Topic
Randomized controlled trial
About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.
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TL;DR: Surgery is more effective than medical treatment for the long-term control of obese patients with type 2 diabetes and should be considered in the treatment algorithm of this disease, however, continued monitoring of glycaemic control is warranted because of potential relapse of hyperglycaemia.
950 citations
Journal Article•
949 citations
TL;DR: In women and men at risk of having a cardiovascular event because of the presence of at least one major risk factor, low-dose aspirin given in addition to treatment of specific risk factors contributes an additional preventive effect, with an acceptable safety profile.
949 citations
TL;DR: EGb was safe and appears capable of stabilizing and, in a substantial number of cases, improving the cognitive performance and the social functioning of demented patients for 6 months to 1 year.
Abstract: Context. —EGb 761 is a particular extract of Ginkgo biloba used in Europe to alleviate symptoms associated with numerous cognitive disorders. Its use in dementias is based on positive results from only a few controlled clinical trials, most of which did not include standard assessments of cognition and behavior. Objective. —To assess the efficacy and safety of EGb in Alzheimer disease and multi-infarct dementia. Design. —A 52-week, randomized double-blind, placebo-controlled, parallelgroup, multicenter study. Patients. —Mildly to severely demented outpatients with Alzheimer disease or multi-infarct dementia, without other significant medical conditions. Intervention. —Patients assigned randomly to treatment with EGb (120 mg/d) or placebo. Safety, compliance, and drug dispensation were monitored every 3 months with complete outcome evaluation at 12, 26, and 52 weeks. Primary Outcome Measures. —Alzheimer's Disease Assessment Scale—Cognitive subscale (ADAS-Cog), Geriatric Evaluation by Relative's Rating Instrument (GERRI), and Clinical Global Impression of Change (CGIC). Results. —From 309 patients included in an intent-to-treat analysis, 202 provided evaluable data for the 52-week end point analysis. In the intent-to-treat analysis, the EGb group had an ADAS-Cog score 1.4 points betterthan the placebo group (P=.04) and a GERRI score 0.14 points better than the placebo group (P=.004). The same patterns were observed with the evaluable data set in which 27% of patients treated with EGb achieved at least a 4-point improvement on the ADAS-Cog, compared with 14% taking placebo (P=.005); on the GERRI, 37% were considered improved with EGb, compared with 23% taking placebo (P=.003). No difference was seen in the CGIC. Regarding the safety profile of EGb, no significant differences compared with placebo were observed in the number of patients reporting adverse events or in the incidence and severity of these events. Conclusions. —EGb was safe and appears capable of stabilizing and, in a substantial number of cases, improving the cognitive performance and the social functioning of demented patients for 6 months to 1 year. Although modest, the changes induced by EGb were objectively measured by the ADAS-Cog and were of sufficient magnitude to be recognized by the caregivers in the GERRI.
948 citations
TL;DR: It is concluded that in healthy middle-aged men at high risk of CHD advice to change eating habits and to stop smoking significantly reduced the incidence of the first event of myocardial infarction and sudden death.
946 citations