OBJECTIVE: To evaluate the efficacy and safety of Xuefuzhuyu decoction for hyperlipidemia. METHODS: Randomized clinical trials on hyperlipidemia treated by Xuefuzhuyu decoction, either alone or with Western Medicine, were searched in electronic databases. Databases searched were: MEDLINE, Allied and Complementary Medicine Database, EMBASE, The Cochrane Library 2013 (Issue 4), China National Knowledge Infrastructure Database, Chinese Biomedical Literature Database, and Wanfang Database up to 2 May, 2013. Study selection, data extraction, quality assessment, and data analysis were conducted according to the Cochrane standards. RESULTS: Six randomized clinical trials involving 748 patients (373 patients in the treatment group, 375 patients in the control group) were included in the analysis. The studies were of low methodological quality. Meta-analysis indicated that the effect of Xuefuzhuyu decoction on hyperlipidemia was better than that in the control group [n=748, OR=5.07, 95% CI (3.40, 7.58), P<0.01]. Weighted mean differences in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and high-density lipoprotein cholesterol were - 0.79, - 0.74, - 0.44, 0.16, respectively, and Meta-analysis revealed that the treatment group was better than the control group with 95% CI ( - 1.21, - 0.36), ( - 0.94, - 0.55), ( - 0.77, - 0.11), (0.04, 0.27), respectively (all P<0.05). Some adverse events in evaluated studies were recorded. CONCLUSION: Xuefuzhuyu decoction may be effective for treating hyperlipidemia. The studies we analyzed were of low methodological quality, which indicates that the above findings should be considered cautiously. Therefore, more strictly designed large-scale randomized clinical trials are needed to evaluate the efficacy of Xuefuzhuyu decoction in hyperlipidemia. (C) 2014 JTCM. All rights reserved.