An Observational Study to Evaluate the Effect of L-ornithine L-aspartate in Patients With Overt Hepatic Encephalopathy Receiving Lactulose and Rifaximin.

BACKGROUND

Hepatic encephalopathy (HE) is one of the most frequent complications and debilitating manifestations of liver disease. The condition ranges from a change in the cognitive status to finally progressing towards confusion, personality alterations, disorientation, lethargy, and coma. Lactulose, rifaximin, oral branched-chain amino acids (BCAA), intravenous L-ornithine L-aspartate (LOLA), and probiotics are used for the treatment.

METHOD: This was a prospective, observational, add-on, parallel-group study with a 12-month duration and a sample size of 53. Patients were divided into two study groups - one group received LOLA along with standard background therapy and the other group received only standard background therapy. The primary outcome measure in this study was the clinical assessment as per West Haven's scoring at the end of one week of treatment. The secondary outcomes were to assess the fasting serum ammonia levels, liver function test (LFT) parameters, psychometric tests, and quality of life using the SF-36 questionnaire. Statistical analysis was performed using GraphPad Prism version 5 software (San Diego, CA: GraphPad Software).

RESULTS

The baseline characteristics between both groups were similar and were non-significant (p>0.05) except for the West Haven criteria. The average age of the participants in the study was 50 years. The mean decrease in West Haven score at the end of one week of treatment in the group receiving LOLA was -1.52, whereas the other group receiving standard background therapy showed a decrease of -1.2 (p=0.0099). The mean decrease in fasting serum ammonia was -13.7 in the group that received LOLA and -11.7 in the other group, but this difference was not statistically significant (p=0.68).

CONCLUSION

In this study, we observed that administering LOLA in conjunction with standard background therapy has significantly improved the grade of HE, as determined by the West Haven scoring system. Fasting serum ammonia levels, LFT parameters, and quality of life as per SF-36 also improved in the group that received LOLA. Thus, the addition of LOLA to the first-line standard therapy was found to be effective and might help in improving the clinical grade of HE.