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Effects of oral potassium on blood pressure. Meta-analysis of randomized controlled clinical trials.

OBJECTIVE: To assess the effects of supplementation with oral potassium on blood pressure in humans. DESIGN: Meta-analysis of randomized controlled trials. DATA SOURCES: English-language articles published before July 1995. STUDY SELECTION: Thirty-three randomized controlled trials (2609 participants) in which potassium supplementation was the only difference between the intervention and control conditions. DATA EXTRACTION: Using a standardized protocol, 2 of us independently abstracted information on sample size, duration, study design, potassium dose, participant characteristics, and treatment results. RESULTS: By means of a random-effects model, findings from individual trials were pooled, after results for each trial were weighted by the inverse of its variance. An extreme effect of potassium in lowering blood pressure was noted in 1 trial. After exclusion of this trial, potassium supplementation was associated with a significant reduction in mean (95% confidence interval) systolic and diastolic blood pressure of -3.11 mm Hg (-1.91 to -4.31 mm Hg) and -1.97 mm Hg (-0.52 to -3.42 mm Hg), respectively. Effects of treatment appeared to be enhanced in studies in which participants were concurrently exposed to a high intake of sodium. CONCLUSIONS: Our results support the premise that low potassium intake may play an important role in the genesis of high blood pressure. Increased potassium intake should be considered as a recommendation for prevention and treatment of hypertension, especially in those who are unable to reduce their intake of sodium.

Administration, Oral↗

Randomized clinical trials in oncology. Principles and obstacles.

Cancer clinical trials have two broad objectives: To identify promising treatments and to determine whether such treatments really do reduce morbidity and mortality. These two objectives generally require different types of clinical trials. The guiding principle of clinical trials is to ask an important question and get a reliable answer. Asking an important question generally means asking a question that has the potential for influencing medical practice, using a control treatment that is widely accepted, using an experimental treatment that is widely applicable, using an endpoint that is a direct measure of patient benefit, and studying a group of patients who are broadly representative. Getting a reliable answer also has many components, including randomized treatment assignment, adequate sample size, intent-to-treat analysis, and testing of prestated hypotheses on mature data. These components are discussed. Several recent developments in clinical trials methodology: interim monitoring boundaries, large simple trials, and metaanalysis, are highlighted here. Major obstacles to conducting randomized clinical trials are also described.

Humans↗