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针刺预防紧张型头痛

Acupuncture for the prevention of tension-type headache.

作者信息

Linde Klaus, Allais Gianni, Brinkhaus Benno, Fei Yutong, Mehring Michael, Shin Byung-Cheul, Vickers Andrew, White Adrian R

机构信息

Institute of General Practice, Klinikum rechts der Isar, Technical University Munich, Orleansstrasse 47, München, Germany, 81667.

出版信息

Cochrane Database Syst Rev. 2016 Apr 19;4(4):CD007587. doi: 10.1002/14651858.CD007587.pub2.

Abstract

BACKGROUND

Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library.

OBJECTIVES

To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache.

SEARCH METHODS

We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials.

SELECTION CRITERIA

We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache.

DATA COLLECTION AND ANALYSIS

Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation).

MAIN RESULTS

Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes.

AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.

摘要

背景

针灸常用于预防紧张型头痛,但其有效性仍存在争议。这是我们Cochrane系统评价的更新版,最初发表于《Cochrane图书馆》2009年第1期。

目的

研究针灸是否a) 比不进行预防性治疗/仅进行常规护理更有效;b) 比“假”(安慰剂)针灸更有效;c) 在减少发作性或慢性紧张型头痛成人的头痛频率方面与其他干预措施效果相当。

检索方法

我们检索了截至2016年1月19日的Cochrane中心对照试验注册库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)和澳大利亚和新西兰医学索引数据库(AMED)。我们检索了世界卫生组织(WHO)国际临床试验注册平台截至2016年2月10日正在进行和未发表的试验。

入选标准

我们纳入了随机化后观察期至少8周的随机试验,这些试验比较了针灸干预与对照组(仅治疗急性头痛或常规护理)、假针灸干预或其他预防性干预措施对发作性或慢性紧张型头痛成人的临床效果。

数据收集与分析

两位综述作者检查了纳入资格;提取了关于参与者、干预措施、方法和结果的信息;并评估了研究的偏倚风险和针灸干预的质量。主要疗效结局指标是治疗完成后(随机化后三至四个月)的反应(头痛频率至少降低50%)。为了评估安全性/可接受性,我们提取了因不良反应退出的参与者数量以及报告不良反应的参与者数量。我们使用GRADE(推荐分级的评估、制定和评价)评估证据质量。

主要结果

12项试验(前一版纳入11项,新识别1项),共2349名参与者(中位数56,范围10至1265)符合纳入标准。在两项大型试验(分别为1265名和207名参与者)中,将针灸与常规护理或仅治疗急性头痛进行了比较,但对照组的基线头痛频率和管理有很大差异。两项试验均未设盲,但试验质量在其他方面较高(偏倚风险低)。虽然两项试验的效应量估计差异很大,但接受针灸治疗的组中头痛频率至少降低50%的参与者比例远高于对照组(中等质量证据;试验1:302/629(48%)对121/636(19%);风险比(RR)2.5;95%置信区间(CI)2.1至3.0;试验2:60/132(45%)对3/75(4%);RR 11;95%CI 3.7至35)。未调查长期效果(四个月以后)。在7项质量中等至高的试验(偏倚风险低)中,将针灸与假针灸进行了比较;5项大型研究为一项或多项Meta分析提供了数据。治疗后,接受针灸的参与者中,391名中有205名(51%)头痛频率至少降低50%,而假针灸组312名中有133名(43%)(RR 1.3;95%CI 1.09至1.5;四项试验;中等质量证据)。随机化后六个月的结果相似。退出率很低:接受针灸的420名参与者中有1名因不良反应退出,接受假针灸的343名参与者中无退出(六项试验;低质量证据)。三项试验报告了报告不良反应的参与者数量:针灸组174名中有29名(17%),假针灸组103名中有12名(12%)(优势比(OR)1.3;95%CI 0.60至2.7;低质量证据)。在4项质量低至中等(偏倚风险高)的试验中,将针灸与物理治疗、按摩或运动进行了比较;研究结果报告不充分。没有试验发现针灸有显著优势,对于某些结局,结果略微有利于对照治疗。这些试验均未报告因不良反应退出的参与者数量或报告不良反应的参与者数量。总体而言,使用GRADE评估的证据质量为中等或低等,主要因缺乏设盲和效应量变化而降级。

作者结论

现有结果表明针灸对治疗频繁发作的发作性或慢性紧张型头痛有效,但需要进一步试验——尤其是将针灸与其他治疗选择进行比较的试验。

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