(Gastroenterology 2011;140:478-487) Cirrhotic patients with minimal hepatic encephaloopathy (MHE) have increased risk of driving offenses and poor insight into their driving skills. This was a randomized, double-blind, placebo controlled trial with aims to study the effect of rifaximin (550 BID) in driving performance using a driving simulator.
Forty-two patients were randomized; median MELD score was 9; none had a history of overt hepatic encephalopathy; all had a minimental status exam score above 25. They were followed for 8 weeks. Primary outcome was the percentage of patients who improved in driving performance.
Results were dramatically in favor of rifaximin use. Total driving errors, speeding tickets and illegal turns all decreased (while collisions did not). Cognitive battery testing improved (p=0.01). There was no improvement in MELD score. There was an improvement in psychosocial dimensions but no physical improvement. The anti-inflammatory marker IL-10 was increased.
This is simply a proof of concept study; duration of follow up was short, the numbers were small, and conditions highly controlled. It is unknown whether the positive gains would become insignificant over time. Since no adverse events required hospitalizations, ER visits or antibiotics, rifaximin is a safe proposition. I think the indications for its use will multiply as more research is published.
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