TY  - JOUR
T1  - Entecavir plus Fuzheng Huayu Compound Reduces the Risk of Portal Hypertension-related Complications in Patients with Compensated Hepatitis B Virus-related Cirrhosis: A Post Hoc Analysis Based on Two Randomized Controlled Trials 
AU  - Guo, Yanan
AU  - Du, Li
AU  - Xie, Qing
AU  - Liu, Chuan
AU  - Xing, Lianjun
AU  - Jiang, Wei
AU  - Chen, Bitao
AU  - Zhu, Ying
AU  - Chen, Xiaorong
AU  - Wang, Jing
AU  - Qi, Xiaolong
AU  - Lv, Jing
AU  - Liu, Chenghai
JF  - Journal of Translational Gastroenterology
VL  - 
IS  - 000
SN  - 2994-8754
SP  - 
EP  - 
Y1  - 2026-09-30
DO  - 10.14218/JTG.2026.00019
UR  - https://www.xiahepublishing.com/2994-8754/JTG-2026-00019
AB  - Background and objectives 
Fuzheng Huayu, a patent herbal product, has shown promise in liver fibrosis and cirrhosis. The effect of Fuzheng Huayu on portal hypertension due to cirrhosis and the consequent complications needs further investigation. In this study, we aimed to evaluate the association of adjunctive Fuzheng Huayu plus entecavir with liver-related events and variceal regression in patients with compensated HBV-related cirrhosis.
Methods
A post hoc analysis was conducted using data from two randomized controlled trials implemented at eight clinical centers in China (ClinicalTrials.gov numbers: NCT02945982; NCT02945956). Patients with compensated hepatitis B virus-related cirrhosis were enrolled from October 2017 to March 2021. The primary endpoint was a composite of liver events and the individual components, including variceal bleeding, ascites, overt hepatic encephalopathy, and hepatocellular carcinoma.
Results
A total of 218 participants (Fuzheng Huayu group: 110 and control group: 108; mean age, 51.5 years; 66.5% male; median observational follow-up time, 23.1 months) were included in the primary analysis. The occurrence of total liver events was less frequent in the Fuzheng Huayu group than in the control group (hazard ratio = 0.408 [0.187–0.892], P = 0.020). Among the individual components of liver events, the incidence of ascites was significantly lower in the Fuzheng Huayu group than in the control group (1.8% vs. 9.3%, P = 0.016). In addition, the rate of variceal regression was significantly higher in the Fuzheng Huayu group (27.3% vs. 10.2%, P < 0.001). Finally, there were no significant differences in the occurrence of adverse events between the two groups.
Conclusions
In this post hoc analysis of two randomized controlled trials, adjunctive Fuzheng Huayu plus entecavir was associated with fewer liver-related events, particularly ascites, and a higher rate of variceal regression than entecavir alone in patients with compensated hepatitis B virus-related cirrhosis. These findings warrant confirmation in adequately powered prospective studies.