Abstract: Objective To evaluate the efficacy and safety of Toutongning capsules in the treatment of chronic headache. Methods Literature related to randomized controlled trials of Toutongning capsules for chronic headache that was published between inception and April 30, 2021 was screened out by searching CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed, Embase and Web of Science. The evaluation criteria of Cochrane Handbook 5.1.0 and RevMan 5.3 software were used for Meta-analysis of the enrolled studies. Results A total of 9 studies were included in the meta-analysis, with a total sample size of 886 cases including 450 cases in the experimental group and 436 cases in the control group. The results of Meta-analysis showed that after the literature with poor heterogeneity was excluded, the headache severity score of Toutongning capsules combined with conventional treatments was better than that of conventional treatments alone (MD=-0.91, 95%CI[-1.19, -0.63], P＜0.000 01), so were the duration of therapeutic effect (MD=-2.32, 95%CI[-3.86, -0.79］, P=0.003) and efficacy(RR=2.55, 95%CI[1.96, 3.30］against chronic headache (P＜0.000 01). In terms of safety, the adverse reactions caused by Toutongning capsules included chest tightness, dizziness, gastrointestinal reaction, stomach discomfort, dizziness and dry mouth, but there was no significant difference in the incidence of adverse reactions between the experimental group and the control group. Conclusion Toutongning capsules alone or combined with conventional treatments are more effective than conventional treatments alone. No serious adverse reactions have been found, which can provide evidence-based data for clinical practice and clinical drug use.

Key words: Toutongning capsule, chronic headache, randomized controlled trial, systematic review, Meta-analysis, efficacy, safety