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. Design Randomized, controlled study. Setting University hospital. Patients Obese patients with body mass indexes (BMI) ≥27 kg/m2 and who had histologic evidence of NASH were recruited. Intervention 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. Main Outcome Measurements 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. Limitations Pilot study with small numbers and short duration. Conclusion 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.
