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.

• Authors: A Sanyal, Z M Younossi, N M Bass, K D Mullen, F Poordad, R S Brown, R P Vemuru, M Mazen Jamal, S Huang, K Merchant, E Bortey, W P Forbes
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 34 Issue 8 Pg. 853-61 (Oct 2011) ISSN: 1365-2036 [Electronic] England
• PMID: 21848797 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2011 Blackwell Publishing Ltd.

Chemical References

• Gastrointestinal Agents
• Rifamycins
• Rifaximin

Topics

• Aged
• Canada
• Double-Blind Method
• Female
• Gastrointestinal Agents (therapeutic use)
• Hepatic Encephalopathy (drug therapy, physiopathology)
• Humans
• Linear Models
• Liver Cirrhosis (drug therapy, physiopathology)
• Male
• Middle Aged
• Quality of Life
• Rifamycins (therapeutic use)
• Rifaximin
• Severity of Illness Index
• Surveys and Questionnaires
• Treatment Outcome
• United States