Incidence and risk factors for non-alcoholic steatohepatitis: prospective study of 5408 women enrolled in Italian tamoxifen chemoprevention trial.

ABSTRACT:

Objective

To assess the incidence, cofactors, and excess risk of development of non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, attributable to tamoxifen in women.

Design

Prospective, randomised, double blind, placebo controlled trial.

Setting and participants

5408 healthy women who had had hysterectomies, recruited into the Italian tamoxifen chemoprevention trial from 58 centres in Italy.

Intervention

Women were randomly assigned to receive tamoxifen (20 mg daily) or placebo for five years.

Main outcome measure

Development of non-alcoholic fatty liver disease in all women with normal baseline liver function who showed at least two elevations of alanine aminotransferase (> or = 1.5 times upper limit of normal) over a six month

SUBMITTER: Bruno S 

PROVIDER: S-EPMC556336 | biostudies-literature | 2005 Apr

REPOSITORIES: biostudies-literature