ABSTRACT
Within the context of the new medical methodology of evidence-based medicine, the ethical issues of making the randomized, placebo-controlled, clinical trial part of the matrix of surgical procedure evaluation are discussed. Surgical trials with alternative research design less rigorous than the double-blind, placebo-controlled, randomized trial leave the alternative: implementing surgical procedures based on anecdotal evidence and weaker scientific research. The conundrum of these clinical trials, as it relates to the evaluation of surgical procedures, is that it appears to confound some of the fundamental ethical principles of beneficence and nonbeneficence. The placebo effect with surgery is so strong that "sham surgery" within the clinical trial context is essential and an appropriate component of the ethics of clinical research. A discussion of these issues is presented.
