A RANDOMIZED TRIPLE BLIND, PLACEBO- CONTROLLED TRIAL TO DETERMINE EFFECTIVENESS OF RIFAXIMIN IN PREVENTING HEPATIC ENCEPHALOPATHY IN PATIENTS WITH CHRONIC LIVER DISEASE

Objective: To study the effectiveness of using rifaximin for prevention of recurrent hepatic encephalopathy (HE) attacks in patients with chronic liver disease (CLD). Methods: This study was conducted at the hepatology department of Mayo Hospital, Lahore, during October 2014 to April 2015 by following randomized, triple blind, placebo-controlled trial. Total 126 patients of CLD, who during remission from hepatic encephalopathy were prescribed rifaximin 550mg, two times a day for six months or placebo was advised twice daily for six months. Patients were advised to either take drug from 6 months or till onset of hepatic encephalopathy episode. These prescriptions were advised after randomly dividing patients into two groups consisting of 63 each. Results: The participants had mean age group 40.2 ± 2.3 years and 42.8 ± 4.5 years in test group and control group, respectively. Hepatitis C was found to be more common cause of cirrhosis as compared to hepatitis B. Forty out of 63 patients remained free from hepatic encephalopathy in test group while 35 patients did not suffer HE in control group during study period. Those who suffered HE had MELD scoring from 21 to 25 in both groups. There were similar adverse reactions and deaths in both groups. Conclusion: Rifaximin has no effective role in preventing hepatic encephalopathy as compared to placebo. Key Words: Hepatic encephalopathy, rifaximin, cirrhosis, placebo, chronic liver disease, recurrence.