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针刺与托吡酯预防慢性偏头痛的随机临床试验。

Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial.

机构信息

Kuang Tien General Hospital, Taiwan.

出版信息

Cephalalgia. 2011 Nov;31(15):1510-21. doi: 10.1177/0333102411420585. Epub 2011 Oct 21.

DOI:10.1177/0333102411420585
PMID:22019576
Abstract

BACKGROUND

The aim of this study was to investigate the efficacy and tolerability of acupuncture compared with topiramate treatment in chronic migraine (CM) prophylaxis.

METHODS

A total of 66 consecutive and prospective CM patients were randomly divided into two treatment arms: 1) acupuncture group: acupuncture administered in 24 sessions over 12 weeks (n = 33); and 2) topiramate group: a 4-week titration, initiated at 25 mg/day and increased by 25 mg/day weekly to a maximum of 100 mg/day followed by an 8-week maintenance period (n = 33).

RESULTS

A significantly larger decrease in the mean monthly number of moderate/severe headache days (primary end point) from 20.2 ± 1.5 days to 9.8 ± 2.8 days was observed in the acupuncture group compared with 19.8 ± 1.7 days to 12.0 ± 4.1 days in the topiramate group (p < .01) Significant differences favoring acupuncture were also observed for all secondary efficacy variables. These significant differences still existed when we focused on those patients who were overusing acute medication. Adverse events occurred in 6% of acupuncture group and 66% of topiramate group.

CONCLUSION

We suggest that acupuncture could be considered a treatment option for CM patients willing to undergo this prophylactic treatment, even for those patients with medication overuse.

摘要

背景

本研究旨在探究针刺与托吡酯治疗慢性偏头痛(CM)预防的疗效和耐受性。

方法

66 例连续前瞻性 CM 患者被随机分为两组:1)针刺组:接受 24 次,12 周(n=33);2)托吡酯组:4 周滴定期,起始剂量 25mg/天,每周增加 25mg/天,最高剂量为 100mg/天,随后维持 8 周(n=33)。

结果

针刺组的平均每月中度/重度头痛天数(主要终点)从 20.2±1.5 天显著减少至 9.8±2.8 天,而托吡酯组从 19.8±1.7 天减少至 12.0±4.1 天(p<0.01)。针刺组在所有次要疗效变量上也有显著差异。当我们关注那些过度使用急性药物的患者时,这些显著差异仍然存在。针刺组发生不良反应的比例为 6%,托吡酯组为 66%。

结论

我们建议针刺可以作为 CM 患者愿意接受这种预防性治疗的一种治疗选择,甚至可以用于那些药物过度使用的患者。

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