Use of placebo controls in the evaluation of surgery: systematic review.
Use of placebo controls in the evaluation of surgery: systematic review.
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DOI：
10.1136/bmj.g3253
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发表时间：
2014-05-21
期刊：
影响因子：
--
通讯作者：
Carr AJ
中科院分区：
文献类型：
--
作者：
Wartolowska K;Judge A;Hopewell S;Collins GS;Dean BJ;Rombach I;Brindley D;Savulescu J;Beard DJ;Carr AJ
目的探讨在评价手术干预措施时是否应采用安慰剂对照。设计系统评审。我们检索了Medline、Embase和Cochrane对照试验注册数据库，从它们成立到2013年11月。研究选择：比较任何手术干预与安慰剂的随机临床试验。外科手术被定义为任何既改变解剖结构又需要皮肤切口或使用内窥镜技术的程序。三位审稿人（KW、BJFD、IR）独立确定了相关试验，并从纳入的研究中提取了研究细节、结果和危害的数据。结果在53个试验中有39个（74%）安慰剂组有改善，在27个（51%）试验中安慰剂组的效果与手术没有差异。在26项（49%）试验中，手术优于安慰剂，但手术干预对安慰剂的影响程度通常很小。安慰剂组有18项试验（34%）和手术组有22项试验（41.5%）报告了严重不良事件；在四项试验中，作者没有具体说明事件发生在哪一组。然而，在许多研究中，不良事件与干预无关或与病情的严重程度有关。现有的安慰剂对照试验只研究了侵入性较小的手术，不涉及开腹、开胸、开颅或广泛的组织剥离。结论安慰剂对照试验是显示手术疗效的有效、可行的方法。与安慰剂相关的不良反应的风险很小。在一半的研究中，结果提供了反对继续使用所调查的外科手术的证据。如果没有精心设计的安慰剂对照手术试验，无效的治疗可能继续不受挑战。
Objective To investigate whether placebo controls should be used in the evaluation of surgical interventions. Design Systematic review. Data sources We searched Medline, Embase, and the Cochrane Controlled Trials Register from their inception to November 2013. Study selection Randomised clinical trials comparing any surgical intervention with placebo. Surgery was defined as any procedure that both changes the anatomy and requires a skin incision or use of endoscopic techniques. Data extraction Three reviewers (KW, BJFD, IR) independently identified the relevant trials and extracted data on study details, outcomes, and harms from included studies. Results In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small. Serious adverse events were reported in the placebo arm in 18 trials (34%) and in the surgical arm in 22 trials (41.5%); in four trials authors did not specify in which arm the events occurred. However, in many studies adverse events were unrelated to the intervention or associated with the severity of the condition. The existing placebo controlled trials investigated only less invasive procedures that did not involve laparotomy, thoracotomy, craniotomy, or extensive tissue dissection. Conclusions Placebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures. The risks of adverse effects associated with the placebo are small. In half of the studies, the results provide evidence against continued use of the investigated surgical procedures. Without well designed placebo controlled trials of surgery, ineffective treatment may continue unchallenged.
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