Evaluation of the efficacy and safety of rifaximin in the treatment of hepatic encephalopathy: a double-blind, randomized, dose-finding multi-centre study.

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.