Surgical "placebo" controls.
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.
Tenery
Robert
R
Council on Ethical and Judicial Affairs of the American Medical Association, Chicago, Illinois 60610, USA.
Rakatansky
Herbert
H
Riddick
Frank A
FA
Goldrich
Michael S
MS
Morse
Leonard J
LJ
O'Bannon
John M
JM
Ray
Priscilla
P
Smalley
Sherie
S
Weiss
Matthew
M
Kao
Audiey
A
Morin
Karine
K
Maixner
Andrew
A
Seiden
Sam
S
D002986:Clinical Trials as Topic; D004992:Ethics, Medical; D006801:Humans; D010919:Placebos; D013514:Surgical Procedures, Operative
D010919:Placebos