The effect of tibolone in postmenopausal women receiving tamoxifen after surgery for breast cancer: a randomised, double-blind, placebo-controlled trial.
OBJECTIVE
To assess the effects of tibolone on climacteric symptoms, endometrium and serum lipid/lipoproteins in postmenopausal women receiving tamoxifen after surgery for breast cancer.


METHODS
Double-blind, randomised, placebo-controlled, multicentre pilot study.


METHODS
Hospital outpatient clinic.


METHODS
Seventy postmenopausal women receiving tamoxifen following surgery for early breast cancer.


METHODS
Women received 20 mg/day oral tamoxifen plus either 2.5 mg/day oral tibolone or placebo for 12 months.


METHODS
Frequency and severity of hot flushes (diary cards); intensity of hot flushes and sweats (Landgren scale); interference of hot flushes and sweats with normal life; frequency and intensity of other climacteric symptoms; endometrial thickness and histology; vaginal bleeding; breast cancer recurrence and serum lipid/lipoproteins.


RESULTS
Daily card data showed no change in the daily number of hot flushes with either tibolone or placebo (P= 0.219) after three months. There was a significant reduction in the severity of flushes with tibolone compared with placebo (-0.4 vs 0.2, P= 0.031). The Landgren scale showed a mean change in the number of hot flushes of -0.6 with tibolone and +1.1 with placebo after 12 months (P= 0.022). Endometrial biopsies were normal and vaginal bleeding was similar in both groups. A significant decrease in triglycerides (-23% vs 1.4%) and HDL (-12% vs 19%) was seen with tibolone compared with placebo after 12 months.


CONCLUSIONS
Tibolone prevented an increase in hot flushes in postmenopausal women given tamoxifen following surgery for breast cancer without untoward effects on the endometrium. Beneficial effects on serum lipid profile were noted.
Kroiss
R
R
Medical University of Vienna, Ludwig Boltzmann Institute for Clinical Experimental Oncology, Austria.
Fentiman
I S
IS
Helmond
F A
FA
Rymer
J
J
Foidart
J M
JM
Bundred
N
N
Mol-Arts
M
M
Kubista
E
E
D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001706:Biopsy; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D004311:Double-Blind Method; D004717:Endometrium / Q000473:pathology; D004965:Estrogen Antagonists / Q000008:administration & dosage; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage; D005260:Female; D019584:Hot Flashes / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D006945:Hyperhidrosis / Q000209:etiology / Q000517:prevention & control; D008055:Lipids / Q000097:blood; D008327:Mammography; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging / Q000209:etiology; D009652:Norpregnenes / Q000008:administration & dosage; D010865:Pilot Projects; D017698:Postmenopause / Q000187:drug effects; D013629:Tamoxifen / Q000008:administration & dosage
D004965:Estrogen Antagonists; D020847:Estrogen Receptor Modulators; D008055:Lipids; D009652:Norpregnenes; D013629:Tamoxifen; C027385:tibolone