title: Rifaximin improves psychometric performance and health-related quality of life in patients with minimal hepatic encephalopathy (the RIME Trial).
abstract: OBJECTIVE
  Cirrhotics with minimal hepatic encephalopathy (MHE) have a poor health-related quality of life (HRQOL). Treatment of MHE is still evolving. The aim of this double-blind randomized pilot study was to assess the efficacy of rifaximin in improving neuropsychometric (NP) test performance and HRQOL in patients with MHE.
  
  
  METHODS
  MHE was diagnosed if any two NP tests (number and figure connection tests, picture completion, digit symbol, and block design tests) were deranged beyond 2 s.d. of normal. HRQOL was assessed using the sickness impact profile (SIP) questionnaire.
  
  
  RESULTS
  A total of 486 patients with cirrhosis were screened and 284 were found eligible. Out of these 115 (40.9%) had MHE, of which 21 refused consent and 94 were randomized to receive placebo (n=45) and rifaximin (n=49; 1200 mg/day) for 8 weeks. At the end of treatment, significantly more number of patients in rifaximin group showed reversal of MHE (75.5% (37/49) vs. 20% (9/45) in placebo group; P<0.0001). Rifaximin group also showed significant reduction in mean number of abnormal NP tests (baseline, 2.35 (95% confidence interval (CI), 2.17-2.53); 2 weeks, 1.29 (95% CI, 1.02-1.56), P=0.002; 8 weeks, 0.81 (95% CI, 0.61-1.02), P=0.000), compared with placebo group (baseline, 2.31 (95% CI, 2.03-2.59); 2 weeks, 2.03 (95% CI, 1.74-2.31); 8 weeks, 1.97 (95% CI, 1.69-2.25), P>0.05). The mean total SIP score also improved significantly in rifaximin group (baseline, 11.67 (95% CI, 10.31-13.03); 8 weeks, 6.45 (95% CI, 5.59-7.30); P=0.000) compared with placebo group (baseline, 9.86 (95% CI, 8.66-11.06); 8 weeks, 8.51 (95% CI, 7.35-9.67); P=0.82). Improvement in HRQOL correlated with improvement in NP tests. Rifaximin was well tolerated.
  
  
  CONCLUSIONS
  Rifaximin significantly improves both cognitive functions and HRQOL in patients with MHE.
authors.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India. sandeep_sidhu97@rediffmail.com
authors.forename: Sandeep Singh
authors.initials: SS
authors.lastname: Sidhu
authors.forename: Omesh
authors.initials: O
authors.lastname: Goyal
authors.forename: Bholeshwar Prashad
authors.initials: BP
authors.lastname: Mishra
authors.forename: Ajit
authors.initials: A
authors.lastname: Sood
authors.forename: Rajoo Singh
authors.initials: RS
authors.lastname: Chhina
authors.forename: Ravinder Kumar
authors.initials: RK
authors.lastname: Soni
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006501:Hepatic Encephalopathy / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010919:Placebos; D011594:Psychometrics; D011788:Quality of Life; D012294:Rifamycins / Q000627:therapeutic use*; D000078262:Rifaximin; D018434:Sickness Impact Profile; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D010919:Placebos; D012294:Rifamycins; D000078262:Rifaximin