Double-Blind Randomized Placebo-Controlled Trial of Orlistat or the Treatment of Nonalcoholic Fatty Liver Disease HIRA ZELBER–SAGI,* ADA KESSLER, ELI BRAZOWSKY, MURIEL WEBB,* YOAV LURIE,* OSHE SANTO,* MOSHE LESHNO,* LAURENCE BLENDIS,* ZAMIR HALPERN,* and RAN OREN*

f ackground & Aims: Few controlled studies have adressed the issue of effective medical treatment for onalcoholic fatty liver disease (NAFLD). We herein asessed the effect of orlistat in patients with NAFLD. ethods: We performed a randomized, double-blind, lacebo-controlled study on 52 patients with NAFLD iagnosed by ultrasound (US) and confirmed by liver iopsy (40 patients). The patients were randomized to eceive either orlistat (120 mg 3 times daily for 6 onths) or placebo. All patients participated in an idenical behavioral weight loss program. All patients underent monthly evaluation by abdominal US; liver enzyme evels, lipid profiles, insulin levels, and anthropometric arameters were monitored, and all patients underwent utritional follow-up evaluation. Twenty-two patients unerwent a second liver biopsy examination at the end of he study. Results: Fifty-two patients were recruited and 4 (mean age, 47.7 y; mean body mass index, 33) ompleted the study. Serum glucose and insulin levels P < .03) were significantly higher in the orlistat group, hich also presented a higher degree of fibrosis. Body ass index was reduced significantly in each group, with nonsignificant difference between the groups. Serum lanine transaminase (ALT) levels decreased signifiantly in both groups, with an almost 2-fold reduction in he orlistat group (48% vs 26.4%). There was a statistially significant reversal of fatty liver by US only in the rlistat group (P < .05). Conclusions: Orlistat improves erum ALT levels and steatosis on US in NAFLD patients, eyond its effect on weight reduction.