Effect of tibolone on breast symptoms resulting from postmenopausal hormone replacement therapy.
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.
Palomba
Stefano
S
Obstetrics and Gynaecology, University Magna Graecia of Catanzaro, Catanzaro, Via Nicolardi 188, 80131 Naples, Italy. stefanopalomba@tin.it
Di Carlo
Costantino
C
Morelli
Michele
M
Russo
Tiziana
T
Noia
Roberto
R
Nappi
Carmine
C
Mastrantonio
Pasquale
P
Zullo
Fulvio
F
D001940:Breast / Q000187:drug effects* / Q000473:pathology; D020847:Estrogen Receptor Modulators / Q000494:pharmacology* / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D009652:Norpregnenes / Q000494:pharmacology* / Q000627:therapeutic use; D010146:Pain; D010147:Pain Measurement; D017698:Postmenopause; D011446:Prospective Studies; D011795:Surveys and Questionnaires
D020847:Estrogen Receptor Modulators; D009652:Norpregnenes; C027385:tibolone