Abstract

BACKGROUND & AIMS: Patients with cirrhosis and minimal hepatic encephalopathy (MHE) have driving difficulties but the effects of therapy on driving performance have not been assessed. We evaluated whether performance on a driving simulator improves in patients with MHE following treatment with rifaximin.

METHODS: Patients with MHE who were current drivers were randomly assigned to placebo or rifaximin groups and followed for 8 weeks (n=42). Patients underwent driving simulation (driving and navigation tasks) at the start (baseline) and end of the study. We evaluated patients' cognitive abilities, quality-of-life (using the Sickness Impact Profile [SIP]), serum levels of ammonia, levels of inflammatory cytokines, and MELD scores. The primary outcome was percent who improved in driving performance, calculated by: total driving errors=speeding + illegal turns + collisions.

RESULTS: Over the 8-week study period, patients given rifaximin made significantly greater improvements than those given placebo in avoiding total driving errors (76% vs. 31%, P=0.013), speeding (81% vs. 33%, P=0.005), and illegal turns (62% vs. 19%, P=0.01). Of patients given rifaximin, 91% improved their cognitive performance, compared with 61% of patients given placebo (P=0.01); they also made improvements in the psycho-social dimension of the SIP, compared with the placebo group (P=0.04). Adherence to the assigned drug averaged 92%. Neither group had changes in ammonia levels or MELD scores, but patients in the rifaximin group had increased levels of the anti-inflammatory cytokine interleukin-10.

CONCLUSIONS: Patients with MHE significantly improve driving simulator performance following treatment with rifaximin, compared with placebo.