No. Siseles et al., A COMPARATIVE-STUDY OF 2 HORMONE REPLACEMENT THERAPY REGIMENS ON SAFETY AND EFFICACY VARIABLES, Maturitas, 21(3), 1995, pp. 201-210
Citations number
67
Categorie Soggetti
Geiatric & Gerontology","Obsetric & Gynecology","Medicine, General & Internal
Objective: To assess the effect of tibolone on endometrial safety, pla
sma estradiol concentrations, lipid metabolism and climacteric symptom
s in comparison to sequential conjugated equine estrogens and medroxyp
rogesterone acetate in postmenopausal women. Methods: In a randomised,
open-label, 6-cycle, group-comparative study, the effects on the afor
ementioned parameters were studied with tibolone 2.5 mg/day (N= 13) co
ntinuously, and with conjugated equine estrogens 0.625 mg/day continuo
usly, combined with medroxyprogesterone acetate 5 mg/day (N=11) (CEE/M
PA) sequentially, during 12 days of each 28-day cycle. Within-group st
atistical analysis was performed with Student's t-test for paired samp
les, whereas between-group statistics were performed using the Student
's t-test for independent groups. Results: Cytological evaluation reve
aled no endometrial stimulation in either group. In the tibolone group
, there were no effects on estradiol levels, whereas in the CEE/MPA gr
oup, an increase in total and non-SHBG-bound estradiol plasma levels w
as reported. In the tibolone group, there were significant decreases i
n plasma total cholesterol, triglycerides, HDL-cholesterol and VLDL-ch
olesterol, whereas no significant changes in LDL-cholesterol and IDL-c
holesterol were reported. In the CEE/MPA group there were significant
decreases in plasma total cholesterol, HDL-cholesterol and LDL-cholest
erol, whereas there were no significant changes in triglycerides,IDL-c
holesterol and VLDL-cholesterol. Climacteric symptoms, particularly va
somotor episodes, decreased similarly in both groups. Conclusions: Bot
h tibolone and CEE/MPA were safe with respect to effects on the endome
trium and both treatments induced changes in the plasma profiles of ce
rtain lipid and lipoprotein parameters. However, the overall clinical
implications of these changes are unknown. Finally, both regimens were
equally effective in the treatment of climacteric symptoms.