The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women: a randomized controlled trial

Serum homocysteine levels may be lowered by hormone replacement therapy, bu t randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormo ne replacement therapy compared with placebo on fasting serum homocysteine levels in 121 perimenopausal women free of cardiovascular disease, and recr uited from the general population. The trial was double-blind with respect to a sequential combined regimen of oral 17 beta -estradiol and desogestrel (17 betaE(2)-D) and the placebo group and open with respect to a combinati on of conjugated equine estrogens and norgestrel (CEE-N). At baseline and a fter 6 months, fasting serum homocysteine levels were measured. Differences in 6 months serum homocysteine levels from baseline between treatment and placebo groups were calculated, and expressed as a percentage of the 6 mont hs placebo level. After 6 months, the difference in serum homocysteine leve ls between women receiving 17 betaE(2)-D and placebo was - 6.3% (95% CI, - 12.4%; 0.0%, P = 0.06). The difference between women receiving CEE-N and pl acebo was - 10.1% (95% CI, - 16.7%; - 2.9%, P <0.01). The difference betwee n the combined group of both types of hormone replacement therapy users and placebo was - 7.8% (95% CI, - 13.2%; - 2.0%, P = 0.01). No significant dif ference was observed between the two active regimens. Our results indicate that hormone replacement therapy decreases homocysteine levels in perimenop ausal women, (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.