4 research outputs found

    Methylxanthine, alcohol-free diet and fibrocystic breast disease : a factorial clinical trial

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    A controlled clinical trial was conducted in Milan, Italy to analyze the effects of methylxanthine (MTX) and alcohol abstention on signs and symptoms of fibrocystic breast disease. A total of 192 women with a clinical and thermographic diagnosis of fibrocystic breast disease were randomly assigned to four groups on the basis of two-by-two factorial design: (1) abstention from MTX-containing beverages, (2) abstention from alcohol, (3) abstention from MTX and alcohol, and (4) no dietary advice. Of these, 162 (84.4%) were followed up at approximately 6 months. No statistically or clinically significant effect of a MTX- or alcohol-free diet was observed on signs and symptoms of fibrocystic breast disease. On the basis of the results of the present and previous randomized controlled studies, it thus appears possible to exclude that abstention from coffee and other MTX-containing beverages can substantially reduce signs and symptoms of fibrocystic breast disease within a few month

    N-3 fatty acids in patients with multiple cardiovascular risk factors

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    Are all people with diabetes and cardiovascular risk factors or microvascular complications at very high risk? Findings from the Risk and Prevention Study

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    N-3 fatty acids in patients with multiple cardiovascular risk factors

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    BACKGROUND: Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction. METHODS: In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes. RESULTS: Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points. CONCLUSIONS: In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. Copyright © 2013 Massachusetts Medical Society
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