An Open-Label Randomized Controlled Non-Inferiority Trial of Arginine Glutamate Injection for the Treatment of Mild Hepatic Encephalopathy
Hai Bo Zhang , Huai Bin Zou , Yun Yi Gao , Li Wang , Yuan Gao , Ming Kong , Wei Wei Kang , Rui Zhong , Xian Shan Yang , Yan Ren , Li Li Feng , Lu Li , Shuang Li , Zhong Ping Duan , Yu Tao Zhan , Yu Chen
Journal of Digestive Diseases ›› 2025, Vol. 26 ›› Issue (5-6) : 241 -249.
An Open-Label Randomized Controlled Non-Inferiority Trial of Arginine Glutamate Injection for the Treatment of Mild Hepatic Encephalopathy
Objective: To compare the efficacy and safety profile of arginine glutamate and L-ornithine-L-aspartate (LOLA) in treating mild hepatic encephalopathy (HE) and hyperammonemia in cirrhotic patients.
Methods: This single-center, open-label, non-inferiority, randomized controlled trial (RCT) enrolled patients aged 18–75 years with cirrhosis and mild HE. The patients were randomly allocated in the ratio of 1:1 using a randomization table to be treated with intravenous administration of arginine glutamate or LOLA for 7 days. The primary end-point was the clinical improvement of mild HE. Secondary end-points included post-treatment change in blood ammonia level and the time to complete the number connection test (NCT)-A. Adverse events and adverse drug reactions were documented.
Results: From July 2020 to June 2021, 108 cirrhotic patients with mild HE were included and randomized to receive either arginine glutamate or LOLA for 7 days. Clinical improvement was observed in 88.9% of the patients receiving arginine glutamate and 90.7% of those having LOLA (between-group difference −1.9%, 95% confidence interval −13.3% to 9.6%), indicating non-inferiority of arginine glutamate to LOLA. The two groups showed comparable reductions in blood ammonia levels and improvements in time to complete NCT-A. The rate of adverse events was similar between the two groups, with only four cases reported adverse drug reactions.
Conclusions: Both regimens effectively alleviated mild HE symptoms and reduced ammonia levels. Arginine glutamate showed non-inferiority to LOLA in terms of clinical improvement, ammonia reduction, and time to complete NCT-A, with no significant adverse events.
arginine glutamate / hepatic encephalopathy / hyperammonemia / liver cirrhosis / ornithylaspartate
2025 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.
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