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To the Editor: In their Special Communication, Dr Miller and colleagues¹ stressed the need for studies that can identify whether complementary and alternative medicine (CAM) treatments produce clinically valuable placebo effects. They argued that such studies should control for the natural progression of disease, and should use objective rather than subjective outcomes.

We disagree with the authors, however, that trial designs must include both placebo-control and no-treatment arms to demonstrate placebo effects. Rather, we propose a simpler design, comprising 2 parallel, blinded trials with different proportions of participants randomized to active-treatment and placebo groups in each of the 2 trials. Participants would be informed of these proportions during informed consent, and thus those in the trial with a higher likelihood of receiving treatment would have higher expectations regarding their probable outcomes. If CAM has placebo effects, participants randomized to active-treatment and placebo groups in the trial in which a higher . . . [Full Text of this Article]

Harvey E. Cantor, MD
Department of Neurology
St Louis University School of Medicine
St Louis, Mo

Anup Malani, JD, PhD
amalani@virginia.edu
University of Virginia Law School
Charlottesville

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