Objective To assess the effectiveness and safety of fukangpian in the treatment of opiate withdrawl symptoms. Methods We performed an electronic search for Cochrane Library (2004 version of Cochrane Controlled Trials Register), Medline (1966-2004), EMbase (1974-2004), and handsearched some Chinese journals for additional articles (such as CBM disc, VIP, CNKI, CMCC) (1980-2004). The quality of included randomized controlled trials was evaluated and meta-analysis was performed. Results We collected 31 studies about fukangpian, of which two studies involving 403 patients met the inclusion criteria. These two studies were of poor quality. Cmpared with clonidine, fukangpian showed a greater decrease than Clonidine group in the withdrawal symptom score for day 1 to day 4 (WMD of 9 points at day 4, 95%CI 5.47 to 12.52). Cmpared with placebo, the two studies for change in the withdrawal symptom score, fukangpian showed a greater decrease at day 1 to 3, but not at day 4 (WMD of 4.10 points at day 4, 95%CI -8.36 to 16.56; 1 study). Conclusions Based on the current evidence fukangpian is an effective and safe drug for abstinence of drug addiction. More high quality randomized controlled trials are required to promote the strength of evidence.