OBJECTIVE: To determine the efficacy of L-ornithine-L-aspartate in treatment of hepatic encephalopathy. STUDY DESIGN: Randomized, placebo-controlled trial. PLACE AND DURATION OF STUDY: Department of Gastroenterology and Hepatology, Sheikh Zayed Hospital, Lahore, from February to August 2005. METHODOLOGY:Cirrhotic patients with hyperammonemia and overt hepatic encephalopathy were enrolled. Eighty patients were randomized to two treatment groups, L-ornithine-L-aspartate (20 g/d) or placebo, both dissolved in 250 mL of 5% dextrose water and infused intravenously for four hours a day for five consecutive days with 0.5 g/kg dietary protein intake at the end of daily treatment period. Outcome variables were postprandial blood ammonia and mental state grade. Adverse reactions and mortality were also determined. RESULTS: Both treatment groups were comparable regarding age, gender, etiology of cirrhosis, Child-Pugh class, mental state grade and blood ammonia at baseline. Although, improvement occurred in both groups, there was a greater improvement in L-ornithine-L-aspartate group with regard to both variables. Four patients in the placebo group and 2 in L-ornithine-L-aspartate group died. CONCLUSION:L-ornithine-L-aspartate infusions were found to be effective in cirrhotic patients with hepatic encephalopathy.
RCT Entities:
OBJECTIVE: To determine the efficacy of L-ornithine-L-aspartate in treatment of hepatic encephalopathy. STUDY DESIGN: Randomized, placebo-controlled trial. PLACE AND DURATION OF STUDY: Department of Gastroenterology and Hepatology, Sheikh Zayed Hospital, Lahore, from February to August 2005. METHODOLOGY: Cirrhotic patients with hyperammonemia and overt hepatic encephalopathy were enrolled. Eighty patients were randomized to two treatment groups, L-ornithine-L-aspartate (20 g/d) or placebo, both dissolved in 250 mL of 5% dextrose water and infused intravenously for four hours a day for five consecutive days with 0.5 g/kg dietary protein intake at the end of daily treatment period. Outcome variables were postprandial blood ammonia and mental state grade. Adverse reactions and mortality were also determined. RESULTS: Both treatment groups were comparable regarding age, gender, etiology of cirrhosis, Child-Pugh class, mental state grade and blood ammonia at baseline. Although, improvement occurred in both groups, there was a greater improvement in L-ornithine-L-aspartate group with regard to both variables. Four patients in the placebo group and 2 in L-ornithine-L-aspartate group died. CONCLUSION:L-ornithine-L-aspartate infusions were found to be effective in cirrhotic patients with hepatic encephalopathy.
Authors: Ee Teng Goh; Caroline S Stokes; Sandeep S Sidhu; Hendrik Vilstrup; Lise Lotte Gluud; Marsha Y Morgan Journal: Cochrane Database Syst Rev Date: 2018-05-15