- 2025-05
- Journal of digestive diseases 26(5-6)
- 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
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- 108 cirrhotic patients with mild HE
- Methods
- single-center, open-label, non-inferiority, randomized controlled trial (RCT), intravenous administration of arginine glutamate or LOLA for 7 days
- Blinding
- Open-label
- Duration
- 7 days
- Funding
- Unclear
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.