Comparison of the effects of tibolone and estrogen therapy on hemostasis in surgical menopause: a randomized, double-blind, placebo-controlled study.

OBJECTIVE

To examine the effects of unopposed estrogen (E) and tibolone therapy on coagulation and natural anticoagulant systems in surgical menopause.

DESIGN

A randomized, double-blind, placebo-controlled study.

SETTING

University hospital clinic in Turkey.

PATIENT(S): Ninety healthy surgically postmenopausal women.

INTERVENTION(S): Ninety surgically postmenopausal women were randomized into three groups: unopposed conjugated ET (0.625 mg/d, group 1), tibolone (2.5 mg/d, group 2), and identical tablets of placebo (group 3).

MAIN OUTCOME MEASURE(S): Effects on parameters in the clotting cascade at baseline and after 24 weeks of treatment.

RESULT(S): After 6 months, fibrinogen, lipoprotein (a), and factor VIIa were decreased, and activated partial thromboplastin time was increased significantly in the ET group compared with in the placebo group. However, tibolone significantly decreased only the serum levels of factor VIIa and factor IX and prolonged the activated partial thromboplastin time, compared with placebo group. In addition, conjugated ET caused a significantly greater decrease in serum fibrinogen level than did tibolone.

CONCLUSION(S): Neither E nor tibolone therapy led to activation of coagulation in the surgically menopausal women. Both preparations changed the overall hemostatic balance to a more fibrinolytic state.