Abstract:

Objective　To evaluate the clinical efficacy, adverse reactions, and potential mechanism of acupuncture combined with Huoxue Quyu prescription in the treatment of migraine. Methods　The China Biomedical Literature Database, CNKI, Wanfang Digital Journal Database, VIP Database, PubMed, and Cochrane Library were searched to collect clinical randomized controlled trials (RCTs) from their establishment to April 10, 2023. The control group were treated with western medicine, and the treatment group with acupuncture and Huoxue Quyu prescription. The review Manager 5.4 software was used for the meta-analysis. The evidence level of the outcome indicators was evaluated by the grading of recommendations assessment, development, and evaluation (GRADE) rating system. The TSA 0.9.5.1 Beta software was used to conduct a sequential analysis of the main outcome measures. Results　A total of 20 RCTs with 2 127 patients were included. The meta-analysis results showed that: among the main outcome indicators, the recovery rate (RR=1.93, 95%CI 1.56-2.38, P<0.000 01) and the total effective rate (RR=1.22, 95%CI 1.16-1.29, P<0.000 01) in the treatment group were higher than those in the control group; there was no statistical difference in adverse reactions between the two groups (RR=0.36, 95%CI 0.12-1.12, P=0.08). Among the secondary outcome measures, the score of Visual Analogue Scale (VAS) in the treatment group (MD=-1.55, 95%CI -2.39--0.70, P=0.000 3) was lower than that in the control group; there was no statistical difference in the anterior cerebral artery (ACA) blood flow velocity (MD=-1.51, 95%CI -3.18-0.16, P=0.08) between the two groups; the middle cerebral artery (MCA) blood flow (MD=-4.12, 95%CI -5.76--2.49, P<0.000 01) and posterior cerebral artery (PCA) blood flow (MD=-2.73, 95%CI -4.14--1.32, P<0.000 1) in the treatment group were lower than those in the control group. The GRADE evidence grading results showed that total effectiveness, recovery rate, adverse reactions, VAS score, and cerebral artery (ACA, MCA, and PCA) blood flow velocities were all low. The sequential analysis of the trials showed that among the main outcome indicators, the included sample size of recovery rate and total effective rate met the requirements of the meta-analysis. However, the adverse reactions still needed to be verified by a larger sample. Conclusion　Acupuncture combined with Huoxue Quyu prescription has definite clinical effect on migraine, and can improve cerebral artery blood flow velocity to a certain extent.

Key words:

Migraine, Acupuncture, Huoxue Quyu prescription, Western medicine, Meta-analysis, Trail sequential analysis

摘要：

目的　评价针刺联合活血祛瘀剂治疗偏头痛的临床疗效、不良反应及治疗潜在机制。方法　检索中国生物医学文献数据库、中国知网、万方数据库、维普数据库、PubMed、Cochrane Library，收集临床随机对照试验（RCT）；对照组患者采用西药治疗，治疗组采用针刺联合活血祛瘀剂治疗；检索时间为建库至2023年4月10日。选用Review Manager5.4软件进行meta分析；改良的定量系统评价证据分级（GRADE）评价结局指标的证据级别；TSA 0.9.5.1Beta软件对主要结局指标进行试验序贯分析。结果　共纳入20项RCT，2 127例患者。meta分析结果显示：主要结局指标中，治疗组的痊愈率（RR=1.93，95%CI 1.56～2.38，P<0.000 01）、总有效率（RR=1.22，95%CI 1.16～1.29，P<0.000 01）均高于对照组；不良反应与对照组比较差异无统计学意义（RR=0.36，95%CI 0.12～1.12，P=0.08）。次要结局指标中：治疗组的视觉模拟量表（VSA）评分（MD=-1.55，95%CI -2.39～-0.70，P=0.000 3）低于对照组；脑动脉血流速度中，治疗组大脑前动脉（ACA）血流速度与对照组比较差异无统计学意义（MD=-1.51，95%CI -3.18～0.16，P=0.08）；治疗组的大脑中动脉（MCA）血流（MD=-4.12，95%CI -5.76～-2.49，P<0.000 01）、大脑后动脉（PCA）血流（MD=-2.73，95%CI -4.14～-1.32，P<0.000 1）均低于对照组。GRADE证据分级结果示：总有效率、痊愈率、不良反应、VAS评分、脑动脉（ACA、MCA、PCA）血流速度均为低级。试验序贯分析示：主要结局指标中，痊愈率、总有效率的纳入的样本量达到meta分析所需要求；而不良反应尚需要更大的样本量验证。结论　针刺联合活血祛瘀剂治疗偏头痛的临床疗效确切，且在一定程度上能改善脑动脉血流速度。

关键词:

偏头痛, 针刺, 活血祛瘀剂, 西药, meta分析, 试验序贯分析