Fan Xue-Ming, Wei Jing-Jing, Zhang Yun-Ling, Liao Xing, Liang Xiao, Fu Guo-Jing, Gong Xiao, Chen Wen-Jie, Piao Jing-Ze, Yan Yu, Guo Chun-Li, Yan Yong-Mei, Yang Jian
Xiyuan Hospital,China Academy of Chinese Medical Sciences Beijing 100091,China Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
Xiyuan Hospital,China Academy of Chinese Medical Sciences Beijing 100091,China Graduate School,Beijing University of Chinese Medicine Beijing 100029,China.
Zhongguo Zhong Yao Za Zhi. 2021 Sep;46(18):4623-4632. doi: 10.19540/j.cnki.cjcmm.20210520.501.
This study aims to systematically evaluate the clinical efficacy and safety of Toutongning Capsules in the treatment of tension-type headache(TTH), so as to provide a corresponding basis for clinical treatment. Eight commonly used medical research databases and two clinical trial registration systems were retrieved with the time interval from the establishment of the database or system to November 2020. The randomized controlled trials of Toutongning Capsules in the treatment of TTH were screened out according to the pre-set criteria. The quality of the included papers was evaluated by the bias risk assessment tool in Cochrane Reviewers Handbook 6.1 and the data were statistically analyzed by RevMan v5.4 provided by Cochrane collaboration. A total of 13 studies were included and the quality of methodology was generally low. Meta-analysis showed that Toutongning Capsules assisted with western medicine therapy can effectively reduce the pain intensity(MD_(VAS)=-1.94,95%CI[-2.50,-1.38],P<0.000 01;MD_(NRS)=-0.83,95%CI[-0.86,-0.80],P<0.000 01), headache duration(SMD=-0.98,95%CI[-1.17,-0.79],P<0.000 01), headache frequency(MD=-1.01,95%CI[-1.16,-0.85],P<0.000 01), headache index(MD=-11.13,95%CI[-12.10,-10.16],P<0.000 01), anxiety and depression scale score(MD_(HAMA)=-4.02,95%CI[-6.58,-1.46],P=0.002;MD_(HAMD)=-2.67,95%CI[-4.04,-1.29],P=0.000 1), while Toutongning Capsules as monotherapy only reduced the headache score(MD=-2.24,95%CI[-2.97,-1.51],P<0.000 01). The available clinical studies demonstrate that Toutongning Capsules combined with western medicine in the treatment of TTH can improve the related outcome indicators, but the clinical safety and efficacy of Toutongning Capsules alone remain unclear. Due to the small number and low quality of the included studies, large-sample, multi-center, high-quality and strictly designed randomized controlled trials are still needed to verify the clinical efficacy in the future.
本研究旨在系统评价头痛宁胶囊治疗紧张型头痛（TTH）的临床疗效和安全性，为临床治疗提供相应依据。检索了8个常用医学研究数据库和2个临床试验注册系统，检索时间范围为数据库或系统建立至2020年11月。根据预设标准筛选出头痛宁胶囊治疗TTH的随机对照试验。采用Cochrane系统评价员手册6.1中的偏倚风险评估工具对纳入文献的质量进行评价，并用Cochrane协作网提供的RevMan v5.4软件对数据进行统计分析。共纳入13项研究，方法学质量普遍较低。Meta分析结果显示，头痛宁胶囊联合西药治疗能有效降低疼痛强度（MD_(VAS)=-1.94，95%CI[-2.50，-1.38]，P<0.000 01；MD_(NRS)=-0.83，95%CI[-0.86，-0.80]，P<0.000 01）、头痛持续时间（SMD=-0.98，95%CI[-1.17，-0.79]，P<0.000 01）、头痛频率（MD=-1.01，95%CI[-1.16，-0.85]，P<0.000 01）、头痛指数（MD=-11.13，95%CI[-12.10，-10.16]，P<0.000 01）、焦虑抑郁量表评分（MD_(HAMA)=-4.02，9５%CI[-6.58，-1.46]，P=0.002；MD_(HAMD)=-2.67，95%CI[-4.04，-1.29]，P=0.000 1）；而头痛宁胶囊单药治疗仅能降低头痛评分（MD=-2.24，95%CI[-2.97，-1.51]，P<0.000 01）。现有临床研究表明，头痛宁胶囊联合西药治疗TTH能改善相关结局指标，但头痛宁胶囊单药治疗的临床安全性和疗效尚不清楚。由于纳入研究数量少、质量低，未来仍需大样本、多中心、高质量、设计严格的随机对照试验来验证其临床疗效。
