OBJECTIVES: To determine the efficacy of L-carnitine in reducing hyperammonaemia and improving neuropsychological performance in patients with hepatic cirrhosis and subclinical hepatic encephalopathy (SHE). DESIGN: Randomised, parallel group, controlled trial. PATIENTS AND METHODS: The study enrolled 31 patients with hepatic cirrhosis resulting from hepatitis C and/or hepatitis B, alcohol abuse and other causes. Patients randomised to active treatment, received oral L-carnitine 6 g/day in two divided doses for 4 weeks. Diagnosis of SHE was based on psychometric tests (subtests of the Wechsler Adult Intelligence Scale-Revised and the Halstead-Reitan Neuropsychological Test Battery) carried out at beginning and end of study. Serum ammonia levels were measured before treatment and weekly thereafter. RESULTS: A total of 27 patients completed the study. Sixteen patients received L-carnitine and 11 served as controls (no treatment). L-carnitine caused rapid and significant reductions in ammonia levels, sustained over the 4-week treatment period (mean reductions 60.1 and 1.4 (μmol/L in the treated and control groups, respectively). Normal ammonia levels were attained in 14 of 16 patients receiving L-carnitine. Based on psychometric test results, seven patients (43.7%) in the L-carnitine group and five (45.5%) in the control group had SHE at baseline. L-carnitine treatment for 4 weeks caused a net overall improvement in psychometric test results compared with controls. No clinically significant adverse events were reported and all patients receiving L-carnitine reported subjective improvements in their condition. CONCLUSIONS: RESULTS of this preliminary study indicate that L-carnitine reduces hyperammonaemia and improves the clinical symptoms of SHE in patients with hepatic cirrhosis.
RCT Entities:
OBJECTIVES: To determine the efficacy of L-carnitine in reducing hyperammonaemia and improving neuropsychological performance in patients with hepatic cirrhosis and subclinical hepatic encephalopathy (SHE). DESIGN: Randomised, parallel group, controlled trial. PATIENTS AND METHODS: The study enrolled 31 patients with hepatic cirrhosis resulting from hepatitis C and/or hepatitis B, alcohol abuse and other causes. Patients randomised to active treatment, received oral L-carnitine 6 g/day in two divided doses for 4 weeks. Diagnosis of SHE was based on psychometric tests (subtests of the Wechsler Adult Intelligence Scale-Revised and the Halstead-Reitan Neuropsychological Test Battery) carried out at beginning and end of study. Serum ammonia levels were measured before treatment and weekly thereafter. RESULTS: A total of 27 patients completed the study. Sixteen patients received L-carnitine and 11 served as controls (no treatment). L-carnitine caused rapid and significant reductions in ammonia levels, sustained over the 4-week treatment period (mean reductions 60.1 and 1.4 (μmol/L in the treated and control groups, respectively). Normal ammonia levels were attained in 14 of 16 patients receiving L-carnitine. Based on psychometric test results, seven patients (43.7%) in the L-carnitine group and five (45.5%) in the control group had SHE at baseline. L-carnitine treatment for 4 weeks caused a net overall improvement in psychometric test results compared with controls. No clinically significant adverse events were reported and all patients receiving L-carnitine reported subjective improvements in their condition. CONCLUSIONS: RESULTS of this preliminary study indicate that L-carnitine reduces hyperammonaemia and improves the clinical symptoms of SHE in patients with hepatic cirrhosis.