Acupuncture trials and informed consent.
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.
Miller
F G
FG
Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland, USA. fmiller@nih.gov
Kaptchuk
T J
TJ
D015670:Acupuncture Therapy / Q000941:ethics*; D002986:Clinical Trials as Topic; D030881:Disclosure / Q000941:ethics; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*