Efficacy of estriol in inhibiting epithelial proliferation in mammary fibroadenoma: Randomized clinical trial

Abstract

Context and Objective: Mammary fibroadenoma is a disease that affects a large number of women of reproductive age. The aim of this study was to evaluate the proliferative activity of mammary fibroadenoma through expression of Ki-67 and c-myc antigens, followinq administration of oral contraceptive with or without estriol. Desing and Setting: Placebo-controlled double-blind randomized clinical trial in the Mastology Sector of the Department of Gynecology, Universidade Federal de São Paulo. Methods: Thirty-three fibroadenoma patients were studied, Ten women (group 1) took an oral contraceptive constituted by levonorgestrel and ethinyl estradiol together with placebo manufactured in the some capsule for four consecutive cycles with a seven-day interval between them. The other 23 patients (group 2) took the some oral contraceptive together with estriol, which was put into the same capsule and used in the same way as among the group 1 patients. After four cycles, the nodules were surgically removed and sent for immunohistochemical analysis of Ki-67 and c-myc expression. Results: The Ki-67 and c-myc analysis did not reveal any significant differences between the study groups. The values were 9.16 and 10.54 for, gmup 1 and 10.86 and 17.03 for group 2, respectively. There was a tendency towards higher expresion of antigens in group 2. Conclusion: Our results showed that there was no Significant statistical difference in Ki-67 and c-myc expression between our study groups, but only a tendency towards higher express on among users, of oral contraceptives containing estriol. Copyright © 2007, Associação Paulista de Medicina.