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In a recent commentary,¹ Miller and Shorr discuss generally the use of placebo controls when there is an existing effective treatment and then consider specifically 3 recent placebo-controlled studies in asthma, all of which they believe did not need to use a placebo. In at least 1 of the 3 studies, the issue is more complex than they allow.

The authors note the recent increased interest in the ethics of the use of placebo controls provoked by the 2000 revision of the Declaration of Helsinki,² which said such controls were not appropriate when there was existing effective therapy. Miller and Shorr clearly recognize, however, the interpretive problems often posed by active control equivalence or noninferiority trials^3-5 and thus the continued need for placebo controls in many situations, even when there is existing therapy. Indeed, a commentary on the 2000 revision by the World Medical Association in 2001⁶ indicates similar recognition, . . . [Full Text of this Article]

RELATED ARTICLE

Continued Need for Placebo in Many Cases, Even When There Is Effective Therapy
Franklin G. Miller and Andrew F. Shorr
Arch Intern Med. 2003;163(3):373.
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