIV by DNA polymerase chain reaction within 48 h and at 6 and 14 weeks of life.\n Enrolment and follow-up data were available for 297 and 309 HIV-positive women, respectively, in the non-lavage and the lavage groups. There was no evidence of a difference in intrapartum MTCT (17.2 versus 15.9%, OR 0.9, 95% CI 0.6-1.4) between the groups. Lavage solely before rupture of the membranes tended towards lower MTCT with chlorhexidine 0.2% (OR 0.6, 95% CI 0.3-1.1), and even more with chlorhexidine 0.4% (OR 0.1, 95% CI 0.0-0.9).\n The need remains for interventions reducing MTCT without HIV testing, often unavailable in countries with a high prevalence of HIV. Vaginal lavage with diluted chlorhexidine during delivery did not show a global effect on MTCT in our study. However, the data suggest that lavage before the membranes are ruptured might be associated with a reduction of MTCT, especially with higher concentrations of chlorhexidine.", "To study mother to child HIV-1 transmission (MTCT) and infant mortality following benzalkonium chloride (BC) disinfection.\n A randomised, double blind phase II placebo controlled trial. Women testing positive for HIV-1 infection in prenatal care units in Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso, from November 1996 to April 1997 were eligible, with their informed consent. Women self administered daily a vaginal suppository of 1% BC (53) or matched placebo (54) from 36 weeks of pregnancy, plus a single dose during labour. The neonate was bathed with 1% BC solution or placebo within 30 minutes after birth. MTCT rate was assessed based on repeated polymerase chain reaction (PCR) and serology results. For the present analysis, children were followed up to 15 months.\n A total of 107 women were enrolled. Of 103 eligible liveborn children, 23 were HIV infected, 75 uninfected, and five of indeterminate status. MTCT transmission rate was 24.2% overall (95% confidence interval (CI): 14.3% to 30.4%). On an intent to treat basis, the transmission rate did not differ between the two groups (23.5%, CI 13.8 to 38.5, in the BC group and 24.8%, CI 15.0 to 39.6, in the placebo group at 15 months). Similarly, there was no difference in mortality at 15 months (22.9%, CI 13.7 to 36.9, in the BC group and 16.5%, CI 9.0 to 29.4, in the placebo group).\n This analysis failed to suggest any benefit of BC disinfection on mother to child HIV transmission or perinatal and infant mortality.", "Antenatal clinics are a key entry point into HIV treatment and care, together with interventions to reduce mother-to-child transmission (MTCT). Further evaluation is needed of interventions linking antenatal with antiretroviral (ARV) treatment services and effectiveness of triple-ARV regimens for reducing MTCT in resource-constrained settings.\n Data were gathered from HIV-infected women attending antenatal care from June 2004 to July 2005 at Coronation Women and Children Hospital, South Africa. After a patient record review, interventions were implemented to strengthen service linkages and integrate ARV treatment within antenatal care. Laboratory investigations were streamlined, including CD4 cell count testing at the first antenatal visit. MTCT risk for women initiating ARV treatment is compared with that of women-infant pairs receiving single-dose nevirapine (sd-NVP).\n In total, 164 pregnant women initiated ARV treatment and 863 received sd-NVP. After changes to service delivery, time-to-treatment initiation was reduced from a median of 56 days to 37 days (P = 0.041). The risk of MTCT for women receiving ARV treatment (5 [4.3%] of 116 women) was lower than for those given sd-NVP (74 [10.7%] of 692 women; P = 0.032).\n Strengthening linkages and integrating key components of ARV treatment within antenatal care reduces time-to-treatment initiation. In this setting, among women with a high MTCT risk, triple-ARV regimens are effective in reducing HIV infection in infants.", "The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.\n This was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly follow-up visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between September 2004 and December 2006 in Lagos and Ibadan, Nigeria, where we enrolled 2153 HIV-negative women at high risk of HIV infection. Participants were randomized 1 ratio 1 to SAVVY or placebo. The effectiveness endpoint was incidence of HIV infection as indicated by detection of HIV antibodies in oral mucosal transudate (rapid test) or blood (ELISA), and confirmed by Western blot or PCR testing. We observed 33 seroconversions (21 in the SAVVY group, 12 in the placebo group). The Kaplan-Meier estimates of the cumulative probability of HIV infection at 12 months were 0.028 in the SAVVY group and 0.015 in the placebo group (2-sided p-value for the log-rank test of treatment effect 0.121). The point estimate of the hazard ratio was 1.7 for SAVVY versus placebo (95% confidence interval 0.9, 3.5). Because of lower-than-expected HIV incidence, we did not observe the required number of HIV infections (66) for adequate power to detect an effect of SAVVY. Follow-up frequencies of adverse events, reproductive tract adverse events, abnormal pelvic examination findings, chlamydial infections and vaginal infections were similar in the study arms. No serious adverse event was attributable to SAVVY use.\n SAVVY did not reduce the incidence of HIV infection. Although the hazard ratio was higher in the SAVVY than the placebo group, we cannot conclude that there was a harmful treatment effect of SAVVY.", "Innovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies in macaques; we aimed to assess efficacy and safety of 2% and 0·5% PRO2000 gels against vaginal HIV-1 transmission in women in sub-Saharan Africa.\n Microbicides Development Programme 301 was a phase 3, randomised, double-blind, parallel-group trial, undertaken at 13 clinics in South Africa, Tanzania, Uganda, and Zambia. We randomly assigned sexually active women, aged 18 years or older (≥16 years in Tanzania and Uganda) without HIV-1 infection in a 1:1:1 ratio to 2% PRO2000, 0·5% PRO2000, or placebo gel groups for 52 weeks (up to 104 weeks in Uganda). Randomisation was done by computerised random number generator. Investigators and participants were masked to group assignment. The primary efficacy outcome was incidence of HIV-1 infection before week 52, which was censored for pregnancy and excluded participants without HIV-1 follow-up data or with HIV-1 infection at enrolment. HIV-1 status was established by rapid tests or ELISA at screening at 12 weeks, 24 weeks, 40 weeks, and 52 weeks, and confirmed in a central reference laboratory. The primary safety endpoint was an adverse event of grade 3 or worse. Use of 2% PRO2000 gel was discontinued on Feb 14, 2008, on the recommendation of the Independent Data Monitoring Committee because of low probability of benefit. This trial is registered at http://isrctn.org, number ISRCTN 64716212.\n We enrolled 9385 of 15 818 women screened. 2591 (95%) of 2734 participants enrolled to the 2% PRO2000 group, 3156 (95%) of 3326 in the 0·5% PRO2000 group, and 3112 (94%) of 3325 in the placebo group were included in the primary efficacy analysis. Mean reported gel use at last sex act was 89% (95% CI 86-91). HIV-1 incidence was much the same between groups at study end (incidence per 100 woman-years was 4·5 [95% CI 3·8-5·4] for 0·5% PRO2000 vs 4·3 [3·6-5·2] for placebo, hazard ratio 1·05 [0·82-1·34], p=0·71), and at discontinuation (4·7 [3·8-5·8] for 2% PRO2000 gel, 3·9 [3·0-4·9] for 0·5% PRO2000 gel, and 3·9 [3·1-5·0] for placebo gel). Incidence of the primary safety endpoint at study end was 4·6 per 100 woman-years (95% CI 3·9-5·4) in the 0·5% PRO2000 group and 3·9 (3·2-4·6) in the placebo group; and was 4·5 (3·7-5·5) in the 2% PRO2000 group at discontinuation.\n Although safe, 0·5% PRO2000 and 2% PRO2000 are not efficacious against vaginal HIV-1 transmission and are not indicated for this use.\n UK Department for International Development, UK Medical Research Council, European and Developing Countries Clinical Trials Partnership, International Partnership for Microbicides, and Endo Pharmaceuticals Solutions.\n Copyright © 2010 Elsevier Ltd. All rights reserved.", "The prevalence of HIV infection continues to increase among women in South Africa while there are few interventions specifically targeting condom use promotion in this population. We report the results of an experimental pilot study of a health education intervention aimed at enhancing coping skills and consistent condom use among HIV-positive women attending primary health clinics in the Western Cape province of South Africa. One hundred and twenty women were randomised into the intervention condition or a control condition. Both groups completed an interviewer administered questionnaire that included measures of self-esteem, attitude towards condom use, and self-efficacy towards condom use and negotiating condom use, and provided vaginal swab specimen at baseline and three months after the intervention. Tests for intervention effects at three months while controlling for baseline revealed that only self-esteem was significantly higher in the intervention group relative to the control group. No significant differences were found on measures of coping skills and condom use behaviour. Importantly, incidence for Chlamydia Trachomatis, Neisseria Gonorrhea and Trichomona vaginalis during the study period were significantly lower in the intervention group than the control group. These results are strong indications that this intervention could serve as a basis for the development of potentially effective interventions to reduce STI-related sexual risk behaviours among HIV-positive black women in South Africa.", "To evaluate the efficacy of an intervention to reduce HIV transmission risk behaviors and sexually transmitted diseases (STDs) and enhance HIV-preventive psychosocial and structural factors among women living with HIV.\n A randomized controlled trial of 366 women living with HIV in Alabama and Georgia.\n The intervention emphasized gender pride, maintaining current and identifying new network members, HIV transmission knowledge, communication and condom use skills, and healthy relationships.\n Unprotected vaginal intercourse. OTHER OUTCOMES: Proportion never used condoms, incident STDs, psychosocial factors, and number of supportive network members.\n Over the 12-month follow-up, women in the WiLLOW intervention, relative to the comparison, reported fewer episodes of unprotected vaginal intercourse (1.8 vs. 2.5; P = 0.022); were less likely to report never using condoms (odds ratio [OR] = 0.27; P = 0.008); had a lower incidence of bacterial infections (Chlamydia and gonorrhea) (OR = 0.19; P = 0.006); reported greater HIV knowledge and condom use self-efficacy, more network members, fewer beliefs that condoms interfere with sex, and fewer partner-related barriers to condom use; and demonstrated greater skill in using condoms.\n This is the first trial to demonstrate reductions in risky sexual behavior and incident bacterial STDs and to enhance HIV-preventive psychosocial and structural factors among women living with HIV.", "To examine the effect of a 15-session coping group intervention compared with a 15-session therapeutic support group intervention among HIV-positive men and women with a history of childhood sexual abuse (CSA) on sexual transmission risk behavior.\n A randomized controlled behavioral intervention trial with 12-month follow-up.\n A diverse sample of 247 HIV-positive men and women with histories of CSA was randomized to 1 of 2 time-matched group intervention conditions. Sexual behavior was assessed at baseline; immediately after the intervention; and at 4-, 8-, and 12-month follow-up periods (5 assessments). Changes in frequency of unprotected anal and vaginal intercourse by intervention condition were examined using generalized linear mixed models for all partners, and specifically for HIV-negative or serostatus unknown partners.\n Participants in the HIV and trauma coping intervention condition decreased their frequency of unprotected sexual intercourse more than participants in the support intervention condition for all partners (P < 0.001; d = 0.38, 0.32, and 0.38 at the 4-, 8-, and 12-month follow-up periods, respectively) and for HIV-negative and serostatus unknown partners (P < 0.001; d = 0.48, 0.39, and 0.04 at the 4-, 8-, and 12-month follow-up periods, respectively).\n A group intervention to address coping with HIV and CSA can be effective in reducing transmission risk behavior among HIV-positive men and women with histories of sexual trauma.", "To evaluate the efficacy of an intervention to reduce incident sexually transmitted disease (STD) and enhance STD/human immunodeficiency virus (HIV)-preventive behaviors and psychosocial mediators.\n A randomized controlled trial of an HIV prevention program.\n Clinic-based sample in Atlanta, Georgia.\n African American adolescent females (N = 715), aged 15 to 21 years, seeking sexual health services. Participants completed an audio computer-assisted self-interview and provided self-collected vaginal specimens for STD testing. Intervention Intervention participants received two 4-hour group sessions and 4 telephone contacts over a 12-month period, targeting personal, relational, sociocultural, and structural factors associated with adolescents' STD/HIV risk, and were given vouchers facilitating male partners' STD testing/treatment. Main Outcome Measure Incident chlamydial infections.\n Over the 12-month follow-up, fewer adolescents in the intervention had a chlamydial infection (42 vs 67; risk ratio [RR], 0.65; 95% confidence interval [CI], 0.42 to 0.98; P = .04) or recurrent chlamydial infection (4 vs 14; RR, 0.25; 95% CI, 0.08 to 0.83; P = .02). Adolescents in the intervention also reported a higher proportion of condom-protected sex acts in the 60 days preceding follow-up assessments (mean difference, 10.84; 95% CI, 5.27 to 16.42; P < .001) and less frequent douching (mean difference, -0.76; 95% CI, -1.15 to -0.37; P = .001). Adolescents in the intervention were also more likely to report consistent condom use in the 60 days preceding follow-up assessments (RR, 1. 41; 95% CI, 1.09 to 1.80; P = .01) and condom use at last intercourse (RR, 1.30; 95% CI, 1.09 to 1.54; P = .005). Intervention effects were observed for psychosocial mediators of STD/HIV-preventive behaviors.\n Interventions for African American adolescent females can reduce chlamydial infections and enhance STD/HIV-preventive behaviors and psychosocial mediators of STD/HIV-preventive behaviors. Trial Registration clinicaltrials.gov Identifier: NCT00633906." ]

[ "12889565", "16009687", "15566514", "8665186", "12759473", "9086006", "17058027", "19075173", "1354275" ]

[ "Comparison of percutaneous acetic acid injection and percutaneous ethanol injection for hepatocellular carcinoma in cirrhotic patients: a prospective study.", "Randomised controlled trial comparing percutaneous radiofrequency thermal ablation, percutaneous ethanol injection, and percutaneous acetic acid injection to treat hepatocellular carcinoma of 3 cm or less.", "Evaluation of transcatheter arterial embolization prior to percutaneous tumor ablation in patients with hepatocellular carcinoma: a randomized controlled trial.", "Adjuvant oral chemotherapy to prevent recurrence after curative resection for hepatocellular carcinoma.", "Small hepatocellular carcinoma in cirrhosis: randomized comparison of radio-frequency thermal ablation versus percutaneous ethanol injection.", "Portal vein chemotherapy for colorectal cancer: a meta-analysis of 4000 patients in 10 studies. Liver Infusion Meta-analysis Group.", "Efficacy of postoperative transarterial chemoembolization and portal vein chemotherapy for patients with hepatocellular carcinoma complicated by portal vein tumor thrombosis--a randomized study.", "Colorectal liver metastases: recurrence and survival following hepatic resection, radiofrequency ablation, and combined resection-radiofrequency ablation.", "Randomised controlled trial of adjuvant chemotherapy by portal-vein perfusion after curative resection for colorectal adenocarcinoma." ]

[ "Ultrasound-guided percutaneous ethanol injection (PEI) and percutaneous acetic acid injection (PAI) are effective in the treatment of hepatocellular carcinoma (HCC). We conducted a prospective study to compare the therapeutic efficacy of both these methods.\n Sixty-three patients were treated by PAI using 50% acetic acid and 62 by PEI using pure ethanol. There were no significant baseline differences in age, sex, Child-Pugh class, tumour size and number, or other clinico-biochemical parameters between the two groups.\n During a follow-up period of 24 +/- 9 (range 6-38) months, 19 (30%) of the PAI group and 21 (34%) of the PEI group died (P = 0.704). The 1- and 3-year survival rates were 84% and 51% for the PAI group and 81% and 46% for the PEI group (P = 0.651). The corresponding tumour recurrence rates were 51% and 74% for the PAI group, and 54% and 64% for the PEI group (P = 0.787). The treatment sessions were 3.9 +/- 1.6 and 6.2 +/- 2.3 for the PAI and PEI groups, respectively, in each treatment cycle (P = 0.008). A multivariate analysis using the Cox regression model revealed that ascites (relative risk (RR) 3.1, 95% confidence interval (CI) 1.5-6.3, P = 0.002), large (>3 cm) or multinodular HCCs (RR 2.4, 95% CI 1.1-5.4, P = 0.04), and development of tumour recurrence (RR 7.0, 95% CI 3.1-16.0, P < 0.001) were independent, poor prognostic factors in both groups.\n PAI and PEI are equally effective in the treatment of HCC. PAI has the advantage of fewer treatment sessions in each treatment course. Careful pretreatment patient selection may improve survival.", "The aim of this study was to compare the outcomes of radiofrequency thermal ablation (RFTA), percutaneous ethanol injection (PEI), and percutaneous acetic acid injection (PAI) in the treatment of hepatocellular carcinoma (HCC).\n A total of 187 patients with HCCs of 3 cm or less were randomly assigned to RFTA (n = 62), PEI (n = 62), or PAI (n = 63). Tumour recurrence and survival rates were assessed.\n One, two, and three year local recurrence rates were 10%, 14%, and 14% in the RFTA group, 16%, 34%, and 34% in the PEI group, and 14%, 31%, and 31% in the PAI group (RFTA v PEI, p = 0.012; RFTA v PAI, p = 0.017). One, two, and three year survival rates were 93%, 81%, and 74% in the RFTA group, 88%, 66%, and 51% in the PEI group, and 90%, 67%, and 53% in the PAI group (RFTA v PEI, p = 0.031; RFTA v PAI, p = 0.038). One, two, and three year cancer free survival rates were 74%, 60%, and 43% in the RFTA group, 70%, 41%, and 21% in the PEI group, and 71%, 43%, and 23% in the PAI group (RFTA v PEI, p = 0.038; RFTA v PAI, p = 0.041). Tumour size, tumour differentiation, and treatment methods (RFTA v PEI and PAI) were significant factors for local recurrence, overall survival, and cancer free survival. Major complications occurred in 4.8% of patients (two with haemothorax, one gastric perforation) in the RFTA group and in none in two other groups (RFTA v PEI and PAI, p = 0.035).\n RFTA was superior to PEI and PAI with respect to local recurrence, overall survival, and cancer free survival rates, but RFTA also caused more major complications.", "Transcatheter arterial embolization (TAE) may reduce the risk of hepatocellular carcinoma (HCC) recurrence when performed before percutaneous tumor ablation (PTA), either percutaneous ethanol injection therapy (PEIT) or radiofrequency ablation (RFA). We conducted a randomized, controlled trial comparing the use of TAE combined with percutaneous ethanol injection therapy (TAE/PEIT) to the use of PEIT only to assess the effects on HCC recurrence and survival. We continued the study after the introduction of RFA and compared TAE combined with RFA (TAE/RFA) with RFA only.\n Between March 1997 and April 2001, 42 HCC patients were enrolled who satisfied the following inclusion criteria: (1) uninodular HCC as determined by angiography under computed tomography, (2) arterial hypervascularity, and (3) no prior history of HCC treatment. Twenty-two patients were treated with TAE/PTA (PEIT, 12; RFA, 10) and 20 patients with PTA only (PEIT, 14; RFA, 6).\n There were four cases of local recurrence in the PTA-only group and none in the TAE/PTA group (P=0.043). The four patients with local recurrence were treated with PEIT. None of the patients treated with RFA showed local recurrence. The effect of TAE on overall recurrence was not significant (P=0.4179). In the multivariate analysis, prior TAE was not significant for survival (P=0.514).\n TAE has a limited use in suppressing local recurrence when performed before PEIT but not before RFA.", "Adjuvant oral chemotherapy was studied in 67 patients with stage II hepatocellular carcinoma who underwent curative resection between May 1988 and December 1990. Patients were stratified into two groups according to preoperative liver dysfunction: 55 had stage I disease (mild dysfunction) and 12 had stage II (moderate dysfunction). A randomized controlled study of postoperative oral administration of 1-hexylcarbamoyl-5-fluorouracil (HCFU) was conducted in each group. From October 1994 HCFU administration was suspended because of side-effects in nine patients with stage I liver dysfunction and in three with stage II dysfunction who had received the drug for more than 4 weeks. Cumulative survival and recurrence-free survival rates of patients with stage I disease in the treatment group were higher (P = 0.08 and P = 0.04 respectively) than those in the control group. However, in patients with stage II disease no significant difference was observed (P = 0.77 and P = 1.0 respectively). This study suggests that the potential benefits of HCFU on tumour recurrence should be weighed against the risk of adverse reactions in patients with mild liver dysfunction.", "To compare the effectiveness of radio-frequency (RF) thermal ablation with that of percutaneous ethanol injection (PEI) for the treatment of small hepatocellular carcinoma (HCC) in patients with cirrhosis.\n A series of 102 patients with hepatic cirrhosis and either single HCC 5 cm in diameter or smaller or as many as three HCCs each 3 cm or smaller (overall number of lesions, 142) randomly received either RF ablation (n = 52) or PEI (n = 50) as the sole first-line anticancer treatment. Mean follow-up was 22.9 months +/- 9.4 (SD) in the RF group and 22.4 months +/- 8.6 in the PEI group. Prognostic value of treatment techniques was assessed with univariate and multivariate Cox proportional hazards regression models.\n One- and 2-year survival rates were 100% and 98% in the RF group and 96% and 88% in the PEI group, respectively (univariate relative risk [RR] = 0.20; 95% CI: 0.02, 1.69; P =.138). One- and 2-year local recurrence-free survival rates were 98% and 96% in the RF group and 83% and 62% in the PEI group, respectively (univariate RR = 0.17; 95% CI: 0.06, 0.51; P =.002). One- and 2-year event-free survival rates were 86% and 64% for the RF group and 77% and 43% for the PEI group, respectively (univariate RR = 0.48; 95% CI: 0.27, 0.85; P =.012). RF treatment was confirmed as an independent prognostic factor for local recurrence-free survival rates with multivariate analysis (adjusted RR = 0.20; 95% CI: 0.05, 0.73; P =.015).\n RF ablation is superior to PEI with respect to local recurrence-free survival rates.", "Systemic delivery of cytotoxic drugs yields relatively low doses in the liver, a major site of recurrence for colorectal cancer. Giving chemotherapy by means of continuous portal vein infusion (PVI) into the liver during the immediate postoperative period may improve therapeutic efficacy.\n We undertook a meta-analysis to assess the effects on recurrence and survival of administering fluorouracil (5-FU)-based chemotherapy by PVI after colorectal cancer surgery.\n Data on mortality and recurrence were sought for all patients enrolled in randomized trials initiated before 1987 in which a few days (range, 5-7 days) of continuous postoperative PVI of cytotoxic drugs was compared with no further treatment. Data from 10 trials (a promising initial study and nine hypothesis-testing trials) involving about 4000 patients were available for analysis. The main cytotoxic drug in each trial was 5-FU (given with heparin); however, mitomycin C was co-administered in two of the trials. Four trials included an additional control group of patients treated with continuous noncytotoxic PVI of either heparin or urokinase alone; one trial included a second control group of patients treated with continuous systemic infusion of 5-FU. Reported P values are two-sided.\n Among the 3499 patients randomly assigned to receive either cytotoxic PVI or no further treatment, 1557 deaths are known to have occurred. Survival with and without PVI appeared to be the same for the first 2 years; thereafter, it diverged significantly, with the absolute survival difference (i.e., improvement) associated with PVI at 5 years being 4.7 % (standard deviation [SD] = 1.2 %) (P = .006). When just the nine hypothesis-testing trials were considered, the absolute survival difference was 3.6% (SD = 1.2%) (P = .04). If, ignoring any potential for bias in stage assignment, attention was restricted to patients with Dukes' stage A, B, or C disease (88.3% of the total), the absolute effect on 5-year survival for all 10 trials increased to 6.0% (SD = 1.8%) (P = .001); this estimate remained statistically significant when the initial study was excluded (absolute survival difference = 4.8%; SD = 1.8%; P = .01). In contrast to the highly significant reduction in liver metastases seen in the initial study (79% reduction; SD = 15%; P = .00000007), the reduction found in the nine hypothesis-testing trials was not significant (14% reduction; SD = 10%; P = .2). In the trials with additional control groups, survival appeared to be better with cytotoxic PVI than with noncytotoxic PVI or with systemic cytotoxic drug infusion.\n PVI of 5-FU (with or without other cytotoxic drugs) for about 1 week after surgery in patients with colorectal cancer may produce an absolute improvement in 5-year survival of a few percent. Although encouraging, this finding is not statistically secure, and additional evidence from randomized trials involving several thousand more patients is needed.", "The aim of this single, randomized study was to explore the efficacy of postoperative transarterial chemoembolization (TACE) and portal vein chemotherapy (PVC) for patients with hepatocellular carcinoma (HCC) complicated by portal vein tumor thrombosis (PVTT) and to evaluate prognostic factors.\n The study cohort consisted of 112 patients with HCC and PVTT randomly divided into three groups: Group A (37 patients), operation only; Group B (35 patients), operation plus TACE; Group C (40 patients), operation plus TACE and PVC. Disease-free survival rates and prognostic factors were analyzed.\n Most of the side effects and complications were related to the operation, catheters, and local chemotherapy and included liver decompensation (15.0%), catheter obstruction (11.6%), and nausea and loss of appetite (22.1%). The disease-free survival curve was significantly different among the three groups, as estimated by the Kaplan-Meier method (both P < 0.05). Group C showed a significantly higher disease-free survival rate than Group A (P < 0.05), but no statistical differences were found between group A and group B, and group B and group C (both P > 0.05). Tumor size, tumor number, PVTT location, and treatment modalities were independent prognostic factors (P < 0.05).\n Postoperative TACE combined with PVC may benefit the survival of patients with HCC complicated by PVTT in the short-term (less than 60 months), but long-term efficacy is not yet certain and needs to be confirmed by further studies.", "Although radiofrequency ablation (RFA) is increasingly an accepted option for patients with colorectal liver metastases, patients treated with resection vs RFA may have different tumor biology profiles, which might confound the relationship between choice of liver-directed therapy and outcome.\n Retrospective review of a prospectively collected database.\n Major hepatobiliary center.\n Between January 1, 1999, and August 30, 2006, 258 patients with colorectal liver metastases underwent hepatic resection with or without RFA.\n Evaluation of outcome following resection alone, combined resection-RFA, and RFA alone using 3 statistical methods (paired-match control, Cox proportional hazards multivariate model, and propensity index) to identify and adjust for potential confounding variables.\n The median number of hepatic lesions was 2, and the median size of the largest lesion was 3.0 cm. One hundred ninety-two patients (74.4%) underwent resection alone, 55 patients (21.3%) underwent resection-RFA, and 11 patients (4.3%) underwent RFA alone. Patients who underwent resection-RFA had significantly increased risk of extrahepatic failure at 1 year vs patients who underwent resection alone or RFA alone (P < .05). On matched control and multivariate analyses, patients who underwent RFA with or without resection had significantly worse disease-free and overall survival than patients who underwent resection alone. Propensity score methods revealed that the aggregate distribution of clinical risk factors for resection-RFA was markedly different from that for resection alone. This suggested a lack of comparability to allow for statistical comparisons in the assessment of causal inferences regarding the efficacy of RFA therapy.\n Although results of matched control and multivariate analyses suggested that RFA with or without resection was associated with worse outcome, propensity score methods revealed that the resection-RFA and resection-alone groups were different with regard to baseline tumor and treatment-related factors, making causal inferences about the efficacy of RFA unreliable.", "About half the patients treated with curative resection for colorectal cancer do not survive long-term. Adjuvant chemotherapy given during and after surgery may prevent hepatic metastases and improve patient survival. In patients with colorectal cancer, we have done a multicentre, randomised controlled trial comparing five-year survival after intraportal infusion of fluorouracil (1 g per day) plus heparin (10,000 U per day) (130 patients) or heparin alone (123) during curative resection and for 7 days thereafter, or after resection alone (145). There was no reduction in liver metastasis or increased overall survival advantage in either active-treatment arm of the study. However, patients who had stage III, Dukes' C (lymph-node-positive) tumours resected and were treated with fluorouracil plus heparin had a significant (p less than 0.03) survival advantage of about 16% compared with surgery-only controls. Further study of intraportal infusion of chemotherapeutic agent as adjuvant treatment to surgery in patients with colorectal cancer appears worthwhile." ]

[ "16682258", "8147352", "2007362", "7797827", "8314510", "15362027", "8150348", "7890238", "2671739" ]

[ "Polymeric diet alone versus corticosteroids in the treatment of active pediatric Crohn's disease: a randomized controlled open-label trial.", "Antimycobacterial therapy in Crohn's disease: results of a controlled, double-blind trial with a multiple antibiotic regimen.", "Controlled trial of antimycobacterial therapy in Crohn's disease. Clofazimine versus placebo.", "A controlled double blind multicenter study of the effectiveness of 5-aminosalicylic acid in patients with Crohn's disease in remission.", "Polymeric enteral diets as primary treatment of active Crohn's disease: a prospective steroid controlled trial.", "Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial.", "Controlled trial of anti-tuberculous chemotherapy for two years in Crohn's disease.", "Controlled trial of oligopeptide versus amino acid diet in treatment of active Crohn's disease.", "A placebo-controlled, double-blind, randomized trial of cyclosporine therapy in active chronic Crohn's disease." ]

[ "Nutritional therapy has been reported to have an almost equivalent efficacy of corticosteroids in achieving clinical remission in active Crohn's disease (CD). However, the effects of both treatments on intestinal mucosal inflammation rarely are reported. In a randomized controlled trial in children with active CD we compared the efficacy of nutritional therapy alone or corticosteroids on clinical variables and intestinal mucosal healing.\n In a prospective, 10-week open-label trial, children with active, naive CD were randomized to orally polymeric formula alone or oral corticosteroids. The clinical activity index and nutritional and activity serum variables were evaluated at week 0 and then every 2 weeks; intestinal mucosal inflammation was assessed through endoscopy and histology at weeks 0 and 10. Primary efficacy outcomes were clinical remission and mucosal healing.\n Of the 37 children randomized, 19 received polymeric formula and 18 received corticosteroids. At week 10, on an intention-to-treat basis, the proportion of patients achieving clinical remission was comparable between the 2 groups (polymeric formula: 15/19 [79%; 95% confidence interval (CI), 56%-92%]; corticosteroid group: 12/18 [67%; 95% CI, 44%-84%]; P = .4; not significant). On the contrary, the proportion of children showing mucosa healing was significantly higher in the polymeric (14/19; 74%; 95% CI, 51%-89%) than the corticosteroid group (6/18 [33%; 95% CI, 16%-57%]; P < .05). At week 10 both endoscopic and histologic scores significantly decreased only in the polymeric group (P < .001).\n In children with active and recently diagnosed CD, a short course of polymeric diet is more effective than corticosteroids in inducing healing of gut inflammatory lesions.", "Several recent reports have suggested an association of atypical mycobacteria with Crohn's disease.\n The goal of this double-blind, placebo-controlled trial was to determine the efficacy of treatment with antimycobacterial drugs in maintaining clinical remission and in reducing active inflammatory lesions.\n Forty patients (15 male) with refractory, steroid-dependent Crohn's disease were randomized to receive 2 months of tapering steroids plus either a 9-month regimen of ethambutol, clofazimine, dapsone and 1-day dose only of rifampicin (n = 22), or identical placebo.\n Three patients (two on active drug) were unable to discontinue steroids, and one patient on active drug was withdrawn for side effects during the first 2 months. Three of the remaining 19 patients on active drug relapsed during the study period, compared with 11 of 17 on placebo (log likelihood ratio = 4.6; p = 0.03). Another patient was withdrawn in remission at 5 months for anemia related to dapsone. Nine patients whose disease relapsed or persisted on placebo were crossed over to active drug; five achieved sustained remission, two failed, and two were withdrawn for side effects. Substantial endoscopic or radiologic healing did not occur.\n This study suggests that the treatment regimen with rifampicin, ethambutol, clofazimine, and dapsone is effective in relief of symptoms and maintenance of remission in some Crohn's disease patients.", "In order to study the effect of clofazimine, a powerful antimycobacterial and antiinflammatory agent, 49 patients with active Crohn's disease were randomized to either corticosteroids plus clofazimine 100 mg daily (N = 25) or to steroids and matching placebo (N = 24). A total of 28 patients (58%) went into disease remission (clofazimine 16, placebo 12; P = NS) with a fall in disease activity score from 10.5 +/- 4.4 to 3.3 +/- 3.5. Patients were treated for a further eight months with clofazimine or placebo and 18 of 28 maintained their remission and completed the study (clofazimine 12, placebo 6; P = NS). Side effects were minor and consisted of skin rash and increased pigmentation. Clofazimine as a solitary antimycobacterial agent appears ineffective in inducing remission in Crohn's disease but may have a role in either disease maintenance or combination chemotherapy.", "We evaluated the efficacy of an oral formulation of 5-amino-salicylic acid in lowering the relapse rate after remission of Crohn's disease. Included were 59 patients who had proven Crohn's disease of at least 1 year's duration, and who had been in continuous remission for at least 6 months, while taking only 5-aminosalicylic acid or no therapy at all. Remission was defined as a Harvey Bradshaw index score (Softley-Clamp modification) of < 4. Patients were given coded mesalzaine 250 mg or placebo tablets (2 x 2 day). They were seen at 0, 1, and 2 months, and then every 2 months until the end of the study. Trial endpoints were 1 year of follow-up, or clinical relapse results. After randomization, 31 patients were included in the placebo arm, and 28 in the treatment arm. There were no significant differences between the two groups at entry. Ten patients were withdrawn from the trial because of noncompliance, loss of follow-up, or headache. There were more clinical relapses in the placebo arm (15 patients, 55%) than in the treatment arm (6 patients, 27%) (p < 0.05). Mesalazine had a significant advantage over placebo (p < 0.05) only in the subgroups of patients with ileal Crohn's disease and in those older than 30 years. We conclude that mesalazine has a moderate but significant benefit in preventing relapse in Crohn's disease in remission; this occurred only in patients with small-bowel involvement or in those older than 30 years.", "Thirty two patients with active Crohn's disease were included in a controlled randomised trial to determine the efficacy and safety of polymeric enteral nutrition compared with steroids, to achieve and maintain clinical remission. The polymeric diet was administered through a fine bore nasogastric tube by continuous, pump assisted infusion (2800 (SEM 120) kcal/day). The steroid group received 1 mg/kg/day of prednisone. Both treatments were effective in inducing clinical remission: 15 of the 17 patients given steroids and 12 of the 15 patients assigned to the polymeric diet went into clinical remission (defined by a Van Hees index < 120) within four weeks of treatment. The percentage reduction of the Van Hees index was 34.8 (4.9)% for steroids and 32.3 (5)% for enteral nutrition (mean difference 2.5%; 95% CI--11.8% to +16.8%). Mean time elapsed to achieve remission was similar in both groups (2.0 (1) v 2.4 (1.2) weeks). Tolerance of the enteral diet was excellent. Four patients in the steroid group had mild complications attributable to this treatment. Ten patients (66.6%) in the steroid group and five (41.6%) in the enteral nutrition group relapsed within a year of discharge, but no differences were found in the cumulative probability of relapse during the follow up period. These results suggest that polymeric enteral nutrition is as safe and effective as steroids in inducing short term remission in active Crohn's disease.", "No therapy has been shown to reliably prevent the evolution of postoperative recurrence of Crohn's disease. The aim of the current trial was to compare 6-mercaptopurine (6-MP) and mesalamine with placebo for the prevention of clinical, endoscopic, and radiographic recurrence of Crohn's disease after resection and ileocolic anastomosis.\n Five centers randomized 131 patients to receive 6-MP (50 mg), mesalamine (3 g), or placebo daily in a double-blind, double-dummy trial. Patients had clinical assessments at 7 weeks and then every 3 months; colonoscopy at 6, 12, and 24 months; and small bowel series at 12 and 24 months. End points were clinical, endoscopic, and radiographic recurrence rates at 24 months.\n Clinical recurrence rates (intent to treat) by life-table analysis at 24 months were 50% (95% confidence interval [CI], 34%-68%), 58% (95% CI, 41%-75%), and 77% (95% CI, 61%-91%) in patients receiving 6-MP, mesalamine, and placebo, respectively. Endoscopic recurrence rates were 43% (95% CI, 28%-63%), 63% (95% CI, 47%-79%), and 64% (95% CI, 46%-81%), and radiographic recurrence rates were 33% (95% CI, 19%-54%), 46% (95% CI, 29%-66%), and 49% (95% CI, 30%-72%), respectively. 6-MP was more effective than placebo ( P < 0.05) at preventing clinical and endoscopic recurrence over 2 years. Patient withdrawals resulted in 69% of the study population evaluable for the clinical recurrence end point.\n 6-MP, 50 mg daily, was more effective than placebo at preventing postoperative recurrence of Crohn's disease and should be considered as a maintenance therapy after ileocolic resection.", "One hundred and thirty patients with active symptoms of Crohn's disease were treated in a double blind randomised controlled trial with rifampicin, isoniazid, and ethambutol, or identical placebos for up to two years. All other treatment considered necessary was continued. Analyses were based on 126 patients, 63 in each treatment group. Thirty seven in the active and 30 in the placebo group had previous surgical procedures. There was no difference in concomitant treatment between the two groups. Thirty in the active and 46 in the placebo groups were taking corticosteroids at entry to the trial. Forty eight of 63 patients in the active and 49 of 63 in the placebo group, completed at least 12 months' therapy. Reasons for early withdrawal included pregnancy, adverse reaction, and failure to comply. There was no significant difference in the mean number of months completed between the two groups. Nineteen adverse reactions were recorded for 17 patients in the active group compared with three reactions in patients on placebo. All of the nine patients withdrawn early because of adverse reactions were in the active group. Fifteen patients on active treatment and 14 on placebo had surgery during the trial with no difference in the type of surgery required between the groups. Radiological assessments based on 98 patients at the end of the trial showed no significant differences between groups in changes of extent of disease. More patients developed strictures on placebo compared with active treatment but without a statistically significant difference. No differences were found between groups for the total prednisolone dose or the number of days on which prednisolone dose was 10 mg or above. Serial measurements of body weight and Crohn's disease activity index (CDAI) together with blood values for albumin, haemoglobin, white cell count, and platelets showed no consistent different differences between groups. There were occasional significant differences for some of these values between groups, which were not sustained. The trail provides little evidence of tangible benefit from the trail treatment.", "Elemental diets are effective in inducing remission in active Crohn's disease, but how they exert this therapeutic effect is unclear. In a previous study a whole protein containing diet proved less effective than one in which food antigens were excluded, suggesting that exclusion of food antigens from the gut was a possible mechanism. This study was designed to test whether an oligopeptide diet of hydrolysed proteins was as effective as an amino acid based diet. These diets were equally antigen free but with different nitrogen sources. Forty four patients with active Crohn's disease were randomised in a controlled trial of amino acid versus oligopeptide diet. The feeds were given by nasogastric tube in equicaloric quantities and were the sole form of nutrition. Treatment was continued for four weeks although failure to improve by day 10 resulted in withdrawal. Quantitative leucocyte scintigraphy was used to investigate the effect of diet treatment on gut inflammation. Clinical and nutritional responses to treatment were also measured. Sixteen patients entered remission (including withdrawal of corticosteroids), six patients could not tolerate the nasogastric tube, and 22 patients failed to respond. The two diets were equally effective. Patients who responded had a rapid drop in clinical index of disease activity and a major reduction in the bowel uptake of leucocytes on scintigraphy. The oligopeptide and amino acid based enteral feeds were equally effective at inducing remission in active Crohn's disease. With both diets clinical improvement was accompanied by a reduction in intestinal inflammation.", "We randomly assigned 71 patients with active chronic Crohn's disease who were resistant to or intolerant of corticosteroids to treatment with oral cyclosporine (5 to 7.5 mg per kilogram of body weight per day) or placebo for three months. Disease activity was assessed on a clinical grading scale without knowledge of the treatment given. At the end of the treatment period, 22 of the 37 cyclosporine-treated patients (59 percent) had improvement, as compared with 11 of the 34 placebo-treated patients (32 percent) (P = 0.032). During cyclosporine treatment, there was significant improvement in plasma orosomucoid levels (P = 0.0025) and the Crohn's Disease Activity Index (P = 0.00012). The effect of treatment became evident after two weeks. In the subsequent three months, during which the patients were gradually withdrawn from treatment, the improvement continued in 14 of the 37 patients (38 percent) in the cyclosporine group and in 5 of the 34 (15 percent) in the placebo group (P = 0.034). No serious adverse events were observed. We conclude that cyclosporine has a beneficial therapeutic effect in patients with active chronic Crohn's disease and resistance to or intolerance of corticosteroids." ]

[ "9832182", "9468460", "8007592", "20433527", "13679494", "7594425", "3904559", "15502721", "15731556" ]

[ "Lack of effect of a single oral dose of cyclosporine on systemic blood pressure and on forearm blood flow and vascular resistance in humans.", "Cyclosporine-induced hypertension and decline in renal function in healthy volunteers.", "Sequential effects of cyclosporine therapy on blood pressure, renal function and neurohormones.", "The impact of lactotripeptides on blood pressure response in stage 1 and stage 2 hypertensives.", "Amlodipine reduces cyclosporin-induced hyperuricaemia in hypertensive renal transplant recipients.", "Serial changes in blood pressure, renal function, endothelin and lipoprotein (a) during the first 9 days of cyclosporin therapy in males.", "Blood pressure response to oral calcium in persons with mild to moderate hypertension. A randomized, double-blind, placebo-controlled, crossover trial.", "Calcium channel blockade and preservation of renal graft function in cyclosporine-treated recipients: a prospective randomized placebo-controlled 2-year study.", "Bendrofluazide fails to reduce elevated blood pressure levels in the immediate post-stroke period." ]

[ "The acute hemodynamic effect of cyclosporine in man is controversial. A randomized, double blind, placebo-controlled, cross-over study was undertaken to evaluate the effect of a single oral dose of cyclosporine (20 mg/kg body weight) on mean blood pressure (MBP), heart rate (HR), forearm blood flow (FBF), and vascular resistance (FVR) in 16 healthy adult subjects. Subjects were studied twice, with an intervening period of 2 weeks, before and after the administration of either cyclosporine or the vehicle olive oil. Blood pressure was measured on brachial and digital arteries. After 30 min of rest, basal measurements were obtained and individuals were randomly assigned to receive either cyclosporine or the vehicle, and the same measurements were repeated 2 h later. Mean whole blood levels of cyclosporine were 1542+/-387 ng/mL (range 1000 to 2550) 2 h after the administration of a single oral dose of cyclosporine. Cyclosporine did not cause any significant change in the hemodynamic parameters when compared with vehicle. Pre- and post-cyclosporine data were as follows (means +/-/SD): MBP (determined by Finapres on the digital artery), 92+/-10 v 95+/-11 mm Hg; HR, 66+/-10 v 68+/-11 beats/min; FBF, 3.90+/-1.3 v 3.8+/-1.8 mL/ 100 mL/min; and FVR, 28+/-9 v 33 +/-18 units, respectively. For the vehicle the results were: MBP, 94+/-9 v 94+/-9; HR, 67+/-9v 67 /-11; FBF, 3.3+/-1.6 v 3.2+/-2.0; FVR, 35+/-14 v 37+/-15, respectively. These figures did not differ from those obtained with the auscultatory method applied to the brachial artery among 10 selected subjects studied with Finapres. In conclusion, we found no evidence that at supratherapeutic doses cyclosporine causes acute increase in blood pressure or peripheral vasoconstriction in humans.", "To investigate the effect of cyclosporine A (CsA; Sandimmun Neoral) on systemic and renal hemodynamics, tubular function, and sodium excretion in healthy volunteers. Furthermore, we studied whether CsA enhances the systemic and renal hemodynamic sensitivity to norepinephrine.\n Eighteen healthy volunteers were administered 10 mg/kg CsA or placebo capsules in a double-blind fashion. The mean arterial blood pressure (MAP), renal vascular resistance (RVR), glomerular filtration rate (GFR), and renal clearances of lithium (CLi) and sodium (CNa) were measured for 8 h after ingestion of the capsules. Norepinephrine (2 microg/kg per h) was infused intravenously for 1.5 h into nine subjects.\n CsA increased the MAP by 17+/-2 mmHg. The GFR decreased by 18+/-2% (P < 0.001) and the RVR increased by 37+/-4% (P< 0.001) after ingestion of CsA. The CsA-induced increase in MAP preceded the CsA-induced fall in GFR. The rise in MAP was followed by an early 35+/-8/0 increase in CNa (P < 0.001). At the end of the 8 h study period, CNa decreased by 25+/-7% (P < 0.001). Using CLi, it was found that the initial natriuresis had been caused by a relative decrease both in proximal and in distal tubular reabsorption of sodium, whereas the late sodium retention was secondary to the CsA-induced fall in GFR. Infusion of norepinephrine increased the MAP, RVR, and filtration fraction, and decreased the renal plasma flow, without CsA having any additional effect.\n It was demonstrated that a single oral dose of CsA caused a rise in blood pressure and transient natriuresis, followed by a fall in GFR and antinatriuresis. Thus, the present study confirms and extends earlier observations that renal dysfunction and sodium retention are not the initiating events in CsA-induced hypertension. The study also affords evidence suggesting that such rises in blood pressure are not mediated by an increased sensitivity to norepinephrine.", "We have studied the sequential effects of cyclosporine during the first four days after its initiation in an effort to elucidate the primary and secondary events in the pathogenesis of cyclosporine induced nephrotoxicity and hypertension. Knowledge about the earliest effects of cyclosporine provides a more logical approach for devising therapeutic strategies to counteract nephrotoxicity and hypertension. On day 1, cyclosporine acutely increased systemic BP and decreased urine volume. Plasma renin activity was suppressed by day 2 and remained so thereafter. Renal sodium excretion was not affected until day 4 at which point a natriuresis occurred. Cyclosporine exerted a more marked antidiuretic effect on day 4 compared to day 1, which was augmented by a physiological infusion of vasopressin. Over the first four days of therapy, glomerular filtration rate and effective renal plasma flow were unchanged. Our data show that cyclosporine induced hypertension in the initial stages is not sodium dependent, and that changes in renal water handling were not dependent on alterations in the glomerular filtration rate or effective renal plasma flow. In fact, a natriuresis occurred which was most likely due to a combination of pressure natriuresis and angiotensin II suppression. The cyclosporine induced antidiuresis may indicate a distal nephron effect since cyclosporine augmented the antidiuretic effect of vasopressin, although vasopressin levels per se were not increased by cyclosporine alone.", "Nearly 70 million Americans have hypertension, and approximately an equal number have prehypertension. The prevalence of both disorders increases with advancing age and obesity. Many at-risk individuals do not have controlled blood pressure (BP). Lifestyle modification for most persons is the first step in a plan to control these conditions. Non-drug treatments offer an appeal to many patients with modest BP elevation. The authors recently evaluated BP response using 24-hour ambulatory BP monitoring and office BP monitoring of lactotripeptides dosed twice daily in 91 previously treated and treatment-naive patients with stage 1 and stage 2 hypertension. In this population, daytime systolic BP, the primary efficacy end point, significantly decreased (-3.6 mm Hg; P=.013), while placebo did not affect systolic BP (0 mm Hg; P=not significant). Treatment-naive patients exhibited a more robust drop in their daytime systolic BP (-7.6 mm Hg; P=.005) compared with placebo (-3.6 mm Hg; P=not significant). Lactotripeptides may be an effective agent in the management of low-risk and low-grade hypertension and prehypertension.", "Hypertension and hyperuricaemia are common side-effects of cyclosporin A (CsA) treatment in renal transplant recipients. While it is well established that the calcium channel blocker amlodipine can control CsA-induced hypertension effectively in this patient population, recent evidence suggests amlodipine might also reduce hyperuricaemia. The present study was designed to compare the effects of the calcium channel blocker amlodipine (5-10 mg/day) and the beta-adrenoceptor antagonist tertatolol (5-10 mg/day) on CsA-induced hyperuricaemia in post-renal transplant recipients with hypertension.\n Forty-eight hypertensive renal transplant recipients on a stable dose of CsA were randomized in a double-blind, parallel-group manner to receive either amlodipine (n = 24) or tertatolol (n = 24) for 60 days. The primary outcome measure was the change from baseline in serum uric acid concentration. Secondary analyses of efficacy were based on changes in renal function and blood pressure.\n Amlodipine significantly decreased serum uric acid levels from 483 +/- 99 to 431 +/- 110 microM/l (P < 0.001), while tertatolol significantly increased uric acid from 450 +/- 98 to 476 +/-84 microM/l (P = 0.006). Amlodipine also significantly increased glomerular filtration rate (P = 0.0048) and the clearance rate of uric acid (P = 0.023) and it reduced the fractional proximal tubular reabsorption of sodium (P < 0.001), compared with tertatolol. Renal plasma flow and filtered fraction were unaffected by both treatments, as was trough CsA blood concentration. Amlodipine lowered systolic blood pressure to a significantly greater extent than did tertatolol (P = 0.007). The time-dependent profile of diastolic blood pressure did not differ significantly between treatment groups. Both drugs were well tolerated.\n Amlodipine could be more appropriate than tertatolol for CsA-induced hypertension and hyperuricaemia in renal transplant recipients.", "To elucidate the sequential mechanisms underlying cyclosporin-induced hypertension and nephrotoxicity.\n A study of healthy males over the first 9 days of drug ingestion to permit the detection of serial changes in renal function and blood pressure in a situation free from the confounding variables of concomitant disease or drugs.\n Double-blind, placebo-controlled, randomized crossover study with cyclosporin (5 mg/kg twice a day) or placebo. Blood pressure and urinary sodium excretion were measured each day, and glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) were measured on days 1, 4, 7 and 9. Cholesterol, lipoprotein (a) and endothelin were measured on days 1 and 9.\n GFR decreased by 9% with cyclosporin and was significantly lower than with placebo on day 4 of therapy. ERPF fell by 24%. The fall in GFR correlated significantly with suppressed plasma renin activity (P < 0.0001). Cyclosporin-induced hypertension occurred in the absence of any change in urinary sodium output or in plasma endothelin. Cyclosporin did not affect lipoprotein (a) levels during 9 days of cyclosporin therapy.\n Cyclosporin-induced hypertension and renal vasoconstriction are well established after 9 days of cyclosporin 5 mg/kg twice a day. We found no evidence to implicate either circulating endothelin or renal sodium retention in the onset of cyclosporin-induced hypertension. Cyclosporin-induced renal vasoconstriction appeared to occur when the protective mechanism of plasma renin activity suppression became exhausted.", "The blood pressure response of 48 hypertensive persons and 32 normotensive persons to elemental calcium (as the carbonate or citrate salt), 1000 mg/d for 8 weeks, was assessed in a randomized, double-blind, placebo-controlled, crossover trial. Compared with placebo, Ca2+ significantly lowered supine systolic blood pressure by 3.8 mm Hg, standing systolic blood pressure by 5.6 mm Hg (p less than 0.02), and supine diastolic blood pressure by 2.3 mm Hg (p less than 0.05) in hypertensive persons. The response in normotensive persons differed significantly from that in hypertensives (p less than 0.03) as their blood pressure was unchanged. Twenty-one (44%) hypertensive and 6 (19%) normotensive persons achieved a reduction in standing systolic arterial pressure of 10 mm Hg or greater. Reported adverse effects were similar between calcium and placebo phases and did not necessitate withdrawal of any patient from the trial. Treatment with 1000 mg/d of oral Ca2+ for 8 weeks represents a safe, well-tolerated, nonpharmacologic intervention that lowers blood pressure in selected patients with mild to moderate hypertension.", "Studies have provided conflicting results as to the protective role of calcium channel blockers (CCB) in cyclosporine-treated patients with regard to blood pressure control and preservation of renal graft function. Lacidipine is a dihydropyridine CCB that possesses antioxidative, anti-atherosclerotic, and anti-adhesion properties and was shown to prevent cyclosporine-induced nephrotoxicity in a rat model.\n We conducted a multicenter prospective, randomized, placebo-controlled study in 131 de novo recipients of a cadaveric renal allograft on cyclosporine therapy. The aim of this 2-year study was to assess the effects of lacidipine on graft function (plasma iohexol clearance), renal plasma flow, anastomotic arterial blood flow, deterioration of renal function, blood pressure, acute rejection, and hospitalization rate.\n A total of 118 recipients were available for intention-to-treat analysis on efficacy (lacidipine: n=59; placebo: n=59). Graft function assessed by serum creatinine concentration and glomerular filtration rate measured as plasma iohexol clearance, was persistently better in lacidipine-treated patients from 1 year onwards (respectively, P<0.01 and P<0.05). Renal plasma flow and anastomotic blood flow were not significantly higher in lacidipine-treated patients. Three patients on lacidipine therapy and four on placebo experienced treatment failure defined as an increase in serum creatinine from baseline of more than 60% (log-rank test: P=0.57). Study groups did not differ in acute rejection rate, trough blood cyclosporine concentrations, blood pressure, number of antihypertensive drugs, hospitalization rate, and adverse event rate.\n The use of calcium channel blockers in cyclosporine-treated renal recipients results in a significantly better allograft function at 2 years and this effect is independent of blood pressure lowering.", "Blood pressure (BP) levels, beat-to-beat blood pressure variability, dynamic cerebral autoregulation and cardiac baroreceptor sensitivity are frequently abnormal following acute stroke and are associated with an adverse short- and long-term prognosis. Thiazide diuretics are effective antihypertensive agents in preventing primary and secondary stroke, but their hypotensive and cerebral autoregulatory effects in the immediate post-stroke period have not been studied.\n Thirty-seven hypertensive neuroradiologically proven ischaemic stroke patients were randomized in a double-blind, placebo controlled, parallel group study to bendrofluazide 2.5 mg daily or matching placebo, within 96 h of stroke onset, for a 7-day period. Casual and non-invasive beat-to-beat arterial BP levels, cerebral blood flow velocity, ECG and transcutaneous carbon dioxide levels were measured within 70 +/- 20 h of cerebral infarction and again 7 days later. Dynamic cerebral autoregulatory indices, pulse interval, BP variability and cardiac baroreceptor sensitivity were also calculated.\n Small, non-significant falls were seen in casual and beat-to-beat BP levels over the 7-day period in both active and placebo-treated patients with no differences between treatments. No significant changes were seen in dynamic cerebral autoregulation or in cardiac baroreceptor sensitivity during the follow-up in either group.\n Following acute ischaemic stroke, the standard dose of bendrofluazide at 2.5 mg daily in this study sample did not lower systemic BP levels over the subsequent 7-day period. There was no evidence that bendrofluazide significantly altered cerebral autoregulation or improved cardiac baroreceptor sensitivity post-ictus. Bendrofluazide appears to be an ineffective hypotensive agent at the standard dosage in the initial post-stroke period.\n Copyright 2005 S. Karger AG, Basel." ]

[ "3305229", "8735733", "17023012", "8155220", "14556770", "1609525", "10076134", "1547173", "17355378" ]

[ "[Effectiveness of Alphastria cream in the prevention of pregnancy stretch marks (striae distensae). Results of a double-blind study].", "Stretching of the cervix and stripping of the membranes at term: a randomised controlled study.", "The cosmetic use of skin-lightening products during pregnancy in Dakar, Senegal: a common and potentially hazardous practice.", "Prevention of perineal trauma by perineal massage during pregnancy: a pilot study.", "Single-blind trial addressing the differential effects of two reflexology techniques versus rest, on ankle and foot oedema in late pregnancy.", "[Attempt of preventive treatment of striae gravidarum using preventive massage ointment administration].", "Randomized controlled trial of prevention of perineal trauma by perineal massage during pregnancy.", "Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage.", "Pregnancy and STD prevention counseling using an adaptation of motivational interviewing: a randomized controlled trial." ]

[ "nan", "To determine whether routine antepartum stretching of the cervix and stripping of the membranes at term would shorten the length of pregnancies, and whether this correlated with cervical status and fetal and maternal parameters.\n A prospective, randomised, controlled study of 293 term gravidas, free of medical complications, divided into two groups: stretching/stripping, and non-stretching/stripping. Digital separation of the fetal membranes from the lower uterine segment, and cervical stretching, were performed during routine vaginal examination of the first group. In the second group, only routine vaginal examination was performed.\n Of 293 patients, 152 underwent a trial of stretching and stripping; 141 served as a control group. The mean interval (hours to delivery after the procedure) was 136 h (S.D. 10), compared to 161 h (S.D. 11) in the control group (P = 0.095; not significant), but with only a trend towards the shorter interval in the first group. When patients were matched according to weeks of gestation and fetal and maternal parameters, only those at 41 weeks' gestation or more had a significant reduction in the interval from the procedure to delivery (mean 91 h (S.D. 8) compared to mean 125 h (S.D. 10) in the control group; P < 0.007). This observation was independent of cervical status and other maternal or fetal parameters.\n Only patients > or = 41 weeks' gestation benefitted from stretching of the cervix and stripping of the fetal membranes. The effect was not dependent on the cervical status or other maternal and fetal parameters.", "Many women of childbearing age from sub-Saharan Africa use topical skin lighteners, some of which present a risk of toxic systemic effects. The goals of this study were to evaluate, in this environment, the frequency of this practice during pregnancy, as well as eventual consequences on pregnancy. Ninety-nine women from 6 to 9 months pregnant were randomly selected among those attending a standard maternal centre in Dakar for a prenatal visit. Investigations consisted of questions about the use of skin lighteners, a standard clinical examination, follow-up until delivery and a morning blood sample for plasma cortisol levels. Sixty-eight of the 99 selected women used skin lighteners during their current pregnancy, the main active ingredients being hydroquinone and highly potent steroids (used by 64 and 28 women, respectively). No difference in the main outcomes of pregnancy were found between skin-lightener users and the others; however, women using highly potent steroids, when compared with those who did not, had a statistically significant lower plasma cortisol level and a smaller placenta, and presented a higher rate of low-birth-weight infants. Skin lightening is a common practice during pregnancy in Dakar, and the use of steroids may result in consequences in the mother and her child.", "Although the performance of perineal massage by a woman or her partner during the last weeks of pregnancy may help to prevent perineal trauma at delivery, the technique has never been evaluated rigorously. This study examined the feasibility of a randomized, controlled trial, and more specifically assessed the participation rate, the acceptability of the intervention, and whether or not an attending physician could remain blind to participants' groups. The pilot study was a single-blinded, randomized, controlled trial. Nulliparous women, 32 to 34 weeks pregnant, were recruited from June 8 to July 31, 1992, at the offices of family physicians and obstetricians who practice at the Hôpital du Saint-Sacrement in Quebec City. Women assigned to the intervention group practiced daily 10-minute perineal massage and completed a diary, and those in the control group had standard care. Women and attending physicians completed a questionnaire about the aspect of blindness. Among the 174 women who delivered during the study period, 104 (59.8%) were approached by a midwife and 46 (26.4%) were randomized. Twenty (91.0%) of the 22 women in the massage group returned their perineal massage diaries. Based on the postpartum questionnaire, 20 women practiced the technique at least four times a week for three weeks or longer. No woman in the control group practiced massage. The attending physician was aware of the woman's group in only three instances (6.7%). Based on the results of this pilot study, a randomized, controlled trial to evaluate the efficacy of perineal massage in preventing perineal trauma at birth appears feasible.", "This single-blind randomised controlled trial explored the differential effects of two different foot reflexology techniques with a period of rest on oedema-relieving effects and symptom relief in healthy pregnant women with foot oedema. Fifty-five women in the third trimester were randomly assigned to one of the three groups: a period of rest, 'relaxing' reflexology techniques or a specific 'lymphatic' reflexology technique for 15 min with pre- and post-therapy ankle and foot circumference measurements and participant questionnaire. There was no statistically significant difference in the circumference measurements between the three groups; however, the lymphatic technique reflexology group mean circumference measurements were all decreased. A significant reduction in the women's symptom mean measurements in all groups (p<0.0001) was apparent. A 'perceived wellbeing' score revealed the lymphatic technique group (p<0.0001) significantly increased their wellbeing the most, followed closely by relaxing techniques (p<0.001) and then the control rest group (p<0.03). Lymphatic reflexology techniques, relaxing reflexology techniques and a period of rest had a non-significant oedema-relieving effect. From the women's viewpoint, lymphatic reflexology was the preferred therapy with significant increase in symptom relief.", "Striae distensae are an appreciable cosmetic problem for many pregnant women. Preventive application of a water/oil massage cream was tested in a group of 24 gravidae (control group: 26 patients). In the untreated control group striae distensae were observed in two-thirds of the patients, whereas the prophylactically-treated gravidae showed development of striae in only one third of the group given the test preparation. Better results were obtained in women with a favourable constitutional predisposition than in patients with a tendency to overweight. The massage cream was well tolerated by all gravidae.", "The aim of the study was to evaluate the effectiveness of perineal massage during pregnancy for the prevention of perineal trauma at birth. Study Design: Pregnant women with (n = 493) and without (n = 1034) a previous vaginal birth from 5 hospitals in the province of Québec, Canada, participated in this single-blind, randomized, controlled trial. All participants received oral and written information on the prevention of perineal trauma. Women in the experimental groups were requested to perform a 10-minute perineal massage daily from the 34th or 35th week of pregnancy until delivery.\n Among participants without a previous vaginal birth, 24.3% (100/411) from the perineal massage group and 15.1% (63/417) from the control group were delivered vaginally with an intact perineum, for a 9.2% absolute difference (95% confidence interval 3.8%-14.6%). The incidence of delivery with an intact perineum increased with compliance with regular practice of perineal massage (chi2 for trend 13.2, P = 0.0003). Among women with a previous vaginal birth, 34.9% (82/235) and 32.4% (78/241) in the massage and control groups, respectively, were delivered with an intact perineum, for an absolute difference of 2.5% (95% confidence interval -6.0% to 11.0%). There were no differences between the groups in the frequency of sutured vulvar and vaginal tears, women's sense of control, and satisfaction with the delivery experience.\n Perineal massage is an effective approach to increasing the chance of delivery with an intact perineum for women with a first vaginal delivery but not for women with a previous vaginal birth.", "To compare by randomized prospective clinical trial the outcome of labours which are managed with the intention to leave the membranes intact, compared with the practice of elective artificial rupture of the membranes (ARM) in early established labour.\n Prospective randomized controlled trial of low risk women admitted in spontaneous labour, with intact membranes.\n The labour ward of St. James's University Hospital, Leeds, UK.\n 362 women in spontaneous labour with intact membranes and no evidence of fetal distress, between 37 and 42 weeks gestation. During the course of the trial it was found that some randomization cards could not be accounted for and a system of daily checks was instituted. The results were analysed for all recorded women (n = 362) and after institution of the more rigorous system (n = 120).\n The duration of each phase of labour, epidural rate, prevalence of an abnormal cardiotocograph (CTG) (assessed blind), method of delivery and neonatal outcome.\n 178 of the 183 women (97%) in the ARM group had their membranes ruptured in early labour, and 83 (46%) of the 179 women allocated to non-intervention had ARM performed at some stage. A significant decrease in the duration of labour (mean 8.3, SD 4.1 h vs mean 9.7, SD 4.8 h, n = 156; P = 0.05) was found amongst primigravidae allocated to ARM when compared with non intervention. The duration of the second stage of labour was unaffected. In the ARM group the epidural rate was higher and labour was more often complicated by CTG abnormalities. There were no differences in the method of delivery, fetal condition at birth (cord blood lactate, Apgar score) or postpartum pyrexia between the ARM and non-intervention groups. The same trends were observed when analysis was confined to women entered into the trial after the system of rigour was instituted.\n Routine ARM results in labour that is slightly shorter than if the membranes are allowed to rupture spontaneously but more epidurals are used suggesting that labour is more painful. There are fewer fetal heart rate abnormalities if the membranes are left intact but amniotomy has no effect on fetal condition at birth.", "Given levels of unintended pregnancy and STDs, an effective counseling intervention is needed to improve women's consistent use of effective prevention methods.\n A sample of 764 women aged 16-44 who were at risk of unintended pregnancy were enrolled in a randomized controlled trial in North Carolina in 2003-2004. Intervention participants received pregnancy and STD prevention counseling, adapted from motivational interviewing, both at enrollment and two months later; controls received only a session of general health counseling. Levels of contraceptive use (categorized as high, low or none on the basis of the effectiveness of the method and the consistency of use) and barriers to use were measured at two, eight and 12 months; chi-square tests were used to compare selected outcomes between the groups. Rates of unintended pregnancy and chlamydia infection were assessed over the study period.\n At baseline, 59% of all participants reported a high level of contraceptive use, 19% a low level and 22% nonuse. At two months, the proportions of intervention and control participants who had improved their level of use or maintained a high level (72% and 66%, respectively) were significantly larger than the proportions who had reported a high level of use at baseline (59% and 58%, respectively). No significant differences were found between the groups at 12 months, or between baseline and 12 months for either group. During the study, 10-11% of intervention and control participants became pregnant, 1-2% received a chlamydia diagnosis and 7-9% had another STD diagnosed.\n Repeated counseling sessions may be needed to improve contraceptive decision-making and to reduce the risk of unintended pregnancy and STDs." ]

[ "12100779", "9602398", "3711252", "594708", "7112052", "15653255", "8124120", "10074017", "7488463" ]

[ "General health screenings to improve cardiovascular risk profiles: a randomized controlled trial in general practice with 5-year follow-up.", "Effects of an assessment of needs for medical and social services on long-term mortality: a randomized controlled study.", "Multiphasic Health Checkup Evaluation: a 16-year follow-up.", "Effects of a health screening on mortality and causes of death in middle-aged men. A prospective study from 1970 to 1974 of mean in Malmö, born 1914.", "The influence of repeated health examinations on mortality in a prospective cohort study, with a comment on the autopsy frequency. The study of men born in 1913.", "Long-term efficacy of a checklist to improve patient education in cardiology.", "Effectiveness of health checks conducted by nurses in primary care: results of the OXCHECK study after one year. Imperial Cancer Research Fund OXCHECK Study Group.", "Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group.", "Mortality in participants and non-participants of a multifactorial prevention study of cardiovascular diseases: a 28 year follow up of the Helsinki Businessmen Study." ]

[ "To investigate the impact of general health screenings and discussions with general practitioners on the cardiovascular risk profile of a random population of patients.\n A population-based, randomized, controlled, 5-year follow-up trial conducted in a primary care setting.\n The study group consisted of 2000 patients, randomly selected middle-aged men and women aged 30 to 50 years from family practices in the district of Ebeltoft, Denmark. Of these patients, 1507 (75.4%) agreed to participate. Patients were randomized into (1) a control group who did not receive health screenings, (2) an intervention group that received 2 health screenings, (3) an intervention group that received both the 2 screenings and a 45-minute follow-up consultation annually with their general practitioner.\n Cardiovascular risk score (CRS), body mass index (BMI), blood pressure, serum cholesterol, carbon monoxide in expiratory air, and tobacco use.\n After 5 years, the CRS, BMI, and serum cholesterol levels were lower in the intervention groups compared with the control group. The improved outcome was greater in the baseline risk groups. The number of patients with elevated CRS in the intervention groups was approximately half the number of patients with elevated CRS in the control group. The difference was not a result of medication use. There was no difference between the group that received consultations after the screenings and the group that had health screenings alone.\n Health screenings reduced the CRS in the intervention groups. After 5 years of follow-up, the number of persons at elevated cardiovascular risk was about half that expected, based on the prevalence/proportion in a population not receiving the health checks (the control group). The impact of intervention was higher among at-risk individuals. Consultations about health did not appear to improve the cardiovascular profile of the study population.", "The aim of this study was to investigate the long-term effects of one general health screening on mortality.\n After stratification and randomization of a population of 450,000 inhabitants, two groups were formed, an intervention group of 3064 people and a control group of 29,122 people. From the National Cause of Death Register, data were collected as regards death and causes of deaths for 1970-1990.\n Multivariate analysis was used to correct for known confounders. We then found no differences between the groups regarding deaths from all causes, cardiovascular diseases, cancer or accidents and poisoning.\n One general health screening seems to have little, if any value in preventing fatal diseases.", "The Multiphasic Health Checkup Evaluation Study, a long-term clinical trial, has been completed. A study group of 5156 men and women age 35-54 at entry was urged to have annual multiphasic health checkups (MHCs) for 16 years. A control group of 5557 comparable subjects was not so urged but was followed up in a comparable fashion. The mean and median number of MHCs per person were 6.8 and 6, respectively, in the study group and 2.8 and 1, respectively, in the control group. During 16 years the study group experienced a 30% reduction (p less than 0.05) in deaths from pre-specified \"potentially postponable\" causes, largely associated with lower death rates from colorectal cancer and hypertension. This reduction was most pronounced in the early years of the study. The two groups did not differ to a statistically significant degree in mortality from all other causes (84% of total mortality) or in total mortality. There was no difference in self-reported disability in the overall groups. In the setting of our prepaid health care plan where MHCs were already available on a voluntary basis, a program of urging middle-aged persons to undergo regular MHCs brought about a substantial reduction in mortality from preselected diseases.", "All men born in even-numbered months in 1914 and domiciled in Malmö were invited in 1969 to participate in an investigation regarding risk factors for cardiovascular disease. Individuals with a blood pressure of 165/110 and over were treated and a sub-sample of heavy smokers were later invited to take part in a quit-smoking project. During the following five year period total and cause-specific mortality in the examined group was compared with corresponding data for men born in uneven months in 1914. Mortality in the examined cohort was lower than among controls and differed significantly from that in the control group with regard to cardiovascular mortality.", "In the Study of Men Born in 1913 it was possible to investigate the influence of repeated health examinations on mortality in a prospective cohort study. On January 1, 1963, 1010 men in the experimental group and 1956 in the control group were alive. The experimental group took part in repeated examinations in 1963, 1967, 1973 and 1980. Overt diseases were treated accordingly. Newly detected hypertension was also treated. By the end of a 15-year-long observation period, the cumulative mortality in the experimental group (14.5%) was not significantly lower than that in the control group (15.7%). In the experimental group, 855 took part. The mortality was significantly higher in the non-participating group. The autopsy frequency decreased for in-hospital deaths but increased for deaths outside hospital during the study period.", "In a randomised controlled trial a Frequently Asked Questions (FAQ) checklist intended to prepare coronary artery disease (CAD) outpatients for a medical check-up visit at the cardiologist was evaluated. The checklist was mailed to patients in preparation to their visits after 1, 4 and 10 months following patients' discharge from hospitalisation for CAD. It was hypothesised that the intervention would result in lower state anxiety, better patient-doctor communication, more knowledge of CAD and greater patient satisfaction, while it would not result in longer visits. Repeated measurements analyses of covariance showed that experimental patients (N = 46) were less anxious before the first visit. This visit was shorter than in the controls, though the third visit was longer. Control patients (N = 59) showed more CAD knowledge than experimental patients at the first and third visit. Experimental patients found the checklist useful, though its value diminished at subsequent visits. Using the checklist thus decreased anxiety prior to the first visit and the duration of that visit, while negatively affecting knowledge. No conclusions about long-term effects could be drawn, due to the likelihood of type II and type III errors. Process evaluation indicated that the approach used is not sufficiently stimulating for patients to use as a preparation to every visit.", "To assess the effectiveness of health checks by nurses in reducing risk factors for cardiovascular disease in patients from general practice.\n Randomised controlled trial.\n Five urban general practices in Bedfordshire.\n 2136 patients receiving an initial health check in 1989-91 and scheduled to be re-examined one year later in 1990-2 (intervention group); 3988 patients receiving an initial health check in 1990-2 (control group). All patients were aged 35-64 years at recruitment in 1989.\n Serum total cholesterol concentration, blood pressure, body mass index, confirmed smoking cessation.\n Mean serum total cholesterol was 2.3% lower in the intervention group than in the controls (difference 0.14 mmol/l (95% confidence interval 0.08 to 0.20)); the difference was greater in women (3.2%, P < 0.0001) than men (1.0%, P = 0.18). There was no significant difference in smoking prevalence, quit rates, or body mass index. Systolic and diastolic blood pressure were 2.5% and 2.4% lower respectively in the intervention group. The proportion of patients with diastolic blood pressure > or = 100 mm Hg was 2.6% (55/2131) in the intervention group and 3.4% (137/3987) in the controls (difference 0.9% (0.0 to 1.7)); the proportion with total cholesterol concentration > or = 8 mmol/l 4.8% (100/2068) and 7.6% (295/3905) (difference 2.7% (1.5 to 4.0)); and that with body mass index > or = 30 12.4% (264/2125) and 14.0% (559/3984) (difference 1.6% (-0.2 to 3.4)).\n General health checks by nurses are ineffective in helping smokers to stop smoking, but they help patients to modify their diet and total cholesterol concentration. The public health importance of this dietary change depends on whether it is sustained.", "To assess the effectiveness of a programme to coordinate and support follow up care in general practice after a hospital diagnosis of myocardial infarction or angina.\n Randomised controlled trial; stratified random allocation of practices to intervention and control groups.\n All 67 practices in Southampton and south west Hampshire, England.\n 597 adult patients (422 with myocardial infarction and 175 with a new diagnosis of angina) who were recruited during hospital admission or attendance at a chest pain clinic between April 1995 and September 1996.\n Programme to coordinate preventive care led by specialist liaison nurses which sought to improve communication between hospital and general practice and to encourage general practice nurses to provide structured follow up.\n Serum total cholesterol concentration, blood pressure, distance walked in 6 minutes, confirmed smoking cessation, and body mass index measured at 1 year follow up.\n Of 559 surviving patients at 1 year, 502 (90%) were followed up. There was no significant difference between the intervention and control groups in smoking (cotinine validated quit rate 19% v 20%), lipid concentrations (serum total cholesterol 5.80 v 5.93 mmol/l), blood pressure (diastolic pressure 84 v 85 mm Hg), or fitness (distance walked in 6 minutes 443 v 433 m). Body mass index was slightly lower in the intervention group (27.4 v 28.2; P=0.08).\n Although the programme was effective in promoting follow up in general practice, it did not improve health outcome. Simply coordinating and supporting existing NHS care is insufficient. Ischaemic heart disease is a chronic condition which requires the same systematic approach to secondary prevention applied in other chronic conditions such as diabetes mellitus.", "To investigate pretrial risk factors and long term mortality (1964-1992) in participants and non-participants of a multifactorial primary prevention trial.\n A prospective study among 3313 initially healthy businessmen. During the 1960s (1964 onwards), 3490 healthy male business executives born between 1919 and 1934 participated in voluntary health checks at the Institute of Occupational Health in Helsinki. From that period cardiovascular disease (CVD) risk factors were available in 3313 men. In the beginning of the 1970s these men were invited to join a multifactorial primary prevention trial of CVD. Six groups were formed: (I) healthy participants in a high risk intervention group (n = 612), and (II) their randomised control group (n = 610); (III) a non-participant low risk group (n = 593); (IV) an excluded group with signs of CVD (n = 563); (V) a refused group (n = 867); and (VI) dead (n = 68). Groups I and II participated in the five year prevention trial which started in 1974. Other groups were followed up through registers, with no personal contact.\n Cardiovascular risk factors during the 1960s. Mortality follow up using national registers up to 31 December, 1992.\n Baseline risk factors were lowest in the low risk group, highest in the excluded group, intermediate and comparable in other groups. Eighteen-year (1974-1992) mortality (per 1000) was 79.3, 106.6, 155.2, 179.9, and 259.3 in the low risk, control, intervention, refused, and excluded groups, respectively (P < 0.001). In the whole population of 3313 men, the 28-year (1964-1992) total (n = 577) and coronary deaths (n = 199) were significantly predicted by smoking, blood pressure, and cholesterol; cancer deaths (n = 163) by smoking only; and violent deaths (n = 83) by none of the risk factors. One-hour postload glucose was significantly associated with total mortality in the intervention group only. When the intervention and control groups were included in the same model, the effect of group on total mortality tended to be dependent on the 1 h blood glucose value (P = 0.06 for the group by 1 h glucose interaction term).\n The traditional risk factors (smoking, blood pressure, and cholesterol) are significantly associated with 28-year mortality in this high social class population with previous health education. Conversely, a \"clustering\" of low risk factors predicted low total, coronary, and cancer mortality. The findings on 1 h blood glucose suggest that factors related to glucose tolerance explain in part the excess mortality in the intervention group compared with the control group." ]

[ "14686958", "12513038", "16723306", "1516762", "7040192", "14770192", "16794994", "16259492", "15802410" ]

[ "Effect of hormone replacement therapy on cardiovascular risk factors in postmenopausal women with diabetes.", "Glycemic effects of postmenopausal hormone therapy: the Heart and Estrogen/progestin Replacement Study. A randomized, double-blind, placebo-controlled trial.", "Contraception in perimenopausal women with diabetes mellitus.", "Habitual physical activity, aerobic capacity and metabolic control in patients with newly-diagnosed type 2 (non-insulin-dependent) diabetes mellitus: effect of 1-year diet and exercise intervention.", "Oral contraception in diabetic women. A cross-over study on serum and high density lipoprotein (HDL) lipids and diabetes control during progestogen and combined estrogen/progestogen contraception.", "Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes.", "Changes in pattern of use, clinical characteristics and persistence rate of hormone replacement therapy among postmenopausal women after the WHI publication.", "Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial.", "Effect of a levonorgestrel intrauterine system on women with type 1 diabetes: a randomized trial." ]

[ "Hormone replacement therapy (HRT) in postmenopausal women improves menopausal symptoms, decreases the incidence of osteoporotic fracture, but the effects on cardiovascular risk factors remain controversial.\n To test the hypothesis that HRT may have beneficial effects on the cardiovascular risk profile in postmenopausal women with diabetes.\n One hundred and fifty postmenopausal patients with type 1 (T1DM) and type 2 diabetes (T2DM) were randomized to receive HRT (Kliofem) or placebo for 12 months. We monitored the effects on cardiovascular risk factors, including lipid profile, glycaemic control, blood pressure and body weight.\n Mean low-density lipoprotein (LDL) cholesterol was associated with a nonsignificant decrease [-0.14 mmol/l (CI=-0.44, 0.17) (p=0.37)] in the Kliofem-treated group. Total cholesterol fell by 0.42 mmol/l (CI=-0.78, -0.05) (p=0.027). High-density lipoprotein (HDL) cholesterol was reduced by a mean of 0.07 mmol/l compared to a mean rise of 0.12 mmol/l on placebo. There were apparent differences in the treatment effects between T1DM and T2DM. There was no change in triglycerides or apoprotein B and no effect on glycaemic control, blood pressure or menopausal symptom scores. In the Kliofem group, BMI fell by 0.66 kg/m2 compared to an increase of 0.14 kg/m2 for placebo patients (p=0.046).\n Although the long-term effects of HRT in women with or without diabetes appear to suggest that some types of HRT either confer no cardiovascular protection or may increase risk, the impact of Kliofem diabetic women on cardiovascular risk factors is probably neutral.", "Randomized trials of postmenopausal hormone therapy have found differing effects on fasting glucose levels. No trial has evaluated the effect of hormone therapy on diabetes incidence.\n To evaluate the effect of hormone therapy on fasting glucose level and incident diabetes.\n Randomized, double-blind, placebo-controlled trial.\n 20 U.S. clinical centers.\n 2763 postmenopausal women with coronary heart disease who were followed for 4.1 years. At baseline, 734 women had diabetes, 218 women had impaired fasting glucose, and 1811 women were normoglycemic; the 2029 women without diabetes were followed for incident diabetes.\n 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate daily, or placebo.\n Fasting glucose level was measured at baseline, at year 1, and at the end of the trial. Incident diabetes was defined by self-report of diabetes or disease complication, fasting glucose level of 6.9 mmol/L or greater (> or =126 mg/dL), or initiation of therapy with diabetes medication.\n Fasting glucose levels increased significantly among women assigned to placebo but did not change among women receiving hormone therapy. The incidence of diabetes was 6.2% in the hormone therapy group and 9.5% in the placebo group (relative hazard, 0.65 [95% CI, 0.48 to 0.89]; P = 0.006). The number needed to treat for benefit to prevent one case of diabetes was 30 (CI, 18 to 103). Changes in weight and waist circumference did not mediate this effect.\n In women with coronary disease, hormone therapy reduced the incidence of diabetes by 35%. This observation provides important insights into the metabolic effects of postmenopausal hormones but is insufficient to recommend the use of hormones for secondary prevention of heart disease.", "To assess the effect of combined oral contraceptives (COCs) and intrauterine devices (IUDs) on carbohydrate and lipid metabolism and hemostasis in perimenopausal diabetic women.\n The open randomized study included a total of 113 diabetic women using COCs with different estrogen/progestogen profiles - ethinylestradiol (EE) 20 microg/desogestrel 150 microg, EE 30 microg/desogestrel 150 microg and EE 30 microg/gestodene 75 microg - and levonorgestrel-releasing or copper IUDs. Average daily insulin requirements, levels of glycosylated hemoglobin, total cholesterol, triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol, the state of coagulation hemostatis and fibrinolytic activity were determined at baseline and after 3, 6, 9 and 12 months of contraception. The control group was composed of 40 age-matched diabetic women who did not use any methods of contraception.\n Neither COCs nor IUDs influenced glycosylated hemoglobin and had little or no influence on the elevation in the requirements for insulin preparations. The majority of the preparations did not exert any unfavorable effect on the blood lipid profile. Taking COCs was accompanied by increased intravascular activation of blood platelets and to a lesser degree by alterations in parameters of hemostatic homeostasis. The use of IUDs had a neutral effect on blood coagulation and fibrinolysis systems.\n Comparing lipid levels and hemostatic variables as a function of glycosylated hemoglobin level, we conclude that diabetes control has greater influence on these parameters than the type and dose of steroids involved in the contraceptive devices.", "The aim of this study was to assess the effects of a 1-year intensified diet and exercise education regimen on habitual physical activity and aerobic capacity in middle-aged, obese patients with newly-diagnosed Type 2 (non-insulin-dependent) diabetes mellitus. In addition, we analysed whether the level and the changes in physical activity and aerobic capacity are related to the metabolic control of diabetes. After a 3-month basic education programme, 78 patients (45 men, 33 women) were randomly placed in an intervention or conventionally treated group. The intervention group received intensified diet education and continuous encouragement to increase physical activity which was monitored using exercise records and questionnaires. Aerobic capacity was assessed by measuring oxygen uptake at anaerobic threshold and at peak exercise. The proportion of patients with regular recreational exercise increased from 24% to 38% in the intervention men (0.10 less than p less than 0.20), remained at 54% in the conventionally treated men, increased from 53% to 70% in the intervention women (0.10 less than p less than 0.20) and from 31% to 50% (0.10 less than p less than 0.20) in the conventionally treated women. No measurable improvement was found in oxygen uptake in any of the groups. When the groups were combined, HbA1c showed an inverse correlation with oxygen uptake at anaerobic threshold (r = 0.27, p less than 0.01) and maximum oxygen uptake (r = 0.28, p less than 0.01) at 12 months.(ABSTRACT TRUNCATED AT 250 WORDS)", "Twenty-three young women with insulin-dependent diabetes were randomly allocated to contraceptive treatment with either a progestogen only (Lynestrenol 0.5 mg) (LYN) or a combined oral contraceptive (OC) (ethinyl estradiol 50 micrograms + lynestrenol 2.5 micrograms) (EE + LYN). After six months treatment the medication was withdrawn for at least two months, after which the patients were placed on the other preparation. Diabetes control and serum and high density lipoprotein (HDL) lipids were assessed before and after 1, 3 and 6 months of treatment. Low-dose LYN administration did not alter the insulin requirement, blood glucose or body weight while the combined EE + LYN treatment increased the insulin requirement (p less than 0.01) without altering blood glucose or body weight. Low-dose LYN reduced serum triglycerides (p less than 0.001), serum cholesterol (p less than 0.001) and serum phospholipids (p less than 0.01) without affecting HDL lipids, while EE + LYN gave an inconsistent increase in serum triglycerides (p less than 0.01) but no change in HDL lipids. These findings confirm our earlier results and we conclude that EE + LYN influences diabetes control slightly more (although still not seriously) than the low-dose LYN. It is suggested that insulin-dependent diabetics (in contrast to non-diabetics) are more sensitive to the influence of 19-norprogestogens than to alkylated estrogens, with respect to lipid metabolism.", "We evaluated the effects of 12-month treatment with sibutramine 15 mg daily compared with placebo on health-related quality of life (HRQL) in obese type II diabetes patients. We examined the associations between the changes in HRQL and in weight, glycaemic control, and haemodynamic variables. We also explored the predictive value of HRQL and its changes early during treatment.\n A randomised clinical trial. The subjects were enrolled in a 2-week single-blind run-in period with a modestly hypocaloric diet (700 kcal daily deficit) and then randomised to receive either sibutramine 15 mg (n=114, 60% female) or placebo (n=122, 58% female) once daily with the hypocaloric diet for 12 months.\n Obese (mean BMI 36 kg/m(2) and age 54 y) type II diabetes patients untreated with antidiabetic medications.\n The main outcome measures included body weight and HRQL (the RAND 36-Item Health Survey 1.0).\n The mean weight loss was greater in the sibutramine group (-7.1 kg) than in the placebo group (-2.6 kg, P<0.001). The baseline HRQL was relatively high. There were no significant differences between the treatment groups in glycaemic control or in any of the RAND-36 scales during the study. The scores on physical functioning (PF) and health change (HC) since last year improved in both groups and this improvement was related to weight loss. When HRQL changes were examined in categories of weight loss, the scores on PF and HC increased with >/=5% weight loss, but the scores on vitality (V) and general health (GH) increased only after >/=15% weight loss. Decrease in HbA1c was associated with increases in the scores of PF, GH, V, mental health, and HC. In the sibutramine group, the increase in diastolic blood pressure was associated with the decrease in the scores of PF, physical role functioning, emotional role functioning (ERF), social functioning (SF), and bodily pain. High baseline scores on ERF and SF, and low scores on V predicted weight loss at 12 months. Also, increasing scores on PF and V during the first 3 months predicted weight loss at 12 months. The sum of four dichotomised HRQL variables (baseline ERF >/=75=1 and <75=0; baseline SF>/=80=1 and <80=0; 3-month change in PF>0=1 and </=0=0; 3-month change in V>0=1 and </=0=0) predicted weight loss: In the group with sum 0, the mean(s.d.) weight change at 12 months was 0.0(2.6)% and with sum 4 it was -9.0(8.1)% of baseline weight.\n Despite the superior weight loss, sibutramine 15 mg daily did not produce HRQL benefits over placebo when measured with the generic RAND-36 in obese type II diabetes patients. PF and HC since last year improved with >/=5% weight loss, but >/=15% weight loss was needed to achieve a cluster of HRQL improvements. The decrease in HbA1c was associated with many HRQL benefits. Poor baseline HRQL and the improvement observed in the first months of treatment may prove to be useful in predicting success in long-term weight loss.", "The WHI was stopped prematurely because of an increased risk of breast cancer, stroke and cardiovascular diseases (CVD) in the hormone replacement therapy (HRT) arm of the trial. Changes in the use of HRT are expected.\n To assess the impact of the Women's Health Initiative (WHI) publication on the rate of HRT prescription, and the clinical characteristics and persistence rate of new users and its determinants.\n From the RAMQ databases, the total numbers of HRT prescriptions, and of new HRT's users were calculated between 2 January 1998 and 31 May 2003. To assess the clinical characteristics of women, two retrospective cohorts of new HRT's users were constructed before (pre-WHI) and after (post-WHI) the WHI study publication. The persistence rate after 1 year of follow-up was estimated using a Kaplan-Meier analysis. Cox regression models were used to estimate the rate ratio of HRT cessation.\n The total numbers of HRT users and of new users declined respectively by 28% and 50% in post-WHI. The standard dosage of HRT was significantly less used, while the proportion of women with risk factors of CVD or at very high risk of coronary artery disease (CAD) did not change. The rate of persistence in the pre-WHI cohort was 59% compared to 45% in the post-WHI (p < 0.0001), and women with risk factors of CVD or at very high risk of CAD were less likely to cease their HRT.\n One year after publication, significant changes had already occurred in the trends of use, women's characteristics and estrogen dosage. No change in the proportion of new users with CVD risk factors or at very high risk of CAD was seen.\n Copyright (c) 2006 John Wiley & Sons, Ltd.", "The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes.\n The study used a randomized controlled trial (RCT) pretest/post-test design with repeated measures. Patients were randomly assigned to either a six-week intervention group or a six-week wait-listed control group. After completing the six sessions, patients were invited to participate in one of two follow-up conditions; attend a monthly support group or receive a monthly phone call from a nurse. Assessment measures included HbA1C, lipids, blood pressure, weight, self-management behavior and psychosocial adaptation.\n Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT. These gains were maintained or improved upon during the one-year follow-up period. For patients in the two follow-up conditions, a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values.\n We believe that results of this study can be attributed to volunteer bias, study effects (ie, providing study data on several occasions to patients and their physicians during the one-year study period), and impact of the interventions. However, the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period.", "Women with diabetes need safe, effective contraception. Although intrauterine devices provide superior contraception, concerns remain that progestin absorbed systemically from the levonorgestrel-releasing device may impair carbohydrate metabolism. To examine the effect of the levonorgestrel-releasing intrauterine system on glucose metabolism in diabetic women.\n We randomly assigned 62 women with uncomplicated insulin-dependent diabetes mellitus to either a levonorgestrel-releasing or a copper T 380A intrauterine device. The primary outcome to assess glucose metabolism was glycosylated hemoglobin; fasting serum-glucose levels and daily insulin dose requirements over 12 months of observation were examined as well.\n Outcome data were available for 29 women using the levonorgestrel-releasing and 30 using the copper device. At 12 months, mean glycosylated levels were similar for women of the 2 groups (6.3%, standard deviation [SD] +/- 1.5 compared with 6.3%, SD +/- 1.3, respectively). The same was true for mean fasting-serum glucose levels (7.4 mM, SD +/- 4.2 compared with 7.5 mM, SD +/- 4.2) and daily insulin doses (35.1 units, SD +/- 12.8 compared with 36.4 units, SD +/- 9.0). No important differences were noted at either 6 weeks or 6 months.\n The levonorgestrel-releasing device had no adverse effect on glucose metabolism, even at the 6-week observation when systemic levels of levonorgestrel would have been higher than at later observations. Concern about a potential adverse effect of this contraceptive on glucose control is unwarranted, and its use in women with diabetes should be liberalized.\n I." ]

[ "12612277", "23119911", "18179756", "17533178", "7862473", "6507997", "18595959", "20430451", "16550943" ]

[ "Frequency of surgery among children who have adenotonsillar hypertrophy and improve after treatment with nasal beclomethasone.", "Chronic adenoid hypertrophy in children - is steroid nasal spray beneficial?", "Intranasal flunisolide treatment in children with adenoidal hypertrophy.", "The role of mometasone furoate aqueous nasal spray in the treatment of adenoidal hypertrophy in the pediatric age group: preliminary results of a prospective, randomized study.", "Pediatric adenoidal hypertrophy and nasal airway obstruction: reduction with aqueous nasal beclomethasone.", "Effect of an intranasally administered corticosteroid (budesonide) on nasal obstruction, mouth breathing, and asthma.", "Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome.", "Medical treatment of adenoid hypertrophy with \"fluticasone propionate nasal drops\".", "Severe nasal polyposis and its impact on quality of life. The effect of a short course of oral steroids followed by long-term intranasal steroid treatment." ]

[ "To describe the long-term outcome of a cohort of children with symptomatic adenotonsillar hypertrophy treated with aqueous nasal beclomethasone.\n The children enrolled completed a 4-week single-blind, saline solution controlled crossover study of aqueous beclomethasone (total: 400 micro g/d). In a 24-week open-label follow-on study, beclomethasone 200 micro g/d was offered to all patients. During a 100-week follow-up, the degree of nasal obstruction and the frequency of adenotonsillectomy were assessed.\n Fifty-three children of the 60 enrolled completed the study. After the 4-week crossover trial, the severity of nasal obstruction of 24 children (45%) significantly decreased during the use of nasal steroids, but no child improved when saline solution was used. At 24, 52, and 100 weeks, the 24 children who had initially improved showed a significant decrease of the severity of nasal obstruction and of the frequency of adenotonsillectomy (54% vs 83%) compared with the 29 children who had not responded after the initial steroidal therapy.\n Evidence from this study suggests that 45% of children with adenoidal hypertrophy improved after 2 weeks of steroidal therapy. Among these children, an additional 24-week treatment at a lower steroid dosage was associated with a significant 52- and 100-week clinical improvement and with reduction of adenotonsillectomy compared with children (55%) who had not responded after the initial 2-week steroidal therapy.", "To the efficacy of naial btvlomethosone spry in the treatmrnl of chronic adenoid hypertrophy in children.\n .-1 randomized double-blind placebo-controlled study Setting: Tertiary academic referral center Patients: Aged 3-12 years diagnosed to have chronic nasal obstruction due to hypertrophied adenoids.\n Intranasal beclomethasone at the dose of 200 microgramslday to one group and placebo to the other group in matched dispensers for 8 weeks. Outcome measures: Reduction of symptoms due to hypertrophied adenoids and the size of enlarged adenoids. Variables were noted at the beginning and end of the study for symptoms score severity. X-ray and flexible nasal endoscopie findings.\n Analysis was done to find any significant improvement between the two groups. The Chisquare test was used to investigate the relationship between discrete variables. 26 children completed the study with 13 each in the drug and placebo group. There were 17 male and 9 female patients from 3 to 12 years of age. There was no significant difference in nasal obstruction, snoring or nasal discharge between the two groups. Comparison of x-rays and endoscopy also showed no significant difference between the 2 groups significant (P value =1.000 and P=0.0666 respectively).\n This study indicates that intranasal beclomelhasone therapy is not useful in treatment of ehronic adenoid hypertrophy in the general pediatrie population.", "Adenoidal hypertrophy (AH) represents one of the most frequent indications for surgery in children and it has been proposed that treatment with intranasal corticosteroids can decrease the size of AH. Therefore, the aim of the study is to evaluate the effect of the use of intranasal flunisolide among children affected by AH. 178 children with AH were evaluated in this randomised and controlled study. Inclusion criteria for the study required that each patient had to have a III or IV degree of AH on the initial endoscopic examination. Children were treated with intranasal flunisolide or isotonic saline solution for 8 weeks. After treatment, endoscopy was performed to re-evaluate AH degree. Flunisolide treatment was associated with significant (p less than 0.04) reduction of AH degree. There was moreover a consistent reduction of children (46 out of 58) proposed to adenoidectomy. No clinically important adverse events were reported. In conclusion, this preliminary study demonstrates that an 8-week treatment with intranasal flunisolide is significantly associated with reduction of AH, thus preventing the recurrence to adenoidectomy, and is safe.", "We evaluated the efficacy of mometasone furoate aqueous nasal spray in decreasing adenoid size and reducing the severity of chronic nasal obstruction symptoms in children affected by adenoidal hypertrophy.\n Sixty children were recruited in a 2-stage, randomized, placebo-controlled trial. All patients complained of chronic nasal obstruction symptoms, and nasal endoscopy showed >75% choanal obstruction attributable to adenoid pads. In the first stage, 30 patients (group A) underwent mometasone treatment (50 microg per nostril per day) for 40 days, and 30 children (group B) received placebo. In the second stage, at the end of the first 40-day treatment period, patients in group A who showed subjective and objective clinical improvement were divided into 2 subgroups; group A1 (11 children) received topical intranasal steroid treatment on alternate days for the first 2 weeks per month, whereas group A2 (10 children) continued daily mometasone treatment for the first 2 weeks per month. After 3 months, all children were reassessed.\n Fifty-seven children completed the study according to the protocol. After the first treatment period, the severity of symptoms and adenoid size decreased for 21 patients (77.7%) in group A. No improvement was observed in the placebo group. After 3 months of additional therapy, group A2 patients demonstrated a more-pronounced reduction in adenoid size compared with group A1 patients. No statistically significant change in symptoms was identified. Mometasone treatment was well tolerated by all patients.\n Mometasone furoate aqueous nasal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy. Children with adenoidal hypertrophy that is not associated with tonsillar hypertrophy should be considered for intranasal mometasone treatment before surgery is planned.", "Pediatric adenoidal obstruction of the nasal airway is associated with significant morbidity and is a frequent indication for surgery. Because efficacious medical alternatives to adenoidectomy are lacking, we assessed the potency of standard-dose topical nasal beclomethasone in reduction of adenoidal obstruction of the nasal airway.\n Seventeen children, 5 to 11 years of age, exhibiting chronic obstructive nasal symptoms and a group mean (+/- SE) adenoid/choana ratio of 91 +/- 1% on rhinoscopic examination, completed an 8-week, double-blind, placebo-controlled crossover study of standard-dose aqueous nasal beclomethasone (total 336 micrograms/day) in the treatment of adenoidal hypertrophy. In a 16-week, open-label, follow-on study, subjects received beclomethasone 1 spray in each nostril twice daily (168 micrograms/day).\n Over the initial 4 weeks, improvements in the mean adenoidal obstruction of the choanae were significantly greater in the group receiving beclomethasone than in the group receiving placebo (right, -14.0% vs. +0.4%, P = .0002) (left, -15.0% vs. -2.0%, P = .0006). In the subsequent crossover 4 weeks, a significant beclomethasone carryover effect resulted in further adenoid size reduction in both treatment groups. All patients demonstrated a decrease in adenoid size with beclomethasone treatment, compared with a mixed response to placebo. Over the full 8-week crossover study, the mean (+/- SE) obstructive symptom score after beclomethasone treatment (20.5 +/- 3.0) was significantly improved compared to patients' initial (43.1 +/- 2.9) and placebo scores (31.1 +/- 4.2, P < or = .05), despite the active drug carryover effect into the placebo treatment period. Significant improvements in adenoidal obstruction and symptom scores over the 8-week crossover study were enhanced in the subsequent 16-week open-label period (P = .0001). By 24 weeks, an 82% reduction in group mean nasal obstruction symptom score accompanied a 29% mean reduction in adenoid/choana ratio. No clinical or demographic characteristic predicted a patient's degree of response to treatment.\n Properly administered aqueous nasal beclomethasone in standard doses can significantly reduce adenoidal hypertrophy and nasal airway obstructive symptoms in children.", "The effect of intranasally administered corticosteroid (budesonide) on nasal symptoms, mode of respiration (nasal versus mouth breathing), and asthma was investigated in 37 asthmatic children who were mouth breathers because of chronic nasal obstruction. After a 2-wk run-in period, the children were allocated randomly to 4 wk of intranasal therapy with either budesonide (400 micrograms/day) or placebo spray. A double-blind, parallel design was used. Diaries for peak expiratory flow, asthma, and rhinitis symptom scores and degree of mouth breathing were recorded at home. Nasal eosinophilia, nasal airway resistance at a flow of 0.2 L/s (NAR0.2), and lung function at rest and after exercise challenge were assessed at the clinic immediately before and at end of the 4-wk treatment. Budesonide, when compared with placebo, significantly decreased nasal obstruction (p less than 0.05), secretion (p less than 0.01), and eosinophilia (p less than 0.02), as well as NAR0.2 (p less than 0.05) and mouth breathing (p less than 0.01). The improvement in nasal obstruction correlated closely to the changes in mouth breathing (r = 0.80, n = 17, p less than 0.001). Furthermore, intranasally administered budesonide resulted in less exercise-induced asthma (EIA) (p less than 0.02) and decreased cough and asthma severity significantly. Pulmonary mechanics were only marginally improved. The present study showed that intranasally administered budesonide is effective in the treatment of perennial allergic rhinitis. An attenuation of EIA and a tendency to less asthma after budesonide therapy suggest a decrease in bronchial reactivity, but the results gave no clear evidence of an association between nasal airway function and asthma.", "Intranasal corticosteroids have been advanced as a nonsurgical therapeutic alternative for pediatric obstructive sleep apnea syndrome, particularly for patients with mild disease, and aims at reducing the size of hypertrophic adenotonsillar tissue.\n Of 71 possible candidates, 62 children with polysomnographically diagnosed mild obstructive sleep apnea syndrome were recruited onto a double-blind, randomized, crossover trial of intranasal budesonide (32 microg per nostril at bedtime) or placebo for 6 weeks followed by an additional 6-week treatment in the alternative treatment arm after allowing for a 2-week washout period. Polysomnographic assessment and radiographs for assessment of adenoid size were performed after completion of each phase.\n There were significant improvements in both polysomnographic measures (sleep latency, slow-wave sleep, and rapid-eye-movement sleep), in the magnitude of respiratory disturbance (apnea/hypopnea index, nadir pulse oxygen saturation), and in adenoid size among the 48 children who completed the treatment phase compared with 32 children who received placebo in their initial arm, with normalization of sleep measures in 54.1% of the treated children. Furthermore, discontinuation of treatment for 8 weeks for 25 children revealed a sustained duration of the initial treatment effect.\n A 6-week treatment with intranasal budesonide effectively reduced the severity of mild obstructive sleep apnea syndrome and the magnitude of the underlying adenoidal hypertrophy, and this effect persisted for at least 8 weeks after cessation of therapy. These findings justify the use of topical steroids as the initial therapeutic option in otherwise healthy children with mild obstructive sleep apnea.", "Adenoid hypertrophy treatment for children is generally planned in accordance with the degree of airway obstruction and related morbidity. If surgical treatment is indicated, the individual risk/benefit analysis of patients should be assessed in terms of anesthetic and postoperative complications. Although there are few alternative treatment options, these may be considered as a nonsurgical approach in less serious cases. Accordingly, studies about intranasal steroid applications under various protocols have been presented.\n The prospective, randomized, placebo-controlled study.\n Tertiary referral center.\n Patients indicated for surgery were randomly divided into two groups. The study group was treated by fluticasone propionate nasal drops (NSD-nasal steroid drops) of 400 microg/day for 8 weeks. The control group was treated by normal saline (NS) in the same way. All the patients were called for follow-up every 4 weeks.\n At the end of 8 weeks, statistically significant improvement (p<0.05) was observed in the NSD treated group compared to the NS treated group in terms of nasal airway obstruction, mouth breathing, speech abnormalities, apnea and night cough. At the end of 8 weeks, the average total symptoms score of the NSD treated group dropped from 13.7 to 2.9 while the NS treated group's score changed from 14.8 to 14.6. After 8 weeks of NSD treatment the initial adenoid/choana (A/C) rate had dropped from 87 to 56% and a total decrease of 35.6% was observed. After 8 weeks of NS treatment the A/C rate dropped from 87 to 85% and a total decrease of 2.2% was observed.\n In this study, the effect of fluticasone propionate nasal drops on adenoid hypertrophy is examined for the first time. This method provides an effective alternative to surgical treatment in children with adenoid hypertrophy. With the protocol applied in this study 76% of the patients were eliminated the surgery and removed from the surgical waiting list.\n Copyright 2010 Elsevier Ireland Ltd. All rights reserved.", "Nasal polyposis is not a life-threatening disorder but has a great impact on the quality of life. Steroids constitute the first line of treatment of nasal polyps. The aims of this study were to evaluate the quality of life in nasal polyp patients after: (1) a short course of oral steroids; and (2) a long-term treatment with intranasal steroids.\n Patients with severe nasal polyps received either oral prednisone (n = 60) or no steroid treatment (control group, n = 18) for 2 weeks. Patients treated with steroids were also followed-up and evaluated after 12, 24, and 48 additional weeks with intranasal budesonide treatment.\n Patients with nasal polyps showed worse scores on all SF-36 domains, except for physical functioning, compared to the Spanish general population. After two weeks, patients treated with oral prednisone demonstrated a significant improvement (p < 0.05) in all impaired QoL domains compared to both control group and baseline. The mental component summary (51.0 +/- 1.2, p < 0.05) and physical component summary (51.0 +/- 0.9, p < 0.05) were improved compared to both control group and baseline. The improvement of all SF-36 domains was sustained by intranasal budesonida (p < 0.05) after 12, 24, and 48 weeks. Nasal obstruction, sense of smell, and polyp size also improved after both the oral short course and the intranasal long-term steroids treatment (p < 0.05).\n These results suggest that the treatment with a short-course of oral steroids improves the quality of life of patients with severe nasal polyps and that this effect is maintained by a long-term treatment with intranasal steroids." ]

[ "15321453", "10730733", "10992845", "9893537", "11454372", "9856707", "15321547", "10427382", "19481203" ]

[ "A randomised controlled trial of fluid pre-loading before low dose epidural analgesia for labour.", "Comparison of combined spinal-epidural and low dose epidural for labour analgesia.", "Randomized study of intravenous fluid preload before epidural analgesia during labour.", "Regional analgesia in early active labour: combined spinal epidural vs. epidural.", "Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial.", "A randomized study of combined spinal-epidural analgesia versus intravenous meperidine during labor: impact on cesarean delivery rate.", "Combined spinal epidural anaesthesia for caesarean section: a randomised comparison of Oxford, lateral and sitting positions.", "[Obstetric analgesia: peridural analgesia versus combined spinal and peridural analgesia].", "Adverse effects of combined spinal-epidural versus traditional epidural analgesia during labor." ]

[ "Preloading with fluid is recommended before regional block in labour. Low dose epidurals may produce less haemodynamic disturbance than traditional stronger solutions of local anaesthetics. Our aim was to compare the incidence of hypotension in normal labouring women who received a low dose epidural (0.1% bupivacaine 15 mL with fentanyl 2 microg microg.mL(-1)) with and without an i.v. crystalloid preload. Women with normal labours were randomised to the intervention group: no i.v. crystalloid preload (n = 85) and the control group: 7 mL mL.kg(-1) i.v. crystalloid solution before epidural injection (n = 83). Mean arterial pressure was recorded every 5 min for 30 min. There was no difference between the groups in mean decrease in mean arterial pressure and similar proportions of women showed falls in mean arterial pressure of 20% or greater (13% vs. 11%, risk ratio 1.2, 95% CI 0.54 to 2.8, P = 0.6). Blinded analysis by independent obstetricians revealed no differences in the fetal heart rate abnormalities (20% vs. 15%, risk ratio 1.3, 95% CI 0.67 to 2.7). A scientifically valid conclusion whether preloading is useful cannot be drawn from this study. This study suggests that about 350 participants in each group would be necessary to exclude a type 2 error in a future study.", "To compare the combined spinal-epidural (CSE) technique with the epidural technique with regard to time to initiate and manage, motor block, onset of analgesia and satisfaction during labour.\n Upon requesting analgesia, 50 healthy term parturients were randomized in a prospective, double-blind fashion to receive either CSE analgesia or lumbar epidural analgesia in the labour floor of a university hospital at an academic medical centre. The epidural group (n = 24) received bupivacaine 0.0625%-fentanyl 0.0002% with 0.05 ml in 10 ml local anesthetic sodium bicarbonate 8.4% and epinephrine 1:200,000. The CSE group (n = 26) received intrathecal 25 microg fentanyl and 2.5 mg bupivacaine. Additional analgesia was provided upon maternal request.\n There were no differences (P>0.05) in time to perform either technique, motor blockade, or parturient satisfaction or in the number of times that the anesthesiologist was called to perform any intervention. Although the first sign of analgesia was not different between the two groups, the onset of complete analgesia was more rapid with the CSE technique (Visual Analogue Pain Score (VAPS) at five minutes < three: 26/26 vs. 17/24, P+/-0.001).\n Although epidural analgesia with a low concentration of local anesthetic and opioid mixture takes longer to produce complete analgesia, it is a satisfactory alternative to CSE.", "We performed a randomized controlled trial of the effect of intravenous fluid preload on maternal hypotension and fetal heart rate (FHR) changes in labour after the first epidural injection. Group 1 (49 women) received 1 litre of crystalloid preload. Group 2 (46 women) received no preload. No statistically significant difference was shown between the two groups for either of the outcomes. Hypotension was found in three women in group 1 and five in group 2 (P = 0.4). Deterioration in FHR pattern was found in four women in group 1 and 11 in group 2 (P = 0.08). This study has not shown a significant increase in the incidence of hypotension when intravenous preload is omitted before epidural analgesia using a low concentration of bupivacaine during labour. Because of the clinical importance of the difference in the rate of FHR deterioration between the two groups, we continue to administer preload for high-risk cases.", "We randomly allocated 93 women in early active labour and requesting epidural analgesia to receive either epidural (n = 48) or combined spinal-epidural analgesia (n = 45). For epidural analgesia 15 ml of bupivacaine 0.1% with 75 micrograms of fentanyl were injected into the epidural space. For combined spinal-epidural analgesia 1 ml of bupivacaine 0.25% with 25 micrograms of fentanyl were injected into the subarachnoid space. For both groups subsequent top-ups of 10 ml of bupivacaine 0.1% with fentanyl 20 micrograms were given using a lightweight patient-controlled epidural analgesia (PCEA) pump with a lockout time of 30 min. We assessed analgesia and the degree of motor blockade and found no significant differences in pain or maternal satisfaction scores between the two groups. The time to first top-up was significantly longer in the epidural group than in the CSE group (p = 0.01). The combined spinal-epidural group had significantly greater motor blockade at 30 min than the epidural group (p = 0.01), but there was no difference after this. The PCEA machine failed completely twice and temporarily many times. We conclude that the combined spinal-epidural technique confers no advantages in early active labour. Also, a lightweight PCEA pump needs to be more reliable before we can recommend its use.", "Epidural analgesia is the most effective labour pain relief but is associated with increased rates of instrumental vaginal delivery and other effects, which might be related to the poor motor function associated with traditional epidural. New techniques that preserve motor function could reduce obstetric intervention. We did a randomised controlled trial to compare low-dose combined spinal epidural and low-dose infusion (mobile) techniques with traditional epidural technique.\n Between Feb 1, 1999, and April 30, 2000, we randomly assigned 1054 nulliparous women requesting epidural pain relief to traditional (n=353), low-dose combined spinal epidural (n=351), or low-dose infusion epidural (n=350). Primary outcome was mode of delivery, and secondary outcomes were progress of labour, efficacy of procedure, and effect on neonates. We obtained data during labour and interviewed women postnatally.\n The normal vaginal delivery rate was 35.1% in the traditional epidural group, 42.7% in the low-dose combined spinal group (odds ratio 1.38 [95% CI 1.01-1.89]; p=0.04); and 42.9% in the low-dose infusion group (1.39 [1.01-1.90]; p=0.04). These differences were accounted for by a reduction in instrumental vaginal delivery. Overall, 5 min APGAR scores of 7 or less were more frequent with low-dose technique. High-level resuscitation was more frequent in the low-dose infusion group.\n The use of low-dose epidural techniques for labour analgesia has benefits for delivery outcome. Continued routine use of traditional epidurals might not be justified.", "Combined spinal-epidural (CSE) analgesia produces rapid-onset pain relief and allows ambulation in early labor. Epidural local anesthetics may contribute to an increase in operative deliveries by decreasing perineal sensation and causing motor weakness. Operative delivery rates might be reduced with CSE, by avoiding or delaying administration of local anesthetics. This study compares the operative delivery rates associated with a CSE technique and those associated with intravenous meperidine for labor analgesia.\n Healthy parturients at full term were assigned randomly to receive CSE or intravenous meperidine analgesia. The CSE group received 10 microg intrathecal sufentanil, followed by epidural bupivacaine and fentanyl at their next request for analgesia. Parturients receiving intravenous meperidine had 50 mg on demand (maximum, 200 mg in 4 h). Labor and delivery outcomes in both groups were recorded and compared.\n An intent-to-treat analysis of 1,223 women indicated that CSE does not increase the rate of cesarean delivery for dystocia in nulliparous and parous women (CSE, 3.5% vs. intravenous meperidine, 4; P=not significant) or in nulliparous women alone (CSE, 7% vs. intravenous meperidine, 8%; P=not significant). Profound fetal bradycardia that necessitated emergency cesarean delivery within 1 h of the time the mother received sufentanil occurred in 8 of 400 parturients (compared with 0 of 352 who received meperidine; P < 0.01). However, the method of fetal monitoring differed between the two groups. Despite this, neonatal outcomes were similar overall.\n Combined spinal-epidural analgesia during labor does not increase the cesarean delivery rate for dystocia in healthy parturient patients at full term, regardless of parity. However, an unexpected increase in the number of cesarean deliveries for profound fetal bradycardia after intrathecal sufentanil was observed. Further investigation is warranted.", "Maternal position during induction of intrathecal anaesthesia for caesarean section influences block height and haemodynamic stability. In a randomised study of 90 women presenting for elective caesarean section using combined spinal-epidural anaesthesia, three positions were compared--the Oxford position (group O), the right lateral to supine wedged (group R) and the sitting to supine wedged (group S). Hyperbaric bupivacaine 12.5 mg with fentanyl 12.5 microg was injected intrathecally using a needle-through-needle CSE technique. Intravenous ephedrine 6 mg was given every minute that systolic blood pressure fell below 80% of baseline. Time required for block height to reach T5 as assessed by light touch, was similar in the three groups. There were no significant differences in blood pressure although ephedrine requirements were less in group R. There were no significant differences in the incidence of maternal nausea and vomiting or in neonatal outcome as assessed by Apgar scores and umbilical cord blood gas analysis. Although the study failed to show any significant differences in block height between the groups, no women in group O had a block above T2 compared with three in group R and three in group S.", "To compare the analgesic efficiency, side effects and obstetrical repercussions of epidural analgesia (EP) and combined spinal-epidural analgesia (CSE).\n Prospective, randomized, double or single-blind studies as required, approved by the ethical committee of the institution.\n The study included 80 parturients, in active labour with a singleton in vertex presentation and a cervical dilatation of 3 cm or less, randomly allocated to receive either EP (n = 40) or CSE (n = 40).\n In the EP group, sufentanil (20 micrograms) and 0.25% bupivacaine (6-8 mL) were injected into the epidural space. In those of the CSE group, sufentanil (10 micrograms) was first injected into the subarachnoid space, followed by an epidural injection of the same agents at the same quantities as for the EP group. Additional analgesia was obtained in both groups by top-ups of 6-8 mL of 0.25% bupivacaine at the request of the patients. Analgesia, course of labour, obstetrical outcome, and neonatal status were assessed. Statistical analysis was performed using Anova, chi 2 analysis, Yates' correction or Fisher's exact test, with a P < 0.05 considered as significant.\n Both groups had similar demographic and obstetric data. The onset of analgesia was more rapid in CSE group (8 +/- 11 min vs. 12 +/- 7 min, P < 0.05), however the duration was similar. Technical incidents were more frequent in the CSE group (30% vs. 7%, P < 0.05). The technique of analgesia did not influence the bupivacaine amounts required for its maintenance. The incidence of adverse effects were comparable with the exception of vertigo, which was more frequent in the EP group (57% vs. 28%, P < 0.05). The first stage of labour was increased by 30% in the CSE group (281 +/- 130 min vs. 216 +/- 97 min, P < 0.05), without significant prolongation of labour length. Durations of second stage and expulsion were similar in both groups, despite the administration of a lower dose of bupivacaine in the CSE group (33 +/- 17 mg vs. 46 +/- 12 mg, P < 0.05). The rates of instrumental deliveries and Caesarien sections were comparable. The Apgar scores were satisfactory at 5 min.\n In the early phase of labour, the CSE technique using intrathecal sufentanil has no significant benefit when compared to the EP technique using bupivacaine and sufentanil. In the CSE group, technical incidents were more frequent and the length of the first stage of labour was increased.", "To compare two neuraxial block techniques during labor for maternal and fetal effects.\n Women in labor at term with cephalic singleton fetuses were randomized (nonblinded) to receive either labor epidural (EPI) or combined spinal-epidural (CSE) analgesia. Primary outcome was prolonged deceleration (PD) of fetal heart rate. Outcomes also included hypotension, mode of delivery, and efficacy of analgesia by visual analog pain scale (VAPS) before and after block placement.\n Randomization occurred in 127 patients: 63 received EPI, 64 received CSE. There was no difference in the rate of PD in the EPI group compared with the CSE group (3.2% vs 6.2% respectively; P=0.43, RR 2.0; 95% CI 0.4-9.3), rate of cesarean delivery, or mean epidural duration. VAPS ratings were significantly lower in the CSE group.\n There were no differences in the rate of PD or other adverse outcomes. Hypotension occurred more frequently with CSE during labor at term. The study supports both EPI and CSE during labor as safe and effective techniques for neuraxial analgesia." ]

[ "2707458", "8299789", "12070543", "12413984", "16543255", "18505764", "2245833", "18321486", "17239866" ]

[ "Unexplained infertility: evaluation of treatment with clomiphene citrate and human chorionic gonadotropin.", "Evaluation of clomiphene citrate and human chorionic gonadotropin treatment: a prospective, randomized, crossover study during intrauterine insemination cycles.", "The effect of metformin plus clomiphene citrate on ovulation and pregnancy rates in clomiphene-resistant women with polycystic ovary syndrome.", "Use of dexamethasone and clomiphene citrate in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome and normal dehydroepiandrosterone sulfate levels: a prospective, double-blind, placebo-controlled trial.", "Clomiphene citrate and dexamethazone in treatment of clomiphene citrate-resistant polycystic ovary syndrome: a prospective placebo-controlled study.", "Extended-release metformin does not reduce the clomiphene citrate dose required to induce ovulation in polycystic ovary syndrome.", "A randomized, controlled trial of clomiphene citrate and intrauterine insemination in couples with unexplained infertility or surgically corrected endometriosis.", "Comparison of clomiphene citrate, metformin, or the combination of both for first-line ovulation induction, achievement of pregnancy, and live birth in Asian women with polycystic ovary syndrome: a randomized controlled trial.", "hCG administration offers no outcome benefit over spontaneous ovulation in anovulatory women treated with clomiphene citrate." ]

[ "A double-blind, randomized, prospective therapeutic trial was conducted in 148 couples with unexplained infertility. Treatment consisted of 4 consecutive months of placebo or clomiphene citrate (CC) (100 mg) by mouth on cycle days 5 to 9, and placebo or human chorionic gonadotropin (hCG) (5,000 IU) intramuscularly on cycle days 19, 22, 25, and 28. There were 14 pregnancies during the trial and 39 pregnancies during observation before and after the trial. Placebo treatment resulted in no pregnancies over 4 months. Clomiphene citrate was significantly better than placebo (P less than 0.04), with a pregnancy rate of 19% over the course of 4 months. The pregnancy rate with hCG either alone (11%) or in combination with CC (7.6%), was not significantly better than placebo. Treatment-independent pregnancies, defined as those before treatment (but after enrollment), or more than 1 month after therapy, occurred in 16% of the couples, with a mean time to conception of 8.8 months. As part of their follow-up, 39 of the study couples subsequently underwent in vitro fertilization (IVF), and 43% were found to have a previously unrecognized male factor or fertilization defect. A pregnancy rate of 16% was achieved after a mean of 1.1 cycles in these 39 couples. The authors conclude that CC is useful in treating unexplained infertility and is a reasonable initial therapy. For couples who fail to conceive, IVF may be diagnostic as well as therapeutic.", "To test the hypothesis that in couples undergoing IUI, actively managed cycles using clomiphene citrate (CC) stimulation, ultrasound monitoring, and hCG timing will result in increased pregnancy rate (PR) per cycle compared with unstimulated urinary LH-timed cycles.\n Fifty-six couples with unexplained infertility (n = 26) or male factor infertility (n = 30) participated in the study.\n Tertiary academic medical center.\n Prospective, randomized, crossover. Couples were randomized initially to one of the two study groups (treatment A: LH-timed IUI; treatment B: CC-stimulated, hCG-timed IUI). If no pregnancy occurred, each couple alternated between the two regimens during subsequent cycles, up to a total of four cycles.\n Twenty-nine couples completed the study and the analysis of 95 cycles revealed that among the male factor infertility group, one pregnancy occurred during the 26 cycles of each treatment group (PR per cycle of 3.9% for both treatment groups). In contrast, among the unexplained infertility group, there was a marked difference in the effect of treatments. During treatment A only one pregnancy occurred in 20 cycles (PR of 5% per cycle) whereas during treatment B, six pregnancies occurred in 23 cycles (PR of 26.1% per cycle).\n If IUI is chosen as the treatment modality in unexplained infertility, the addition of active ovulation management that includes CC stimulation, ultrasound monitoring of folliculogenesis, and hCG timing of ovulation increases the PR per cycle. In couples with male infertility, PR per cycle is low and is apparently not affected by the addition of active ovulation management.", "To study the effect of metformin in combination with clomiphene citrate, as compared with placebo plus clomiphene citrate, on the ovulation and pregnancy rates in clomiphene citrate-resistant women with polycystic ovary syndrome.\n This study was carried out at King Hussein Medical Center, Amman, Jordan, during the period January 2001 through to July 2001. Twenty-eight clomiphene citrate-resistant polycystic ovary syndrome women were evaluated prospectively for 6 treatment cycles by receiving metformin, 850mg twice daily throughout the cycle along with 50 mg clomiphene citrate, starting on day 5-9 of the same cycle (N=16), or by taking placebo with clomiphene citrate (N=12). During cycles 2-6, clomiphene citrate was added with increments of 50mg (up to 200 mg/day) for both groups. Progesterone level on day 21 and 28 >5ng/dl was indicative of ovulation.\n A statistically significant increase in the rates of ovulation (68.6% versus 25%, p<0.05) and pregnancy (56.3% versus 16.6%, p<0.05) were observed in the metformin-clomiphene citrate group as compared with the placebo-clomiphene citrate controls. Insignificant increase in the rate of ovarian hyperstimulation was noted in the placebo-clomiphene citrate group.\n Metformin-clomiphene citrate regimen in resistant-clomiphene citrate polycystic ovary syndrome women significantly increases the ovulation and pregnancy rates, and decreases the occurrence of ovarian hyperstimulation syndrome.", "To evaluate the effects of short-course administration of dexamethasone (DEX) combined with clomiphene citrate (CC) in CC-resistant patients with polycystic ovary syndrome (PCOS) and normal DHEAS levels.\n Prospective, double-blind, placebo-controlled, randomized study.\n Referral university hospitals.\n Two hundred thirty women with PCOS and normal DHEAS who failed to ovulate after a routine protocol of CC.\n The treatment group received 200 mg of CC from day 5 to day 9 and 2 mg of DEX from day 5 to day 14 of the menstrual cycle. The control group received the same protocol of CC combined with placebo.\n Follicular development, hormonal status, ovulation rate, pregnancy rate.\n Mean follicular diameters were 18.4124 +/- 2.4314 mm and 13.8585 +/- 2.0722 mm for the treatment and control groups, respectively. Eighty-eight percent of the treatment group and 20% of the control group had evidence of ovulation. The difference in the cumulative pregnancy rate in the treatment and control groups was statistically significant.\n Hormonal levels, follicular development, and cumulative pregnancy rates improved with the addition of DEX to CC in CC-resistant patients with PCOS and normal DHEAS. This regimen is recommended before any gonadotropin therapy or surgical intervention.", "The aim of this work was to evaluate the efficacy of adding dexamethazone (DEX) (high dose, short course) to clomiphene citrate (CC) in CC-resistant polycystic ovary syndrome (PCOS) with normal dehydroepiandrosterone sulphate (DHEAS) in induction of ovulation.\n Eighty infertile women with CC-resistant PCOS were randomly assigned into two groups. Group I: Clomiphene citrate 100 mg/day was given from day 3 to day 7 of the cycle and DEX 2 mg/day from day 3 to day 12 of the cycle. Group II: Same protocol of CC combined with placebo (folic acid tablets) was given from day 3 to day 12 of the cycle. The main outcome was ovulation. Secondary measures included number of follicles >18 mm endometrial thickness and pregnancy rate. Ovarian follicular response was monitored by transvaginal ultrasound. HCG 10,000 U was given when at least one follicle measured 18 mm, and timed intercourse was advised.\n There were no statistically significant differences between groups as regards age, duration of infertility, BMI, waist-hip ratio (WHR), menstrual pattern, hirsutism, serum DHEAS or day of HCG administration. The mean number of follicles>18 mm at the time of HCG administration and the mean endometrial thickness were significantly higher in the DEX group than in the placebo group (P<0.05). Similarly, there were significantly higher rates of ovulation (75 versus 15%) (P<0.001) and pregnancy (40 versus 5%) (P<0.05) in the DEX group. Dexamethazone was very well tolerated as no patients complained of any side effect. There was a significant difference between the responders and non-responders in the presence of oligomenorrhea, amenorrhea or hirsutism.\n Induction of ovulation by adding DEX (high dose, short course) to CC in CC-resistant PCOS with normal DHEAS is associated with no adverse anti-estrogenic effect on the endometrium and higher ovulation and pregnancy rates in a significant number of patients. Induction with DEX appears to be independent on age, period of infertility, BMI or WHR.", "When used for ovulation induction, higher doses of clomiphene may lead to antiestrogenic side effects that reduce fecundity. It has been suggested that metformin in combination with clomiphene can restore ovulation to some clomiphene-resistant anovulators with polycystic ovary syndrome (PCOS).\n Our objective was to determine if cotreatment with extended-release metformin (metformin XR) can lower the threshold dose of clomiphene needed to induce ovulation in women with PCOS.\n A secondary analysis of data from the National Institute of Child Health and Human Development Cooperative Multicenter Reproductive Medicine Network prospective, double-blind, placebo-controlled multicenter clinical trial, Pregnancy in Polycystic Ovary Syndrome, was performed.\n Study volunteers at multiple academic medical centers were included.\n Women with PCOS and elevated serum testosterone who were randomized to clomiphene alone or with metformin (n = 209 in each group) were included in the study.\n Clomiphene citrate, 50 mg daily for 5 d, was increased to 100 and 150 mg in subsequent cycles if ovulation was not achieved; half also received metformin XR, 1000 mg twice daily. Treatment was for up to 30 wk or six cycles, or until first pregnancy.\n Ovulation was confirmed by a serum progesterone more than or equal to 5 ng/ml, drawn prospectively every 1-2 wk.\n The overall prevalence of at least one ovulation after clomiphene was 75 and 83% (P = 0.04) for the clomiphene-only and clomiphene plus metformin groups, respectively. Using available data from 314 ovulators, the frequency distribution of the lowest clomiphene dose (50, 100, or 150 mg daily) resulting in ovulation was indistinguishable between the two treatment groups.\n Metformin XR does not reduce the lowest dose of clomiphene that induces ovulation in women with PCOS.", "This study was initiated to test the hypothesis that treatment with clomiphene citrate (CC) and intrauterine insemination (IUI) results in increased fecundity when compared with periovulatory intercourse in couples with either unexplained infertility or surgically corrected endometriosis. Sixty-seven couples entered a randomized, prospective trial comparing CC/IUI with observation. During the study, there were 14 pregnancies in 148 treated cycles (fecundity = 0.095) compared with 5 pregnancies in 150 untreated cycles (fecundity = 0.033). Using life-table analysis and the log-rank test, the difference in fecundities was statistically significant. Pregnancy outcome was not significantly different between the two groups. When comparing conception with nonconception cycles during treatment, no differences between the size of the lead follicle or the number of dominant follicles was detected. We conclude that treatment with CC/IUI improves fecundity in couples with unexplained infertility or surgically corrected endometriosis.", "To determine the first-line medication to be used in anovulatory patients with polycystic ovary syndrome (PCOS) for ovulation induction and pregnancy achievement.\n Randomized controlled trial.\n Infertility unit of a public hospital.\n One hundred fifteen newly diagnosed patients with PCOS based on ESHRE/ASRM criteria.\n These patients were assigned to three groups: group 1 (38 patients) received 500 mg of metformin three times a day; group 2 (39 patients) received clomiphene citrate (CC) at an incremental dose; group 3 (38 patients) received both medications.\n Rates of ovulation, pregnancy (PR), and live birth.\n The ovulation rate was 23.7% in the metformin group, 59% in the CC group, and 68.4% in the combination treatment group. This was translated into a similar PR and live birth rate, which were higher in the CC and combination groups compared to the metformin group (PR: 7.9%, 15.4%, and 21.1%; live birth rate: 7.9%, 15.4%, and 18.4% in metformin, CC, and combination treatment groups, respectively), although statistically the differences were not significant. There were no multiple pregnancies and the rate of spontaneous first trimester loss was similar to the general population.\n Clomiphene citrate should be the first-line treatment for ovulation induction in anovulatory patients with PCOS.", "This randomized controlled trial compared spontaneous ovulation versus hCG-triggered ovulation in anovulatory women treated with clomiphene citrate. No statistically significant differences were observed between the two groups in terms of ovulation and pregnancy rates." ]

[ "12694632", "15108041", "11730399", "15190995", "15066200", "19366977", "9746022", "11490051", "16084254" ]

[ "Randomised controlled trial of a theoretically grounded tailored intervention to diffuse evidence-based public health practice [ISRCTN23257060].", "Randomized controlled trial of the efficacy of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil and uracil/tegafur.", "Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses.", "A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia.", "An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475].", "Customized feedback to patients and providers failed to improve safety or quality of diabetes care: a randomized trial.", "Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?", "Randomized clinical trial of a quality improvement intervention in nursing homes.", "Combination antibiotic susceptibility testing to treat exacerbations of cystic fibrosis associated with multiresistant bacteria: a randomised, double-blind, controlled clinical trial." ]

[ "Previous studies have shown that Norwegian public health physicians do not systematically and explicitly use scientific evidence in their practice. They work in an environment that does not encourage the integration of this information in decision-making. In this study we investigate whether a theoretically grounded tailored intervention to diffuse evidence-based public health practice increases the physicians' use of research information.\n 148 self-selected public health physicians were randomised to an intervention group (n = 73) and a control group (n = 75). The intervention group received a multifaceted intervention while the control group received a letter declaring that they had access to library services. Baseline assessments before the intervention and post-testing immediately at the end of a 1.5-year intervention period were conducted. The intervention was theoretically based and consisted of a workshop in evidence-based public health, a newsletter, access to a specially designed information service, to relevant databases, and to an electronic discussion list. The main outcome measure was behaviour as measured by the use of research in different documents.\n The intervention did not demonstrate any evidence of effects on the objective behaviour outcomes. We found, however, a statistical significant difference between the two groups for both knowledge scores: Mean difference of 0.4 (95% CI: 0.2-0.6) in the score for knowledge about EBM-resources and mean difference of 0.2 (95% CI: 0.0-0.3) in the score for conceptual knowledge of importance for critical appraisal. There were no statistical significant differences in attitude-, self-efficacy-, decision-to-adopt- or job-satisfaction scales. There were no significant differences in Cochrane library searching after controlling for baseline values and characteristics.\n Though demonstrating effect on knowledge the study failed to provide support for the hypothesis that a theory-based multifaceted intervention targeted at identified barriers will change professional behaviour.", "We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT).\n Patients with stage II, III, or IV (Dukes' B, C) colorectal cancer were enrolled and randomly assigned to one of three groups: an immunochemotherapy group (mitomycin C [MMC] + 5-fluorouracil [5-FU] + HCFU + OK-432), a chemotherapy group (MMC + 5-FU + HCFU), and a control group (surgery alone) for those with colon cancer (study 1); and an immunochemotherapy group (MMC + 5-FU + UFT + OK-432), a chemotherapy group (MMC + 5-FU + UFT), and a control group (surgery alone) for those with rectal cancer (study 2).\n A total of 760 patients with colon cancer and 669 patients with rectal cancer were entered into this randomized clinical trial (RCT). The incidence of side-effects was in the order of: immunochemotherapy group > chemotherapy group > control group in both the cohort of patients with colon cancer and the cohort with rectal cancer. In particular, the frequency of leucopenia and skin disorders was significantly higher than control groups. There were no severe adverse events such as death related to the adjuvant therapy. In both the colon cancer and rectal cancer cohorts, no significant difference in the 5-year survival rate and disease-free survival rate was noted among the three groups.\n The results of an RCT demonstrated that the combination of MMC + 5-FU + HCFU + OK-432 for colon cancer and that of MMC + 5-FU + UFT + OK-432 for rectal cancer could not prolong the survival of patients with surgically resected colorectal cancer, but that both combinations were well tolerated as adjuvant therapy. We investigated the efficacy and safety of adjuvant immunochemotherapy and adjuvant chemotherapy for colorectal cancer, using different combinations of the intracutaneous streptococcal preparation OK-432 and the oral pyrimidines 1-hexylcarbamoyl-5-fluorouracil (carmofur, HCFU) and uracil/tegafur (UFT).", "To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses.\n Meta-analyses of randomized trials that included at least one large trial (>/=1000 participants) were included, regardless of the therapeutic area. Eligible meta-analyses were identified through electronic searches and bibliographies of relevant articles.\n Full-length randomized trials.\n Methodologic quality was assessed according to reported randomization, double blinding, and follow-up as separate components and by using the Jadad composite scale.\n Fourteen meta-analyses involving 190 randomized trials from eight therapeutic areas were included. Compared with large trials, intervention effects were exaggerated in small trials with inadequate allocation sequence generation (ratio of odds ratios, 0.46 [95% CI, 0.25 to 0.83]; P = 0.011), inadequate allocation concealment (ratio of odds ratios, 0.49 [CI, 0.27 to 0.86]; P = 0.014), and no double blinding (ratio of odds ratios, 0.52 [CI, 0.28 to 0.96]; P = 0.01). Large trials did not differ significantly from small trials with adequate generation of the allocation sequence, adequate allocation concealment, or adequate double blinding. No association was seen between reported follow-up and intervention effects. The Jadad scale provided no additional information because the scale and the quality components overlapped substantially.\n Inadequate generation of the allocation sequence, allocation concealment, and double blinding lead to exaggerated estimates of intervention benefit and may contribute to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses.", "To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.\n A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n = 36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p = .014), but not for the other groups.\n Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.", "The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting.\n Twenty facilities took part in a randomized controlled trial with a seven month follow-up period. Two outreach visits were delivered by a pharmacist. At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates, psychotropic drug prescribing and stroke risk reduction practices (BP monitoring, aspirin and warfarin use) for the facility relevant to the physician. The effect of the interventions was determined via pre- and post-intervention case note audit. Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications. Chi-square tests, independent samples t-test, and logistic regression were used in the analysis.\n Data were available from case notes at baseline (n = 897) and seven months follow-up (n = 902), 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits. Pre-and post-intervention data were available for 715 participants. There were no differences between the intervention and control groups for the three month fall rate. We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention. The exception was significantly greater use of \"as required\" antipsychotics in the intervention group compared with the control group after the pharmacy intervention (RR = 4.95; 95%CI 1.69-14.50). There was no statistically significant difference between groups for the numbers of patients \"at risk of stroke\" on aspirin at follow-up.\n While the strategy was well received by the physicians involved, there was no change in prescribing patterns. Patient care in residential settings is complex and involves contributions from the patient's physician, family and residential care staff. The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained.", "To assess whether providing customized clinical information to patients and physicians improves safety or quality of diabetes care.\n Study subjects included 123 primary care physicians and 3,703 eligible adult diabetic patients with elevated A1C or LDL cholesterol, who were randomly assigned to receive customized feedback of clinical information as follows: 1) patient only, 2) physician only, 3) both the patient and physician, or 4) neither patient nor physician. In the intervention groups, patients received customized mailed information or physicians received printed, prioritized lists of patients with recommended clinical actions and performance feedback. Hierarchical models were used to accommodate group random assignment.\n Study interventions did not improve A1C test ordering (P = 0.35) and negatively affected LDL cholesterol test ordering (P < 0.001) in the 12 months postintervention. Interventions had no effect on LDL cholesterol values (P = 0.64), which improved in all groups over time. Interventions had a borderline unfavorable effect on A1C values among those with baseline A1C >or=7% (P = 0.10) and an unfavorable effect on A1C values among those with baseline A1C >or=8% (P < 0.01). Interventions did not reduce risky prescribing events or increase treatment intensification. Time to next visit was longer in all intervention groups compared with that for the control group (P < 0.05).\n Providing customized decision support to physicians and/or patients did not improve quality or safety of diabetes care and worsened A1C control in patients with baseline A1C >or=8%. Future researchers should consider providing point-of-care decision support with redesign of office systems and/or incentives to increase appropriate actions in response to decision-support information.", "Few meta-analyses of randomised trials assess the quality of the studies included. Yet there is increasing evidence that trial quality can affect estimates of intervention efficacy. We investigated whether different methods of quality assessment provide different estimates of intervention efficacy evaluated in randomised controlled trials (RCTs).\n We randomly selected 11 meta-analyses that involved 127 RCTs on the efficacy of interventions used for circulatory and digestive diseases, mental health, and pregnancy and childbirth. We replicated all the meta-analyses using published data from the primary studies. The quality of reporting of all 127 clinical trials was assessed by means of component and scale approaches. To explore the effects of quality on the quantitative results, we examined the effects of different methods of incorporating quality scores (sensitivity analysis and quality weights) on the results of the meta-analyses.\n The quality of trials was low. Masked assessments provided significantly higher scores than unmasked assessments (mean 2.74 [SD 1.10] vs 2.55 [1.20]). Low-quality trials (score < or = 2), compared with high-quality trials (score > 2), were associated with an increased estimate of benefit of 34% (ratio of odds ratios [ROR] 0.66 [95% CI 0.52-0.83]). Trials that used inadequate allocation concealment, compared with those that used adequate methods, were also associated with an increased estimate of benefit (37%; ROR=0.63 [0.45-0.88]). The average treatment benefit was 39% (odds ratio [OR] 0.61 [0.57-0.65]) for all trials, 52% (OR 0.48 [0.43-0.54]) for low-quality trials, and 29% (OR 0.71 [0.65-0.77]) for high-quality trials. Use of all the trial scores as quality weights reduced the effects to 35% (OR 0.65 [0.59-0.71]) and resulted in the least statistical heterogeneity.\n Studies of low methodological quality in which the estimate of quality is incorporated into the meta-analyses can alter the interpretation of the benefit of intervention, whether a scale or component approach is used in the assessment of trial quality.", "The purpose of the study was to determine if simply providing nursing facilities with comparative quality performance information and education about quality improvement would improve clinical practices and subsequently improve resident outcomes, or if a stronger intervention, expert clinical consultation with nursing facility staff, is needed.\n Nursing facilities (n = 113) were randomly assigned to one of three groups: workshop and feedback reports only, workshop and feedback reports with clinical consultation, and control. Minimum Data Set (MDS) Quality Indicator (QI) feedback reports were prepared and sent quarterly to each facility in intervention groups for a year. Clinical consultation by a gerontological clinical nurse specialist (GCNS) was offered to those in the second group.\n With the exception of MDS QI 27 (little or no activity), no significant differences in resident assessment measures were detected between the groups of facilities. However, outcomes of residents in nursing homes that actually took advantage of the clinical consultation of the GCNS demonstrated trends in improvements in QIs measuring falls, behavioral symptoms, little or no activity, and pressure ulcers (overall and for low-risk residents).\n Simply providing comparative performance feedback is not enough to improve resident outcomes. It appears that only those nursing homes that sought the additional intensive support of the GCNS were able to effect enough change in clinical practice to improve resident outcomes significantly.", "We did a randomised, double-blind, controlled clinical trial to prospectively assess whether use of combination antibiotic susceptibility testing improved clinical outcomes in patients with acute pulmonary exacerbations of cystic fibrosis who were infected with multiresistant bacteria.\n 251 patients with cystic fibrosis who were chronically infected with multiresistant gram negative bacteria gave sputum at 3-month intervals for conventional culture and sensitivity tests and for combination antibiotic susceptibility tests using multiple combination bactericidal antibiotic testing (MCBT). Patients who developed an exacerbation of pulmonary disease were randomised to receive a 14-day course of any two blinded intravenous antibiotics chosen on the basis of either results from conventional sputum culture and sensitivity testing or the result of MCBT. The primary outcome was time from randomisation until the patient's next pulmonary exacerbation. Analysis was by intention-to-treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN60187870.\n 132 patients had a pulmonary exacerbation and were randomised during the 4.5-year study period. The time to next pulmonary exacerbation was not prolonged in the MCBT-treated group (hazard ratio 0.86 in favour of the conventionally-treated group, 95% CI 0.60-1.23, p=0.40). There was no difference between the groups in treatment failure rate. After 14 days of intravenous antibiotic therapy, changes in lung function, dyspnoea, and sputum bacterial density were similar in both groups.\n Antibiotic therapy directed by combination antibiotic susceptibility testing did not result in better clinical and bacteriological outcomes compared with therapy directed by standard culture and sensitivity techniques. The non-bactericidal effects of antibiotic therapy might play an important part in determining improvement in patients with cystic fibrosis pulmonary exacerbations." ]

[ "320856", "1556523", "11248360", "14672612", "1580295", "15541406", "2446877", "9627740", "8601552" ]

[ "Quantitative evaluation of vitamin E in the treatment of angina pectoris.", "EDTA treatment of intermittent claudication--a double-blind, placebo-controlled study.", "Vitamin E as treatment for chronic hepatitis B: results of a randomized controlled pilot trial.", "A randomized placebo controlled trial of vitamin E for alcoholic hepatitis.", "Vitamin E in the treatment of chemotherapy-induced mucositis.", "Effectiveness and acceptability of vitamin E and low-dose aspirin, alone or in combination, on Norplant-induced prolonged bleeding.", "Clinical effects of intravenous iloprost in patients with intermittent claudication.", "Long-term treatment effects of vitamin E for tardive dyskinesia.", "A double-blind placebo-controlled study of vitamin E treatment of tardive dyskinesia." ]

[ "Because of previous reports of the beneficial effect of vitamin E in angina pectoris patients, 48 patients, with both stable angina and positive (chest pain plus ishemic ST depression) maximal exercise treadmill tests, participated in a double-blind cross-over study of 6 months of vitamin E and 6 months of placebo therapy, separated by a 2 month no treatment period. All 48 patients had positive selective coronary arteriograms (75 per cent obstruction of at least a major coronary artery) and/or Q wave ECG evidence of previous myocardial infarction (Minnesota criteria). Evaluation of drug effectiveness was based on performance of serial maximal exercise treadmill tests, serial systolic time interval measurements, and daily angina diaries. No statistically significant differences between the two treatment studied. It is concluded that a large dose of vitamin E (1,600 I.U. of d-alpha-tocopherol succinate daily) for 6 months in patients with stable angina pectoris fails to increase the exercise capacity, improve left ventricular function, or reduce the frequency of chest pain.", "A double-blind, randomized multicentre study was undertaken to evaluate the possible effect of chelation treatment with ethylenediamine-tetraacetic acid (EDTA) in patients with severe intermittent claudication. A total of 153 patients received 20 intravenous infusions of either 3 g Na2EDTA or placebo during a period of 5-9 weeks. Vitamin, mineral and trace element supplements were administered orally. The changes observed in the pain-free and maximal walking distances, measured on a treadmill, were similar in the two groups. During the 3-month (n = 149) and 6-month (n = 123) follow-up period, no long-term therapeutic effect of EDTA could be demonstrated. The ankle-brachial blood pressure index remained unchanged throughout the study period. This study failed to demonstrate any effect of EDTA chelation treatment in intermittent claudication.", "Interferon-alpha treatment has been the treatment of choice for chronic hepatitis with unpredictable results. Recently, Lamivudine has been licensed for use against HBV infection with good results. Unfortunately, recurrence of viremia after lamivudine withdrawal is common and prolonged treatment can induce the emergence of resistant mutant strains. It has been shown that vitamin E can increase the host immune response, and this may provide protection against infectious diseases.\n We evaluated vitamin E supplementation as therapy for chronic hepatitis B in a pilot study including 32 patients. Patients were randomly allocated to receive vitamin E at the dose of 300 mg twice daily for 3 months (15 patients) or no treatment (17 patients). They were seen monthly during the first 3 months and thereafter quarterly for additional 12 months.\n The two groups were comparable at enrollment. At the end of the study period, alanine aminotransferase (ALT) normalization was observed in 7 (47%) patients in vitamin E group and only in 1 (6%) of the controls (P=0.011); HBV-DNA negativization was observed in 8 (53%) patients in the vitamin E group as compared to 3 (18%) in the control group, respectively (P=0.039). A complete response (normal ALT and negative HBV-DNA) was obtained in 7 (47%) patients taking vitamin E and in none of the controls (P=0.0019).\n Vitamin E supplementation might be effective in the treatment of chronic hepatitis B.", "The effect of vitamin E administration on clinical and laboratory parameters of liver function and on markers of fibrogenesis was assessed in patients with mild to moderate alcoholic hepatitis in a double blind placebo controlled randomized trial.\n Twenty-five patients received 1000 I.U. of vitamin E per day, while 26 patients received placebo for 3 months. The patients were followed for 1 year after entry into the trial.\n Vitamin E did not result in significant greater decreases in serum aminotransferases and serum bilirubin or in greater increases in serum albumin as compared with placebo. Prothrombin time did not change, while serum creatinine remained in the normal range. Monocyte nuclear nuclear factor-kappa B binding activity decreased in patients who remained abstinent, regardless of whether they received vitamin E. As regards markers of hepatic fibrogenesis, vitamin E treatment decreased serum hyaluronic acid (P<0.05) while serum aminoterminal peptide of type III procollagen did not change in either group. Four patients in the treatment group and five in the placebo group died during the 1-year study.\n Vitamin E treatment improves serum hyaluronic acid but has no beneficial effects on tests of liver function in patients with mild to moderate alcoholic hepatitis.", "To determine the efficacy of vitamin E in the treatment of chemotherapy-induced mucositis in patients with malignancy.\n A randomized, double-blind, placebo-controlled study was performed to evaluate the efficacy of topical vitamin E in the treatment of oral mucositis in patients receiving chemotherapy for various types of malignancy. A total of 18 patients, 17 of whom had solid tumors and one with acute leukemia, were included in this study. Lesions were observed daily prior to and 5 days after topical application of either vitamin E or placebo oil.\n Six of nine patients receiving vitamin E had complete resolution of their oral lesions. In eight of nine patients who received placebo, complete resolution of their oral lesions was not observed. This difference is statistically significant (p = 0.025 by Fisher's exact test). No toxicity was observed in this study.\n These results suggest that vitamin E may be an effective therapy in patients with chemotherapy-induced mucositis.", "A study (ISRCTN 77665712) was undertaken to test the effectiveness and the acceptability of vitamin E and low-dose aspirin, alone or in combination, as treatment for prolonged vaginal bleeding induced by Norplant. A total of 486 Norplant users who were requesting treatment for bleeding lasting longer than 7 days were enrolled in five centers: Beijing, China; Jakarta, Indonesia; Santiago, Chile; Santo Domingo, Dominican Republic; and Tunis, Tunisia. They were randomized to one of four different 10-day oral treatments: 200 mg vitamin E daily, 80 mg aspirin daily, both or a placebo. Treatment packs were designed to ensure blinding of both the subjects and the clinical staff. Neither vitamin E nor low-dose aspirin nor their combination was found to have any effect on reducing the length of the bleeding episode for which treatment was taken or on the vaginal bleeding patterns these women experienced during the year of follow-up.", "In a randomized patient-blind study iloprost or hydroxy-ethyl starch 200/0.5 were given i.v. 5 h daily for 2 weeks to 24 patients suffering from severe intermittent claudication due to peripheral vascular disease. An increase in pain-free walking distance of more than 50% occurred in 6 of 11 patients after the iloprost infusions and in 7 of 12 patients after HES treatment. No significant effects on haemodynamic or clinical chemistry tests were observed.", "Several studies have found that alpha-tocopherol (vitamin E) can effectively treat tardive dyskinesia (TD). A limitation of these trials is their short treatment durations (maximum of 12 weeks), which do not allow us to address the effects of long-term treatment.\n To participate, patients had to have TD and be on stable oral medications. The study enrolled 40 patients who received up to 36 weeks of treatment with d-vitamin E (1600 IU per day) or placebo.\n Using the Abnormal Involuntary Movements Scale (AIMS) score (sum of items #1-7) to measure TD severity, the study found a significant difference (3 points) in mean AIMS scores, in favor of vitamin E, starting at 10 weeks of treatment and continuing through the full 36 weeks. We used linear mixed-effects regression to quantify the impact of several covariates, and found that treatment assignment. TD duration, and chlorpromazine equivalents had significant effects on decreasing the AIMS score.\n The study's finding that vitamin E is effective in treating TD agrees with results from prior studies and provides evidence that the effect may extend to treatment of up to 36 weeks. These findings are in direct contrast to those of VA Cooperative Study #394, a much larger, long-term, multi-site study, conducted by many of the same investigators, in which Vitamin E was not superior to placebo.", "This study was designed to determine if vitamin E is effective in reducing the severity of abnormal movements in patients with tardive dyskinesia (TD).\n Thirty-five patients completed a double-blind placebo-controlled parallel-group study of vitamin E. Seventeen of the patients were randomly assigned to receive 800 IU b.i.d. of vitamin E and 18 were assigned to placebo for 2 months. Twenty-nine patients had a diagnosis of schizophrenia and 6 of mood disorder. Patients were assessed using modified versions of the Abnormal Involuntary Movement Scale (mAIMS), Simpson-Angus Scale for extrapyramidal side effects, and Brief Psychiatric Rating Scale. Additionally, a subgroup of 23 patients were assessed using instrumental measurements of dyskinesia.\n There was a significant reduction of dyskinesia in the vitamin E group, but not the placebo group, on both the mAIMS and the instrumental assessments. The overall reduction in mAIMS in the active group was 24%, with 5 (29%) of 17 patients demonstrating greater than 33% reduction in score. There was a greater reduction in mean mAIMS score (35%) with vitamin E in the subgroup of patients with TD for 5 years or less compared with the reduction (11%) in patients with TD for greater than 5 years. No change was observed in parkinsonism. In the patients with schizophrenia, there was a reduction in positive symptoms after vitamin E.\n Vitamin E appears to be effective in reducing the severity of TD, especially in patients who have had TD for 5 years or less." ]

[ "8229541", "11871742", "1403448", "15629973", "18216861", "9351723", "16843936", "21463215", "18829790" ]

[ "Gastrointestinal tolerance, fat absorption, plasma ketone and urinary dicarboxylic acid levels in low-birth-weight infants fed different amounts of medium-chain triglycerides in formula.", "Short-term efficacy of enteral nutrition in the treatment of active Crohn's disease: a randomized, controlled trial comparing nutrient formulas.", "Comparison of two preterm formulas with or without addition of medium-chain triglycerides (MCTs). I: Effects on nitrogen and fat balance and body composition changes.", "Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants.", "The early use of minimal enteral nutrition in extremely low birth weight newborns.", "A prospective, randomized trial of early enteral feeding after resection of upper gastrointestinal malignancy.", "Long-chain triglycerides reduce the efficacy of enteral feeds in patients with active Crohn's disease.", "The impact of oral glutamine supplementation on the intestinal permeability and incidence of necrotizing enterocolitis/septicemia in premature neonates.", "Oral probiotics prevent necrotizing enterocolitis in very low birth weight preterm infants: a multicenter, randomized, controlled trial." ]

[ "This study was conducted to evaluate the effect of medium-chain triglycerides (MCT) in a formula for low-birth-weight (LBW) infants on gastrointestinal tolerance, fat absorption, plasma ketone levels, and urinary dicarboxylic acid (DCA) excretion. At the start of enteral feedings, 64 LBW infants (< or = 1500 g) were randomly assigned to one of four experimental formulas. The formulas contained either 0, 17, 34, or 50% of the total fat as MCT oil. The nonfat constituents of all four formulas were the same and identical to Similac Special Care 24 (SCF). Infants were studied from the start of enteral feeding until approximately 7 days after reaching full feeds. Growth and tolerance were assessed in all infants over the entire feeding period. A 48-h balance study was conducted after enteral intake exceeded 100 kcal/kg/day for 3 days. Stool fat, plasma D-(-)-3-hydroxybutyrate (3HB) and carnitine, serum glucose, and urinary DCA levels were determined. Groups did not differ in growth, formula intake, fat absorption (76-84%), serum glucose, or plasma carnitine levels. Gastrointestinal tolerance was excellent and did not differ among groups. Plasma 3HB was significantly different (p < 0.05) only between the 0 and 50% MCT groups, 50 +/- 10 versus 120 +/- 20 microM, respectively. The excretion of urinary DCAs increased with increasing amounts of MCT in the formula. In conclusion, fat absorption and gastrointestinal tolerance were not affected by different MCT levels (0 to 50% of the total fat), but higher levels of plasma 3HB and urinary DCAs were associated with higher levels of MCT in the LBW formulas studied.", "The optimal dietary fat content to induce clinical remission in active Crohn's disease has been the subject of controversy. We therefore performed a prospective, randomized, controlled study to compare the effects of nutrient formulas differing in the amount of medium-chain triglycerides (MCT).\n Thirty-six patients with active Crohn's disease whose Crohn's disease activity index (CDAI) was > or =150 were included in the study. A formula with 3.4 g of fat per 2000-kcal dose was used as the nutrient formula with a low-fat content (ED group), and a formula with 55.6 g of fat per 2000-kcal dose was used as the nutrient formula with a high amount of MCT (TL group).\n The rate of short-term remission induction at 6 weeks was 67% in the ED group and 72% in the TL group (p = NS). Therapy markedly reduced the high CDAI and van Hees activity index in both groups, with no significant difference in the pattern of the time-course changes. C-reactive protein levels, erythrocyte sedimentation rate, and low serum albumin and plasma prealbumin levels normalized over the course of therapy, with no significant difference between the 2 groups. The assessment of fatty acid fractions revealed that the triene/tetraene ratio began to increase at 2 weeks in the ED group. The serum levels of linoleic acid, an omega-6 fatty acid, almost always varied within the normal range during the treatment period in the TL group, but in the ED group, levels began to decrease significantly at 2 weeks. The levels of linolenic acid, an omega-3 fatty acid, decreased in both groups.\n Both nutrient formulas induced clinical remission in about two-thirds of patients. The results of the present study suggest that it is not necessary to restrict the amount of MCT when given in liquid form to patients with active Crohn's disease.", "Medium-chain triglycerides (MCTs) are included in the fat blend of several preterm formulas because of their complete absorption and rapid oxidation. The effects of two different fat blend compositions on nitrogen and fat balances and macronutrient oxidation were investigated in 28 healthy very-low-birth weight infants at 4 weeks of age. A preterm formula with a traditional corn oil/MCT blend containing 38% MCTs (MCT group) was compared to a new fat blend, designed to resemble human milk more, containing 6% MCTs (LCT group). There were no differences in nitrogen absorption or in excretion. Median nitrogen retention was 74% (MCT) vs. 71% (LCT) of intake. Fat absorption was higher (p less than 0.05) in the MCT group (88%) vs. 79% in the LCT group (median values). MCTs did not stimulate fat oxidation as measured by indirect calorimetry, so fat deposition was also higher on the MCT formula. As weight gain was not different between groups, the percentage of weight gain consisting of fat accretion was significantly (p less than 0.005) higher with the MCT formula (24% vs. 21%). On the other hand, there was no increase in percent protein accretion (both 15% of weight gain). We conclude that the existence of a slightly lower fat absorption in the healthy growing neonate fed a LCT formula compared with a MCT formula does not impair growth or nitrogen retention, but merely induces a slight decrease in the high relative fat accretion encountered in the preterm neonate.", "We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.\n A prospective, masked, randomized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW (<1500 g) infants. VLBW infants who started to fed enterally and survived beyond the seventh day after birth were eligible for the trial. They were randomized into 2 groups after parental informed consents were obtained. The infants in the study group were fed with Infloran (Lactobacillus acidophilus and Bifidobacterium infantis) with breast milk twice daily until discharged. Infants in the control group were fed with breast milk alone. The clinicians caring for the infants were blinded to the group assignment. The primary outcome was death or NEC (>or= stage 2).\n Three hundred sixty-seven infants were enrolled: 180 in the study group and 187 in the control group. The demographic and clinical variables were similar in both groups. The incidence of death or NEC (>or= stage 2) was significantly lower in the study group (9 of 180 vs 24 of 187). The incidence of NEC (>or= stage 2) was also significantly lower in the study when compared with the control group (2 of 180 vs 10 of 187). There were 6 cases of severe NEC (Bell stage 3) in the control group and none in the study group. None of the positive blood culture grew Lactobacillus or Bifidobacterium species.\n Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants.", "To gather information regarding the efficacy of early minimal enteral nutrition on overall feeding tolerance in extremely low birth weight infants.\n Prospective randomized controlled trial comparing the early use of minimal enteral nutrition in extremely low birth weight infants from day 2 to day 7 vs control infants. On day 8, feeding volume in both groups were advanced by 10 ml kg(-1) day(-1) until full enteral feedings were reached. Time to full feeds, number of intolerance episodes, anthropometric measurements, peak total bilirubin levels, incidence of necrotizing enterocolitis and incidence of sepsis were compared between the two groups with t-test and chi (2) test.\n Eighty-four infants were enrolled in the study but only 61 infants completed the feeding protocol. No statistically significant differences were found between the groups with regards to growth patterns, feeding tolerance, mortality, length of hospital stay and incidence of sepsis and necrotizing enterocolitis.\n Early minimal enteral nutrition use in extremely low birth weight infants did not improve feeding tolerance.", "The purpose of the study was to determine whether early postoperative enteral feeding with an immune-enhancing formula (IEF) decreases morbidity, mortality, and length of hospital stay in patients with upper gastrointestinal (GI) cancer.\n Early enteral feeding with an IEF has been associated with improved outcome in trauma and critical care patients. Evaluable data documenting reduced complications after major upper GI surgery for malignancy with early enteral feeding are limited.\n Between March 1994 and August 1996, 195 patients with a preoperative diagnosis of esophageal (n = 23), gastric (n = 75), peripancreatic (n = 86), or bile duct (n = 11) cancer underwent resection and were randomized to IEF via jejunostomy tube or control (CNTL). Tube feedings were supplemented with arginine, RNA, and omega-3 fatty acids, begun on postoperative 1, and advanced to a goal of 25 kcal/kg per day. The CNTL involved intravenous crystalloid solutions. Statistical analysis was by t test, chi square, or logistic regression.\n Patient demographics, nutritional status, and operative factors were similar between the groups. Caloric intake was 61% and 22% of goal for the IEF and CNTL groups, respectively. The IEF group received significantly more protein, carbohydrate, lipids and immune-enhancing nutrients than did the CNTL group. There were no significant differences in the number of minor, major, or infectious wound complications between the groups. There was one bowel necrosis associated with IEF requiring reoperation. Hospital mortality was 2.5% and median length of hospital stay was 11 days, which was not different between the groups.\n Early enteral feeding with an IEF was not beneficial and should not be used in a routine fashion after surgery for upper GI malignancies.", "Elemental diets are effective treatments for active Crohn's disease. To determine which dietary constituents are of therapeutic importance, the effectiveness of four separate feeds was related to their compositions, and the findings substantiated by meta-analysis of previous dietary studies. 76 patients with active Crohn's disease were recruited. 17 were randomised to an amino acid-based elemental diet (E028), 22 to E028 with added long-chain triglyceride (E028 LCT), 18 to a semi-elemental, peptide based diet (Pepdite 2+) and 19 received E028 with added medium-chain triglyceride (E028 MCT). Disease activity fell in all groups and remission rate was negatively correlated with the amount of energy derived from LCT (r = -0.97, p = 0.016). Inflammatory indices fell in the groups (E028 + E028 MCT) containing least LCT. No other dietary constituents correlated with remission rate. A meta-analysis of published studies confirmed a negative correlation between remission rate and LCT (r = -0.63, p = 0.006) but not other constituents. The association between dietary LCT and remission rate may have pathogenic significance and allow the development of more effective enteral feeds.", "To examine the impact of oral glutamine (Gln) supplementation on gut integrity and on the incidence of necrotizing enterocolitis (NEC)/septicemia of premature neonates.\n Preterm neonates (n = 101, gestational age <34 weeks, birth weight <2000 g) were randomly allocated to receive from day 3 to day 30 postpartum, either oral Gln (0.3 g/kg/day, n = 51-Gln group) or placebo (caloreen-isocaloric, n = 50-control group). Intestinal permeability was determined from the urinary lactulose/mannitol recovery (L/M ratio) following their oral administration and assessed at three time points: day 2 (before first administration), day 7 and day 30 of life. The incidence of NEC and septicemia over the study period was also recorded.\n A decrease of lactulose recovery at days 7 (p = 0.001) and 30 (p < 0.001) and a decrease of L/M ratio at day 7 (p = 0.002) were observed only in the Gln group. Lactulose recovery and L/M ratio at day 7 (p = 0.022 and p = 0.004, respectively), as well as lactulose recovery (p = 0.001), mannitol recovery (p = 0.042), and L/M ratio (p = 0.001) at day 30, were decreased in the Gln group as compared to controls. NEC and septicemia were lower in the Gln group at the end of the first week (p = 0.009 and p = 0.041, respectively) and up to the end of the study (p < 0.001 and p = 0.048, respectively).\n Oral Gln administration may have beneficial effects on intestinal integrity and the overall incidence of NEC/septicemia in preterm infants.", "The goal was to investigate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis for very low birth weight preterm infants.\n A prospective, blinded, randomized, multicenter controlled trial was conducted at 7 NICUs in Taiwan, to evaluate the beneficial effects of probiotics in necrotizing enterocolitis among very low birth weight infants (birth weight: <1500 g). Very low birth weight infants who survived to start enteral feeding were eligible and were assigned randomly to 2 groups after parental informed consent was obtained. Infants in the study group were given Bifidobacterium bifidum and Lactobacillus acidophilus, added to breast milk or mixed feeding (breast milk and formula), twice daily for 6 weeks. Infants in the control group were fed with breast milk or mixed feeding. The clinicians caring for the infants were blinded to the group assignment. The primary outcome measurement was death or necrotizing enterocolitis (Bell's stage >or=2).\n Four hundred thirty-four infants were enrolled, 217 in the study group and 217 in the control group. The incidence of death or necrotizing enterocolitis (stage >or=2) was significantly lower in the study group (4 of 217 infants vs 20 of 217 infants). The incidence of necrotizing enterocolitis (stage >or=2) was lower in the study group, compared with the control group (4 of 217 infants vs 14 of 217 infants). No adverse effect, such as sepsis, flatulence, or diarrhea, was noted.\n Probiotics, in the form of Bifidobacterium and Lactobacillus, fed enterally to very low birth weight preterm infants for 6 weeks reduced the incidence of death or necrotizing enterocolitis." ]

[ "22624531", "22738085", "16790652", "18542921", "21857015", "9503219", "11331169", "6190466", "17054812" ]

[ "Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study.", "Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.", "The value of an albumin-based intravascular volume replacement strategy in elderly patients undergoing major abdominal surgery.", "A pilot randomized study comparing high and low volume hemofiltration on vasopressor use in septic shock.", "Resuscitation with hydroxyethyl starch improves renal function and lactate clearance in penetrating trauma in a randomized controlled study: the FIRST trial (Fluids in Resuscitation of Severe Trauma).", "Volume therapy in the critically ill: is there a difference?", "Hydroxyethyl starch (HES) does not directly affect renal function in patients with no prior renal impairment.", "Efficacy of hetastarch in the resuscitation of patients with multisystem trauma and shock.", "A total balanced volume replacement strategy using a new balanced hydoxyethyl starch preparation (6% HES 130/0.42) in patients undergoing major abdominal surgery." ]

[ "ABSTRACT: INTRODUCTION: Inadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients. METHODS: In order to compare the hemodynamic efficacy and safety of 6% HES 130/0.4 and NaCl 0.9% for HDS in patients with severe sepsis, we designed a prospective, multicenter, active-controlled, double-blind, randomized study in intensive care units. RESULTS: 174 out of 196 patients reached HDS (88 and 86 patients for HES and NaCl, respectively). Significantly less HES was used to reach HDS vs. NaCl (1,379 ±886 ml in the HES group and 1,709 ±1,164 ml in the NaCl group (mean difference = -331± 1,033, 95% CI -640 to -21, P = 0.0185). Time to reach HDS was 11.8 10.1 hours vs. 14.3 ±11.1 hours for HES and NaCl, respectively. Total quantity of study drug infused over four consecutive days, ICU and hospital LOS, and area under the curve of SOFA score were comparable. Acute renal failure occurred in 24 (24.5%) and 19 (20%) patients for HES and NaCl, respectively (P = 0.454). There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality, coagulation, or pruritus up to 90 days after treatment initiation. CONCLUSION: Significantly less volume was required to achieve HDS for HES vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups. CLINICALTRIALS.GOV: NCT00464204.", "Hydroxyethyl starch (HES) [corrected] is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis.\n In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization.\n Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P=0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P=0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline.\n Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.).", "The value of human albumin (HA) for treating hypovolemia is controversial. Less expensive alternatives such as hydroxyethyl starch (HES) are sometimes refused because of unwanted side effects. We prospectively randomized 50 patients older than 70 years old undergoing major abdominal surgery to receive either 5% HA (n = 25) or a third generation HES preparation (6% HES 130/0.4; n = 25) when mean arterial blood pressure was <60 mm Hg and central venous pressure was <10 mm Hg. Hemodynamics, inflammation (interleukin-6), endothelial activation-integrity (adhesion molecules), coagulation (thrombelastography), and renal function (including kidney-specific proteins) were monitored after the induction of anesthesia, after surgery, 5 h in the intensive care unit, and on the first postoperative day. HA patients received 3960 +/- 590 mL of HA and 5070 +/- 1030 mL of Ringer's lactate solution, and HES patients received 3500 +/- 530 mL of HES and 4550 +/- 880 mL of Ringer's lactate solution. Total protein remained normal only in the HA-treated patients. No significant differences (P > 0.1) between the groups were seen with regard to hemodynamics, coagulation, and kidney function. Plasma levels of interleukin-6 and soluble adhesion molecules were significantly (P < 0.05) higher in the HA- than in the HES-treated patients. We conclude that HA in elderly patients undergoing major abdominal surgery can easily be replaced by a modern HES preparation. Because of the decreased inflammatory response and endothelial activation-injury, HES 130/0.4 seems to be the more appropriate fluid strategy for these patients.", "High volume hemofiltration (HVHF) has shown potential benefits in septic animals and a few reports suggested a hemodynamic improvement in humans. However, randomized studies are still lacking. Our goal was to evaluate the hemodynamic effects of HVHF in septic shock patients with acute renal failure (ARF).\n Prospective randomized study in an intensive care unit (ICU).\n Twenty patients with septic shock and ARF.\n Patients were randomized to either high volume hemofiltration [HVHF 65 ml/(kg h)] or low volume hemofiltration [LVHF 35 ml/(kg h). Vasopressor dose was adjusted to reach a mean arterial pressure (MAP) > 65 mmHg.\n We performed six hourly measurements of MAP, norepinephrine dose, PaO(2)/FiO(2) and lactate, and four daily urine output and logistic organ dysfunction (LOD) score. Baseline characteristics of the two groups were comparable on randomization. Mean norepinephrine dose decreased more rapidly after 24 h of HVHF treatment compared to LVHF treatment (P = 0.004) whereas lactate and PaO(2)/FiO(2) did not differ between the two treatment groups. During the 4-day follow-up, urine output was slightly increased in the HVHF group (P = 0.059) but the LOD score evolution was not different. Duration of mechanical ventilation, renal replacement therapy and ICU length of stay were also comparable. Survival on day 28 was not affected.\n HVHF decreased vasopressor requirement and tended to increase urine output in septic shock patients with renal failure. However, a larger trial is required to confirm our results and perhaps to show a benefit in survival.", "The role of fluids in trauma resuscitation is controversial. We compared resuscitation with 0.9% saline vs hydroxyethyl starch, HES 130/0.4, in severe trauma with respect to resuscitation, fluid volume, gastrointestinal recovery, renal function, and blood product requirements.\n Randomized, controlled, double-blind study of severely injured patients requiring >3 litres of fluid resuscitation. Blunt and penetrating trauma were randomized separately. Patients were followed up for 30 days.\n A total of 115 patients were randomized; of which, 109 were studied. For patients with penetrating trauma (n=67), the mean (sd) fluid requirements were 5.1 (2.7) litres in the HES group and 7.4 (4.3) litres in the saline group (P<0.001). In blunt trauma (n=42), there was no difference in study fluid requirements, but the HES group required significantly more blood products [packed red blood cell volumes 2943 (1628) vs 1473 (1071) ml, P=0.005] and was more severely injured than the saline group (median injury severity score 29.5 vs 18; P=0.01). Haemodynamic data were similar, but, in the penetrating group, plasma lactate concentrations were lower over the first 4 h (P=0.029) and on day 1 with HES than with saline [2.1 (1.4) vs 3.2 (2.2) mmol litre⁻¹; P=0.017]. There was no difference between any groups in time to recovery of bowel function or mortality. In penetrating trauma, renal injury occurred more frequently in the saline group than the HES group (16% vs 0%; P=0.018). In penetrating trauma, maximum sequential organ function scores were lower with HES than with saline (median 2.4 vs 4.5, P=0.012). No differences were seen in safety measures in the blunt trauma patients.\n In penetrating trauma, HES provided significantly better lactate clearance and less renal injury than saline. No firm conclusions could be drawn for blunt trauma. Study registration: ISRCTN 42061860.", "There are still several concerns about the extensive and prolonged use of hydroxyethylstarch solution (HES) in critically ill patients. The effects of volume replacement with HES over 5 days on hemodynamics, laboratory data, and organ function were compared with volume therapy using human albumin (HA).\n Prospective, randomized study.\n Clinical investigations on a surgical intensive care unit (ICU) of a university hospital.\n 150 traumatized patients (injury severity score > 15) and 150 postoperative patients with sepsis were analyzed.\n Either 10% low-molecular weight HES (HES-trauma, n = 75; HES-sepsis, n = 75) or 20% HA (HA-trauma, n = 75; HA-sepsis, n = 75) was given for 5 days to maintain the pulmonary capillary wedge pressure (PCWP) between 12 and 15 torr. The entire management of therapy of the patients was performed by physicians who were not involved in the study and blinded to the infusion regimen.\n In addition to extensive cardiorespiratory monitoring, several routine laboratory parameters for assessing pulmonary, renal, hepatic, and coagulation function were analyzed from arterial blood samples on the day of admission to the ICU and on the day of sepsis diagnosis, respectively (\"baseline\" value) and daily over the following 5 days. Mortality during and after the study did not differ significantly between the infusion groups. There were also no differences between the incidence of pulmonary, renal, or hepatic failure in the two subgroups. Mean arterial pressure, heart rate, and PCWP were similar in both subgroups, whereas cardiac index, oxygen delivery index, oxygen consumption index, and the ratio between the partial pressure of oxygen in arterial blood and fractional inspired oxygen were higher in the HES- than in the HA-treated groups. Standard coagulation parameters did not differ, albumin concentration increased significantly in both HA groups, and lactate concentrations decreased only in the HES-sepsis patients (from 2.8 +/- 0.5 to 1.5 +/- 0.4 mg/dl). Volume replacement using albumin was significantly (p < 0.001) more costly than therapy with HES.\n Volume therapy with 10% HES for 5 days in the ICU patient showed no disadvantages compared with an infusion regimen using 20% albumin. Volume replacement using HES may even be associated with improved hemodynamics. HES appears to be a valuable and significantly cheaper alternative to albumin--even for prolonged volume therapy in the critically ill patient.", "To examine the effects of hydroxyethyl starch (HES) on renal function.\n Randomized, controlled trial.\n Operating theatre of a university hospital.\n 60 ASA physical status I and II male patients undergoing middle ear surgery.\n Patients received either lactated Ringer's solution (LRS) or one of three HES solutions. The HES solutions were administered in a dose of 15 mL/kg bodyweight (bw), the Ringer's solution in a dose of 60 mL/kg bw, after induction of anesthesia over a period of one hour.\n Blood and urine samples for hormone and enzyme tests were obtained at defined times before, during, and after surgery. Urine excretion, glomerular filtration rate (GFR), renal plasma flow, and routine hemodynamic parameters were measured simultaneously.\n There were no significant intergroup differences regarding GFR, renal plasma flow, or tubular and glomerular integrity as measured by specific proteins and enzymes (alpha-1-microglobulin, Tamm-Horsfall-protein, immunoglobulin G, and N-acetyl-beta-D-glucosaminidase). Arginine vasopressin decreased in all groups during and following anesthesia, aldosterone and plasma renin activity decreased only in the HES groups, and angiotensin II decreased only in the HES 200/0.5 group. Central venous pressure increased during fluid administration in the LRS group and returned to baseline sooner in the HES groups.\n Hydroxyethyl starch administration appears to be risk-free with regard to renal function in patients without preexisting renal dysfunction who undergo general anesthesia. The relevance of the decrease in aldosterone following HES therapy needs further investigation.", "A prospective trial of 6% hetastarch (HES) v 5% plasma protein fraction (PPF) as the colloid component of intravenous (IV) fluid resuscitation was conducted in 32 patients with multisystem trauma and/or hemorrhagic shock. Patient age, mechanism and pattern of injury, and IV fluid requirements were similar in both groups. No intergroup differences were noted in indexes of hepatic, pulmonary, or renal function or in the incidence of infection. The frequency of other complications, including bleeding diatheses, and mortality were identical in the two groups. Although this investigation should be viewed as a pilot study, our results suggest that, compared with PPF, HES in large volumes is a safe, effective colloid solution in the resuscitation of patients with multisystem trauma and/or hemorrhagic shock. Further study of HES in a larger number of patients is warranted by these findings.", "The kind of fluid for correcting hypovolaemia is still a focus of debate. In a prospective, randomized, controlled and double-blind study in patients undergoing major abdominal surgery, a total balanced volume replacement strategy including a new balanced hydroxyethyl starch (HES) solution was compared with a conventional, non-balanced fluid regimen.\n In Group A (n = 15), a new balanced 6% HES 130/0.42 was given along with a balanced crystalloid solution; in Group B (n = 15), an unbalanced conventional HES 130/0.42 plus an unbalanced crystalloid (saline solution) were administered. Volume was given when mean arterial pressure (MAP) was <65 mmHg and central venous pressure (CVP) minus positive end-expiratoric pressure (PEEP) level was <10 mmHg. Haemodynamics, acid-base status, coagulation (thrombelastography (TEG)) and kidney function (including kidney-specific proteins, N-acetyl-beta-d-glucosaminidase (beta-NAG) and alpha-1-microglobulin) were measured after induction of anaesthesia, at the end of surgery, 5 and 24 h after surgery.\n Group A received 3533 +/- 1302 mL of HES and 5333 +/- 1063 mL of crystalloids, in Group B, 3866 +/- 1674 mL of HES and 5966 +/- 1202 mL of crystalloids were given. Haemodynamics, laboratory data, TEG data and kidney function were without significant differences between the groups. Cl- concentration and base excess (-5 +/- 2.4 mmol L-1 vs. 0.4 +/- 2.4 mmol L-1) were significantly higher in patients of Group B than of Group A.\n A complete balanced volume replacement strategy including a new balanced HES preparation resulted in significantly less derangement in acid-base status compared with a non-balanced volume replacement regimen. The new HES preparation showed no negative effects on coagulation and kidney function." ]

[ "11777093", "9177594", "12851185", "21098340", "12757574", "1466871", "14999030", "16181164", "17636154" ]

[ "Effect of a physical therapeutic intervention for balance problems in the elderly: a single-blind, randomized, controlled multicentre trial.", "A comparison of the effects of three types of endurance training on balance and other fall risk factors in older adults.", "Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial.", "Effect of music-based multitask training on gait, balance, and fall risk in elderly people: a randomized controlled trial.", "A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients.", "A clinical trial of strengthening and aerobic exercise to improve gait and balance in elderly male nursing home residents.", "The effects of multidimensional home-based exercise on functional performance in elderly people.", "A community-based fitness and mobility exercise program for older adults with chronic stroke: a randomized, controlled trial.", "Sensory-specific balance training in older adults: effect on proprioceptive reintegration and cognitive demands." ]

[ "To establish the effect of a short, individualized exercise programme on balance dysfunction in the elderly.\n A single-blind, randomized, controlled, multicentre trial.\n Physical and recreational therapy departments from two rehabilitation centres.\n Ninety-four subjects of >75 years with functional balance problems living independently or in a residential care facility. Seventy-seven subjects completed the intervention period and four-week follow-up. At a one-year follow-up 49 subjects were evaluated on balance functioning.\n Twelve sessions of an individualized balance training programme (experimental group) or 12 sessions of an individualized extra attention programme (control group) given in 4-6 weeks.\n Berg Balance Scale and the Dynamic Gait Index to establish balance functioning, a visual analogue scale to establish fear of falling in daily life and the Hospital Anxiety Depression Scale to verify feelings of anxiety and depression.\n Subjects in the experimental group improved significantly more on the Berg Balance Scale and the Dynamic Gait Index than those in the control group (p f 0.001, p f 0.001, respectively). However the effect disappeared at a one-year follow-up on the Berg Balance Scale. No prognostic factors could be identified to determine who would benefit most from the individualized exercise programme. Results on the other response variables revealed no effect of the intervention.\n A short individualized exercise programme can improve functional balance in people aged 75 years and older. This improvement was maintained at least for one month but had worn off by one year.", "We hypothesized that short-term endurance training improves balance in older adults, if training involves movements that \"stress\" balance. We tested the hypothesis by looking for a dose-response relationship between movement during exercise and balance improvement. The study was a single-blinded, randomized controlled trial. Subjects were sedentary adults (N = 106) aged 68-85 with at least mild deficits in balance. Exercise groups were: stationary cycle (low movement), walking (medium movement), and aerobic movement (high movement). Subjects attended supervised exercise classes three times a week for three months, followed by self-directed exercise of any type for three months. The primary test of the hypothesis compared changes in balance after three months of supervised exercise. One balance measure (distance walked on a six-meter narrow balance beam) improved in the hypothesized dose-response manner (cycle, 3% improvement; walking, 7% improvement; aerobic movement, 18% improvement: p < 0.02, test of trend). Other balance measures did not improve with exercise. Only walking exercise improved gait speed (by 5%, p < 0.02) and SF-36 role-physical score (by 24%, p < 0.05). VO2max improved with walking (18%, p < 0.004) and aerobic movement (10%, p < 0.01), but improved less with cycling (8%, p > 0.1). Leg strength improved significantly in all exercise groups. The study hypothesis was supported only for one balance measure. Only walking improved at least one measure of all major outcomes (endurance, strength, gait, balance, and health status), suggesting that walking is most useful for all prevention. Cycle exercise appeared least useful.", "recent studies have found that moderate intensity exercise is an effective intervention strategy for preventing falls in older people. However, research is required to determine whether supervised group exercise programmes, conducted in community settings with at-risk older people referred by their health care practitioner are also effective in improving physical functioning and preventing falls in this group.\n to determine whether participation in a weekly group exercise programme with ancillary home exercises over one year improves balance, muscle strength, reaction time, physical functioning, health status and prevents falls in at-risk community-dwelling older people.\n the sample comprised 163 people aged over 65 years identified as at risk of falling using a standardised assessment screen by their general practitioner or hospital-based physiotherapist, residing in South Western Sydney, Australia. Subjects were randomised into either an exercise intervention group or a control group. Physical performance and general health measures were assessed at baseline and repeated 6-months into the trial. Falls were measured over a 12-month follow-up period using monthly postal surveys.\n at baseline both groups were well matched in their physical performance, health and activity levels. The intervention subjects attended a median of 23 exercise classes over the year, and most undertook the home exercise sessions at least weekly. At retest, the exercise group performed significantly better than the controls in three of six balance measures; postural sway on the floor with eyes open and eyes closed and coordinated stability. The groups did not differ at retest in measures of strength, reaction time and walking speed or on Short-Form 36, Physical Activity Scale for the Elderly or fear of falling scales. Within the 12-month trial period, the rate of falls in the intervention group was 40% lower than that of the control group (IRR=0.60, 95% CI 0.36-0.99).\n these findings indicate that participation in a weekly group exercise programme with ancillary home exercises can improve balance and reduce the rate of falling in at-risk community dwelling older people.", "Falls occur mainly while walking or performing concurrent tasks. We determined whether a music-based multitask exercise program improves gait and balance and reduces fall risk in elderly individuals.\n We conducted a 12-month randomized controlled trial involving 134 community-dwelling individuals older than 65 years, who are at increased risk of falling. They were randomly assigned to an intervention group (n = 66) or a delayed intervention control group scheduled to start the program 6 months later (n = 68). The intervention was a 6-month multitask exercise program performed to the rhythm of piano music. Change in gait variability under dual-task condition from baseline to 6 months was the primary end point. Secondary outcomes included changes in balance, functional performances, and fall risk.\n At 6 months, there was a reduction in stride length variability (adjusted mean difference, -1.4%; P < .002) under dual-task condition in the intervention group, compared with the delayed intervention control group. Balance and functional tests improved compared with the control group. There were fewer falls in the intervention group (incidence rate ratio, 0.46; 95% confidence interval, 0.27-0.79) and a lower risk of falling (relative risk, 0.61; 95% confidence interval, 0.39-0.96). Similar changes occurred in the delayed intervention control group during the second 6-month period with intervention. The benefit of the intervention on gait variability persisted 6 months later.\n In community-dwelling older people at increased risk of falling, a 6-month music-based multitask exercise program improved gait under dual-task condition, improved balance, and reduced both the rate of falls and the risk of falling. Trial Registration clinicaltrials.gov Identifier: NCT01107288.", "To evaluate the effectiveness of an enhanced balance training program in improving mobility and well-being of elderly people with balance problems.\n Prospective, single-blind, randomized, controlled trial.\n District general hospital.\n One hundred ninety-nine patients aged 60 and older with a Berg Balance Scale (BBS) score of less than 45.\n Six weeks enhanced balance training consisting of a series of repetitive tasks of increasing difficulty specific to functional balance. The control group received physiotherapy conforming to existing practice in elderly patients with mobility problems.\n Ten-meter timed walk test (TWT), BBS, Frenchay Activities Index (FAI), Falls Handicap Inventory (FHI), and European Quality of Life questionnaire (Euroqol) measured at 6, 12, and 24 weeks after intervention.\n The mean age +/- standard deviation of subjects was 82.7 +/- 5.6, and baseline characteristics were comparable between the groups. Both groups showed improvements in TWT (intervention: 22.5-16.5 seconds, P =.001; control: 20.5-15.8 seconds, P =.054), BBS (intervention: 33.3-42.7, P =.001; control: 33.4-42.0, P <.0001), FAI (18-21, P =.02 in both groups), FHI score (intervention: 31-17, P =.0001; control: 33-17, P =.0001) and Euroqol score (intervention: 58-65, P =.04; control: 60-65, P =.07). There were no intergroup differences at any time. More patients reported increased confidence in walking indoors (36% vs 28%; P =.04) and outdoors (27% vs 18%; P =.02) in the enhanced balance-training group.\n Exercise programs significantly improve balance and mobility in patients with balance problems, independent of strategy. Enhanced balance training may, in addition, improve confidence and quality of life but needs further investigation.", "The purpose of this study was to determine whether a moderate to high intensity strengthening and aerobic exercise program can improve the strength, exercise capacity, gait and balance of deconditioned male nursing home residents. Ambulatory subjects who scored 30 or less on the modified Tinetti gait and balance assessment scale, who demonstrated less than 80% of age-matched lower extremity strength on isokinetic muscle testing and who gave informed consent were enrolled. Subjects were randomized to either an exercise (n = 8) or a control (n = 6) group. All participants underwent an exercise test to determine maximal oxygen uptake (VO2max) and received quantitative gait and balance measurements. The subjects assigned to the exercise group than completed a 12-wk program of weight training for the lower extremities and stationary cycling. Both the exercise and control groups were then retested. Ten outcome variables were assessed: Tinetti mobility scores, VO2max, isokinetic-tested lower extremity strength and endurance, stride length, gait velocity, stance time, gait duration, cadence and balance. The exercise group, after completion of the program, demonstrated significant improvements in Tinetti mobility scores (P < 0.05), combined right and left quadricep muscle strength (P < 0.01), right and left lower extremity muscular endurance (P < 0.01), left stride length and gait velocity (P < 0.05), although other outcome variables changed insignificantly. The control group revealed no changes of significance with the exception of improvement of the combined right and left hamstring muscle strength (P < 0.05). Nevertheless, for those outcome variables that had improved significantly in the exercise group, the changes amounted to only a 5 to 10% increase over the baseline measurements. These findings showed that an appropriately designed high intensity exercise program can result in significant although limited improvements for clinical mobility scores, strength, muscular endurance and certain gait parameters.", "This study tested the hypothesis that a home-based exercise program would improve functional performance in elderly people.\n We conducted a 6-month, single-blinded, randomized controlled trial. 72 community dwelling men and women (aged >/=70 years) with self-reported and laboratory-based functional impairment were recruited for the study. Participants were randomly assigned to either a home-based progressive strength, balance, and general physical activity intervention or an attention-control group that received home-based nutrition education. Functional performance was measured in the laboratory using the Physical Performance Test (PPT) and the Established Populations for Epidemiologic Studies of the Elderly (EPESE) short physical performance battery. Physiologic capacity was measured by strength (one repetition maximum), dynamic balance (tandem walk), gait speed (2-meter walk), and cardiovascular endurance (6-minute walk).\n 70 participants (97%) completed the 6-month trial. Compliance with study interventions within each group ranged from 75% in controls to 82% in exercisers. PPT increased by 6.1 +/- 13.4% in exercisers and decreased by 2.8 +/- 13.6% in controls (p =.02). EPESE improved by 26.2 +/- 37.5% in exercisers and decreased by 1.2 +/- 22.1% in controls (p =.001). Dynamic balance improved by 33.8 +/- 14.4% in exercisers versus 11.5 +/- 23.7% in controls (p =.0002). There were no differences between groups in the change in strength, gait speed, or cardiovascular endurance.\n Minimally supervised exercise is safe and can improve functional performance in elderly individuals. The improvements in functional performance occurred along with improvements in balance but without a significant change in muscle strength or endurance.", "To examine the effects of a community-based group exercise program for older individuals with chronic stroke.\n Prospective, single-blind, randomized, controlled intervention trial.\n Intervention was community-based. Data collection was performed in a research laboratory located in a rehabilitation hospital.\n Sixty-three older individuals (aged > or = 50) with chronic stroke (poststroke duration > or = 1 year) who were living in the community.\n Participants were randomized into intervention group (n=32) or control group (n=31). The intervention group underwent a fitness and mobility exercise (FAME) program designed to improve cardiorespiratory fitness, mobility, leg muscle strength, balance, and hip bone mineral density (BMD) (1-hour sessions, three sessions/week, for 19 weeks). The control group underwent a seated upper extremity program.\n Cardiorespiratory fitness (maximal oxygen consumption), mobility (6-minute walk test), leg muscle strength (isometric knee extension), balance (Berg Balance Scale), activity and participation (Physical Activity Scale for Individuals with Physical Disabilities), and femoral neck BMD (using dual-energy x-ray absorptiometry).\n The intervention group had significantly more gains in cardiorespiratory fitness, mobility, and paretic leg muscle strength than controls. Femoral neck BMD of the paretic leg was maintained in the intervention group, whereas a significant decline of the same occurred in controls. There was no significant time-by-group interaction for balance, activity and participation, nonparetic leg muscle strength, or nonparetic femoral neck BMD.\n The FAME program is feasible and beneficial for improving some of the secondary complications resulting from physical inactivity in older adults living with stroke. It may serve as a good model of a community-based fitness program for preventing secondary diseases in older adults living with chronic conditions.", "Age-related changes in the ability to adjust to alterations in sensory information contribute to impaired postural stability. The purpose of this randomized controlled trial was to investigate the effect of sensory-specific balance training on proprioceptive reintegration.\n The subjects of this study were 36 older participants who were healthy.\n Participants were randomly assigned to a balance exercise group (n=17) or a falls prevention education group (n=19). The primary outcome measure was the center-of-pressure (COP) velocity change score. This score represented the difference between COP velocity over 45 seconds of quiet standing and each of six 5-second intervals following proprioceptive perturbation through vibration with or without a secondary cognitive task. Clinical outcome measures included the Fullerton Advanced Balance (FAB) Scale and the Activities-specific Balance Confidence (ABC) Scale. Assessments were conducted at baseline, postintervention, and at an 8-week follow-up.\n Following the exercise intervention, there was less destabilization within the first 5 seconds following vibration with or without a secondary task than there was at baseline or in the falls prevention education group. These training effects were not maintained at the 8-week follow-up. Postintervention improvements also were seen on the FAB Scale and were maintained at follow-up. No changes in ABC Scale scores were identified in the balance exercise group, but ABC Scale scores indicated reduced balance confidence in the falls prevention education group postintervention.\n The results of this study support short-term enhanced postural responses to proprioceptive reintegration following a sensory-specific balance exercise program." ]

[ "10190639", "9702146", "9470264", "9321533", "14572438", "17804046", "9618623", "11676378", "20537841" ]

[ "The relationship between tobacco access and use among adolescents: a four community study.", "The effects of community policies to reduce youth access to tobacco.", "Interventions with retailers to reduce cigarette sales to minors: a randomised controlled trial.", "The effect of enforcing tobacco-sales laws on adolescents' access to tobacco and smoking behavior.", "Is restricting tobacco sales the answer to adolescent smoking?", "Reducing underage cigarette sales in an isolated community: the effect on adolescent cigarette supplies.", "Evaluation of an enforcement program to reduce tobacco sales to minors.", "The effects of licensing and inspection enforcement to reduce tobacco sales to minors in Greater Philadelphia, 1994-1998.", "Mass media interventions to reduce youth smoking prevalence." ]

[ "The objective of this study was to examine the effectiveness of a longitudinal community intervention on the reduction of tobacco sales to minors and subsequent effects on tobacco consumption by youths. The study was conducted in Monterey County, CA. Four rural communities were randomized into treatment and comparison arms of the study and middle and high school students in each of these communities completed surveys assessing knowledge, attitude, and behavior. The main outcome measures were retail tobacco sales to minors as measured through store visits (tobacco purchase surveys) and self-reported consumption of tobacco. Over a three-year period, a diverse array of community interventions were implemented in the intervention communities. These included community education, merchant education, and voluntary policy change. In the treatment communities, the proportion of stores selling tobacco to minors dropped from 75% at baseline to 0% at the final post-test. In the comparison communities, the proportions were 64% and 39%, respectively. Although the availability of tobacco through commercial outlets was reduced substantially in intervention communities, youths reported still being able to obtain tobacco from other sources. Predicted treatment effects on reported use of tobacco among youths were observed cross-sectionally and longitudinally for younger students (7th graders). The intervention did not impact tobacco use among older students (9th and 11th graders) although the trends were in the predicted direction for 9th graders. A significant intervention effect was found for sex--females in the intervention communities were less likely to use tobacco post-intervention than females in the comparison communities. Tobacco sales to minors can be reduced through a broad-based intervention. To prevent or reduce tobacco use by youths, however, multiple supply-and demand-focused strategies are needed.", "This study tested the hypothesis that adoption and implementation of local policies regarding youth access to tobacco can affect adolescent smoking.\n A randomized community trial was conducted in 14 Minnesota communities. Seven intervention communities participated in a 32-month community-organizing effort to mobilize citizens and activate the community. The goal was to change ordinances, merchant policies and practices, and enforcement practices to reduce youth access to tobacco. Outcome measures were derived from surveys of students before and after the intervention and from tobacco purchase attempts in all retail outlets in the communities. Data analyses used mixed-model regression to account for the clustering within communities and to adjust for covariates.\n Each intervention community passed a comprehensive youth access ordinance. Intervention communities showed less pronounced increases in adolescent daily smoking relative to control communities. Tobacco purchase success declined somewhat more in intervention than control communities during the study period, but this difference was not statistically significant.\n This study provides compelling evidence that policies designed to reduce youth access to tobacco can have a significant effect on adolescent smoking rates.", "We aimed to determine the relative effectiveness of an education intervention and a threat-of-enforcement intervention in reducing sales of cigarettes to under-age youth by randomly allocating 300 retailers in a nonmetropolitan region of New South Wales to: a control group with no intervention; a minimal-intervention group, which received an educational letter; and a maximal-intervention group, which received a threat of enforcement followed by a visit from a public health officer. Retailers were checked for compliance at pretest and post-test, six months apart, by twelve 18-year-olds who were judged by independent raters to look younger. The retailers were surveyed by telephone at both times for knowledge, attitudes and self-reported sales practices. Neither intervention achieved significant improvements for the two key behavioural outcomes: requiring proof of age and display of a warning sign. Neither was there an intervention effect on knowledge about the law. The greatest improvement in the proportion of retailers who believed that the legal age should be 18 or over was in the minimal-intervention group, and both intervention groups were less likely than the control group at post-test to think that it was acceptable to sell to a person who was nearly 18. There was poor overall compliance with the revised legislation at pre-test. The finding of a pretest-to-post-test improvement but no differential intervention effect highlights the methodological difficulties of such research. The interventions may, however, have been partly successful in modifying the attitudes of retailers.", "Enforcing laws banning tobacco sales to minors is widely advocated as a way to reduce young people's access to tobacco and tobacco use. Whether this approach is successful is not known.\n In a two-year controlled study, we assessed sales of tobacco to minors and young people's access to and use of tobacco in six Massachusetts communities. Three communities (the intervention group) enforced tobacco-sales laws, whereas three matched communities (the control group) did not. To assess compliance with the law, minors working for the study investigators attempted to purchase tobacco from all retail vendors in each community every six months. Three annual anonymous surveys of a total of 22,021 students in grades 9 through 12 (response rate, 84 percent) measured access to tobacco and smoking behavior.\n At base line, 68 percent of 487 vendors sold tobacco to minors. Compliance with the law improved significantly faster in the intervention communities than in the controls (P<0.001). By the study's end, 82 percent of the merchants in the intervention communities complied with the law, as compared with 45 percent in the control communities (P<0.001). However, adolescents under 18 years old reported only a small drop in their ability to purchase tobacco and no decline in its use. Communities with and those without enforcement programs did not differ with respect to these outcomes.\n Enforcing tobacco-sales laws improved merchants' compliance and reduced illegal sales to minors but did not alter adolescents' perceived access to tobacco or their smoking. Test purchases of tobacco do not accurately reflect adolescents' self-reported access to tobacco, and reducing illegal sales to less than 20 percent of attempts -- the goal of a new federal law-- may not decrease young people's access to or use of tobacco.", "Enforcement of legislation restricting retail access to tobacco is increasingly relied on to reduce adolescent smoking rates. In 1996, health authorities in the Northern Sydney Health Area began monitoring tobacco retailer compliance (PROOF program) with staged purchase attempts by adolescents below the legal age (18 years). Repeat cross-sectional surveys before (1995) and after (2000) the introduction of PROOF monitored changes in adolescent smoking behaviour. Students aged 12 to 17 years from 11 Northern Sydney metropolitan public secondary schools were surveyed for self-reported smoking and tobacco purchasing behavior in 1995 (n = 5,206) and 2000 (n = 4,120). Between 1996 and 2000, 545 retailer compliance checks found 34% unlawfully sold cigarettes to minors and 28% of these repeated the offence. Nine prosecutions resulted. Modelling revealed a significant association between the intervention and never having smoked (adjusted OR = 1.16, 95% CI = 1.01-1.33) although there was no significant association with being a current smoker. The odds of being a smoker were greater for students from coeducational schools, with this effect being modified by gender. There was no reduction in adolescent smoking with active enforcement of tobacco access laws despite an apparent increase in students who reported never to have smoked.", "The current study explored the practicality of preventing underage retail cigarette sales and the relationship to cigarette supplies among adolescents.\n In Fort Morgan, Colorado, an isolated rural community with below-average socioeconomic status and a large Latino population, supervised teenaged employees repeatedly attempted to buy cigarettes from every store over a 9-month period in 2005. Repeated violations were penalized. Cigarette acquisition and exchange among community adolescents were assessed before and after intervention using a high school student survey.\n The measured violation rate declined from 47% in the first week to 3.4% during the final three months, and high school student reliance on retail cigarette purchases declined. Adolescent cigarette supplies declined by approximately 15%.\n Isolated rural communities can reduce adolescent cigarette supplies by conducting consistent enforcement against retail cigarette sales to minors. Previous research suggests that reducing these sales may help reduce adolescent smoking. The current study demonstrates that enforcement is practical and effective.", "This study evaluated an active enforcement program to increase retailers' compliance with the law prohibiting tobacco sales to minors.\n Tobacco sales to minors were monitored in 319 outlets in 6 pairs of communities in Erie County, New York. One community in each pair was randomly assigned to an enforcement intervention.\n Retailers' compliance with the law increased from 35% in 1994 to 73% in 1995. However, the change in compliance rates was roughly the same for stores in the enforcement and nonenforcement communities.\n Active compliance checking of retail outlets as a strategy to reduce illegal tobacco sales to minors may only be necessary insofar as it contributes to an increase in retailers' perception that the threat of enforcement is real.", "This study examined the changes in tobacco sales to minors after active enforcement of merchant compliance to the Synar regulation and the city of Philadelphia Youth Access to Tobacco Ordinance 732. Data for the present study were obtained through Tobacco-free Education and Action Coalition for Health (TEACH) Program in a 5-year, follow-up retail compliance check survey of 1649 stores in 14 cluster areas of Philadelphia, PA. Trend analysis was conducted ofthe sales of tobacco to minors by type of retail outlet, gender, and age of the buyer, and gender, age, and race of the store clerk, and whether restriction policy signs were posted. Analysis indicates that there was a reduction in tobacco sales to minors after implementation of enforcement; sales dropped from 85% in 1994 to 43% in 1998. There were less sales to minors when signs were posted. There were differences in sales if the buyer was asked his or her age and whether the minor was asked to show identification. In addition, the age of the buyer and the brand of cigarettes were associated with sales. Future research should focus on both commercial and social availability and provision of tobacco to minors.", "Mass media interventions for reduction of youth cigarette smoking have been recommended based on a broad array of evidence, although few randomized community trials have been reported.\n Four matched pairs of independent media markets were identified; one member of each pair was randomized to receive the intervention. School surveys were conducted in all markets, in 2001 before (n=19,966) and in 2005 after (n=23,246) the interventions were completed.\n Grade 7-12 students from public schools in these eight medium-sized metropolitan areas participated in the summative evaluations; Grades 4-12 students were targeted to receive mass media interventions in four of these markets.\n Four simultaneous campaigns consisting of specially developed messages based on behavioral theory and targeted to defined age groups of racially and ethnically diverse young people were placed in popular TV, cable, and radio programming using purchased time for 4 years.\n Prevalence of youth smoking and psychosocial mediators of smoking.\n No significant impacts of these interventions on smoking behaviors or mediators were found for the overall samples. A positive effect was found for one mediator in subgroups. Among Hispanic participants a marginally favorable effect on smoking prevalence and significant effects on mediators were found. General awareness of smoking prevention TV messages was slightly higher over time in the intervention areas.\n Mass media interventions alone were unable to induce an incremental difference in youth smoking prevalence, probably because of a relatively strong tobacco control environment that included a substantial national smoking prevention media campaign.\n Copyright 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved." ]

[ "10428523", "7641897", "11679528", "9459084", "8513962", "10992178", "16446331", "12909492", "20883991" ]

[ "A gonadotrophin-releasing hormone agonist compared with expectant management after conservative surgery for symptomatic endometriosis.", "Gonadotropin-releasing hormone analogue (goserelin) plus hormone replacement therapy for the treatment of endometriosis: a randomized controlled trial.", "Post-operative GnRH analogue treatment after conservative surgery for symptomatic endometriosis stage III-IV: a randomized controlled trial.", "Gonadotropin-releasing hormone analogue plus hormone replacement therapy for the treatment of endometriosis: a randomized controlled trial.", "A gonadotropin-releasing hormone agonist versus a low-dose oral contraceptive for pelvic pain associated with endometriosis.", "Postoperative administration of monophasic combined oral contraceptives after laparoscopic treatment of ovarian endometriomas: a prospective, randomized trial.", "Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study.", "Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study.", "Postoperative medical treatment of chronic pelvic pain related to severe endometriosis: levonorgestrel-releasing intrauterine system versus gonadotropin-releasing hormone analogue." ]

[ "To ascertain whether the frequency of pelvic pain recurrence is reduced and time to symptoms recurrence is prolonged in women with symptomatic endometriosis undergoing conservative surgery and post-operative hormonal therapy compared with women treated with surgery only. Pregnancy rates and time to conception in women wanting children were also evaluated.\n A multicentre, prospective, randomised controlled study.\n Nineteen Italian academic departments and teaching hospitals specialising in reparative and reconstructive surgery.\n A total of 269 women undergoing conservative surgery for mild to severe symptomatic endometriosis.\n After surgery the women were assigned to treatment with subcutaneous goserelin depot injections for six months or to expectant management. Dysmenorrhoea, deep dyspareunia, nonmenstrual pain and general discomfort were graded according to a verbal rating scale from 0 (absent) to 3 (severe) and the scores summed to give a total symptoms score. Only patients with at least one preoperative moderate or severe symptom were enrolled. The women were evaluated regularly for two years.\n Post-operative pain recurrences (total symptoms scores > or = 5), time to recurrence, pregnancy rates and time to conception in the two study groups.\n At one- and two-year follow up visits, 14/107 (13.1%) and 19/81 (23.5%) patients had moderate or severe symptoms recurrence in the goserelin group compared with, respectively, 22/103 (21.4%) and 27/74 (36.5%) in the expectant management group (P = 0.143 at 1 year and 0.082 at 2 years). Time to symptoms recurrence was significantly longer in the goserelin group according to survival analysis (Wilcoxon test, P = 0.041). Among women wanting children, few conceptions occurred in both the goserelin (8/69, 11.6%) and the expectant management group (14/76, 18.4%). There was no significant difference at survival analysis (Wilcoxon test, P = 0.427).\n Post-operative treatment with goserelin significantly prolonged the pain-free interval after conservative surgery for symptomatic endometriosis and did not influence reproductive prognosis.", "To determine whether treatment of endometriosis with a GnRH analogue (GnRH-a; goserelin) combined with continuous estrogen and progestogen hormone replacement therapy (HRT) would prevent the hypoestrogenic effects, including loss of bone density, while maintaining efficacy for treatment of endometriosis.\n Randomized controlled trial.\n Fifty premenopausal women with laparoscopically diagnosed endometriosis (revised American Fertility Score for endometriosis implants equal to four or greater) and significant symptoms of dysmenorrhoea, dyspareunia, and other pelvic pain.\n Patients were randomized to receive either goserelin alone, 3.6 mg SC depot every 4 weeks for 24 weeks, or goserelin, 3.6 mg SC depot every 4 weeks for 24 weeks, plus HRT (25 micrograms transdermal 17 beta E2 daily and 5 mg medroxyprogesterone acetate orally daily) for 20 weeks commencing with the second goserelin injection.\n There was a significant reduction in the extent of pelvic endometriosis in both groups, with no difference between the groups. Both groups experienced an improvement in symptoms and signs, again with no difference between groups. Hypoestrogenic side effects of hot flushes and loss of libido were significantly less in the group that received HRT. The amount of bone mineral density loss was significantly less in the HRT group at the lumbar spine, although it was not prevented completely.\n The addition of HRT to GnRH-a for the treatment of endometriosis did not reduce the efficacy of treatment, and adverse hypoestrogenic effects were decreased, although not abolished.", "In order to decrease endometriosis recurrence after surgical therapy, it has been proposed to use a post-surgical oestrogen-lowering medical treatment. Results from previous trials on this topic are contradictory.\n A total of 89 women were randomized, by computer-generated list, after laparoscopic conservative surgery for symptomatic endometriosis stage III-IV to receive monthly i.m. injections of gonadotrophin-releasing hormone (GnRH) analogue, leuprolide acetate depot (3.75 mg) for 3 months (n = 44) or to an expectant management (n = 45). All patients were followed up every 6 months for evaluation of pain symptoms, fertility and objective disease recurrence.\n During the follow-up, which ranged from 6-36 months, five (33%) of the 15 women who wanted children and who were allocated the GnRH analogue and six (40%) of the 15 given no treatment became pregnant (not significant). Moderate/severe pelvic pain recurred during the follow-up in 10 (23%) of the women allocated the GnRH analogue and 11 (24%) of those allocated no treatment; the cumulative pain recurrence rates at 18 months were 23 and 29% respectively (not significant). Four women (9%) treated with GnRH analogue and four women (9%) who received no treatment had objective disease recurrence as demonstrated by gynaecological examination and/or pelvic ultrasonography.\n This study does not support the routine post-operative use of a 3 month course of GnRH analogue in women with symptomatic endometriosis stage III-IV.", "The aim of this study was to determine whether or not continuous combined HRT used with GnRH-a for the treatment of endometriosis can prevent hypoestrogenic side effects associated with GnRH-a.\n Forty premenopausal women with laparoscopically proven endometriosis entered the study. The patients were randomized into two groups. Group I (n = 19) received 3.75 mg i.m. leuprolide acetate (LA) every 4 weeks for 24 weeks. Group II (n = 21) received 3.7 mg LA combined with 1.25 mg oral conjugated equine estrogen (CEE) and 5 mg oral medroxyprogesterone acetate (MA).\n Total revised AFS score as well as total pelvic pain scores decreased significantly (P < .001) in both groups. However, a statistically significant difference of hot flushes and sweating was reported by women receiving LA + HRT as compared to those treated with LA alone (P < .001). Furthermore, the bone loss at the lumbar spine was 4.2% in group I compared to 0.9% in group II at the end of the study.\n This study suggests that 1.25 mg CEE + 5 mg MA is effective in preventing hypoestrogenic side effects caused by GnRH-a, while the treatment of endometriosis is not impaired.", "To evaluate the efficacy of goserelin versus a low-dose cyclic oral contraceptive (OC) in improving pelvic pain in women with endometriosis and to compare recurrence of symptoms during follow-up.\n Open-label, randomized trial.\n University hospital endometriosis center.\n Fifty-seven women with moderate or severe pelvic pain and laparoscopically diagnosed endometriosis.\n Six-month treatment with goserelin depot (n = 29) or a low-dose cyclic OC (n = 28) followed by 6-month follow-up.\n Variation in severity of symptoms during treatment and at the end of follow-up as shown by a linear analog scale and a verbal rating scale.\n At 6 months of treatment, a significant reduction in deep dyspareunia was observed in both groups, with goserelin superior to the OC at linear analog scale assessment. Nonmenstrual pain was diminished on both scales without differences between treatments. Women taking the OC experienced a significant reduction in dysmenorrhea. At the end of follow-up, symptoms reappeared without differences in severity between the groups.\n Low-dose cyclic OCs may be a valuable alternative for the treatment of dysmenorrhea and nonmenstrual pain associated with endometriosis. Symptoms recurred in most subjects 6 months after drug withdrawal.", "We sought to evaluate the efficacy of postoperative administration of monophasic, combined, low-dose oral contraceptives on endometrioma recurrence and on persistence-recurrence of associated pain symptoms after laparoscopic treatment of moderate-to-severe endometriosis.\n In a prospective, randomized trial 70 patients who were not attempting to conceive, aged 20 to 35 years, underwent laparoscopic excision of ovarian endometriomas, followed by either postoperative administration of low-dose cyclic oral contraceptives for 6 months or no treatment on the basis of a computer-generated sequence. At 3 and 6 months after surgery and then at 6-month intervals, both groups underwent ultrasonographic examination for possible evidence of endometrioma recurrence and for evaluation of the absence, persistence, or recurrence of pain symptoms.\n Two patients in the oral contraceptive group did not complete the study. After a mean follow-up of 22 months (range, 12-48 months), there were 2 (6.1%) endometrioma recurrences in the 33 patients who received postoperative oral contraceptives versus 1 (2.9%) recurrence in the 35 patients in the control group (not significant). The moderate-to-severe pain recurrence rate was 9.1% in the oral contraceptive group versus 17.1% in the control group (not significant). The mean time to recurrence of either symptoms or endometriomas was 18.2 months in the oral contraceptive group versus 12.7 months in the control group. The 12-month cumulative recurrence rate at life-table analysis was significantly lower for patients receiving oral contraceptives versus control subjects, whereas no significant difference was evident at 24 and 36 months.\n Postoperative administration of low-dose cyclic oral contraceptives does not significantly affect the long-term recurrence rate of endometriosis after surgical treatment. A delay in recurrence is evident at life-table analysis.", "To determine the effect of estrogen replacement therapy (ERT) on recurrence rate and survival in women who have undergone surgery for stage I or II endometrial cancer.\n After surgery, eligible patients were allocated to therapy with ERT or placebo after undergoing hysterectomy with or without pelvic and aortic nodal sampling. Planned duration of hormonal versus placebo treatment was 3 years, with an additional 2 years of follow-up.\n The median follow-up time for all 1,236 eligible and assessable patients was 35.7 months. Stage, grade, histologic subtype, and percentage of patients receiving adjuvant therapy were similarly distributed between the groups. The median age at diagnosis for the 618 patients randomly assigned to ERT was 57 years (range, 26 to 91 years). Two hundred fifty-one patients (41.1%) were compliant with ERT for the entire treatment period. Disease recurrence was experienced in 14 patients (2.3%). Eight patients (1.3%) developed a new malignancy. There were 26 deaths (4.2%), and five deaths (0.8%) were a result of endometrial cancer. The median age at diagnosis for the 618 patients in the placebo group was 57 years (range, 30 to 88 years). Twelve patients (1.9%) experienced disease recurrence. Ten patients (1.6%) developed a new malignancy. There were 9 deaths (3.1%) in the placebo group, and four deaths (0.6%) were a result of endometrial cancer.\n Although this incomplete study cannot conclusively refute or support the safety of exogenous estrogen with regard to risk of endometrial recurrence, it is noteworthy that the absolute recurrence rate (2.1%) and the incidence of new malignancy were low.", "To determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a levonorgestrel-releasing intrauterine device (Lng-IUD) is inserted after operative laparoscopy compared with those treated with surgery only.\n Open-label, parallel-group, randomized, controlled trial.\n A tertiary care and referral center for patients with endometriosis.\n Parous women with moderate or severe dysmenorrhea undergoing first-line operative laparoscopy for symptomatic endometriosis.\n Randomization to immediate Lng-IUD insertion or expectant management after laparoscopic treatment of endometriotic lesions. Proportions of women with recurrence of moderate or severe dysmenorrhea in the two study groups 1 year after surgery and overall degree of satisfaction with treatment. Moderate or severe dysmenorrhea recurred in 2 of 20 (10%) subjects in the postoperative Lng-IUD group and 9/20 (45%) in the surgery-only group. Thus, a medicated device inserted postoperatively will prevent the recurrence of moderate or severe dysmenorrhea in one out of three patients 1 year after surgery. A total of 15/20 (75%) women in the Lng-IUD group and 10/20 (50%) in the expectant management group were satisfied or very satisfied with the treatment received.\n Insertion of an Lng-IUD after laparoscopic surgery for symptomatic endometriosis significantly reduced the medium-term risk of recurrence of moderate or severe dysmenorrhea.", "To compare efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena) with depot GnRH analogue (GnRH-a; gosareline acetate; Zoladex) on endometriosis-related chronic pelvic pain (CPP) in patients with severe endometriosis during 12 months.\n Prospective, randomized, controlled study.\n The reproductive endocrinology unit of a tertiary, research and education hospital.\n Forty women with severe endometriosis (revised The American Fertility Society [AFS] classification >40) and endometriosis-related CPP and control groups were enrolled in the study.\n The patients were treated with either LNG-IUS (n = 20) or GnRH-a (n = 20). The GnRH-a dose was repeated every 4 weeks for 24 weeks.\n Scores of CPP were evaluated using a visual analogue scale (VAS) and total endometriosis severity profile (TESP).\n The TESP score decreased in the LNG-IUS group at first, third, and sixth month follow-up visits, whereas at the 12th month follow-up visit, the TESP scores were increased to values similar to pretreatment values. Although the VAS score had no significant alteration during the follow-up period in the LNG-IUS group, the GnRH-a group showed a significant decrease in the VAS score and TESP score at the end of 1 year. The LNG-IUS treatment showed a lower patient satisfaction.\n Both treatment modalities showed comparable effectiveness in the treatment of CPP-related endometriosis.\n Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved." ]

[ "12850603", "15467557", "1547173", "10021717", "14744821", "15890830", "15321623", "9504513", "16814225" ]

[ "A randomized controlled trial of prophylactic maneuvers to reduce head-to-body delivery time in patients at risk for shoulder dystocia.", "Randomized trial of McRoberts versus lithotomy positioning to decrease the force that is applied to the fetus during delivery.", "Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage.", "Use of surfactant for prophylaxis versus rescue treatment of respiratory distress syndrome: experience from an Italian-Bulgarian trial.", "Randomised controlled trial of effect of hands and knees posturing on incidence of occiput posterior position at birth.", "The effect of unrestricted oral carbohydrate intake on labor progress.", "The use of thromboembolic deterrent stockings and a sequential compression device to prevent spinal hypotension during caesarean section.", "Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial.", "Clinical implications from an exploratory study of postural management of breech presentation." ]

[ "To assess whether prophylactic use of the McRoberts maneuver and suprapubic pressure decreased the head-to-body time, as a proxy for shoulder dystocia, in at-risk patients.\n Patients with estimated fetal weights over 3800 g were randomized to undergo the McRoberts maneuver and suprapubic pressure before delivery of the fetal head (prophylactic maneuvers) or to undergo maneuvers only after delivery of the head, if necessary (controls). A total of 185 patients were enrolled in the study. After exclusions (eg, abdominal delivery), there were 128 evaluable vaginal deliveries. The study had the power to detect a 30% difference in head-to-body time between groups.\n Head-to-body delivery times did not differ between the prophylactic and control patients (24 +/- 18 seconds versus 27 +/- 20 seconds, P =.38). In addition, the two groups did not differ in rates of admission of the infant to the special care nursery or in birth injuries. There was a significant increase in the risk of delivering by cesarean for patients randomized to the use of prophylactic maneuvers.\n This study does not support the hypothesis that prophylactic use of the McRoberts maneuver and suprapubic pressure speeds delivery in a population of patients at increased risk for shoulder dystocia.", "In an effort to reduce shoulder dystocia incidence and morbidity, some obstetricians use prophylactic maternal hip hyperflexion (McRoberts maneuver), with the hope of facilitating delivery and decreasing the traction needed for delivery. The objective of this study was to evaluate whether the delivery force is reduced with the prophylactic McRoberts maneuver in a prospective, objective manner.\n Between April 2002 and July 2003, we randomly assigned multiparous women with term, cephalic singleton gestations to delivery in the lithotomy or McRoberts position. A single physician used a force-measuring system that consisted of a custom glove with force sensors to record the amount of force that was exerted on the fetal head. The primary outcomes of the study were peak force (pounds; highest force needed to accomplish entire delivery), peak force for delivery of anterior shoulder (pounds), and peak force rate (pounds per second; the duration required to reach the peak force).\n The peak force was not different between the patients in the lithotomy position (n=13) versus the McRoberts position (n=14; 7.2 +/- 0.8 lbs vs 8.0 +/- 0.7 lbs; P = .5). The peak force for delivery of the anterior shoulder (6.7 +/- 0.8 lbs vs 7.1 +/- 0.7 lbs; P = .7) and peak force rate (32.3 +/- 7.0 lbs/sec vs 29.1 +/- 3.5 lbs/sec; P = .7) were not different between the patients in the lithotomy position versus the McRoberts position, respectively. There was no difference between the groups for gestational age, birth weight, incidence of diabetes mellitus, or operative vaginal delivery. The subjective degree of difficulty of the delivery correlated with the peak force (R2 = 0.53; P = .001).\n The use of the McRoberts maneuver before clinical diagnosis of shoulder dystocia provides no reduction in the force that is used in traction on the fetal head during vaginal delivery in multiparous patients. The acceptance of this maneuver to be used prophylactically requires re-evaluation.", "To compare by randomized prospective clinical trial the outcome of labours which are managed with the intention to leave the membranes intact, compared with the practice of elective artificial rupture of the membranes (ARM) in early established labour.\n Prospective randomized controlled trial of low risk women admitted in spontaneous labour, with intact membranes.\n The labour ward of St. James's University Hospital, Leeds, UK.\n 362 women in spontaneous labour with intact membranes and no evidence of fetal distress, between 37 and 42 weeks gestation. During the course of the trial it was found that some randomization cards could not be accounted for and a system of daily checks was instituted. The results were analysed for all recorded women (n = 362) and after institution of the more rigorous system (n = 120).\n The duration of each phase of labour, epidural rate, prevalence of an abnormal cardiotocograph (CTG) (assessed blind), method of delivery and neonatal outcome.\n 178 of the 183 women (97%) in the ARM group had their membranes ruptured in early labour, and 83 (46%) of the 179 women allocated to non-intervention had ARM performed at some stage. A significant decrease in the duration of labour (mean 8.3, SD 4.1 h vs mean 9.7, SD 4.8 h, n = 156; P = 0.05) was found amongst primigravidae allocated to ARM when compared with non intervention. The duration of the second stage of labour was unaffected. In the ARM group the epidural rate was higher and labour was more often complicated by CTG abnormalities. There were no differences in the method of delivery, fetal condition at birth (cord blood lactate, Apgar score) or postpartum pyrexia between the ARM and non-intervention groups. The same trends were observed when analysis was confined to women entered into the trial after the system of rigour was instituted.\n Routine ARM results in labour that is slightly shorter than if the membranes are allowed to rupture spontaneously but more epidurals are used suggesting that labour is more painful. There are fewer fetal heart rate abnormalities if the membranes are left intact but amniotomy has no effect on fetal condition at birth.", "To show if surfactant applied in different social-sanitary realities as prophylaxis of respiratory distress syndrome (RDS) is equally useful and able to reduce mortality and incidence of 3-4 radiological grade RDS.\n Two neonatal intensive care units (NICU) in Italy, one NICU in Bulgaria and one NICU in Romania were involved in a randomized controlled clinical trial of prophylaxis vs rescue treatment of RDS. Babies with gestational age 26-30 wks were randomized before birth to prophylaxis in the delivery-room with 200 mg/kg of porcine surfactant (prophylaxis) or to routine assistance (control). Subsequently the babies developing RDS requiring mechanical ventilation and fraction of inspired oxygen (FiO2) > or = 0.4 to maintain PaO2 about 50 mmHg were allowed to be treated rescue with 200 mg/kg of the same surfactant. To reach end-points of reducing mortality by 40% and incidence of radiological grade 3-4 RDS a total number of 174 patients were required.\n Due to logistic, practical and social-political problems the study was interrupted after enrollment of 93 babies (61 in Italy and 32 in Bulgaria). The Romanian centre did not start the study because it was impossible in the scheduled times to equip it for mechanical ventilation of the newborn infants. Analysis done on an intention to treat basis did not show significant reductions of mortality and 3-4 radiological grade RDS, even if there was a trend towards a reduction in the babies given prophylaxis. A significantly lower number of babies given prophylaxis required a subsequent rescue treatment compared to controls (p < 0.001). There was no difference in other complications such as intraventricular haemorrhage, air-leak syndromes and infections between prophylaxis and control infants. As regards pulmonary gas exchange, the PaO2/FiO2 ratio was significantly improved in the babies given prophylaxis for the first 12 hours of life vs the controls.\n Even if the study was terminated before term, the analysis of the data shows that prophylaxis with surfactant is equally effective in different social-clinical conditions to improve pulmonary gas-exchange, especially in the first critical hours of life of premature babies.", "To evaluate the efficacy of hands and knees position and pelvic rocking exercises on the incidence of fetal occiput posterior position at birth.\n Multicentre randomised controlled trial.\n Seven maternity units in New South Wales, Australia, encompassing teaching hospitals and district general hospitals.\n 2547 pregnant women at 37 weeks' gestation; 1292 randomised to the intervention group and 1255 to the control group.\n Hands and knees position and pelvic rocking exercises from 37 weeks' gestation until the onset of labour.\n Incidence of fetal occiput posterior position at birth.\n 1046 women in the intervention group and 1209 women in the control group remained in the study until they went into labour. No significant difference existed between the groups for the incidence of occiput posterior position at birth: 105 (8.1%) women in the intervention group and 98 (7.8%) in the control group had a baby in a posterior position at delivery (difference in risk 0.3%, 95% confidence interval -1.8 to 2.4). The incidence of fetal transverse arrest was 3.4% (44 women) in the intervention group and 3.0% (38 women) in the control group (difference in risk 0.4, -1 to 1.7). No differences occurred between intervention and control groups for induction of labour, use of epidural, duration of labour, mode of delivery, use of episiotomy, or Apgar score.\n Hands and knees exercise with pelvic rocking from 37 weeks' gestation to the onset of labour did not reduce the incidence of persistent occiput posterior position at birth.", "To determine if unrestricted oral carbohydrate intake during labor reduced the incidence of dystocia in low-risk nulliparous women.\n A randomized clinical trial at a university-affiliated hospital in southeastern Ontario. Low-risk nulliparous women were randomized between 30 and 40 weeks gestation to either an intervention or usual care group.\n Women in the intervention group received, prenatally, guidelines about food and fluid intake during labor and were encouraged to eat and drink as they pleased during labor. Women in the usual care group received no prelabor information and were restricted to ice chips and water during labor in the hospital.\n The incidence of dystocia, defined as a cervical dilatation rate of less than 0.5 cm/hr for a period of 4 hrs after a cervical dilatation of 3 cm.\n Three hundred twenty-eight women were randomized to the intervention (n = 163) or usual care (n = 165) groups. Women in the intervention group reported a significantly different pattern of oral intake during early labor in the hospital (chi(2) = 40.7, p < .001). The incidence of dystocia was 36% (n = 58) in the intervention group and 44% (n = 72) in the usual care group and was not significantly different (OR = 0.71, 95% CI = 0.46, 1.11). There were no significant differences in the other secondary outcomes or in the incidence of adverse maternal or neonatal complications.\n Eating and drinking early in labor had no significant impact on the incidence of dystocia and/or adverse maternal or neonatal outcomes.", "Hypotension is a common side effect of spinal anaesthesia for caesarean section. We have performed a randomised, controlled study to determine the efficacy of a sequential compression device (SCD) (Kendall) in combination with thromboembolic deterrent (TED) stockings (Kendall) to reduce the incidence of hypotension in this setting. Within 20 min of spinal injection, there was no statistically significant difference in the incidence of hypotension (defined as less than 100 mmHg and less than 80% of baseline blood pressure) (TED/SCD group 65%, control 80%, P = 0.12). However, there was a trend for those receiving TED/SCD prophylaxis to require less ephedrine to maintain normotension than the control group (median TED/SCD 3 mg, control 6 mg, P = 0.08). The administration of ephedrine deviated from protocol on a total of 46 occasions (2.3% of recordings). To try to reduce the influence of this, we reinspected our data using time to first episode of hypotension with a Kaplan-Meier survival analysis. This showed that the instantaneous risk (hazard) of developing hypotension was 1.8 (95% CI: 1.1-2.9) times higher in controls than those receiving TED/SCD prophylaxis (P = 0.02). Despite demonstrating some benefit of TED/SCD prophylaxis to prevent hypotension, we do not consider that the magnitude of this benefit warrants their routine use.", "This study tested the hypotheses that active management of the third stage of labour lowers the rates of primary postpartum haemorrhage (PPH) and longer-term consequences compared with expectant management, in a setting where both managements are commonly practised, and that this effect is not mediated by maternal posture.\n 1512 women judged to be at low risk of PPH (blood loss >500 mL) were randomly assigned active management of the third stage (prophylactic oxytocic within 2 min of baby's birth, immediate cutting and clamping of the cord, delivery of placenta by controlled cord traction or maternal effort) or expectant management (no prophylactic oxytocic, no cord clamping until pulsation ceased, delivery of placenta by maternal effort). Women were also randomly assigned upright or supine posture. Analyses were by intention to treat.\n The rate of PPH was significantly lower with active than with expectant management (51 [6.8%] of 748 vs 126 [16.5%] of 764; relative risk 2.42 [95% CI 1.78-3.30], p<0.0001). Posture had no effect on this risk (upright 92 [12%] of 755 vs supine 85 [11%] of 757). Objective measures of blood loss confirmed the results. There was more vomiting in the active group but no other important differences were detected.\n Active management of the third stage reduces the risk of PPH, whatever the woman's posture, even when midwives are familiar with both approaches. We recommend that clinical guidelines in hospital settings advocate active management (with oxytocin alone). However, decisions about individual care should take into account the weights placed by pregnant women and their caregivers on blood loss compared with an intervention-free third stage.", "The results from an exploratory study of the effectiveness of maternal knee-chest posture for producing cephalic version of breech presentation are shown. Methods are briefly described and clinical implications are presented. Among 25 women, fewer who performed the maternal knee-chest postural intervention experienced fetal cephalic version than women in the control group who did nothing to influence breech presentation. Despite limitations of the underpowered findings, trends in the data may indicate that parity and gestational age were potentially relevant covariates of version. Postural management is not an evidence-based practice. This exploratory study indicates that maternal knee-chest posture may work opposite to the expected direction, but the small sample size precludes generalizations about efficacy of knee-chest postural management. At least one adequately powered trial that controls for parity and gestational age is needed to determine whether knee-chest postural management results in no effect, a small, or small to moderate clinically significant effect." ]

[ "15235901", "7543781", "8826606", "7691114", "16823067", "10382902", "7751732", "16110136", "7595716" ]

[ "A prospective randomised evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia.", "Effect of granulocyte colony-stimulating factor (G-CSF) on chemotherapy-induced oral mucositis.", "Results of a randomized trial of granulocyte colony-stimulating factor in patients with infection and severe granulocytopenia.", "Granulocyte colony-stimulating factor (G-CSF) with or without a quinolone in the prevention of infection in cancer patients.", "Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer.", "Prevention of febrile leucopenia after chemotherapy in high-risk breast cancer patients: no significant difference between granulocyte-colony stimulating growth factor or ciprofloxacin plus amphotericin B.", "[Chemoprophylaxis of bacterial infections in granulocytopenic patients with new quinolone: a comparison of trimethoprim-sulfamethoxazole (ST) alone with ST plus ciprofloxacin].", "Therapeutic efficacy by recombinant human granulocyte/monocyte-colony stimulating factor on mucositis occurring in patients with oral and oropharynx tumors treated with curative radiotherapy: a multicenter open randomized phase III study.", "Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy." ]

[ "Febrile neutropenia (FN) remains a major dose-limiting complication among patients treated with chemotherapy. Haematopoietic colony stimulating factors (G-CSF and GM-CSF) made possible a significant improvement in the management of FN, both in the therapeutic and in the prophylactic approach. The use of antibiotic prophylaxis also permits a definite reduction of severe infections during neutropenia. Nevertheless, the possible role of these two interventions for secondary prevention of FN is still unclear.\n We conducted a prospective randomised trial by comparing the efficacy of granulocyte-colony stimulating factor (G-CSF) and the association of G-CSF with oral antibiotics in the secondary prevention of FN. We included in our study those patients who, after an episode of FN, continued to be treated with the same chemotherapy without reduction of dose intensity. They were randomised into two groups: the first received G-CSF (group G; filgrastim, 5 microg/kg day), and the second was treated with an association of G-CSF and amoxicillin/clavulanate plus ciprofloxacin (group G/ACC).\n Forty-eight patients were randomised (group G: n=23 and group G/ACC: n=25). There was no recurrence of FN among the patients receiving G-CSF and only one episode in the combined therapy group (p=1). With regard to the side effects, there was no significant difference in the two groups.\n The use of G-CSF for the secondary prevention of FN is extremely effective and allows the maintenance of chemotherapy dose intensity. Our study showed that the addition of antibiotics does not seem to be required.", "In this study, the ability of granulocyte colony-stimulating factor (G-CSF) to treat or prevent chemotherapy-induced oral mucositis in patients with advanced breast cancer was evaluated. A total of 14 patients who received intraarterial (i.a.) adriamycin (ADM) preoperatively were divided into two groups according to whether or not G-CSF was given. Thus, group A (n = 7) was given G-CSF and group B (n = 7) was not. G-CSF therapy reduced both the incidence and duration of ADM-induced oral mucositis, and a positive correlation was also seen between the incidence of mucositis and ADM-induced leukopenia (< 2,000/mm3). Group A was further divided into two subgroups according to whether G-CSF was given after or before the leukopenia had dropped below 2,000/mm3: group A-1 (n = 3) and group A-2 (n = 4), respectively. ADM-induced mucositis was observed in two of the three patients in group A-1, but in none of the four patients in group A-2. These results strongly support the idea that G-CSF can effectively treat and prevent ADM-induced oral mucositis.", "A study was carried out to investigate the efficacy and toxicity of granulocyte colony-stimulating factor (G-CSF) in the treatment of infection in 119 severely granulocytopenic patients with hematological malignancies after intensive chemotherapy. Patients were assigned randomly to receive either antibiotics alone (ceftazidime, 2 g, i.v., every 8 h + amikacin 7.5 mg/kg, i.v., every 12 h) or the same antimicrobial regimen plus G-CSF (5 micrograms/kg/day, s.c.). Measurements were clinical improvement, eradication of infection and toxicity. Patients who received antibiotics plus G-CSF had more clinical responses (82 versus 60%), less superinfections (6 versus 20%), less mortality (5 versus 15 patients), less days in hospital (median 10 versus 27) and reduced antibiotic usage compared to patients who received only antibiotics. Hematological recovery (granulocytes > 1.0 x 10(9)/l) was also shorter in these patients (12 versus 23 days). Fungal infections occurred only in the group treated with antibiotics alone. Toxicity secondary to G-CSF was absent. We conclude that the addition of G-CSF to broad spectrum antibiotics is useful in selected patients with severe granulocyctopenia after intensive chemotherapy and infection, because if may prove the outcome in these patients.", "59 patients who had earlier developed an infection following antineoplastic chemotherapy were randomised to receive either granulocyte colony-stimulating factor (G-CSF) alone or G-CSF+quinolone as prophylaxis during subsequent identical chemotherapy courses. 30 patients received 48 courses of G+CSF, while 29 patients received 44 courses of G-CSF+ofloxacin or ciprofloxacin. The overall infection rate was 23%. Patients with WHO grade IV leukopenia at the onset of prophylactic treatment developed infection in 61% of cases when on G-CSF, but only in 22% when on G-CSF+quinolone (P = 0.002). Patients with initial leukopenia of grade WHO III-I had only a 11% infection rate showing no significant difference between the treatment groups. The median duration of leukopenia < 1 x 10(9)/l was 4 days for patients receiving G-CSF alone and 3.5 days for those receiving additional quinolone. Patients developing infection had grade IV leukopenia for a median of 5 days. Both prophylactic treatments were well tolerated. We conclude that when prophylactic G-CSF is initiated at WHO grade IV leukopenia, addition of an oral quinolone reduces the risk of infection.", "Acute mucositis is dose-limiting in many accelerated radiotherapy schedules for head and neck cancer. Cytokines may be one means of reducing the severity of mucositis. A study was designed to assess the effect of subcutaneous molgramostin (granulocyte-macrophage colony stimulating factor; GM-CSF) injections on acute radiation morbidity in patients undergoing accelerated radiotherapy for laryngeal cancer. A prospective, randomized, observer-blind, controlled trial was conducted in 29 patients who were to receive radical radiotherapy over 3 weeks for early stage laryngeal cancer. Patients were randomized to receive 150 microg (approximately 2 microg kg(-1)) GM-CSF subcutaneously once daily for 14 days after the second week of radiotherapy, or no GM-CSF. Patients were assessed weekly for grade of mucositis, skin reactions and related parameters. The severity of mucositis was reduced in the GM-CSF arm (p<0.05). No other end-points reached statistical significance. Two patients failed to complete their courses of GM-CSF. Three developed influenza type symptoms and in one an allergic reaction was noted. There was no difference in tumour control rates. Subcutaneous GM-CSF reduced the severity of mucositis in patients undergoing accelerated radiotherapy. Injections were well tolerated. Further studies of cytokines are warranted, to assess the feasibility of increasing the total doses of accelerated radiotherapy given, with the aim of improving tumour cure rates.", "In a prospective randomized trial, 40 stage IV breast cancer patients undergoing intermediate high-dose chemotherapy (cyclophosphamide, 5-fluorouracil plus epirubicin or methotrexate), received either recombinant human G-CSF (rhG-CSF, group I) or ciprofloxacin and amphotericin B (CAB, group II) for prevention of febrile leucopenia (FL). In group I, seven of 18 patients developed FL (after 10/108 courses); in group II, seven of 22 patients (7/98 courses) (P = NS). Median hospitalization duration and costs were not different. RhG-CSF was 6.6 times more expensive per course than CAB. In conclusion, prophylactic CAB has similar efficacy to rhG-CSF in this setting, and is more cost-effective.", "Fifty-three granulocytopenic patients were studied in a randomized trial comparing trimethoprim-sulfamethoxaxole (ST) alone with ST + ciprofloxacin (CPFX) for prevention of bacterial infections. Seventeen febrile episodes occurred in 24 patients receiving ST alone, and 9 febrile episodes occurred in 29 patients receiving ST + CPFX. ST + CPFX was significantly effective than ST alone (p < 0.005). Although ST alone was effective to prevent infections in moderately granulocytopenic patients, it could not prevent infections in severely granulocytopenic patients whose minimal granulocyte count was less than 250/microliters during prophylactic treatment. In contrast, ST + CPFX was effective in severely as well as in moderately granulocytopenic patients. Clinically significant adverse reactions were not observed in both regimens. These results suggest that combination with ST and CPFX is more efficacious than ST alone for the prevention of bacterial infections in granulocytopenic patients.", "Previous studies suggested granulocyte-macrophage-colony stimulating factor (GM-CSF) might be beneficial for radiotherapy-induced mucositis. This trial examined the efficacy of GM-CSF in reducing mucositis of the oral cavity and/or oropharynx compared with conventional treatment.\n Mucositis, documented by a five-grade scale, was defined in patients with tumors of the head-neck. Centers were allowed to use their own preferred fractionation regimen. Randomization to treatment was decided before radiotherapy. Treatment with GM-CSF 4 microg/kg/d subcutaneous, started when patients displayed a mucositis score > or = 1.5.\n Ninety-two patients entered the study according to intention-to-treat principle. Twenty did not reach a mucositis index of 1.5. Sixty-one patients were included in the statistical analysis. Forty-five percent of the patients randomized to receive GM-CSF had a significant reduction of the mucositis more than one grade compared to 9% of the conventional treated.\n In severe mucositis, GM-CSF is more effective than conventional treatment.", "To evaluate prospectively the efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) in the reduction of chemotherapy-induced oral mucositis.\n Twenty patients with stage IV squamous cell carcinoma of head and neck were studied. Two-cycles (periods) of identical doses of cisplatin, fluorouracil (5-FU), and leucovorin (PFL) chemotherapy with cisplatin 20 mg/m2/d, 5-FU 800 mg/m2/d, leucovorin 90 mg/m2/d by 96-hour continuous intravenous infusion every 3 weeks were given to each patient. After PFL chemotherapy, GM-CSF 4 micrograms/kg subcutaneously from days 5 to 14 or no therapy was given by a randomized self-controlled crossover study design. Oral mucositis was graded with modified Radiation Therapy Oncology Group criteria.\n In the first cycle of PFL chemotherapy, GM-CSF significantly reduced the incidence, mean duration, and mean area under the curve (AUC) of severe oral gross mucositis (grade > or = 3) compared with no therapy. These beneficial effects continued into the second cycle of PFL chemotherapy after crossover to no GM-CSF. The incidence of severe mucositis was reduced when GM-CSF was given in the second cycle of PFL. Analysis of variance indicated significant direct GM-CSF treatment effects on the mean AUC of gross/functional scores and duration of moderate gross mucositis (grade > or = 2) over both periods. There was a significant period effect in favor of giving GM-CSF in the first cycle of chemotherapy.\n GM-CSF can significantly reduce the severity and duration of chemotherapy-induced oral mucositis after PFL chemotherapy." ]

[ "16735589", "11307071", "10424554", "12130413", "15122134", "11988719", "10401657", "12463655", "15695959" ]

[ "Arthroscopic versus open shoulder stabilization for recurrent anterior instability: a prospective randomized clinical trial.", "Comparison of an arthroscopic and an open procedure for posttraumatic instability of the shoulder: a prospective, randomized multicenter study.", "Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder.", "A prospective, randomized evaluation of arthroscopic stabilization versus nonoperative treatment in patients with acute, traumatic, first-time shoulder dislocations.", "Arthroscopic versus open treatment of Bankart lesion of the shoulder: a prospective randomized study.", "Arthroscopic versus open acromioplasty: a prospective, randomized, blinded study.", "Arthroscopic lavage reduced the recurrence rate following primary anterior shoulder dislocation. A randomised multicentre study with 1-year follow-up.", "The results of shoulder arthroplasty in patients with rheumatoid arthritis.", "Arthrographic distension of the shoulder joint in the management of frozen shoulder." ]

[ "Arthroscopic stabilization for anterior shoulder instability has been reported to result in a higher rate of recurrent instability compared to traditional open techniques.\n To test the null hypothesis that there is no difference in the clinical outcomes in patients with recurrent anterior shoulder instability treated with open or arthroscopic stabilization.\n Randomized controlled trial; Level of evidence, 1.\n A consecutive series of 64 patients with recurrent anterior shoulder instability were randomized to receive either arthroscopic or open stabilization by a single surgeon. Magnetic resonance arthrogram studies were obtained preoperatively. These findings were compared to arthroscopic findings. Postoperative evaluations included range of motion, stability, and subjective assessments including Single Assessment Numeric Evaluation, Simple Shoulder Test, Western Ontario Instability Index, and University of California, Los Angeles evaluation. Failure was defined as a second dislocation, recurrent subluxation, or symptoms precluding return to previous work or unrestricted active military duty.\n Sixty-one patients, 29 who received open stabilization and 32 who received arthroscopic stabilization, were evaluated at a mean of 32 months postoperatively (range, 24-48 months). Patient demographics were equivalent. Preoperative magnetic resonance arthrogram findings were confirmed at arthroscopic examination. The mean operative time was significantly shorter for the arthroscopic repairs (59 vs 149 minutes; P < .001). There were 3 clinical failures (2 open stabilizations, 1 arthroscopic stabilization) by the established criteria. There was a statistically significant improvement from preoperative to postoperative Single Assessment Numeric Evaluation scores in both groups (P < .001). The mean loss of motion (compared to the contralateral shoulder) was greater in the open shoulders. Subjective evaluations were equal in both groups. Conclusion: Clinical outcomes after arthroscopic and open stabilization were comparable. Preoperative magnetic resonance arthrograms in shoulders with anterior instability allow an accurate diagnosis of intra-articular abnormality that correlates well with operative findings. Arthroscopic stabilization for recurrent anterior shoulder instability can be performed safely; the clinical outcomes are comparable to those after traditional open stabilization.", "From 1993 through 1996, a multicenter study was conducted on the surgical treatment of patients with posttraumatic recurrent anterior shoulder dislocations. Fifty-six patients (40 men, 16 women; mean age 26 years [range 18-51 years]), were evaluated with shoulder arthroscopy. If a Bankart lesion was present, the patients were randomly allocated to either an arthroscopic reconstruction with the use of biodegradable tacks or an open reconstruction with suture anchors. The postoperative rehabilitation protocol for the two groups was identical. In all patients, the range of shoulder motion, stability, and the Constant and Rowe scores were evaluated at 3, 12, and 24 months postoperatively. Thirty patients were surgically treated with the arthroscopic technique and 26 patients with the open technique. In the arthroscopic group, there were recurrences in 7 (23%) of 30 patients at a mean of 13 months (range 5 to 21 months) after surgery. All patients with stable shoulders had a negative apprehension test result. In the open group, there were recurrences in 3 (12%) of 26 patients at a mean of 10 months (range 2 to 23 months) after surgery (P = not significant). In the arthroscopic group, 2 patients had new traumatic redislocations, whereas 1 patient redislocated during an epileptic seizure. In the open group, 1 traumatic redislocation occurred. The 2-year results in this study demonstrate a large number of redislocations after reconstruction, even in the open surgery group. Patient noncompliance with the rehabilitation protocol and predisposing disease may partially explain these results. A tendency was seen toward more redislocations in the arthroscopic group, which emphasizes the importance of correct patient selection and careful surgical technique in the difficult surgical procedure.", "Our purpose was to compare the effectiveness of traditional treatment with immediate arthroscopic stabilization in young patients who have sustained a first traumatic anterior dislocation of the shoulder. Forty skeletally mature patients younger than 30 years of age were randomly allocated to immobilization for 3 weeks followed by rehabilitation (group T) or arthroscopic stabilization (within 4 weeks of injury) followed by an identical immobilization and rehabilitation protocol (group S). A blinded research assistant performed all follow-up evaluations. The dominant arm was involved in 35% of subjects. The injury occurred in a sporting event in 70% of subjects. At 24 months, there was a statistically significant difference in the rate of redislocation (T = 47%, S = 15.9%, P = .03). An intention-to-treat analysis comparing disease-specific quality of life using the validated Western Ontario Shoulder Instability (WOSI) index showed statistically significantly better results in the surgically treated group at the 33 months (T = 633.93 v S = 287.1, P = .03) and no significant difference in range of motion. At an average 32 months follow-up, a significant reduction in redislocation and improvement in disease-specific quality of life is afforded by early arthroscopic stabilization in patients less than 30 year of age with a first, traumatic, anterior dislocation of the shoulder.", "Nonoperative treatment of traumatic shoulder dislocations leads to a high rate of recurrent dislocations.\n Early arthroscopic treatment for shoulder dislocation will result in a lower recurrence rate than nonoperative treatment.\n Prospective, randomized clinical trial.\n Two groups of patients were studied to compare nonoperative treatment with arthroscopic Bankart repair for acute, traumatic shoulder dislocations in young athletes. Fourteen nonoperatively treated patients underwent 4 weeks of immobilization followed by a supervised rehabilitation program. Ten operatively treated patients underwent arthroscopic Bankart repair with a bioabsorbable tack followed by the same rehabilitation protocol as the nonoperatively treated patients. The average follow-up was 36 months.\n Three patients were lost to follow-up. Twelve nonoperatively treated patients remained for follow-up. Nine of these (75%) developed recurrent instability. Six of the nine have required subsequent open Bankart repair for recurrent instability. Of the nine operatively treated patients available for follow-up, only one (11.1%) developed recurrent instability.\n Arthroscopic stabilization of traumatic, first-time anterior shoulder dislocations is an effective and safe treatment that significantly reduces the recurrence rate of shoulder dislocations in young athletes when compared with conventional, nonoperative treatment.", "The purpose of this study was to compare the results of arthroscopic and open repair of isolated Bankart lesions of the shoulder using metallic suture anchors.\n Prospective randomized clinical study.\n Sixty patients with traumatic anterior shoulder instability underwent a surgical repair of an isolated Bankart lesion. The patients were divided into 2 groups of 30 patients each. In group 1, an arthroscopic repair was performed, and in group 2, an open procedure was performed. The groups were homogeneous for gender, age, dominance, number of dislocations, time elapsed between first dislocation and surgery, and pathologic findings. In all cases of both groups, the lesion was repaired using metallic suture anchors carrying nonabsorbable braided sutures. Postoperative rehabilitation was the same for the 2 groups. Two years' follow-up evaluation included Constant and Rowe shoulder scores. Statistical analysis of data was performed using an unpaired t test (significance for P <.05).\n No recurrence of dislocation of the involved shoulder has been reported in either group. Follow-up Constant and Rowe scores of the 2 groups were not significantly different. The only significant difference seen between the 2 groups was for range of motion evaluation with the Constant score. The mean value for group 1 (39.6 +/- 0.8) was significantly greater (P =.017) than that for group 2 (37.8 +/- 2.0).\n Arthroscopic repair with suture anchors is an effective surgical technique for the treatment of an isolated Bankart lesion. Open repair does not offer a significantly better 2-year result in terms of stability, and furthermore, can negatively affect the recovery of full range of motion of the shoulder.\n Level I.", "The purpose of this study is to determine whether arthroscopic acromioplasty is equivalent or superior to open acromioplasty, in a prospective, randomized, controlled, blinded clinical trial. Seventy-one patients with a clinical diagnosis of impingement syndrome were randomized to arthroscopic or open acromioplasty. Nine were excluded because of full-thickness rotator cuff tears diagnosed after randomization. Sixty-two patients (49 men and 13 women) with a minimum follow-up of 12 months (mean, 25 months) were included. The patient groups were virtually identical with regard to duration of symptoms, shoulder functional demands, age, sex, hand dominance, mechanism of onset, range of motion, strength, joint laxity, and the presence of a compensation claim. Patients were prospectively randomized to arthroscopic or open acromioplasty after stratification for age (>50 years),associated ligamentous laxity, and the presence of an ongoing compensation claim. The main outcome measure was visual analog scales for pain and function. Also recorded were UCLA shoulder scores and visual analog scales for postoperative improvement, patient satisfaction, and a variety of clinical measures. An independent blinded examiner assessed all patients. There was no significant difference between open and arthroscopic acromioplasty in visual analog scales for postoperative improvement (P =.30), patient satisfaction (P =.94), UCLA shoulder score (P =.69), or strength (P =.62); however, open was superior to arthroscopic acromioplasty for pain and function (P =.01). Overall, 67% of patients had a good or excellent result. This increased to 87% when unsettled compensation claims were excluded. Repeat (open) acromioplasty was performed in 5 patients in the unsuccessful arthroscopic group without improvement. Open acromioplasty was equivalent to arthroscopic acromioplasty for UCLA scores and patient satisfaction. For pain and function, both gave significant improvement but the open technique may be superior. Unsettled compensation is a predictor of poor outcome.", "Young individuals have a high recurrence rate following non-operative treatment of traumatic primary anterior shoulder dislocation. The present multicentre study was undertaken to find out whether the results could be improved by using arthroscopic lavage as treatment. Sixty patients aged 16-30 years, with traumatic primary anterior shoulder dislocation were randomised into two groups. One group was treated with arthroscopic lavage within 10 days, while the other group was treated non-operatively. Rehabilitation was otherwise identical. At 1-year follow-up, 4 of 30 patients (13%) in the lavage group had had redislocation compared with 13 of 30 (43%) in the group treated non-operatively (P = 0.01). The difference in recurrence rate was more pronounced in younger patients. The functional outcome according to the Rowe shoulder score was better in the lavage group (P = 0.003), as was the anterior stability according to the apprehension test (P = 0.008). We conclude that arthroscopic lavage reduced the recurrence rate and produced a better functional outcome at 1-year follow-up than the non-operative treatment in young individuals.", "We have performed a clinical and radiological analysis of 105 shoulder arthroplasties in patients with rheumatoid arthritis. The clinical results showed improvements in the Constant-Murley and Association of Shoulder and Elbow Surgeons score of 21 and 35, respectively. Both were statistically significant (p < 0.001). This improvement was maintained over a period of 8.8 years. There was no statistically significant difference in the scores after hemiarthroplasty and those after total arthroplasty. The presence of an intact rotator cuff was associated with improved function in both groups. In spite of the use of an uncemented humeral stem, no implant was radiologically loose or at risk. There was lucency in a single zone in 14 implants. One glenoid component was at risk and 16 had lucency in a single zone. There was, however, a significant difference in the amount of lucency which was associated with pegged and keeled glenoid components (p = 0.005). In the group with hemiarthroplasty, two or more years after surgery there was superior migration of the humeral component by more than 5 mm in 18 shoulders (28%) and medial migration by more than 2 mm in eight (16%). Both superior and medial migration had an effect on the outcome. Revision was undertaken in four patients for persistent pain relating to medial migration. With revision taken as the endpoint for survival after eight years, 92% were found to be still in situ.", "The study was an open randomized controlled trial to compare the outcome at 8 weeks with two different modalities in the treatment of 'Frozen shoulder'. Clinical cases with painful limitation of movement of shoulder were randomized to receive physical therapies alone versus physical therapies and shoulder arthrography with intra-articular steroid in a sequential randomization process. Cases suspected of having a concomitant illness and has potential to cause secondary frozen shoulder were excluded, such as, history of trauma to shoulder over the last 6 months, symptomatic clinical cervical degenerative diseases, and causes in and around the shoulder (infective and non-infective). Physical Therapies provided to all patients were therapeutic exercises, transcutaneous electrical nerve stimulation (TENS) and infra-red radiation (IRR). Outcome measures were improvement of pain on a Visual Analogue Scale (VAS) score and range of motion measured by Goniometer at 8 weeks. Patients were followed weekly for 8 weeks and outcome parameters were recorded on every evaluation. The baseline range of motion in the two groups was comparable. At 8 weeks a statistically significant difference in outcome were observed in the two groups. The chi-square means difference of improvement in range of motion for abduction was p <0.00 and for external rotation was p <0. 00. The pain reduction on VAS score was not significant in the two groups (p <0. 40). In the present small series, the distension arthrography with intra-articular (IA) steroid plus physical therapy was superior over physical therapy alone in the functional improvement of the frozen shoulder. Further studies with larger sample size are required to confirm the observations." ]

[ "9523803", "11159241", "10714841", "9523805", "10757577", "11167171", "9523804", "11159240", "11012500" ]

[ "Transient neurologic symptoms after spinal anesthesia with mepivacaine and lidocaine.", "Transient neurologic symptoms after spinal anesthesia with lidocaine in obstetric patients.", "The incidence of transient neurologic symptoms (TNS) after spinal anaesthesia in patients undergoing surgery in the supine position. Hyperbaric lidocaine 5% versus hyperbaric bupivacaine 0.5%.", "Transient neurologic symptoms after spinal anesthesia: a lower incidence with prilocaine and bupivacaine than with lidocaine.", "A randomised study of lidocaine and prilocaine for spinal anaesthesia.", "Transient neurologic symptoms after spinal anaesthesia using isobaric 2% mepivacaine and isobaric 2% lidocaine.", "Incidence of transient neurologic symptoms after hyperbaric subarachnoid anesthesia with 5% lidocaine and 5% prilocaine.", "Does pregnancy protect against intrathecal lidocaine-induced transient neurologic symptoms?", "The incidence of transient neurological symptoms after spinal anaesthesia with lidocaine compared to prilocaine." ]

[ "Spinal anesthesia with lidocaine is ideal for ambulatory surgery because of its short duration of action. However, transient neurologic symptoms (TNS) occur in 0-40% of patients. The incidence of TNS with mepivacaine, which has a similar duration of action, is unknown.\n Sixty ambulatory patients undergoing knee arthroscopy received spinal anesthesia in a randomized, double-blinded manner, with either 45 mg 1.5% mepivacaine or 60 mg 2% lidocaine. An L3-L4 midline approach was used with a 27-gauge Whitacre needle and a 20-gauge introducer. The local anesthetic was injected over approximately 30 s with the aperture of the Whitacre needle in a cephalad direction. Two to 4 days after operation, each patient was questioned about the development of TNS. In addition, the two groups were compared for time to regression of sensory and motor blockade and time to discharge milestones.\n Three patients receiving lidocaine were lost to follow-up. None of the 30 patients in the mepivacaine group developed TNS, whereas 6 of 27 (22%) in the lidocaine group did (P = 0.008). Time to regression to the L5 sensory level and to complete resolution of motor block were similar in both groups. The times to discharge milestones were also comparable.\n The incidence of TNS is greater with 2% lidocaine than with 1.5% mepivacaine for patients having unilateral knee arthroscopy under spinal anesthesia. Mepivacaine seems to be a promising alternative to lidocaine for outpatient surgical procedures because of its similar duration of action. Further studies are warranted to determine the optimal dose of intrathecal mepivacaine for ambulatory surgery and the incidence of TNS with other doses and concentrations of intrathecal mepivacaine.", "We investigated the relationship between intrathecal lidocaine and transient neurologic symptoms in the obstetric population because lidocaine spinal anesthetics are commonly used for various obstetric procedures, and little has been reported in this regard from within this population. In this study, 58 ASA physical status I patients presenting for postpartum bilateral tubal ligation under spinal anesthesia were randomized to receive either hyperbaric 5% lidocaine or 0.75% bupivacaine in a double-blinded manner. All patients were in the supine position for their surgery. Postoperatively, all patients were followed by a blinded investigator using a standardized symptom checklist. The incidence of transient neurologic symptoms with lidocaine was 3% (95% confidence interval = 0.1%--17.8%) and that with bupivacaine was 7% (95% confidence interval = 0.9%--23.5%), (P = not significant). Symptoms consistent with this syndrome occurred within 24 h without any associated sensory or motor deficits or functional impairment, and resolved within 48 h without any intervention.", "The incidence of TNS after spinal anaesthesia is a problem. Especially the use of hyperbaric lidocaine in patients placed in the lithotomy position during surgery has been associated with a high incidence of TNS. The present study was performed to investigate whether TNS is present more frequently in patients undergoing surgery in the supine position with use of hyperbaric lidocaine compared with hyperbaric bupivacaine.\n Seventy patients were included and randomised to receive either hyperbaric lidocaine or hyperbaric bupivacaine. All patients were contacted on the first and third postoperative days by an anaesthesiologist blinded to the local anaesthetic used. The patients were asked about symptoms of TNS, pain not associated with the operation area, and asked to grade the complaints after a verbal analogue score from 0 to 10.\n We found a total of ten patients who showed signs of TNS. There were nine patients in the lidocaine group (26%) who showed signs of TNS compared to only one patient in the bupivacaine group (3%) (P<0.01). The average score of TNS complaints was 3.5. A total of 13 patients (19%) complained of back pain. There were no significant differences with regard to which local anaesthetic was used. The average score of back pain was 3.3.\n TNS is a significant problem in patients having spinal anaesthesia with hyperbaric lidocaine compared to hyperbaric bupivacaine, both in the supine position. For day-case surgery, TNS would start after dismissal from hospital. The use of hyperbaric lidocaine is therefore questionable, even though these problems are of an order that the majority of patients would still choose spinal anaesthesia for future operations.", "Recent evidence suggests that transient neurologic symptoms (TNSs) frequently follow lidocaine spinal anesthesia but are infrequent with bupivacaine. However, identification of a short-acting local anesthetic to substitute for lidocaine for brief surgical procedures remains an important goal. Prilocaine is an amide local anesthetic with a duration of action similar to that of lidocaine. Accordingly, the present, prospective double-blind study compares prilocaine with lidocaine and bupivacaine with respect to duration of action and relative risk of TNSs.\n Ninety patients classified as American Society of Anesthesiologists physical status I or II who were scheduled for short gynecologic procedures under spinal anesthesia were randomly allocated to receive 2.5 ml 2% lidocaine in 7.5% glucose, 2% prilocaine in 7.5% glucose, or 0.5% bupivacaine in 7.5% glucose. All solutions were provided in blinded vials by the hospital pharmacy. Details of spinal puncture, extension and regression of spinal block, and the times to reach discharge criteria were noted. In the evening of postoperative day 1, patients were evaluated for TNSs by a physician unaware of the drug administered and the details of the anesthetic procedure.\n Nine of 30 patients receiving lidocaine experienced TNSs, 1 of 30 patients receiving prilocaine (P = 0.03) had them, and none of 30 patients receiving bupivacaine had TNSs. Times to ambulate and to void were similar after lidocaine and prilocaine (150 vs. 165 min and 238 vs. 253 min, respectively) but prolonged after bupivacaine (200 and 299 min, respectively; P < 0.05).\n Prilocaine may be preferable to lidocaine for short surgical procedures because it has a similar duration of action but a lower incidence of TNSs.", "Transient neurologic symptoms (TNS) are common after lidocaine-induced spinal anaesthesia (SA). Recent data indicate that TNS may be less frequent after prilocaine-induced spinal anaesthesia, for which reason the isobaric solution was compared with lidocaine.\n One hundred patients scheduled for short urologic procedures under spinal anaesthesia were randomised to receive 80 mg prilocaine or lidocaine, both 20 mg/ml. The clinical course and the duration of anaesthesia were monitored. The following day an anaesthesiologist unaware of the randomisation interviewed the patients using a structured questionnaire.\n Following prilocaine spinal anaesthesia the mean time until 2-segment regression was 123(SD 42) min and total sensory block lasted 221(49) min, compared to 106(26) and 181(48) min following lidocaine. TNS occurred in 7/49 patients in the lidocaine group and in 2/50 in the prilocaine group (ns).\n TNS occurred also after isobaric prilocaine SA. The frequency was not significantly different from that following lidocaine SA but larger studies are needed to establish the relative risk of TNS following SA induced by the two local anaesthetics. Isobaric prilocaine has a longer duration of action than an equal dose of lidocaine and may be an alternative drug for spinal anaesthesia of intermediate or short duration.", "Transient Neurological Symptoms (TNS) syndrome following subarachnoid anaesthesia was initially associated with hyperbaric lidocaine 50 mg/ml, but has also been reported with most local anaesthetics, including hyperbaric mepivacaine 40 mg/ml. The aim of this study was to determine the incidence of TNS after subarachnoid anaesthesia using isobaric mepivacaine 20 mg/ml and isobaric lidocaine 20 mg/ml.\n Eighty patients of both sexes, ASA class I-II, scheduled for elective minor orthopaedic surgery under subarachnoid anaesthesia, were prospectively included and randomly allocated to receive 40-60 mg of either isobaric mepivacaine 20 mg/ml (Group M) or isobaric lidocaine 20 mg/ml (Group L). Patients were evaluated on the first postoperative day by one investigator unaware of the grouping, looking for symptoms suggestive of TNS, such as pain or dysaesthesias in the buttocks or lower limbs with or without back pain.\n TNS symptoms were observed in three patients (7.5%) of Group M and in one patient (2.5%) of Group L, without statistically significant differences between the groups. Symptoms had an abrupt onset and relief, lasted from 45 min to 24 h, and had a complete resolution without sequelae. The only statistically significant difference between groups was longer motor blockade in Group M (P=0.0031).\n In this study TNS was associated with isobaric mepivacaine 20 mg/ml, with an incidence of 7.5%, and with isobaric lidocaine 20 mg/ml, with an incidence of 2.5%, in patients having orthopaedic procedures in the supine position.", "Hyperbaric 5% lidocaine has been associated with transient neurologic symptoms (TNSs) after spinal anesthesia. A prospective, masked, randomized study was conducted to compare the incidence of TNSs after spinal anesthesia with hyperbaric 5% lidocaine or 5% prilocaine to assess the utility of prilocaine as an alternative to lidocaine in patients having short surgical procedures.\n The number of patients to be enrolled (100 per group) was determined by power analysis (80%, P = 0.05) considering an incidence of TNSs after spinal anesthesia with lidocaine of at least 11% according to data reported in other studies. Two hundred patients scheduled for elective surgery expected to last <60 min were allocated at random to receive spinal anesthesia with hyperbaric 5% lidocaine or hyperbaric 5% prilocaine. Three to 5 days after spinal anesthesia, all patients were interviewed by an anesthesiologist who was blinded to the group assignment and details of the anesthetic and surgical technique using a standardized symptom checklist. Patients with symptoms underwent neurologic examination.\n Both groups were comparable with regard to demographic data and details of the surgical and anesthetic procedures. The incidence of TNSs in both groups was low and differences were not found (4% in the lidocaine group and 1% in the prilocaine group). The mean age of patients with TNSs (58 yr) was higher than that of patients without TNSs (48 yr; P < 0.05). No relation with any of the other variables was found.\n The low incidence of TNSs among lidocaine-anesthetized patients (4%) may account for the lack of significant differences between hyperbaric 5% lidocaine and 5% prilocaine and to the insufficient power of the study to exclude the possibility of a type II error.", "We investigated the incidence of transient neurologic symptoms (TNS) after the use of hyperbaric lidocaine as compared with hyperbaric bupivacaine in patients undergoing cesarean delivery under spinal anesthesia. Two hundred women scheduled for cesarean delivery were randomly allocated to receive spinal anesthesia with 75 mg hyperbaric lidocaine 5% (n = 100) or 12 mg hyperbaric bupivacaine 0.75% (n = 100). Spinal anesthesia was administered to all patients in the sitting position with a 25-gauge Whitacre needle. The level of sensory blockade, time to full recovery, and intraoperative hemodynamic profile were noted in all patients. The patients were interviewed postoperatively for three consecutive days to detect the occurrence of TNS. The incidence of TNS was zero (95% confidence interval 0%--3%) in both the Lidocaine and the Bupivacaine Groups. Our results indicate that the frequency of postoperative TNS does not exceed 3% in patients undergoing cesarean delivery at term using hyperbaric lidocaine 5% or hyperbaric bupivacaine 0.75%.", "The purpose of this double-blind study was to investigate the incidence of transient neurological symptoms after the use of isobaric lidocaine and isobaric prilocaine for spinal anaesthesia. Seventy patients (ASA 1-2, age between 18 and 70 years) were randomly assigned to two groups of 35 patients each, to receive either isobaric 2% lidocaine 4 ml or isobaric 2% prilocaine 4 ml intrathecally, at the L3-4 interspace. One patient in the prilocaine group could not be included because data were incomplete. On the first postoperative day, patients were evaluated for transient neurological symptoms. Pain was scored on a 10-point scale. Seven patients (20%) in the lidocaine group had transient neurological symptoms with a mean pain score of 5.3, whereas no patient in the prilocaine group had these complaints (p = 0.006). Symptoms disappeared within 4 days. Prilocaine results in a lower incidence of transient neurological symptoms than lidocaine intrathecally and therefore it is more suitable for short surgical procedures." ]

[ "8878223", "2123239", "8849215", "3057159", "3302916", "3923180", "8637789", "15084807", "7559195" ]

[ "Evaluation of the efficacy, safety and toleration of azithromycin vs. penicillin V in the treatment of acute streptococcal pharyngitis in children: results of a multicenter, open comparative study. The Swiss Tonsillopharyngitis Study Group.", "Lack of impact of early antibiotic therapy for streptococcal pharyngitis on recurrence rates.", "Comparative efficacy and safety of 3-day azithromycin and 10-day penicillin V treatment of group A beta-hemolytic streptococcal pharyngitis in children.", "Standardized symptomatic treatment versus penicillin as initial therapy for streptococcal pharyngitis.", "Adverse and beneficial effects of immediate treatment of Group A beta-hemolytic streptococcal pharyngitis with penicillin.", "Effect of antibiotic therapy on the clinical course of streptococcal pharyngitis.", "Rheumatic fever prophylaxis using benzathine penicillin G (BPG): two- week versus four-week regimens: comparison of two brands of BPG.", "Streptococcal-A tonsillopharyngitis: a 5-day course of cefuroxime axetil versus a 10-day course of penicillin V. results depending on the children's age.", "A double-blind randomized trial comparing the efficacy and safety of a 5-day course of cefotiam hexetil with that of a 10-day course of penicillin V in adult patients with pharyngitis caused by group A beta-haemolytic streptococci." ]

[ "For many years alternatives to penicillin have been studied for the management of pediatric group A beta-hemolytic Streptococcus (GABHS) pharyngitis. As a result of its pharmacokinetic profile azithromycin is unique among these alternative antimicrobials in allowing once daily dosing and shorter duration of treatment. However, the optimum dose (e.g. 10 or 12 mg/kg/day) and duration (e.g. 3 or 5 days) of azithromycin therapy have not been defined yet.\n An open, comparative multicenter study was conducted in 343 children with clinical symptoms of GABHS pharyngitis and a positive culture to evaluate the efficacy and safety of azithromycin (10 mg/kg) once daily for 3 days compared with penicillin V three times daily for 10 days.\n Among the evaluable patients bacteriologic eradication documented at follow-up visits was inferior with azithromycin when compared with penicillin V therapy: at Days 9 to 20 (mean, 12 days), negative cultures in 65% (99 of 152 patients) vs. 82% (128 of 126 patients) (P < 0.001); and at Days 17 to 57 (mean, 25 days), in 55% vs. 80% (P < 0.001). Overall clinical success (cure or improvement) was achieved in 93% (149 of 160 patients) of azithromycin-treated and in 89% (143 of 160 patients) of penicillin-treated patients (P > 0.50). There was no correlation between bacteriologic response and clinical outcome, as assessed shortly after completion of therapy or during 6-month follow-up. Both treatments were well-tolerated.\n In the present study on GABHS pharyngitis in children, a once daily (10-mg/kg), 3-day oral regimen of azithromycin was as clinically effective and as safe as traditional penicillin but appeared inferior in eliminating GABHS from the throat.", "To determine whether recurrence rates for group A beta-hemolytic streptococcal (GABHS) pharyngitis are related to the time of initiation of antibiotic therapy, we randomly assigned 113 patients with GABHS pharyngitis either to a group that began a 10-day course of penicillin V at the time of diagnosis or to a group that began the same antibiotic regimen after a dealy of 48 hours. Follow-up throat culture specimens were obtained 4 days, 2 months, and 4 months after the completion of antibiotic therapy, as well as during any interim episodes of acute pharyngitis. Serotyping of all GABHS isolates was performed to distinguish between recurrences with homologous serotypes and new acquisitions with heterologous serotypes. There was no significant difference between the two treatment groups in age, gender, duration of illness before enrollment in the study, initial clinical presentation, or compliance. Of the 50 patients in the immediate-treatment group, 6 (12%) had homologous serotypes of GABHS isolated on one of the follow-up throat cultures. Of the 63 patients in the delayed-treatment group, 9 (14%) had homologous serotypes of GABHS isolated on one of the follow-up throat cultures. These data indicate that a 48-hour delay in the initiation of penicillin therapy for GABHS pharyngitis does not reduce the recurrence rate.", "The efficacy and safety of a 3-day course of azithromycin oral suspension (10 mg/kg of body weight once daily) were compared with those of penicillin V (50,000 U/kg/day in two divided doses) in children aged 3 to 12 years for the treatment of symptomatic pharyngitis caused by the group A beta-hemolytic streptococcus (GABHS). For the 154 evaluable patients, the original infecting strain of GABHS was eliminated at the end of follow-up (34 to 36 days after treatment started) from 67 (85.8%) of 78 penicillin-treated patients and 41 (53.9%) of 76 azithromycin-treated patients (P < 0.0001). Overall clinical success was achieved in 71 (91.0%) of 78 penicillin V-treated patients and 57 (75.0%) of 76 azithromycin-treated patients (P < 0.05). Potential drug-related adverse events were reported for 5.5 and 8.6% of the penicillin V- and azithromycin-treated patients, respectively (P = 0.6). In the present study, a once-daily (10 mg/kg), 3-day oral regimen of azithromycin was as safe as a 10-day course of penicillin but did not represent an effective alternative to penicillin for the treatment of GABHS pharyngitis, even for those children with azithromycin-susceptible strains.", "A multicenter, double-blind, randomized, placebo-controlled trial was conducted to determine whether the addition of penicillin was superior to patient education and anti-inflammatory drug therapy for relief of the acute discomforts of pharyngitis caused by group A beta-hemolytic streptococcus (GABHS). One hundred seventy-eight patients, aged 4 to 29 years, received appropriate symptomatic therapy, including specific doses of aspirin or acetaminophen, plus penicillin (91 patients) or placebo (87) for the initial 48 hours of illness. All had 24-hour office and 48-hour telephone reevaluations. In 123 patients (57 with clinically severe pharyngitis), throat cultures yielded GABHS. Penicillin provided a margin of 20% improvement over anti-inflammatory therapy for the complaint of sore throat only after 48 hours of treatment (for the 123 patients with GABHS, p = 0.01; for the 57 with both severe pharyngitis and GABHS, p = 0.05). No significant improvement was noted for fever, malaise, odynophagia, exudate, adenitis, or pharyngitis. The failure of penicillin to provide much additional benefit makes its routine early prescription specifically for symptomatic relief questionable.", "One hundred forty-two children with presumed Group A beta-hemolytic streptococcal (GABHS) pharyngitis were enrolled in a randomized double blind prospective study comparing the consequences of immediate penicillin treatment with treatment delayed for 48 to 56 hours. One hundred fourteen of the enrolled patients were culture-positive. An adverse impact of early antibiotic therapy was noted; the incidence of subsequent infections with GABHS was significantly greater in those treated at the initial office visit with penicillin. In the month following documented evaluation of GABHS, a recurrence occurred 2 times more frequently in those treated with penicillin immediately compared with those for whom treatment was delayed 48 to 56 hours. Late recurrences (beyond 1 month but in the same streptococcal season) occurred 8 times more frequently (P less than 0.035). Delay in penicillin treatment did not increase GABHS intrafamilial spread. Symptoms of both groups were assessed for 2 days following the initiation of treatment. Both placebo-treated and penicillin-treated groups used aspirin or acetaminophen ad libitum. Penicillin was shown to reduce fever and relieve sore throat, dysphagia, headache, abdominal pain, lethargy and anorexia significantly beyond that achieved with aspirin or acetaminophen alone. Penicillin had no effect on culture-negative cases.", "We examined the effect of antibiotic therapy on the clinical course of group A beta-hemolytic streptococcal (GABHS) pharyngitis in 260 children. After a throat culture had been obtained, each child was evaluated for the presence of predetermined signs and symptoms, and was then randomized in a double-blind manner to receive penicillin V, cefadroxil, or placebo. Of the 194 children with throat cultures positive for GABHS, 68 received penicillin V, 70 received cefadroxil, and 56 received placebo. Approximately 18 to 24 hours later, each patient returned for reevaluation. Significantly fewer children who had received either penicillin or cefadroxil had persistence of each of the three objective signs and each of the three subjective symptoms than did children who had received placebo. In addition, the evaluating physician, parents, and patients all believed that significantly fewer of the patients given antibiotic failed to demonstrate overall clinical improvement.", "This prospective study was aimed at answering two important questions: 1) Is a biweekly schedule of 1.2 million U intramuscular benzathine penicillin G (BPG) superior to a 4-week one in the prevention of upper respiratory Group A beta-hemolytic streptococcal (GABHS) infections and rheumatic fever (RF) recurrences? 2) Is there a difference in the bioavailability of BPG obtained from different manufacturers?\n Three hundred sixty rheumatic patients aged 4 to 20 years were randomly assigned to either a biweekly (190 patients) or 4-week (160 patients) BPG prophylactic schedule and were followed-up monthly for 2 years by clinical examination, throat swab culture for GABHS and measurement of antistreptolysin O titer to detect GABHS infection and/or recurrences of RF (according to revised Jones' Criteria). Thereafter, 34 rheumatic subjects, aged 8 to 16 years were randomly assigned to receive a 4-week injection of 1.2 million U of either a locally manufactured BPG brand (22 patients) or an imported one (12 patients). Sera of all patients were tested for penicillin level by plate diffusion method on days 1, 2, 3, 4, 5, 6, 7, 14, 21, and 28 after the intramuscular injection of BPG.\n The GABHS infection rate was found to be 0.2% and 0.3% for patients on the biweekly and 4-week BPG schedules, respectively, with no significant differences between them. However, the RF recurrence rate/patient/year for the 4-week schedule patients (0.12) was double that for the biweekly schedule ones (0.06). Estimation of the bioavailability of the two different brands of BPG demonstrated a difference in their pharmacokinetics and a decrease in the serum penicillin concentration below the minimum inhibitory concentration 3 weeks after the injection of either brand.\n Although a biweekly schedule may not be superior in preventing upper respiratory GABHS infection, it may play a role in preventing the sequelae of such infections. The short duration of penicillinemia explains the superiority of the 2-week schedule in RF prophylais. The difference in the pharmacokinetics of penicillin brands might contribute to the high recurrence rate of RF reported in Egypt.", "The recommended duration of antibiotic treatment of tonsillopharyngitis caused by group A beta-hemolytic streptococci (GABHS) with penicillin V (PenV) is mostly 10 days. However, compliance with 10-day courses is bad. Shorter therapeutic courses are necessary, especially in young children.\n In a prospective, randomized, multi-center study, children aged 1-17 years with acute tonsillopharyngitis and a positive culture for GABHS were treated with cefuroxime axetil (CAE) 20 mg/kg/day (max. 500 mg) b.i.d. for 5 days or with PenV 50,000 IU/kg (30 mg/kg) t.i.d. for 10 days. Patients were evaluated for clinical efficacy 2-4 and 7-9 days after the end of therapy. Throat swabs were taken 2-4 days after the end of therapy and at the first follow-up visit. Follow-up visits were carried out 7-8 weeks, 6 months and 12 months after study inclusion.\n 1,952 patients (CAE for 5 days, 496 patients/PenV for 10 days, 1,456 patients) could be included in the intent-to-treat analysis. Two to 4 days after completion of the treatment course, the bacteriological eradication in group A (1-5 years) and group B (6-17 years) was 90.52 and 89.53% (CAE) vs. 84.13 and 84.20% (PenV), respectively; p = 0.0172; 0.0382; clinical success was 98.30% (CAE) versus 93.25% (PenV), p = 0.0017. Recurrent infections were significantly higher in younger children (group A) under both treatment regimens. Poststreptococcal sequelae (glomerulonephritis) were observed in only 1 case, in the PenV group.\n CAE b.i.d. for 5 days was at least as effective as PenV t.i.d. for 10 days. Incountries with a low incidence of rheumatic fever, CAE for 5 days can be recommended for the therapy of tonsillopharyngitis due to GABHS - also in young children.\n Copyright 2004 S. Karger AG, Basel", "A 10-day course of penicillin is the antibiotic regimen currently recommended by the American Heart Association (AHA) as treatment for patients with tonsillitis caused by group A beta-haemolytic streptococci (GABHS), with the aim of preventing both the suppurative and non-suppurative complications of this infection. This prospective, multicentre, randomized, double-blind, double-dummy clinical trial was undertaken in order to compare the efficacy of, tolerability of and compliance with a 5-day course of cefotiam hexetil (CTM) 200 mg bd with that of a 10-day course of penicillin V (PEV) 1 megaunit (600 mg) tds, to investigate the significance of recovering GABHS during or after treatment and to evaluate the potential economic advantages of short-term regimens. Two hundred and fifty ambulatory adult patients with a presumptive diagnosis (based on a positive rapid antigen detection test) of GABHS tonsillitis were recruited in 60 centres; the diagnosis was subsequently confirmed by a positive culture of a throat swab. At the time of entry into the trial there was no statistically significant difference between the groups in terms of clinical symptoms. In an intention-to-treat analysis, both the clinical and bacteriological response rates at days 10 and 30 were comparable for each group i.e. 106 of 119 (89.1%) patients and 90 of 109 (82.6%) patients respectively in the CTM group and 103 of 117 (88.0%) patients and 92 of 107 (86.0%) patients respectively in the PEV group. The times until defervescence and resolution of symptoms were also similar. Of the 115 patients in each group who were assessed at day 90, there were three clinical relapses in the CTM group and seven in the PEV group. No non-suppurative complications of GABHS infection were detected. Tolerance was significantly better in the CTM group than in the PEV group, 14 of 119 (11.8%) patients and 26 of 117 (22.2%) patients in the former and latter groups respectively reporting adverse events. In three cases in each group treatment was discontinued prematurely because of adverse events; none of these in the CTM group was serious but one patient in the PEV group experienced a severe allergic reaction. Compliance in both groups was good during the first 5 days of therapy but, by the end of each course, 93.6% of patients in the CTM group had completed treatment, compared with 73.0% in the PEV group.(ABSTRACT TRUNCATED AT 400 WORDS)" ]

[ "7724098", "9351414", "6378516", "299462", "8191328", "6586395", "4533699", "2905287", "7726651" ]

[ "Second-trimester abortion by intramuscular 15-methyl-prostaglandin F2 alpha or intravaginal prostaglandin E2 suppositories: a randomized trial.", "Effects of prostaglandin treatment and paracervical blockade on postoperative pain in patients undergoing first trimester abortion in general anesthesia.", "Randomized comparison of prostaglandin treatment in hospital or at home with vacuum aspiration for termination of early pregnancy.", "Use of prostaglandin, hypertonic saline and oxytocin for second-trimester abortion.", "Mid-trimester termination of pregnancy--a randomised controlled trial of two prostaglandin regimens.", "Randomized trial of intracervical prostaglandin E2 gel and intraamniotic prostaglandin F2 alpha for induction of second trimester abortion.", "Prostaglandin F2alpha and oxytocin compared with hypertonic saline and oxytocin for the induction of second trimester abortion.", "Intracervical administration of prostaglandin E2-gel prior to therapeutic abortion: a prospective randomized double-blind study.", "Gemeprost for first trimester missed abortion." ]

[ "To compare intramuscular (IM) prostaglandin 15 methyl-F2 alpha (15M-PGF2 alpha) with prostaglandin E2 (PGE2) vaginal suppositories for second-trimester abortion in terms of efficacy and side effects.\n Fifty-one women were randomized to receive either 15M-PGF2 alpha IM injections or PGE2 intravaginal suppositories for second-trimester abortion. Efficacy and side effects of the two agents were analyzed by two-tailed t tests, chi 2 analysis with Fisher exact test, and survival analysis.\n The mean times to rupture of membranes, delivery of fetus, and delivery of placenta were significantly less for women receiving PGE2 vaginal suppositories. The cumulative abortion rate after 24 hours for the PGE2 group was 96%, compared with 69% for the 15M-PGF2 alpha group. Although there were few differences in side effects, the 15M-PGF2 alpha group had significantly fewer headaches, fevers, and chills.\n Intravaginal PGE2 is superior to IM 15M-PGF2 alpha for second-trimester abortion.", "The postoperative analgesic efficacy of a paracervical blockade (PCB) as an adjunct to general anesthesia (GA) during outpatient abortion (dilatation and curettage) is unclear, and the present study was initiated to evaluate if PCB is of significant importance per- or postoperatively.\n Two hundred women (aged 18-49 years) were assigned to one of four groups; group 1 received vaginal prostaglandin (PG) (PGE1, gemeprost 1 mg) for softening of the cervix preoperatively and surgery was performed in GA, group 2 received preoperative PG and surgery was performed in GA + PCB; group 3 did not receive PG treatment and surgery was performed in GA and group 4 were subjected to GA + PCB without preoperative PG.\n Women receiving preoperative prostaglandin treatment (groups 1 and 2) reported significantly higher pain intensity already preoperatively, but also postoperatively as compared to patients not treated with PG. The patients subjected to prostaglandin treatment (groups 1 and 2) also had a significantly higher consumption of analgesics as compared to non-PG treated groups (3 and 4). The addition of PCB did not influence pre- and postoperative pain intensity significantly or consumption of analgesics. Patients receiving PG also reported significantly more nausea than the others although nausea was of low intensity. Patients receiving PG were, however, discharged earlier than the others from the hospital.\n Preoperative treatment of the cervix with prostaglandins was associated with significantly higher pain intensity both pre- and postoperatively, and increased need for analgesics postoperatively and more intense nausea. PCB given just before surgery did not result in significant postoperative analgesia. More efficient techniques for pain control should be developed for women subjected to first trimester abortion with preoperative PG treatment.", "In the present study the efficacy and the acceptability of vaginal administration of a prostaglandin E analogue (9-deoxo-16, 16-dimethyl-9-methylene-PGE2) in hospital or at home were randomly compared with vacuum aspiration for termination of very early pregnancy. Prerequisites for acceptance of the patients were a normal pregnancy, a duration of amenorrhea of 49 days or less, at least one previous full-term pregnancy, and a healthy status. Fifty-three patients fulfilled these criteria and adhered to the protocol. Seventeen patients were treated with prostaglandin at home, 18 with prostaglandin in the hospital (9-methylene-PGE2, 50 to 60 mg twice at 6-hour intervals), and 18 with vacuum aspiration. Each patient was interviewed twice by a trained female psychologist before the treatment and two weeks after. Both the surgical and the nonsurgical methods (at home and in the hospital) were found to be equally effective in terms of frequency of complete abortion. Prostaglandin therapy was associated with a higher frequency of gastrointestinal side effects, pain, and a longer duration of bleeding than was the surgical procedure. The acceptability study showed that prostaglandin treatment was positively received. The patients who were treated with prostaglandin remained very positive after the abortion; a majority of these patients intended to use the same procedure in case of a repeated abortion, and would also recommend the treatment to a relative or a friend. The results of the present study indicate that termination of early pregnancy by a medical method, even if self-administered, is an acceptable procedure at least in selected patients. Further efforts to improve the treatment seem therefore justified.", "The management of second-trimester abortion is still not satisfactory with respect to safety and side-effects; it is considered to be in a state of evolution. The goal of this investigation has been to combine, in reduced quantity, prostaglandin and hypertonic saline in order to minimize the complications and side-effects associated with the separate administration of each component. This study documents the results of a random sample of 385 abortions performed in the second trimester, induced by intra-amniotic instillation of prostaglandin (20 mg) and NaCl 5 and 10 g in different volumes and concentrations augmented with oxytocin. In a series of 20 patients, the coagulation profile is presented and the clinical characteristics of 4 groups are compared. This study demonstrated no coagulation defects. The gastrointestinal side-effects were reduced. In spite of the reduced dosage of each component, the instillation abortion interval still remained 17.08 h on the average. Incomplete abortion ranged from 32% to 48.78%. The data presented in this report suggests that combination of prostaglandin, hypertonic saline and oxytocin is feasible for midtrimester abortion.", "To determine the more applicable of two ways of prostaglandin induction currently in use in second trimester induced abortions for congenital or chromosomal abnormalities.\n A prospective randomised controlled trial.\n Department of Obstetrics and Gynaecology, Tygerberg Hospital, CP.\n Twenty consecutive patients admitted for termination of pregnancy for congenital or chromosomal abnormalities between 14 and 26 weeks' pregnancy duration.\n Patients were randomly selected to receive either 1.5 mg prostaglandin E2 (PGE2) gel extra-amniotically or 25 mg prostaglandin F2 alpha (PGF2 alpha) intra-amniotically. Patients in both groups received oxytocin to a maximum dosage of 120 mU per minute if they had not aborted 18 hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 hours after commencement of treatment, management was considered unsuccessful.\n Proportion of successful inductions and complications.\n Complications of management were rare and did not differ between the two management groups. However, there were significantly more failures in the group who received intra-amniotic PGF2 alpha (7 v. 2 patients) as well as a significantly higher need for oxytocin in this group (10 v. 4 patients).\n With promising drugs such as prostaglandin analogues and anti-progesterones not universally available, methods of induction suitable to the local situation should be sought. Extra-amniotic PGE2 seems more suitable than intra-amniotic PGF2 alpha because of a shorter induction-to-delivery time without increased morbidity.", "For the purpose of reducing the side effects and complication rate when inducing second trimester abortion, intracervically administered PGE2 gel was tested for the first time and compared with a single intraamniotic instillation of PGF2 alpha by a randomized allocation of 41 consecutive patients in the 13th to 24th week of gestation. In both groups the treatment was supplemented with oxytocin 5 - 6 hours after starting the induction. The methods proved of equal value as regards the abortion success rate and the induction-abortion interval, whereas the incidence of gastrointestinal side effects on intracervical application of PGE2 gel was only half as high and the occurrence of diarrhea significantly lower (p less than 0.05) with this non-invasive method than with intraamniotic PGF2 alpha. Intracervical PGE2 gel also possessed other advantages, being int. al. more acceptable by the patients and technically easier to administer.", "Second trimester abortion was induced in a randomized investigation using a single dose of prostaglandin F2alpha (PGF2alpha) in combination with oxytocin in one group of patients, and hypertonic saline (20%) in combination with oxytocin in another group of patients. Oxytocin was administered in order to induce a rapid abortion, and was given intravenously in a glucose drip (100 I.U. oxytocin added to 1 litre of 5% glucose). Administration rate was 10 I.U./hour. The PG-group consisted of 16 patients. The mean induction-abortion interval for this group was 14.2 hours, and all patients aborted within 24 hours. In three cases the bleeding exceeded 200 ml. In one of these cases infection occurred. Only mild side effects occurred. The saline group also consisted of 16 patients. The mean induction-abortion interval in this group was 21.5 hours. Eleven patients aborted within 24 hours. In two cases the bleeding exceeded 200 ml. No side effects occurred. Intraamniotic instillation of PGF2alpha seems to be a good alternative to hypertonic saline for termination of second trimester pregnancies.", "Forty primigravid women due to undergo first trimester termination of pregnancy were randomly selected for intracervical application of 1 mg prostaglandin E2 in gel or gel only as placebo. In the PGE2-gel group, a marked dilatation of the cervical canal was obtained, with post-gel treatment mean Hegar dilatation of 11.18 mm in that group, compared to 4.4 mm in the control group (P 0.001). Moreover, 16 (80%) patients in the PGE2-gel group had a complete abortion, one (5%) patient had an incomplete abortion and in the remaining three (15%) patients, fetal demise was observed. The mean induction-abortion interval in this group was 7.5 h. In the placebo group, none of the above effects were observed. The only side effect noted was vomiting, which occurred in five (25%) of the patients in the PGE2-gel group. Termination of pregnancy was found to be easier in the PGE2-gel group, compared to the placebo group.", "In 87 patients with a missed abortion prior to 13 weeks, the application of a prostaglandin (PG) E1 derivative (1 mg gemeprost, Cergem) was compared to conventional surgical termination of pregnancy by cervical dilatation and curettage. In 33 patients with PGE1 application, complete expulsion of the abnormal pregnancy occurred after an average of 2.8 +/- 1.5 vaginal suppositories. PGE1 treatment was effective in 76.7%, and surgical management was effective in 90.9% of patients. Sixty percent of the patients in the PGE1 group required analgesia because of uterine pain in comparison to 4.5% in the surgical group. The possibility of medical termination with synthetic PG derivatives should be further investigated." ]

[ "18434189", "10549990", "19462303", "17511748", "11825860", "21990176", "17165363", "10093649", "12681528" ]

[ "An open randomized study of the treatment of escitalopram alone and combined with gamma-hydroxybutyric acid and naltrexone in alcoholic patients.", "Gamma-hydroxybutyric acid (GHB) in the treatment of alcohol withdrawal syndrome: a randomized comparative study versus benzodiazepine.", "Gamma-hydroxybutyric acid versus clomethiazole for the treatment of alcohol withdrawal syndrome in a medical intensive care unit: an open, single-center randomized study.", "Oxcarbazepine--efficacy and tolerability during treatment of alcohol withdrawal: a double-blind, randomized, placebo-controlled multicenter pilot study.", "Double-blind controlled trial of gamma-hydroxybutyrate and clomethiazole in the treatment of alcohol withdrawal.", "Treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial.", "Comparing treatments of alcoholism on craving and biochemical measures of alcohol consumptionst.", "[Gamma-hydroxybutyrate for treatment of alcohol withdrawal syndrome in intensive care patients. A comparison between with two symptom-oriented therapeutic concepts].", "Gamma-hydroxybutyric acid versus naltrexone in maintaining alcohol abstinence: an open randomized comparative study." ]

[ "gamma-hydroxybutyric acid (GHB) and the selective serotonin reuptake inhibitor escitalopram are effective in inducing and maintaining abstinence in alcohol. Naltrexone (NTX), an opioid antagonist, may be effective in preventing relapse in alcohol-dependent subjects. To evaluate whether each drug and its combination help to maintain alcohol abstinence, we determined the relapse rate over 6 months in 3 groups of patients. Group 1 (11 patients) received escitalopram (20 mg/day) orally administered; group 2 (12 patients) received NTX (50 mg/day) and escitalopram (20 mg/day); group 3 (12 patients) received GHB (75 mg/kg body weight) and escitalopram (20 mg/day); and group 4 (12 patients) received NTX (50mg/day) plus GHB (75 mg/kg) and escitalopram (20 mg/day). All groups received psychological support and underwent urine tests for alcohol metabolites twice a week. In group 1 (escitalopram only), 6 patients relapsed within 3 months and 3 after 6 months; whereas 2 patients remained abstinent. In group 2 (SSRI+NTX), 5 patients relapsed after 3 months and 3 after 6 months; whereas 4 patients remained abstinent. In group 3 (GHB+SSRI), 3 patients relapsed after 3 months and 3 after 6 months; whereas 6 patients remained abstinent. Finally, in group 4 (NTX+GHB+SSRI), 1 patient relapsed after 3 months and 1 after 6 months, whereas 10 patients remain abstinent. In conclusion, the combination of NTX+GHB+SSRI was the most effective in preventing relapses.", "Benzodiazepine has been shown to be one of the most effective class of drugs in the management of alcohol withdrawal syndrome (AWS). Gamma-hydroxybutyric acid (GHB) has recently been introduced in the treatment of alcohol problems, including AWS. At present there are no comparative studies between benzodiazepines and GHB in AWS treatment. The aim of the present randomized, controlled, single-blind study was to evaluate the efficacy and safety of GHB compared with diazepam in the treatment of AWS.\n Sixty alcoholics affected by AWS were enrolled in the study. Diazepam (0.5-0.75 mg/kg body weight for 6 days, tapering the dose 25% daily until day 10) was administered orally to 30 patients (25 males, 5 females; mean age 44.3 +/- 10.9 years); GHB (50 mg/kg body weight for 10 days) was administered orally to 30 patients (26 males,4 females; mean age 41.7 +/- 10.4 years). The Clinical Institute Withdrawal Assessment for Alcohol-revised scale (CIWA-Ar) was used to evaluate the AWS physical symptoms. The State Anxiety Inventory test for current anxiety assessment and the Zung self-rating Depression Scale for current depression assessment were performed.\n Eight patients (26.6%) in the diazepam group and 4 patients (13.3%) in the GHB group dropped out. Both treatments were effective in reducing AWS. No significant difference was found between the groups in CIWA-Ar total score at baseline and at the different times of observation. Considering the CIWA-Ar subscore and Zung scale, a significant reduction of anxiety on day 4 (p < 0.02), agitation on day 5 (p < 0.02) and time of recovery of depression on day 5 (p < 0.02) was observed in the GHB group with respect to the diazepam group. Drowsiness and vertigo developed after initial drug administration in the GHB (19.2%) and diazepam (36.4%) groups and quickly resolved in both groups.\n GHB is as effective in the management of AWS as benzodiazepine and it seems to be quicker in reducing anxiety, agitation, and depression. Both drugs are safe and well-tolerated in AWS management.", "Clomethiazole (CLO) has been shown to be effective in treating alcohol withdrawal syndrome (AWS). Gamma-Hydroxybutyric acid (GHB) has also been introduced in the treatment of alcoholic patients and is effective in surgical intensive care unit (ICU) patients in preventing and treating AWS. There are no comparative studies between CLO and GHB in a medical ICU setting.\n Twenty-six alcoholic patients with severe AWS and concomitant medical diseases were randomally enrolled in the study. CLO was given orally to 12 patients in a dosage of 250 mg every 4 hours as a liquid; GHB (initially 30 mg/kg body weight (BW) followed by 15 mg/kg BW) was administered intravenously to 14 patients. Four major AWS symptoms (tremor, sweating, nausea, restlessness) were scored, and the administration of additional medication was registered.\n GHB was more effective in treating AWS symptoms. In the GHB group, AWS score dropped from 6.6 +/- 2.6 to 1.8 +/- 2.1 (p <.01), while in the CLO group, the score dropped from 6 +/- 2.5 to 4.1 +/- 2.4 (n. s.). Differences between groups were significant (p =.021, two-way ANOVA). The treatment did not alter outcome or the duration of ICU stay. No serious side effects were detected.\n GHB effectively controls AWS symptoms in medical ICU patients. The rapid initial treatment response of GHB in contrast to CLO has no influence on duration of patient withdrawal.", "Alcohol withdrawal syndrome (AWS) is a serious complication of alcohol dependence and often requires intensive medical treatment. Antiepileptic drugs (AEDs) have been shown to be as efficacious in the treatment of AWS in several controlled trials as benzodiazepines and superior to placebo in relieving alcohol withdrawal symptoms. Oxcarbazepine (OXC), a newer anticonvulsive drug, has a favorable safety profile over carbamazepine (CBZ) and other older AEDs due to its excellent efficacy and better side-effect profile.\n The efficacy and tolerability of OXC versus placebo were investigated in 50 inpatients during a 6-day treatment of alcohol withdrawal in a 4-site, double-blind, randomized, placebo-controlled pilot study. The amount of rescue medication of clomethiazole (CLO) capsules needed was chosen as the primary variable. The data were collected between May 2003 and September 2004.\n No initial differences were found regarding sociodemographic data and alcohol-related parameters, indicating successful randomization. No differences were found in the need for rescue medication CLO, decrease of withdrawal symptoms, or craving for alcohol between the OXC and the placebo group. Subjectively experienced side effects, normalization of vegetative parameters, craving, or improvement of psychopathological parameters were not different between the groups.\n Despite the negative finding, which may be attributable to the design of the study, OXC still poses an interesting alternative to CBZ and other drugs because other studies have found it not only as efficient but also as having no addictive potential, while additionally possessing an anti-craving effect. Therefore, well-designed investigations with larger cohorts are required to further elucidate this issue.", "The aim of this double-blind, comparative study was to assess the efficacy and safety of gamma-hydroxybutyrate (GHB) in ameliorating the symptoms of alcohol withdrawal. Newly admitted alcohol-dependent patients (n = 98) were randomized to receive either clomethiazole 1000 mg daily (CLO group) (n = 33), or 50 mg GHB/kg body wt (n = 33) or 100 mg GHB/kg body wt (n = 32). This dose was administered for 5 days, halved on day 6, and on days 7 and 8 only placebo was given. As CLO is available as capsules and GHB as syrup, a double-dummy method was used to try to ensure blindness. The groups were matched in terms of baseline demographic and alcohol-related variables. There was no difference between the three treatments in ratings of alcohol withdrawal symptoms nor requests for additional medication. After tapering off the active medication, there was no increase in withdrawal symptoms, indicating that physical tolerance did not develop to either GHB or CLO within the 5-day treatment period. The most frequently reported side-effect of GHB was transient vertigo, particularly after the evening double dose.", "Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS).\n To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS.\n Prospective, randomized, double-blind, placebo-controlled clinical study.\n Two tertiary-care hospitals in Duluth, Minnesota.\n Inpatient adults admitted for any reason (including AWS) judged to be at high risk for AWS.\n Inpatients who developed symptoms of AWS received symptom-triggered benzodiazepine treatment using lorazepam by standard protocol, and were randomized to receive baclofen 10 mg or placebo, 3 times per day, orally.\n AWS severity was assessed using the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar); lorazepam dose was monitored.\n Seventy-nine subjects were enrolled. The 44 subjects who developed symptoms of AWS were randomized to baclofen or placebo. Thirty-one subjects (18 baclofen, 13 placebo) completed 72 hours of assessments, either entirely as inpatients or with outpatient follow-up. The need for high doses of benzodiazepines (20 mg or more of lorazepam over 72 hours) to control AWS was less likely in the baclofen treatment group (1 of 18) than in the placebo-treated group (7 of 13) (P = 0.004).\n We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low-dose baclofen in the management of AWS deserves further study, as reduced dependence on high-dose benzodiazepines in AWS management could improve patient safety.\n Copyright © 2011 Society of Hospital Medicine.", "An open randomized study was conducted to compare different treatments of alcoholism on ethanol intake, craving, and on biochemical measures of alcohol consumptions. Eighty-six alcoholics were abstinent for a mean of two weeks prior to random assignment to g-hydroxybutyrate (GHB, 50 mg/kg of body weight t.i.d), naltrexone (NTX, 50 mg/day) or disulfiram (DSF, 200 mg/ day) treatment for 12 months. All treatments were equally effective in reducing alcohol intake and in maintaining abstinence. In all patients, the treatments were able to reduce both craving and the altered biological markers of alcohol abuse. The maximum effects were observed in GHB-treated patients. The results of the present study suggest that GHB might act both as anticraving and cellular protector agent.", "Seeing as gamma-hydroxybutyrate (GHB) and benzodiazepines interact with the GABA-transmitter system, we investigated whether GHB can replace the conventional therapy, which uses benzodiazepines in the treatment of alcohol withdrawal syndrome in ICU settings.\n 42 chronic alcoholics were included in this prospective and randomized study. Following the development of alcohol withdrawal syndrome, the patients were randomly allocated to the GHB or to the flunitrazepam group. In addition to this, clonidine was administered in order to treat autonomic signs of withdrawal. In cases were hallucinations occurred, haloperidol was administered.\n There was no significant difference in the efficacy of treatment used in the duration of mechanical ventilation and intensive care unit stay between groups. The patients in the GHB-group required significantly higher dosages of haloperidol and significantly lower dosages of clonidine. 14 out of 21 patients from the GHB-group developed hypernatriaemia and 15 out of 21 developed a metabolic alkalosis.\n Symptoms of the autonomic nervous system were more effectively prevented by GHB as evident in the lower dosage requirement of clonidine. However, GHB may not sufficiently block the hyperactivity of the dopaminergic system or may have an hallucinogenic effect itself. This may be evident from the higher dosages of haloperidol which were necessary. Due to the latter fact, the administration of GHB cannot be recommended in all patients suffering from AWS in ICU settings.", "Maintaining abstinence from alcohol is the main goal in the treatment of alcohol dependence. Naltrexone (NTX) and gamma-hydroxybutyric acid (GHB) have proved able to maintain alcohol abstinence in alcoholic subjects. The aim of our study was to evaluate the efficacy of GHB compared with NTX in maintaining abstinence from alcohol after 3 months of treatment. A total of 35 alcohol-dependent outpatients were randomly enrolled in two groups: the GHB group consisted of 18 patients treated with oral doses of GHB (50 mg/kg of body weight t.i.d) for 3 months; the NTX group consisted of 17 patients treated with oral doses of NTX (50 mg/day) for 3 months. At the end of the study, a statistically significant difference (P=0.02) was found in the number of abstinent patients between the GHB and the NTX groups. In patients who failed to be abstinent, no relapses in heavy drinking were observed in the NTX group, while in the GHB group all patients relapsed. The results of the present study show that GHB is more effective than NTX in maintaining abstinence from alcohol in a short-term treatment period; on the other hand, NTX confirmed its ability to reduce alcohol relapses." ]

[ "15297305", "11533321", "10645510", "16389536", "17403764", "12069673", "3200183", "12623317", "10790817" ]

[ "Effectiveness of a multiple intervention to reduce antibiotic prescribing for respiratory tract symptoms in primary care: randomised controlled trial.", "A community intervention trial to promote judicious antibiotic use and reduce penicillin-resistant Streptococcus pneumoniae carriage in children.", "An evaluation of statewide strategies to reduce antibiotic overuse.", "Changing antibiotics prescribing practices in health centers of Khartoum State, Sudan.", "Barriers to optimal antibiotic use for community-acquired pneumonia at hospitals: a qualitative study.", "Changes in antibiotic prescribing for children after a community-wide campaign.", "Changing antibiotic prescribing by educational marketing.", "Impact of a multidisciplinary approach to the control of antibiotic prescription in a general hospital.", "Pilot study for appropriate anti-infective community therapy. Effect of a guideline-based strategy to optimize use of antibiotics." ]

[ "To assess the effectiveness of a multiple intervention aimed at reducing antibiotic prescription rates for symptoms of the respiratory tract in primary care.\n Randomised controlled trial.\n Twelve peer review groups including 100 general practitioners with their collaborating pharmacists in the region of Utrecht, Netherlands.\n The intervention consisted of group education meetings, with a consensus procedure on indication for and type of antibiotics and with training in communication skills; monitoring and feedback on prescribing behaviour; group education for assistants of general practitioners and pharmacists; and education material for patients. The control group did not receive any of these elements.\n Antibiotic prescription rates for acute symptoms of the respiratory tract and patients' satisfaction.\n 89 general practitioners completed the study (89%). At baseline, prescription rates for antibiotics for respiratory tract symptoms did not differ between intervention and control group (27% v 29%, respectively). After nine months, the prescription rates in the intervention group fell to 23%, whereas the control group's rose to 37% (mean difference in change -12%, 95% confidence interval -18.9% to -4.0%). Multilevel analysis confirmed the results of the unadjusted analysis (intervention effect -10.7%, -20.3% to -1.0%). Patients' satisfaction was high and did not differ in the two groups at baseline or after the intervention.\n A multiple intervention reduced prescribing rates of antibiotics for respiratory tract symptoms while maintaining a high degree of satisfaction among patients. Further research should focus on the sustainability and cost effectiveness of this intervention.", "Inappropriate use of antibiotics is common in primary care, and effective interventions are needed to promote judicious antibiotic use and reduce antibiotic resistance. The objective of this study was to assess the impact of parent and clinician education on pediatric antibiotic prescribing and carriage of penicillin-nonsusceptible Streptococcus pneumoniae in child care facilities.\n A nonrandomized, controlled, community intervention trial was conducted in northern Wisconsin Clinicians. Clinic staff received educational materials and small-group presentations; materials were distributed to parents through clinics, child care facilities, and community organizations. Prescribing data were analyzed for 151 clinicians who provided primary pediatric care; nasopharyngeal carriage of penicillin-nonsusceptible S pneumoniae was assessed for 664 children in the baseline period (January-June 1997) and for 472 children in the postintervention period (January-June 1998).\n The median number of solid antibiotic prescriptions per clinician declined 19% in the intervention region and 8% in the control region. The median number of liquid antibiotic prescriptions per clinician declined 11% in the intervention region, compared with an increase of 12% in the control region. Retail antibiotic sales declined in the intervention region but not in the control region. Among participating children in child care facilities, there were no significant differences in antibiotic use or penicillin-nonsusceptible S pneumoniae colonization between the intervention and control regions.\n A multifaceted educational program for clinicians and parents led to community-wide reductions in antibiotic prescribing, but in child care facilities, there was no apparent impact on judicious antibiotic use or colonization with drug-resistant S pneumoniae. Longer follow-up time or greater reductions in antibiotic use may be required to identify changes in the pneumococcal susceptibility.", "The rapid increase of antibiotic resistance poses a significant threat to human health. Overuse of antibiotics has been linked to rates of antibiotic resistance. This study assessed the utility of two common interventions--1) practice profiling and feedback and 2) patient education materials--implemented to decrease antibiotic prescribing for pediatric upper respiratory infections (URIs).\n Based on Medicaid regions in Kentucky, primary care physicians managing pediatric respiratory infections in Medicaid were randomized into four groups. Groups received either 1) performance feedback only, 2) patient education materials only, 3) both feedback and education materials, or 4) no intervention. Participating physicians had their antibiotic prescribing assessed for the period of July 1, 1996, to November 30, 1997, with an intervention in June 1997. The study included 216 physicians and 124,092 episodes of care.\n All groups increased in proportion of episodes with antibiotics between the pre-intervention and post-intervention periods. Prescribing in the patient education group and the patient education and feedback group increased at a significantly lower rate than in the control group. Physicians did not change their coding of illness to justify antibiotics after the intervention, and there was no significant generalization of effect of the pediatric intervention on prescribing for adult URIs.\n These interventions demonstrate little if any impact on promoting appropriate antibiotic prescribing. Antibiotic prescribing for viral respiratory infections continues to increase, suggesting concomitant increases in antibiotic resistance.", "A major problem with inappropriate use of antibiotics is the emergence of resistance. Thus, cost-effective interventional strategies are required to improve their use. This study aimed to evaluate the effect of multifaceted interventions on prescribing practices of antibiotics in health centers of Khartoum State, Sudan.\n Twenty health centers were randomly assigned to receive: (1) no intervention; (2) audit and feedback; (3) audit and feedback + seminar; or (4) audit and feedback + academic detailing. A total of 1,800 patient encounters, 30 from each health center, were randomly collected. The total number of encounters with antibiotics prescribed were determined in each health center and they were evaluated with regard to antibiotic choice, dose and duration of therapy before the study and at 1 and 3 months post-intervention.\n In comparison to the control group, the prescriber targeted interventions involving audit and feedback, together with academic detailing (4), reduced the mean number of encounters with an antibiotic prescribed by 6.3 and 7.7 (p<0.001) at 1 and 3 months post-intervention, respectively. In addition, the mean number of encounters with an inappropriate antibiotic with respect to diagnosis, doses and/ or duration of therapy was reduced by 5.3 and 5.9 (p<0.001) at 1 and 3 months post-intervention, respectively. For audit and feedback together with seminars (3) and for audit and feedback alone (2), the corresponding reductions were 5.3, 7.1, 4.4 and 5.1 (p<0.001) and 1.4, 2.8, 1.8 and 1.9 (p>0.05), respectively.\n Inappropriate prescribing patterns of antibiotics in health centers of Khartoum State, Sudan, are alarmingly high. Multifaceted interventions involving audit and feedback combined with either academic detailing or seminars appear more effective in changing prescribing practices of antibiotics than audit and feedback alone.", "Physician adherence to key recommendations of guidelines for community-acquired pneumonia (CAP) is often not optimal. A better understanding of factors influencing optimal performance is needed to plan effective change.\n The authors used semistructured interviews with care providers in three Dutch medium-sized hospitals to qualitatively study and understand barriers to appropriate antibiotic use in patients with CAP. They discussed recommendations about the prescription of empirical antibiotic therapy that adheres to the guidelines, timely administration of antibiotics, adjusting antibiotic dosage to accommodate decreased renal function, switching and streamlining therapy, and blood and sputum culturing. The authors then classified the barriers each recommendation faced into categories using a conceptual framework (Cabana).\n Eighteen interviews were performed with residents and specialists in pulmonology and internal medicine, with medical microbiologists and a clinical pharmacist. Two additional multidisciplinary small group interviews which included nurses were performed. Each guideline recommendation elicited a different type of barrier. Regarding the choice of guideline-adherent empirical therapy, treating physicians said that they worried about patient outcome when prescribing narrow-spectrum antibiotic therapy. Regarding the timeliness of antibiotic administration, barriers such as conflicting guidelines and organisational factors (for example, delayed laboratory results, antibiotics not directly available, lack of time) were reported. Not streamlining therapy after culture results became available was thought to be due to the physicians' attitude of \"never change a winning team\".\n Efforts to improve the use of antibiotics for patients with CAP should consider the range of barriers that care providers face. Each recommendation meets its own barriers. Interventions to improve adherence should be tailored to these factors.", "Overuse of antibiotics has contributed to microbial resistance, compromising the treatment of bacterial infections. Very high levels (>50%) of antibiotic resistance among invasive Streptococcus pneumoniae have been documented in Knox County, Tennessee.\n To determine the effectiveness of a community-wide intervention aimed at reducing inappropriate antibiotic use among children.\n The Knox County Health Department led a multifaceted year-long campaign (May 1997 through April 1998) aimed at decreasing unnecessary antibiotic use among children. Tennessee's 3 other major urban counties (Shelby, Hamilton, and Davidson) did not conduct similar campaigns and served as controls. Evaluation included white and black children (aged <15 years) enrolled in Tennessee's Medicaid Managed Care Program in the 4 study counties, representing 36% of the study counties' children (464 200 person-years observed).\n Educational efforts were directed toward health care practitioners (primarily via peer leader presentations) and to the parents of young children and the public (primarily via printed materials).\n The intervention-attributable effect on antibiotic use, defined as the excess percentage change in oral antibiotic prescription rates in Knox County between the 12-month preintervention and postintervention periods, relative to that of control counties.\n Antibiotic prescription rates declined 19% and 8% among Knox County and control county children, respectively, yielding an 11% intervention-attributable decline (95% confidence interval, 8%-14%; P<.001). The intervention-attributable decrease in prescription rates was greatest among children aged 1 to less than 5 years (among white children, 8% [P<.001]; among black children, 18% [P<.001]).\n A community-wide educational intervention reduced antibiotic prescription levels among children in Knox County.", "A controlled cross-over study in 12 Victorian public hospitals was performed to examine the power of marketing techniques in influencing prescribing. The targeted prescribing behaviour was the use of antibiotic prophylaxis in surgery, and the criteria for judging the appropriateness of therapy were its duration and timing, as are detailed in the fourth edition of the booklet Antibiotic guidelines. The first intervention was mounted in 1985 in six hospitals (two metropolitan teaching hospitals, one suburban general hospital and three rural hospitals), and six matched hospitals acted as control hospitals. One year later, the intervention was mounted in the six hospitals that previously had been the control hospitals. The interventional campaign consisted of material that was similar to that which is used by the pharmaceutical industry, including an \"academic\" representative. Its effect was assessed by audits that were performed before and after the first interventional campaign and again, one year later, after the second interventional campaign. The proportion of antibiotic courses that were assessed as satisfactory in terms of duration increased significantly after the first campaign in the hospitals where the intervention was mounted. No significant changes in prescribing occurred in the control hospitals. In the hospitals which were control hospitals in 1985, and in which the intervention occurred in 1986, the proportion of antibiotic courses that were assessed as satisfactory also increased significantly after the interventional campaign. A fall-off in performance occurred during the 12 months after the campaign in the 1985-interventional hospitals. Calculated cost savings more than outweighed the costs of the campaign. We conclude that inappropriate prescribing behaviour in hospitals can be modified successfully by educational marketing techniques.", "We examined the impact of a rational antibiotic prescription programme based on a multidisciplinary consultative approach in a 600-bed hospital. The programme involved four measures: (1). drawing up of a local prescribing consensus with all prescribers; (2). a restricted prescriptions policy for the most expensive antibiotics; (3.assessment of the prescription of these antibiotics by regular audits; and (4). institutional training and information for prescribers. The impact of the programme was assessed by comparing actual prescriptions with the criteria of the local consensus, compliance with the restrictive prescription policy, changes in the average daily cost of antibiotic therapy per inpatient and changes in the local ecology of methicillin-resistant Staphylococcus aureus (MRSA), Enterobacteriaceae producing extended-spectrum beta-lactamases (EPESB) and ceftazidime-resistant Pseudomonas species (CRP). Using a participatory consensual approach, 182 reference recommendations were established (104 for adults, 78 for children), corresponding to 85% of the clinical settings encountered in the hospital. Six audits, conducted since June 1997, show that the rate of unjustified prescriptions first fell significantly (from 6 to 0%, P<0.001), then increased significantly (from 0 to 3%, P<0.05) before stabilizing at 3%. The cost of antimicrobials per inpatient day fell significantly (from US dollars 13.8 in 1997 to US dollars 11 in 2000, P<0.001). The prevalence of MRSA and CRP remained stable, while that of EPESB fell significantly (P<0.001). This multidisciplinary consultative approach thus reduced antibiotic costs, contributed to infection control, and improved the quality of antibiotic prescription.", "To determine whether a community-wide, multi-intervention educational strategy (CoMPLI model) could enhance adoption of clinical guidelines and improve the use of antibiotics.\n Before-after trial using baseline and study periods with a control group.\n A small community in central Ontario.\n Health professionals, the general public, and the pharmaceutical industry.\n The educational strategy (CoMPLI), carried out during 6 winter months, consisted of continuing medical education sessions for health professionals and pharmaceutical representatives and a parallel public education campaign that included town hall meetings and pamphlets distributed by local pharmacists. The two main messages were: do not use antibiotics for viral respiratory infections, and use drugs recommended in the publication, Anti-infective Guidelines for Community-Acquired Infections.\n Total number of antibiotic claims and adjusted odds ratios (OR) were used to measure the likelihood of physicians prescribing first- or second-line agents compared with the previous year and compared with control physicians.\n Claims in the study community decreased by nearly 10% during the 6-month study period compared with the baseline period from the previous year. Study physicians were 29% less likely (OR-1 = 0.71, range 0.67 to 0.76) to prescribe second-line antibiotics during the study period than physicians in the rest of the province.\n Physicians participating in the pilot study were more likely to follow drug recommendations outlined in published guidelines." ]

[ "19767384", "18715214", "19132857", "16801571", "20711715", "15595336", "20587585", "12728068", "21294770" ]

[ "Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study.", "Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study.", "Patient-reported outcomes for an integrated real-time continuous glucose monitoring/insulin pump system.", "Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial.", "Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment.", "Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial.", "Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes.", "Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study.", "Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial." ]

[ "To compare the improvements in glycemic control associated with transitioning to insulin pump therapy in patients using continuous glucose monitoring versus standard blood glucose self-monitoring.\n The RealTrend study was a 6-month, randomized, parallel-group, two-arm, open-label study of 132 adults and children with uncontrolled type 1 diabetes (A1C >or=8%) being treated with multiple daily injections. One group was fitted with the Medtronic MiniMed Paradigm REAL-Time system (PRT group), an insulin pump with integrated continuous subcutaneous glucose monitoring (CGM) capability, with instructions to wear CGM sensors at least 70% of the time. Conventional insulin pump therapy was initiated in the other group (continuous subcutaneous insulin infusion [CSII] group). Outcome measures included A1C and glycemic variability.\n A total of 115 patients completed the study. Between baseline and trial end, A1C improved significantly in both groups (PRT group -0.81 +/- 1.09%, P < 0.001; CSII group -0.57 +/- 0.94%, P < 0.001), with no significant difference between groups. When the 91 patients who were fully protocol-compliant (including CGM sensor wear >or=70% of the time) were considered, A1C improvement was significantly greater in the PRT group (P = 0.004) (PRT group -0.96 +/- 0.93%, P < 0.001; CSII group -0.55 +/- 0.93%, P < 0.001). Hyperglycemia parameters decreased in line with improvements in A1C with no impact on hypoglycemia.\n CGM-enabled insulin pump therapy improves glycemia more than conventional pump therapy during the first 6 months of pump use in patients who wear CGM sensors at least 70% of the time.", "The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems.\n This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >or=7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated.\n A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P<0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P=0.0456). Fourteen severe hypoglycemic events occurred (11 in the SG group and three in the CG group, P=0.04).\n A1C reduction was no different between the two groups. Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use; however, there was no increase in hypoglycemia AUC or number of events in the SG group. Subjects with greater sensor utilization showed a greater improvement in A1C levels.", "A 16-week, two-site study evaluated outcomes for a new device (the Paradigm 722 System, Medtronic MiniMed, Northridge, CA) that combines a \"smart\" continuous subcutaneous insulin infusion (CSII) pump with real-time (RT) continuous glucose monitoring (CGM) and CareLinktrade mark data management software (DMS).\n CSII-naive adults with type 1 diabetes in suboptimal control (mean glycosylated hemoglobin [A1C] = 8.6%) were randomized to the control arm, consisting of multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG), or the study arm (CSII with RT-CGM as an adjunct to SMBG). Participants (n = 28) completed the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and the parallel Blood Glucose (BG) Monitoring System Rating Questionnaire (BGMSRQ) at study start and end. Participants in the study arm (n = 14) also completed newly developed User Acceptance Questionnaires (UAQs) for CSII, RT-CGM, and DMS at study end.\n A1C reduction from study start to end was significant (P < 0.05) in both arms (-1.7% for study arm;-1.0% for control arm); there was no significant change in weight in either arm. The IDSRQ showed significantly (P < 0.05) greater benefit for the study arm in convenience, acceptability of BG monitoring requirements, BG control efficacy, diabetes worries, and interpersonal hassles, as well as higher overall satisfaction/preference. The BGMSRQ showed significantly (P < 0.05) greater benefit for the study arm in the BG monitoring system's ability to help manage glycemic control and less interest in changing to another BG monitoring system. The Study Arm UAQs showed positive ratings of system features.\n Several patient-reported outcomes were significantly more positive in the study arm than the control arm; none was significantly more positive in the control arm. The features of the integrated RT-CGM/CSII system were frequently used and highly rated by participants, with high user satisfaction.", "This randomized controlled trial assesses the effect on glycemic control of continuous glucose monitoring system (CGMS)-guided insulin therapy adjustment in young people with type 1 diabetes on intensive diabetes treatment regimens with continuous subcutaneous insulin infusion (CSII) or glargine.\n Pediatric subjects were recruited if they had an HbA(1c) (A1C) <10% and had been on CSII or glargine for at least 3 months. Thirty-six subjects were randomized to insulin adjustment on the basis of 72 h of CGMS every 3 weeks or intermittent self-monitoring of blood glucose (SMBG) for 3 months. A1C and fructosamine were measured at baseline and 6 and 12 weeks. Follow-up A1C was measured at 6 months. Mean baseline A1C was 8.2% (n = 19) in the CGMS group and 7.9% (n = 17) in the control group.\n There was a significant improvement in A1C from baseline values in both groups, but there was no difference in the degree of improvement in A1C at 12 weeks between the CGMS (-0.4% [95% CI -0.7 to -0.1]) and the control group (-0.4% [-0.8 to 0.2]). In the CGMS group, improved A1C was at the cost of increased duration of hypoglycemia.\n CGMS is no more useful than intermittent fingerstick SMBG and frequent review in improving diabetes control in reasonably well-controlled patients on near-physiological insulin regimens when used in an outpatient clinic setting.", "The value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined.\n A total of 160 children (aged 1-16 years, mean ± SD: 8.7 ± 4.4 years; 47.5% girls) were randomised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements. The primary outcome was the level of HbA(1c) after 12 months. Other analyses included fasting C-peptide, glycaemic variability, sensor usage, adverse events, children's health-related quality of life and parent's wellbeing.\n HbA(1c) was not significantly different between the two groups, but patients with regular sensor use had lower values (mean 7.1%, 95% CI 6.8-7.4%) compared with the combined group with no or low sensor usage (mean 7.6%, 95% CI 7.3-7.9%; p=0.032). At 12 months, glycaemic variability was lower in the sensor group (mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7; p=0.037). Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients (0.25 ± 0.12 nmol/l) compared with those treated with insulin pump alone (0.19 ± 0.07 nmol/l; p=0.033). Severe hypoglycaemia was reported only in the group without sensors (four episodes).\n Sensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children, although regular sensor use is a prerequisite for improved glycaemic control.\n ISRCTN.org ISRCTN05450731\n Medtronic International Trading Sàrl, Tolochenaz, Switzerland.", "To show improved glycemic control in patients with insulin-treated diabetes after adjustments to the diabetes management plan based on either continuous glucose monitoring using the Continuous Glucose Monitoring System (CGMS) or frequent self-monitoring of blood glucose (SMBG) using a home blood glucose meter.\n From January to September 2000, patients aged 19 to 76 years with insulin-treated diabetes were assigned to insulin therapy adjustments based on either CGMS or SMBG values. At the end of the study, patients in both groups used the CGMS for 3 days; these values were used to calculate measures of hypoglycemia. Repeated-measures analysis of variance with post hoc comparisons were used to test differences in hemoglobin A1c levels and hypoglycemia between the 2 study groups.\n A total of 128 patients were enrolled in the study. Nineteen discontinued study participation, leaving 51 in the CGMS group and 58 in the SMBG group. No significant differences were noted in demographics or baseline characteristics between the 2 groups. There were no significant differences in hemoglobin A1c levels between the CGMS group and the SMBG group at baseline (9.1% +/- 1.1% vs 9.0% +/- 1.0%, P = .70), and both groups showed statistically significant (P < .001) and similar (P = .95) improvement in hemoglobin A1c levels after 12 weeks of study. However, the CGMS group had a significantly shorter duration of hypoglycemia (sensor glucose, < or = 60 mg/dL) at week 12 of the study (49.4 +/- 40.8 vs 81.0 +/- 61.1 minutes per event, P = .009).\n Use of the CGMS to guide therapy adjustments in patients with insulin-treated diabetes reduces the duration of hypoglycemia compared with therapy adjustments guided by SMBG values alone.", "Recently developed technologies for the treatment of type 1 diabetes mellitus include a variety of pumps and pumps with glucose sensors.\n In this 1-year, multicenter, randomized, controlled trial, we compared the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes. Patients received recombinant insulin analogues and were supervised by expert clinical teams. The primary end point was the change from the baseline glycated hemoglobin level.\n At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group.\n In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (Funded by Medtronic and others; ClinicalTrials.gov number, NCT00417989.)\n 2010 Massachusetts Medical Society", "To improve metabolic control and prevent complications, both acute and late, we need to adjust treatment on the basis of the blood glucose (BG) profile, as not even the most active BG self-monitoring gives sufficient information.\n We have used Continuous Glucose Monitoring System (CGMS; Medtronic MiniMed, Northridge, CA) in a controlled crossover study including 27 diabetic patients aged 12.5 +/- 3.3 (mean; standard deviation; range: 5-19) years. All patients were treated with intensive insulin therapy, 14 with multiple injections, and 13 with pumps. The patients were randomized into an open or blind study arm. Both arms wore the CGMS sensor for 3 days every 2 weeks. CGMS profiles were used in the open study arm to adjust insulin therapy at follow-up visits every 6 weeks. Both the patients and the diabetes team were masked to the CGMS profiles in the blinded arm, and insulin therapy adjustments were based solely on 7-point BG profiles performed by the patients. At 3 months the 2 study arms were crossed over.\n Despite initial problems with a device new to both patients and the diabetes team, hemoglobin A(1)C decreased significantly in the open arm (from 7.70%-7.31%) but not in the blind arm (7.75%-7.65%). A total of 26/27 patients experienced daytime low subcutaneous glucose (<3.0 mmol/L;.8 episodes/day; duration 58 +/- 29 minutes; 5.5% of total time), and 27/27 patients had at least 1 nocturnal episode of low subcutaneous glucose (.4 episodes/night; duration 132 +/- 81 minutes; 10.1% of total time).\n Use of CGMS facilitated an improved treatment, and patients received new insight and increased motivation. In this study, we found CGMS to be a useful tool for education and improving metabolic control.", "To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes.\n In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed.\n The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group.\n Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections.\n © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK." ]

[ "16317669", "20073212", "8855091", "8841797", "15143715", "16965225", "22695903", "12585148", "9453428" ]

[ "Intrahepatic cholestasis of pregnancy: a randomized controlled trial comparing dexamethasone and ursodeoxycholic acid.", "[Effect of integrative Chinese and Western medicine in treating pregnant women with intrahepatic cholestasis].", "Ursodeoxycholic acid therapy in pregnant women with cholestasis.", "S-adenosylmethionine versus ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: preliminary results of a controlled trial.", "[Analysis on therapeutic effect of Western and Chinese drug in treating intrahepatic cholestasis pregnancy].", "Randomized prospective comparative study of ursodeoxycholic acid and S-adenosyl-L-methionine in the treatment of intrahepatic cholestasis of pregnancy.", "Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial.", "[Observation on effect of danxiaoling in supplementary treatment of intrahepatic cholestasis in pregnancy].", "Ursodeoxycholic acid in the treatment of cholestasis of pregnancy: a randomized, double-blind study controlled with placebo." ]

[ "Intrahepatic cholestasis of pregnancy (ICP) is characterized by troublesome maternal pruritus, elevated serum bile acids (> or =10 micromol/L) and increased fetal risk. Recently we determined a cutoff level of serum bile acids, > or =40 micromol/L, to be associated with impaired fetal outcome. We have now studied the effects of ursodeoxycholic acid (UDCA) and dexamethasone on pruritus, biochemical markers of cholestasis, and fetal complication rates in a double-blind, placebo-controlled trial. For this purpose, 130 women with ICP were randomly allocated to UDCA (1 g/day for three weeks), or dexamethasone (12 mg/day for 1 week and placebo during weeks 2 and 3), or placebo for 3 weeks. Pruritus and biochemical markers of cholestasis were analyzed at inclusion and after 3 weeks of treatment. Fetal complications (spontaneous preterm delivery; asphyxial events; and meconium staining of amniotic fluid, placenta, and membranes) were registered at delivery. An intention-to-treat analysis showed significant reduction of alanine aminotransferase (ALT) (P = .01) and bilirubin (P = .002) in the UDCA group only. In a subgroup analysis of ICP women with serum bile acids > or =40 micromol/L at inclusion (n = 34), UDCA had significant effects on pruritus (-75%), bile acids (-79%), ALT (-80%), and bilirubin (-50%) as well, but not on fetal complication rates. Dexamethasone yielded no alleviation of pruritus or reduction of ALT and was less effective than UDCA at reducing bile acids and bilirubin. In conclusion, 3 weeks of UDCA treatment improved some biochemical markers of ICP irrespective of disease severity, whereas significant relief from pruritus and marked reduction of serum bile acids were only found in patients with severe ICP.", "To evaluate the therapeutic effect of compound salvia injection combined with ursodeoxycholic acid (UDCA) in treating pregnant women with intrahepatic cholestasis (ICP) and its influence on perinatal babies.\n One hundred and twenty-eight patients of ICP were assigned to two groups. The 72 patients in the treatment group were treated with salvia injection (20 mL in 10% glucose 500 mL for intravenous dripping once a day) and UDCA (15 mg, thrice daily by oral taken), and the 56 patients in the control group were treated with UDCA alone, all were treated for 14 days. Changes of itching symptom (estimated by scoring) and serum levels of biochemical indexes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (TBil) and glycocholic acid (GCA), were determined before and after treatment, and conditions of the newborns were compared after delivery.\n Compared with before treatment, scores of itching were lowered from 3.6 scores to 1.4 scores in the treatment group, and from 3.4 scores to 1.6 scores in the control group, showing no significant difference between groups (P > 0.05), but the lowering was shown earlier in the former. Levels of biochemical indexes were improved significantly (P < 0.01) in both groups, but the improvements were more significant in the treatment group, the difference between groups was significant (P < 0.05). The difference between groups in the incidence of fetal distress, meconium-stained fluid and neonatal asphyxia were insignificant (P > 0.05). The birth weights of the newborns were higher in the treatment group than in the control group (3,108 +/- 236 g vs 2,681 +/- 269 g, P < 0.05).\n The combined therapy of compound salvia injection and UDCA shows better effect in treating ICP than that of UDCA alone.", "To test the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of intrahepatic cholestasis of pregnancy (ICP) by a randomized, double-blind, placebo-controlled trial.\n Eight patients with pruritus and abnormal liver function tests received 600 mg/day of UDCA in two doses for 20 days, compared with a control group of eight patients who received placebo for 20 days.\n No adverse reactions were detected in any patient. During UDCA therapy a statistically significant improvement in pruritus, serum bile salt levels, serum glutamic pyruvic transaminase, alkaline phosphatase, gamma-glutamyl transpeptidase and total and direct bilirubin was observed. Only two patients treated with UDCA underwent cesarean sections due to reasons unrelated to the therapeutic trial. All newborns had an Apgar score >7 and normal postnatal growth.\n Although the number of patients in this study was very small, we suggest that UDCA treatment has a role in improving clinical and biochemical results in ICP.", "To evaluate the efficacy of S-adenosylmethionine (SAMe) and ursodeoxycholic acid (UDCA) in intrahepatic cholestasis of pregnancy (ICP).\n Twenty patients in the last trimester of pregnancy were randomly assigned to receive either SAMe (1000 mg/day i.m.) or UDCA (450 mg/day) until delivery; the treatment lasted at least 15 days in all cases.\n After UDCA the women exhibited significantly lower levels of total bile acids (P < 0.02), but no significant differences were noted in AST, ALT, or alkaline phosphatase. All ten patients showed a complete resolution of pruritus. After SAMe no significant changes were noted in pruritus, total bile acids or liver function tests. No adverse reactions on mother or child were recorded during either UDCA or SAMe treatment and the outcome of pregnancy was favorable in both groups.\n These findings show that UDCA is more effective than SAMe in controlling pruritus and total bile acids, which are considered a prognostic parameter in ICP with respect to the fetus. Nevertheless, before UDCA is introduced as an effective and safe treatment for ICP, which also has a beneficial effect on fetal prognosis, we believe these results should be confirmed and extended in other clinical trials.", "To evaluate the therapeutic effect of Yinchenghao decoction (YCHD) and S-adenosy-L-methionine (SAM) in treating intrahepatic cholestasis of pregnancy (ICP) and improving prognosis of perinatal newborn babies.\n Sixty in-patients of ICP were randomly divided into two groups, the group A treated with YCHD and the group B treated with SAM. The symptom of itching and serum biochemical indexes, including glycocholic acid, bilirubin and transaminase, were observed after 3 weeks treatment, and the prognosis of perinatal newborn babies between the two groups was compared after delivery.\n After treatment, the symptom of itching, serum levels of glycocholic acid, bilirubin and transaminase improved significantly (P < 0.05) in both groups, and the prognosis of newborn in the two groups was similar (P > 0.05).\n Both YCHD and SAM could effectively treat ICP. The former is rather cheaper, so it is more feasible for spreading.", "To compare the efficacy of the ursodeoxycholic acid (UDCA) and S-adenosyl-L-methionine (SAMe) monotherapy with their combined effect on intrahepatic cholestasis of pregnancy (ICP).\n We studied singleton pregnancies at <36 weeks with a moderate or severe form of ICP between January 1999 and March 2004. Patients were randomized to either oral UDCA 3x250 mg daily or 500 mg SAMe twice daily in slow running infusion for twelve days followed by oral administration of 500 mg twice daily until delivery. Intensive hematological, biochemical and fetal monitoring were carried out.\n Of the 78 women enrolled, 25 received SAMe monotherapy, 26 received UDCA, and 27 received combined therapy. Groups were initially comparable in terms of gestational age, duration of therapy, parity and biochemical characteristics. All therapies improved the pruritus. The combined therapy and the monotherapy with UDCA (later) led to improving of the serum concentrations of bile acids and transaminases compared with SAMe monotherapy (P<0.01). Combined therapy led to a faster decrease of serum concentrations of bile acids and transaminases compared with UDCA monotherapy (borderline significance). Gestational ages were similar in all groups. No adverse effects were noted on the fetuses or neonates with either therapy.\n UDCA is an effective drug in the treatment of ICP, and combined with SAMe, has probably a synergistic effect on biochemical parameters. This mode of treatment seems more effective but the effect of the successful treatment on the fetus is unclear. Therefore, the ante- and intrapartum monitoring of the fetus should be part of the management of severe forms of ICP. The project is supported by IGA MZ CR (No. NH/7376-3).", "To test whether ursodeoxycholic acid reduces pruritus in women with intrahepatic cholestasis of pregnancy, whether early term delivery does not increase the incidence of caesarean section, and the feasibility of recruiting women with intrahepatic cholestasis of pregnancy to trials of these interventions.\n First phase of a semifactorial randomised controlled trial.\n Nine consultant led maternity units, United Kingdom.\n 125 women with intrahepatic cholestasis of pregnancy (pruritus and raised levels of serum bile acids) or pruritus and raised alanine transaminase levels (>100 IU/L) recruited after 24 weeks' gestation and followed until delivery. 56 women were randomised to ursodeoxycholic acid, 55 to placebo, 30 to early term delivery, and 32 to expectant management.\n Ursodeoxycholic acid 500 mg twice daily or placebo increased as necessary for symptomatic or biochemical improvement until delivery; early term delivery (induction or delivery started between 37+0 and 37+6) or expectant management (spontaneous labour awaited until 40 weeks' gestation or caesarean section undertaken by normal obstetric guidelines, usually after 39 weeks' gestation).\n The primary outcome for ursodeoxycholic acid was maternal itch (arithmetic mean of measures (100 mm visual analogue scale) of worst itch in past 24 hours) and for the timing of delivery was caesarean section. Secondary outcomes were other maternal and perinatal outcomes and recruitment rates.\n Ursodeoxycholic acid reduced itching by -16 mm (95% confidence interval -27 mm to -6 mm), less than the 30 mm difference prespecified by clinicians and women as clinically meaningful. 32% (14/44) of women randomised to ursodeoxycholic acid experienced a reduction in worst itching by at least 30 mm compared with 16% (6/37) randomised to placebo. The difference of 16% (95% confidence interval -3 to 34); this would represent a number needed to treat of 6, but it failed to reach significance. Early term delivery did not increase caesarean sections (7/30 (23%) in the early term delivery group versus 11/32 (33%) in the expectant management group (relative risk 0.70, 95% confidence interval 0.31 to 1.57). No serious harms were noted in either trial. 22% (73/325) of eligible women participated in the drug trial and 19% (39/209) in the timing of delivery trial; both groups had a similar spectrum of disease severity to non-participants.\n Ursodeoxycholic acid significantly reduces pruritus, but the size of the benefit may be too small for most doctors to recommend it, or for most women to want to take it. Women are, however, likely to differ in whether they consider the benefit to be worthwhile. Planned early term delivery seems not to increase incidence of caesarean section, although a small increase cannot be excluded. A trial to test whether ursodeoxycholic acid reduces adverse perinatal outcomes would have to be large, but is feasible. A trial to test the effect of early term delivery on adverse fetal outcomes would have to be significantly larger and may not be feasible.\n Current Controlled Trials ISRCTN37730443.", "To evaluate the curative effect of Danxiaoling Pill (DXLP), a Chinese herbal preparation, in treating intrahepatic cholestasis in pregnancy (ICP).\n Fifty-eight cases of ICP were divided randomly into two groups and treated by DXLP and Composite Yiganling as control respectively with the other identical conventional treatment. The changes of clinical symptoms, related laboratory parameters after treatment and the condition of labor were observed.\n The total effective rate in both groups was 100%, but the markedly effective rate in the DXLP treated group was higher than that in control group (P < 0.01). Levels of blood cholyglycine acid (CGA), alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, total cholesterol and low density lipoprotein were all decreased in both groups after treatment, but DXL showed a better efficacy in decreasing CGA, ALT and AST than that of Yiganling. Moreover, the amniotic fluid meconium contaminated rate, premature delivery occurrence in the DXLP group were lower than those in the control group, while the weight of newborn baby was higher in the former than in the latter.\n DXLP could effectively lower the serum bile acid and improve liver function in treating ICP.", "Intense pruritus and the risk of stillbirths and premature deliveries justify the search for an effective pharmacologic treatment of intrahepatic cholestasis of pregnancy. This study was designed to test the efficacy of ursodeoxycholic acid in maternal pruritus, the biochemical abnormalities and the outcome of pregnancy, in patients with intrahepatic cholestasis of pregnancy of early onset.\n Pregnant patients hospitalized in a secondary case-referral center with intense pruritus and abnormal serum levels of bile salts and aminotransferases, detected before week 33 of pregnancy, were randomly assigned to receive ursodeoxycholic acid, 1 g per day orally, or an identical placebo, until delivery, in a double-blind study. A 3-week trial period was chosen to compare drug and placebo effects. The follow-up was extended for 3 months after delivery.\n Twenty-four patients entered the trial; eight had deliveries before 2 weeks of treatment and one dropped out. The study was then completed in 15 patients: eight received ursodeoxycholic acid and seven placebo. No adverse effects were detected in the mothers or in their babies. After 3 weeks of treatment, patients receiving ursodeoxycholic acid (mean daily dose 16 mg/kg body weight) had a significant improvement in pruritus (p<0.02), in serum bilirubin (0.36+/-0.19 mg/dl (mean+/-SD) versus 0.95+/-0.48 in patients receiving placebo, p<0.01), in aspartate aminotransferase (52+/-42 IU/l vs 98+/-44, p<0.05) and in alanine aminotransferase (54+/-50 IU/l vs 229+/-154, p<0.01); serum total bile salts also tended to be lower in patients receiving ursodeoxycholic acid (26.3+/-33.7 micromol/l vs 55.0+/-44.8, p N.S.). Deliveries occurred at or near term in all mothers who received ursodeoxycholic acid (mean week of pregnancy: 38), while they occurred before week 36 of pregnancy in five patients who received placebo, including one stillbirth. All babies born alive had birth weights adequate for gestational age and they were thriving normally 3 months after delivery.\n Ursodeoxycholic acid is effective and safe in patients with intrahepatic cholestasis of pregnancy of early onset, attenuating pruritus and correcting some biochemical abnormalities in the mothers. Relevant aspects of fetal outcome were also improved in patients receiving ursodeoxycholic acid compared to placebo." ]

[ "10379017", "8625660", "11243949", "9713447", "10343624", "10542974", "10095821", "11050258", "10359405" ]

[ "Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. Department of Veterans Affairs Cooperative Study Group.", "Effects of long-term treatment with corticosteroids in COPD.", "Systemic glucocorticoids in severe exacerbations of COPD.", "Randomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary disease.", "Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis.", "The effect of high-dose fluticasone propionate and budesonide on lung function and asthma exacerbations in patients with severe asthma.", "The response to inhaled and oral steroids in patients with stable chronic obstructive pulmonary disease.", "Randomized controlled trial of supported discharge in patients with exacerbations of chronic obstructive pulmonary disease.", "Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial." ]

[ "Although their clinical efficacy is unclear and they may cause serious adverse effects, systemic glucocorticoids are a standard treatment for patients hospitalized with exacerbations of chronic obstructive pulmonary disease (COPD). We conducted a double-blind, randomized trial of systemic glucocorticoids (given for two or eight weeks) or placebo in addition to other therapies, for exacerbations of COPD. Most other care was standardized over the six-month period of follow-up. The primary end point was treatment failure, defined as death from any cause or the need for intubation and mechanical ventilation, readmission to the hospital for COPD, or intensification of drug therapy.\n Of 1840 potential study participants at 25 Veterans Affairs medical centers, 271 were eligible for participation and were enrolled; 80 received an eight-week course of glucocorticoid therapy, 80 received a two-week course, and 111 received placebo. About half the potential participants were ineligible because they had received systemic glucocorticoids in the previous 30 days. Rates of treatment failure were significantly higher in the placebo group than in the two glucocorticoid groups combined at 30 days (33 percent vs. 23 percent, P=0.04) and at 90 days (48 percent vs. 37 percent, P=0.04). Systemic glucocorticoids (in both groups combined) were associated with a shorter initial hospital stay (8.5 days, vs. 9.7 days for placebo, P=0.03) and with a forced expiratory volume in one second that was about 0.10 liter higher than that in the placebo group by the first day after enrollment. Significant treatment benefits were no longer evident at six months. The eight-week regimen of therapy was not superior to the two-week regimen. The patients who received glucocorticoid therapy were more likely to have hyperglycemia requiring therapy than those who received placebo (15 percent vs. 4 percent, P=0.002).\n Treatment with systemic glucocorticoids results in moderate improvement in clinical outcomes among patients hospitalized for exacerbations of COPD. The maximal benefit is obtained during the first two weeks of therapy. Hyperglycemia of sufficient severity to warrant treatment is the most frequent complication.", "To determine the effectiveness of treatment with corticosteroids in patients with COPD.\n In this study, we investigated the effect of a 2-year treatment with corticosteroids on clinical symptoms and the decline of lung function in 58 nonallergic patients with COPD. Subjects were treated in a double-blind, randomized, placebo-controlled, parallel way with inhaled budesonide (bud), 1,600 micrograms/d; inhaled budesonide, 1,600 micrograms/d, plus oral prednisolone, 5 micrograms/d (bud + pred); or placebo (plac). Clinical assessment (history, physical examination, and spirometry) was carried out every 2 months. The rate of decline in FEV1 was assessed by calculating individual regression co-efficients from linear regression of FEV1 on time for each subject.\n Eleven patients dropped out. The number of withdrawals due to pulmonary problems was significantly higher in the plac group (n = 5 out of 18) than in the actively treated groups (n = 2 out of 40). Treatment with corticosteroids significantly reduced pulmonary symptoms. Median decline of FEV1 was 60 mL/yr in the plac group, 40 mL/yr in the bud + pred group, and 30 mL/yr in the bud group. Variation was large and differences were not statistically significant. No treatment effect was found on frequency or duration of exacerbations, possibly because of the high number of withdrawals due to pulmonary deterioration in the plac group. Treatment with a combination of inhaled plus oral corticosteroids was not more effective than inhaled corticosteroids alone. Morning plasma cortisol levels remained within the normal range in all three groups.\n Our study shows beneficial effects of long-term daily treatment with inhaled corticosteroids in patients with COPD with regard to symptoms and drop out due to pulmonary problems. Lung function decline tends to decrease during treatment with inhaled corticosteroids. The observed effects are limited but warrant further studies on the effectiveness of corticosteroids in larger numbers of patients with COPD.", "This study aimed to compare the efficacies of 3-day and 10-day courses of methylprednisolone (MP) treatment in severe COPD exacerbations necessitating hospitalization for respiratory failure.\n Prospective, randomized, single-blind study.\n Tertiary-care center.\n Thirty-six patients were included in the study and randomized into two groups: group 1 received MP, 0.5 mg/kg q6h for 3 days, and group 2 was administered the same dosage of MP for the first 3 days, after which it was tapered and terminated on the tenth day. There was no difference between the groups for age, baseline FEV(1), PaO(2), PaCO(2), and pH levels. One patient in group 1 who developed pneumothorax and one patient in group 2 who had steroid-related psychosis could not complete the study.\n Both groups showed significant improvements in PaO(2) and FEV(1) levels, but these were more marked in group 2 (p = 0.012 and p = 0.019, respectively). There was a significant increase in FVC levels in group 2 only (p = 0.003). Group 2 also had a more marked improvement in dyspnea on exertion. There was no difference between the two groups with regards to other parameters, including pH, PaCO(2) levels, and other symptom scores. Six patients in group 1 and five patients in group 2 developed new exacerbations within the following 6 months. Hyperglycemia occurred in two patients in each group.\n In severe COPD exacerbations, a 10-day course of steroid treatment is more effective than a 3-day course in improving the outcome, but has no benefit in reducing exacerbation rates.", "Inhaled corticosteroids are known to be beneficial for patients with asthma, but their role in treating patients with stable chronic obstructive pulmonary disease (COPD) remains controversial. A study was undertaken to determine whether inhaled corticosteroids are of functional benefit in patients who did not show improvement with a trial of oral corticosteroids.\n In phase I patients with stable COPD were given a two week course of oral placebo followed by two weeks of prednisone 40 mg per day in a single blind manner to distinguish between responders and non-responders to oral corticosteroids. In phase II a double blind, randomised, parallel group trial of inhaled budesonide 1600 micrograms per day versus placebo was carried out in 79 nonresponders to oral corticosteroids. The primary outcome measure was forced expiratory volume in one second (FEV1), and secondary outcome measures were exercise capacity, dyspnoea with exertion, quality of life, peak expiration flow rate, and respiratory symptoms.\n Randomisation allocated 39 subjects to inhaled corticosteroids and 40 to placebo. There was no difference in the change in FEV1 from baseline between the treatment and placebo groups; mean difference -12 ml (95% CI -88 to 63) at three months and -4 ml (95% CI -95 to 87) at six months. The proportion of patients with a 15% or greater improvement was no higher among those receiving inhaled corticosteroids than in the placebo group at any of the follow up visits. Changes in secondary outcomes were also no different.\n Inhaled corticosteroids, even at high doses, were of no physiological or functional benefit in these patients with advanced COPD.", "The role of inhaled corticosteroids in the long term management of chronic obstructive pulmonary disease (COPD) is still unclear. A meta-analysis of the original data sets of the randomised controlled trials published thus far was therefore performed. The main question was: \"Are inhaled corticosteroids able to slow down the decline in lung function (FEV1) in COPD?\"\n A Medline search of papers published between 1983 and 1996 was performed and three studies were selected, two of which were published in full and one in abstract form. Patients with \"asthmatic features\" were excluded from the original data. Ninety five of the original 140 patients treated with inhaled corticosteroids (81 with 1500 micrograms beclomethasone daily, six with 1600 micrograms budesonide daily, and eight with 800 micrograms beclomethasone daily) and 88 patients treated with placebo (of the initial 144 patients) were included in the analysis. The effect on FEV1 was assessed by a multiple repeated measurement technique in which points of time in the study and treatment effects (inhaled corticosteroids compared with placebo) were investigated.\n No baseline differences were observed (mean age 61 years, mean FEV1 45% predicted). The estimated two year difference in prebronchodilator FEV1 was +0.034 l/year (95% confidence interval (CI) 0.005 to 0.063) in the inhaled corticosteroid group compared with placebo. The postbronchodilator FEV1 showed a difference of +0.039 l/year (95% CI -0.006 to 0.084). No beneficial effect was observed on the exacerbation rate. Worsening of the disease was the reason for drop out in four patients in the treatment group compared with nine in the placebo group. In the treatment group six of the 95 subjects dropped out because of an adverse effect which may have been related to the treatment compared with two of the 88 patients in the placebo group.\n This meta-analysis in patients with clearly defined moderately severe COPD showed a beneficial course of FEV1 during two years of treatment with relatively high daily dosages of inhaled corticosteroids.", "The purpose of this study was to investigate the comparative efficacy and safety of equal doses of inhaled fluticasone propionate (FP) and inhaled budesonide (BUD) using their respective dry powder inhalers in a population of severe asthmatics requiring high doses of inhaled corticosteroid. This double-blind double-dummy parallel-group study compared the effects of 24 weeks of treatment with FP (2000 micrograms daily via a Diskhaler inhaler; Glaxo Wellcome, Evreux, France) and BUD (2000 micrograms daily via a Turbuhaler inhaler; Astra Pharmaceuticals, Rijswijka, Netherlands) on lung function and asthma exacerbations in 395 patients with asthma. FP was statistically significantly superior to BUD with respect to the percentage of symptom-free days (P = 0.02), the incidence of days free from rescue bronchodilator usage (P = 0.02) and the distribution of change in peak expiratory flow (PEF) expressed as a percentage of the predicted PEF (P = 0.04). During the treatment period FP was statistically significantly superior to BUD for change in forced expiratory volume in 1 sec (FEV1) at 8, 16 and 24 weeks, change in the median daytime symptom score during weeks 5-16, for incidence of symptom-free days and incidence of days free from rescue bronchodilator usage during weeks 17-24. There was no significant difference between FP and BUD with respect to the number of patients experiencing one or more asthma exacerbation (33.8 and 28.4% of patients, respectively). There was, however, evidence that the exacerbations were clinically less severe in patients treated with FP, in that the time to resolution was quicker (11.0 vs. 14.7 days; P = 0.035), mean duration of all exacerbations (for an individual patient) tended to be shorter (18.5 vs. 23.6 days; P = 0.12), the time off work was reduced (4.2 vs. 7.6 days; P = 0.012) and the lowest PEF recorded during the exacerbation was higher (301 vs. 263 l min-1; P = 0.07). There were no clinically relevant differences in the safety (serum cortisol levels, markers of bone turnover, adverse events) of FP and BUD at these microgram equivalent doses. The patients recruited into this study, in retrospect, probably had no need for such high doses of inhaled corticosteroid but, irrespective of this, FP at microgram equivalent doses showed evidence of superior efficacy to BUD with respect to lung function and severity of asthma exacerbations without producing any greater adverse systemic effect.", "A significant minority of patients with COPD have favourable response to corticosteroid treatment. In addition, the benefit of corticosteroid treatment may be outweighed by the side-effects. Long-term administration of inhaled steroids is a safe means of treatment. However, only a few studies have addressed the role of inhaled steroids in patients with COPD, with conflicting results.\n Forty-four patients with stable COPD were defined as 'responders to bronchodilators' (increase in FEV1 > or = 20% following administration of beta 2-agonist) (group A), and 124 as 'non-responders to bronchodilators' (group B). All patients were randomized to receive a 6-week course of either a daily dose of 800 micrograms of inhaled budesonide or placebo, separated by 4 weeks when no medication was taken; were randomized again to receive a 6-week course of either 1600 micrograms day-1 of inhaled budesonide, or 800 micrograms day-1 of inhaled budesonide plus placebo; and were randomized once again to receive a 6-week course of either 40 mg day-1 of prednisone or placebo. All stages were performed in a double-blind cross-over design.\n Following administration of 800 micrograms day-1 of inhaled budesonide, there was an increase in the mean FEV1 from 1.40 +/- 0.20 to 1.92 +/- 0.22 L (P < 0.001) and a significant decrease in inhaled beta 2 agonist consumption in group A. These changes remained almost stable during the increased dose of inhaled budesonide or during prednisone treatment. The mean FEV1 did not change during the placebo period, or in group B in either treatments.\n Treatment with inhaled steroids improved spirometry data and inhaled beta 2-agonist consumption in about one-quarter of patients with stable COPD, and this rate increased to about three-quarters in patients who responded to beta 2-agonist inhalation. There was no additional benefit in using a higher dose of inhaled budesonide or prednisone.", "A randomised trial was performed on patients presenting to hospital with an exacerbation of chronic obstructive pulmonary disease (COPD) to compare outcomes in those managed at home with support with those admitted to hospital in the standard manner.\n Over an 18 month period all patients presenting to the Royal Infirmary of Edinburgh on weekdays (n=718) with a diagnosis of an exacerbation of COPD were assessed for inclusion in the trial. Patients with impaired level of consciousness, acute confusion, acute changes on radiography, or an arterial pH of <7.35 or with other serious medical or social reasons for admission were excluded. Patients randomised to home support were discharged with an appropriate treatment package (antibiotics, corticosteroids, nebulised bronchodilators and, if necessary, home oxygen). They were visited by a nurse the following day and thereafter at intervals of 2-3 days until recovery when they were discharged from follow up. Parallel observations were made on patients allocated to normal hospital admission up to the point of discharge. Patients in both groups were assessed at home eight weeks after the initial assessment.\n Among weekday patients 353 (50%) were considered obligatory admissions, 140 (19%) were admitted because of co-morbidity, 17 (2%) because of poor social circumstances, and 24 (3%) did not consent to the trial. The remaining 184 (26%) were randomised (2:1) either to home support or to a standard hospital admission. The median time to discharge was 7 days for the home support group and 5 days for the admitted group (p<0.01); 25% of the home support group and 34% of the admitted group were readmitted before the final assessment at eight weeks (p>0.05). There were no significant differences between the groups in attendances by GPs and carers or in health status measured eight weeks after the initial assessment. Satisfaction with the service was good. The mean total health service cost per patient was estimated as 877 pounds sterling for the home support group and 1753 pounds sterling for the admitted group.\n This study shows that home supported discharge is a well tolerated, safe, and economic alternative to hospital admission for a proportion of patients referred to hospital for admission for an exacerbation of COPD.", "Little is known about the long-term efficacy of inhaled corticosteroids in chronic obstructive pulmonary disease (COPD). We investigated the efficacy of inhaled budesonide on decline in lung function and respiratory symptoms in a 3-year placebo-controlled study of patients with COPD.\n We used a parallel-group, randomised, double-blind, placebo-controlled design in a singlecentre study, nested in a continuing epidemiological survey (the Copenhagen City Heart Study). Inclusion criteria were as follows: no asthma; a ratio of forced expiratory volume in 1 s (FEV1) and vital capacity of 0.7 or less; FEV1 which showed no response (<15% change) to 1 mg inhaled terbutaline or prednisolone 37.5 mg orally once daily for 10 days. 290 patients were randomly assigned budesonide, 800 microg plus 400 microg daily for 6 months followed by 400 microg twice daily for 30 months, or placebo for 36 months. The mean age of the participants was 59 years and the mean FEV1 2.37 L or 86% of predicted. The main outcome measure was rate of FEV1 decline. Analyses were by intention to treat.\n The crude rates of FEV1 decline were slightly smaller than expected (placebo group 41.8 mL per year, budesonide group 45.1 mL per year). The estimated rates of decline from the regression model did not differ significantly (49.1 mL vs 46.0 mL per year; difference 3.1 mL per year [95% CI -12.8 to 19.0]; p=0.7). Before the study, the minimum relevant difference was defined as 20 mL per year; this difference was outside the 95% CI. No effect of inhaled budesonide was seen on respiratory symptoms. 316 exacerbations occurred during the study period, 155 in the budesonide group and 161 in the placebo group. Treatment was well tolerated.\n Inhaled budesonide was of no clinical benefit in COPD patients recruited from the general population by screening. We question the role of long-term inhaled corticosteroids in the treatment of mild to moderate COPD." ]

[ "9311492", "11596162", "17675317", "12550014", "3296295", "19703826", "11208637", "14514944", "17005060" ]

[ "Nocturnal ventilatory support in patients with cystic fibrosis: comparison with supplemental oxygen.", "Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study.", "Randomised placebo controlled trial of non-invasive ventilation for hypercapnia in cystic fibrosis.", "[Non-invasive ventilation in kyphoscoliosis. A comparison of a volumetric ventilator and a BIPAP support pressure device].", "Evaluation of positive expiratory pressure as an adjunct to chest physiotherapy in the treatment of cystic fibrosis.", "Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis.", "Low-flow oxygen and bilevel ventilatory support: effects on ventilation during sleep in cystic fibrosis.", "Non-invasive ventilation assists chest physiotherapy in adults with acute exacerbations of cystic fibrosis.", "Chest physiotherapy with positive airway pressure: a pilot study of short-term effects on sputum clearance in patients with cystic fibrosis and severe airway obstruction." ]

[ "Progressive deterioration of lung function in cystic fibrosis (CF) patients may lead to significant hypoxaemia and hypercapnia, especially during sleep. The effects of bi-level noninvasive positive pressure nasal mask ventilation (NIPPV) on respiration and sleep were compared to those of low-flow oxygen therapy in six CF patients (mean +/- SD age 22.3 +/- 4.7 yrs, with severe lung disease (forced expiratory volume in one second (FEV1) 29.4 +/- 3.4% predicted). Compared to the control night, NIPPV and oxygen therapy significantly improved overall night-time oxygen saturation during both rapid eye movement (REM) and non-rapid eye movement (NREM) sleep stages. However, significant increases in transcutaneous CO2 tension occurred during oxygen therapy, while NIPPV markedly improved alveolar ventilation during all sleep states. Sleep architecture and arousals remained unchanged during NIPPV and oxygen therapy treatment nights. We conclude that noninvasive positive pressure ventilation improves sleep-related hypoxaemia and hypercapnia in severe cystic fibrosis patients without affecting sleep. The long-term compliance and benefits of noninvasive positive pressure ventilation remain unclear.", "Enhanced airway clearance is thought to result in better-maintained pulmonary function in cystic fibrosis (CF). Postural drainage, percussion, and vibration (PDPV) have been the primary airway clearance technique (ACT) employed in CF for over 40 years. Two new airway clearance modalities are high-frequency chest wall oscillation (HFCWO) and oscillating positive expiratory pressure (OPEP). This pilot study was undertaken to evaluate the efficacy of these techniques during home use, assess patient satisfaction with them as compared to PDPV, and assess the feasibility of performing a definitive comparative trial. The prospective, randomized, multicenter crossover trial was conducted at three urban academic CF Care Centers. Twenty-nine CF patients, 9-39 years of age, participated. Subjects performed 4 weeks each of HFCWO and OPEP following 2-week lead-in/washout periods. Spirometry, lung volumes, National Institutes of Health and Petty Scores, and a satisfaction survey were performed at baseline and after each treatment period. An ACT preference survey was completed at the conclusion of the study. Twenty-four subjects completed both therapies. There were no statistically significant differences between therapies for spirometry, lung volumes, or clinical scores. No significant safety issues arose during the study period. Compliance between therapies was similar. Significant differences among therapies existed in patient satisfaction. Given a choice of therapy, 50% of subjects chose HFCWO, 37% OPEP, and 13% PDPV. This study suggests that HFCWO and OPEP are safe and as effective as patients' routine therapies when used for airway clearance in a home setting. Patient satisfaction and preference differ among ACTs and should be considered when prescribing home therapy. A definitive, multi-center, comparative study evaluating long-term efficacy of these techniques is feasible.\n Copyright 2001 Wiley-Liss, Inc.", "The clinical benefits of domiciliary non-invasive positive pressure ventilation (NIV) have not been established in cystic fibrosis (CF). We studied the effects of nocturnal NIV on quality of life (QoL), functional and physiological outcomes in CF subjects with awake hypercapnia (arterial carbon dioxide pressure PaCO2>45 mm Hg).\n In a randomised, placebo controlled, crossover study, eight subjects with CF, mean (SD) age 37 (8) years, body mass index 21.1 (2.6) kg/m2, forced expiratory volume in 1 s 35 (8)% predicted and PaCO2 52 (4) mm Hg received 6 weeks of nocturnal (1) air (placebo), (2) oxygen and (3) NIV. The primary outcome measures were CF specific QoL, daytime sleepiness and exertional dyspnoea. Secondary outcome measures were awake and asleep gas exchange, sleep architecture, lung function and peak exercise capacity.\n Compared with air, NIV improved the chest symptom score in the CF QoL Questionnaire (mean difference 10; 95% CI 5 to 16; p = 0.002) and the transitional dyspnoea index score (mean difference 3.1; 95% CI 1.2-5.0; p = 0.01). It reduced maximum nocturnal pressure of transcutaneous CO2 (PtcCO2 mean difference -17 mm Hg; 95% CI -7 to -28 mm Hg; p = 0.005) and increased exercise performance on the Modified Shuttle Test (mean difference 83 m; 95% CI 21 to 144 m; p = 0.02). NIV did not improve sleep architecture, lung function or awake PaCO2.\n 6 weeks of nocturnal NIV improves chest symptoms, exertional dyspnoea, nocturnal hypoventilation and peak exercise capacity in adult patients with stable CF with awake hypercapnia. Further studies are required to determine whether or not NIV can improve survival.", "Non-invasive intermittent positive pressure ventilation (NIPPV) at home is the treatment of choice for patients with chronic respiratory insufficiency secondary to severe kyphoscoliosis. Our aim was to compare clinical course, blood gases and lung function after one month of domiciliary NIPPV with two types of ventilator and to assess sleep pattern changes in patients enrolled in a prospective, randomized crossover study. Ten patients with chronic respiratory insufficiency due to kyphoscoliosis were enrolled and randomly assigned to the first device. After one month of use, the patients underwent clinical and functional examinations and polysomnographic studies while using the ventilator. The same protocol was applied with the second device after a ten-day washout period. Baseline polysomnographs showed fragmented sleep with low percentages of deep non-REM sleep and of REM sleep, as well as respiratory patterns characterized by very high frequencies coinciding with significant desaturations. In all cases symptoms and arterial blood gas improvements were significant, with no differences between the two treatment periods. The percentages of time spent with SaO2 below 90% of reference in sleep studies were significantly lower than baseline with both ventilators. All but one patient had better tolerance of the bilevel positive airway pressure (BIPAP) support mode than of the volumetric ventilator. Our study shows that NIPPV is equally effective for patients with kyphoscoliosis whether administered with a volumetric ventilator or a BIPAP device. Subjective response and tolerance seem to be slightly better with BIPAP.", "It has been suggested that positive expiratory pressure may assist the clearance of bronchial secretions in the treatment of cystic fibrosis. It has been compared with currently used postural drainage techniques. Three treatment regimens were compared in 18 patients with cystic fibrosis. Treatment A consisted of breathing exercises emphasising inspiration, interspersed with the forced expiration technique in gravity assisted positions; treatment B comprised breathing exercises with positive expiratory pressure alternating with the forced expiration technique in the same gravity assisted positions; and treatment C comprised breathing exercises with positive expiratory pressure and the forced expiration technique in the sitting position. During treatment A a significantly greater quantity of sputum was produced than during treatments B and C (p less than 0.025 and p less than 0.001 respectively). Treatment B produced more sputum than treatment C (p less than 0.005). There were no significant differences in arterial oxygen saturation, FEV1 or forced vital capacity. Most adolescent and adult patients are able to carry out their treatment independently using gravity assisted positions, breathing exercises emphasising inspiration, and the forced expiration technique. Sputum clearance was less effective when positive expiratory pressure was included in the treatment regimen.", "High frequency chest wall oscillation (HFCWO) is standard treatment for airway clearance in the USA and has recently been introduced in the UK and Europe. There is little published research comparing HFCWO with airway clearance techniques (ACTs) frequently used in the UK and Europe. The aim of this study was to compare the short-term effects of HFCWO with usual ACTs in patients with cystic fibrosis hospitalised with an infective pulmonary exacerbation.\n A 4-day randomised crossover design was used. Patients received either HFCWO on days 1 and 3 and usual ACTs on days 2 and 4 or vice versa. Wet weight of sputum, spirometry and oxygen saturation were measured. Perceived efficacy, comfort, incidence of urinary leakage and preference were assessed. Data were analysed by mixed model analysis.\n 29 patients (72% male) of mean (SD) age 29.4 (8.4) years and mean (SD) forced expiratory volume in 1 s (FEV(1)) percentage predicted (FEV(1)%) 38 (16.7) completed the study. Significantly more sputum was expectorated during a single treatment session and over a 24 h period (mean difference 4.4 g and 6.9 g, respectively) with usual ACTs than with HFCWO (p<0.001). No statistically significant change in FEV(1)% or oxygen saturation was observed after either HFCWO or usual ACTs compared with baseline. 17 patients (55%) expressed a preference for their usual ACT.\n During both a finite treatment period and over 24 h, less sputum was cleared using HFCWO than usual ACT. HFCWO does not appear to cause any adverse physiological effects and may influence adherence.", "We measured ventilation in all sleep stages in patients with cystic fibrosis (CF) and moderate to severe lung disease, and compared the effects of low-flow oxygen (LFO2) and bilevel ventilatory support (BVS) on ventilation and gas exchange during sleep. Thirteen subjects, age 26 +/- 5.9 yr (mean +/- 1 SD), body mass index (BMI) 20 +/- 3 kg/m2, FEV1 32 +/- 11% predicted, underwent three sleep studies breathing, in random order, room air (RA), LFO2, and BVS +/- O2 with recording of oxyhemoglobin saturation (SpO2) (%) and transcutaneous carbon dioxide (TcCO2) (mm Hg). During RA and LFO2 studies, patients wore a nasal mask with a baseline continuous positive airway pressure (CPAP) of 4 to 5 cm H2O. Minute ventilation (V I) was measured using a pneumotachograph in the circuit and was not different between wake and non-rapid eye movement (NREM) sleep on any night. However, V I was reduced on the RA and LFO2 nights from awake to rapid eye movement (REM) (p < 0.01) and from NREM to REM (p < 0.01). On the BVS night there was no significant difference in V I between NREM and REM sleep. Both BVS and LFO2 improved nocturnal SpO2, especially during REM sleep (p < 0.05). The rise in TcCO2 seen with REM sleep with both RA and LFO2 was attenuated with BVS (p < 0.05). We conclude that BVS leads to improvements in alveolar ventilation during sleep in this patient group.", "Chest physiotherapy is essential to the management of cystic fibrosis (CF). However, respiratory muscle fatigue and oxygen desaturation during treatment have been reported. The aim of this study was to determine whether non-invasive ventilation (NIV) during chest physiotherapy could prevent these adverse effects in adults with exacerbations of CF.\n Twenty six patients of mean (SD) age 27 (6) years and forced expiratory volume in 1 second (FEV1) 34 (12)% predicted completed a randomised crossover trial comparing standard treatment (active cycle of breathing technique, ACBT) with ACBT + NIV. Respiratory muscle strength (PImax, PEmax), spirometric parameters, and dyspnoea were measured before and after treatment. Pulse oximetry (SpO2) was recorded during treatment. Sputum production during treatment and 4 and 24 hours after treatment was evaluated.\n There was a significant reduction in PImax following standard treatment that was correlated with baseline PImax (r=0.73, p<0.001). PImax was maintained following NIV (mean difference from standard treatment 9.04 cm H2O, 95% confidence interval (CI) 4.25 to 13.83 cm H2O, p=0.006). A significant increase in PEmax was observed following the NIV session (8.04 cm H2O, 95% CI 0.61 to 15.46 cm H2O, p=0.02). The proportion of treatment time with SpO2 < or =90% was correlated with FEV1 (r=-0.65, p<0.001). NIV improved mean SpO2 (p<0.001) and reduced dyspnoea (p=0.02). There were no differences in FEV1, forced vital capacity (FVC) or sputum weight, but FEF(25-75) increased following NIV (p=0.006).\n Reduced inspiratory muscle strength and oxygen desaturation during chest physiotherapy are associated with inspiratory muscle weakness and severity of lung disease in adults with exacerbations of CF. Addition of NIV improves inspiratory muscle function, oxygen saturation and small airway function and reduces dyspnoea.", "The periodic administration of positive airway pressure combined with directed cough could aid mucus clearance in patients with cystic fibrosis (CF) and severe airway obstruction.\n To compare the short-term effect of positive expiratory pressure (PEP) physiotherapy via mask (mask PEP), continuous positive airway pressure (CPAP), and noninvasive positive-pressure ventilation (NPPV) physiotherapies on amount of sputum collected.\n Directed cough was standardized for each patient and used as the control treatment. We studied 17 patients with CF (mean +/- SD age 28 +/- 7 y) and severe airway obstruction (forced expiratory volume in the first second 25 +/- 6% of predicted) admitted for pulmonary exacerbation. Mask PEP, CPAP, NPPV, and the control treatment (directed cough) were administered in a random sequence. Each patient received each treatment twice a day (in 70-min sessions) for 2 consecutive days. We measured the wet and dry weight of sputum collected and the number of directed and spontaneous coughs during each session. Spirometry and pulse oximetry were conducted before and after each session. For mask PEP, CPAP, and NPPV, each patient gave a subjective score for the efficacy and tolerability of the treatment, compared to the control treatment.\n There was no statistically significant difference in the dry weight of sputum collected: mask PEP 0.9 +/- 0.6 g, CPAP 0.8 +/- 0.4 g, NPPV 0.9 +/- 0.6 g, control treatment 1.0 +/- 0.8 g. There was a statistically significant difference in the wet weight of sputum collected: mask PEP 15.8 +/- 5.5 g, CPAP 13.7 +/- 5.5 g, NPPV 13.2 +/- 5.0 g, control treatment 14.0 +/- 5.0 g (p < 0.05), but that difference became nonsignificant when we took into account the number of spontaneous coughs. There were no statistically significant changes in the spirometry and pulse-oximetry values. The patients' subjective efficacy scores were similar for mask PEP, CPAP, and NPPV. Less fatigue was reported after NPPV and CPAP than after mask PEP.\n There were no differences in sputum clearance or pulmonary-function measures between mask PEP and short-term administration of either CPAP or NPPV combined with directed cough. After mask PEP these patients felt more tired than after CPAP or NPPV secretion-clearance therapy." ]

[ "17854434", "9725926", "15586837", "17995993", "17372796", "11007655", "2030194", "19213683", "17074945" ]

[ "Cost-effectiveness of motivational interviewing for smoking cessation and relapse prevention among low-income pregnant women: a randomized controlled trial.", "Use and cost effectiveness of smoking-cessation services under four insurance plans in a health maintenance organization.", "Results of a randomized controlled trial of intervention to implement smoking guidelines in Veterans Affairs medical centers: increased use of medications without cessation benefit.", "Proactive interventions for smoking cessation in general medical practice: a quasi-randomized controlled trial to examine the efficacy of computer-tailored letters and physician-delivered brief advice.", "Randomized controlled trial of a computer-based, tailored intervention to increase smoking cessation counseling by primary care physicians.", "Predictors of smoking cessation in an incentive-based community intervention.", "Evaluation of intrinsic and extrinsic motivation interventions with a self-help smoking cessation program.", "A randomized, controlled trial of financial incentives for smoking cessation.", "A randomized controlled trial of a smoking cessation intervention among people with a psychotic disorder." ]

[ "Low-income women have high rates of smoking during pregnancy, but little is known about the costs, benefits, and cost-effectiveness of motivational interviewing (MI), focused on the medical and psychosocial needs of this population, as an intervention for smoking cessation and relapse prevention.\n A sample of 302 low-income pregnant women was recruited from multiple obstetrical sites in the Boston metropolitan area into a randomized controlled trial of a motivational intervention for smoking cessation and relapse prevention versus usual care (UC). The findings of this clinical trial were used to estimate the costs, benefits, and cost-effectiveness of the intervention from a societal perspective, incorporating published quality-adjusted life-year (QALY) and life-year (LY) estimates. Outcomes included smoking cessation and relapse, maternal and infant outcomes, economic costs, LYs and QALYs saved, and incremental cost-effectiveness ratios.\n The cost-effectiveness of MI for relapse prevention compared to UC was estimated to be $851/LY saved and $628/QALY saved. Including savings in maternal medical costs in sensitivity analyses resulted in cost savings for MI for relapse prevention compared to UC. For smoking cessation, MI cost more but did not provide additional benefit compared to UC. In one-way sensitivity analyses, the incremental cost-effectiveness of MI versus UC would have been $117,100/LY saved and $86,300/QALY saved if 8% of smokers had quit. In two-way sensitivity analyses, MI was still relatively cost-effective for relapse prevention ($17,300/QALY saved) even if it cost as much as $2000/participant and was less effective. For smoking cessation, however, a higher level of effectiveness (9/110) and higher cost ($400/participant) resulted in higher incremental cost-effectiveness ratios ($112,000/QALY).\n Among low-income pregnant women, MI helps prevent relapse at relatively low cost, and may be cost-saving when net medical cost savings are considered. For smoking cessation, MI cost more but provided no additional benefit compared to UC, but might offer benefits at costs comparable to other clinical preventive interventions if 8-10% of smokers are induced to quit.", "Lack of information about the effect of insurance coverage on the demand for and use of smoking-cessation services has prevented widescale adoption of coverage for such services.\n In a longitudinal, natural experiment, we compared the use and cost effectiveness of three forms of coverage with those of a standard form of coverage for smoking-cessation services that included a behavioral program and nicotine-replacement therapy. The study involved seven employers and a total of 90,005 adult enrollees. The standard plan offered 50 percent coverage of the behavioral program and full coverage of nicotine-replacement therapy. The other plans offered 50 percent coverage of both the behavioral program and nicotine-replacement therapy (reduced coverage), full coverage of the behavioral program and 50 percent coverage of nicotine-replacement therapy (flipped coverage), or full coverage of both the behavioral program and nicotine-replacement therapy.\n Estimated annual rates of use of smoking-cessation services ranged from 2.4 percent (among smokers with reduced coverage) to 10 percent (among those with full coverage). Smoking-cessation rates ranged from 28 percent (among users with full coverage) to 38 percent (among those with standard coverage). The estimated percentage of all smokers who would quit smoking per year as a result of using the services ranged from 0.7 percent (with reduced coverage) to 2.8 percent (with full coverage). The average cost to the health plan per user who quit smoking ranged from $797 (with standard coverage) to $1,171 (with full coverage). The annual cost per smoker ranged from $6 (with reduced coverage) to $33 (with full coverage). The annual cost per enrollee ranged from $0.89 (with reduced coverage) to $4.92 (with full coverage).\n Use of smoking-cessation services varies according to the extent of coverage, with the highest rates of use among smokers with full coverage. Although the rate of smoking cessation among the benefit users with full coverage was lower than the rates among users with plans requiring copayments, the effect on the overall prevalence of smoking was greater with full coverage than with the cost-sharing plans.", "The AHRQ Clinical Practice Guideline for Treating Tobacco Use and Dependence recommends screening and treatment of all tobacco users. Effective methods to implement recommendations are needed because simple guideline dissemination does not necessarily result in changes in practice.\n The Guideline Implementation for Tobacco (GIFT) study tested an organizational intervention to improve Guideline implementation.\n GIFT randomized 20 Veterans Affairs medical centers to intervention or control conditions. We trained prime movers at each site to improve identification of smoking status, promote primary care interventions and increase availability of smoking cessation medications. Sites and patients were evaluated before and after intervention.\n GIFT included 20 Veterans Affairs medical centers and 5678 subjects.\n Data regarding smoking status, delivery of treatment, medication use, and smoking cessation were collected from participant surveys, medical record review, survey of site leaders, and Pharmacy Benefits Management.\n The intervention did not increase participant report of being asked about smoking status or receipt of counseling. It did increase the rate of identification of smoking status in the medical record (P = 0.0001) but did not increase the rate of counseling to stop smoking. Site level data showed no increase in the number of patients receiving smoking cessation medications or dollars spent on medications. Individual smoker data showed a significant increase in the use of medications for smoking cessation in intervention sites (odds ratio = 6.89, P < 0.0001); however, only a small minority of smokers received medication even after the intervention. There was no difference in smoking cessation rates between participants at the intervention and treatment sites.\n We conclude that improvements in smoking cessation rates are likely to require more intensive intervention in this population.", "To test the efficacy of (i) computer-generated tailored letters and (ii) practitioner-delivered brief advice for smoking cessation against an assessment-only condition; and to compare both interventions directly.\n Quasi-randomized controlled trial.\n A total of 34 randomly selected general practices from a German region (participation rate 87%).\n A total of 1499 consecutive patients aged 18-70 years with daily cigarette smoking (participation rate 80%).\n The tailored letters intervention group received up to three individualized personal letters. Brief advice was delivered during routine consultation by the practitioner after an onsite training session. Both interventions were based on the Transtheoretical Model of behaviour change.\n Self-reported point prevalence and prolonged abstinence at 6-, 12-, 18- and 24-month follow-ups.\n Among participants completing the last follow-up, 6-month prolonged abstinence was 18.3% in the tailored letters intervention group, 14.8% in the brief advice intervention group and 10.5% in the assessment-only control group. Assuming those lost to follow-up to be smokers, the rates were 10.2%, 9.7% and 6.7%, respectively. Analyses including all follow-ups confirmed statistically significant effects of both interventions compared to assessment only. Using complete case analysis, the tailored letters intervention was significantly more effective than brief advice for 24-hour [odds ratio (OR) = 1.4; P = 0.047] but not for 7-day point prevalence abstinence (OR = 1.4; P = 0.068) for prolonged abstinence, or for alternative assumptions about participants lost to follow-up.\n The study demonstrated long-term efficacy of low-cost interventions for smoking cessation in general practice. The interventions are suitable to reach entire populations of general practices and smoking patients. Computer-generated letters are a promising option to overcome barriers to provide smoking cessation counselling routinely.", "The primary care visit represents an important venue for intervening with a large population of smokers. However, physician adherence to the Smoking Cessation Clinical Guideline (5As) remains low. We evaluated the effectiveness of a computer-tailored intervention designed to increase smoking cessation counseling by primary care physicians.\n Physicians and their patients were randomized to either intervention or control conditions. In addition to brief smoking cessation training, intervention physicians and patients received a one-page report that characterized the patients' smoking habit and history and offered tailored recommendations. Physician performance of the 5As was assessed via patient exit interviews. Quit rates and smoking behaviors were assessed 6 months postintervention via patient phone interviews. Intervention effects were tested in a sample of 70 physicians and 518 of their patients. Results were analyzed via generalized and mixed linear modeling controlling for clustering.\n Intervention physicians exceeded controls on \"Assess\" (OR 5.06; 95% CI 3.22, 7.95), \"Advise\" (OR 2.79; 95% CI 1.70, 4.59), \"Assist-set goals\" (OR 4.31; 95% CI 2.59, 7.16), \"Assist-provide written materials\" (OR 5.14; 95% CI 2.60, 10.14), \"Assist-provide referral\" (OR 6.48; 95% CI 3.11, 13.49), \"Assist-discuss medication\" (OR 4.72;95% CI 2.90, 7.68), and \"Arrange\" (OR 8.14; 95% CI 3.98, 16.68), all p values being < 0.0001. Intervention patients were 1.77 (CI 0.94, 3.34,p = 0.078) times more likely than controls to be abstinent (12 versus 8%), a difference that approached, but did not reach statistical significance, and surpassed controls on number of days quit (18.4 versus 12.2, p < .05) but not on number of quit attempts.\n The use of a brief computer-tailored report improved physicians' implementation of the 5As and had a modest effect on patients' smoking behaviors 6 months postintervention.", "The Quit and Win Challenge, an incentive-based intervention, was implemented in two counties in Eastern Ontario to encourage adult smokers to quit smoking. Participants (n = 231) were compared with adult smokers selected at random (n = 385) from a larger, four-county area. Baseline characteristics were assessed by telephone interview, including socio-demographic and smoking-related factors. Follow-up interviews were also conducted by telephone. Initial and follow-up response rates were high (over 84%) in both groups. Compared with the random survey group, Quit and Win participants tended to be younger, more educated, employed and heavier smokers, with fewer friends or co-workers who smoked. After one year, 19.5% of them reported that they were smoke-free, whereas less than 1% of the random group had achieved cessation. This translates into an impact rate of 0.17%, affecting 1 in 588 adult smokers. With the exception of the smokers' baseline \"stage of change,\" none of the socio-demographic or smoking factors was predictive of cessation. We conclude that this intervention achieved only limited success and attracted certain sectors of the community disproportionately, i.e. smokers who were highly motivated to quit. We argue that increased access to proven cessation therapies would improve the impact of such interventions.", "Personalized feedback and a financial incentive, developed from an intrinsic/extrinsic motivation framework, were evaluated as adjuncts to self-help materials for smoking cessation. Ss (N = 1,217) were randomized to 4 treatment groups and were followed up at 3 and 12 months. Consistent with hypotheses derived from the motivation framework, the financial incentive increased the use of self-help materials, did not increase cessation rates among program users, and was associated with higher relapse rates among those who did manage to quit. The personalized feedback increased both smoking cessation and use of the materials 3 months after distribution of the materials. Continuous abstinence (abstinence at 3 and 12 months) in the group that received the personalized feedback alone was twice the rate of the other groups.", "Smoking is the leading preventable cause of premature death in the United States. Previous studies of financial incentives for smoking cessation in work settings have not shown that such incentives have significant effects on cessation rates, but these studies have had limited power, and the incentives used may have been insufficient.\n We randomly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs (442 employees) or to receive information about programs plus financial incentives (436 employees). The financial incentives were $100 for completion of a smoking-cessation program, $250 for cessation of smoking within 6 months after study enrollment, as confirmed by a biochemical test, and $400 for abstinence for an additional 6 months after the initial cessation, as confirmed by a biochemical test. Individual participants were stratified according to work site, heavy or nonheavy smoking, and income. The primary end point was smoking cessation 9 or 12 months after enrollment, depending on whether initial cessation was reported at 3 or 6 months. Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs.\n The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment (14.7% vs. 5.0%, P<0.001) and 15 or 18 months after enrollment (9.4% vs. 3.6%, P<0.001). Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program (15.4% vs. 5.4%, P<0.001), completion of a smoking-cessation program (10.8% vs. 2.5%, P<0.001), and smoking cessation within the first 6 months after enrollment (20.9% vs. 11.8%, P<0.001).\n In this study of employees of one large company, financial incentives for smoking cessation significantly increased the rates of smoking cessation. (ClinicalTrials.gov number, NCT00128375.)\n 2009 Massachusetts Medical Society", "Despite extremely high rates of smoking among individuals with psychotic disorders and the associated financial and health costs, few studies have investigated the efficacy of smoking cessation interventions among this group. The purpose of this study was to compare an integrated psychological and nicotine replacement therapy intervention for people with a psychotic disorder with routine care alone.\n The authors recruited 298 regular smokers with a psychotic disorder residing in the community and randomly assigned them to a routine care comparison condition (N=151) or an eight-session, individually administered smoking cessation intervention (N=147), which consisted of nicotine replacement therapy, motivational interviewing, and cognitive behavior therapy. Outcome variables included continuous and point-prevalence abstinence rates, smoking reduction status, and changes in symptoms and functioning.\n While there were no overall differences between the treatment group and comparison group in abstinence rates, a significantly higher proportion of smokers who completed all treatment sessions stopped smoking at each of the follow-up occasions (point-prevalence rates: 3 months, 30.0% versus 6.0%; 6 months, 18.6% versus 4.0%; and 12 months, 18.6% versus 6.6%). Smokers who completed all treatment sessions were also more likely to have achieved continuous abstinence at 3 months (21.4% versus 4.0%). There was a strong dose-response relationship between treatment session attendance and smoking reduction status, with one-half of those who completed the intervention program achieving a 50% or greater reduction in daily cigarette consumption across the follow-ups, relative to less than one-fifth of the comparison subjects. There was no evidence of any associated deterioration in symptoms or functioning.\n These findings demonstrate the utility of a nicotine replacement therapy plus motivational interviewing/cognitive behavior therapy smoking cessation intervention among individuals with a psychotic disorder. Further development of more efficacious interventions is required for those who do not respond to existing interventions." ]

[ "8673548", "18005909", "9116877", "11505787", "20573492", "10534147", "10929163", "9648698", "9643859" ]

[ "Pilot randomized controlled trial of Chinese herbal treatment for HIV-associated symptoms.", "Efficacy of a pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial.", "Evaluation of efficacy of traditional Chinese medicines in the treatment of childhood bronchial asthma: clinical trial, immunological tests and animal study. Taiwan Asthma Study Group.", "Efficacy of Echinacea purpurea in patients with a common cold. A placebo-controlled, randomised, double-blind clinical trial.", "Chinese herbs in treatment of influenza: a randomized, double-blind, placebo-controlled trial.", "Randomized, placebo-controlled trial of Chinese herb therapy for HIV-1-infected individuals.", "Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial.", "The common cold: effects of intranasal fluticasone propionate treatment.", "Zinc gluconate lozenges for treating the common cold in children: a randomized controlled trial." ]

[ "We wished to determine the short-term safety and efficacy of a Chinese medicinal herb preparation in treating symptoms of human immunodeficiency virus (HIV) infection in a 12-week randomized, double-blind, placebo-controlled clinical trial in a University-affiliated acquired immunodeficiency syndrome (AIDS) clinic at a public general hospital. Thirty adults with symptomatic HIV infection, no previous AIDS-defining diagnosis, and CD4+ counts of 0.200-0.499 x 10(9)/L (200-499/mm3) received 28 tablets each day of either a standardized oral preparation of 31 Chinese herbs or a cellulose placebo. Primary outcome measures were changes in life satisfaction, perceived health, and number and severity of symptoms. Other outcomes included adherence, and changes in weight, CD4+ count, depression, anxiety, physical and social function, and mental health. Two placebo- and no herb-treated subjects had mild adverse events (AE). Subjects on both arms reported taking 94% of prescribed tablets. No differences between treatment groups reached the p < 0.05 level. Life satisfaction improved in herb-treated [+0.86, 95% confidence interval (CI): +0.29, +1.43] but not in placebo-treated subjects (+0.20, 95% CI -0.35, + 0.75). Number of symptoms was reduced in subjects receiving herbs (-2.2, 95% CI -4.1, -0.3) but not in those receiving placebo (-0.3, 95% CI -3.2, +2.7). There were trends toward greater improvements among herb-treated subjects on all symptom subscales except dermatologic. Believing that one was receiving herbs was strongly associated with reporting that the treatment had helped (p < 0.005), but not with changes in life satisfaction or symptoms. There were improvements in life satisfaction and symptoms among subjects receiving the herbal therapy. Whether Chinese herbs are effective in the management of symptomatic HIV infection can be adequately addressed only by larger trials of longer duration.", "The common cold is a viral infection with symptoms such as sneezing, sore throat, and running nose. It is one of the most prevalent illnesses in the world, and although commonly caused by rhinoviruses, antibiotics are often prescribed unnecessarily. Therefore, it is of utmost importance to evaluate alternative treatments such as herbal medications, whose efficacy and safety is proven by pharmacological and clinical studies.\n The aim of the present study was to evaluate the efficacy of a liquid herbal drug preparation from the roots of Pelargonium sidoides compared with placebo in adult patients with the common cold.\n The study was designed as a multicenter, prospective, randomized, double blind, parallel group, placebo-controlled phase III clinical trial with an adaptive group-sequential design.\n The study took place in eight outpatient departments affiliated with hospitals.\n One hundred three male and female adult patients with at least two major and one minor or with one major and three minor cold symptoms (maximum symptom score of 40 points), present for 24 to 48 hours, and who gave provision of informed consent were randomized to receive either 30 drops (1.5 mL) of the liquid herbal drug preparation EPs or placebo three times a day.\n Patients received randomized treatment for a maximum period of 10 days.\n The primary outcome criterion was the sum of symptom intensity differences (SSID) of the cold intensity score (CIS) from day one to day five. The CIS consists of the following 10 cold symptoms: nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, and fever.\n From baseline to day five, the mean SSID improved by 14.6 +/- 5.3 points in the EPs group compared with 7.6 +/- 7.5 points in the placebo group. This difference was statistically significant (P < .0001). The mean CIS decreased by 10.4 +/- 3.0 points and 5.6 +/- 4.3 points in EPs and placebo-treated patients, respectively. After 10 days, 78.8% versus 31.4% in the EPs versus placebo group were clinically cured (CIS equals zero points or complete resolution of all but a maximum of one cold symptom; P < .0001). The mean duration of inability to work was significantly lower in the EPs treatment group (6.9 +/- 1.8 days) than in the placebo group (8.2 +/- 2.1 days; P = .0003). Treatment outcome (rates of complete recovery or major improvement from disease [integrative medicine outcomes scale]) was assessed better in the EPs treatment group than in the placebo group by both the investigator and the patient on day five (P < .0001). Adverse events occurred in three of 103 patients (2.9%), with two of 52 (3.8%) and one of 51 (2.0%) patients in the EPs and placebo group, respectively. All adverse events were assessed as nonserious. At the end of treatment, all patients (100%) in the active treatment group judged the subjective tolerability of EPs as good or very good.\n EPs represents an effective treatment of the common cold. It significantly reduces the severity of symptoms and shortens the duration of the common cold compared with placebo. The herbal drug is well tolerated.", "Traditional Chinese medicines (TCM) have been used to treat bronchial asthma for several centuries and a certain degree of clinical benefit has been observed; however, scientific substantiation is lacking. A multicenter, double-blind and placebo-controlled study was therefore conducted to evaluate the clinical efficacy in terms of symptom score, medication score, morning and evening PEFRs, and changes of immunoregulatory function, such as distribution of lymphocyte subsets and in vivo and in vitro production of lymphokines (IFN-gamma and IL-4) and inflammatory mediators (histamine, PGE2 and LTC4). Furthermore, the protective effect of TCM on the late asthmatic reaction (LAR) was evaluated by using asthmatic guinea pigs. Three hundred and three asthmatic children were classified by Chinese doctors, according to a standardized questionnaire designed on the basis of basic logic of Chinese medicine, into three groups of specific constitution (group A, B and C). Group A consisted of 32 herb A-treated patients and 34 placebo-treated; group B, 74 herb B-treated and 64 placebo-treated; and group C, 55 herb C-treated and 44 placebo-treated. The study period was six months. The results were: 1) Both treatment group and placebo group showed an improvement in all clinical parameters, thus demonstrating a placebo effect. However, the improvement was usually greater in the former than the latter, although only the difference in PEFR was significant; 2) Herb A could increase total T cell and decrease B cell; 3) Herb A and B enhanced production of PGE2 but not LTC4, IFN-gamma and IL-4; 4) There was a general tendency for in vivo and in vitro production of histamine to decrease at the end of study in both treatment group and placebo group; however, the decrease was significantly greater in the former than the latter; 5) In asthmatic guinea pigs, 10-day's pretreatment with Chinese herbs could reverse the decrease of sGaw, suppress eosinophilia in bronchoalveolar lavage fluid (BALF), prevent the eosinophil infiltration of airways, increase PGE2 production and decrease LTC4 production in serum and BALF. Thus, traditional Chinese medicines did show a certain degree of clinical efficacy. The decreased production of histamine and LTC4, increased production of PGE2 that were found in both asthmatic children and asthmatic guinea pigs, and prevention of occurrence of LAR by suppressing eosinophil infiltration of airways and preserving airway conductance that were observed in asthmatic guinea pigs after allergen challenge might be used to account partly for the effectiveness.", "Common colds are one of the most frequent acute illnesses with major economical impact. Echinaceae purpureae herba (Echinacin, EC31J0) has shown promising results in the relief of common cold symptoms and the time taken to improvement compared to placebo. This study was aimed to confirm these findings by performing a randomised, double-blind, placebo-controlled clinical trial. A total of 80 adult male or female patients with first signs of a cold were recruited. The number of days of illness with a complete picture of the common cold (defined by the modified Jackson score of at least 5 points and experience of rhinorrhea and/or a subjective sensation of having a cold) was the primary end-point. In the verum group the median time of illness was 6.0 days compared to 9.0 days in the placebo group, assigning zero time for patients without a complete picture (one-sided p = 0.0112). EC31J0 was well tolerated and clinically effective in alleviating symptoms more rapidly than placebo in patients with a common cold.", "To investigate the efficacy and safety of Antiwei, a traditional Chinese prescription, in the treatment of influenza.\n In a multi-center, randomized, double-blind, placebo-controlled trial, we recruited 480 adults aged 18 to 65 years within 36 h of onset of influenza-like symptoms. There were 225 patients with confirmed influenza. Eligible patients were randomly assigned 6 g of Antiwei (n = 360) or placebo (n = 120) twice daily for three days. All patients recorded their temperature and symptoms on diary cards during treatment. Analyses were performed in both the influenza-like population and the influenza-confirmed population.\n Antiwei increased patients' recovery by 17% (P < 0.001), and reduced the severity of illness measured by the median symptom score by 50% (P < 0.001) in both the influenza-like and the influenza-confirmed populations, compared to placebo. The influenza-confirmed patients reported reductions in the severity of fever (P = 0.002), cough (P = 0.023) and expectoration (P = 0.004) after one-day of treatment with Antiwei, compared to placebo. The adverse event profiles were similar for Antiwei and placebo.\n Antiwei was effective and well tolerated in treatment of natural influenza infection in adults. Antiwei represents a clinically valuable intervention in the management of influenza.", "Alternative medicine or complementary remedies that have not been scientifically tested are nonetheless widely used to treat chronic illnesses, particularly if curative options are limited.\n To assess the effectiveness of Chinese medicinal herbs in reducing symptoms and improving the quality of life of HIV-infected persons.\n Prospective, placebo-controlled double-blind study.\n University-based HIV outpatient clinic.\n 68 HIV-infected adults with CD4 cell counts <0.5 x 10(9)/L.\n Participants were randomized to receive four daily doses of seven pills containing a standardized preparation of 35 Chinese herbs or placebo for 6 months.\n Symptoms, HIV disease progression, HIV-1 RNA plasma viral loads, CD4 and CD8 cell counts, and scores on standard questionnaires for quality of life, depression, anxiety, and coping.\n Intervention and placebo groups were equivalent at baseline regarding, respectively, previous antiretroviral therapy (74% versus 79%), median CD4 cell counts (0.20 x 10(9)/L versus 0.25 x 10(9)/L), and median HIV-1 plasma viral loads (35,612 copies/ml versus 52,027 copies/ml). At enrollment, none of the study subjects was seriously ill or depressed, and average coping and quality of life scores were in the normal range. In all, 53 (78%) participants completed the study. Patients taking Chinese herbs reported significantly more gastrointestinal disturbances (79% versus 38%; p = .003) than those receiving placebo. No therapy-related toxicities were observed. At completion of the study, no significant differences between the intervention and placebo groups were found regarding plasma viral loads, CD4 cell counts, symptoms, and psychometric parameters. HIV-1 RNA level was unchanged at study end. Among participants who were not on concomitant antiretroviral therapy, median CD4 cell counts declined by 0.05 x 10(9)/L in both the intervention and placebo groups.\n This standardized formulation of Chinese herbs for HIV-infected individuals did not improve quality of life, clinical manifestations, plasma virus loads, or CD4 cell counts. The data suggest that this formulation of Chinese herbs is not effective when administered in a Western medicine setting.", "Adults and children in the United States get two to six colds per year. Evidence that zinc is effective therapy for colds is inconsistent.\n To test the efficacy of zinc acetate lozenges in reducing the duration of symptoms of the common cold.\n Randomized, double-blind, placebo-controlled trial.\n Detroit Medical Center, Detroit, Michigan.\n 50 ambulatory volunteers recruited within 24 hours of developing symptoms of the common cold.\n Participants took one lozenge containing 12.8 mg of zinc acetate or placebo every 2 to 3 hours while awake as long as they had cold symptoms.\n Subjective symptom scores for sore throat, nasal discharge, nasal congestion, sneezing, cough, scratchy throat, hoarseness, muscle ache, fever, and headache were recorded daily for 12 days. Plasma zinc and proinflammatory cytokine levels were measured on day 1 and after participants were well.\n Forty-eight participants completed the study (25 in the zinc group and 23 in the placebo group). Compared with the placebo group, the zinc group had shorter mean overall duration of cold symptoms (4.5 vs. 8.1 days), cough (3.1 [95% CI, 2.1 to 4.1] vs. 6.3 [CI, 4.9 to 7.7] days), and nasal discharge (4.1 [CI, 3.3 to 4.9] vs. 5.8 [CI, 4.3 to 7.3] days) and decreased total severity scores for all symptoms (P < 0.002, test for treatment x time interaction). Mean changes in soluble interleukin-1 receptor antagonist level differed nonsignificantly between the zinc group and the placebo group (difference between changes, -89.4 pg/mL [CI, -243.6 to -64.8 pg/mL]).\n Administration of zinc lozenges was associated with reduced duration and severity of cold symptoms, especially cough. Improvement in clinical symptoms with zinc treatment may be related to a decrease in proinflammatory cytokine levels; however, in this study, the observed differences between changes in cytokine levels in zinc and placebo recipients were not significant.", "A double-blind, randomized, placebo-controlled trial was conducted to study the effect of the intranasal corticosteroid, fluticasone propionate (FP), in the naturally occurring common cold.\n One hundred ninety-nine young adults received high-dose FP (200 microg four times daily) or placebo beginning 24 to 48 hours after onset of the common cold for 6 days. All symptoms were recorded on diary cards on days 1 to 20, and clinical examinations were carried out on days 1, 7, and 21. Nasopharyngeal aspirates were collected on days 1 and 7 for detection of rhinoviruses (found in 105 subjects) and Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis (found in 52 subjects) in the nasopharynx.\n In general, FP treatment had no clinically recognizable effects on the symptoms of the common cold, although it significantly reduced nasal congestion and cough on some study days. After treatment, rhinoviruses were cultured more often in the FP treatment group (37% vs 14%, p < 0.001), but this had no effect on the symptoms of common cold. FP treatment produced no changes in the colonization of pathogenic bacteria in the nasopharynx. Some symptoms of common cold were significantly more severe during days 1 to 10 (p < 0.05) in subjects found to have positive cultures for S. pneumoniae, H. influenzae, or M. catarrhalis in the nasopharynx on day 1 (n = 33).\n FP treatment does not have any marked effects on the symptoms of the common cold. FP treatment induced prolonged shedding of viable rhinoviruses. Some symptoms of the common cold were significantly more severe in subjects with pathogenic bacteria in the nasopharynx.", "The common cold is one of the most frequently occurring illnesses and is responsible for substantial morbidity and economic loss. Biochemical evidence suggests that zinc may be an effective treatment, and zinc gluconate glycine (ZGG) lozenges have been shown to reduce the duration of cold symptoms in adults.\n To determine the efficacy of ZGG treatment of colds in children and adolescents.\n A randomized, double-masked, placebo-controlled study.\n Two suburban school districts in Cleveland, Ohio.\n A total of 249 students in grades 1 through 12 were enrolled within the first 24 hours of experiencing at least 2 of 9 symptoms of the common cold.\n Zinc lozenges, 10 mg, orally dissolved, 5 times a day (in grades 1-6) or 6 times a day (in grades 7-12).\n Time to resolution of cold symptoms based on subjective daily symptom scores for cough, headache, hoarseness, muscle ache, nasal congestion, nasal drainage, scratchy throat, sore throat, and sneezing.\n Time to resolution of all cold symptoms did not differ significantly between students receiving zinc (n = 124) and those receiving placebo (n = 125) (median, 9 days; 95% confidence interval [CI], 8-9 days; median, 9 days, 95% CI, 7-10 days, respectively; P=.71). There were no significant differences in the time to resolution of any of the 9 symptoms studied. Compared with controls, more students in the zinc group reported adverse effects (88.6% vs 79.8%; P=.06); bad taste (60.2% vs 37.9%; P=.001); nausea (29.3% vs 16.1%; P=.01); mouth, tongue, or throat discomfort (36.6% vs 24.2%; P=.03); and diarrhea (10.6% vs 4.0%; P=.05).\n In this community-based, randomized controlled trial, ZGG lozenges were not effective in treating cold symptoms in children and adolescents. Further studies with virologic testing are needed to clarify what role, if any, zinc may play in treating cold symptoms." ]

[ "12798791", "19808135", "12499477", "17285226", "14628981", "15669893", "17050212", "9106123", "19367356" ]

[ "Reduction in excess daytime sleepiness by modafinil in patients with myotonic dystrophy.", "Modafinil for the treatment of hypersomnia associated with myotonic muscular dystrophy in adults: a multicenter, prospective, randomized, double-blind, placebo-controlled, 4-week trial.", "Modafinil reduces excessive somnolence and enhances mood in patients with myotonic dystrophy.", "Does modafinil enhance activity of patients with myotonic dystrophy?: a double-blind placebo-controlled crossover study.", "Adjunct modafinil for the short-term treatment of fatigue and sleepiness in patients with major depressive disorder: a preliminary double-blind, placebo-controlled study.", "A multicenter, placebo-controlled study of modafinil augmentation in partial responders to selective serotonin reuptake inhibitors with persistent fatigue and sleepiness.", "Cognitive performance during sustained wakefulness: A low dose of caffeine is equally effective as modafinil in alleviating the nocturnal decline.", "Selegiline in the treatment of hypersomnolence in myotonic dystrophy: a pilot study.", "Modafinil effects in multiple sclerosis patients with fatigue." ]

[ "Patients with myotonic dystrophy frequently suffer from excess daytime sleepiness, which can be a significant cause of disability. Previous studies have indicated that this excess daytime sleepiness is only occasionally due to obstructive sleep apnoea and may be principally of central nervous system origin. Modafinil has been successfully used to treat narcolepsy, a central disorder causing excess daytime sleepiness. We have investigated the use of this drug in myotonic dystrophy patients with excess daytime sleepiness. Patients were recruited from a clinic population on the basis of screening with the Epworth Sleepiness Scale. Patients scoring 10 and above were invited to participate in a randomized double-blind crossover trial of modafinil versus placebo, with four weeks in each arm of the study separated by a 2-week washout period. Patients were assessed by polysomnography at baseline. The primary outcome measures were change in both the Epworth Sleepiness Scale and a modified Maintenance of Wakefulness Test, which were measured at the start of each arm of the trial and in week 3 of each intervention period. In agreement with previous smaller studies, sleepiness is not correlated with CTG expansion size. Treatment with modafinil showed a non-significant reduction in median Epworth Sleepiness Scale. However, the median Maintenance of Wakefulness Test score was prolonged by treatment (31.7-40 min, P=0.006). There were no significant adverse cardiac effects of the drug in this group of patients (resting 12 lead and 24 h ECG monitoring). Selected patients with myotonic dystrophy and excess daytime sleepiness may benefit from modafinil. In this patient group the Epworth Sleepiness Scale may not be the most reliable measure of sleepiness. Despite the potential for cardiac disease in these patients, the drug was well tolerated with no adverse effects.", "Myotonic muscular dystrophy type 1 (MMD1) is the most common form of adult MD, with a mean prevalence of 1 in 8000. Excessive daytime sleepiness (ie, hypersomnia) is a common complication of MMD1.\n The aim of this study was to evaluate the efficacy and tolerability of modafinil for the treatment of hypersomnia in adults with MMD1.\n This multicenter, prospective, randomized, double-blind, placebo-controlled study consisted of a prerandomization period (90 to 2 days before randomization) and a 4-week randomization period in which patients were assigned to receive either active treatment (modafinil 300 mg/d) or placebo. The study was conducted at 3 clinics in France between February 2000 and June 2002. Adult patients aged > or =18 years, with genetically proven MMD1, an Epworth Sleepiness Scale (ESS) score >10, and a mean latency to sleep onset < or =8 minutes measured by the Multiple Sleep Latency Test (MSLT) were eligible. The primary efficacy end point was the Maintenance of Wakefulness Test (MWT) score at 4 weeks. Secondary end points included the mean MSLT score and scores from the ESS, physician's assessment of the therapeutic effect and the patient's global self-assessment via visual analog scale, the 17-item Hamilton Depression Rating Scale, and the Short Form Health Survey (SF-36) quality-of-life assessment.\n A total of 28 patients (15 men, 13 women; mean [SD] age, 40 [12.7] years [range, 18-69 years]; 100% white; modafinil group, 13; placebo group, 15) completed the study without protocol violations. Of the 28 patients with MMD1 included in the analysis, 21 had adult-onset MMD1. At 4 weeks, the mean MWT score was 16.4 (3.3) minutes in the modafinil group and 15.8 (3.8) minutes in the placebo group (P = NS). At the end of the randomization period, there were no significant between-group differences in any secondary outcome. A total of 8 patients (4 in each group) reported > or =1 adverse event, including digestive, neurologic, and skin symptoms. Weight loss was reported in 1 patient (2 kg).\n In this small study conducted in an adult population with MMD1 and a high prevalence of hyper-somnia, modafinil had no significant effects on daytime somnolence measured using objective MWTs.", "To evaluate the potential of modafinil in reducing excessive daytime somnolence (EDS) and enhancing indexes of quality of life and mood in patients with myotonic dystrophy (DM).\n Forty patients with DM were randomized to receive modafinil and placebo for 14 days each, using a double-blind, cross-over design. Before and after each trial, subjects completed handgrip strength testing, spirometry, and quality-of-life measures (RAND). On days 7 and 14, each subject completed the Epworth Sleepiness Scale (ESS), the Stanford Sleepiness Scale (SSS), and the Profile of Mood States (POMS).\n ESS scores were lower while taking modafinil (mean 248 mm; 95% confidence limit 220 to 276 mm) as compared with placebo (309 mm; 281 to 336 mm) (p < 0.001). Mean SSS scores were also lower during the modafinil trial (3.05; 2.77 to 3.33) than during the placebo trial (3.45; 3.18 to 3.71) (p < 0.05). The POMS indicated that modafinil decreased fatigue-inertia (p < 0.001) and increased vigor-activity and tension-anxiety (p < 0.001) indexes. The total mood disturbance score was also decreased during the modafinil trial as compared with placebo (p < 0.05). The RAND quality-of-life measures of energy (p < 0.001) and health change (p < 0.05) were both significantly enhanced during the modafinil treatment phase. No changes in maximal grip strength or forced expired volume in 1 second were detected over the course of the study. Headache was the most frequently reported adverse event. Four patients withdrew from the study, three because of side effects (two during modafinil ingestion and one during placebo ingestion).\n Modafinil reduces somnolence and improves mood in patients with DM.", "We performed a double-blind placebo-controlled crossover study in 13 patients with myotonic dystrophy to address the question whether modafinil, known to improve hypersomnolence in myotonic dystrophy, may improve levels of activity as well. We used the Epworth Sleepiness Scale as a measure of hypersomnolence and a structured interview of the patient and the partner or housemate as a measure of activity. We additionally used a restricted form of the RAND-36 to relate a possible improvement of activity to perceived general health. We confirmed earlier positive findings of modafinil regarding reduced somnolence (p=0.015), but no significant effects were seen regarding activity levels (p=0.2 for patients' self-reports and 0.5 for partners' reports).", "Fatigue and sleepiness are primary symptoms of depression that may not resolve with antidepressant therapy. Modafinil is a novel agent that has been shown to improve wakefulness and lessen fatigue in a variety of conditions. In this study, we examined the utility of modafinil as an adjunct therapy to treat fatigue and sleepiness in patients with major depression who are partial responders to antidepressants.\n Patients with partial response to anti-depressant therapy given for at least a 6-week period for a current major depressive episode (DSM-IV criteria) were enrolled in this 6-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Patients received once-daily doses (100-400 mg) of modafinil or matching placebo as adjunct treatment to ongoing antidepressant therapy. The effects of modafinil were evaluated using the Hamilton Rating Scale for Depression (HAM-D), the Fatigue Severity Scale (FSS), the Epworth Sleepiness Scale (ESS), the Clinical Global Impression of Change (CGI-C), and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Adverse events were monitored throughout the study.\n One hundred thirty-six patients were randomized to treatment, with 118 patients (87%) completing the study. Most patients (82%) were fatigued, and one half of patients (51%) were sleepy. Modafinil rapidly improved fatigue and daytime wakefulness, with significantly greater mean improvements from baseline than placebo in fatigue (FSS) scores at week 2 (p < .05) and sleepiness (ESS) scores at week 1 (p < .01); the differences between modafinil and placebo at week 6 were not statistically significant. Assessment of the augmentation effects of modafinil (HAM-D, CGI-C, and SF-36) did not significantly distinguish modafinil from placebo. Modafinil was well tolerated in combination with a variety of antidepressants.\n Modafinil may be a useful adjunct therapy for the short-term management of residual fatigue and sleepiness in patients who are partial responders to antidepressant therapy.", "Up to one half of depressed patients have partial or no response to antidepressant monotherapy. This multicenter, placebo-controlled study evaluated the efficacy of modafinil augmentation in major depressive disorder (MDD) patients with fatigue and excessive sleepiness despite selective serotonin reuptake inhibitor (SSRI) monotherapy.\n Patients (18-65 years) with a DSM-IV diagnosis of MDD and partial response to SSRI monotherapy (> or = 8 weeks) at a stable dose for > or = 4 weeks were eligible. Patients had screening/baseline 31-item Hamilton Rating Scale for Depression (HAM-D) scores of 14 to 26, Epworth Sleepiness Scale (ESS) scores > or = 10, and Fatigue Severity Scale (FSS) scores > or = 4. Patients were randomly assigned to augmentation therapy with modafinil 200 mg/day or placebo for 8 weeks. Assessments included the ESS, Clinical Global Impressions-Improvement scale (CGI-I), 31- and 17-item HAM-D, FSS, Brief Fatigue Inventory (BFI), and Montgomery-Asberg Depression Rating Scale (MADRS).\n Of 311 enrolled patients who received > or = 1 dose of study drug, 158 were randomly assigned to modafinil (70% women) and 153 to placebo (72% women); 85% of each treatment group completed the study. At final visit, modafinil significantly improved patients' overall clinical condition compared with placebo on the basis of CGI-I scores (p = .02), and there were trends toward greater mean reductions in ESS, 31- and 17-item HAM-D, and MADRS scores versus placebo. Modafinil significantly reduced BFI scores for worst fatigue at final visit (p < .05 vs. placebo). There were no significant differences between modafinil and placebo at final visit in FSS or BFI total scores. Adverse events significantly more common during modafinil compared with placebo treatment were nausea (9% vs. 2%; p = .01) and feeling jittery (4% vs. 1%; p = .03).\n These findings suggest that modafinil is a well-tolerated and potentially effective augmenting agent for SSRI partial responders with fatigue and sleepiness.", "Cognitive performance at night exhibits a substantial drop, typically before dawn. One of the means of dealing with this phenomenon, as well as with the accompanying sleepiness during sustained wakefulness, is the administration of stimulants. The most widely used and well-documented stimulants are caffeine, amphetamines, and modafinil. Of these, amphetamines are the least recommended, as they may severely affect behavior. Caffeine and modafinil seem to produce relatively milder side effects and usually only at high doses. Previous comparison studies have revealed equal efficacy of both the stimulants in maintaining alertness and performance during sustained wakefulness. However, these studies used relatively high, and thus not completely safe, doses of these drugs (600 mg caffeine and 400 mg modafinil). Therefore, the aim of the present study was to assess the efficacy of a low and medically safe dose of caffeine (200 mg) and modafinil (200 mg) in maintaining cognitive performance during sustained wakefulness. A flight simulation task was chosen for the assessment of the stimulants in a counter-balanced, within-subject design under four different conditions: baseline (no drugs), placebo, caffeine (200 mg), and modafinil (200 mg). The equal effectiveness of both drugs in abolishing the nocturnal drop in cognitive performance, as well as of oral temperature and blood pressure, supported the use of low doses of caffeine and modafinil for the maintenance of alertness in healthy subjects during sustained wakefulness.", "Patients with myotonic dystrophy frequently complain of hypersomnolence, a symptom which seriously restricts their social life. The pathogenesis of this symptom is a matter of debate: it has been attributed to both alveolar hypoventilation and pathological changes in the brainstem. As selegiline has been shown to reduce the number of sleep attacks in nacrolepsy, we tested whether hypersomnolence in myotonic dystrophy would respond to the same treatment. Ten patients with myotonic dystrophy received selegiline/placebo (20 mg daily) in a double-blind crossover trial. We monitored daytime sleepiness by means of a multiple sleep latency test. Treatment appeared to be well tolerated but did not alter hypersomnolence in myotonic dystrophy. Further studies to assess the effect of higher doses of selegiline are warranted.", "To investigate the effects of Modafinil on focused attention, motor function and motor excitability in patients with multiple sclerosis (MS) and fatigue.\n 21 MS patients with fatigue were enrolled in this double-blind placebo-controlled study. Modafinil (MOD) or placebo (PL) was administered for 8 weeks. The d2 alertness test, the Nine Hole Peg Test (9HPT) and several transcranial magnetic stimulation (TMS) techniques were applied prior to and after the first drug ingestion and well as after 8 weeks of drug intake.\n Prior to the first drug intake, the two groups were comparable. After the first drug ingestion, fatigue as measured by the Fatigue Severity Scale (FSS), performance of the d2 test and the 9HPT improved significantly in the MOD group and remained better than in the PL group after 8 weeks of treatment. Patients in the MOD group made fewer mistakes in the D2 test without being slower. They completed the 9HPT faster. Motor evoked potential amplitudes produced by paired pulse TMS were larger in the MOD group than the PL group. Motor thresholds and silent period durations remained unchanged.\n Compared to PL, MOD improved fatigue, focused attention and dexterity and enhanced motor cortex excitability in this group of patients. MOD may be helpful in MS patients with fatigue to improve cognitive and motor abilities." ]

[ "1728157", "1984763", "10770458", "10486394", "17148938", "11779284", "16190799", "6431586", "10807488" ]

[ "A double-blind comparison of valproate and lithium in the treatment of acute mania.", "Valproate in the treatment of acute mania. A placebo-controlled study.", "Valproate as an adjunct to neuroleptic medication for the treatment of acute episodes of mania: a prospective, randomized, double-blind, placebo-controlled, multicenter study. European Valproate Mania Study Group.", "Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects.", "A placebo-controlled trial of valproate for agitation and aggression in Alzheimer's disease.", "Efficacy of olanzapine in combination with valproate or lithium in the treatment of mania in patients partially nonresponsive to valproate or lithium monotherapy.", "A double-blind, placebo-controlled study of valproate for aggression in youth with pervasive developmental disorders.", "[Efficacy of sodium valproate in partial epilepsy. Crossed study of valproate and carbamazepine].", "A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Divalproex Maintenance Study Group." ]

[ "This study was carried out to compare the efficacy of lithium carbonate with that of valproate in acute mania and to determine whether pretreatment clinical characteristics, such as the presence of a mixed affective state, might predict a differential response to the two drugs.\n Twenty-seven patients meeting DSM-III-R criteria for acute manic episodes underwent a 3-week, randomized, double-blind, parallel-groups trial of treatment with lithium carbonate or valproate. Symptom severity was measured by using the Schedule for Affective Disorders and Schizophrenia, change version (SADS-C), the Global Assessment Scale (GAS), and the Brief Psychiatric Rating Scale (BPRS). Drug effects were compared by using repeated measures analysis of variance (ANOVA).\n At the end of the study, nine of 14 patients treated with valproate and 12 of 13 patients treated with lithium had responded favorably, as measured by changes in the SADS-C mania, BPRS, and GAS scores. Elevated pretreatment SADS-C depression scores were associated with good response to valproate. ANOVA revealed a significant interaction between drug and mixed affective state with respect to treatment response.\n Lithium and valproate were both effective in improving manic symptoms, and lithium was slightly more efficacious overall. Unlike the case with lithium, favorable response to valproate was associated with high pretreatment depression scores. Therefore, treatment with valproate alone may be particularly effective in manic patients with mixed affective states.", "We conducted a placebo-controlled, double-blind study of valproate, a drug originally developed as an antiepileptic, in 36 patients with acute manic episodes who had previously failed to respond to or to tolerate lithium carbonate. Treatment duration was 7 to 21 days, with no other psychotropic medications permitted except lorazepam up to 4 mg/d during the first 10 days of treatment. Serum valproate concentrations were measured three times weekly; an unblinded investigator then adjusted dosage to produce serum concentrations between 50 and 100 mg/L. Valproate proved superior to placebo in alleviating manic symptoms. The 17 patients randomized to active drug demonstrated a median 54% decrease in scores on the Young Mania Rating Scale as compared with a median 5.0% decrease among the 19 patients receiving placebo. On the 100-point Global Assessment Scale of overall psychiatric functioning, patients receiving valproate improved by a median of 20 points as compared with a zero-point change with placebo. Significant differences also emerged on the Brief Psychiatric Rating Scale and in the number of supplemental doses of lorazepam required by the patients in each group. Substantial antimanic effects appeared within 1 to 4 days of achieving therapeutic serum valproate concentrations. Adverse effects were infrequent, with no adverse effect appearing significantly more frequently with valproate than with placebo. We conclude that valproate represents a useful new drug for the treatment of manic patients.", "To compare the efficacy of sodium valproate administered as adjunct to neuroleptic medication for patients with acute mania with the efficacy of neuroleptics alone, the authors conducted a 21-day, randomized, double-blind, parallel-group, placebo-controlled trial. The study design closely reflected a clinical psychiatric setting in Europe where patients with acute mania commonly receive neuroleptic medication. In this trial, 136 hospitalized patients met the ICD-10 criteria for acute manic episodes; these patients received a fixed dose of 20 mg/kg of body weight of sodium valproate (Orfiril, Desitin Arzneimittel GmbH, Hamburg, Germany) orally, in addition to basic neuroleptic medication, preferably haloperidol and/or perazine. The primary outcome measure was the mean dose of neuroleptic medication (after conversion into haloperidol-equivalents) for the 21-day study period. Severity of symptoms was measured using the Young Mania Rating Scale (YMRS), the Global Assessment Scale, and the Clinical Global Impression Scale. Intent-to-treat analysis was based on 69 patients treated with valproate and 67 patients who received placebo. Groups were comparable with regard to demographic and clinical baseline data. Premature discontinuations occurred in only 13% of the patients. The mean neuroleptic dose declined continuously in the valproate group, whereas only slight variations were observed in the placebo group; the difference was statistically significant (p = 0.0007) for study weeks 2 and 3. The combination of neuroleptic and valproate proved superior to neuroleptics in attempts to alleviate manic symptoms. The proportion of responders (a 50% improvement rate shown on the YMRS) was higher for the combination with valproate than for the group receiving only neuroleptics (70% vs. 46%; p = 0.005). Adverse events consisted of those known for valproate or neuroleptics; the only adverse event was asthenia, which occurred more frequently with the combination therapy. Valproate represents a useful adjunct medication for the treatment of acute manic symptoms. Valproate is beneficial because it allows the administration of fewer neuroleptic medications and produces improved and quicker remission of manic symptoms.", "To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy.\n A prospective, stratified, randomised, double blind single centre clinical trial was performed, comparing two groups of 50 patients each, who underwent craniotomy for different pathological conditions and who were treated for 1 year after surgery with either 300 mg phenytoin/day or 1500 mg sodium valproate/day. During the study period patients were seen in the outpatient clinic at 1.5, 3, 6, and 12 months, when medical history, adverse events, and drug plasma concentrations were evaluated. Neuropsychological functioning and quality of life were assessed on the last three visits. In cases of a seizure an EEG was performed, drug plasma concentration assessed, and medication subsequently increased.\n Of the 100 included patients 14 (seven in each group) experienced one or more postoperative seizures. Severity of the seizures was comparable in the two groups. In all patients, drug plasma concentrations were in the low or subtherapeutic ranges at the time of the first postoperative seizure. Five patients in the phenytoin group and two in the valproate group had to stop their treatment due to drug related adverse events. Sixty patients completed the 12 month period. Analysis of neuropsychological and quality of life data showed no significant differences.\n For efficacy, tolerability, impact on cognitive functioning, and quality of life, no major differences were found between phenytoin and valproate prophylaxis. Valproate is an alternative for anticonvulsant prophylaxis in patients after craniotomy.", "To assess the efficacy and tolerability of valproate for the treatment of agitation and aggression in moderate-to-severe Alzheimer's disease (AD).\n This was a randomized, double-blind, placebo-controlled crossover trial of valproate in institutionalized AD patients. Patients were assessed with the Neuropsychiatric Inventory (NPI) and Cohen-Mansfield Agitation Inventory at baseline and after 6 weeks of treatment with valproate and placebo, with 2 weeks between phases to allow for placebo washout and tapering.\n Fourteen patients (8 male/6 female) aged 85.6 +/- 4.5 years with baseline Mini Mental State Examination scores of 4.5 +/- 4.6 and NPI agitation/aggression scores of 6.4 +/- 3.5 were randomized to treatment. NPI agitation/aggression treatment change scores significantly worsened during valproate treatment compared with placebo (Z = -2.03, p = 0.04). Tolerability of valproate was also poor, with patients experiencing a significantly greater mean number of adverse events during valproate therapy compared to placebo (Z = -2.82, p = 0.005).\n Valproate is not effective for the management of agitation in moderate-to-severe AD, and may be poorly tolerated in this population.\n Copyright (c) 2007 S. Karger AG, Basel.", "A 6-week double-blind, randomized, placebo-controlled trial was conducted to determine the efficacy of combined therapy with olanzapine and either valproate or lithium compared with valproate or lithium alone in treating acute manic or mixed bipolar episodes.\n The primary objective was to evaluate the efficacy of olanzapine (5-20 mg/d) vs placebo when added to ongoing mood-stabilizer therapy as measured by reductions in Young Mania Rating Scale (YMRS) scores. Patients with bipolar disorder (n = 344), manic or mixed episode, who were inadequately responsive to more than 2 weeks of lithium or valproate therapy, were randomized to receive cotherapy (olanzapine + mood-stabilizer) or monotherapy (placebo + mood-stabilizer).\n Olanzapine cotherapy improved patients' YMRS total scores significantly more than monotherapy (-13.11 vs -9.10; P = .003). Clinical response rates (> or = 50% improvement on YMRS) were significantly higher with cotherapy (67.7% vs 44.7%; P< .001). Olanzapine cotherapy improved 21-item Hamilton Depression Rating Scale (HAMD-21) total scores significantly more than monotherapy (4.98 vs 0.89 points; P< .001). In patients with mixed-episodes with moderate to severe depressive symptoms (DSM-IV mixed episode; HAMD-21 score of > or = 20 at baseline), olanzapine cotherapy improved HAMD-21 scores by 10.31 points compared with 1.57 for monotherapy (P< .001). Extrapyramidal symptoms (Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale) were not significantly changed from baseline to end point in either treatment group. Treatment-emergent symptoms that were significantly higher for the olanzapine cotherapy group included somnolence, dry mouth, weight gain, increased appetite, tremor, and slurred speech.\n Compared with the use of valproate or lithium alone, the addition of olanzapine provided superior efficacy in the treatment of manic and mixed bipolar episodes.", "The aim of this study was to study valproate efficacy and safety for aggression in children and adolescents with pervasive developmental disorders (PDD).\n In this prospective double-blind, placebo-controlled study, 30 subjects (20 boys, 10 girls) 6-20 years of age with PDD and significant aggression were randomized and received treatment with valproate (VPA) or placebo (PBO) for 8 weeks as outpatients. Mean VPA trough blood levels were 75.5 mcg/mL at week 4 and 77.8 mcg/mL at week 8.\n No treatment difference was observed statistically between VPA and PBO groups. The Aberrant Behavior Checklist--Community Scale (ABC-C) Irritability subscale was the primary outcome measure (p = 0.65), and CGI--Improvement (p = 0.16) and OAS (p = 0.96) were secondary outcome measures. Increased appetite and skin rash were significant side effects. Only 1 subject was dropped from the study owing to side effects, notably a spreading skin rash, which then resolved spontaneously. Two subjects receiving VPA developed increased serum ammonia levels, one with an associated parent report of slurred speech and mild cognitive slowing. Poststudy, of 16 VPA and PBO subjects receiving VPA, 10 subjects demonstrated sustained response, 4 of whom later attempted taper, with significant relapse of aggression.\n The present negative findings cannot be viewed as conclusive, partly owing to the large placebo response, subject heterogeneity, and size of the groups. Larger studies are needed to expand upon these findings.", "An open response-conditional cross-over study of valproate versus carbamazepine has been done in previously untreated patients with partial seizures. Thirty-one patients entered the study. Nineteen were followed up to one year. It appeared that valproate was at least as effective as carbamazepine: at one year, 11 patients were seizure-free on valproate and only 8 were seizure-free on carbamazepine. Furthermore no side-effect was noted in valproate therapy, whereas carbamazepine was stopped in 2 patients because of skin rashes. The efficacy of sodium valproate in partial epilepsy remains controversial. It is of course limited when given as co-therapy in severe epilepsies, uncontrolled with other major antiepileptic drugs. However in naive patients, with recent and previously untreated partial epilepsies, a one-drug treatment with valproate appears to be as effective as carbamazepine or phenytoin. It has less unwanted side-effects and should be prescribed as first line treatment.", "Long-term outcomes are often poor in patients with bipolar disorder despite treatment; more effective treatments are needed to reduce recurrences and morbidity. This study compared the efficacy of divalproex, lithium, and placebo as prophylactic therapy.\n A randomized, double-blind, parallel-group multicenter study of treatment outcomes was conducted over a 52-week maintenance period. Patients who met the recovery criteria within 3 months of the onset of an index manic episode (n = 372) were randomized to maintenance treatment with divalproex, lithium, or placebo in a 2:1:1 ratio. Psychotropic medications were discontinued before randomization, except for open-label divalproex or lithium, which were gradually tapered over the first 2 weeks of maintenance treatment. The primary outcome measure was time to recurrence of any mood episode. Secondary measures were time to a manic episode, time to a depressive episode, average change from baseline in Schedule for Affective Disorders and Schizophrenia-Change Version subscale scores for depression and mania, and Global Assessment of Function scores.\n The divalproex group did not differ significantly from the placebo group in time to any mood episode. Divalproex was superior to placebo in terms of lower rates of discontinuation for either a recurrent mood episode or depressive episode. Divalproex was superior to lithium in longer duration of successful prophylaxis in the study and less deterioration in depressive symptoms and Global Assessment Scale scores.\n The treatments did not differ significantly on time to recurrence of any mood episode during maintenance therapy. Patients treated with divalproex had better outcomes than those treated with placebo or lithium on several secondary outcome measures." ]

[ "14681639", "8245265", "2403699", "1920650", "15580451", "14974959", "8066108", "1862126", "12625392" ]

[ "Randomized trial and local biological effect of autologous platelets used as adjuvant therapy for chronic venous leg ulcers.", "Randomized trial comparing cryopreserved cultured epidermal allografts with hydrocolloid dressings in healing chronic venous ulcers.", "Stimulation of repair in chronic, nonhealing, cutaneous ulcers using platelet-derived wound healing formula.", "A prospective randomized trial of autologous platelet-derived wound healing factors for treatment of chronic nonhealing wounds: a preliminary report.", "[Venous leg ulcers: no improvement of wound healing with 685-nm low level laser therapy. Randomised, placebo-controlled, double-blind study].", "Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial.", "Comparison of ultrasound/ultraviolet-C and laser for treatment of pressure ulcers in patients with spinal cord injury.", "Ketanserin promotes wound healing: clinical and preclinical results.", "Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: a prospective study." ]

[ "Platelet products have been proposed as adjuvant therapy for wound healing. We undertook this study to determine the healing effect of topically applied frozen autologous platelets (FAP) on chronic venous ulcers, compared with effect of placebo, and whether use of topical FAP modifies local expression of vascular endothelial growth factor (VEGF), keratinocyte growth factor (KGF), interleukin 8 (IL-8), and tissue inhibitor of metalloproteinase-1 (TIMP-1) in wound fluid.\n This randomized, placebo-controlled, double-blind trial was carried out in institutional practice, with ambulatory patients with proved chronic venous leg ulcers. In all patients, whole venous blood was drawn for preparation of FAP. FAP or normal saline solution was applied three times per week for up to 12 weeks, together with hydrocolloids and standardized compression bandages. Leg ulcer surface was assessed with numerical pictures. IL-8, VEGF, KGF, and TIMP-1 levels were determined (enzyme-linked immunosorbent assay) in wound fluid after each 4 weeks of treatment.\n Fifteen patients were randomized into two groups with comparable leg ulcer characteristics. Mean percent reduction in ulcer area was 26.2% in the FAP group versus 15.2% in the placebo group (P =.94). One ulcer in each group was completely healed at study end. Levels of TIMP-1 increased significantly during FAP treatment. IL-8 concentration was significantly lower in wound fluid of healing ulcers than in the fluid of nonhealing ulcers, in both FAP and placebo groups. Growth factor levels were not modified with FAP treatment.\n Topical autologous platelets have no significant adjuvant effect on healing of chronic venous leg ulcers and increased wound fluid TIMP-1 concentration. Ulcer healing is associated with a decrease in wound fluid IL-8.", "Cultured epidermal allografts have been successfully used to treat a variety of wounds. Their postulated mechanism of action is through release of cytokines that stimulate epithelialization. On the basis of previous experience we expected ulcers treated with cryopreserved cultured allografts (CCAs) to be healed by 6 weeks. Hydrocolloid dressings (HCDs) have also been reported to be effective in the treatment of venous ulcers.\n Our purpose was to compare the effectiveness of CCAs with HCDs in healing chronic venous ulcers.\n Forty-three patients with 47 ulcers were enrolled in a randomized controlled trial. Ulcers not healed by 6 weeks were changed to the other treatment.\n No difference in the number of healed ulcers between the two groups was observed at 6 weeks. Healing rate, percent reduction of initial ulcer size, and radial progression toward wound closure were significantly greater for CCAs than for HCDs. Pain relief was not significantly different.\n CCAs achieve more rapid healing and greater reduction in ulcer size than HCDs.", "Chronic, nonhealing, cutaneous ulcers are a serious clinical problem. The results of previous studies using platelet-derived wound healing formula (PDWHF), derived from autologous platelets, provided evidence that PDWHF actively stimulates repair of the wound. To test whether or not PDWHF accelerates repair, a prospectively randomized, blinded trial was conducted using a placebo control. A total of 32 patients with chronic, nonhealing, cutaneous wounds of the lower extremity were randomized and treated for eight weeks with PDWHF or placebo. Epithelialization of the wound was the end point of study. In the group who received treatment, 81 per cent of patients had epithelialization in eight weeks compared with 15 per cent in the control group (p less than 0.0001). After crossover to treatment with PDWHF, all of the patients in the control group had epithelialization in an average of 7.1 weeks. Regression analysis of the rates of epithelialization also showed significant differences during the initial eight week trial and showed no difference after crossover of the control group to therapy with PDWHF. Results from this study demonstrate a highly statistically significant effect of topically applied platelet-derived growth factors on the repair of chronic, nonhealing, cutaneous ulcers.", "Previous studies have suggested that topically applied platelet-derived wound healing factors (PDWHF) accelerate wound healing by stimulating angiogenesis, fibroblast proliferation, and collagen synthesis. To assess the ability of platelet factors to facilitate healing of chronic cutaneous ulcers we performed a randomized, prospective, double-blind, placebo-controlled study of topical PDWHF in 18 patients with 26 lower extremity wounds refractory to conventional therapy. Wounds were present for at least 8 weeks (mean, 5.5 +/- 4.3 months). They were extensively debrided initially and were measured and photographed at weekly intervals for 12 weeks. Eight patients with nine wounds were treated with placebo solution (controls), and 10 patients with 17 wounds were treated with PDWHF (treatment group). Seventy-eight percent of patients had diabetes mellitus, 72% had occlusive peripheral vascular disease, and 28% had venous disease; distribution of these disorders was equivalent in both groups. Ankle-brachial indexes, which were often spuriously elevated, averaged 0.93 +/- 0.54 in controls and 1.04 +/- 0.56 in patients treated with PDWHF (p greater than 0.5). Mean transcutaneous oxygen tension was 37.8 +/- 11.9 mmHg in controls and 37.1 +/- 9.1 mmHg in patients treated with PDWHF. Initial wound area was larger in controls than in the patients treated with PDWHF (28.9 +/- 45.2 cm2 vs 13.0 +/- 4.4 cm2), but this difference was not statistically significant (p = 0.19). Three (33%) wounds (in two patients) healed in controls, and four (24%) wounds (in three patients) healed in the PDWHF group (p greater than 0.5). The rate of healing in controls was 1.9 +/- 2.7 cm2/week.(ABSTRACT TRUNCATED AT 250 WORDS)", "Venous leg ulcers (ulcera crurum venosa) are frequently seen in elderly patients. It has been suggested that low level laser irradiation has a biostimulative and wound healing effect; however, this has not yet been clinically verified by controlled studies.\n The difference in size reduction of leg ulcers with and without low level laser or placebo laser treatment was measured in 44 patients randomised into two treatment groups (685-nm low level laser and placebo laser) or a control group which served to quantify the effect of laser application. All patients received standardized wound care.\n The aim of the study was to compare the effectiveness of low level laser irradiation with that of a placebo \"light source\". The size of the ulcers was planimetrically measured at baseline (day 1), at the end of therapy (day 28) and 2 months later (day 90). The difference in wound size was evaluated.\n There were no statistically significant differences in reduction of wound size between the three groups, thus suggesting that low level laser light does not have any stimulatory effect on wound healing in ulcera crurum venosa.", "Vacuum-assisted closure has become a new technique in the challenging management of contaminated, acute, and chronic wounds. Although promising clinical results have been described, scientific proof to substantiate the mechanism of action of this therapy is scarce. In the present study, we examined whether the positive effect on wound healing found in vacuum-assisted closure-treated wounds could be explained by an effect on the bacterial load. Fifty-four patients who needed open wound management before surgical closure were included in this study. Wounds were randomized to either vacuum-assisted closure therapy (n= 29) or treatment by conventional moist gauze therapy (n= 25). Healing was characterized by development of a clean granulating wound bed (\"ready for surgical therapy\") and reduction of wound surface area. To quantify bacterial load, biopsies were collected. No significant difference was found in time needed to reach \"ready for surgical therapy\" comparing both therapies. Wound surface area reduction was significantly larger in vacuum-assisted closure-treated wounds: 3.8 +/- 0.5 percent/day (mean +/- SEM) compared to conventional-treated wounds (1.7 +/- 0.6 percent/day; p < 0.05). The total quantitative bacterial load was generally stable in both therapies. However, nonfermentative gram negative bacilli showed a significant decrease in vacuum-assisted closure-treated wounds (p < 0.05), whereas Staphylococcus aureus showed a significant increase in vacuum-assisted closure-treated wounds (p < 0.05). In conclusion, this study shows a positive effect of vacuum-assisted closure therapy on wound healing, expressed as a significant reduction of wound surface area. However, this could not be explained by a significant quantitative reduction of the bacterial load.", "The purpose of this study was to compare in patients with spinal cord injury the effect on wound healing of nursing care alone with the effect on wound healing of nursing care combined with either laser treatment or a regimen of ultrasound and ultraviolet-C (US/UVC).\n Twenty patients (22 wounds) were randomly assigned to the treatment groups.\n All patients received standard wound care consisting of wound cleaning twice daily, application of moist dressings, and continuous relief of pressure until the wounds were healed. The laser protocol consisted of three treatments weekly using a cluster probe with an 820-nm laser diode and 30 superluminous diodes (10 each at 660, 880, and 950 nm), and energy density of 4J/cm2, and a pulse repetition rate of 5,000 pulses per second. The US/UVC regimen consisted of five treatments weekly, alternating the treatment modality daily. The pulsed US was applied at a frequency of 3 MHz and a spatial average-temporal average intensity of 0.2 W/cm2 (1:4 pulse ratio) for 5 minutes per 5 cm2 of wound area. The UVC dosage (95% emission at 250 nm) was calculated each session according to wound appearance. The dosage level was E1 for clean/granulating areas, E3 for purulent/slow-granulating areas, E4 for heavily infected areas, and 2E4 for wound debridement. Wounds were traced every 14 days, and surface areas were calculated using the Sigma-Scan Measurement System. Weekly percentage changes in wound area were compared.\n Results showed that US/UVC treatment had a greater effect on wound healing than did nursing care, either alone or combined with laser.\n Ultrasound/ultraviolet-C may decrease healing time and may allow faster return to rehabilitation programs, work, and leisure activities for patients with spinal cord injury who have pressure ulcers.", "nan", "Pressure sores are a common complication of patients with spinal injuries. The vacuum-assisted closure technique is widely used to induce and promote wound healing. We tested our clinical impression that pressure sores healed faster with vacuum-assisted closure, and compared it with the traditional wet-to-dry/wet-to-wet technique with gauze soaked in Ringer's solution changed three times a day. Consecutive patients with pressure sores were entered into the study. Two randomised groups of 11 patients each with pressure sores of the pelvic region were included. We found no difference in time to reach 50% of the initial wound volume between the two methods. The vacuum-assisted group took a mean (SD) of 27 (10) days and the traditional group 28 (7) days. The two methods were equally effective in forming granulation tissue, so one can profit from the other advantages of the vacuum-assisted treatment (reduced costs and improved comfort) knowing that the effect on the formation of granulation tissue is as good as with the traditional treatment." ]