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Trials Used (trials + used)
Selected AbstractsResults, Rhetoric, and Randomized Trials: The Case of DonepezilJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2008John R. Gilstad MD Whether donepezil provides meaningful benefit to patients with Alzheimer's disease (AD) is controversial, but drug sales annually total billions of dollars. A review of data from published randomized clinical trials (RCTs) found rhetorical patterns that may encourage use of this drug. To create a reproducible observation, the sentences occurring at five specific text sites in all 18 RCTs of donepezil for AD were tabulated, as were study design, sources of financial support, and outcomes that could be compared between trials. Rhetoric in the 13 vendor-supported trials (15 publications) was strongly positive. Three early trials used the motif "efficacious (or effective) , treating , symptoms" four times. "Well-tolerated and efficacious" or an equivalent motif appeared 11 times in five RCTs. Nine RCTs referred 15 times to previously proven effectiveness. Seven trials encourage off-label use, for "early" cognitive impairment, severe dementia in advance of the Food and Drug Administration labeling change, or behavioral symptoms. These rhetorical motifs and themes appeared only in the vendor-supported trials. Trials without vendor support described the drug's effects as "small" or absent; two emphasized the need for better treatments. RCT results were highly consistent in all trials; the small differences do not explain differences in rhetoric. At these text sites in the primary research literature on donepezil for AD, uniformly positive rhetoric is present in all vendor-supported RCTs. Reference to the limited benefit of donepezil is confined to RCTs without vendor support. Data in the trials are highly consistent. This observation generates the hypothesis that rhetoric in vendor-supported published RCTs may promote vendors' products. [source] Exercise parameters in the treatment of clinical depression: a systematic review of randomized controlled trialsJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 3 2010Luke G. Perraton BPT MPT Abstract Rationale, aims and objectives, Previous systematic reviews have concluded that exercise programmes are effective in the management of clinical depression. The aim of this review was to analyse the parameters of exercise programmes reported in the primary research, in order to provide clinicians with evidence-based recommendations for exercise prescription for clinical depression. Methods, A systematic review of randomized controlled trials was undertaken. Only trials that reported exercise to be effective in treating depression were included and our review was limited to adults. Appropriate databases and reference lists were searched using established keywords. Data relating to the type, intensity, frequency, duration, mode of exercise and mode of application of exercise was extracted and collated. Results, A total of 14 randomized controlled trials were included in this review and from these trials 20 intervention arms were analysed. The majority of trials used an aerobic exercise intervention and were supervised. The most common exercise parameters were 60,80% of maximum heart rate for 30 minutes three times per week for an overall duration of 8 weeks. There is an equal volume of evidence supporting group as opposed to individually completed exercise programmes and no trends were identified which would support one mode of exercise over another. Conclusions, Currently the primary research on this topic supports the use of aerobic exercise which is supervised in some capacity. The current evidence base supports a prescription of three 30-minute sessions per week of aerobic exercise at 60,80% of maximum heart rate for at least 8 weeks. [source] Systematic review: secondary prevention with band ligation, pharmacotherapy or combination therapy after bleeding from oesophageal varicesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2009J. CHEUNG Summary Background, Variable methods are available for secondary prevention after oesophageal variceal bleeding (EVB). Aim, To compare band ligation (BL), pharmacotherapy (PT) and BL+PT for EVB secondary prevention. Methods, A systematic search of databases, references and meeting abstracts was conducted for randomized trials of BL, PT or BL+PT. The outcomes were mortality, rebleeding and adverse events. A random-effects model was used for meta-analyses. Results, Twelve trials were included (6 BL vs. PT, 4 BL+PT vs. BL, 2 BL+PT vs. PT). All trials used beta-blockers ± isosorbide mononitrate (ISMN) as PT. Mortality was not significantly different among trials. Rebleeding was not significantly different for BL vs. PT (RR 1.00, 95% CI 0.73,1.37). BL reduced rebleeding compared with PT for trials with mean beta-blocker dose <80 mg/day (RR 0.67, 95% CI 0.49,0.91). There were nonsignificant differences in rebleeding for BL+PT vs. BL (RR 0.57, 95% CI 0.31,1.08) and BL+PT vs. PT (RR 0.76, 95% CI 0.56,1.03). There was no difference in adverse events between BL vs. PT, but was higher with BL+PT vs. BL. Conclusion, Band ligation and PT alone are comparable for secondary prevention of rebleeding after EVB. Further trials with adequate PT dosing are required to determine the efficacy of combination BL+PT therapy. [source] A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myelomaBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2006Axel Glasmacher Summary The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial. A systematic review of the published clinical trials of these patients could reduce the possible bias of single phase-II studies. A systematic search identified 42 communications reporting on 1674 patients. Thirty-two trials used an escalating dosing regimen and four a fixed dose regimen (one dose with 50 mg/d, three doses with 200 mg/d). The target dose in the dose escalating trials was 800 mg/d in 17 trials, 400,600 mg/d in 10 and 200 mg/d in one trial. The intention-to-treat population for efficacy was 1629 patients with a median age of 62 years. The complete and partial (>50% reduction in monoclonal protein) response rate was 29·4% (95%-confidence interval, 27,32%). The rates for minor responses or stable disease were 13·8% (12,16%) and 11·0% (9,13%). Progressive disease was reported in 9·9% (8,11%). The median overall survival from all trials was reported at 14 months. Severe adverse events (grade III,IV) included somnolence 11%, constipation 16%, neuropathy 6%, rash 3%, thrombo-embolism 3%, cardiac 2%. In conclusion, thalidomide monotherapy achieved complete and partial responses in 29·4% of patients with relapsed or refractory multiple myeloma. [source] | ||||||||||