The efficacy and safety of cinobufacini injection on chronic hepatitis B were evaluated. The cochrane central register of controlled trials (CCTR), PubMed, CBM, CNKI, VIP databases up to Dec. 2012 was searched. The methodol. quality assessment and data extraction of the including studies were conducted by two reviewers independently according to the inclusion and exclusion criteria. Meta-analyses were performed for homogeneous studies using RevMan 4.2.10 software. A total of 17 studies involving 1 635 patients met the inclusion criteria. None of the studies enforced allocation concealment and performed blinding. Cinobufacini injection might be effective in normalizing alanine aminotr ansferase (ALT) levels, clearing hepatitis B virus (HBV) DNA, achieving virus seroconversion and improving hepatic fibrosis, without any serious adverse effects. However, the overall combination effect anal. could not be conducted, because the including studies were performed in small sample with low-quality. More evidence is needed to support this anal.