September 2005

Double-Blind, Placebo-Controlled Trials for Surgical Interventions in Parkinson Disease

Author Affiliations

Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005

Arch Neurol. 2005;62(9):1343-1344. doi:10.1001/archneur.62.9.1343

In this issue of the ARCHIVES, Kim et al1 report that the vast majority of surveyed Parkinson disease (PD) clinical researchers in the United States and Canada favor the use of double-blind, placebo-controlled studies in evaluating surgical interventions as therapies for PD. Ninety-seven percent of those surveyed think that sham surgery–controlled, double-blind trials are better than unblinded studies for evaluating the efficacy of neurosurgical interventions in PD. Indeed, 50% believe that relying solely on unblinded efficacy trials would be unethical because it may lead to a falsely positive result. Ninety percent felt that burr holes were justified in a sham-control group, and 22% indicated that even penetration of brain tissue in a control group is justified to obtain an unambiguous answer. It is clear that clinical researchers in North America require that surgical trials for PD be assessed in double-blind controlled trials before concluding that they are effective, even though these studies involve the inclusion of a sham-operated control group.

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