A randomized, double-blind, controlled trial comparing rifaximin plus lactulose
with lactulose alone in treatment of overt hepatic encephalopathy.
Author(s): Sharma BC(1), Sharma P, Lunia MK, Srivastava S, Goyal R, Sarin SK.
Affiliation(s): Author information:
(1)Department of Gastroenterology, GB Pant Hospital, New Delhi, India.
drbcsharma@hotmail.com
Publication date & source: 2013, Am J Gastroenterol. , 108(9):1458-63
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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