title: Efficacy of estriol in inhibiting epithelial proliferation in mammary fibroadenoma: randomized clinical trial.
abstract: 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, following administration of oral contraceptive with or without estriol.
  
  
  METHODS
  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 same capsule for four consecutive cycles with a seven-day interval between them. The other 23 patients (group 2) took the same 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 group 1 and 10.86 and 17.03 for group 2, respectively. There was a tendency towards higher expression of antigens in group 2.
  
  
  CONCLUSIONS
  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 expression among users of oral contraceptives containing estriol.
authors.affiliation: Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil. rodrigoestevao@terra.com.br
authors.forename: Rodrigo Augusto Fernandes
authors.initials: RA
authors.lastname: Estevão
authors.forename: Edmund Chada
authors.initials: EC
authors.lastname: Baracat
authors.forename: Angela Flávia
authors.initials: AF
authors.lastname: Logullo
authors.forename: Celina Tizuko Fujiyama
authors.initials: CT
authors.lastname: Oshima
authors.forename: Afonso Celso Pinto
authors.initials: AC
authors.lastname: Nazário
mesh_terms: D000328:Adult; D001706:Biopsy; D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology*; D049109:Cell Proliferation / Q000187:drug effects; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004847:Epithelial Cells / Q000187:drug effects*; D004964:Estriol / Q000009:adverse effects / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000009:adverse effects; D005260:Female; D018226:Fibroadenoma / Q000378:metabolism / Q000473:pathology*; D016259:Genes, myc / Q000502:physiology; D006801:Humans; D007150:Immunohistochemistry; D019394:Ki-67 Antigen / Q000032:analysis* / Q000378:metabolism; D016912:Levonorgestrel / Q000009:adverse effects; D042361:Mammary Glands, Human / Q000187:drug effects; D018809:Proliferating Cell Nuclear Antigen / Q000378:metabolism; D013194:Staining and Labeling; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D019394:Ki-67 Antigen; D018809:Proliferating Cell Nuclear Antigen; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; D004964:Estriol