Do catheter washouts extend patency time in long-term indwelling urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care. Lactitol, a second-generation disaccharide for treatment of chronic portal-systemic encephalopathy. A double-blind, crossover, randomized clinical trial. Assessment of the use of bladder washouts/instillations in patients with long-term indwelling catheters. The effects of joint washout and steroid injection compared with either joint washout or steroid injection alone in rheumatoid knee effusion. Saline washout for knee osteoarthritis: results of a controlled study. Articular debridement versus washout for degeneration of the medial femoral condyle. A five-year study. A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients. The effectiveness of topical diclofenac for lateral epicondylitis. Open-label, multicenter, phase 3 extension study of the safety and efficacy of donepezil in patients with Alzheimer disease. A prospective randomised trial comparing intra-articular Hyalgan injection and arthroscopic washout for knee osteoarthritis. Hydrofluoroalkane-134A beclomethasone or chlorofluorocarbon fluticasone: effect on small airways in poorly controlled asthma.
Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue, but evidence on optimal management is lacking. Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage.
                A multisite randomized controlled trial.
                Adults with long-term indwelling catheters that required changing every 3 weeks or less, living in the community, and requiring supportive or continuing care were recruited. Participants were randomly assigned to 1 of 3 groups: control (usual care, no washout), saline washout, or commercially available acidic washout solution (Contisol Maelor Pharmaceuticals Ltd, Wrexham, UK).
                At baseline visit, the catheter was changed and participants were followed weekly for 8 weeks, with checks for catheter patency and urine pH. Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution. Endpoints were 8 weeks (completion data), 3 or more catheter changes in the 8-week period, or symptomatic urinary tract infection (UTI) requiring antibiotics. The study hypothesis was that catheter life would be extended by 25% in the commercial solution group. It was not possible to blind participants or research nurses to washout versus no intervention, but participants in the saline and washout solution groups were blinded to solution type.
                One hundred twelve potential participants were screened; 73 were enrolled, randomized, and included in the final analysis. Of these, 53 completed the full 8 weeks of data collection; 16 terminated early because of 3 catheter changes or self-reported 'UTI'. Other reasons for termination were hematuria, latex sensitivity, deceased/severe illness, or personal choice. Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study. Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change.
                At this time, the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking. No increased risk of UTI was associated with washout regimes. A double-blind crossover trial was performed to test the therapeutic usefulness and safety of lactitol, a beta-galactoside sorbitol, against lactose in 18 patients with chronic portal-systemic encephalopathy (PSE). The study included four periods: two for washout and two for lactitol and lactose administration. During washout periods, which lasted two weeks each, patients were stabilized with neomycin plus milk of magnesia. Lactitol and lactose were administered during four weeks each. Ten patients were randomly assigned to receive lactose (group A) and eight patients to receive lactitol (group B) first. PSE parameters, ie, mental state, number connection test performance, asterixis and blood ammonia levels were assessed fortnightly. Electroencephalographic tracings and stool pHs were evaluated at the end of each study period. After the first administration of lactose and lactitol, no statistically significant differences in PSE parameters were found. At the same stage, a significant stool acidification (P less than 0.05) was detected. It is concluded that lactitol seems to be safe and efficacious in treating patients with chronic PSE. A randomised cross-over study of 3 bladder washout treatments--saline, Suby G and Solution R--was conducted on 25 elderly females with long-term catheters in order to examine crystal formation and catheter encrustation. With 2 exceptions, all patients produced crystals; only 14 completed the study. While a significant reduction in struvite crystals was found in the returned acidic washout fluid, there was no significant reduction of crystals in the neutral (saline) washout following any of the 3-week periods of treatment. Uric acid crystals appeared with Suby G and Solution R and these solutions were associated with higher red cell deposits in the urine. There was no significant difference in catheter encrustation between the various washouts. Patients with rheumatoid arthritis attending rheumatology out-patients who had a symptomatic knee effusion were randomly allocated to receive one of three treatments: group I, a steroid injection without washout; group II, a joint washout with normal saline; group III, a joint washout with normal saline and steroid injection. Sixty knees in all were studied. Laboratory parameters for disease activity (erythrocyte sedimentation rate, C-reactive protein) were monitored in all patients prior to the study and at 3 months. Clinical assessment of disease activity (pain, morning stiffness involving the knee, circumference of the knee, walking distance and range of movement) were recorded prior to the study, at 1 month and at 3 months. All three treatments, resulted in a reduction of pain and increased movement. However, patients who had a joint washout alone showed significantly less improvement as compared with the other two groups. Symptomatic improvement was marginally greater in patients following joint washout and injection than in those who had had joint injection alone. The results of the study indicate that the simple procedure of joint aspiration and steroid injection, which can be carried out in the out-patient clinic, provides satisfactory relief of symptoms in rheumatoid patients with knee effusions. Joint washout alone was less beneficial. Twenty patients with persistent symptoms due to osteoarthritis of the knee were randomly allocated to a saline washout or control group. Both groups showed improvement. Knee washout conferred no more benefit than intra-articular saline injection. In a prospective randomised trial 76 knees with isolated degenerative changes in the medial femoral condyle of grades 3 or 4 were treated by either arthroscopic debridement (40) or washout (36). All knees were followed up for at least one year and 58 for five years. The mean follow-up time was 4.5 years in the debridement group and 4.3 years in the washout group. At one year 32 of the debridement group and five of the washout group were painfree and at five years 19 of a total of 32 survivors in the debridement group and three of the 26 in the washout group were also free from pain. The mean improvement in a modified Lysholm score was 28 for the debridement group at one year and 21 at five years. In the washout group it was only 5 at one year and 4 at five years. For knees with lesions of the medial femoral condyle of grades 3 or 4, arthroscopic debridement appears to be the treatment of choice with over half the patients free from pain after five years. We have previously shown sevelamer hydrochloride (RenaGel) to be an effective and well-tolerated treatment for hyperphosphatemia in hemodialysis patients.
                We performed a randomized clinical trial to compare the efficacy of RenaGel alone and RenaGel with calcium, using the serum phosphorus concentration and intact parathyroid hormone (PTH) as the principal outcomes of interest. Calcium (900 mg elemental) was provided as a once-nightly dose on an empty stomach. 71 patients were randomized and included in the intent-to-treat population; 55 completed the 16-week study period (2 weeks washout, 12 weeks treatment, 2 weeks washout). 49% of subjects were taking vitamin D metabolites.
                Serum phosphorus and PTH rose significantly when patients stopped their phosphate binders during both washout periods. RenaGel and RenaGel with calcium were equally effective at reducing serum phosphorus (mean change -2.4 mg/dL vs. -2.3 mg/dL). RenaGel with calcium was associated with a small increase in serum calcium (mean change 0.3 mg/dL vs. 0.0 mg/dL in RenaGel group, P = 0.09) that was not statistically significant. During the treatment phase, the reduction in PTH tended to be greater in the RenaGel with calcium group (median change -67.0 vs. -22.5 pg/mL in RenaGel group, P = 0.07). Non-users of vitamin D metabolites treated with RenaGel with calcium experienced a significant decrease in PTH (median change -114.5 vs. -22 pg/mL in RenaGel group, P = 0.006). Adverse events were seen with equal frequency in both groups, being generally mild in intensity, and rarely attributable to the drugs.
                We conclude that RenaGel and RenaGel with calcium are similarly effective in the treatment of ESRD-related hyperphosphatemia. Provision of supplemental calcium or metabolites of vitamin D with RenaGel may enhance control of hyperparathyroidism. Gastrointestinal upset and local pain commonly limit the use of oral nonsteroidal anti-inflammatory drugs and corticosteroid injection as treatments for lateral epicondylitis. Transdermal administration of an anti-inflammatory drug could avoid these adverse effects.
                To determine the effectiveness of topical diclofenac as a treatment of lateral epicondylitis.
                A convenience sample of 14 subjects meeting clinical criteria of chronic lateral epicondylitis participated in this randomized, double blind, crossover study. Each subject applied a pluronic lecithin liposomal organo-gel (PLO) over the affected lateral elbow three times daily for I week, followed by a 1-week "washout" period of no gel. A second topical PLO gel was then applied similarly for 1 week. Both gels were identical, but only one gel contained 2% diclofenac. Treatment order was randomized, and both the subject and tester were blinded. Pain and isometric wrist extension strength were measured using a visual analog pain scale (VAS) and a mounted manual muscle testing dynamometer, respectively, at the following time periods: just before application of the first gel, the last day of using the first gel, the last day of the washout week, and the last day of using the second gel. Analysis was performed using repeated measures analysis of variance.
                When subjects used diclofenac PLO, pain was significantly less than that during the pretreatment, washout, and placebo PLO periods (mean VAS: diclofenac PLO, 2.1; pretreatment, 3.5; washout, 3.4; placebo PLO, 3.6). Average wrist extension strength was significantly greater when subjects used diclofenac PLO (8.4 kg) than it was before treatment (5.9 kg). One subject developed a local rash while using diclofenac PLO.
                Topical 2% diclofenac in PLO appears to provide effective short-term reduction in elbow pain and wrist extensor weakness associated with chronic lateral epicondylitis. Donepezil hydrochloride is a selective acetylcholinesterase inhibitor approved for the symptomatic treatment of mild to moderately severe Alzheimer disease (AD). Controlled clinical trials of up to 24 weeks have demonstrated that donepezil treatment (5 and 10 mg/d) significantly improves cognition and global function.
                To investigate the long-term benefits of donepezil treatment in patients with AD.
                Multicenter, open-label, 144-week extension of 2 US phase 3, double-blind, placebo-controlled clinical trials: a 15-week study (12 weeks of treatment followed by a 3-week placebo washout) and a 30-week study (24 weeks of treatment followed by a 6-week placebo washout).
                All patients (N = 763) initially received donepezil, 5 mg/d, for 6 weeks, after which an increase to 10 mg/d was encouraged.
                Primary efficacy measures were the Alzheimer's Disease Assessment Scale-cognitive subscale and the Clinical Dementia Rating-Sum of the Boxes.
                After the shorter 3-week placebo washout, donepezil-associated benefits remained above original baseline values for an additional 24 weeks of open-label treatment. Benefits on Alzheimer's Disease Assessment Scale-cognitive subscale scores for patients who received 10 mg/d in the double-blind study were evident compared with the other groups for 108 weeks of open-label treatment. In contrast, donepezil-associated benefits were lost after the 6-week placebo washout, and scores decreased below original baseline values for all patient groups. Although scores improved relative to the new open-label study baseline scores after drug use was restarted, patients remained below original baseline values. The most common adverse events were associated with the nervous and digestive systems and were generally mild and transient; 17% of patient discontinuations were associated with adverse events.
                Donepezil is an effective and safe drug for the long-term symptomatic treatment of mild to moderately severe AD for up to 144 weeks (2.8 years), and sustained treatment may confer some advantages. Thirty-eight patients with symptomatic knee osteoarthritis without mechanical symptoms were randomised after informed consent to receive either a course of intra-articular Hyalgan injections or an arthroscopic washout. The patients were prospectively assessed pre-intervention, 6 weeks, 3 months, 6 months and 1 year using a 10 cm visual analogue pain score, the Knee Society function score and the Lequesne index. There was no significant difference between the two groups at 6 weeks, 3 months, 6 months or 1 year. The use of intra-articular Hyalgan injections in patients with knee osteoarthritis without mechanical symptoms gives results comparable with arthroscopic washout. Hyalgan is an alternative to arthroscopy in this patient group. Further study is needed to confirm these findings and improve patient selection. Inflammation in asthma extends into the small airways (< 2 mm diameter). Most inhaled corticosteroids are suspensions with a particle size > 2 mm. Therefore, inflammation in the small airways of patients with asthma may not be adequately treated with these preparations. Some inhaled corticosteroids, on the other hand, are compounded with alcohol, resulting in a solution producing an aerosol that has a mean particle diameter of < 2 mm. This study was designed to compare the addition of equivalent amounts of two inhaled corticosteroids (one a suspension and one a solution) to the treatment of patients with asthma, which was uncontrolled despite treatment with moderate to high doses of inhaled corticosteroids and usually additional controller medications. The study was performed with 30 patients, > or = 18 years of age. Subjects were randomized in a single-blind fashion to receive, in addition to their current asthma therapy, either CFC-FP 220 microg each morning and 110 microg each evening (n = 10) or HFA-BDP 160 mcg twice daily (n = 20). Pre- and postbronchodilator spirometry, single breath nitrogen washout for closing volume and residual volume by plethysmography were assessed before and after 3 months of therapy. In the subjects who received HFA-BDP, the ratio of closing volume (CV) to vital capacity (VC) and residual volume (RV) decreased significantly (p = 0.0214 and 0.0433, respectively), whereas forced expiratory flow over 25-75% of the vital capacity (FEF25-75%), forced expiratory volume in 1 second (FEV1), and morning peak flow improved significantly (p = 0.0014, 0.0184, and 0.0321). Improvements from baseline of CV, CV/VC, and postbronchodilator FEF25-75%, were statistically significant in the HFA-BDP group compared with the CFC-FP group (p = 0.0049, 0.0194, and 0.0355, respectively). These preliminary findings suggest that the addition of HFA-BDP, compared with CFC-FP in patients with poorly controlled asthma despite receiving moderate to high doses of inhaled steroids, has a greater effect on parameters reflecting small airway patency presumably secondary to reduction in inflammation.
The data from five trials comparing differing washout policies were sparse and trials were generally of poor quality or poorly reported. The evidence was too scanty to conclude whether or not washouts were beneficial. In the first instance we require further rigorous, high quality trials with adequate power to detect any benefit from washout being performed as opposed to none. Then trials comparing different washout solutions, washout volumes, frequencies/timings and routes of administration are needed.