Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study. Brief intervention for harm reduction with alcohol-positive older adolescents in a hospital emergency department. Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral Vascular Disease Outcome Study (SCS-EPOS). [Spinal cord electric stimulation vs. femoro-distal bypass in critical ischemia of the legs. Preliminary results in a randomized prospective study]. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. Effect of short-term therapy with propylthiouracil in patients with alcoholic liver disease. Transcutaneous oxygen pressure as predictive parameter for ulcer healing in endstage vascular patients treated with spinal cord stimulation. Influence of sports climbing and yoga on spasticity, cognitive function, mood and fatigue in patients with multiple sclerosis. Teaching patients to monitor their risk factors retards the progression of vascular complications in high-risk patients with Type 2 diabetes mellitus--a randomized prospective study. Randomized clinical trial of the effects of preoperative and postoperative oral nutritional supplements on clinical course and cost of care. Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department.
This study was designed to test the hypothesis that spinal cord stimulation (SCS) improves limb salvage in patients with inoperable severe leg ischaemia.
                Prospective randomised controlled study with 18 months follow-up.
                Vascular surgical units in two university hospitals.
                Atherosclerotic (n = 41) and diabetic (n = 10) patients having chronic leg ischaemia with rest pain and/or ischaemic ulcerations due to technically inoperable arterial occlusions.
                Limb salvage and amount of tissue loss within 18 months, pain relief.
                Twenty-five patients were randomized to SCS and 26 to analgesic (control) treatment. Macrocirculatory parameters were not different in the two groups during follow-up. Long-term pain relief was observed only in the SCS group. At 18 months, limb salvage rates in the SCS and control groups were 62% and 45% (N.S.). Tissue loss was less (p = 0.05) in the SCS group. A subgroup analysis of patients without arterial hypertension showed a significantly lower amputation rate in the SCS vs the control group.
                SCS provided long-term pain relief but limb salvage at 18 months was not significantly improved by SCS in this rather small study. The results suggest that SCS may reduce amputation levels in patients with severe inoperable leg ischaemia and be most effective in patients without arterial hypertension. This study evaluated the use of a brief motivational interview (MI) to reduce alcohol-related consequences and use among adolescents treated in an emergency room (ER) following an alcohol-related event. Patients aged 18 to 19 years (N = 94) were randomly assigned to receive either MI or standard care (SC). Assessment and intervention were conducted in the ER during or after the patient's treatment. Follow-up assessments showed that patients who received the MI had a significantly lower incidence of drinking and driving, traffic violations, alcohol-related injuries, and alcohol-related problems than patients who received SC. Both conditions showed reduced alcohol consumption. The harm-reduction focus of the MI was evident in that MI reduced negative outcomes related to drinking, beyond what was produced by the precipitating event plus SC alone. To determine the effect of spinal cord stimulation (SCS) on limb survival in patients with non-reconstructable critical leg ischaemia, and the value of patient selection on the basis of transcutaneous oxygen pressure (TcpO2) measurements and trial screening.
                A prospective, controlled, European multicentre study.
                Non-reconstructable patients with stable critical leg ischaemia were divided into three groups. The SCS-Match group comprised patients with a baseline forefoot TcpO2 of < 30 mmHg and both sufficient pain relief and sufficient paraesthesia coverage (> 75%) after a test stimulation period of at least 72 h. If baseline TcpO2 was < 10 mmHg, the TcpO2 should have exceeded 20 mmHg after test stimulation. The SCS-Match group was compared with patients not meeting these criteria, who were treated either with SCS (SCS-No-Match) or without SCS (No-SCS).
                At baseline, the mean (+/- SD) supine TcpO2 was 14.9 +/- 8.3 mmHg in the SCS-Match group (n = 41), 11.3 +/- 13.3 mmHg in the SCS-No-Match group (n = 32) and 15.3 +/- 17.1 mmHg in the No-SCS group (n = 39). In the SCS-Match group a significant improvement in pain relief (p < 0.005) and TcpO2 (p < 0.001) was seen. After 12 months, cumulative limb survival of patients treated with SCS was significantly better than that of patients not treated with SCS (p < 0.03), and limb survival in the SCS-Match group was significantly higher (p < 0.03) than that in the SCS-No-Match and No-SCS groups (78, 55 and 45%, respectively).
                SCS treatment of non-reconstructable critical leg ischaemia provides a significantly better limb survival rate compared with conservative treatment. Patient selection based on TcpO2 and the results of trial screening further increase the probability of limb survival after SCS therapy. In the last few years the development of new and improved surgical procedures caused a more aggressive approach, by femoro-distal bypass, to the limb affected by critical ischaemia. A good surgical result is related to the crural vessel patency, the presence of an adequate autologous vein and the possibility to visualize inframalleolar and foot arteries by selective angiograms. Should all these conditions not be present, an outflow procedure might be at high risk for failure. On the other hand, several studies show that SCS relieves rest pain and improves trophic lesion healing although there is no evident increase in peripheral blood flow, but these studies refer to heterogeneous non-randomized patients. In order to evaluate the effectiveness of SCS compared to distal arterial reconstruction, we started this prospective and randomized study. In a period of 15 months, 12 patients affected by critical limb ischaemia at 4th stage of Fontaine with angiographic multilevel distal lesions were randomised for SCS (7 cases: group A) and distal bypass (5 cases: group B). The result of the therapy was judged as good or fair when either complete or evident pain regression and trophic lesion healing were obtained; otherwise the result was considered as poor. Actually the study is in progress, the follow-up is partial (3-12 months), the results are preliminary. In the patients of group A the results were good or fair in 5 cases (72%) and poor in 2 (28%). In the patients of group B the results were good or fair in 2 cases (40%) and poor in 3 (60%).(ABSTRACT TRUNCATED AT 250 WORDS) Methadone maintenance programs (MMP) have the potential to play an important role in reducing HIV risk, given the appropriate type and level of ancillary treatments. In this study, we investigated the efficacy of a 12-session harm reduction group intervention for injection drug users, based upon the Information-Motivation-Behavioral skills model of behavior change, that focused on reducing both drug and sex risk. Two hundred and twenty patients entering an MMP were randomized to receive either standard care (SC)-2 hours of counseling per month and a single-session risk reduction intervention-or SC plus the harm reduction group (HRG). Results showed that during treatment, patients receiving HRG were more likely to be abstinent from cocaine and to report fewer unsafe sexual practices. Post-treatment, HRG patients scored higher on a sexual risk quiz and reported increased self-efficacy in high risk sexual situations. Enhancing methadone maintenance with a weekly harm reduction group treatment was somewhat more expensive but can bring about positive changes in behaviors and attitudes that are associated with the transmission of HIV. The effect of propylthiouracil (PTU; 300 mg/day) on alcoholic liver disease was evaluated in 133 patients in a short-term randomized double-blind trial. Severity of the disease was assessed by a composite clinical and laboratory index (CCLI). A normalization rate (NR) representing the rate of improvement in CCLI was calculated. Patients with alcoholic hepatitis, with and without cirrhosis, showed a significantly higher NR on PTU (43.6 +/- 4.6) than on placebo (19.8 +/- 3.3; P less than 0.001). A similar effect was observed in patients with abnormal prothrombin (no biopsy): NR was 32.9 +/- 6.9 on PTU and 2.6 +/- 3.7 on placebo (P less than 0.005). The effect of PTU on each clinical and laboratory component of the CCLI was also compared in these two groups. In 38 patients with alcoholic hepatitis and in 25 with abnormal prothrombin, those on PTU showed a greater improvement in 15 of 15 items (P less than 0.001) and 14 of 15 (P less than 0.01), respectively. When patients were divided according to the severity of the disease into those in the lower and upper halves of the CCLI range (81 and 52 patients, respectively), PTU was shown to have a significant effect only in the latter: The NR was 41.4 +/- 3.8 on PTU and 22.5 +/- 4.2 on placebo (P less than 0.005). PTU was ineffective in patients with inactive cirrhosis. This study was designed to test the hypothesis that initial TcPO2 helps predict clinical outcome in vascular patients treated with spinal cord stimulation. A randomized-controlled study with one year follow-up was made in 86 Fontaine stage IV patients with endstage peripheral arterial occlusive disease (PAOD) undergoing 21 day intravenous prostaglandin E1 (PGE1) therapy for nonhealing ulcers.
                All patients had arteriosclerosis, 13 also diabetes mellitus. Entry criteria included: non-reconstructible PAOD as proven by intra-arterial angiography or patient condition, ankle systolic pressure < 50 mmHg, severe rest pain despite analgetic medication, and presence of nonhealing foot ulcers or dry gangrene. One week after the start of PGE1 therapy, patients were randomized into receiving SCS plus PGE1 (n = 45 patients), or just PGE1 (n = 41 patients). Follow-up examinations were done at 1, 3, 6 and 12 months. BASELINE: There were no significant differences between both groups in the following: age, sex distribution, ischemic skin lesions, risk factors and several key group mean physiological values including ankle systolic pressure, ankle/brachial ratio (ABI) and foot TcPO2. The SCS group had more prior vascular leg surgeries (1.77 vs 1.58 per patient). RESULTS AT 12 MONTHS: There was significantly better total healing of foot ulcers in the SCS-group (69 vs 17%; p < 0.0001). Significantly more SCS-patients achieved an outcome of Fontaine stage II (claudication pain, no rest pain or lesions) (40 vs 10%, p = 0.0014). The frequency of minor and major amputations was not different, respectively 13 vs 15% and 16 vs 20%. The mean ABI at 12 months of the treated limb of the SCS-patients was not significantly greater. Foot TcPO2 increased significantly for the SCS-group (+213 vs -2%; p < 0.0001). Patients in either group whose TcPO2 rose to 26.0 +/- 8.6 mmHg on average were able to heal ulcers or toe amputation wounds. PGE1-patients had temporary TcPO2 elevations of about 33% on average but this was gone by six months. SCS-patients had steady increases in TcPO2, and maintained them at 12 months. Among the SCS-patients, those with baseline TcPO2 < = 10 mmHg had significantly less success at 12 months, this was not observed for the OMT-patients. The regional perfusion index increased significantly, 187 vs 0%; p < 0.001.
                Spinal cord stimulation appears to provide a major benefit for lesion improvement in stage IV patients with non-reconstructible PAOD. Patients with an initial TcPO2 > 10 mmHg will respond better to the stimulation therapy. With pain relief and ulcer healing quality of life improved. Effects on limb salvage do not appear. Spasticity, cognitive impairment, depression and fatigue significantly reduce the quality of life in multiple sclerosis (MS) patients. To find out whether nonpharmalogical treatment approaches can reduce these symptoms we investigated effects of sports climbing (SC) and yoga on spasticity, cognitive impairment, mood change and fatigue in MS patients. Sports climbing (SC) and yoga are aerobic physical activities comprised a series of stretching techniques, implementation of which demands body control and planning of complex movements.
                20 subjects with relapsing-remitting or progressive MS, 26-50 years of age, with EDSS<or=6 and EDSS pyramidal functions score (EDSSpyr)>2 were enrolled in a randomized prospective study. The participants were randomly divided into SC and yoga group. We evaluated spasticity, cognitive function, mood and fatigue before and after both programs, that lasted 10 weeks, with standardized assessment methods.
                There were no significant improvements in spasticity after SC and yoga. In the SC group we found a 25% reduction (p=0.046) in EDSSpyr. There were no differences in executive function after the completion of both programs. There was a 17% increase in selective attention performance after yoga (p=0.005). SC reduced fatigue for 32.5% (p=0.015), while yoga had no effect. We found no significant impact of SC and yoga on mood.
                Yoga and SC might improve some of the MS symptoms and should be considered in the future as possible complementary treatments. Intensive management of risk parameters in diabetic patients may retard the progression of both micro- and macrovascular complications. Intensified care requires expert staff and is expensive. The aim of the present study was to examine whether sharing the therapeutic responsibility with the patients will improve the outcome.
                A randomized prospective study of 165 patients with diabetes mellitus Type 2, hypertension (> 140/90 mmHg) and hyperlipidaemia (LDL-C > 120 mg/dl). Patients were randomly allocated to standard annual consultation (SC) or to a patient participation programme (PP). The medical care for both groups was administered by primary care physicians, who were unaware of the nature of the intervention.
                At 4 years the mean blood pressure was 148/88 (+/- 6.1/1.7) mmHg in the SC patients vs. 142/84 (+/- 5.8/1.8) mmHg in the PP group (P = 0.02). The mean LDL-C was 124 +/- 8 and 114 +/- 6 mg/dl (P = 0.01) and the mean HbA1c was 8.9 +/- 1.2% and 8.2 +/- 1.5% (P = 0.04) in the SC and PP groups, respectively. The average annual fall in estimated glomerular filtration rate was 3.5 ml/min per year in the SC group vs. 2.25 in the PP group (P < 0.05). Albumin/creatinine ratio > 300 mg/g developed in four SC patients vs. none of the PP patients. There was a total of 36 cardiovascular events in the SC group vs. 23 in the PP group (P = 0.04). All patients in the PP group received ACE inhibitors (or AII blockers) and statins vs. 52% and 43%, respectively, in the SC group. Glucose-lowering regimens were similar.
                Well-informed and motivated patients were more insistent to reach and maintain target values of the main risk factors of diabetic complications. The differences between the PP and SC groups were of the same order of magnitude as those between intensive and standard care groups in other studies albeit with, comparatively, a very modest cost. Postoperative oral nutritional supplementation has been shown to be of clinical benefit. This study examined the clinical effects and cost of administration of oral supplements both before and after surgery.
                This was a randomized clinical trial conducted in three centres. Patients undergoing lower gastrointestinal tract surgery were randomized to one of four groups: group CC received no nutritional supplements, group SS took supplements both before and after surgery, group CS received postoperative supplements only, and group SC were given supplements only before surgery. Preoperative supplements were given from the time it was decided to operate to 1 day before surgery. Postoperative supplements were started when the patient was able to take free fluids and continued for 4 weeks after discharge from hospital. Data collected included weight change, complications, length of stay, nutritional intake, anthropometrics, quality of life and detailed costings covering all aspects of care.
                Some 179 patients were randomized, of whom 27 were withdrawn and 152 analysed (CC 44, SS 32, CS 35, SC 41). Dietary intake was similar in all four groups throughout the study. Mean energy intake from preoperative supplements was 536 and 542 kcal/day in the SS and SC groups respectively; that 2 weeks after discharge from hospital was 274 and 361 kcal/day in the SS and CS groups respectively. There was significantly less postoperative weight loss in the SS group than in the CC and CS groups (P < 0.050), and significantly fewer minor complications in the SS and CS groups than the CC group (P < 0.050). There were no differences in the rate of major complications, anthropometrics and quality of life. Mean overall costs were greatest in the CC group, although differences between groups were not significant.
                Perioperative oral nutritional supplementation started before hospital admission for lower gastrointestinal tract surgery significantly diminished the degree of weight loss and incidence of minor complications, and was cost-effective.
                Copyright 2004 British Journal of Surgery Society Ltd. The study aim was to test whether a brief motivational intervention, with or without a booster session, would improve drinking-related outcomes more than standard Emergency Department (ED) treatment.
                The study population consisted of 539 (78% male) injured patients treated in the ED and discharged to the community following their treatment. Injured patients met inclusion criteria if they were assessed as hazardous or harmful drinkers by scoring eight or more on the AUDIT and/or having alcohol in their system at the time of their injury or ED visit. Patients were randomly assigned to either standard care (SC), brief intervention (BI) or brief intervention plus a booster session (BIB). At 1-year follow-up, 447 patients (83% of the sample) were re-interviewed to measure alcohol-related negative consequences, injuries and drinking.
                Patients receiving BIB, but not B1 patients, reduced alcohol-related negative consequences and alcohol-related injuries more than did those in the SC group. All three groups reduced their days of heavy drinking. Patients with histories of hazardous drinking responded to BIB, whether or not they had consumed alcohol prior to their injury.
                Together, these results indicate that the effects of a booster session that is added to a brief intervention in the ED can be helpful to injured patients with a history of hazardous or harmful drinking, irrespective of whether they have consumed alcohol prior to their injury.
There is evidence to favour SCS over standard conservative treatment alone to improve limb salvage and clinical situations in patients with NR-CCLI. The benefits of SCS must be considered against the possible harm of relatively mild complications and the costs.