Lyon wrote:Have a surgeon or group of surgeons perform the operation/sham and then remove them from farther participation in the trial....DON'T use stents as they would show up on imaging and ruin the blind.
fogdweller wrote:Lyon wrote:Have a surgeon or group of surgeons perform the operation/sham and then remove them from farther participation in the trial....DON'T use stents as they would show up on imaging and ruin the blind.
Will someone who really knows weigh in?
I don't think sham surgery can ever be done ethically. Surgery, especially if it involves anesthesia, always has some risk, and if there is guaranteed no benefit because the surgery is sham, then it is unethical to subject the patient to that risk, however minor.
In a company where I was recently on Sr. staff, we conducted a surgical trial to determine the efficacy of a catheter treatment, similar to a stent. Here is how we did the double blind type studyl to get scientifically valid data: We enrolled the patients in the study. They read and signed the informed consent. Then an envelope was chose at random that had either treatment or non-treatment arm in the sealed envelope. Half (or some percentage) of the patients enrolled were in the treatment arm, and the rest were in the non-treatment arm. At the end of the study the results were compared to see if the treatment resulted in a significant improvement.
TFau wrote:The double blind trial was not designed to assess the efficacy of surgical intervention, it was designed for pharmaceuticals to remove as much bias as possible. Trying to fit an assessment of risk vs. benefit of CCSVI treatment into a double blind trial paradigm seems narrow-minded and disingenious.
Sham surgery is ethically unacceptable as a placebo control in trials of fetal-cell transplantation in patients with Parkinson's disease. Sham surgery, with accompanying anesthesia, poses the risks of any surgical intervention that would not be used alone for therapeutic purposes. In trials that use antibiotics to protect subjects against infection, there are the added risks associated with antibiotic treatment. In trials that forgo the use of antibiotics in the sham-surgery group, there are the added risks of infection.
One question remains to be answered. Those who defend the use of sham surgery could argue that the possibility of a strong placebo response to surgery20 does, in fact, confer a benefit on the subjects who are randomly assigned to the control group. Might the benefit of the placebo effect outweigh the risks of the sham surgery and therefore justify its use in research? The answer is no, unless the sham surgery would be recommended solely for therapeutic purposes outside the research context.
A related question is whether it would be ethical to conduct trials specifically designed to document the placebo effect of surgery. Three groups would be needed: an untreated control group, a group undergoing sham surgery, and a group undergoing real surgery.20 Johnson argues that "for surgical procedures, as for drugs, the placebo effect must always be taken into account if any assessment is to be objective."20 Yet despite the importance of the research question, Johnson contends that "none of the means of measuring placebo [effects] can be applied to surgical operations because it is unethical, for example, to make an abdominal incision and sew it up again without undertaking any procedure."20
Perhaps some defenders of the use of sham surgery in randomized, controlled trials would be prepared to go this far. In response to the question, "If phony operations can help people, why not just do them?" one surgeon said, "That is an important point. What to do with it, medicine is going to have to decide."13 One cannot always predict what the medical community will decide. But one conclusion seems apparent. The placebo-controlled trial may well be the gold standard of research design, but unlike pure gold, it can be tarnished by unethical applications.
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