ObjectiveThere are many clinical reports on traditional Chinese medicine (TCM) combined with nucleoside (acid) analogues (NAs) for the treatment of chronic hepatitis B (CHB), but its efficacy and safety are not completely clear. This meta-analysis aims to evaluate the clinical efficacy and safety thus providing evidence for clinical applications.

MethodsWe searched Chinese databases the China National Knowledge Infrastructure (CNKI), Wanfang Data, and China Science and Technology Journal Database (VIP), as well as English databases PubMed and Cochrane Library, from time of establishment to April 14, 2021. Literature quality was evaluated according to the bias risk assessment criteria of Cochrane Collaboration network. RevMan 5.3 and Stata 12.0 software were used to perform this research.

ResultsA total of 23 articles, 3 282 patients, and 25 TCM prescriptions were included in this study. NAs plus TCM remarkably improved the clinical total effective rate Odds ratio (OR) = 3.92, P < 0.000 01, TCM syndrome score (Mean difference = − 3.73, P < 0.000 01), hepatitis B virus (HBV) DNA negative conversion rate (OR = 1.49, P = 0.000 1), hepatitis Be antigen (HBeAg) negative conversion rate (OR = 2.03, P < 0.000 01), alanine aminotransferase levels Std mean difference (SMD) = − 0.95, P < 0.000 01, and aspartate aminotransferase levels (SMD = − 0.70, P = 0.000 4). Adverse reaction rates did not increase in the combined treatment group (OR = 0.97, P = 0.84). A comprehensive analysis of the 25 TCM prescriptions suggested that the combination of spleen-strengthening prescriptions with NAs showed better effects than other prescriptions.

ConclusionTCM in combination with NAs, demonstrated better clinical efficacy against CHB than NAs alone. In addition, the combination of spleen-strengthening prescriptions and NAs was identified as the best therapeutic strategy. However, more randomized controlled trials of high quality are needed to provide more reliable clinical basis for the application of TCM.