What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports.
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.
Frank
Samuel
S
Boston University, MA, USA. samfrank@bu.edu
Kieburtz
Karl
K
Holloway
Robert
R
Kim
Scott Y H
SY
D016380:Brain Tissue Transplantation / Q000009:adverse effects; D004311:Double-Blind Method; D006801:Humans; D019635:Neurosurgical Procedures / Q000009:adverse effects*; D010300:Parkinson Disease / Q000601:surgery*; D015990:Placebo Effect; D010919:Placebos / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000706:statistics & numerical data; D018570:Risk Assessment / Q000592:standards; D033581:Stem Cell Transplantation / Q000009:adverse effects; D016896:Treatment Outcome
D010919:Placebos