Abstract: OBJECTIVE To systematically evaluate the efficacy and safety of trimebutine maleate combined with oryzanol in treating irritable bowel syndrome(IBS). METHODS Randomized controlled trials(RCTs) of trimebutine maleate combined with oryzanol in treating IBS were identified by searching electronic databases including Cochrane Library, Springer Link, CNKI, PubMed, Embase, CBM, Wanfang Data and VIP Database. Two reviewers extracted data independently and assessed literature quality according to the Cochrane Collaboration Risk Assessment Criteria and meta-analysis was conducted by using RevMan 5.3 software. RESULTS A total of 15 RCTs were included, involving 1 338 patients. The results of meta-analysis showed that compared with the control group, trimebutine maleate combined with oryzanol had better clinical efficacyRR=1.26, 95%CI(1.20, 1.33), P<0.000 01, and improved clinical symptoms, abdominal painSMD=-0.94, 95%CI(-1.22, -0.66), P<0.000 01, diarrheaSMD=-1.33, 95%CI(-1.68, -0.98), P<0.000 01, daily average number of bowel movementsSMD=-1.41, 95%CI(-1.79, -1.03), P<0.000 01, abnormal proportion of stool characteristicsSMD=-2.82, 95%CI(-3.42, -2.22), P<0.000 01), and reduced adverse reactionsRR=0.40, 95%CI(0.27, 0.60), P<0.000 1 in the treatment of IBS. CONCLUSION Trimebutine maleate combined with oryzanol has better clinical efficacy and lower adverse reactions compared with trimebutine maleate in the treatment of IBS.