Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Health Services Research Unit, Health Sciences Building, University of Aberdeen, Aberdeen, UK.
Lancet. 2020 Mar 7;395(10226):828-838. doi: 10.1016/S0140-6736(19)33137-X.
Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.
在评估手术干预疗效的随机试验中，安慰剂对照越来越受到关注。本综述旨在总结手术试验中安慰剂对照的知识。在手术环境中，安慰剂对照是一种复杂的对照类型，尽管很有效，但也带来了许多挑战。本综述概述了安慰剂对照的含义，并介绍了在手术背景下对该工具的理解。我们从伦理论证和监管要求的角度考虑了手术中安慰剂对照何时可以接受（以及何时可取），如何设计安慰剂对照，如何识别和减轻试验参与者的风险，以及如何进行和解释此类试验。在有强有力的科学和伦理理由的情况下，在随机对照试验中使用安慰剂对照是合理的。当手术程序的疗效证据不足且有合理的担忧认为试验结果会因安慰剂效应而带来较高的偏倚风险时，手术安慰剂可能最为合适。建议进行可行性研究，以优化随机对照试验的设计和实施。本综述为最佳实践提供了一个大纲，并以 ASPIRE（即 Applying Surgical Placebo in Randomised Evaluations 的缩写）检查表的形式为那些考虑在手术随机对照试验中使用安慰剂对照的人提供了指导。
