The ethics of placebo-controlled trials: A comparison of inert and active placebo controls
The ethics of placebo-controlled trials: A comparison of inert and active placebo controls
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DOI：
10.1007/s00268-005-7621-7
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发表时间：
2005-05-01
影响因子：
2.6
通讯作者：
Swift, T
中科院分区：
文献类型：
--
作者：
Edward, SJL;Stevens, AJ;Swift, T
由于最近有争议的假手术用于评估帕金森病的胎儿组织移植的例子，在手术试验中使用“活性”安慰剂的伦理学重新引起了人们的兴趣，否则就没有惰性程序可用，在药理学试验中，有惰性物质，但患者可能会猜测他们被分配到哪个手臂。本文旨在澄清在试验中使用活性安慰剂的伦理争论，并建立一个符号，更普遍地评估试验的伦理。我们首先建立一个框架，伦理委员会可以分析这样的试验。我们检查（1）研究的科学价值;（2）对个体患者的预期风险和益处;（3）同意的自愿性质。然后，我们对比惰性和积极的安慰剂对照试验，分别这一框架的影响。特别是，我们分析了他们的相对预期效用使用三个主要的效用因素，即，治疗效果，安慰剂效应和利他主义。我们的结论是，当干预措施已经广泛使用时，活性安慰剂试验比惰性安慰剂试验更严重地依赖利他主义，当干预措施受到限制时，这种过度依赖可能不需要。我们的分析提供了明确的理由，说明机构审查委员会或伦理委员会在审查虚假操作时，特别是在预期伤害不小且剥削风险很高的情况下，应该表现出明显的谨慎。
Because of the recent and controversial example of sham surgery for the evaluation of fetal tissue transplants for Parkinson's disease, there is renewed interest in the ethics of using "active" placebos in surgical trials, where otherwise there are no inert procedures available, and in pharmacological trials, where there are inert substances, but where patients may guess to which arm they have been allocated. This paper seeks to clarify the ethical arguments surrounding the use of active placebos in trials, and to set up a notation for assessing the ethics of trials more generally. We first establish an framework by which ethics committees can analyze such trials. We examine (1) the scientific value of the research; (2) the expected risks and benefits to individual patients, and (3) the voluntary nature of consent. We then contrast the implications of this framework for inert and active placebo-controlled trials, respectively. In particular, we analyze their relative expected utility using three main utility factors, namely, treatment effects, placebo effects, and altruism. We conclude that, when the intervention is already widely available, active placebo trials rely more heavily on altruism than do inert placebo trials and, when the intervention is restricted, this excess reliance may not be needed. What our analysis provides is the explicit justification for the apparent caution of Institutional Review Boards or ethics committees when reviewing sham operations, especially when the expected harm is not trivial and the risk of exploitation is high.