To assess the safety and efficacy of oestriol in relieving post-menopausal
symptoms 53 post-menopausal Japanese women with climacteric symptoms, 27 wi
th natural menopause (group I) and 26 with surgically induced menopause (gr
oup II), received oral oestriol, 2 mg daily for 12 months. Clinical paramet
ers including Kupperman index (KI) and the degree of satisfaction with symp
tomatic relief; serum concentrations of oestradiol, FSH and LH; serum lipid
s; blood pressure; bone mineral density, serum calcium (Ca), alkaline phosp
hatase (ALP), and urinary Ca were compared between the two groups. Oestriol
improved KI in groups I and II by 49 and 80% respectively. Satisfaction wi
th treatment was 85% in group I and 93% in group II. For both parameters, v
alues were significantly different between groups I and II (P < 0.05 for bo
th). Serum concentrations of oestradiol, FSH and LH changed in group I vers
us group II 6 months after initiation. A significant decrease in serum ALP
and Ca/Cr was observed in group I at 6 months. Except for serum triglycerid
es, oestriol had no significant effect on lipids, Systolic and diastolic bl
ood pressures were significantly decreased in group I at 3 months versus ba
seline. Slight vaginal bleeding occurred in 14.3% of group I. Histological
evaluation of the endometrium in all women of group I and ultrasound assess
ment of the breasts following 12 months of oestriol treatment found normal
results in all women. Therefore, oestriol appeared to be safe and effective
in relieving symptoms of menopausal women. The beneficial biochemical effe
cts of oestriol were marked in the natural menopause. Overall, oestriol may
serve as a good choice for hormone replacement therapy to protect against
other climacteric symptoms in post-menopausal women who do not need medicat
ion for osteoporosis or coronary artery disease.