Ethical Issues in Research in Complementary and Alternative Medicine

　　To the Editor: Dr Miller and colleagues1 categorized the acupuncture study by Smith et al2 as "negative" because the difference between sham and active acupuncture treatments was not statistically significant. Lewith and Vincent,3 however, argued that sham acupuncture is a weak active treatment, as suggested in this case by the lag in antinausea effect between the sham and the 2 active treatments. Women receiving the highest dose of acupuncture (ie, the traditional acupuncture group) reported significantly less nausea throughout the trial. Women receiving the next highest dose of acupuncture reported significantly less nausea from the second week in the trial, while women receiving the lowest dose of acupuncture (ie, sham acupuncture) reported significantly less nausea from the third week in the trial.

　　Although the authors could have cited high-quality RCTs with positive results,4 they reported that most trials have negative results. Linde and Willich5 point out that different systematic reviews have reached different conclusions about the efficacy of CAM.

　　In Reply: Drs Cantor and Malani claim that placebo effects can be demonstrated by comparing a pair of 2-arm trials of active treatment vs placebo that have different proportions of participants randomized to receive active treatment. This is an interesting speculation; however, we are unaware of any data to support this claim or to indicate that this design is just as able, or more able, to discriminate placebo effects than would be a 3-arm trial comparing active treatment, placebo, and no treatment. Their alternative design may suggest placebo effects but still leaves open the critical question of whether either the active treatment or placebo-control is better than no treatment.
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　　Dr Jonas and colleagues question who determines the social value of CAM research and advocate for public input. For biomedical research in general, the public's position on an approach is expressed through participation on institutional review boards, data and safety monitoring boards, and certainly in their willingness to serve as research participants. In the case of government agencies, such as the National Center for Complementary and Alternative Medicine, the research mission and budget is accountable to elected representatives of the public. Moreover, their research priorities are set with the approval of their chartered national advisory councils, whose members are appointed by the Secretary of the Department of Health and Human Services and include representatives of diverse stakeholder groups including patient advocates.

　　We argued for placebo-controlled trials of CAM treatments, when they are feasible, but did not argue that this is the only valid research design. Active-controlled superiority trials evaluating 2 CAM therapies or a CAM therapy vs a conventional treatment would also provide valuable and valid data. An adequately powered, randomized, active-controlled trial would demonstrate the superiority of their proposed first treatment over their second.

　　The legitimacy of recommending low-risk therapies that benefit patients solely or mainly by virtue of the placebo effect is controversial but deserves further inquiry and debate. We agree with Drs Kaptchuk and Lembo that well-designed research is needed to assess the potential clinical benefits of placebo treatments and better understand the mechanisms that account for placebo effects.

　　We disagree with Dr Marusic that it is necessary to lie to patients when recommending a treatment that is believed to work by virtue of a placebo effect. If solid evidence exists to support the efficacy of a placebo, the clinician can truthfully communicate to the patient that the treatment has been found to be superior to no treatment in relieving symptoms.

　　We disagree with Dr Millea that we misinterpreted the findings of the study by Smith et al regarding acupuncture to treat nausea and vomiting in early pregnancy.1 His claim that we overreported negative studies of CAM misses the point of our article, which was to examine ethical issues relating to rigorous research on CAM. We selected specific studies to illustrate methodological and ethical issues; we were not attempting a systematic review or meta-analysis of the evidence for the therapeutic value of specific CAM treatments.
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　　Disclaimer: The opinions expressed are those of the authors and do not reflect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

　　Franklin G. Miller, PhD; Ezekiel J. Emanuel, MD, PhD
　　Department of Clinical Bioethics
　　National Institutes of Health

　　Donald L. Rosenstein, MD
　　Office of the Clinical Director
　　National Institute of Mental Health

　　Stephen E. Straus, MD