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Sham Surgery in Clinical Trials
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To the Editor: In his Editorial on the Spine Patient Outcomes Research Trial (SPORT),1 which compared operative vs nonoperative treatment for lumbar disk herniation, Dr Flum2 criticized the authors for not including a sham surgery group in the trial. He correctly stated that sham controls are important in determining efficacy of interventions that have subjective outcomes. However, he incorrectly characterized the nature of a sham intervention in the SPORT trial as being an ethical alternative.
Although patient expectations may have an effect on subjective complaints after surgery, the possibility of a sham surgery group raises too many potential ethical problems to have been a reasonable alternative in this study. First, SPORT compared surgery with best medical therapy rather than comparing surgery with no treatment. If a patient were randomized to a sham surgery group, that person would not be receiving the standard nonoperative treatment, including physical therapy and counseling on . . . [Full Text of this Article]
Peter Angelos, MD, PhD
pangelos@surgery.bsd.uchicago.edu
Department of Surgery
University of Chicago
Chicago, Ill
RELATED LETTER
Sham Surgery in Clinical Trials—Reply
David R. Flum
JAMA. 2007;297(14):1546.
EXTRACT
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RELATED ARTICLES
Surgical vs Nonoperative Treatment for Lumbar Disk Herniation: The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial
James N. Weinstein, Tor D. Tosteson, Jon D. Lurie, Anna N. A. Tosteson, Brett Hanscom, Jonathan S. Skinner, William A. Abdu, Alan S. Hilibrand, Scott D. Boden, and Richard A. Deyo
JAMA. 2006;296(20):2441-2450.
ABSTRACT
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Interpreting Surgical Trials With Subjective Outcomes: Avoiding UnSPORTsmanlike Conduct
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JAMA. 2006;296(20):2483-2485.
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