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Treatment options for nonalcoholic fatty liver disease

a double-blinded randomized placebo-controlled trial

Anushiravani, Amira; Haddadi, Niloufarb; Pourfarmanbar, Maedehb; Mohammadkarimi, Vahidc

European Journal of Gastroenterology & Hepatology: May 2019 - Volume 31 - Issue 5 - p 613–617
doi: 10.1097/MEG.0000000000001369
Original Articles: Hepatology

Introduction Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and is becoming the most frequent indication of liver transplantation. Cardiovascular disease is the main cause of death in these patients. There is no Food and Drug Association-approved medication for NAFLD patients. We aimed to provide more robust evidence on the use of medications that are inexpensive and available, namely, metformin, silymarin, pioglitazone, and vitamin E, for treating NAFLD.

Materials and methods We conducted a randomized double-blinded, placebo-controlled trial on 150 consecutive patients with NAFLD who were assigned to five groups: lifestyle plus placebo, metformin 500 mg/day, silymarin 140 mg/day, pioglithasone 15 mg/day, and vitamin E 400 IU/day, all for 3 months. Anthropometric and biochemical variables were measured at baseline and 3 months later.

Results The mean age of the patients was 47.0±9.1 (range: 18–65) years and the sex distribution was 73 (48.7%) women and 77 (51.3%) men. Patients in all groups showed a significant improvement in anthropometric parameters such as waist circumference and BMI. There was no statistically significant difference in alanine transaminase and aspartate transaminase in the control group after treatment (P=0.51, 0.18, respectively); however, both liver enzymes decreased significantly in the other groups.

Discussion and conclusion This randomized double-blinded placebo-controlled clinical trial suggested a significant benefit of silymarin, pioglitazone, and vitamin E in improving liver aminotransferases in patients with NAFLD after only 3 months, without exerting any specific side effects.

aDigestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran

bDepartment of Internal Medicine, International Brach of Shiraz University of Medical Sciences

cDepartment of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Correspondence to Vahid Mohammadkarimi, MD, Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz 7187914678, Iran Tel: +98 917 704 3855; fax: +98 713 647 4316; e-mail:

Received December 8, 2018

Accepted January 10, 2019

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