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April 11, 2007

Sham Surgery in Clinical Trials

Author Affiliations

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

JAMA. 2007;297(14):1545-1546. doi:10.1001/jama.297.14.1545-c

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.