A COMPARISON OF THE EFFECTS OF ORAL CONJUGATED EQUINE ESTROGEN AND TRANSDERMAL ESTRADIOL-17-BETA COMBINED WITH AN ORAL PROGESTIN ON QUALITY-OF-LIFE IN POSTMENOPAUSAL WOMEN

Objective: To compare the effect of transdermal estradiol-17 beta and oral conjugated equine estrogen when combined with an oral progestin o n quality of life in post-menopausal women. Design: Randomized control led double-blind trial. A randomization error lead to the exclusion of six subjects but the soundness of the remaining randomization was con firmed. Setting: Large urban community. Patients: Women 2-7 years afte r menopause with a uterus and ovaries, and not currently using hormone replacement therapy. Seventy-four women completed the trial. Interven tions: After baseline measures of quality of life, subjects were rando mly assigned to either continuous oral conjugated equine estrogen 0.62 5 mg daily or continuous transdermal estradiol-17 beta 50 meg twice we ekly, for four 4-week cycles. Medroxyprogesterone acetate 10 mg oral t ablets was administered to both groups for the last 12 days of each cy cle. Outcomes measured: Quality of life was determined using the Menop ause-Specific Quality of Life Questionnaire. Tolerability was determin ed by a specifically designed list of adverse effects, Both measures w ere recorded at base-line and in mid-cycle during the second, third an d fourth cycles of treatment. Results: There were no statistically sig nificant differences in any of the domains at baseline between the ora l and transdermal treatment groups. In the vasomotor domain, scores fo r the oral and transdermal groups improved from baseline levels of 3.1 4 and 3.09, respectively, to 1.32 and 1.23; physical domain scores imp roved from 2.45 and 2.73 to 2.04 and 1.78; psychosocial domain scores improved from 2.72 and 3.04 to 2.21 and 1.94; sexual domain scores imp roved from 2.32 and 2.16 to 1.64 and 1.30. There were no statistically significant group differences or time/group interactions. Both forms of therapy were equally well tolerated. Conclusions: Improvement in al l domains, measured by the Menopause-Specific Quality of Life Question naire, was observed in both the oral and transdermal groups. In the ab sence of a placebo control group, the improvements observed cannot be attributed solely to the therapy. Neither form of therapy offered an a dvantage over the other in respect to improvement in quality of life.