Original Contribution | Published: 23 July 2013

Liver

A Randomized, Double-Blind, Controlled Trial

Comparing Rifaximin Plus Lactulose With Lactulose
Alone in Treatment of Overt Hepatic
Encephalopathy
Barjesh Chander Sharma MD, DM , Praveen Sharma MD, DM, Manish Kumar Lunia MD, Siddharth Srivastava MD, DM, Rohit
Goyal MD, DM & S K Sarin MD, DM

The American Journal of Gastroenterology 108, 1458–1463 (2013) | Download Citation

Abstract

OBJECTIVES:
Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used
in the treatment of HE are primarily directed at the reduction of the blood ammonia
levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the
efficacy and safety of rifaximin plus lactulose vs. lactulose alone for treatment of overt
HE.

METHODS:
In this prospective double-blind randomized controlled trial, 120 patients with overt HE
were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63)
and group B (lactulose (n=57) plus placebo). The primary end point was complete
reversal of HE and the secondary end points were mortality and hospital stay.

RESULTS:
A total of 120 patients (mean age 39.4±9.6 years; male/female ratio 89:31) were included
in the study. 37 (30.8%) patients were in Child–Turcotte–Pugh (CTP) class B and 83
(69.2%) were in CTP class C. Mean CTP score was 9.7±2.8 and the MELD (model for end-
stage liver disease) score was 24.6±4.2. At the time of admission, 22 patients (18.3%) had
grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%)
in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004).
 There was a significant decrease in mortality after treatment with lactulose plus
rifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly
more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas
there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4,
P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS).
Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8±3.4 vs.
8.2±4.6 days, P=0.001).

CONCLUSION:
Combination of lactulose plus rifaximin is more effective than lactulose alone in the
treatment of overt HE.

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The American Journal of Gastroenterology ISSN 1572-0241 (online)

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