title: Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Non-inferiority of rifaximin over lactulose for MHE reversal was not established.
authors.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
authors.forename: Sandeep S
authors.initials: SS
authors.lastname: Sidhu
authors.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
authors.forename: Omesh
authors.initials: O
authors.lastname: Goyal
authors.affiliation: Edinburgh Health Services Research Unit, University of Edinburgh, Edinburgh, UK.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Parker
authors.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
authors.forename: Harsh
authors.initials: H
authors.lastname: Kishore
authors.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
authors.forename: Ajit
authors.initials: A
authors.lastname: Sood
mesh_terms: D000328:Adult; D000368:Aged; D003071:Cognition / Q000187:drug effects; D005260:Female; D006501:Hepatic Encephalopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D006801:Humans; D007194:India; D007792:Lactulose / Q000009:adverse effects / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000150:complications / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D012294:Rifamycins / Q000009:adverse effects / Q000627:therapeutic use*; D000078262:Rifaximin; D018434:Sickness Impact Profile; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D012294:Rifamycins; D007792:Lactulose; D000078262:Rifaximin
keywords: lactulose; minimal hepatic encephalopathy; rifaximin