A systematic review and meta-analysis of randomized controlled trials (RCTs) examined the effectiveness and safety of Compound Biejia-Ruangan tablet (CBRT) as an additional modality to Entecavir for the treatment of hepatitis B infection complicated with liver fibrosis.

Databases including the Wangfang, CBM, VIP, CNKI, Embase, Cochrane Library, and PubMed were explored for relevant trials. The major endpoints were biochemical characteristics of type IV collagen, pretype-III collagen, laminin, and serum hyaluronic acid. The total effect rate, the frequency of adverse events, and the liver function indicators of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin levels were the secondary endpoints ascertained. Study selection, extraction of data, and quality evaluation were conducted. Statistical analysis was conducted with RevMan 5.3 software.

Overall, eight RCTs with 747 volunteers were incorporated. CBRT, used as an adjunct to Entecavir, had a more positive impact on serum levels of hyaluronic acid (mean difference [MD] = -28.15), laminin (MD = -29.46), pretype-III collagen (MD = -11.83), and type IV collagen (MD = -19.62); ALT (MD = -16.83), AST (MD = -20.52), and total bilirubin (MD = -7.54); and total effect rate (odds ratio = 3.53). Additionally, CBRT as an additional therapy to Entecavir had a lower incidence rate of adverse events (odds ratio = 0.54) than Entecavir monotherapy.

CBRT, when used as an adjunct to Entecavir, may benefit patients with hepatitis B complicated with liver fibrosis.