Efficacy of Rifaximin in prevention of recurrence of hepatic encephalopathy in patients with cirrhosis of liver.

OBJECTIVE: To determine the efficacy of Rifaximin in prevention of repeated episodes of hepatic encephalopathy in patients with liver cirrhosis as compared to placebo.

STUDY DESIGN: Triple-blind, randomized placebo-controlled trial.

PLACE AND DURATION OF STUDY: Department of Gastroenterology-Hepatology, Shaikh Zayed Hospital, Lahore, from October 2012 to April 2013.

METHODOLOGY: Patients in remission from recurrent hepatic encephalopathy resulting from cirrhosis were randomly assigned to receive either Rifaximin, at a dose of 550 mg twice daily (63 patients), or placebo (63 patients.) Patients were requested to take the drug orally twice daily for 6 months or until they developed a breakthrough episode of hepatic encephalopathy.

RESULTS: Mean age of patients in treatment and control group was 40.21 ± 2.33 years and 42.87 ± 4.54 years respectively. The most common etiology of cirrhosis was hepatitis C followed by hepatitis B. Patients who remained free of hepatic encephalopathy during study period were 40 out of 63 patients in control group and 35 patients out of 63 patients (p = 0.56). Most of the patients who developed breakthrough hepatic encephalopathy had a MELD score range of 21-25 in both groups. The number of deaths and adverse events was similar in both groups.

CONCLUSION: Over a 6-month period, treatment with Rifaximin failed to maintain remission from hepatic encephalopathy more effectively than placebo in the studied group.