The Long-term Effect of Acupuncture for Migraine Prophylaxis

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The Long-term Effect of Acupuncture for Migraine Prophylaxis

A Randomized Clinical Trial

针刺预防偏头痛的远期疗效：一项随机临床试验。

[url=]Zhao L[/url]1, [url=]Chen J[/url]1, [url=]Li Y[/url]1, [url=]Sun X[/url]2, [url=]Chang X[/url]3, [url=]Zheng H[/url]1, [url=]Gong B[/url]4, [url=]Huang Y[/url]5, [url=]Yang M[/url]1, [url=]Wu X[/url]1, [url=]Li X[/url]4, [url=]Liang F[/url]1.

　

Abstract

摘要

01

IMPORTANCE:   重要性

The long-term prophylactic effects of acupuncture for migraine are uncertain.

针刺对偏头痛长期的预防效果尚不确定。

02

OBJECTIVE:    目的

To investigate the long-term effects of true acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis.

研究针刺与假针刺的长期疗效对比，并设置了预防偏头痛的对照组等待名单。

03

DESIGN, SETTING, AND PARTICIPANTS:

设计，设置和参与者：

This was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to true acupuncture, sham acupuncture, or a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at 3 clinical sites in China. A total of 249 participants 18 to 65 years old with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.

这是一个为期24周的随机临床试验（治疗4周后随访20周）。参与者被随机分配到针刺组，假针刺组，或对照组（等待）。试验从2012年10月到2014年9月在中国的门诊设置了3个临床基地。根据国际头痛协会的标准，共249位年龄在18至65岁之间，偏头痛发生率为每月2到8次的无先兆偏头痛患者参加了本次试验。

04

INTERVENTIONS:    干预

Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial.

针刺组和假针刺组接受每周5天的治疗，持续4周，共20个疗程。在等待组的参与者没有接受针灸，但会告知他们，试验结束时将免费提供20个疗程的针灸治疗作为补偿。

05

MAIN OUTCOMES AND MEASURES:

主要成果及措施：

Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.

以日记记录参与者偏头痛的发作。主要结果是从未治疗前的基线水平到第16周偏头痛发作频率的变化。次要结局指标包括偏头痛天数、平均头痛严重程度和24周内每4周的药物摄入情况。

06

RESULTS:    结果

A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. One hundred eighty-nine (77.1%) were women. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (P < .001); the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the shamacupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, -0.1 to 1.4; P = .07).

总共有249名年龄在18至65岁之间的参与者，其中包括245个意向治疗分析。有189（77.1%）是女性。3组间的基线特征具有可比性。同期3组间偏头痛的平均发作频率发生明显不同的改变是在随机试验进行16周后出现的（P<0.001）；针灸组同期平均发作频率下降3.2（2.1），假针灸组下降2.1（2.5），对照组1.4（2.5）；观察到针刺治疗比假针刺治疗的偏头痛发作频率有更大程度的下降（相差1.1；95% CI，0.4-1.9；P = 002），针刺组与对照组相比（相差1.8；95% CI，1.1-2.5；P <0.001）。假针刺与对照组相比（之间有0.7的差异，95% CI，- 0.1至1.4；P = 0.07）无统计学差异。

07

CONCLUSIONS AND RELEVANCE:

结论与相关性：

Among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.

在无先兆的偏头痛患者中，针刺与假针刺或对照组相比，针刺可能对偏头痛复发长期的缓解有一定的帮助。

08

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01687660

“JAMA Intern Med. doi:10.1001/jamainternmed.2016.9378Published online February 20, 2017.
Acupuncture is widely used for managing migraine in China and western countries, especially for drug-refractory patients.7,8 The goals of acupuncture are usually 2-fold: relief of pain during migraine (acute effect)9,10 and prevention of future migraine attacks (long-term effect). Several trials with a small sample size11-14 have shown that true acupuncture (TA) may be more effective than sham acupuncture (SA) (simulated, or needling at nonacupoint locations) in the reduction of migraine intensity, frequency of migraine attacks, and number of migraine days; others,15-18 however, have reported no differences. The inconsistency of these findings may result from variations in the design characteristics (eg, length of follow-up, interventions used) and study population. The long-term effect of acupuncture is critical to successful prophylaxis and reduction of migraine recurrence. One important unanswered question is whether TA is superior to SA in preventing future migraine attacks. Therefore, we further conducted a 24-week, multicenter, 3-arm, parallel randomized clinical trial (RCT) to compare the long-term effect of TA vs SA or waiting list (WL) in migraineurs.