针刺疗法预防月经相关性偏头痛：一项多中心随机对照试验。
Acupuncture for menstruation-related migraine prophylaxis: A multicenter randomized controlled trial.
作者信息
Liu Lu, Zhang Claire-Shuiqing, Liu Hui-Lin, He Fan, Lyu Tian-Li, Zeng Lin, Zhao Luo-Peng, Wang Mi-Na, Qu Zheng-Yang, Nie Li-Min, Guo Jia, Zhang Xiao-Zhe, Lu Yong-Hui, Wang Ke-Lun, Li Bin, Jing Xiang-Hong, Wang Lin-Peng
机构信息
Department of Acupuncture and Moxibustion, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.
School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.
出版信息
Front Neurosci. 2022 Aug 26;16:992577. doi: 10.3389/fnins.2022.992577. eCollection 2022.
OBJECTIVE
The aim of this study was to evaluate the efficacy of acupuncture, an alternative medicine therapy, as a preventive treatment for menstruation-related migraine (MRM).
PATIENTS AND METHODS
This was a prospective, multicenter, double-dummy, participant-blinded, randomized controlled clinical trial conducted in China between 1 April 2013, and 30 April 2014. The participants were enrolled from four study centers and randomized to into either the acupuncture group, which received 24 sessions of acupuncture at traditional acupoints plus placebo, or the medication group, which received sham acupuncture plus naproxen. The primary endpoint was change from the baseline average number of migraine days per perimenstrual period over cycles 1-3. The secondary endpoints included changes from the baseline average number of migraine days outside the perimenstrual period, mean number of migraine hours during and outside the perimenstrual period, mean visual analog scale score during and outside the perimenstrual period, ≥50% migraine responder rate, and the proportion of participants who used acute pain medication over cycles 1-3 and 4-6.
RESULTS
A total of 172 women with MRM were enrolled; 170 in the intention-to-treat analyses. Our primary outcome reported a significant between-group difference that favored the acupuncture group (95% CI, 0.17-0.50; < 0.001), with the average reduction of migraine days per perimenstrual period from the baseline was 0.94 (95% CI, 0.82-1.07) in the acupuncture group and 0.61 (95% CI, 0.50-0.71) in the medication group over cycles 1-3.
CONCLUSION
This study showed that compared to medication, acupuncture reduces the number of migraine days experienced by patients with MRM. For patients who received the acupuncture treatment over three cycles, the preventive effect of the therapy was sustained for six cycles.
CLINICAL TRIAL REGISTRATION
[https://www.isrctn.com/ISRCTN57133712], identifier [ISRCTN15663606].
目的
本研究旨在评估替代医学疗法针灸作为月经相关性偏头痛（MRM）预防性治疗的疗效。
患者与方法
这是一项前瞻性、多中心、双盲、受试者设盲、随机对照临床试验，于2013年4月1日至2014年4月30日在中国进行。参与者从四个研究中心招募，随机分为针灸组（接受24次传统穴位针灸加安慰剂）或药物组（接受假针灸加萘普生）。主要终点是第1 - 3周期每个月经周期偏头痛天数的基线平均值变化。次要终点包括月经周期外偏头痛天数的基线平均值变化、月经周期内和周期外偏头痛小时数的平均值、月经周期内和周期外视觉模拟量表评分的平均值、≥50%偏头痛缓解率，以及第1 - 3周期和第4 - 6周期使用急性疼痛药物的参与者比例。
结果
共招募了172例MRM女性患者；170例纳入意向性分析。我们的主要结果显示组间存在显著差异，针灸组更具优势（95%CI，0.17 - 0.50；P < 0.001），在第1 - 3周期，针灸组每个月经周期偏头痛天数较基线平均减少0.94天（95%CI，0.82 - 1.07），药物组为0.61天（95%CI，0.50 - 0.71）。
结论
本研究表明，与药物治疗相比，针灸可减少MRM患者的偏头痛天数。对于接受三个周期针灸治疗的患者，该疗法的预防效果在六个周期内持续存在。
临床试验注册
[https://www.isrctn.com/ISRCTN57133712]，标识符[ISRCTN\15663606]
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