Policy ForumMedicine

Placebo-Controls in Short-Term Clinical Trials of Hypertension

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Science  15 Jun 2001:
Vol. 292, Issue 5524, pp. 2013-2015
DOI: 10.1126/science.1057783

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The decision to use placebo or active controls in clinical trials is critical to protecting research subjects and conducting worthwhile clinical investigations. On the one hand, it has been argued that using placebo is inappropriate when there exists a proven treatment for a particular disease under study. On the other hand, in some settings using placebos can increase the likelihood that the scientific endeavor will achieve interpretable results, an important ethical obligation whenever exposing patient-subjects to the risks and inconveniences of research. The decision about the use of controls hinges in large part on the likelihood of harming subjects, which is primarily an empirical question. In a meta-analysis of clinical trials of hypertension, a condition for which there are proven treatments, Al-Khatib et al. found that exposure to placebo-controls in short-term clinical trials of antihypertensives was not associated with an increased risk of serious adverse events. This demonstrates the importance of using data to inform decisions about the appropriate selection of controls in clinical trials.