Effect of tibolone on breast symptoms resulting from postmenopausal hormone replacement therapy.

Abstract

OBJECTIVE:

To evaluate the incidence of breast symptoms in a population treated with various hormone replacement therapy (HRT) regimens and to detect the variations in breast symptomatology after HRT changing to tibolone administration.

METHODS:

This prospective placebo-controlled clinical trial was conducted on healthy women on HRT reporting breast symptoms. A questionnaire was given to each woman to detect breast symptomatology. Breast tenderness and mastalgia were evaluated using a visual analogue scale (VAS). According to the choice of the each woman with breast symptoms, the HRT was changed to tibolone (2.5 mg/day per os) or to calcium carbonate (1 tab/day, placebo group). The duration of treatment was of 12 months. After 6 and 12 months breast symptomatology was re-evaluated.

RESULTS:

Among the 600 screened women, 64 (10.7%) were suffering from breast symptomatology. After 6 and 12 months of treatment with tibolone or placebo, mean VAS score for breast tenderness and for mastalgia resulted significantly (P<0.05) decreased, without differences between groups, in comparison with basal value. Only one woman had no improvement from the breast symptoms with tibolone administration.

CONCLUSIONS:

Shifting from classical HRT to tibolone is followed by a significant reduction of breast symptomatology in postmenopausal women with breast complaints similar to that obtained with treatment withdrawal.

• Authors: Stefano Palomba, Costantino Di Carlo, Michele Morelli, Tiziana Russo, Roberto Noia, Carmine Nappi, Pasquale Mastrantonio, Fulvio Zullo
• Journal: Maturitas (Maturitas) Vol. 45 Issue 4 Pg. 267-73 (Aug 20 2003) ISSN: 0378-5122 [Print] Ireland
• PMID: 12927313 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article)

Chemical References

• Estrogen Receptor Modulators
• Norpregnenes
• tibolone

Topics

• Breast (drug effects, pathology)
• Estrogen Receptor Modulators (pharmacology, therapeutic use)
• Estrogen Replacement Therapy
• Female
• Hot Flashes (drug therapy)
• Humans
• Incidence
• Middle Aged
• Norpregnenes (pharmacology, therapeutic use)
• Pain
• Pain Measurement
• Postmenopause
• Prospective Studies
• Surveys and Questionnaires