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Annals of Surgery:
Advances In Surgical Technique

Surgical “Placebo” Controls

Tenery, Robert MD, Dallas, TX–Chair; Rakatansky, Herbert MD, Providence, RI–Vice-Chair; Riddick, Frank A. Jr., MD, New Orleans, LA; Goldrich, Michael S. MD, Highland Park, NJ; Morse, Leonard J. MD, Worcester, MA; O’Bannon, John M. III, MD, Richmond, VA; Ray, Priscilla MD, Houston, TX; Smalley, Sherie MD, Salt Lake City, UT–Resident Member; Weiss, Matthew Chicago, IL–Student Member. Staff to the Council on Ethical and Judicial Affairs; Kao, Audiey MD, PhD, Acting Vice President, Ethics Standards Group, American Medical Association; Morin, Karine LLM, Council Secretary and Staff Author; Maixner, Andrew Council Staff Associate; Seiden, Sam Council Staff Associate.

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Abstract

Objective: To set ethical guidelines on the use of surgical placebo controls in the design of surgical trials.

Background Data: Ethical concerns recently arose from surgical trials where subjects in the control arm underwent surgical procedures that had the appearance of a therapeutic intervention, but during which the essential therapeutic maneuver was omitted. Although there are ethical guidelines on the use of a placebo in drug trials, little attention has been paid to the use of a surgical placebo control in surgical trials.

Methods: The Council on Ethical and Judicial Affairs developed ethical guidelines based on a wide literature search and consultation with experts.

Results: Surgical placebo controls should be limited to studies of new surgical procedures aimed at treating diseases that are not amenable to other surgical therapies, and are reasonably anticipated to be susceptible to substantial placebo effects. If the standard nonsurgical treatment is efficacious and acceptable to the patient, then it must be offered as part of the study design.

Conclusions: Surgical placebo controls should be used only when no other trial design will yield the requisite data and should always be accompanied by a rigorous informed consent process and a careful consideration of the related risks and benefits. The recommended ethical guidelines were adopted as AMA ethics policy and are now incorporated in the AMA’s Code of Medical Ethics.

© 2002 Lippincott Williams & Wilkins, Inc.

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