title: Surgical "placebo" controls.
abstract: OBJECTIVE
  To set ethical guidelines on the use of surgical placebo controls in the design of surgical trials.
  
  
  BACKGROUND
  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.
authors.affiliation: Council on Ethical and Judicial Affairs of the American Medical Association, Chicago, Illinois 60610, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Tenery
authors.forename: Herbert
authors.initials: H
authors.lastname: Rakatansky
authors.forename: Frank A
authors.initials: FA
authors.lastname: Riddick
authors.forename: Michael S
authors.initials: MS
authors.lastname: Goldrich
authors.forename: Leonard J
authors.initials: LJ
authors.lastname: Morse
authors.forename: John M
authors.initials: JM
authors.lastname: O'Bannon
authors.forename: Priscilla
authors.initials: P
authors.lastname: Ray
authors.forename: Sherie
authors.initials: S
authors.lastname: Smalley
authors.forename: Matthew
authors.initials: M
authors.lastname: Weiss
authors.forename: Audiey
authors.initials: A
authors.lastname: Kao
authors.forename: Karine
authors.initials: K
authors.lastname: Morin
authors.forename: Andrew
authors.initials: A
authors.lastname: Maixner
authors.forename: Sam
authors.initials: S
authors.lastname: Seiden
mesh_terms: D002986:Clinical Trials as Topic; D004992:Ethics, Medical; D006801:Humans; D010919:Placebos; D013514:Surgical Procedures, Operative
chemical_list: D010919:Placebos