Comparison of Two Continuous Combined Estrogen Progeterone Regimens in Postmenopausal Women: A Randomized Trial

Park, S H

Abstract

At Chosun University Kwangyang Hospital, a prospective randomized trial wasperformed to compare two different type of progestogen: medroxyprogesterone acetate(MPA)and norethisterone in the aspects of the impact of these two regimens on lipid metabolism,bone mineral densitometry and compliance from Feb. 1996 to Jan. 1997.Forty-five postmenopausal women complaining of menopausal symptoms were randomizedto two groups. They were treated with continuous combined oral regimen composedof 17beta estradiol 2 mg and norethisterone 1 mg(Kliogest)/day(Kliogest group, 25 patients)and of conjugated equine estrogen 0.625 mg and MPA 2.5 mg/day(CEE/MPA group, 20patients). BMD and lipid profile were determined at the first visit and cycle 6.The results were as follows;1. Those who had taken drug >6 months were 19 patients(76%) in the Kliogest group(Group I) and 13 patients(65%) in the CEE/MPA group(Group II).2. The bone mineral density of spine(L2~L4) and femoral neck wasincreased(1.162+/-15.2*, 1.151+/-0.08 in Group I ; 1.025+/-0.043, 1.019+/-0.097 in Group II) from thebaseline after 6 months of treatment in both group(*, p < 0.05).3. Serum lipid and lipoprotein level demonstrates decrease in Total Cholesterol*(0.845+/-0.136), Triglyceride*(0.878+/-0.468), LDL-cholesterol(0.839+/-0.305) and increase in HDL-cholesterol*(1.217+/-0.17) from baseline after treatment in Group I(*,p < 0.05).4. Serum lipid and lipoprotein level demonstrates decrease in Total Cholesterol(0.932+/-0.048), LDL-cholesterol(0.856+/-0.122) and increase in Triglyceride*(1.12+/-0.458), HDL-cholesterol(1.117+/-0.054) from baseline after treatment in Group II(*, p < 0.05).5. Those who withdrew from the treatment <5 months were 6 patients (14%) in theKliogest group(Group III) and 7 patients(35%) in the CEE/MPA Group(Group IV) and themost common etiology was irregular vaginal spotting(33.3% in Group III and 42.9% inGroup IV).6. The mean months of discontinuance of treatment was 3.7 months in Group III and3.4 months in Group IV.* All levels are described in ratio(mean+/-SD) from the baseline.