Abstract
Dr. Wright raises a question about the choice of appropriate control groups in placebo surgery (or, perhaps more correctly, sham surgery) trials. He is concerned that explanatory trials, with only sham surgical controls, might dissect out effects of the most invasive surgical elements yet prove clinically irrelevant because sham surgery is not a viable treatment option. He argues for pragmatic rather than purely explanatory trials, ones that also include a no-treatment control. In a similar vein, London and Kadane [1] have argued that explanatory sham surgical trials can only be justified if there is disagreement among experts about whether clinical trial-proven better outcomes from surgery (compared with pharmacologic treatments for the same condition) result from the procedure itself or from surgical periphera such as wounding or anesthesia.
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