Weight reduction and ursodeoxycholic acid in subjects with nonalcoholic fatty liver disease. A double-blind, placebo-controlled trial.

OBJECTIVE Nonalcoholic fatty liver disease is an increasingly recognized condition that may progress to end-stage liver disease. We investigated the effects of weight reduction and ursodeoxycholic acid administration in patients with this disease. RESEARCH METHODS AND PROCEDURES A double-blind, placebo-controlled trial. Twenty-seven women with a body mass index of >30 kg/m2 and willing to participate in the diet plan for six weeks were studied were assigned to one of two treatment groups (ursodeoxycholic acid, n = 14: placebo n = 13). Both groups received a normal diet (1,200 kcal/d) plus 1200 mg/d of ursodeoxycholic acid or placebo. Hepatic steatosis, was assessed by abdominal ultrasound. Fasting glucose, cholesterol, triglycerides, and aminotransferases levels were determined before and after treatment. RESULTS Body mass index decreases significantly from 34.2 +/- 4.2 kg/m2 and 33.3 +/- 1.6 kg/m2 to 31.8 +/- 4.5 kg/m2 and 30.6 +/- 2.6 kg/m2 in the ursodeoxycholic acid and placebo groups, p < 0.001. The hepatic steatosis index decreased from 2.3 +/- 0.7 to 1.0 +/- 0.6 and 2.2 +/- 0.7 to 1.1 +/- 0.7 in the ursodeoxycholic acid and placebo groups, p<0.003. Serum AST decreased significantly from 41.2 +/- 5.6 to 34.5 +/- 3.4 in the ursodeoxycholic acid group, p <0.001, and from 43.6 +/- 4.2 to 35.3 +/- 2.9 in the placebo group, p <0.001. Serum ALT decreased from 62.9 +/- 6.5 to 44.0 +/- 3.5 in the ursodeoxycholic acid group, p <0.001, and from 63.5 +/- 4.5 to 44.0 +/- 3.5 in the placebo group. We did not find any differences in all variables studied between groups. CONCLUSIONS The present study shows beneficial effect of weight reduction, producing improvements in biochemical and imaging markers of liver disease.