Randomised trial of chelation therapy.
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OBJECTIVES: To review the epidemiology of published randomised controlled trials in infertility treatment over the last 25 years, with special emphasis on the number and quality of trials. DESIGN: Computer literature review by MEDLINE backed up by a manual search of 41 journals. Each trial was classified according to the methodology described and quality criteria. The results were recorded in a computer database. Odds ratios (OR) and confidence intervals (CI) were calculated where the data were sufficient. SUBJECTS: Couples suffering from primary or secondary infertility. The trials studied 33,761 patients overall. SETTING: Institute of Epidemiology and Health Services Research, Leeds. RESULTS: Five hundred and one randomised trials in male and female infertility treatment were identified between 1966 and 1990. Pregnancy was an outcome in 291 (58%) and these were the subject of detailed analysis. Two hundred and twenty-four (77%) and 67 (23%) 'pregnancy trials' were concerned, respectively, with female and male infertility. Four per cent of the trials were preceded by a sample size calculation, and the average sample size was 96 patients (range 5-933); 700 patients per group would be required to demonstrate plausible success rates for most treatments. The method of randomisation was unstated or pseudo-randomised in 206 (71%) of trials where pregnancy was an outcome. Only 29 (5.8%) of studies were multicentre. The method of confirmation of pregnancy was omitted for 70% of papers. Cross-over design was used in 103 (21%) of cases. Meta-analysis is possible for selected topics such as the use of anti-oestrogens in idiopathic oligospermia and unexplained female infertility. Eight cases of double reporting were identified. CONCLUSIONS: Trials using randomised methodology were relatively few in comparison with other branches of medicine, although their use is important in the evaluation of treatment for infertility as treatment-independent pregnancy is common. It was encouraging to note that an exponential increase in the use of this methodology occurred during the last three years, especially in association with assisted conception techniques, and meta-analysis has become possible for selected topics. However, many trials suffer from an unrealistically small sample size, inappropriate use of cross-over design or pseudo-randomisation. The trend towards properly controlled studies should be encouraged but these studies should be of improved quality and organised on a multicentre or even international basis.
OBJECTIVE: To review the effectiveness and safety of topical non-steroidal anti-inflammatory drugs in acute and chronic pain conditions. DESIGN: Quantitative systematic review of randomised controlled trials. DATA SOURCES: 86 trials involving 10,160 patients. MAIN OUTCOME MEASURES: Measures of treatment success approximating at least 50% reduction in pain, local and systemic adverse effects. Analysis at 1 week for acute and 2 weeks for chronic conditions with relative benefit and number needed to treat. RESULTS: In acute pain conditions (soft tissue trauma, strains, and sprains) placebo controlled trials had a relative benefit of 1.7 (1.5 to 1.9), the number needed to treat was 3.9 (3.4 to 4.4). With analysis by drug (at least three trials), ketoprofen (number needed to treat 2.6), felbinac (3.0), ibuprofen (3.5), and piroxicam (4.2) had significant efficacy. Benzydamine and indomethacin were no different from placebo. In chronic pain conditions (osteoarthritis, tendinitis) placebo controlled trials had a relative benefit of 2.0 (1.5 to 2.7); the number needed to treat was 3.1 (2.7 to 3.8). Small trials (< 40 treated patients) exaggerated effectiveness of topical non-steroidals by 33% in acute conditions but not in chronic conditions. There was no relation between trial quality and treatment effect. In both acute and chronic pain local and systemic adverse events and withdrawal from the study related to the drug had a low incidence and were no different from placebo. CONCLUSION: Topical non-steroidal anti-inflammatory drugs are effective in relieving pain in acute and chronic conditions.
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PURPOSE AND METHODS: One of the outcomes of reforming mental health care in Germany has been the establishment of a range of community mental health services. However, current evidence for the effectiveness of these services is slight. Based on a literature search this article provides a systematic overview of empirical research in this sphere. In detail, social psychiatric services, crisis centres, psychosocial contact points, day care centres, and various models of supported housing and work/employment are assessed. Available results on effectiveness are classified according to their level of scientific evidence. RESULTS: The current state of research is characterised by the situation that effectiveness of the care approach provided by social psychiatric services and some types of supported housing and work/employment has been demonstrated at a medium level of scientific evidence. In contrast, the evidence level of mental health care provided in crisis centres, psychosocial contact points, and day care centres is poor. CONCLUSION: The major reasons for this lack of research are: heterogeneity of care models and staffing levels in the different community mental health services, lack of standardised documentation and reporting system in these services, and lack of research culture to utilise routine outcome data. The consequences of aiming at increasing the level of scientific evidence in this sphere would be to intensify funding of research projects and to implement high quality research designs such as randomised controlled trials.
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BACKGROUND: Earwax is a common problem in both primary and secondary care. There is uncertainty as to the most effective topical treatment. AIM: To assess the evidence concerning the efficacy of topical preparations used for treating earwax. DESIGN OF STUDY: Systematic review and meta-analysis. METHOD: Searching for randomised controlled trials (RCTs) of relevant studies. Classification of preparations into three groups, enabling pooling of data and meta-analysis. RESULTS: Of the 18 RCTs included in the review, four were judged to be of high quality. Fifteen preparations including saline and plain water were studied. Oil-based and water-based preparations were equally effective at clearing earwax without syringing (odds ratio [OR] = 0.9, 95% confidence interval [CI] = 0.4 to 2.3) and facilitating successful syringing (OR = 1.0, 95% CI = 0.6 to 1.6). A non-water-, non-oil-based preparation appeared more effective than an oil-based preparation at both clearing earwax without syringing, and facilitating successful syringing. Immediate syringing after application of a preparation may be as effective as using eardrops for several days and delaying syringing. CONCLUSIONS: On current evidence, there is little to choose between water-based and oil-based preparations; non-water-, non-oil-based preparations appear promising at both clearing earwax and facilitating successful syringing, but further large trials are needed. Although immediate ear syringing is effective and convenient for patients, it may be less cost-effective than using eardrops and perhaps avoiding syringing. Most of the evidence regarding such a common and time-consuming problem is not of high quality.
STUDY DESIGN: Review. OBJECTIVES: To review published articles on the assessment, diagnosis and treatment of pain following spinal cord injury (SCI) and to synthesise evidence from these materials to formulate and propose a systematic approach to management. METHODS: Relevant articles regarding the treatment of pain were identified from electronic databases using the search terms (('spinal cord injury' or 'spinal cord injuries') and 'pain') and both ('treatment') and ('randomised controlled trials'). Relevant articles were also identified through citations in indexed journal publications and book chapters on this topic. RESULTS: Review of the literature indicates that there are a large variety of treatments used in the management of pain following SCI with a small number supported by strong evidence for effectiveness. A treatment algorithm is proposed based on identification of underlying pain contributors and application of appropriate treatment. CONCLUSION: Although there are relatively few studies clearly indicating efficacy in this population, an algorithm for the management of pain following SCI might assist to maximise our effectiveness in the treatment of this condition. It is recognised that choice of treatment is also determined by factors such as medication availability, cost and side effects as well as the preferences and characteristics of the person being treated. Nevertheless, an algorithm is proposed as a way to synthesise our current level of knowledge, identify gaps for further study and aid in the management of this difficult problem.
A randomised, double-blind, placebo-controlled trial with lithium succinate ointment was conducted in patients with AIDS-associated facial seborrhoeic dermatitis. Twice daily applications of the ointment brought about a rapid (2.5 days) and highly significant (P = 0.007) improvement in the severity of the condition. Lithium succinate ointment is well tolerated and can be a useful treatment for seborrhoeic dermatitis in this group of patients.