A double-blind, randomized, placebo-controlled trial of intravenous L-ornithine-L-aspartate on postural control in patients with cirrhosis.
BACKGROUND
Hepatic encephalopathy (HE) is a complication of liver disease. Several treatments have been introduced but only L-ornithine-L-aspartate (LOLA) shows proven efficacy. This double-blind, randomized, placebo-controlled trial evaluated the effect of LOLA on postural control in cirrhotics.


METHODS
Forty patients were randomized to either LOLA or a placebo. HE was evaluated by psychometric testing (PSE Syndrome Test) and critical flicker frequency (CFF). Posturography [equilibrium score (ES)] provided information regarding postural control. Peripheral blood was analysed for ammonia concentration (NH(3)) and the partial pressure of ammonia (pNH(3)).


RESULTS
Both groups were comparable regarding baseline variables. Posturography and PSE Syndrome Test improved in both groups; improvement was greater in the LOLA group (ES: 5.3%; PSE: 1.9) compared with the placebo (ES: 3.9%; PSE: 1.3) but did not reach significance (ES: P=0.3; PSE: P=0.5). CFF remained unchanged during treatment and between groups (P=NS). NH(3) decreased in the LOLA group (Delta: -15 micromol/L) and slightly increased in the placebo group (Delta: 11.1 micromol/L), but the differences did not reach statistical significance (P=0.07). pNH(3) remained largely unchanged (LOLA Delta: -1.2 x 10(-5) mmHg vs. placebo Delta: -0.3 x 10(-5) mmHg; P=0.21).


CONCLUSIONS
In the LOLA group, an improvement of posturographic control and PSE Syndrome Test was observed, but a similar improvement was also achieved by the placebo. In LOLA, ammonia levels tended to decrease while they tended to increase in the placebo group. LOLA might augment the improvement achieved by intravenous fluids alone but a larger cohort will be needed to show this effect with statistical significance.
Schmid
Monika
M
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria. monika.schmid@meduniwien.ac.at
Peck-Radosavljevic
Markus
M
König
Franz
F
Mittermaier
Christian
C
Gangl
Alfred
A
Ferenci
Peter
P
D000368:Aged; D000641:Ammonia / Q000097:blood; D001707:Biopsy, Needle; D004151:Dipeptides / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006501:Hepatic Encephalopathy / Q000150:complications / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000523:psychology; D006801:Humans; D007150:Immunohistochemistry; D007262:Infusions, Intravenous; D008103:Liver Cirrhosis / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D004856:Postural Balance / Q000187:drug effects*; D011594:Psychometrics; D012016:Reference Values; D018570:Risk Assessment; D012678:Sensation Disorders / Q000188:drug therapy* / Q000209:etiology*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
D004151:Dipeptides; D000641:Ammonia; C002939:ornithylaspartate