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Objective: To investigate the clinical efficacy and safety of the Ganning formula (肝 宁 方) for the treatment of liver fibrosis in patients with chronic hepatitis B.Methods: In a multicenter,randomized,controlled clinical trial,150 patients with liver fibrosis secondary to hepatitis B virus (HBV) infection were randomly assigned in equal numbers to receive either the Ganning formula (a Chinese herbal decoction; active treatment group) or oral entecavir (control group) for two 3-month courses.Patients were monitored for any treatment-induced changes in liver function test parameters (ALT,AST,and GGT),liver fibrosis markers (LN,HA,(Ⅳ)-C,and PC(Ⅲ)),HBV DNA level,hepatosplenic imaging,quality of life scores,or psychological and social functioning scores.Patients were also observed for any adverse effects.Results: After treatment,patients in both groups experienced significant improvements in liver function,HBV DNA load,hepatosplenic B-mode ultrasonography,quality of life,and psychological and social functioning (P＜0.05 or P＜0.01).Patients receiving the Ganning formula achieved greater improvements in HA,(Ⅳ)-C,quality of life,and psychological and social functioning compared with those on entecavir (P＜0.05 or P＜0.01).There were no abnormal changes in blood tests,urine,feces,renal function,or electrocardiogram.Additionally,no adverse effects were observed in any patients in either group.Conclusions: The Ganning formula appears to have the potential to inhibit liver fibrosis and therefore improve liver function by inhibiting HBV replication in patients with chronic hepatitis B.Additionally,this formula is helpful in improving quality of life and psychological and social functioning.