Objective To assess the effectiveness and safety of Shenfutuodu capsule in the treatment of opioid withdrawal syndrome. Methods We searched The Cochrane Library (Issue 1 , 2005 ) , MEDLINE (1966 -2005) , EMBASE (1974-2005) , and some Chinese databases for additional articles (CBMdisc, CMCC, VIP, CNKI ) (1980-2005 ). The quality of included randomized controlled trials was evaluated and meta-analysis was performed.Results Our initial search identified just three studies involving 293 patients met the inclusion criteria and were of higher quality. There was a statistical difference between Shenfutuodu capsule and clonidine groups on the fifth day in withdrawl symptom score with weight mean difference (WMD) -3.14 and 95% confidence interval (CI) -6.28 to -0.01. And no statistical difference was detected between the two groups in withdrawal symptom score on the 0th-4th day and the 6th-10th daywith WMD 58.45(95% CI 53.88 to 63.02), -1. 15 (95% CI -5.69 to 3.40) , -0.42(95% CI -4.55 to 3.70), -0.77(95%CI -4.37 to 2. 84), -1.54(95%CI -4.78 to 1.69), -1.76(95%CI -4.25 to0.74) , -1.74(95%CI -3.89 to0.41), -1.24(95%CI -3.28 to0.80), -0.52(95%CI -1.96 to0.92 ) and -0.27(95% CI -1.64 to 1.11 ) respectively. There was no statistical difference on effectiveness between the two groups on the third day with WMD 1.52, (95% CI 0.79 to 2.95). There was no statistical difference between the two groups in HAMA score on the first , fifth and tenth day with WMD -0.55(95% CI -3.74 to 2.64) , 0.34 (95% CI -2.02 to 2.70) , 0. 63 (95% CI -0.21 to 1.47 ) respectively. There was a statistical difference between the two groups in dizziness rate with RR 0.73 (95% CI 0.62 to 0.87 ) . No statistical difference was detected between the two groups in dry mouth with RR 1.11(95% CI 0.95 to 1.29) , somnolence with RR 0.99(95% CI 0.82 to 1.21) , and blurred vision with RR 0.92(95% CI 0.70 to 1.19). Statistical difference was detected between the two groups in side effect score on the second day with WMD -1.26 (95% CI -2.40 to -0. 12 ). No statistical difference was detected between the two groups in side effect score on the first day, the third to tenth day with WMD -0.55 ( 95% CI -1.48 to0.38), -0.63 (95%CI -1.67 to0.42), -0.84 (95%CI -1.77 to0.09), -0.29 (95%CI -1.09 to 0.51), 0.15 (95% CI -0.52 to 0.81), 0. 22 (95% CI -0.22 to 0.67), 0.09(95% CI -0.25 to 0.44), 0.03 (95% CI -0.21 to 0.27) , -0.03 (95% CI -0.33 to 0.26) respectively. Conclusions Based on the current evidence, Shenfutuodu capsule may be an effective and safe drug or abstinence of drug addiction. More well designed randomized controlled trials are required .