Hepatology research : the official journal of the Japan Society of Hepatology · 2013
Oral l-ornithine-l-aspartate in minimal hepatic encephalopathy: A randomized, double-blind, placebo-controlled trial.
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Alvares-da-Silva Mario Reis, de Araujo Alexandre, Vicenzi João Reinhardt, da Silva Gabriel Veber, Oliveira Fabiana Bazanella, Schacher Fernando, Oliboni Lucas, Magnus Aline, Kruel Leticia Pinto, Prieb Rita, Fernandes Luiz Nelson Teixeira
Аннотация
AIM: Evaluate efficacy/safety of oral l-ornithine-l-aspartate (LOLA) in controlling minimal hepatic encephalopathy (MHE).
METHODS: Consecutive cirrhotic outpatients with MHE (defined by psychometric number connection tests A/B [NCT-A/B] and digit symbol substitution test [DSST] score of >2 standard deviations) were randomized to a 60-day oral LOLA (5 g t.i.d) or placebo group. Critical flicker frequency test (CFF), quantitative electroencephalogram (qEEG), arterial ammonia (NH3), Beck's anxiety-depression forms and liver disease quality of life (LD-QOL) were assessed. Patients were followed for 6 months after the end of the study to assess LOLA prophylactic role on overt hepatic encephalopathy (OHE).
RESULTS: Sixty-four patients were included, 63 (98.4%) with MHE. In six of these patients, CFT was less than 39 Hz (9.52%); NH3 was increased in 32 (50.8%); 25% had abnormal qEEG. Age, sex, scholarship, Child-Pugh (CP), Model for End-Stage Liver Disease, 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 psychometric battery, CFF, LD-QOL and Beck's forms. No serious adverse effects occurred. Patients taking LOLA had less episodes of OHE at 6 months (5% vs 37.9%, P = 0.016), as they have significant improvement on liver function assessed by CP (P < 0.001).
CONCLUSION: A 60-day oral LOLA course was not better than placebo in treating MHE, but was useful in preventing further episodes of OHE.
METHODS: Consecutive cirrhotic outpatients with MHE (defined by psychometric number connection tests A/B [NCT-A/B] and digit symbol substitution test [DSST] score of >2 standard deviations) were randomized to a 60-day oral LOLA (5 g t.i.d) or placebo group. Critical flicker frequency test (CFF), quantitative electroencephalogram (qEEG), arterial ammonia (NH3), Beck's anxiety-depression forms and liver disease quality of life (LD-QOL) were assessed. Patients were followed for 6 months after the end of the study to assess LOLA prophylactic role on overt hepatic encephalopathy (OHE).
RESULTS: Sixty-four patients were included, 63 (98.4%) with MHE. In six of these patients, CFT was less than 39 Hz (9.52%); NH3 was increased in 32 (50.8%); 25% had abnormal qEEG. Age, sex, scholarship, Child-Pugh (CP), Model for End-Stage Liver Disease, 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 psychometric battery, CFF, LD-QOL and Beck's forms. No serious adverse effects occurred. Patients taking LOLA had less episodes of OHE at 6 months (5% vs 37.9%, P = 0.016), as they have significant improvement on liver function assessed by CP (P < 0.001).
CONCLUSION: A 60-day oral LOLA course was not better than placebo in treating MHE, but was useful in preventing further episodes of OHE.