头痛：随机临床试验对照组中的安慰剂效应；系统评价分析
Headache: the placebo effects in the control groups in randomized clinical trials; an analysis of systematic reviews.
作者信息
de Groot Femke M, Voogt-Bode Annieke, Passchier Jan, Berger Marjolein Y, Koes Bart W, Verhagen Arianne P
机构信息
Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.
出版信息
J Manipulative Physiol Ther. 2011 Jun;34(5):297-305. doi: 10.1016/j.jmpt.2011.04.007. Epub 2011 May 19.
OBJECTIVE
The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients.
METHOD
This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group. The different types of "no treatment" and placebo interventions were assessed and classified into 6 subgroups. The analyses were carried out according to type of outcome variable.
RESULTS
In total, 119 studies were included (7119 participants). The mean recovery rate in all control groups was 35.7%. Significantly more participants recovered in control groups of pharmacological studies than in nonpharmacological studies: 38.5% vs 15.0%, respectively. Adults were more likely to recover in nonpharmacological studies and children in pharmacological studies.
CONCLUSIONS
The mean recovery rate in the control groups was 36%. The recovery rate varied substantially between type of intervention and patients.
目的
本研究旨在描述头痛患者试验中安慰剂组和“无治疗”组的效果。
方法
这是一项对8项系统评价中的随机对照试验以及选定的设有“无治疗”或安慰剂对照组的试验进行的二次分析。对不同类型的“无治疗”和安慰剂干预措施进行了评估，并分为6个亚组。分析根据结局变量类型进行。
结果
总共纳入了119项研究（7119名参与者）。所有对照组的平均恢复率为35.7%。药理学研究对照组中恢复的参与者明显多于非药理学研究对照组：分别为38.5%和15.0%。在非药理学研究中成年人更有可能恢复，而在药理学研究中儿童更有可能恢复。
结论
对照组的平均恢复率为36%。恢复率在干预类型和患者之间有很大差异。
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