Short-term efficacy and safety of l-ornithine l-aspartate therapy in patients with cirrhosis and minimal hepatic encephalopathy: a real-life cohort study

Abstract

Introduction and Objectives: MHE is related to a higher risk of accidents and deterioration in the quality of life; it can be detected with PHES and CFP. There is currently insufficient evidence that treatment with oral LOLA improves performance in PHES and CFP in patients with MHE. This study aimed to verify the response and safety of LOLA treatment in a real-life cohort of patients with MHE. Materials and Methods: Cirrhotic patients in the Hepatology clinic diagnosed with MHE received LOLA 6 grams three times a day for three days and were reassessed with PHES and CFP. The results were analyzed by descriptive statistics, the comparison between parameters by paired t-Student or Wilcoxon test as appropriate, a value of p<0.01 was considered significant. The trial was approved by the research ethics committee, and informed consent was obtained. Results: ninety-eight patients with cirrhosis were evaluated; 38.8% had baseline MHE, 68.4% were women, the mean age of 53.3 years, and the median education was nine years. According to Child-Pugh: 68.4% A, 23.7% B, and 7.9% C. 34 patients were analyzed, the PHES score improved significantly post-treatment (baseline -6.44±1.7 vs -2.79±1.9; p<0.0001), CFP improved (baseline 37±1.8 vs 39.8±2.2; p<0.0001). According to PHES 88.2% and CFP 85.3%, patients showed remission. The incidence rate ratio for persisting with MHE was 4 and 5 per 34 person-times, and the prevented fraction of 0.88 and 0.85 according to PHES and CFP, respectively. No adverse effect was reported. Conclusions: LOLA is effective in improving cognitive performance and reversing very early alterations in PHES and CFP in patients with cirrhosis and MHE. Funding: Donation from LOLA by the volunteer ladies of the Hospital General de México “Dr. Eduardo Liceaga.” Declaration of interest: The authors declare no potential conflicts of interest.