头痛是非常普遍的一种现象,90%以上的人都曾经历过此等烦恼。头痛一般分为紧张型头痛(TTH)和偏头痛。它们会产生较大的社会经济影响,并将扰乱大部分日常活动。治疗方法包括药理干预和行为干预。《按摩与生理学疗法杂志》今日在线发布的一项研究中,荷兰研究人员们对119个随机对照临床试验(RCT)展开分析并确定了安慰剂和无治疗对头痛康复率的影响幅度。
"虽然在调查研究中有意控制和安慰剂干预相对无效,不过问题是,哪些因素有可能促使这些群体出现改善,"荷兰鹿特丹伊拉斯马斯医学研究中心全科医学系助理教授Arianne P. Verhagen博士说道,"本研究的目的是观察在针对TTH和偏头痛患者分别采取'无治疗'和安慰剂干预措施后产生的影响并进行详细分析。"
在头痛临床试验中,"无治疗"和安慰剂组具有较高的总体康复率(36%)。药理试验对照组的反应率高于行为(非药理)试验(38.5% vs. 15.0%)。急性治疗的患者康复率高于预防治疗(39.6% vs. 32.8%)。考虑日常头痛治疗的效益和风险时,应当了解大部分患者无须经过治疗即可出现改善,这一点很重要。
药理治疗往往在非药理治疗(如改变生活方式、放松疗法及认知疗法等)不起作用时方才启动。许多处方药或非处方药(如非甾体抗炎药)可能会导致不良反应和药物过度使用性头痛。考虑到不良反应的风险,作者建议"医生应当根据每个患者的具体情况开药。基于药理试验中'无治疗'对照组的康复结果,问题是,这种开药方式是否始终优于无治疗(等待和观望)方式,尤其在TTH群体中。"(生物谷Bioon.com)
生物谷推荐原文出处;
Journal of Manipulative and Physiological Therapeutics doi:10.1016/j.jmpt.2011.04.007
Headache: the Placebo Effects in the Control Groups in Randomized Clinical Trials; an Analysis of Systematic Reviews
Femke M. de Groot BSc, Annieke Voogt-Bode BSc, Jan Passchier PhD, Marjolein Y. Berger MD, Bart W. Koes PhD and Arianne P. Verhagen PhD
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.