安慰剂效应和随机临床试验。

G Elander, G Hermerén
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引用次数: 7

摘要

达到最佳治疗效果的前提是使用适当的治疗方法并最大限度地利用安慰剂效应。在随机临床试验(rct)中,这些目标有时可能难以满足。因此,问题出现了,治疗的目标和实验研究的目标之间是否存在冲突;如果是,到什么程度,临床医生和研究人员在实践中是如何处理的。在与随机对照试验相关的几份报告中讨论了各种伦理问题。但我们没有发现关于获得知情同意和促进最佳安慰剂效应之间冲突的讨论。关于随机对照试验的信息可以通过多种方式提供。有时关于随机对照试验的适当信息涉及到安慰剂效应的非最佳利用。这就产生了伦理和方法上的问题,本文将对此进行讨论。
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Placebo effect and randomized clinical trials.

The achievement of optimal therapeutic results presupposes the use of appropriate treatment combined with maximal utilization of placebo effects. These aims may sometimes be difficult to satisfy in randomized clinical trials (RCTs). The question thus arises whether there is a conflict between the goals of therapy and those of experimental research; and if so, to what extent, and how is it handled in practice by clinicians and researchers. Various ethical problems have been discussed in several reports connected with RCTs. But we have found no discussion concerning the conflict between obtaining informed consent and promoting optimal placebo effects. Information about RCTs can be given in various ways. Sometimes appropriate information about RCTs to patients involves non-optimal utilization of placebo effects. This gives rise to ethical and methodological problems, which are discussed in this article.

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