Randomised clinical trial: rifaximin improves health-related quality of life in cirrhotic patients with hepatic encephalopathy - a double-blind placebo-controlled study

Abstract

Background: Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life.

Aim: To evaluate the effect of rifaximin on health-related quality of life (HRQL) in cirrhotic patients with HE.

Methods: Patients with cirrhosis in remission from HE (Conn score = 0 or 1) and a documented history of recurrent HE episodes (≥2 within 6 months of screening) were randomised to rifaximin 550 mg twice daily (N = 101) or placebo (N = 118) for 6 months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time-weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment.

Results: The time-weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P-values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P-values were <0.0001).

Conclusion: Rifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy.

Trial registration: ClinicalTrials.gov NCT00298038.

© 2011 Blackwell Publishing Ltd.