A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease

Clin Gastroenterol Hepatol. 2006 May;4(5):639-44. doi: 10.1016/j.cgh.2006.02.004. Epub 2006 Apr 17.


Background & aims: Few controlled studies have addressed the issue of effective medical treatment for nonalcoholic fatty liver disease (NAFLD). We herein assessed the effect of orlistat in patients with NAFLD.

Methods: We performed a randomized, double-blind, placebo-controlled study on 52 patients with NAFLD diagnosed by ultrasound (US) and confirmed by liver biopsy (40 patients). The patients were randomized to receive either orlistat (120 mg 3 times daily for 6 months) or placebo. All patients participated in an identical behavioral weight loss program. All patients underwent monthly evaluation by abdominal US; liver enzyme levels, lipid profiles, insulin levels, and anthropometric parameters were monitored, and all patients underwent nutritional follow-up evaluation. Twenty-two patients underwent a second liver biopsy examination at the end of the study.

Results: Fifty-two patients were recruited and 44 (mean age, 47.7 y; mean body mass index, 33) completed the study. Serum glucose and insulin levels (P<.03) were significantly higher in the orlistat group, which also presented a higher degree of fibrosis. Body mass index was reduced significantly in each group, with a nonsignificant difference between the groups. Serum alanine transaminase (ALT) levels decreased significantly in both groups, with an almost 2-fold reduction in the orlistat group (48% vs 26.4%). There was a statistically significant reversal of fatty liver by US only in the orlistat group (P<.05).

Conclusions: Orlistat improves serum ALT levels and steatosis on US in NAFLD patients, beyond its effect on weight reduction.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Obesity Agents / therapeutic use*
  • Biopsy, Needle
  • Body Mass Index
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Fatty Liver / drug therapy*
  • Fatty Liver / pathology*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunohistochemistry
  • Lactones / therapeutic use*
  • Liver Function Tests
  • Male
  • Middle Aged
  • Orlistat
  • Probability
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Treatment Outcome
  • Ultrasonography, Doppler
  • Weight Loss / drug effects


  • Anti-Obesity Agents
  • Lactones
  • Orlistat