Acupuncture for the prevention of episodic migraine.
Acupuncture for the prevention of episodic migraine.
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DOI：
10.1002/14651858.cd001218.pub3
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发表时间：
2016-06-28
期刊：
影响因子：
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通讯作者：
White AR
中科院分区：
文献类型：
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作者：
Linde K;Allais G;Brinkhaus B;Fei Y;Mehring M;Vertosick EA;Vickers A;White AR
针灸常用于预防偏头痛，但其有效性仍存在争议。我们对 2009 年 Cochrane 综述进行了更新。调查针灸是否 a) 比仅进行预防性治疗/常规护理更有效； b) 比假针灸（安慰剂）更有效； c) 与药物预防性治疗一样有效地减少成人阵发性偏头痛的头痛频率。我们检索了 Cochrane 对照试验中央注册库（CENTRAL：2016 年第 1 期）； MEDLINE（通过 Ovid，2008 年至 2016 年 1 月）；奥维德EMBASE（2008年至2016年1月）；和奥维德·AMED（1985 年至 2016 年 1 月）。我们在 PubMed 上检索了截至 2016 年 4 月的最新出版物。我们在世界卫生组织 (WHO) 临床试验注册平台上检索了截至 2016 年 2 月正在进行的和未发表的试验。我们纳入了持续至少八周的随机试验，对阵发性偏头痛参与者进行针灸干预与非针灸对照（无预防性治疗或仅常规护理）、假针灸干预或预防性药物的比较。两名评审员检查资格；提取有关参与者、干预措施、方法和结果的信息，并评估针灸干预的偏倚风险和质量。主要结局是治疗后和随访时的偏头痛频率（如果未测量/报告偏头痛天数，最好是偏头痛天数、发作或头痛天数）。次要结果是反应（频率至少降低 50%）。安全性结果是由于不良反应而退出的参与者人数以及报告至少一种不良反应的参与者人数。我们使用固定效应模型计算了汇总效应大小估计值。我们使用 GRADE 评估证据并创建“结果摘要”表。共有 4985 名参与者（中位数 71 名，范围 30 至 1715 名）的 22 项试验符合我们更新的选择标准。我们从本次更新中排除了 5 项之前纳入的试验，因为它们纳入了偏头痛不足 12 个月的患者，并纳入了 5 项新试验。 5 项试验设有非针灸对照组（仅治疗发作或不受监管的常规护理），15 项试验设有假针灸对照组，5 项试验设有接受预防性药物治疗的比较组。与非针灸对照组和接受预防性药物治疗的组相比，由于不可能进行盲法，因此存在表现和检测偏倚的风险。总体而言，证据质量中等。与治疗后不进行针灸相比，针灸可适度减少头痛频率（四项试验，2199 名受试者；标准化均数差 (SMD) -0.56；95% CI -0.65 至 -0.48）；研究结果存在统计学异质性（I2 = 57%；证据质量中等）。治疗后，41% 接受针灸治疗的参与者和 17% 未接受针灸治疗的参与者的头痛频率至少减半（合并风险比 (RR) 2.40；95% CI 2.08 至 2.76；4 项研究，2519 名参与者），相应数量需要治疗才能获得额外有益结果 (NNTB) 为 4（95% CI 3 至 6）；没有迹象表明统计异质性（I2 = 7%；证据质量中等）。唯一一项进行治疗后随访的试验在随机分组后 12 个月发现了微小但显着的获益（RR 2.16；95% CI 1.35 至 3.45；NNT 7；95% 4 至 25；377 名受试者，低质量证据）。在治疗后（12 项试验，1646 名受试者）和随访时（10 项试验，1534 名受试者），与假手术相比，针灸的频率略有下降，但具有统计学意义（中等质量证据）。治疗后SMD为-0.18（95% CI -0.28至-0.08；I2 = 47%），随访时为-0.19（95% CI -0.30至-0.09；I2 = 59%）。治疗后，50% 接受真针灸治疗的参与者和 41% 接受假针灸治疗的参与者头痛频率至少减半（汇总 RR 1.23，95% CI 1.11 至 1.36；I2 = 48%；14 项试验，1825 名参与者），随访时头痛频率分别为 53% 和 42%（汇总 RR 1.25，95% CI） 1.13 至 1.39；I2 = 61%；11 项试验，1683 名参与者，中等质量证据）。相应的 NNTB 分别为 11（95% CI 7.00 至 20.00）和 10（95% CI 6.00 至 18.00）。因不良反应而退出的参与者人数（比值比 (OR) 2.84；95% CI 0.43 至 18.71；7 项试验，931 名受试者；低质量证据）和报告不良反应的受试者人数（OR 1.15；95% CI 0.85 至 1.56；4 项试验，1414 名受试者；中等质量证据）在针灸和假治疗之间没有显着差异组。治疗后针灸比药物预防更能显着降低偏头痛频率（SMD -0.25；95% CI -0.39 至 -0.10；3 项试验，739 名受试者），但随访时显着性并未维持（SMD -0.13；95% CI -0.28 至 0.01；3 项试验，744 名受试者；中等质量证据）。三个月后，57% 接受针灸的参与者和 46% 接受预防药物的参与者头痛频率至少减少一半（汇总 RR 1.24；95% CI 1.08 至 1.44），六个月后分别为 59% 和 54%（汇总 RR 1.11；95% CI 0.97 至 1.26；中等质量证据）。各试验的结果一致，所有分析中 I2 均为 0%。与接受预防性药物的参与者相比，接受针灸治疗的试验参与者因不良反应而退出的可能性较小（OR 0.27；95% CI 0.08至0.86；4项试验，451名受试者），报告不良反应（OR 0.25；95% CI 0.10至0.62；5项试验931名受试者）（中等质量证据）。现有证据表明，在对症治疗中加入针灸可以减少头痛的发生频率。与之前的发现相反，最新的证据也表明，相对于假手术，有一定的影响，但这种影响很小。现有的试验还表明，针灸可能至少与预防性药物治疗具有相似的效果。对于愿意接受这种治疗的患者来说，针灸可以被视为一种治疗选择。至于其他偏头痛治疗，缺乏持续一年以上的长期研究。
Acupuncture is often used for migraine prevention but its effectiveness is still controversial. We present an update of our Cochrane review from 2009. 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 prophylactic treatment with drugs in reducing headache frequency in adults with episodic migraine. We searched the Cochrane Central Register of Controlled Trials (CENTRAL: 2016, issue 1); MEDLINE (via Ovid, 2008 to January 2016); Ovid EMBASE (2008 to January 2016); and Ovid AMED (1985 to January 2016). We checked PubMed for recent publications to April 2016. We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials. We included randomized trials at least eight weeks in duration that compared an acupuncture intervention with a no-acupuncture control (no prophylactic treatment or routine care only), a sham-acupuncture intervention, or prophylactic drug in participants with episodic migraine. Two reviewers checked eligibility; extracted information on participants, interventions, methods and results, and assessed risk of bias and quality of the acupuncture intervention. The primary outcome was migraine frequency (preferably migraine days, attacks or headache days if migraine days not measured/reported) after treatment and at follow-up. The secondary outcome was response (at least 50% frequency reduction). Safety outcomes were number of participants dropping out due to adverse effects and number of participants reporting at least one adverse effect. We calculated pooled effect size estimates using a fixed-effect model. We assessed the evidence using GRADE and created ’Summary of findings’ tables. Twenty-two trials including 4985 participants in total (median 71, range 30 to 1715) met our updated selection criteria. We excluded five previously included trials from this update because they included people who had had migraine for less than 12 months, and included five new trials. Five trials had a no-acupuncture control group (either treatment of attacks only or non-regulated routine care), 15 a sham-acupuncture control group, and five a comparator group receiving prophylactic drug treatment. In comparisons with no-acupuncture control groups and groups receiving prophylactic drug treatment, there was risk of performance and detection bias as blinding was not possible. Overall the quality of the evidence was moderate. Acupuncture was associated with a moderate reduction of headache frequency over no acupuncture after treatment (four trials, 2199 participants; standardised mean difference (SMD) −0.56; 95% CI −0.65 to −0.48); findings were statistically heterogeneous (I2 = 57%; moderate quality evidence). After treatment headache frequency at least halved in 41% of participants receiving acupuncture and 17% receiving no acupuncture (pooled risk ratio (RR) 2.40; 95% CI 2.08 to 2.76; 4 studies, 2519 participants) with a corresponding number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 6); there was no indication of statistical heterogeneity (I2 = 7%; moderate quality evidence). The only trial with post-treatment follow-up found a small but significant benefit 12 months after randomisation (RR 2.16; 95% CI 1.35 to 3.45; NNT 7; 95% 4 to 25; 377 participants, low quality evidence). Both after treatment (12 trials, 1646 participants) and at follow-up (10 trials, 1534 participants), acupuncture was associated with a small but statistically significant frequency reduction over sham (moderate quality evidence). The SMD was −0.18 (95% CI −0.28 to −0.08; I2 = 47%) after treatment and −0.19 (95% CI −0.30 to −0.09; I2 = 59%) at follow-up. After treatment headache frequency at least halved in 50% of participants receiving true acupuncture and 41% receiving sham acupuncture (pooled RR 1.23, 95% CI 1.11 to 1.36; I2 = 48%; 14 trials, 1825 participants) and at follow-up in 53% and 42%, respectively (pooled RR 1.25, 95% CI 1.13 to 1.39 ; I2 = 61%; 11 trials, 1683 participants; moderate quality evidence). The corresponding NNTBs are 11 (95% CI 7.00 to 20.00) and 10 (95% CI 6.00 to 18.00), respectively. The number of participants dropping out due to adverse effects (odds ratio (OR) 2.84; 95% CI 0.43 to 18.71; 7 trials, 931 participants; low quality evidence) and the number of participants reporting adverse effects (OR 1.15; 95% CI 0.85 to 1.56; 4 trials, 1414 participants; moderate quality evidence) did not differ significantly between acupuncture and sham groups. Acupuncture reduced migraine frequency significantly more than drug prophylaxis after treatment (SMD −0.25; 95% CI −0.39 to −0.10; 3 trials, 739 participants), but the significance was not maintained at follow-up (SMD −0.13; 95% CI −0.28 to 0.01; 3 trials, 744 participants; moderate quality evidence). After three months headache frequency at least halved in 57% of participants receiving acupuncture and 46% receiving prophylactic drugs (pooled RR 1.24; 95% CI 1.08 to 1.44) and after six months in 59% and 54%, respectively (pooled RR 1.11; 95% CI 0.97 to 1.26; moderate quality evidence). Findings were consistent among trials with I2 being 0% in all analyses. Trial participants receiving acupuncture were less likely to drop out due to adverse effects (OR 0.27; 95% CI 0.08 to 0.86; 4 trials, 451 participants) and to report adverse effects (OR 0.25; 95% CI 0.10 to 0.62; 5 trials 931 participants) than participants receiving prophylactic drugs (moderate quality evidence). The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.