Elsevier

Maturitas

Volume 34, Issue 2, 15 February 2000, Pages 169-177
Maturitas

Efficacy and safety of oral estriol for managing postmenopausal symptoms

https://doi.org/10.1016/S0378-5122(99)00108-5Get rights and content

Abstract

Objective: to assess the therapeutic efficacy and safety of oral estriol for the treatment of climacteric symptoms in postmenopausal women. Methods: 68 postmenopausal women with climacteric symptoms received oral estriol, 2 mg/day, daily for 12 months. We evaluated the degree of climacteric complaints with estriol therapy; serum levels of gonadotropins, estradiol (E2) and lipids; biochemical markers of bone metabolism; blood pressure; and side effects both at baseline and during treatment. Climacteric symptoms were assessed according to the menopausal index (MI), a version of the Kupperman index that had been modified for Japanese women. Results: oral estriol therapy significantly reduced total MI scores. The greatest relief was noted for hot flushes, night sweats, and insomnia. Estriol treatment significantly lowered serum follicle stimulating hormone (FSH) and luteinizing hormone (LH) concentrations but did not affect any of the other parameters (lipids, bone, liver and blood pressure) during the study period. Slightly vaginal bleeding occurred in 14.3% of those who underwent natural menopausal women. Histologic evaluation of the endometrium and ultrasound assessment of the breasts following 12 months of estriol treatment found normal results in all women. Conclusion: Estriol is a safe and effective alternative for relieving climacteric symptoms in postmenopausal Japanese women.

Introduction

With the increasing longevity of the population age hormone replacement therapy (HRT) has been suggested to be necessary for obtaining a better quality of life and for avoiding metabolic disturbances resulting from hypoestrogenism in postmenopausal women. It has been well established, however, that unopposed estrogen administration may contribute significantly to the development of uterine endometrial cancer [1], [2] and breast cancer [3], [4]. Although these potential risks remain controversial, the addition of sequential or combined progesterone thus has been recognized as essential during estrogen replacement therapy [5]. For obtaining a better quality of life relieving climacteric symptoms, and preventing osteoporosis and cardiovascular disease in postmenopausal women it is important to continue HRT for long period of time. Unfortunately, however, major adverse effects, including regular or irregular uterine bleeding, may impede patient compliance with long-term HRT. Consequently, the biologically weak estrogen, estriol, which has a much weaker stimulating effect on endometrial growth than E2 and does not commonly cause vaginal bleeding appears to be best suited for HRT [6]. Although estriol appears to be much safer than estrone or estradiol, its continuous use in high doses may have a stimulatory effect on both breast and endometrial tissue [7]. The efficacy and safety of orally-administered estriol in the treatment of climacteric symptoms, however, has been investigated rarely [8], [9].

The present study therefore was designed to assess various indicators of therapeutic efficacy and safety of oral estriol for treating climacteric complains in postmenopausal women.

Section snippets

Materials and methods

The study included 68 postmenopausal women ages 35–62 years (mean±S.D., 49.9±5.9 years) with climacteric symptoms, including 35 women ages 45–62 years (53.8±4.4 years) who had undergone natural menopause (time since menopause, 61.9±28.3 months, range 36–116 months) and 33 women ages 35–54 years (45.8±4.4 years) who had undergone surgically induced menopause (time since hysterectomy with bilateral oophorectomy, 50.7±9.3 months, range 36–68 months). All subjects gave written informed consent. The

Results

Of the 68 participants, 88.2% completed the 12-month trial. Eight women dropped out during the trial. Of these women, one had unexpected vaginal spottings during the third month of treatment. Three women dropped out for lack of efficacy after 3–9 months of treatment, two for self-assessed complete relief of climacteric symptoms after 5–10 months of treatment, and two for unknown reasons after 10–11 months of treatment. Unexpected vaginal bleeding for 2–3 days occurred in five women (14.3%) of

Discussion

The present study investigated the efficacy and safety of oral estriol in the treatment of climacteric symptoms in postmenopausal women. Estriol levels in postmenopausal women are likely to be low, even through the metabolic clearance rate of estriol is decreased by 13% [14]. The decrease in estriol levels probably results from the reduction in serum E2 levels, which are significantly lower in postmenopausal women than during the early follicular phase of the menstrual cycle. While

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