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Sham surgery is justified in clinical trials in Parkinson’s disease provided strict criteria are followed to ensure that it is used safely and effectively, according to an article which defends the practice in judging outcome of fetal tissue implantation treatment.
Sham surgery is controversial and used rarely. Its recent use in two trials assessing treatment for Parkinson’s disease has, naturally enough, provoked much ethical debate. According to bioethicist Ruth Macklin, the concept of sham surgery controls produces, “tension between the highest standards of research and the highest standards of ethics.” Other critics see the bigger picture, recognising that clinical trials need to benefit patients, society, and research, though still opposing sham surgery as unnecessary.
The article’s author, a neurologist, emphasises the paramount need to exclude false positive results in these trials in the interests of patient and public safety. In Parkinson’s disease this need can be fulfilled only by sham surgery controls, he argues, because of the significant and sustained placebo effect reported in medical clinical trials and its confounding of subjective outcomes so often relied on for assessing treatment. A recently published trial using sham surgery controls in the United States showed that despite promising initial results the long term results differed little between treatment and control arms because of the significant surgical placebo effect. “The recent experience with intracerebral fetal tissue grafting for Parkinson’s disease suggests that sham surgery controls can be done in a safe and ethical manner.”