Abstract:

Objective　To systematically evaluate the efficacy of calming internal wind agent combined with acupuncture in the treatment of migraine. Methods　CNKI,Wan Fang, VIP, SinoMed, PubMed,Web of Science, Cochrane Library, and Embase were searched to collect the clinical randomized controlled trials of calming internal wind agent combined with acupuncture in the treatment of migraine from their construction to 30 November 2023. The meta-analysis was performed using the RevMan5.4 software. The GRADE grading system was used to evaluate the evidence level of the observation indicators. The TSA 0.9.5.1 Beta software was used for sequential analysis of the trial. Results　A total of 14 randomized controlled trials involving 1 396 patients were included. The results of the meta-analysis showed that the cured rate in the experimental group was higher than that in the control group (RR=1.69,95%CI 1.43～1.99, P<0.000 01); the score of Visual Analogue Scale (VAS) in the experimental group was lower than that in the control group (MD=-1.22,95%CI -1.56--0.87, P<0.000 01); there were no statistical differences in the duration and frequency of headache between the experimental group and the control group (MD=-1.71,95%CI -4.04-0.62，P=0.15; MD=-1.22, 95%CI -2.54-0.11， P=0.07). The results of GRADE evidence grading showed that the recovery rate was moderate; the total effective rate and score of VAS were low; the duration and frequency of headache were extremely low. The sequential analysis of the trials for total efficacy showed that the sample sizes included had met the requirements needed for the meta-analysis; the false positive possibility was ruled out; the efficacy results after penalization statistics were reliable. Conclusion　The clinical efficacy of the combination of calming internal wind agent and acupuncture for migraine is better than that of western medicines.

Key words:

Migraine, Calming internal wind agent, Acupuncture, Meta-analysis, Trail sequential analysis

摘要：

目的　系统评价平息内风剂联合针刺治疗偏头痛的疗效。方法　检索知网、万方、维普、SinoMed、PubMed、Web of Science、Cochrane Library、Embase，收集平息内风剂联合针刺治疗偏头痛的临床随机对照试验，检索时间为建库至2023年11月30日。选用RevMan5.4软件进行meta分析，GRADE分级系统评价观察指标的证据级别，TSA 0.9.5.1 Beta软件进行试验序贯分析。结果　共纳入14项随机对照试验，1 396例患者。Meta分析结果示：试验组的痊愈率高于对照组（RR=1.69，95%CI 1.43～1.99，P<0.000 01），视觉模拟评分法（VSA）评分低于对照组（MD=-1.22，95%CI -1.56～-0.87，P<0.000 01），头痛持续时间、头痛发作频次与对照组比较差异无统计学意义（MD=-1.71、-1.22，95%CI -4.04～0.62、-2.54～0.11，P=0.15、0.07）。GRADE证据分级：痊愈率为中级，总有效率、VAS评分均为低级，头痛持续时间、头痛发作频次均为极低级。总有效率的试验序贯分析示，纳入样本量均已达到meta分析所需要求，且排除假阳性可能；惩罚统计后的疗效结果可靠。结论　平息内风剂联合针刺治疗偏头痛的临床疗效优于西药。

关键词:

偏头痛, 平息内风剂, 针刺, Meta分析, 试验序贯分析