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To the Editor: Dr Connolly and colleagues¹ found that pacemaker therapy did not reduce the risk of recurrent syncope in patients with vasovagal syncope. Patients in the control group all underwent pacemaker implantation, but their pacemakers were set for sensing only, without pacing in the event of a dysrhythmia. The authors justified this nontherapeutic surgical intervention by noting that control patients could have their devices activated for pacing once the study had been completed. Although there is controversy about the ethical aspects of such sham surgery,^2-3 this study is unique in that the patients were left with an implanted device.

Three things could be done with the pacemakers in the control patients at the conclusion of such studies. First, they could be activated, so that the control patients would receive pacing. However, this would be inconsistent with the results of the blinded trial, and would thus not be an evidence-based . . . [Full Text of this Article]

Paul S. Heckerling, MD
Department of Medicine
University of Illinois at Chicago

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