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Oral L-ornithine-L-aspartate therapy of chronic hepatic encephalopathy: results of a placebo-controlled double-blind study.

AbstractBACKGROUND/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:
Oral L-ornithine-L-aspartate is a safe, well-tolerated treatment with a good compliance rate and a beneficial therapeutic effect in patients with cirrhosis and stable, overt, chronic hepatic encephalopathy.
AuthorsS 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
JournalJournal of hepatology (J Hepatol) Vol. 28 Issue 5 Pg. 856-64 (May 1998) ISSN: 0168-8278 [Print] DENMARK
PMID9625322 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
Chemical References
  • Dietary Proteins
  • Dipeptides
  • Placebos
  • Ammonia
  • ornithylaspartate
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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