The metabolic and bone density effects of continuous combined 17-beta estradiol and noresthisterone acetate treatments in Thai postmenopausal women: a double-blind placebo-controlled trial.

ABSTRACT

OBJECTIVE: To compare the changes of lipid parameters, liver function tests, fasting plasma glucose and bone density in Thai postmenopausal women who received this combined hormonal treatment and placebo. STUDY DESIGN: Double-blinded, randomized controlled trial study. MATERIAL AND METHOD: Sixty postmenopausal women attending the menopause clinic at Chulalongkorn Hospital from July, 1996 to December, 1996, were enrolled in the study. The patients were randomized to receive the placebo or drug (17 beta-estradiol 2 mg and norethisterone acetate 1 mg) continuously. Patient characteristics, physical examination, liver function tests, fasting plasma glucose, lipid parameters (fasting total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein (HDL) and triglyceride level) and bone densitometry were performed before beginning the study. The lipid parameters were repeated at 3, 6 and 12 months. Fasting plasma glucose, liver function tests and bone densitometry were repeated at 12 months. RESULTS: In the drug group, there were significant changes in the cholesterol at 3, 6 and 12 months when compared to the baseline. There were significant differences at 3, 6 and 12 months when compared between groups. The HDL values were not significantly different within groups. The LDL values at 3, 6, 12 months were significantly lower than the baseline in the drug group when compared within groups and at 6, 12 months in the placebo group. The triglyceride values were not significantly different between groups and within groups. There was no significant change between groups and within groups of fasting plasma glucose, total bilirubin, direct bilirubin, AST, ALT, albumin and globulin. The alkaline phosphatase values were significantly decreased at 12 months in the drug group. The bone density of total BMD and T-score at the spine of the drug group increased significantly at 12 months. The per cent change per year was +5.1. In contrast, the values in the placebo group decreased significantly, the per cent change per year was -0.9. The same pattern was also found in the bone density of the total hip. But when focused to the femoral neck, we found no significant change in both groups. CONCLUSION: This continuous combined treatment resulted in beneficial changes of bone density and lipid profiles. The therapy prevented bone loss and the changes in serum lipoprotein were concordant with a lipid profile associated with a decreased risk of coronary heart disease in Thai postmenopausal women.