A double-blind, randomized, placebo-controlled trial of intravenous l-ornithine-l-aspartate on postural control in patients with cirrhosis
| Autor: | Christian Mittermaier, Monika Schmid, Alfred Gangl, Franz König, Peter Ferenci, Markus Peck-Radosavljevic |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Liver Cirrhosis
Male medicine.medical_specialty Cirrhosis Psychometrics Placebo-controlled study Pilot Projects Placebo Risk Assessment Severity of Illness Index Gastroenterology Drug Administration Schedule Statistics Nonparametric law.invention Double-Blind Method Liver Function Tests Randomized controlled trial Ammonia Reference Values law Statistical significance Internal medicine medicine Humans Infusions Intravenous Postural Balance Hepatic encephalopathy Aged Dose-Response Relationship Drug Hepatology medicine.diagnostic_test business.industry Biopsy Needle Posturography Dipeptides Middle Aged medicine.disease Immunohistochemistry Surgery Survival Rate Treatment Outcome Hepatic Encephalopathy Sensation Disorders Female business Liver function tests Follow-Up Studies |
| Zdroj: | Liver International. 30:574-582 |
| ISSN: | 1478-3231 1478-3223 |
| Popis: | Introduction 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). Conclusion 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. |
| Databáze: | OpenAIRE |
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