Characteristic and incidental (placebo) effects in complex interventions such as acupuncture
Characteristic and incidental (placebo) effects in complex interventions such as acupuncture
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DOI：
10.1136/bmj.330.7501.1202
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发表时间：
2005-05-21
影响因子：
105.7
通讯作者：
Dieppe, P
中科院分区：
文献类型：
--
作者：
Paterson, C;Dieppe, P
随机双盲对照试验已被证明是测试新药疗效的宝贵工具。然而，它现在被用来评估复杂的非药物干预措施，其中许多是基于不同的治疗理论。例如，随机对照试验用于测试物理疗法，这是一种基于生物医学理论的复杂干预措施，而针灸通常基于中医。为了使用安慰剂或假对照设计，干预措施必须分为特征（特异性）和偶然（安慰剂，非特异性）元素。然而，最近的研究表明，将复杂的干预措施分为特征性和偶然性因素是没有意义的。在药物试验中被归类为偶然事件的元素可能是非药物干预的组成部分。如果这是真的，在评价复杂的非药物干预时使用安慰剂或假对照试验设计可能会产生假阴性结果。
The randomised double blind controlled trial has proved an invaluable tool for testing the efficacy of new drugs. However, it is now used to evaluate complex non-pharmaceutical interventions, many of which are based on different therapeutic theories. For example, randomised controlled trials are used to test physiotherapy, a complex intervention with a basis in biomedical theory, and acupuncture, which is often based on Chinese medicine. In order to use a placebo or sham controlled design, an intervention has to be divided into characteristic (specific) and incidental (placebo, non-specific) elements. However, recent research suggests that it is not meaningful to split complex interventions into characteristic and incidental elements. Elements that are categorised as incidental in drug trials may be integral to non-pharmaceutical interventions. If this is true, the use of placebo or sham controlled trial designs in evaluating complex non-pharmaceutical interventions may generate false negative results.