title: Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis.
abstract: Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty-one overweight or obese individuals (body mass index [BMI], 25-40 kg/m(2)) with biopsy-proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group (P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) (P = 0.05). Percent weight reduction correlated significantly with improvement in NAS (r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (>or=7%), compared with those who lost less than 7%, had significant improvements in steatosis (-1.36 versus -0.41, P < 0.001), lobular inflammation (-0.82 versus -0.24, P = 0.03), ballooning injury (-1.27 versus -0.53, P = 0.03) and NAS (-3.45 versus -1.18, P < 0.001).
  
  
  CONCLUSIONS
  Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH.
authors.affiliation: Division of Gastroenterology and Hepatology, The Warren Alpert Medical School of Brown University, Providence, RI 02903, USA. Kittichai_Promrat@Brown.edu
authors.forename: Kittichai
authors.initials: K
authors.lastname: Promrat
authors.forename: David E
authors.initials: DE
authors.lastname: Kleiner
authors.forename: Heather M
authors.initials: HM
authors.lastname: Niemeier
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Jackvony
authors.forename: Marie
authors.initials: M
authors.lastname: Kearns
authors.forename: Jack R
authors.initials: JR
authors.lastname: Wands
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Fava
authors.forename: Rena R
authors.initials: RR
authors.lastname: Wing
mesh_terms: D000328:Adult; D005234:Fatty Liver / Q000178:diet therapy / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008019:Life Style; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications; D015431:Weight Loss