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ABSTRACT: In order to study dose-response relationships of estrogen in normal postmenopausal women, 100 volunteers were randomized to 12 months' treatment with placebo or one of three different doses (high, medium, or low) of natural estrogens (17 beta-estradiol and estriol), sequentially combined with norethisterone acetate for 10 of the 28 cycle days. A total of 87 women completed the trial with examinations every 3 months. Relief of climacteric symptoms was dose related, being 70%, 56%, and 33% in the high, medium, and low estrogen groups and unchanged in the placebo group. Regular vaginal bleeding occurred in 78% receiving high-dose in 64% receiving medium-dose, and in 40% receiving low-dose estrogen. Bone mass increased in the high and medium groups, was unchanged in the low group, and declined in the placebo group. Dose-related decreases in serum cholesterol of 10%, 5%, and 3% occurred in the three respective estrogen groups. Serum triglyceride levels, blood pressure, and body weight remained unchanged in all groups.
American Journal of Obstetrics and Gynecology 01/1983; 144(8):873-9. · 3.47 Impact Factor
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Acta endocrinologica 10/1982; 101(1):87-92.
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Acta endocrinologica 09/1982; 100(4):486-91.
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ABSTRACT: The effects of estrogen/gestagen (e/g) treatment given in a 28-day cycle (Trisequens forteR, Novo) on menopausal symptoms and plasma concentrations of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were studied in a placebo trial. 119 normal women in the early postmenopausal period with mild to moderate climacteric complaints were included. At 3-month intervals for 2 years the participants were examined and filled in questionnaires containing the 11 symptoms of the Kupperman index (10). For each symptom a score was given. In the e/g group 77% (43/56) completed the trial compared with 83% (54/63) in the control group. A total of 61% of the women complained of hot flushes and from 9% to 44% complained of the remaining 10 Kupperman symptoms. At all eight examinations e/g treatment was found to have reduced the symptom score as well as the proportion of women with hot flushes, paresthesia, insomnia, nervousness, vertigo and formication. The symptom score of hot flushes and insomnia declined significantly (p less than 0.01). In the 24 women with hot flushes and in the 19 without, e/g caused similar reduction in the mean score of the other 10 symptoms. No placebo effect was seen. E/g caused a significant (p less than 0.01) fall in the elevated plasma concentrations of FSH and LH. Vaginal bleeding was regular in 38/43 and irregular in 4/43 women during hormone treatment. No serious side effects were attributed to e/g therapy. It is concluded that e/g treatment, in addition to its beneficial effects on hot flushes and insomnia, also alleviates several other climacteric symptoms.
Acta Obstetricia Et Gynecologica Scandinavica 02/1982; 61(3):237-41. · 1.77 Impact Factor
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Ugeskrift for laeger 09/1981; 143(35):2230-4.
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ABSTRACT: Eighty-four normal women, 2.5--5 years after their natural menopause, participated in a controlled double-blind trial. The effect of various therapeutic regimens on postmenopausal bone mineral loss was measured by photonabsorptiometric determination of the bone mineral content of both forearms. The women were randomized into four treatment groups: 1,25-dihydroxycholecalciferol (1,25(OH)2D3) alone in a daily dose of 0.25 micrograms, oestrogens/gestagen alone or combined with 1,25(OH)2D3, and placebo. The groups treated with oestrogens/gestagen (without and with 1,25(OH)2D3) showed a similar increase in bone mineral content of about 1% during one year of treatment. In contrast, both the placebo group and the 1,25(OH)2D3 group demonstrated a decrease of 1.9% and 2.1%, respectively, within the same period of time. While 1,25(OH)2D3 did not alter the rate of bone loss, it caused the characteristic and pronounced increase in urinary calcium excretion (15%). It is concluded that 1,25 (OH)2D3 neither serves as an alternative nor as an additive to gonadal hormones in the prevention of postmenopausal osteoporosis.
European Journal of Clinical Investigation 09/1981; 11(4):305-9. · 3.02 Impact Factor
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ABSTRACT: Eighty-four normal women, 2.5-5 years after their natural menopause, participated in a controlled double-blind trial. The effect of various therapeutic regimens on postmenopausal bone mineral loss was measured by photonabsorptiometric determination of the bone mineral content of both forearms. The women were randomized into four treatment groups: 1,25-dihydroxycholecalciferol (1,25(OH)2D3) alone in a daily dose of 0.25 μg, oestrogens/gestagen alone or combined with 1,25(OH)2D3, and placebo. The groups treated with oestrogens/gestagen (without and with 1,25(OH)2D3) showed a similar increase in bone mineral content of about 1% during one year of treatment. In contrast, both the placebo group and the 1,25(OH)2D3 group demonstrated a decrease of 1.9% and 2.1%, respectively, within the same period of time. While 1,25(OH)2D3 did not alter the rate of bone loss, it caused the characteristic and pronounced increase in urinary calcium excretion (15%).It is concluded that 1,25(OH)2D3 neither serves as an alternative nor as an additive to gonadal hormones in the prevention of postmenopausal osteoporosis.
European Journal of Clinical Investigation 07/1981; 11(4):305 - 309. · 3.02 Impact Factor
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ABSTRACT: A 2-year double-blind trial designed for studying the separate and combined effects of bendroflumethiazide (BFTZ) and cyclical administration of 17 beta-estradiol + estriol/norethisterone (E/N) on coronary risk factors and bone mineral loss (reported elsewhere) was undertaken. Serum lipids, fasting blood glucose, body weight and blood pressure were measured every 3 months in 97 normal women in their early menopause. All participants received a supplement of 500 mg calcium and were randomized to one of the following treatment groups: 1) placebo (P) + P (n = 33); 2) P + E/N (n=21); 3) BFTZ + E/N (n=22); and 4) BFTZ + P (n=21). As compared with placebo BFTZ raised serum cholesterol by 6.0% (p less than 0.01), decreased systolic and diastolic blood pressures (p less than 0.01) and reduced body weight (p less than 0.001). E/N decreased serum cholesterol by 9.8% (p less than 0.001) and diastolic blood pressure to the same extent as BFTZ (p less than 0.01), but left systolic blood pressure unchanged. Neither BFTZ nor E/N affected serum triglycerides or blood glucose significantly. During their combined use E/N easily overcame the hypercholesterolemic action of BFTZ, as serum cholesterol remained 6.5% and 12.5% below the mean values of the placebo and BFTZ group, respectively (p less than 0.001). The tendency of both BFTZ and E/N to raise serum triglycerides was added to cause a significant increase of 6.5% (p less than 0.01). No other additive effects were observed. In conclusion, the thiazide increased one (serum cholesterol) and decreased another (blood pressure) of the important coronary risk factors, whereas cyclical estrogen/-gestagen reduced both risk factors, also when given in combination with thiazide.
Acta Obstetricia Et Gynecologica Scandinavica 02/1981; 60(4):407-12. · 1.77 Impact Factor
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Ugeskrift for laeger 11/1980; 142(44):2896-901.
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ABSTRACT: With the aim of preventing postmenopausal bone loss, a placebo-controlled double-blind trial of 2 years duration was performed. We randomized 315 healthy volunteers in their early natural menopause to seven treatment and three placebo groups: 17 beta-oestradiol, oestriol and sequential norethisteron (hormones); bendroflumethiazide 5 mg/day (thiazide); hormones and thiazide; sodium fluoride 20 mg/day; vitamin D3 2000 IU/day (D3); fluoride and D3; and 1 alpha (OH) vitamin D3 0.25 microgram/day (1 alpha D3). All participants were given daily calcium supplement of 500 mg. Every 3 months we measured the bone mineral content (BMC) of both forearms by photon absorptiometry and chemical quantities in blood and 48 h urinary collections. The study was completed by 264 (84%). The combined placebo groups showed a linear fall in BMC reaching 3.3% after 2 years (P < 0.001). Hormones and hormones and thiazide led to a 2.5% gain in BMC (P < 0.01). Thiazide alone postponed the BMC fall for 6 months. After 2 years the thiazide group showed a BMC fall of 1.5% (P < 0.05), less than that of the placebo group (P < 0.05). BMC declined by 3.6%, 4.5%, 3.7% and 3.7% during the respective use of fluoride, D3, fluoride and D3 and 1 alpha D3. Nevertheless, the urinary calcium excretion during 1 alpha D3 and D3 treatment was 1--1.5 mmol/day higher than in the placebo groups. Apparently, there is no real alternative to oestrogen/gestagen in the prevention of postmenopausal osteoporosis.
European Journal of Clinical Investigation 08/1980; 10(4):273-9. · 3.02 Impact Factor
