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Another article written by Australian researchers, also states the insistence on sham surgery as a placebo control is largely a North American viewpoint. Hmmm - if other less potentially dangerous methods are acceptable among researchers in other parts of the world -- why not in the U.S.? Linda www.pdpipeline.org Brain Research Bulletin 67 (2005) 290–297 Ethics, methodology and the use of placebo controls in surgical trials Stephen Polgar , Joanna Ng School of Public Health, La Trobe University, Bundoora, Vic. 3038, Australia Abstract "There is an emergent view among North American researchers and bioethicists that not only is the use of sham surgery ethical, but that it should also be mandatory when conducting trials to evaluate surgical procedures such as neural grafting. This view is based on erroneous assumptions concerning the magnitude of the placebo effects associated with surgery. A detailed analysis of four recent clinical trials failed to provide consistent evidence for pronounced and long term improvements in sham operated patients. There was no evidence that the results of the placebo control groups were necessary for identifying unsafe and ineffectual surgical procedures. We contend that the advancement of clinical science and the protection of individual patients are best guaranteed by adopting the principles of evidence-based medicine." -- "M.Schild" <[log in to unmask]> wrote: > This is very interesting. Do you know why sham surgery is not used in > clinical trials in France (is this the case throughout the EU)  and what > types of placebo controls are used instead? My private european neuroscientist tells me that usually, in Europe, sham surgery is found too much of a burden on a person suffering from chronic disease. I found this on: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=544278 European and American Perspectives on the Use of Sham Surgery in Parkinson’s Disease Research Samuel Frank *, Karl Kieburtz *, Robert Holloway *, Renee Wilson *, Carol Zimmerman *, and Scott Kim †* Department of Neurology, University of Rochester, Rochester, New York; †Psychiatry and Bioethics Program, University of Michigan, Ann Arbor, Michigan Introduction: The use of sham surgery in clinical trials for Parkinson’s disease (PD) is controversial. We assessed and compared the views of basic and clinical researchers from the United States and Europe regarding sham surgery as a control condition in a hypothetical gene transfer neurosurgical trial for PD. Procedures: We distributed the survey at the annual meeting of the Huntington Study Group (HSG) and at the Network of European CNS Transplantation and Restoration (NECTAR). The three-page survey assessed researchers’ views regarding the following: prior probability of efficacy and safety of the proposed gene transfer intervention; the ethical and scientific merits of blinded (sham surgery) versus open control condition and whether the burdens of sham surgery condition are justified by the potential benefits; and vulnerability of PD research subjects. Results: The response rates were 59 of 230 (26%) for HSG and 39 of 68 (57%) for NECTAR. Most HSG respondents were neurologists (90%); most NECTAR respondents were neuroscientists (75%). The NECTAR group was more optimistic about the probable efficacy of the intervention (46% vs 31.3%, p < 0.001). 90% of HSG respondents believed the risk of sham surgery is justified by the potential benefits to science and to society versus 53% for NECTAR respondents. 31% of NECTAR respondents believed PD subjects are too vulnerable to offer randomized controlled trial involving sham surgery to them, versus 9% of HSG respondents. In univariate analyses, location of meeting and professional roles predicted responses; in multivariate analysis, only location of meeting was a significant predictor, with HSG respondents much more likely to favor sham surgery (odds ratio, 54; 95% confidence interval 4-663; p < 0.001). Conclusions: lthough the majority of surveyed researchers believe sham surgery control is scientifically and ethically justified, European respondents (and perhaps basic scientists more than clinical scientists) are more opposed to sham surgery controls in PD surgical trials. The ethics and science of sham surgery controls in PD trials deserve further discussion in the field. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn