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Published online before print July 20, 2005, doi:10.1212/01.wnl.0000171957.90640.b5)
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NEUROLOGY 2005;65:1101-1103
© 2005 American Academy of Neurology
Brief Communications

What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports

Samuel Frank, MD, Karl Kieburtz, MD, MPH, Robert Holloway, MD, MPH and Scott Y.H. Kim, MD, PhD

From Boston University (Dr. Frank), MA; University of Michigan (Dr. Kim), Ann Arbor; and University of Rochester (Drs. Kieburtz and Holloway), NY.

Address correspondence and reprint requests to Dr. Samuel Frank, 715 Albany Street, C329, Boston, MA 02118; e-mail: samfrank{at}bu.edu

Placebo, or sham surgery, as a control condition in surgical clinical trials in Parkinson disease (PD) remains controversial. The authors reviewed the adverse effects reported in double blind, placebo surgery controlled trials for PD. Placebo surgeries were generally safe and well tolerated but the number of subjects receiving the procedure was small. Harm occurred more frequently in subjects randomized to the experimental intervention.

Editorial, see page 982.

This article was previously published in electronic format as an Expedited E-Pub on July 20, 2005, at www.neurology.org.

Disclosure: The authors report no conflicts of interest.

Received February 2, 2005. Accepted in final form May 16, 2005.




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Correspondence:

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What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports
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