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August 12/26, 2002

Unnecessary Use of Placebo Controls: The Case of Asthma Clinical Trials

Arch Intern Med. 2002;162(15):1673-1677. doi:10.1001/archinte.162.15.1673

THE ETHICS of placebo-controlled clinical trials has generated considerable controversy in recent years. Critics, often citing the Declaration of Helsinki, have argued that use of placebo controls is unethical in trials of medications to treat conditions for which proven effective treatments exist. Defenders of placebo-controlled trials contend that the alternative of clinical trials that compare active treatments without placebo controls are often subject to serious methodological weaknesses. In the present article we develop a middle-ground position on the ethics of placebo-controlled trials, which is applied to recent clinical trials of treatments for asthma. Questions are raised about 3 recent placebo-controlled asthma trials on the grounds that the scientific questions that these trials were designed to answer did not require use of placebo. However, use of placebo controls in initial trials of investigational treatments is defended, provided that patient volunteers randomized to placebo are not exposed to serious risks of irreversible harm or intolerable discomfort.

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