OBJECTIVE: To evaluate the medium- to long-term efficacy of ligustrazine plus conventional medicine treating ischemic stroke. METHODS: Randomized controlled trials (RCTs) testing ligustrazine in the treatment of acute ischemic stroke were retrieved from Cochrane Library, PubMed, Excerpta Medica Database, Chinese Medical Journal Database, Chinese Biomedical Database, China National Knowledge Infrastructure Database, and Chinese Clinical Trial Register, and then identified by the inclusive and exclusive criteria. The quality of trials was assessed with the Cochrane Handbook 5.1, a risk of bias assessment tool. RevMan 5.1 was used for meta-analysis. RESULTS: Three RCTs involving 643 patients were included. Compared to conventional medicine treatment alone, ligustrazine plus conventional medicine treatment showed significant difference in reduction of stroke recurrence either at the end of 1-year follow-up [RR=0.42, 95% CI (0.18, 0.94), P<0.05] or 3-years observation [RR=0.48, 95% CI (0.27, 0.83), P<0.05]. The ligustrazine group also showed higher survival rate [RR=1.67, 95% CI (1.02, 0.2.71), P<0.05] and significantly better effective rate [RR=1.28, 95% CI (1.10, 1.50), P<0.05] than that of the control group at the end of 1 year visit. Only one trial conducted safety assessment and no adverse events were reported. The methodological quality of all the trials included was generally poor. CONCLUSION: The findings provided evidence that the combination of ligustrazine and conventional medication was medium- and long-term beneficial to the patients suffering ischernic stroke. But more RCTs of high quality are needed to further prove the efficacy and safety of using ligustrazine for ischemic stroke. (C) 2013 JTCM. All rights reserved.