School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Division of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Minimal hepatic encephalopathy (MHE) is common in cirrhotic. Its optimal treatment is still under investigation.
To assess efficacy/safety of oral l-ornithine-l-aspartate (LOLA) in controlling MHE.
Consecutive cirrhotic outpatients with MHE - psychometric tests (PHES) - NCT-A/B and DSST> 2 standard deviation, were randomized to 60-day oral LOLA (5g t.i.d) or placebo. Critical Flicker test (CFF), quantitative EEG (qEEG), arterial ammonia (NH3), Beck's anxiety-depression forms and LD-QOL were assessed. Patients were followed by 6 months after the end of the study to assess LOLA prophylactic role on overt hepatic encephalopathy (OHE).
64 patients were included - 63 (98.4%) with MHE. In 6/63 CFF was <39Hz (9.52%); NH3 was increased in 32 (50.8%); 25% had abnormal qEEG. Age, sex, scholarship, Child-Pugh (CP), MELD, NCT-A/B, DSST, CFF and NH3 were similar in both groups at the baseline. LOLA led to a significant improvement in NCT-B age-controlled z-score (3.4 ± 3.4 vs. 1.5 ± 2.3 - P=0.01) and CFF (42.2 ± 5.8 vs. 45.2 ± 5.8 - P=0.02), comparing the first and the last visit, but there were no differences between LOLA and placebo regarding the whole PHES battery, CFF, LD-QOL and Beck's forms. No serious adverse effects occurred. Patients taking LOLA had fewer episodes of OHE at 6-month (5% vs. 37.9% - P=0.016), as they have significant improvement on liver function assessed by CP (P<0.001).
A 60-day oral LOLA course was not better than placebo on treating MHE, but was useful on preventing further episodes of OHE. Clinical Trials (NCT-00896831).