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Randomised clinical trial: rifaximin improves health-related quality of life in cirrhotic patients with hepatic encephalopathy- a double-blind placebo-controlled study
Alimentary Pharmacology and Therapeutics, 08/18/2011
Clinical Article
Sanyal A et al. – Rifaximin significantly improved health–related quality of life(HRQL) in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy.
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.
- Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded.
- 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.
- 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).