Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy.

Abstract

BACKGROUND & AIMS:

Lactulose and rifaximin have already been shown to improve both cognitive functions and health related quality of life (HRQOL) in MHE patients. We aimed to compare the efficacy of rifaximin with lactulose in reversal of MHE and improvement in HRQOL in cirrhotic patients with MHE.

METHOD:

This prospective, randomized, open label, non-inferiority trial, was conducted at the Gastroenterology department of a tertiary care institute in Northern India. MHE was diagnosed if any two of the five neuro-psychometric (NP) tests were positive. HRQOL was assessed using the sickness impact profile (SIP) questionnaire (John Hopkins University, USA).

RESULTS:

Of 527 cirrhotics screened, 351 were found eligible and tested for MHE. A total of 112 (31.9%) patients were found to have MHE and then randomized into two groups group A (lactulose; 30-120 ml/day) and B (Tablet. rifaximin; 400 mg thrice a day). Based on the intention-to-treat population, the proportion of patients with MHE reversal at 3 months was 73.7% (42/57) in the rifaximin arm and 69.1% (38/55) in the lactulose arm [4.6% difference (90% CI -9.3% to 18.4%)]. However, non-inferiority of rifaximin over lactulose could not be established as the pre-specified non-inferiority margin (-5%) lies within the two-sided 90% confidence interval of the difference. HRQOL was significantly improved in both groups (P = 0.20). However, the proportion of patients with flatulence (P = 0.004) and diarrhoea (P = 0.0002) was significantly higher in patients who took lactulose.

CONCLUSION:

Non-inferiority of rifaximin over lactulose for MHE reversal was not established.

• Authors: Sandeep S Sidhu, Omesh Goyal, Richard A Parker, Harsh Kishore, Ajit Sood
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 36 Issue 3 Pg. 378-85 (Mar 2016) ISSN: 1478-3231 [Electronic] United States
• PMID: 26201713 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Rifamycins
• Lactulose
• Rifaximin

Topics

• Adult
• Aged
• Cognition (drug effects)
• Female
• Hepatic Encephalopathy (diagnosis, drug therapy, etiology, psychology)
• Humans
• India
• Lactulose (adverse effects, therapeutic use)
• Liver Cirrhosis (complications, diagnosis)
• Male
• Middle Aged
• Neuropsychological Tests
• Prospective Studies
• Psychometrics
• Quality of Life
• Rifamycins (adverse effects, therapeutic use)
• Rifaximin
• Sickness Impact Profile
• Time Factors
• Treatment Outcome