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

Neurology. 2005 Oct 11;65(7):1101-3. doi: 10.1212/01.wnl.0000171957.90640.b5. Epub 2005 Jul 20.

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.

Publication types

  • Review

MeSH terms

  • Brain Tissue Transplantation / adverse effects
  • Double-Blind Method
  • Humans
  • Neurosurgical Procedures / adverse effects*
  • Parkinson Disease / surgery*
  • Placebo Effect
  • Placebos / adverse effects*
  • Randomized Controlled Trials as Topic / ethics
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Risk Assessment / standards
  • Stem Cell Transplantation / adverse effects
  • Treatment Outcome

Substances

  • Placebos