Rifaximin versus metronidazole in management of acute episode of hepatic encephalopathy: An open labeled randomized clinical trial

Abstract

Background and study aims: Many regimens are tried in managing overt hepatic encephalopathy (HE). We investigated the efficacy of rifaximin versus metronidazole in management of an acute episode of HE on top of cirrhosis.

Patients and methods: An open label prospective controlled trial was conducted on patients with an acute episode of HE on top of cirrhosis who were randomly divided into metronidazole-group (M-group) and rifaximin-group (R-group) with 60 patients in each. The main outcome measure was the clinical improvement of HE, duration of hospital stay and the changes in the level of serum ammonia after 3 days of starting therapy.

Results: Both M-group and R-group were comparable as regards age and sex (mean age 51 ± 11 years and 49 ± 12; male/female ratio 45:15 and 50:10, respectively). Forty-six patients (76.7%) in M-group compared with forty-five (75%) in R-group showed clinical improvement (p = 0.412). Hospital stays were comparable between both group; 4.2 ± 2.1 and 3.9 ± 1.7 for M-group and R-group; respectively (p = 0.435). There was no significant difference of venous ammonia levels (Mean of delta 160.77 ± 185.34 µg/dL and 207.95 ± 218.43 µg/dL with p 0.664 and 0.974 in M-group and R-group, respectively). No adverse events were reported throughout the whole study.

Conclusion: Rifaximin and metronidazole are equally effective in management of acute episode of overt HE, therefore, re-auditing of treatment protocols of HE are warranted especially in limited resource settings.

Keywords: Ammonia; Hepatic encephalopathy; Metronidazole; Rifaximin.