What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports
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To the Editor:
After nearly a century of uncontrolled neurosurgical efforts to ameliorate symptoms of parkinsonism, it is good to know of the evolving consensus that new research must provide reliable double-blind control strategies.1,2 If the only distinction required of a phase 3 study were the difference between placebo suggestibility and certain biological proof of the injectate's theoretical mechanism, then a scalp incision/burr hole double-blind control would provide adequate protocol design.
But the stubborn complexity of the pathophysiologic circuitry of parkinsonism, along with the theoretical baggage of various invasive techniques, leads to the logical necessity for brain penetration control data.
Experience provides evidence for four possible classes of clinical effects; unfortunately, they are …
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