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Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy
Author(s) -
Sidhu Sandeep S.,
Goyal Omesh,
Parker Richard A.,
Kishore Harsh,
Sood Ajit
Publication year - 2016
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12921
Subject(s) - rifaximin , lactulose , medicine , hepatic encephalopathy , flatulence , confidence interval , randomized controlled trial , gastroenterology , population , quality of life (healthcare) , cirrhosis , nursing , environmental health , microbiology and biotechnology , biology , antibiotics
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.