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A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease.
Am J Gastroenterol. 2005 May; 100(5):1082-90.AJ

Abstract

OBJECTIVES

Metformin proved useful in the treatment of nonalcoholic fatty liver disease (NAFLD), but its superiority over nutritional treatment and antioxidants has never been demonstrated. We aimed to compare the usefulness of metformin versus prescriptive diet or vitamin E.

METHODS

In an open label, randomized trial, nondiabetic NAFLD patients were given metformin (2 g/day; n = 55) for 12 months. The control cases were given either vitamin E (800 IU/day; n = 28) or were treated by a prescriptive, weight-reducing diet (n = 27). Outcome measures were liver enzymes, insulin resistance (homeostasis model assessment), parameters of the metabolic syndrome, and histology.

RESULTS

Aminotransferase levels improved in all groups, in association with weight loss. The effects in the metformin arm were larger (p < 0.0001), and alanine aminotransferase normalized in 56% of cases (odds ratio (OR) versus. controls, 3.11; 95% confidence interval (CI), 1.56-6.20; p= 0.0013). In multivariate analysis, metformin treatment was associated with higher rates of aminotransferase normalization, after correction for age, gender, basal aminotransferases, and change in body mass index (OR, 5.98; 95% CI, 2.05-17.45). Differences were maintained when the two control groups were separately analyzed. The distribution of positive criteria for the metabolic syndrome was reduced only in the metformin arm (p= 0.001, signed rank test). A control biopsy in 17 metformin-treated cases (14 nonresponders) showed a significant decrease in liver fat (p= 0.0004), necroinflammation, and fibrosis (p= 0.012 for both). No side effects were observed during metformin treatment.

CONCLUSIONS

Metformin treatment is better than a prescriptive diet or vitamin E in the therapy of NAFLD patients receiving nutritional counseling. Limited histological data support an association between improved aminotransferases and biopsy findings, which require confirmation in a double-blind trial with appropriate statistical power based on liver histology.

Authors+Show Affiliations

Department of Gastroenterology, University of Turin, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15842582

Citation

Bugianesi, Elisabetta, et al. "A Randomized Controlled Trial of Metformin Versus Vitamin E or Prescriptive Diet in Nonalcoholic Fatty Liver Disease." The American Journal of Gastroenterology, vol. 100, no. 5, 2005, pp. 1082-90.
Bugianesi E, Gentilcore E, Manini R, et al. A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease. Am J Gastroenterol. 2005;100(5):1082-90.
Bugianesi, E., Gentilcore, E., Manini, R., Natale, S., Vanni, E., Villanova, N., David, E., Rizzetto, M., & Marchesini, G. (2005). A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease. The American Journal of Gastroenterology, 100(5), 1082-90.
Bugianesi E, et al. A Randomized Controlled Trial of Metformin Versus Vitamin E or Prescriptive Diet in Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2005;100(5):1082-90. PubMed PMID: 15842582.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease. AU - Bugianesi,Elisabetta, AU - Gentilcore,Elena, AU - Manini,Rita, AU - Natale,Stefania, AU - Vanni,Ester, AU - Villanova,Nicola, AU - David,Ezio, AU - Rizzetto,Mario, AU - Marchesini,Giulio, PY - 2005/4/22/pubmed PY - 2005/6/2/medline PY - 2005/4/22/entrez SP - 1082 EP - 90 JF - The American journal of gastroenterology JO - Am J Gastroenterol VL - 100 IS - 5 N2 - OBJECTIVES: Metformin proved useful in the treatment of nonalcoholic fatty liver disease (NAFLD), but its superiority over nutritional treatment and antioxidants has never been demonstrated. We aimed to compare the usefulness of metformin versus prescriptive diet or vitamin E. METHODS: In an open label, randomized trial, nondiabetic NAFLD patients were given metformin (2 g/day; n = 55) for 12 months. The control cases were given either vitamin E (800 IU/day; n = 28) or were treated by a prescriptive, weight-reducing diet (n = 27). Outcome measures were liver enzymes, insulin resistance (homeostasis model assessment), parameters of the metabolic syndrome, and histology. RESULTS: Aminotransferase levels improved in all groups, in association with weight loss. The effects in the metformin arm were larger (p < 0.0001), and alanine aminotransferase normalized in 56% of cases (odds ratio (OR) versus. controls, 3.11; 95% confidence interval (CI), 1.56-6.20; p= 0.0013). In multivariate analysis, metformin treatment was associated with higher rates of aminotransferase normalization, after correction for age, gender, basal aminotransferases, and change in body mass index (OR, 5.98; 95% CI, 2.05-17.45). Differences were maintained when the two control groups were separately analyzed. The distribution of positive criteria for the metabolic syndrome was reduced only in the metformin arm (p= 0.001, signed rank test). A control biopsy in 17 metformin-treated cases (14 nonresponders) showed a significant decrease in liver fat (p= 0.0004), necroinflammation, and fibrosis (p= 0.012 for both). No side effects were observed during metformin treatment. CONCLUSIONS: Metformin treatment is better than a prescriptive diet or vitamin E in the therapy of NAFLD patients receiving nutritional counseling. Limited histological data support an association between improved aminotransferases and biopsy findings, which require confirmation in a double-blind trial with appropriate statistical power based on liver histology. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/15842582/A_randomized_controlled_trial_of_metformin_versus_vitamin_E_or_prescriptive_diet_in_nonalcoholic_fatty_liver_disease_ L2 - https://Insights.ovid.com/pubmed?pmid=15842582 DB - PRIME DP - Unbound Medicine ER -