The efficacy of two dosages of a continuous combined hormone replacement regimen.
OBJECTIVE
To evaluate the efficacy of a low-dose combination of estradiol (E2) and norethisterone acetate (NETA) on bone markers, lipid and bleeding profiles and menopausal symptoms.


METHODS
Ninety-six healthy Chinese postmenopausal women were allocated randomly to receive 1 mg E2/0.5 mg NETA (low-dose hormone replacement therapy (HRT)) or 2 mg E2/1 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.


CONCLUSIONS
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.
Loh
Foo Hoe
FH
Department of Obstetrics and Gynaecology, National University Hospital, 5 Lower Kent Ridge Road, Kent Ridge Wing, Singapore 119074, Singapore. obglohfh@nus.edu.sg
Chen
Lin Han
LH
Yu
Su Ling
SL
Jorgensen
Lars Nellemann
LN
D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D000596:Amino Acids / Q000097:blood; D044466:Asian People; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003094:Collagen / Q000097:blood; D024042:Collagen Type I; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D020249:Hormone Replacement Therapy; D019584:Hot Flashes / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077563:Norethindrone Acetate; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000235:genetics; D010455:Peptides / Q000097:blood; D017698:Postmenopause; D011446:Prospective Studies; D012846:Singapore; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D014592:Uterine Hemorrhage
D000596:Amino Acids; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D024042:Collagen Type I; D010455:Peptides; D014280:Triglycerides; C052929:collagen type I trimeric cross-linked peptide; D004958:Estradiol; C036020:deoxypyridinoline; D003094:Collagen; D002784:Cholesterol; D000077563:Norethindrone Acetate; D000469:Alkaline Phosphatase; D009640:Norethindrone