Abstract | BACKGROUND/AIMS: In the current state of knowledge of the pathophysiology of hepatic encephalopathy, a reduction in hyperammonemia is the most important evidence of effective treatment. Therefore, the therapeutic efficacy of oral L-ornithine-L-aspartate, which improves impaired ammonia detoxification, was investigated in patients with cirrhosis, hyperammonemia and stable, overt, chronic hepatic encephalopathy, and in subclinical hepatic encephalopathy in a randomized, double-blind, placebo-controlled clinical trial. METHODS: Oral L-ornithine-L-aspartate was administered three times daily at fixed times for 14 consecutive days in a total dose of 18 g per day. The design was chosen to prevent an increase in ammonia induced by a protein meal of 0.25 g/kg body weight, given at the start of the daily treatment period. Efficacy variables were: fasting and postprandial ammonia concentration, Number-Connection-Test time, mental state grades, and a Portosystemic Encephalopathy Index. Analyses were based on the total study sample of 32 placebo- and 34 L-ornithine-L-aspartate-treated patients as well as on the subgroup samples in the overt (20 placebo- and 23 L-ornithine-L-aspartate-treated) and subclinical hepatic encephalopathy (12 placebo- and 11 L-ornithine-L-aspartate-treated) patients. RESULTS: Number Connection Test performance times (p<0.01) as well as fasting (p<0.01) and postprandial (p<0.05) venous blood ammonia concentrations in the L-ornithine-L-aspartate-treated group showed improvement in comparison to placebo. Also, the mental state grade (p<0.05) and the Portosystemic Encephalopathy Index (p<0.01), improved to a much greater degree in the L-ornithine-L-aspartate group than in the placebo group. Adverse events were observed in neither the placebo nor the L-ornithine-L-aspartate-treated patients. CONCLUSION:
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Authors | S Stauch, G Kircheis, G Adler, K Beckh, H Ditschuneit, R Görtelmeyer, R Hendricks, A Heuser, C Karoff, P Malfertheiner, D Mayer, W Rösch, J Steffens |
Journal | Journal of hepatology
(J Hepatol)
Vol. 28
Issue 5
Pg. 856-64
(May 1998)
ISSN: 0168-8278 [Print] Netherlands |
PMID | 9625322
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Dietary Proteins
- Dipeptides
- Placebos
- Ammonia
- ornithylaspartate
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Topics |
- Administration, Oral
- Adult
- Ammonia
(blood)
- Dietary Proteins
- Dipeptides
(administration & dosage, therapeutic use)
- Double-Blind Method
- Female
- Hepatic Encephalopathy
(blood, drug therapy, psychology)
- Humans
- Male
- Mental Status Schedule
- Middle Aged
- Neuropsychological Tests
- Placebos
- Postprandial Period
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