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[Treatment of interdigital tinea pedis].

BACKGROUND AND OBJECTIVE: Local antimycotic therapy of interdigital tinea pedis is widely accepted and efficacious. In Germany at present, the azoles and allylamines--part from the hydroxypyridone derivative ciclopiroxolamine--are the pharmacological agents applied most often. This study focuses on the efficacy of topical therapeutic options in Germany, by regarding the mycological and clinical cure rates of interdigital tinea pedis. METHODS: Only randomised, double-blind and controlled clinical trials of tinea pedis therapy were selected for the evaluation. Microbiological culture and microscopic information were indispensable criteria for the clinical diagnoses. RESULTS: The data from 40 randomised clinical trials of azoles and allylamines were included in the analysis. The comparison of azoles with the placebo revealed mycological cure rates between 60 - 91 % (placebo 10 - 67 %) and clinical cure rates between 64 - 95 % (placebo 10 - 63 %). Placebo-controlled trials of allylamines (naftifine and terbinafine) indicated mycological cure rates between 62 - 100 % (placebo 10 - 45 %) and clinical cure rates between 66 - 86 % (placebo 4 - 44 %). Both the azoles and the allylamines were significantly superior to the placebo. Comparative studies between azoles and allylamines occasionally indicated the significantly superior cure rates of allylamines (especially terbinafine). The high cure rates of terbinafine could be detected after therapy duration of merely one week, whereas the azoles have to be applied for four weeks before good efficacy was reached. CONCLUSION: In several trials the allylamines--especially terbinafine--proved superior to the azoles. This may be explained by the fungicidal mode of action of the allylamines and the favourable pharmacokinetic characteristics of terbinafine, in contrast to the fungistatic mechanism of the azoles.

Allylamine↗

Interventions for treating plantar heel pain.

BACKGROUND: Ten percent of people may experience pain under the heel (plantar heel pain) at some time. Injections, insoles, heel pads, strapping and surgery have been common forms of treatment offered. The absolute and relative effectiveness of these interventions are poorly understood. OBJECTIVES: The objective of this review was to identify and evaluate the evidence for effectiveness of treatment in treating plantar heel pain. SEARCH STRATEGY: MEDLINE (from 1966 to December 1997), EMBASE and the Cochrane Library were searched. Three podiatry journals (The Foot, The Chiropodist (later The Journal of British Podiatric Medicine), and The British Journal of Podiatric Medicine) were handsearched. We contacted known investigators in the field to identify unpublished data or research in progress. Non English language reports were excluded from the review. SELECTION CRITERIA: Randomised and quasi randomised trials of interventions for plantar heel pain in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated studies for inclusion, extracted data and assessed study quality. Additional information was obtained by direct contact with investigators. No poolable data were identified. Where measures of variance were available we have calculated the weighted mean differences based on visual analogue scale (VAS) scores. MAIN RESULTS: Eleven randomised trials involving 465 participants were included. Study quality was generally poor, and pooling of data was not possible. All studies measured a reduction in heel pain as the primary outcome. Seven trials evaluated interventions against placebo/dummy or no treatment. There was limited evidence for the effectiveness of topical corticosteroid, administered by iontophoresis in reducing pain. There was no evidence for the effectiveness of injected corticosteroid. There was limited evidence for the effectiveness of low energy extracorporeal shock wave therapy in reducing night pain, resting pain and pressure pain in the short term (12 weeks). In individuals with chronic pain (longer than six months), there was limited evidence for the effectiveness of dorsiflexion night splints in reducing pain. There was no evidence to support the effectiveness of therapeutic ultrasound, low-intensity laser therapy, exposure to an electron generating device or insoles with magnetic foil. No randomised trials evaluating orthotic devices, surgery, or radiotherapy against a control population were identified. There was limited evidence for the superiority of corticosteroid injections over orthotic devices. REVIEWER'S CONCLUSIONS: Although there is limited evidence for the effectiveness of local corticosteroid therapy, the effectiveness of other frequently employed treatments in altering the clinical course of plantar heel pain has not been established in comparative studies. Well designed and conducted randomised studies are required.

Adrenal Cortex Hormones↗

Antibiotics for acute bacterial conjunctivitis.

BACKGROUND: There are concerns regarding whether antibiotic therapy confers significant benefit in the treatment of acute bacterial conjunctivitis. OBJECTIVES: The aim of this review is to assess the benefit and harm of antibiotic therapy in the management of acute bacterial conjunctivitis. SEARCH STRATEGY: We searched the Cochrane Eyes and Vision Group specialised register, the Cochrane Controlled Trials Register - Central, MEDLINE and the reference lists of identified trial reports. We used the Science Citation Index to look for articles that cited the relevant studies, and we contacted investigators and pharmaceutical companies for information about additional trials. The most recent searches were carried out in September 1998. SELECTION CRITERIA: We included double masked randomised controlled trials in which any form of antibiotic treatment had been compared with placebo in the management of acute bacterial conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic usage. DATA COLLECTION AND ANALYSIS: One reviewer extracted data and the accuracy was checked by a second reviewer. Relative risks were summarised. We tested for heterogeneity between studies. MAIN RESULTS: Six published trials were identified of which three fulfilled the eligibility criteria for inclusion in this review. One trial was single masked and therefore excluded. A second report, when translated, was found to have no placebo group and was therefore excluded. One trial is currently 'awaiting assessment'. This has been published in abstract form and has yet to be fully reported. All the trials thus far identified appear to have been conducted on a selected specialist care patient population. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. Meta-analysis indicates that acute bacterial conjunctivitis is frequently a self-limiting condition, as clinical remission (cure or significant improvement) occurred by days two to five in 64% (95% confidence interval (CI) 57% to 71%) of those treated with placebo. Treatment with antibiotics was, however, associated with significantly better rates of clinical remission (days two to five: relative risk (RR) 1.31 95% CI 1.11 to 1.55, NNT=5) with a suggestion that this benefit was maintained for late clinical remission (days six to 10: RR 1.27 95% CI 1.00 to 1.61, NNT=5). Antibiotic treatment was associated with rates of microbiological remission (pathogen eradication or reduction). No serious outcomes were reported in either the active or placebo arms of these trials, indicating that important sight-threatening complications are an infrequent occurrence. REVIEWER'S CONCLUSIONS: Acute bacterial conjunctivitis is frequently a self-limiting condition but the use of antibiotics is associated with significantly improved rates of early clinical remission and early and late microbiological remission. Since trials to-date have been conducted in selected specialist care patient populations these results may not necessarily be generalisable to a primary care based population. A trial based in primary care designed to assess the cost-effectiveness of commonly prescribed antibiotic(s) versus placebo in acute bacterial conjunctivitis is warranted.

Acute Disease↗

Alpha-glucosidase inhibitors for type 2 diabetes mellitus.

BACKGROUND: Alpha-glucosidase inhibitors such as acarbose or miglitol, have the potential to improve glycemic control in type 2 diabetes mellitus. The true value of these agents, especially in relation to diabetes related mortality and morbidity, has never been investigated in a systematic literature review and meta-analysis. OBJECTIVES: To assess the effects of alpha-glucosidase inhibitors s in patients with type 2 diabetes mellitus. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, Current Contents, LILACS, databases of ongoing trials, reference lists of reviews on the topic of alpha-glucosidase inhibitors and we contacted experts and manufacturers for additional trials. Date of most recent search: December 2003 (Current Contents) and April 2003 (other databases). SELECTION CRITERIA: Randomised controlled trials of at least 12 weeks duration comparing alpha-glucosidase inhibitor monotherapy in patients with type 2 diabetes with any other intervention and that included at least one of the following outcomes: mortality, morbidity, quality of life, glycemic control, lipids, insulin levels, body weight, adverse events. DATA COLLECTION AND ANALYSIS: Two reviewers read all abstracts, assessed quality and extracted data independently. Discrepancies were resolved by consensus or by the judgement of a third reviewer. A statistician checked all extracted data entrance in the database. We attempted to contact all authors for data clarification. MAIN RESULTS: We included 41 trials (8130 participants), 30 investigated acarbose, seven miglitol, one trial voglibose and three trials compared different alpha-glucosidase inhibitors. Study duration was 24 weeks in most cases and only two studies lasted amply longer than one year. We found only few data on mortality, morbidity and quality of life. Acarbose had a clear effect on glycemic control compared to placebo: glycated haemoglobin -0.8% (95% confidence interval -0.9 to -0.7), fasting blood glucose -1.1 mmol/L (95% confidence interval -1.4 to -0.9), post-load blood glucose -2.3 mmol/L (95% confidence interval -2.7 to -1.9). The effect on glycated haemoglobin by acarbose was not dose-dependent. We found a decreasing effect on post-load insulin and no clinically relevant effects on lipids or body weight. Adverse effects were mostly of gastro-intestinal origin and dose dependent. Compared to sulphonylurea, acarbose decreased fasting and post-load insulin levels by -24.8 pmol/L (95% confidence interval -43.3 to -6.3) and -133.2 pmol/L (95% confidence interval -184.5 to -81.8) respectively and acarbose caused more adverse effects. AUTHORS' CONCLUSIONS: It remains unclear whether alpha-glucosidase inhibitors influence mortality or morbidity in patients with type 2 diabetes. Conversely, they have a significant effect on glycemic control and insulin levels, but no statistically significant effect on lipids and body weight. These effects are less sure when alpha-glucosidase inhibitors are used for a longer duration. Acarbose dosages higher than 50 mg TID offer no additional effect on glycated hemoglobin but more adverse effects instead. Compared to sulphonylurea, alpha-glucosidase inhibitors lower fasting and post-load insulin levels and have an inferior profile regarding glycemic control and adverse effects.

1-Deoxynojirimycin↗

The (ir)relevance of framing nutrition education messages.

Persuasive health education messages can either stress the positive consequences of performing a healthy behaviour (gain-frame) or the negative consequences of not performing a healthy behaviour (loss-frame). Based on studies on topics such as sun protection and breast self-examination there is evidence that messages in different action frames may differ in persuasive effects. Three randomised controlled trials were conducted to test framing effects in nutrition education on specific nutrition-related attitudes and intentions. In study 1, effects of gain-framed and loss-framed messages were studied among 152 adult education students on attitudes and intentions related to fat, fruit and vegetable consumption. In study 2 we confronted 149 regular students with differently framed messages related to a (more or less fictive) preventive dietary behaviour that was expected to be unknown to the study population, intake of flavonoids and risk for chronic disease. The impact on attitudes and intentions to use flavonoid-enriched spreads was studied. In study 3 we studied the effects of differently framed messages on attitudes and intentions related to more immediate and more personally relevant diet nutrition behaviour: folic acid supplement use before and during pregnancy among 100 female students. No significant differences in attitudes or intentions to perform the preventive nutrition behaviours were found between the gain-frame conditions and the loss-frame conditions in all three studies. The (lack of) effects were not moderated by factors such as perceived personal relevance, credibility or novelty of the information, or the perceived importance of the topic addressed. The results of the present studies suggest that action-frame choice has a very limited impact on the effectiveness of nutrition education in changing precautionary motivation.

Adolescent↗

Colchicine for alcoholic and non-alcoholic liver fibrosis and cirrhosis.

BACKGROUND: The majority of liver fibrosis and liver cirrhosis cases in the Western World is caused by alcohol and hepatotoxic viruses. Colchicine is an anti-inflammatory and anti-fibrotic medication. Several randomised clinical trials have addressed the question whether colchicine has any efficacy in patients with alcoholic as well as non-alcoholic fibrosis and cirrhosis. OBJECTIVES: The objectives were to assess the efficacy of colchicine on mortality, clinical symptoms and complications, liver biochemistry, liver fibrosis markers, liver histology, alcohol consumption, quality of life, and health economics in patients with alcoholic and non-alcoholic fibrosis or cirrhosis, excluding primary biliary cirrhosis and other rarer forms of fibrosis/cirrhosis. Also adverse events were assessed. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, MEDLINE, and full text searches were combined. SELECTION CRITERIA: Only randomised clinical trials were included studying patients with alcoholic fibrosis, alcoholic hepatitis and/or alcoholic cirrhosis as well as patients with viral induced or cryptogenic fibrosis and/or cirrhosis according to the diagnostic work-up of the individual trial. Interventions encompassed peroral colchicine at any dose versus placebo or no intervention. The trials could be double-blind, single-blind or unblinded. The trials could be unpublished or published and no language limitations were applied. DATA COLLECTION AND ANALYSIS: All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by the Jadad-scale. MAIN RESULTS: Combining the results of 14 randomised clinical trials including 1150 patients demonstrated no significant effects of colchicine on mortality (Peto odds ratio (OR) 0.90, 95% confidence interval (CI) 0.63 to 1.29), liver related mortality (OR 1.05, 95% CI 0.61 to 1.80), complications (OR 1.01, 95% CI 0.63 to 1.62), liver biochemistry, liver histology, and alcohol consumption (OR 1.02, 95% CI 0.58 to 1.79). Colchicine was associated with a significantly increased risk of adverse events (OR 4.92, 95% CI 2.66 to 9.10; P< 0.001). REVIEWER'S CONCLUSIONS: Colchicine should not be used for alcoholic, viral, or cryptogenic liver fibrosis or liver cirrhosis outside randomised trials.

Colchicine↗

Propylthiouracil for alcoholic liver disease.

BACKGROUND: Alcohol is the most common cause of liver disease in the Western world today. Randomised clinical trials have addressed the question whether propylthiouracil has any efficacy in patients with alcoholic liver disease. OBJECTIVES: The objectives were to assess the efficacy of propylthiouracil on mortality, clinical symptoms and complications, liver biochemistry, and liver histology in patients with alcoholic liver disease. Adverse events were also analysed. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register (searched July 2001), The Cochrane Controlled Trials Register (Cochrane Library Issue 3, 2001), MEDLINE (January 1966 to July 2001), EMBASE (January 1985 to July 2001) were searched. These electronic searches were combined with full text searches. Manufacturers and researchers in the field were also contacted. SELECTION CRITERIA: Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention. The trials could be double-blind, single-blind, or unblinded. The trials could be unpublished or published as an article, an abstract, or a letter and no language limitations were applied. DATA COLLECTION AND ANALYSIS: All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by components of quality and the Jadad-scale. MAIN RESULTS: Combining the results of six randomised clinical trials including 710 patients demonstrated no significant effects of propylthiouracil versus placebo on mortality (Peto odds ratio (OR) 0.91, 95% confidence interval (CI) 0.59 to 1.40), liver related mortality (OR 0.78, 95% CI 0.45 to 1.33), complications of the liver disease (OR 1.14, 95% CI 0.58 to 2.24), or liver histology. Propylthiouracil was associated with a non significant trend towards an increased risk of non-serious adverse events (OR 1.49, 95% CI 0.74 to 2.99) and with the seldom occurrence of serious adverse events (leukopenia). REVIEWER'S CONCLUSIONS: This systematic review could not demonstrate any significant efficacy of propylthiouracil on any clinically important outcomes (mortality, liver related mortality, liver complications, and liver histology) of patients with alcoholic liver disease and propylthiouracil was associated with adverse events. Accordingly, there is no evidence for using propylthiouracil for alcoholic liver disease outside randomised clinical trials.

Antimetabolites↗