To evaluate the efficacy and safety of Duliang Soft Capsules in the treatment of migraine.Methods:Databases，such as Cochrane Library，PubMed，EMbase，CCD，CSPD，CNKI，and SinoMed and ClinicalTrials.gov were electronically searched for relevant randomized controlled trials (RCTs) on the effect of Duliang Soft Capsules alone or in combination against migraine from database inception to May 2020.After two researchers screened the literature papers independently，extracted the data，evaluated the risk of bias，and cross-checked the results，RevMan 5.3 was used for Meta-analysis.Results:Fourteen RCTs were included，involving 1 325 patients.Subgroup analysis was conducted according to the combined medication of Duliang Soft Capsules with western medicine and types of western medicine，respectively.The results showed that Duliang Soft Capsules combined with western medicine were superior to western medicine alone in improving total effective rate，relieving headache，reducing headache frequency，shortening headache duration，reducing serum calcitonin gene-related peptide (CGRP) levels，and improving cerebral hemodynamics.Duliang Soft Capsules were superior to flunarizine in improving total effective rate，relieving headache，reducing headache frequency，and shortening headache duration.In terms of the incidence of adverse events，Duliang Soft Capsules were lower than western medicine，and the adverse events of Duliang Soft Capsules combined with western medicine were similar to those of western medicine alone.No serious adverse events were observed.Conclusion:Duliang Soft Capsules are superior to flunarizine in the treatment of migraine，and combined medication with western medicine was more effective and safer than western medicine alone.Due to the limitations of low methodological quality and small amount of included literature papers，the clinical evidence provided by the conclusion of this study needs to be further verified.