17 beta-estradiol and norethisterone acetate in low doses as continuous combined hormone replacement therapy.

OBJECTIVES: To evaluate low doses of 17 beta-estradiol (E2) and norethisterone acetate (NETA) as continuous combined hormone replacement therapy (HRT) in their effects on vasomotor symptoms, bleeding episodes, endometrial histology and mastalgia. METHOD: Sixty postmenopausal women were randomly allocated to three treatment groups and were given 1 mg E2 and 0.25 mg NETA (A), 1 mg E2 and 0.5 mg NETA (B) and 2 mg E2 and 1.0 mg NETA (C) in daily doses. The treatment period was 1 year. RESULTS: A similar statistically significant reduction of climacteric symptoms (P < 0.05) was found in all groups. Bleedings, mainly as spottings, occurred most commonly during the first treatment months. Fewer bleeding episodes and a higher percentage of amenorrhea was noted in group B compared to the other groups but did not reach statistical significance. All endometrial biopsies showed atrophy. Women in group A and B had less severe mastalgia (P < 0.05) compared to group C, given higher doses of steroids. CONCLUSION: Postmenopausal women taking 1 mg of E2 plus 0.5 mg NETA as continuous combined HRT reported a marked reduction of climacteric complaints and good bleeding control. No endometrial proliferation was detected after 1 year of treatment. This type of therapy may be beneficial especially for elderly women, in whom bleeding may be annoying.

Transdermally administered oestradiol combined with oral medroxyprogesterone acetate: the effects on lipoprotein metabolism in postmenopausal women.

OBJECTIVE: To investigate the effects of two doses of transdermally applied oestradiol on lipid and lipoprotein metabolism in climacteric women. DESIGN: A randomised double blind cross-over comparison. SETTING: Departments of Obstetrics and Gynaecology, Ostra and Sahlgren's Hospital, Göteborg and Karolinska Hospital, Stockholm, Sweden. SUBJECTS: Fifty-two women with climacteric symptoms were treated with oestradiol transdermally applied (50 micrograms and 100 micrograms/24 h). A daily dose of 5 mg oral medroxyprogesterone acetate was added 14 days each treatment cycle of four weeks. INTERVENTIONS: Blood samples were drawn after an overnight fast before and after four and eight months of treatment. MAIN OUTCOME MEASURES: Assays for serum triglycerides and cholesterol as well as low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol including the subfractions HDL2 and HDL3 were performed. RESULTS: Significant decrements were found in triglycerides and serum and LDL cholesterol during treatment with both doses. A modest rise in HDL2 cholesterol was observed after treatment with the 100 micrograms/24 h dose. CONCLUSIONS: The serum lipid and lipoprotein profile encountered in these women was similar to that reported with oral formulations except for a decrease in triglycerides. The metabolic differences between the two doses of transdermal oestradiol is probably of minor clinical significance in normal postmenopausal women.

A new methodological approach to the evaluation of quality of life in postmenopausal women.

An approach employing a range of standardized questionnaires, which included the Nottingham Health Profile (NHP), the Psychological General Well-Being (PGWB) index and the Mood Adjective Check List (MACL), was used to assess health-related quality of life (QoL) in conjunction with a study comparing two doses of transdermal oestrogen (50 or 100 micrograms/24 h) combined with an oral progestogen (5 mg medroxyprogesterone acetate for 14 days each cycle). In addition to the QoL measures, climacteric symptoms were self-rated and also summarized by means of the Kupperman index. In all, 59 women, median age 52 (39-71) years, who completed 4 months of therapy were evaluated. The use of a battery of standardized questionnaires enabled a comprehensive evaluation to be made of perceived health, well-being and day-to-day functioning. Not only was symptomatic relief, e.g. reduced frequency of sweating episodes, sleep disturbance and hot flushes, observed during treatment, but there were also improvements in terms of sleep, energy and emotions. The frequency of health-related problems associated with paid employment, housework, social life, home life and sex life decreased, indicating enhanced ability to take part in daily activities. The PGWB index showed improvement in the subscales representing well-being, anxiety, depression, vitality, health and self-control, while the mood scales indicated that the women experienced less tension and more satisfaction. Although the results of this study need to be further documented on the basis of a placebo-controlled trial, the findings nevertheless imply that the use of a battery of standardized questionnaires optimizes the possibility of evaluating climacteric complaints reliably before and after treatment.

Endometrial sampling using the Mi Mark procedure as a primary routine: first year's experience.

This study reports on the Mi Mark technique as a primary method of endometrial sampling in routine practice. The experience gained during the first year was evaluated with regard to diagnostic accuracy and acceptability. In total, 736 patients were examined using either the Mi Mark technique or dilatation and curettage (D&C). In the pre-menopausal and post-menopausal women, in the study group, 11% and 30%, respectively, of the Mi Mark specimens proved too scanty for evaluation. In women aged over 60 the proportion of specimens that were inadequate for diagnosis was around 60% and the Mi Mark technique was not therefore considered to be suitable for use in this age group. If the latter group is excluded, the Mi Mark procedure could replace D&C in 47% of cases. Where the sampling material obtained was inadequate a secondary D&C was performed, following which an atrophic endometrium was usually found, although endometrial cancers were detected in 2 cases. Thus, an inadequate specimen obtained by means of the Mi Mark helix did not exclude the possibility of endometrial malignancy. When questioned, 8% of the patients stated that they considered the pain associated with the examination to be severe. On the other hand, 93% were prepared to undergo another Mi Mark procedure if necessary. The Mi Mark technique was considered to be adequate in terms of both acceptability and accuracy provided a D&C was performed in cases where the Mi Mark specimen was inadequate for evaluation.