The efficacy of two dosages of a continuous combined hormone replacement regimen

Abstract

Objectives: To evaluate the efficacy of a low-dose combination of estradiol (E 2) and norethisterone acetate (NETA) on bone markers, lipid and bleeding profiles and menopausal symptoms. Method: Ninety-six healthy Chinese postmenopausal women were allocated randomly to receive 1 mg E 2/0.5 mg NETA (low-dose hormone replacement therapy (HRT)) or 2 mg E 2/1 mg NETA (high-dose HRT) for 6 months. Results: Bone resorption markers (collagen I N-terminal telopeptides (NTX) and deoxypyridinoline (dPyr)) were significantly reduced; −66 and −32%, respectively, in high-dose HRT versus −55 and −24%, respectively, in low-dose HRT. Bone-specific alkaline phosphatase remained unchanged with either combination of hormones. Total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) levels were decreased significantly (−12 and −13%, respectively, in high-dose HRT vs. −7 and −8% in low-dose HRT). High density lipoprotein cholesterol (HDL-C) was decreased to a lesser extent in low-dose HRT and triglycerides (TG) levels remained unchanged. Both the low and high-dose HRT were effective in alleviating menopausal symptoms. After 6 months of treatment, 2% of women in the low-dose HRT were bleeding compared with 23% in the high-dose HRT. Breast pain occurred in 2% of women in low-dose HRT compared with 15% in high-dose HRT. The endometrium in the majority of the women remained normal. Conclusion: Menopausal symptoms were reduced effectively in postmenopausal women on either low-dose or high-dose HRT. TC, LDL-C levels and bone resorption markers were reduced in a dose-dependent manner. Low-dose HRT provided a better bleeding profile and the incidence of breast pain was low.