Li Yi-Fan, Hu Hui-Min, Wang Bo-Ning, Zhang Yi, Liu Xing, Mao Peng, Fan Bi-Fa
Graduate School of Beijing University of Chinese Medicine, Beijing 100029, China.
Department of Pain Medicine, China-Japan Friendship Hospital, Beijing 100029, China.
Evid Based Complement Alternat Med. 2021 Dec 22;2021:6203999. doi: 10.1155/2021/6203999. eCollection 2021.
To evaluate the efficacy and safety of Chuanxiong Qingnao Granule (CQG) to treat migraine.
This study was a randomized, double-blind, placebo-controlled trial. All migraineurs were recruited and randomly assigned into a treatment group treated with CQG and a control group treated with a placebo. The whole research process included a 4-week baseline, 12-week intervention, and 12-week follow-up. The primary outcome was responder rate, defined as the percentage of migraineurs with 50% or more reduction in the frequency of migraine attack during treatment and posttreatment period compared with the baseline. The secondary outcomes were the number of migraine days, migraine attack frequency, visual analogue scale (VAS), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HAMD), and Migraine Disability Assessment (MIDAS).
A total of 346 migraineurs completed the research and were included in the intention-treatment analyses. The response rates differed significantly between the treatment group and the control group (71.5% vs. 12.1% at week 12 and 83.1% vs. 3.4% at week 24). Attack frequency, days of headache attack, VAS, FSS, HAMD, and MIDAS decreased at week 12 in both groups with more reduction in the treatment group ( < 0.001). No severe adverse events were observed in this trial.
Chuanxiong Qingnao Granule can significantly improve headache symptoms in patients with migraine while improving disability, fatigue, and depression with a good safety profile.
评价川芎清脑颗粒（CQG）治疗偏头痛的疗效和安全性。
本研究为随机、双盲、安慰剂对照试验。招募所有偏头痛患者并随机分为接受CQG治疗的治疗组和接受安慰剂治疗的对照组。整个研究过程包括4周的基线期、12周的干预期和12周的随访期。主要结局为缓解率，定义为治疗期和治疗后期偏头痛发作频率较基线期降低50%或更多的偏头痛患者的百分比。次要结局为偏头痛天数、偏头痛发作频率、视觉模拟量表（VAS）、疲劳严重程度量表（FSS）、汉密尔顿抑郁量表（HAMD）和偏头痛残疾评估量表（MIDAS）。
共有346例偏头痛患者完成研究并纳入意向性分析。治疗组和对照组的缓解率差异显著（第12周时分别为71.5%和12.1%，第24周时分别为83.1%和3.4%）。两组在第12周时发作频率、头痛发作天数、VAS、FSS、HAMD和MIDAS均下降，治疗组下降更明显（<0.001）。本试验未观察到严重不良事件。
川芎清脑颗粒可显著改善偏头痛患者的头痛症状，同时改善残疾、疲劳和抑郁状况，安全性良好。
