Objective To assess the efficacy and safety of Xuezhikang capsule (XZK) for hyperlipidemia. Methods MEDIINE，EMBASE, Cochrane Central Register of Controlled Trials(CCTR), Cochrane Metabolic and Endocrine Disorders Group data bank, and Chinese Biomedical Database(CBM), China Hospital Knowledge Database(CHKD) were searched，and the published/unpublished information was handsearched (updated to Dec., 2005) to identify randomized controlled trials (RCTs) or quasi-RCT of XZK versus statins or other lipid lowering drugs in treating hyperlipidemia patients. The quality evaluation, data extraction and analysis were conducted by the method recommended in Cochrane Reviewer’s Handbook 4.2.2. Data were analyzed using Review Manager (Version 4.2). Results Eleven trials (conducted in China) were identified, including 1 073 patients with hyperlipidemia met the inclusion criteria. All the included RCTs were graded as B or C. ① The effect of XZK in reducing TC: There were no significant differences between XZK and statins ( WMD 0.06, 95%CI-0.09 to 0.20 and RR1.02, 95%CI 0.93 to 1.12), XZK and fibrates (WMD 0.05, 95%CI -0.22 to 0.31) and XZK and probucol(WMD 0.42, 95%CI -0.01 to 0.85). XZK was superior to hexanicit (WMD 0.96, 95%CI 0.73 to 1.18). ② The effect of XZK in reducing TG: XZK had the same effect as statins (WMD 0.02, 95%CI -0.10 to 0.14 and RR 1.17, 95%CI 0.92 to 1.49) and hexanicit (WMD 0.28, 95%CI -0.17 to 0.73 ).Meanwhile, XZK was superior to probucol (WMD 0.71, 95%CI 0.22 to 1.20), but it was not as good as fibrates (WMD -0.81, 95%CI -1.40 to -0.23). ③ The effect of XZK in increasing HDL-C：XZK had the same effect as that of statins (WMD -0.03, 95%CI -0.10 to 0.04 and RR 1.03, 95% CI 0.80 to 1.33). The effect of XZK was better than that of hexanicit (WMD 0.15, 95%CI 0.01 to 0.29). XZK had the same effect of fibrates (WMD 0.03, 95%CI -0.08 to 0.15) and probucol (WMD 0.04, 95%CI -0.16 to 0.24). ④ The effect of XZK in reducing LDL-C：The effects of XZK and statins were the same (WMD -0.23, 95%CI -0.61 to 0.15 and RR 1.15, 95%CI 0.75 to 1.77). The effect of XZK was better than that of hexanicit (WMD 0.53, 95%CI 0.16 to 0.90). Meanwhile, XZK had the same effect as those of fibrates (WMD 0.19, 95%CI -0.12 to 0.50) and probucol (WMD 0.35, 95%CI -0.03 to 0.73). ⑤ The adverse reactions of XZK were mainly the gastrointestinal tract reaction, while liver function abnormality and myalgia were scarcely found. Conclusion Xuezhikang capsule have the same effects as those of statins in reducing the levels of TC, TG, LDL-C and raising HDL-C in patients with hyperlipidemia. No obvious adverse reactions are found during the short-term treatment. But further confirmation with clinical randomized controlled trials of high quality, large sample and long-term follow-up is needed.