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April 11, 2007

Sham Surgery in Clinical Trials—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2007;297(14):1545-1546. doi:10.1001/jama.297.14.1546

In Reply: Dr Angelos and I agree on the importance of distinguishing the placebo effect from the more direct effect of the therapy. Randomization to sham surgical procedures may be the only effective means to accomplish this in trials of surgical procedures with subjective outcomes. The ethical framework for randomized trials including sham interventions has been well considered and described.1 Patients in a sham group should not be denied treatment known to be effective. Angelos notes that in a sham trial a patient undergoing sham surgery would not receive “best medical” therapy. However, the patients not undergoing an operation in SPORT did not receive “best medical” care but, rather, usual care; patients undergoing operations in SPORT also received this usual supportive therapy (eg, physical therapy, pain management) as needed. A sham-controlled surgical group could also receive this usual adjunctive care.