Prospective, single-center, randomized, controlled, open-label study

Liver cirrhotic patients with CHE aged between 18-70 years

Diagnosis of CHE by both psychometric hepatic encephalopathy score (PHES) and Stroop test

A total of 40 patients were randomized to low-dose rifaximin 800 mg/day (400mg, bid) (n=12), high-dose rifaximin 1,200 mg/day (600mg, bid) (n=14), and control groups (n=14), and treated for 8 weeks

Reversal of CHE at 4 and 8 weeks

Improvement in health-related quality of life (HRQOL) assessed by sickness impact profile (SIP) scale at 8 weeks

Changes in PHES and Stroop test at 4 and 8 weeks

Incidence of adverse events (AEs)

The baseline clinical and demographic characteristics were similar among the 3 groups.

There were no significant differences in proportion of patients with CHE reversal at 4 weeks.

However, at 8 weeks, the percentage of patients with CHE reversal was significantly higher in both the low-dose and high-dose groups than in the control group as seen in Figure 1.

The improvement in the total SIP score was significant in both the rifaximin groups as compared to control group.

There were no significant differences in the CHE reversal rate, total SIP score improvement, and incidence of adverse event between the low-dose and high-dose groups (p>0.05).

The PHES mZ-score was remarkably higher in the high-dose rifaximin group than control at 8 weeks; p=0.017

Low-dose and high-dose rifaximin groups had significantly higher changes in PHES mZ score (4.92+4.32 vs 1.36+3.32, p=0.021: 4.71+3.65 vs 1.36+3.32, p=0.023 respectively)

Changes in the Stroop test scores were not significant at both the timepoints.

The efficacy and safety of low-dose rifaximin 800 mg/day was equivalent to that of high-dose 1200 mg/day in terms of covert hepatic encephalopathy reversal and improvement in health-related quality-of-life in cirrhotic patients after 8 weeks of treatment.