Efficacy and Safety of Yanggan Jian in Hepatitis B Virusrelated Decompensated Cirrhosis:A Randomized,Doubleblind,Controlled Trial

Background and Aims:The aim was to evaluate the efficacy and safety of Yanggan Jian(YGJ)in HBV-infected patients with decompensated cirrhosis.Methods:This randomized,double-blind controlled trial enrolled 160 patients with HBV-related decompensated cirrhosis who were already receiving or about to start antiviral therapy.Patients were randomly assigned to receive YGJ or placebo for 24 weeks,and were followed-up to 36 weeks.The primary outcome was the proportion of patients with a≥2 point reduction in Child-Turcotte-Pugh(CTP)score from baseline at week 24.Secondary outcomes were CTP class and score,serum liver function indices,mortality,incidence of hepatocellular carcinoma and variceal bleeding.Results:The proportion of patients with a CTP score reduction≥2 was significantly greater in the YGJ than in the placebo group(p=0.009);the percentage of patients with CTP class C was significantly less than that in the placebo group(p<0.05),and the YGJ group had a significantly greater mean change from baseline in CTP score at week 24(p=0.034).The improvement in measured values and change from baseline of prothrombin time,serum albumin,platelets,cholinesterase,international normalized ratio,and activated partial thromboplastin time were significantly better with YGJ than with placebo.Between-group differences in cumulative rates of variceal bleeding,hepatocellular carcinoma,death,or the frequency of any adverse event(AE),AEs related to treatment,or discontinuation because of AEs were not significant.Conclusions:YGJ significantly improved CTP scores and hepatic synthetic and reserve function in patients with HBV-related decompensated cirrhosis,and was safe and well tolerated.