Objective
To determine the efficacy, tolerability and safety of oral rifaximin given at three dose levels in patients with cirrhosis and mild to moderate hepatic encephalopathy (HE).
Design
Prospective, double-blind, randomized, parallel-group study.
Setting
Multi-centre trial in four university teaching hospitals.
Participants
Fifty-four patients with cirrhosis and mild to moderate HE.
Intervention
Seven days treatment with rifaximin, 600, 1200 or 2400 mg/day in three divided doses.
Main outcome measure
Change in the portal-systemic encephalopathy (PSE) index between baseline and day 7, calculated on the basis of mental state, asterixis, number connection test time, EEG mean cycle frequency and blood ammonia concentrations.
Results
Treatment with rifaximin was associated with an improvement in the PSE index. There was a trend towards a greater treatment effect of rifaximin with the highest dose of 2400 mg/day. Rifaximin was well tolerated; the few treatment-related adverse events showed no consistent pattern or dose relationship.
Conclusion
Rifaximin may be useful as alternative or adjuvant therapy for grade I-III hepatic encephalopathy in patients with cirrhosis at a dose of 1200 mg/day.Eur J Gastroenterol Hepatol12:203-208 © 2000 Lippincott Williams & Wilkins
European Journal of Gastroenterology & Hepatology 2000, 12:203-208
