Sequential Oral Conjugated Estrogen/MPA and 17B-Estradiol Gel/MPA Therapy in Postmenopausal Thai Women : Effects on Hormonal and Lipid Profiles

Abstract

Objective To compare the effects of oral conjugated equine estrogen (CEE) and transdermal estradiol gel, both combined with an oral progestin, on hormonal and lipid profiles in postmenopausal Thai women.

Subjects Twenty-seven naturally menopausal Thai women were randomly allocated to two treatment groups for the period of 12 months. The first group (N = 13) received conjugated equine estrogen (CEE) 0.625 mg/day orally for 21 days. The second group (N = 14) was given estradiol gel (17-B E, gel) 1.5 mg/day for 21 days. Medroxyprogesterone acetate (MPA) 10 mg/day was added orally to both treatment groups on the last 14 days (day 8-21) of each cycle of medication. There was a medication free period during the last 10 days (day 22-30 or 31) of each month.

Main outcome measures Blood samples were obtained before treatment and on day 20 or day 21 after 1, 3, 6 and 12 months of therapy for hormonal (FSH, LH, E,, E.) and lipid (TC, TG, HDL, LDL, Apo A,, Apo B) study. Demographic data was analyzed by Unpaired t-test. Friedman test and Mann-Whitney U-test were run on data where it appropriated.

Results Serum estrone (E.), and estradiol (E.) increased in both groups with a statistical significance. In the oral (CEE) group the serum estrone (Ev) increased markedly, whereas serum estradiol (E.) increased more prominently in the gel groups. A higher EE, ratio was therefore observed in the gel group. In comparison between the two groups during the 12 months of treatment, the changes of serum E, and serum E, were statistically significant different at 3, 6 months and at 3, 6, 12 months respectively. Serum FSH and LH were suppressed in both groups significantly with a steeper decreasing trend in the CEE group more than in the gel group. Comparison between serum FSH and LH in both groups were statistically significant different at 3, 6 months and at 0, 1, 6 months respectively. In both groups, most plasma lipids did not change with a statistical significance before and after treatment, only serum total cholesterol (TC) in the CEE group decreased significantly. Comparison of the plasma lipids TC, TG, HDL, LDL, Apo A,, Apo B between the two groups during the study period did not show statistical differences in all parameters. The clinical response to treatment for climacteric symptoms was the same in both regimens.

Conclusion The estradiol gel groups had higher EE, ratio, it showed high bioavailability than in the CEE group. Both therapies had the same effects in relieving typical climacteric in all subjects. However, the insignificance on the positive effect in most lipid profile in both types of estrogen preparations may be attributable to the small population and to large intra-individual of these parameters measured. Further more extensive studies are needed in Asain women setting.