Continuous combined hormone replacement therapy compared with tibolone

Objective: To compare relief of vasomotor symptoms, changes in lipoproteins , and bleeding patterns in postmenopausal women receiving either continuous combined hormone replacement therapy (HRT) of estradiol valerate and noret histerone or tibolone 2.5 mg/day. Methods: In a multicenter, randomized, open-label study, 235 postmenopausal women received one of the above-mentioned treatments. Fasting lipoproteins were measured at baseline and at 3, 6, and 12 months. At each visit, parti cipants completed Greene climacteric questionnaires and recorded any bleedi ng episodes. Data are presented as mean +/- standard deviation if normally distributed, median and interquartile range if non-normally distributed, or as frequency count. For menopausal symptoms and diary card data, the diffe rences were tested by Wilcoxon rank-sum test. Results: One hundred sixteen women received continuous combined HRT and 119 women received tibolone; 72 and 76 women, respectively, completed 12 month s of therapy. Both treatments effectively relieved vasomotor symptoms and r educed serum total cholesterol. Continuous combined HRT, but not tibolone, significantly reduced low-density lipoprotein levels. Both treatments reduc ed high-density lipoprotein levels, but the effect was more profound with t ibolone. The initial bleeding score was higher for women taking continuous combined HRT; however, by the end of the study, the percentages of amenorrh eal women were comparable. Endometrial histology was similar for both treat ments at the end of the study, although two cases of proliferative endometr ium were found in the tibolone group. Conclusion: Estradiol valerate-norethisterone continuous combined HRT contr ols symptoms and is associated with a safe lipid profile. (Obstet Gynecol 1 999;93:258-64. (C) 1999 by The American College of Obstetricians and Gyneco logists.).