title: Effects of tibolone on the breast.
abstract: OBJECTIVE
  to evaluate the effect of hormone replacement therapy and tibolone on the breast.
  
  
  METHODS
  prospective, controlled, randomized study.
  
  
  METHODS
  Outpatient Menopause Clinic of the Second University of Naples.
  
  
  METHODS
  forty four women in spontaneous menopause without any risk factor for breast cancer were randomly allocated to three groups: 15 patients (group A) were treated with transdermal oestrogens 50 microg, 2 patches/week for 3 weeks per month, plus acetate nomegestrolo per os 5 mg/die for 12 days per cycle, 17 patients (group B) were treated with tibolone 2.5 mg/die. Twelve patients not given any medication represented the control group (group C).
  
  
  METHODS
  at the time of recruitment and after at least 12 months of therapy the patients were subjected to a questionnaire aimed at quantifying the slight, moderate or severe presence of the tension/mastodynia symptoms and to a mammographic test to assess the parenchymal pattern according to a quantitative method: type 1 (less than 25% of mammary gland covered by dense tissue), type 2 (from 25% to 75% of total glandular area covered by dense tissue), type 3 (more than 75% of mammary parenchyma covered by dense tissue). Statistical analysis was carried out by means of Fisher's exact test.
  
  
  RESULTS
  after at least 12 months of treatment in Group A 5 out of 15 patients (33%) showed a trend of increase in mammographic density not statistically significant (P=0.22) when compared with group B in which one patient showed a swift from type 1 to type 2 and another from type 2 to type 3. The analysis of tension/mastodynia symptoms revealed a significantly difference between the two groups (P=0.02): in group A mastodynia appeared in three previously asymptomatic women and increased in five women, with a total increase in the symptomatology in 8 out of 15 patients (53.3%), in group B only in one case (5%) mastodynia turned from slight to moderate.
  
  
  CONCLUSIONS
  in postmenopausal women oestroprogestogenic replacement therapy may be associated with an increase in mammographic density and with the onset or increase in mastodynia. On the contrary tibolone does not seem to affect normostructured mammas and may be considered a first-rate replacement therapy in case of mammas showing particular density or benign mastopathies.
authors.affiliation: Second University of Naples, School of Medicine, Institute of Gynecology and Obstetrics, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Colacurci
authors.forename: D
authors.initials: D
authors.lastname: Mele
authors.forename: P
authors.initials: P
authors.lastname: De Franciscis
authors.forename: V
authors.initials: V
authors.lastname: Costa
authors.forename: N
authors.initials: N
authors.lastname: Fortunato
authors.forename: L
authors.initials: L
authors.lastname: De Seta
mesh_terms: D045930:Anabolic Agents / Q000009:adverse effects*; D001940:Breast / Q000473:pathology; D001941:Breast Diseases / Q000139:chemically induced* / Q000473:pathology; D015914:Estrogen Replacement Therapy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D009652:Norpregnenes / Q000009:adverse effects*; D010146:Pain; D017698:Postmenopause; D011446:Prospective Studies
chemical_list: D045930:Anabolic Agents; D009652:Norpregnenes; C027385:tibolone