Comparison of Rifaximin Plus Lactulose with the Lactulose Alone for the Treatment of Hepatic Encephalopathy.

INTRODUCTION: Hepatic encephalopathy is challenging complication of liver dysfunction. Therapeutic treatment options for hepatic encephalopathy are currently limited and have appreciable risks and benefits associated with their use. Rifaximin is a novel anti microbiological agent with wide spectrum of activity that has shown promise as an alternative option for hepatic encephalopathy. AIMS AND OBJECTIVE: The present study was undertaken to compare the effectiveness of Rifaximin and Lactulose as a combination vs Lactulose alone, to compare the adverse effects and to study the rapidity of therapeutic effects of Rifaximin and Lactulose. METHODS: It was a prospective observational study. 60 patients suffering from hepatic encephalopathy (HE) were studied. Patients were investigated and treated as per treating physician's decision. At the time of analysis, patients were divided into 2 groups, Rifaximin group who received Rifaximin+Lactulose (R+L) and Lactulose group(L), who received Lactulose only. Parameters such as mental status grade, Asterixis grade, Serum Ammonia grade, Number Connection Test grade (NCT grade), Hepatic Encephalopathy Index (HE index) were evaluated and compared in both groups. Clinical efficacy was determined using HE index improvement. Primary end points were decrease in HE index and reversal of HE grades. Secondary end points were mortality from HE or any other cause, decrease in mental status grade, asterixis grade, serum Ammonia grade, NCT grade. RESULTS: Out of 60 patients, 32 received Rifaximin+Lactulose combination and 28 patients received Lactulose alone. Mean Child-Turcotte-Pugh score (CTP score) was 10.6 in R+L group and 10.32 in L group. There was statistically significant improvement in mental status grade, Asterixis grade, Serum Ammonia grade, NCT grade, Hepatic encephalopathy index in both groups, p value <0.05 but no statistically significant difference between improvement in mental status grade, Asterixis grade, Serum Ammonia grade, NCT grade, HE index between the two groups. Rifaximin + Lactulose combination was effective in 31 out of 32 i.e.96.87% and Lactulose alone in 24 out of 28 patients, i.e. in 85.71%, which is not statistically different, p=0.3251. DISCUSSION: Rifaximin+ Lactulose combination is not superior to Lactulose alone in treatment of refractory hepatic encephalopathy. Addition of Rifaximin may help in the treatment of refractory hepatic encephalopathy. CONCLUSIONS: Rifaximin + Lactulose combination is effective, but not superior to Lactulose alone in treatment of hepatic encephalopathy.