Placebo effect studies are susceptible to response bias and to other types of biases
Placebo effect studies are susceptible to response bias and to other types of biases
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DOI：
10.1016/j.jclinepi.2011.01.008
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发表时间：
2011-11-01
影响因子：
7.2
通讯作者：
Miller, Franklin G.
中科院分区：
文献类型：
--
作者：
Hrobjartsson, Asbjorn;Kaptchuk, Ted J.;Miller, Franklin G.
目的：安慰剂效应的研究通常具有挑战性，难以进行和解释。安慰剂的历史表明，其临床意义的评估具有真实的偏倚可能性。我们分析和讨论了安慰剂研究中的典型偏倚类型。研究设计和设置：方法学分析和讨论。安慰剂和未治疗之间固有的非盲比较是我们在临床和实验环境中估计安慰剂效果的最佳研究设计，但安慰剂和未治疗之间的差异仍然是安慰剂干预的真实效果的近似和相当粗略的反映。一个主要的问题是基于病人报告的试验结果的反应偏差。其他偏倚包括不同的共同干预和患者脱落、发表偏倚和结果报告偏倚。此外，外推到临床环境的结果是具有挑战性的，因为缺乏明确的因果关系的识别在许多临床试验中，和非临床设置和最短的持续时间的实验室experiments.Conclusions：需要创造性的实验努力，严格评估安慰剂干预的临床意义和调查的组成元素，可能有助于治疗的好处。(C)2011 Elsevier Inc. All rights reserved.
Objective: Investigations of the effect of placebo are often challenging to conduct and interpret. The history of placebo shows that assessment of its clinical significance has a real potential to be biased. We analyze and discuss typical types of bias in studies on placebo.Study Design and Setting: A methodological analysis and discussion.Results: The inherent nonblinded comparison between placebo and no-treatment is the best research design we have in estimating effects of placebo, both in a clinical and in an experimental setting, but the difference between placebo and no-treatment remains an approximate and fairly crude reflection of the true effect of placebo interventions. A main problem is response bias in trials with outcomes that are based on patients' reports. Other biases involve differential co-intervention and patient dropouts, publication bias, and outcome reporting bias. Furthermore, extrapolation of results to a clinical settings are challenging because of a lack of clear identification of the causal factors in many clinical trials, and the nonclinical setting and short duration of most laboratory experiments.Conclusions: Creative experimental efforts are needed to assess rigorously the clinical significance of placebo interventions and investigate the component elements that may contribute to the therapeutic benefit. (C) 2011 Elsevier Inc. All rights reserved.