Miller Franklin G
National Institutes of Health.
Am J Bioeth. 2003 Autumn;3(4):41-8. doi: 10.1162/152651603322614580.
Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.
出于伦理方面的考虑，外科临床试验很少使用“假手术”或安慰剂手术作为对照。最近，一些伦理评论家认为，假手术要么本质上不道德，要么推定不道德。在本文中，我认为这些观点是错误的，并且在临床试验中绝对禁止假手术没有合理的伦理依据。通过对三例假手术案例的思考，特别是对最近报道的膝关节关节炎关节镜手术假手术对照试验结果的思考，我进行了一项伦理分析，重点关注使用假手术的方法学原理、风险效益评估和知情同意。
