RESUMO
OBJECTIVE: To systematically evaluate the effectiveness of Fuzheng Huayu preparation (/, FZHY) plus tenofovir disoproxil fumarate (TDF) on hepatitis B. METHODS: Numerous databases - PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database, WanFang Database, China Science and Technology Journal Database, and China Biological Medicine Database - were searched to identify the randomized controlled trials published from the inception of the database to November 2021. Two researchers independently conducted literature screening, data extraction, and bias risk assessment. RevMan 5.4 software was used for Meta-analysis. RESULTS: Eight studies involving 990 patients met the inclusion criteria in the current Meta-analysis. Levels of alanine transaminase, aspartate aminotransferase, total bilirubin, hyaluronic acid, type III procollagen, laminin, and type IV collagen after combination therapy were significantly lower than those after TDF therapy alone. However, albumin levels did not differ significantly between the two regimens. Subgroup analysis based on disease progression suggested that the combination therapy improved albumin levels in patients with chronic hepatitis B but not in patients with hepatitis B-related cirrhosis. Moreover, subgroup analysis based on treatment duration suggested that the albumin levels were increased and the type III procollagen levels were decreased with the > 24-week combination therapy but not with the ≤ 24-week combination therapy. CONCLUSIONS: A combination regimen of TDF and FZHY is more effective in treating hepatitis B than TDF alone. The combination therapy can effectively alleviate hepatic fibrosis and improve liver function. However, more standardized, high-quality studies with larger sample sizes are warranted to validate the study results.