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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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October 11 Highlights

Neurology 2005 65: 976-977. [Full Text]  

Assessing the risk of a necessary harm: Placebo surgery in Parkinson disease
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Neurology 2005 65: 982-983. [Full Text]  



This article has been cited by other articles:


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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.
[Full Text] [PDF]


Home page
NeurologyHome page
O. Rascol
Assessing the risk of a necessary harm: Placebo surgery in Parkinson disease
Neurology, October 11, 2005; 65(7): 982 - 983.
[Full Text] [PDF]

Correspondence:

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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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