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Sham surgery: An ethical analysis

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Abstract

Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.

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Authors and Affiliations

  1. Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, 20892-1156, Bethesda, MD, USA

    Franklin G. Miller Ph.D.

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  1. Franklin G. Miller Ph.D.
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Correspondence to Franklin G. Miller Ph.D..

Additional information

This paper is reprinted by permission of the American Journal of Bioethics and MIT Press Journals and appeared originally as follows: Franklin G. Miller, ‘Sham Surgery: An Ethical Analysis’, American Journal of Bioethics 3:4 (Fall, 2003), pp. 41–48. © 2003 by the Massachusetts Institute of Technology.

The opinions expressed are those of the author and do not necessarily reflect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

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Miller, F.G. Sham surgery: An ethical analysis. SCI ENG ETHICS 10, 157–166 (2004). https://doi.org/10.1007/s11948-004-0073-x

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  • DOI: https://doi.org/10.1007/s11948-004-0073-x

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