title: Intragastric balloon significantly improves nonalcoholic fatty liver disease activity score in obese patients with nonalcoholic steatohepatitis: a pilot study.
abstract: BACKGROUND
  There is no satisfactory treatment for nonalcoholic steatohepatitis (NASH). The Bioenterics intragastric balloon (BIB) can be an effective treatment for weight reduction in obese patients.
  
  
  OBJECTIVE
  We evaluated the efficacy of the BIB in improving the histology of NASH in obese patients.
  
  
  METHODS
  Randomized, controlled study.
  
  
  METHODS
  University hospital.
  
  
  METHODS
  Obese patients with body mass indexes (BMI) ≥27 kg/m(2) and who had histologic evidence of NASH were recruited.
  
  
  METHODS
  Patients were randomly assigned to a step 1 American Heart Association (AHA) diet plus exercise and BIB placement or step 1 AHA diet plus exercise and sham BIB placement for a period of 6 months.
  
  
  METHODS
  Liver histology was the primary outcome measure recorded before and after treatment.
  
  
  RESULTS
  A total of 18 patients completed the study. Baseline characteristics of the BIB and sham groups were similar. At 6 months, a significant reduction in the mean BMI was seen in the BIB group (1.52 vs 0.8; P = .0008). The median nonalcoholic fatty liver disease activity scores at the end of treatment were significantly lower in the BIB-treated compared with the sham-treated groups (2 [0.75] vs 4 [2.25]; P = .03). There was a trend toward improvement in the median steatosis scores (1 [0.75] vs 1 [1]; P = .075). There was no change in the median loblular inflammation, hepatocellular ballooning, or fibrosis scores in both groups after treatment.
  
  
  CONCLUSIONS
  Pilot study with small numbers and short duration.
  
  
  CONCLUSIONS
  Results from this pilot study demonstrated that addition of BIB for 6 months provided a greater loss of BMI and improvement in 2 of 5 histologic parameters of nonalcoholic fatty liver disease. A longer study with larger numbers will be required to prove whether or not the therapy is meaningful in the treatment of NASH.
authors: Department of Gastroenterology/Hepatology, National University Health System Singapore, Singapore.
authors: Yin-Mei
authors: YM
authors: Lee
authors: How Cheng
authors: HC
authors: Low
authors: Lee Guan
authors: LG
authors: Lim
authors: Yock Young
authors: YY
authors: Dan
authors: Myat Oo
authors: MO
authors: Aung
authors: Chee Leong
authors: CL
authors: Cheng
authors: Aileen
authors: A
authors: Wee
authors: Seng Gee
authors: SG
authors: Lim
authors: Khek Yu
authors: KY
authors: Ho
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D003131:Combined Modality Therapy; D004035:Diet Therapy; D016099:Endoscopy, Gastrointestinal; D005081:Exercise Therapy; D005234:Fatty Liver / Q000473:pathology / Q000628:therapy*; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D008099:Liver / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease; D009765:Obesity / Q000150:complications*; D010865:Pilot Projects; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D015431:Weight Loss