Efficacy of Lactulose Vs Lactulose with Rifaxamin in patients with Hepatic Encephalopathy: A Randomized Control Trial

Abstract

Introduction: Hepatic encephalopathy (HE) is one of the deadliest complications of cirrhosis. The basic underlying pathophysiology is the increased production of ammonia which can cross the blood brain barrier and can influence in multiple ways. For managing HE various therapeutic regime have been tried in the past with varying degree of success grate and side effect profiles. Neomycin, Enema, Lactulose, Metronidazole, Vancomycin, Rifaxamin etc. are the various modalities used. Lactulose is the most widely used and Rifaxamin; an antibiotic is recently used with good success rate.

Objective: To compare the outcome of lactulose alone versus lactulose with Rifaxamin in cases with hepatic encephalopathy.

Methodology: A randomized control trial was conducted on indoor patients of medical departments, Mayo Hospital. Lahore from June 2017 to December 2017. The cases of hepatic encephalopathy of any grade within last 7 days of its onset with age range of 20-60 years were included. The cases with end stage cardiac or renal failure were excluded. The cases were divided into two groups; A and B. The group A was treated with lactulose alone in a dose to 20 to 100 ml per day to maintain stool frequency of at least 2 per day and the group B was treated with same amount of lactulose along with Rifaxamin in a dose of 550 mg thrice a day. The efficacy was assessed daily till there were no signs and symptoms of hepatic encephalopathy till day 7 where final outcome was seen to label efficacy or mortality as Yes or No.

Results: In the present study, 100 cases of hepatic encephalopathy were included. Out of these 50 were in each group.  The maximum cases were in Child Pugh class in both groups comprising 26 (52%) and 25 (50%) in group A and B respectively. The mean age at presentation was 46.73± 9.13 years in A as compared to 51.25± 9.04 years in group B with p= 0.54. The efficacy in group A was seen in 28 (56%) of cases and in group B as 38 (76%) of cases with p= 0.01. This difference was also statistically significant in terms of mortality which was seen I n 22 (44%) of cases in group A and 12 (24%) in group B (p=0.01).

Conclusion: Combination of lactulose plus Rifaxamin is significantly better as compared to lactulose alone for the treatment as well as to reduce mortality in cases of hepatic encephalopathy.

Key words: Lactulose, Rifaxamin, Cirrhosis, Encephalopathy