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Related Experiment Videos

Acupuncture trials and informed consent.

F G Miller1, T J Kaptchuk

  • 1Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland, USA. fmiller@nih.gov

Journal of Medical Ethics
|January 9, 2007
PubMed
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Investigators often withhold information about sham acupuncture in clinical trials, failing to obtain true informed consent. Patients in acupuncture studies deserve accurate disclosure about potential sham interventions, mirroring drug trial ethics.

Area of Science:

  • Integrative Medicine
  • Clinical Trial Ethics
  • Acupuncture Research

Background:

  • Randomized, placebo-controlled acupuncture trials frequently involve sham interventions.
  • Participants are typically not informed they might receive sham acupuncture.
  • This practice raises ethical concerns regarding informed consent.

Purpose of the Study:

  • To highlight the ethical implications of nondisclosure of sham acupuncture in clinical trials.
  • To advocate for transparent disclosure of sham interventions to participants.
  • To align acupuncture trial practices with those of placebo-controlled drug trials.

Main Methods:

  • Analysis of ethical standards in clinical research.
  • Review of informed consent principles in randomized controlled trials.

Related Experiment Videos

  • Comparison of disclosure practices in acupuncture versus drug trials.

    • Main Results:

    • Current practices in acupuncture trials often involve deceptive disclosure regarding sham interventions.
    • This lack of transparency violates the ethical principle of informed consent.
    • There is no strong methodological justification for withholding this information.

    Conclusions:

    • Accurate disclosure of sham acupuncture is ethically imperative in randomized controlled trials.
    • Participants must be fully informed about the possibility of receiving sham acupuncture.
    • Ethical standards require transparency, consistent with placebo-controlled drug trials.