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Published online before print July 20, 2005, doi:10.1212/01.wnl.0000171957.90640.b5)
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Received February 2, 2005
Accepted May 16, 2005

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.


* To whom correspondence should be addressed. E-mail: samfrank{at}bu.edu.

Abstract-- 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.




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W. Landau, S. A. Frank, K. Kieburtz, R. Holloway, and S. Y.H. Kim
What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports
Neurology, June 13, 2006; 66(11): 1788 - 1789.
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O. Rascol
Assessing the risk of a necessary harm: Placebo surgery in Parkinson disease
Neurology, October 11, 2005; 65(7): 982 - 983.
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What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports
William Landau
Neurology Online, 8 Mar 2006 [Full text]
Reply from the authors
Samuel A. Frank, et al.
Neurology Online, 8 Mar 2006 [Full text]

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