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To the Editor: In their study comparing the efficacy of inhaled corticosteroids (ICs), salmeterol monotherapy, and placebo,¹ Dr Lazarus and colleagues concluded that it is probably unsafe to switch patients with moderate persistent asthma from ICs to monotherapy with salmeterol. Some patients received placebo, and all patients received a placebo during a 6-week run-out period at the end of the study. Although the study protocol was approved by a federal protocol review committee and the institutional review boards at each of the clinical sites, the report did not fully address several complex and controversial ethical issues in the study design.

The authors did not address whether there was clinical equipoise² between the safety or efficacy of either of these agents compared with placebo. If no equipoise exists between the study arms, then we question whether it was justifiable to expose the placebo group to the risks of undertreatment, and all . . . [Full Text of this Article]

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JAMA. 2001;285(20):2583-2593.
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