A pilot study of hormone replacement therapy with tibolone in women with mastopathic breasts

Citation
C. Egarter et al., A pilot study of hormone replacement therapy with tibolone in women with mastopathic breasts, MATURITAS, 40(2), 2001, pp. 165-171
Citations number
14
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Reproductive Medicine","Medical Research General Topics
Journal title
MATURITAS
ISSN journal
0378-5122 → ACNP
Volume
40
Issue
2
Year of publication
2001
Pages
165 - 171
Database
ISI
SICI code
0378-5122(20011130)40:2<165:APSOHR>2.0.ZU;2-1
Abstract
Objective: Our purpose was to investigate the effect of tibolone in a prosp ective randomized, double-blind pilot study in postmenopausal women with cl inically palpable mastopathic changes. Methods: Twenty postmenopausal non-u sers of hormone replacement therapy undergoing mammography were randomly al located to receive either 2.5 mg tibolone (Livial (R), Organon) or placebo (2 mg lactose). Mammographic density according to the Wolfe classification, severity of breast discomfort, parity, smoking habits, body weight and fol licle-stimulating hormone (FSH) and estradiol (E-2) levels were documented at baseline and after 6 months of treatment. Results: There were no statist ically significant differences between the two treatment groups in terms of parity, smoking, body weight and FSH and E-2 levels. At 6 months, four pat ients in the tibolone group showed reduced breast density, compared with on e patient in the placebo group. Whereas no significant differences were fou nd between the two treatment groups when the categories 'minimal reduction' and 'reduction' in mammographic density were combined, combination of the categories 'no change' and 'minimal reduction' showed a significant differe nce (P < 0.036). Also, women in the tibolone group showed a statistically s ignificant improvement in breast discomfort (P < 0.019), Conclusion: This p ilot study showed decreases in breast density as well as an attendant signi ficant alleviation of breast discomfort in women with baseline mastopathic changes treated with tibolone for 6 months, which may be due to the inhibit ory effect of tibolone on the enzymes involved in the biosynthesis of estra diol demonstrated in previous trials and should be further evaluated in lon g-term studies. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.