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Acupuncture trials and informed consent
  1. F G Miller1,
  2. T J Kaptchuk2
  1. 1Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, USA
  2. 2Osher Institute, Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to:
 Dr Franklin G Miller
 Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland, USA; fmiller{at}


Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture, consistent with the practice of placebo-controlled drug trials.

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  • Funding: TJK is funded in part from grant 1 R01 AT001414-01 from the National Center for Complementary and Alternative Medicine.

  • Competing interests: None declared.

  • The opinions expressed are those of FGM 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.