Effect
of oral or transdermal hormone replacement therapy on homocysteine levels:
a randomized clinical trial.
F. Bruschi,
D. Dal Pino, V. Fiorea, F. Parazzìni, R. Di Pace, B. M.Cesana,
D. Melotti, P. G. Crosignani.
Maturitas 48 (2004) 33 - 38 |
Objective: Aim of this randomized trial was evaluate the
effect on homocysteine plasma levels of two different hormone replacement
therapy (HRT) formulations in a group of late postmenopausal women.
Methods: Eligible for this study were women: in postmenopause
since 5 years or more (confirmed from FSH level >_40 mIU/I); with
body mass index (BMI) <_35; without endocrine, hepatic or renal
diseases; not current users of vitamin B or folic acid supplements;
not users of any lipid-lowering drugs and sex steroids in the 6 months
before trial entry. Group A: oral estradiol valerate 2 mg per day
per oral normegestrol acetate 2.5 mg per day (n=98) for 12 months;
Group B: a weekly patch releasing estradiol (50 Pg per day) per oral
normegestrol acetate 2.5 mg per day (rr--101) for 12 months. Results:
The mean values of the homocysteine levels in the group A and B at
baseline, 3, 6 and 12 months were 7.9 and 9.1, 8.7 and 8.9, 9.3 and
10.2, 9.6 and 10.2, respectively, the differences between the two
treatments were not statistically significant (time by treatment interaction,
P=0.32). Otherwise, the changes of homocysteine level at the four
visits was statistically significant (P-1-0.0001) in both groups.
In particular, in the oral treatment group homocysteine levels increased
from baseline of 10.5% at 3 months, of 17.2% after 6 months of therapy
and of 21.9% at the end of the study; in the transdermal group, after
a little decrease at 3 months (1.5%), the increases were of 12.1 and
12.9%, respectively. Conclusions: This study does not show
any different effect of oral and transdermal treatment with estradiol
plus normegestrol acetate on homocysteine levels. Further it does
not support previous suggestion of a lowering effect of HRT on plasma
homocysteine.
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