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12-Jun-2001
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Arch Hellen Med, 17(6), November-December 2000, 600-608
ORIGINAL PAPER
Low dose estradiol valerate plus estriol can preserve
bone loss
in the forearm and attenuate climacteric symptoms
in early postmenopausal women
Z.
KAMENOV,1 G. KOLAROV,2
M. ORBETZOVA,3 N. AOKI,4
M. IMAMURA,4
H. HIGASHINO,5 M. PROTICH,1
B. NALBANSKI2
1Clinic
of Endocrinology, "Aleksandrovska" University Hospital, Medical University,
Sofia
2Clinic of Gynecology, "Maichin dom" University
Hospital, Medical University, Sofia
3Clinical Centre of Endocrinology and Gerontology,
Medical University, Sofia, Bulgaria
4Clinic of Endocrinology, 2nd Department of
Internal Medicine, Kinki University, School of Medicine, Osaka
5Department of Pharmacology, Kinki University,
School of Medicine, Osaka, Japan
OBJECTIVE The aim of the
study was to establish whether a combination of low dose estradiol valerate
(EV) and estriol (E3) is able to alleviate climacteric symptoms and preserve
bone in early postmeno-pausal women.
METHOD A one-year prospective non-randomized study
was conducted of two groups of women: control group (n=31) and hormone replacement
therapy (HRT) group (n=35), treated with 1 mg EV and 2 mg E3, combined with
sequential levonorgestrel 0.25 mg. The criteria for inclusion were: 9–18 months
after last menstrual bleeding, FSH>25 IU/L, moderate climacteric symptoms,
bone mineral density (BMD) of less than 2.5 SD below peak adult bone mass. None
of the women had any pre-existing medical condition which could affect bone
metabolism. BMD was estimated by single-energy X-ray absorptiometry on the distal
and ultradistal areas of the forearm at the start of the study and after 1 year.
The Kupperman menopausal index (KI), Hamilton anxiety scale (HAMA), and adverse
effects were recorded at baseline and at the 3rd, 6th and 12th months.
RESULTS No differences
in age, height, menstrual history, parity, physical activity, exposure to sunlight,
coffee intake, HAMA and distal BMD were observed between the groups. In the
control group body mass index (BMI) and ultradistal BMD were higher and KI lower
than in the HRT group. During the study KI and HAMA decreased significantly
in the HRT group compared to initial values and to the control group. BMD increased
significantly in the HRT group for both distal and ultradistal areas while in
the control group a significant decrease in these parameters was observed.
CONCLUSIONS Treatment
with low dose EV+E3 is sufficient to reduce climacteric symptoms and prevent
bone loss with acceptable tolerability in early menopause.
Key words: Bone mineral density, Early menopause, Hamilton anxiety scale, Hormone replacement therapy, Kupperman menopausal index.