Objective：To systematically evaluate the effect of modified Shoutai pills combined with western medicine on pregnancy outcome in patients with recurrent spontaneous abortion.Methods：Electronically searched PubMed，EMBASE，Cochrane Library，China national knowledge infrastructure，VIP periodical database，China biomedical literature database and Wanfang database.For the related literatures published from the time of database establishment to September in 2018，the quality evaluation and data extraction of the included studies was carried out by two researchers respectively，independently and strictly，Performed a Meta-analysis on the randomized controlled trials accorded with requirement by RevMan5.2 software and conducted the trial sequential analysis by TSA v0.9 software.Results：14 literatures and a total of 1 034 sample sizes were included，among which 516 cases were treated with routine western medicine and 518 cases were treated with modified Shoutai pills combined with western medicine.Compared with the routine western medicine therapy，the total effective rate in the treatment which received modified Shoutai pills combined with western medicine was obviously better［OR=5.69，95%CI(3.83～8.48)，P ＜ 0.000 01］，and the success rate of the secondary pregnancy was significantly improved［OR=3.23，95%CI(92.45～4.25)，P ＜ 0.000 01］.Conclusion：The curative effect of the application of modified Shoutai pills combined with western medicine for recurrent spontaneous abortion is better than that of routine western medicine.