Biomedical subjects
G Samsioe
Publications and source records attributed to G Samsioe.
Effects of norethisterone acetate addition to estradiol in long term HRT.
OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of hormone replacement therapy (HRT) among postmenopausal women living in the Lund area of Southern Sweden and to analyze treatment effects in different types or routes of HRT administration, as well as to compare with unopposed estrogen therapy. METHOD: in an ongoing, large population-based, prospective cohort study, this interim analysis included 3900 women. Of them, 693 postmenopausal women were eligible in the present analyses as they continued to use one of the four commercial HRT products for at least 2-3 years, i.e. continuous oral estradiol (E(2)) 2 mg+norethisterone acetate (NETA) 1 mg (CON-O), sequential oral estradiol 2 mg + norethisterone acetate 1 mg (CYC-O), sequential transdermal estradiol 50 microg + norethisterone acetate 250 microg (CYC-TRANS) and estradiol monotherapy. These women completed one generic questionnaire and one specific 'hormonal' questionnaire, as well as a personal interview pertaining to socio-demographics, detailed status of HRT use, and therapeutic efficacy and untoward side-effects by HRT. RESULTS: comparing the three combined E(2)+NETA groups with E(2) monotherapy, the beneficial effects on sexual desire and emotional well-being were significantly less in the combined groups than in E(2) monotherapy group. There was no significant difference regarding the negative side-effects between the groups. No significant difference was found between CON-O and CYC-O groups either in positive effects or in negative side-effects. A higher prevalence of positive effects was found in CYC-TRANS group than that in CYC-O group, especially in amelioration of sleep and urinary symptoms. Higher odd ratios of negative effects by HRT, such as irregular bleeds, weight gain, food craving and skin disorders were also found in CYC-TRANS group. CONCLUSION: in long-term HRT administration, the addition of a progestogen in HRT could compromise the beneficial effects of estradiol, particularly, the effects on women's emotional well being and psychosexual functioning. Administration of NETA continuously and sequentially had similar therapeutic efficacy and tolerability. More marked positive effects, such as improving of sleep and urinary symptoms, as well as nuisance side-effects, i.e. irregular bleeds, weight gain, food craving and skin disorders were encountered by the women using sequential transdermal regimen
Maturitas, the european menopause journal, becomes 'Official journal of the european menopause and andropause society'
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Dyslipidaemia and impaired well-being in middle-aged women reporting low Sense of Coherence. The Women's Health in the Lund Area (WHLA) Study.
OBJECTIVE: A low Sense of Coherence (SOC) is a concept related to a feeling of ill health. Not much is known about possible relationships between SOC and biological factors. SETTING: Population-based study of middle-aged women. SUBJECTS AND METHODS: Four-hundred-and-fifty women participated as a subgroup of a larger study of cardiovascular risk factor screening. A self-administered questionnaire with 29 questions related to SOC was completed in addition to questions on social background factors and medical history. RESULTS: The mean score of SOC was 150.9 (SD 23.4). HDL cholesterol was lower (p < 0.05) and triglyceride levels higher (p < 0.05) in women with low SOC (1.5 and 2.1 mmol/L) compared to women with medium (1.8 and 1.4 mmol/L) or high SOC (1.7 and 1.5 mmol/L). In multiple regression analysis, a low HDL cholesterol level was still significantly associated with low SOC (p < 0.05) after adjustment for possible confounders. Women reporting low SOC were further characterised by a higher proportion of subjects with regular clinical visits for health care (49% vs 35% and 29%). CONCLUSIONS: Middle-aged women reporting low SOC showed lower HDL cholesterol and higher triglyceride levels, and reported more clinical visits and medical symptoms than women with higher SOC.
Quality of life in long-term survivors of cervical cancer.
OBJECTIVE: The aim of this study was to evaluate the quality of life within a sample of cervical cancer survivors. STUDY DESIGN: In this study, 46 cervical cancer survivors at clinical stage I or II and one survivor at stage 0, were evaluated. Two control groups were selected from an ongoing cohort study, in which 527 women were postmenopausal and 344 women were postmenopausal with HRT. All controls and cancer survivors completed a self-evaluating questionnaire pertaining to personal conditions, medical surveillance, individual well-being and quality of life. RESULTS: Eighteen cervical cancer survivors were ovaries preserved. A total of 28 survivors, who had an oophorectomy, were compared with the controls. Most of the cancer survivors had a good socio-economic background and an active lifestyle. Forty-two percent were currently under medical surveillance and used medication regularly. The ratio of HRT users was higher in the oophorectomy group (36% in both short- and long-term therapy). With regard to the quality of life, there were no remarkable differences between oophorectomy survivors and controls. Except that the psychological condition in the ovaries preserved group was worse, the rest of the findings concerning the quality of life derived from the ovaries preserved group were rather close to that of the oophorectomy group. CONCLUSION: The quality of life in long-term cervical cancer survivors is generally satisfactory. The positive results may be due to the higher ratio of HRT use, ovarian preservation, good education, working conditions, as well as an active lifestyle.
Quality of life in endometrial cancer survivors.
OBJECTIVE: The aim of this study was to evaluate the health-related quality of life in survivors of endometrial cancer (EC); and to identify common problems that they may encounter, in the hope of paving the way to improving their quality of life. STUDY DESIGN: We investigated and compared the health conditions and quality of life between EC survivors and the general population as a control group. There were 61 EC patients who were at clinical stage I-III and survived for 5-7 years after the primary treatments. The control group was composed of 527 healthy postmenopausal women. All of them completed a self-evaluated questionnaire pertaining to personal conditions, medical surveillance, individual well-being and quality of life. RESULTS: The EC survivors were divided into two groups: an older group (n = 34) and a younger group (n = 27). The latter was compared with the controls. In general, most of the EC survivors were old, low-educated women. The majority of them were in a poor condition. They were inactive, received medical surveillance and had regular medication. The distribution of various complications was higher in the older EC group while the climacteric symptoms were more common in the younger EC group. In both EC groups, the quality of life was lower than in the controls. The prevalence of somatic symptoms was higher in the older EC survivors and psychological problems were a common complaint of the younger EC survivors. CONCLUSION: The quality of life was poor in the EC survivors. To improve their life quality, earlier psychological counseling should be offered to EC survivors, in particular to younger and single women, and hormone replacement therapy (HRT) should be recommended, but on a selective basis, to those patients at low risk of cancer recurrence.
Urogenital symptoms in women aged 50-59 years. Women's Health in Lund Area (WHILSA) Study Group.
Problems related to the urogenital tract are common in elderly women. Control of micturition is often impeded and questionnaire-based studies have reported a prevalence of poor control of micturition in about 30% of postmenopausal women. In an ongoing cohort comprising women born between 1935 and 1945, an interim analysis was performed in 1800 women based on an interview and questionnaire. The prevalence of urinary incontinence was found to be 33%, which is in accordance with previous reports. The main difference between the interview and the questionnaire was that the interview could take into account intensity as well as intermittence of symptoms. There were no differences between premenopausal women and postmenopausal women using or not using hormone replacement therapy. In agreement with earlier studies, we found poorer control of micturition in parous women. A higher percentage of incontinence was also found in women who had lost more than 5 kg in body weight during the preceding 5 years. In addition, women with a family history of diabetes were more prone to complaints of incontinence. Of the 155 women who had a family history of diabetes, 66 were incontinent (p < 0.01). It was also found that women who were incontinent were more often on regular surveillance for various diseases, using more medications regularly and had been hospitalized during the last 5 years more often than women who were continent. There were no differences in smoking habits. The present results imply that urinary incontinence in women is of a complicated origin and that the hormonal situation plays a minor role for this socially handicapping symptom.
Cardiovascular disease in postmenopausal women.
With many risk factors for cardiovascular disease, myocardial infarction in particular now being well defined, it becomes increasingly clear that a majority of these factors are not only age, but also gender specific. Confidential risk factors such as smoking, hypertension, diabetes mellitus, overweight and hyperlipaemia, might have a different impact in women than in men. Moreover, there are substantial clinical differences between male and female ischaemic heart disease, both as to presentation, as well as to diagnosis, therapy and prognosis. In addition to a discussion to the risk factors mentioned above, the cardioprotective actions of oestrogens will be reviewed.
Urogenital aging--a hidden problem.
Urogenital problems in the elderly female population are experienced by one third of women from the age 50 years and onward. Symptoms from the lower urinary tract include incontinence, urethritis, and recurrent urinary tract infections. Atrophic changes within the bladder neck and urethra could be corrected by estrogen administration even at doses so low that endometrial proliferation is avoided. Hence such estrogens could be given without progestogen comedication. Control of micturition is a complex process of which estrogen deficiency is only one of several factors. The aging process with subsequent changes in membrane permeability, neuromuscular function, and collagen synthesis contributes to the local problems of control of micturition. In addition, the central control may also be affected by degenerative changes of the nervous system. Vaginal symptoms comprise dryness of vagina, dyspareunia, and recurrent vaginitis often followed by a foul odor and discharge. The microflora with lactobacilli and low pH as seen in fertile women is gradually replaced by a mixed germ flora including several of the pathogenic organisms common in urinary tract infections. Vaginal pH increases from around 4 to between 6 and 7. It is a puzzling fact that the urogenital tissues seem to be more "sensitive" to estrogens than other tissues. Conformational changes of the estrogen receptor(s) brought about by the local cytokine milieu is one possibility to explain the situation. The systemic absorption of low-dose estrogen preparations is dependent on the status of the vaginal mucosa. Absorption is high when the vaginal mucosa is atrophic and gradually decreases (but not to zero) as the vaginal mucosa matures under estrogen influence.
A study of European womens' experience of the problems of urogenital ageing and its management.
OBJECTIVES: A six country Pan-European study of aspects of urogenital ageing (UGA). METHODS: The study was carried out using a stratified random sample of 3000 women between the ages of 55 and 75 years. RESULTS: A total of 30% suffered from UGA symptoms, of whom 60% made efforts to alleviate their UGA problems, most commonly using HRT. There were some international differences regarding womens' perceptions of HRT, sexual relationships, prevalence and treatment of UGA problems and their attitudes to them across the six European States. CONCLUSIONS: Despite some international differences there was a generally similar experience of UGA problems across the six European populations studied, with a minority of women suffering significantly, however the distress of that subgroup highlighted the need for health professionals to appreciate the impact of UGA on those affected and to understand that many of these older women may be reticent in seeking help.
Osteoporosis--an update.
Osteoporosis and subsequent fractures is a rapidly growing major health problem in many parts of the world. Even if prevalence and incidence are high in Europe, rate of increase is even higher in Asia. The majority of fractures occur in women underlining the importance of ovarian deficiency. Genetic factors and lifestyle greatly influence the incidence and prevalence both in men and women and the importance of estrogen deficiency at ages over 85, where a large number of fractures actually occur, may well be questioned. Among several risk factors the amount of bone mass remains crucial. Several techniques adequate in accuracy and precision exist to determine bone mass. The costs for these measurements are not negligible. Several pharmacologic regimens look promising for the prevention of osteoporosis and indeed for treatment of established osteoporosis. However, long-term data and clinical experience are warranted prior to establishing these pharmacological tools in the field of osteoporosis. For HRT and ERT such data are available. ERT and indeed HRT may halve the risk of osteoporotic fractures in women at least in current users. The effect at least on bone mass wears off after discontinuation of treatment but is never totally lost. In the interest of health care costs it is suggested that HRT could be started 15-20 years after the menopause and still provide protection for subsequent fractures.
Hormone replacement therapy and vaginal bleeds. Theoretical aspects and clinical management.
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Effects of vaginally delivered estrogens.
INTRODUCTION: Atrophic condition in the vagina and lower parts of the urethral tract are common in elderly women. From population based surveys it has been estimated that 40% or more of women over 60 complain of insufficient control of micturation. In addition, lower urinary tract infections are common in this age group and recurrent cystitis is a scourge for many women (1, 2). Vaginal problems such as vaginal dryness, dyspareunia as well as infectious and non infectious disorders in the vagina may be even more common in elderly women (3) Vasomotor symptoms such as sweats and hot flushes commonly commence around the time of the menopause. In the majority of cases urogenital dysfunction does not become a problem until a decade later. Endogenous estrogens decline during the climacteric and the fall of estradiol levels from the time of onset of vasomotor symptoms until commencement of urogenital problems cannot be disregarded. In other words, it seems as if urogenital integrity can be maintained at lower estrogen levels than those required to resist vasomotor symptoms and conserve bone mass. Further evidence for this concept is achieved from numerous clinical studies in which various estrogens have been administered both orally and vaginally to elderly women with signs of urogenital atrophy which have resulted in amelioration. Such an alleviation of urogenital symptoms can be achieved without provoking endometrial growth.
The menopause revisited.
The continuing growth of female life expectancy has resulted in a marked increase of women in years beyond the menopause. Women can nowadays expect to live one-third of their lives in a potential hormonal deficiency state. Women over 50 comprise 17% of the total population of any country in the modern western world. Any decision regarding their health issues will have a great impact on our limited health care resources. There is no doubt that estrogen replacement therapy effectively mitigates hot flushes and other vasomotor symptoms and more effectively so than other treatment modalities. Vasomotor symptoms affect more than half of the female population around the menopause with a mean duration of 2-3 years. When used to treat vasomotor symptoms hormone replacement therapy has repeatedly been shown to be cost effective. It is also well documented that hormone replacement therapy effectively prevents bone loss and osteoporotic fractures as well as heart disease. The majority of cases of both fractures and heart disease occur at ages over 75 and concern has been expressed if treatment from the menopausal age to the onset of fractures or heart disease is cost effective with regard to the perceived increase in risk of side effects, especially breast cancer. One important aspect in this scenario is the control system that we impose on women on HRT. Given our present preparations women are recommended an annual check-up. If the number of office procedures and visits to the clinic cannot be substantially reduced long-term therapy with HRT is not cost effective. An exception from this rule is the treatment of urogenital estrogen deficiency using low dose vaginal estrogens. Systemic concentrations of estrogens following such administration are negligible. Hence, low dose estrogen topical applications can be made an OTC preparation. As no control system is needed this therapy seems to be highly cost effective. The pharmaceutical industry is urged to produce better products so that side effects such as bleeding problems leading to a number of visits to the clinic and fear of cancer among women can be avoided. Recent data also imply that estrogen treatment may confer protection against Alzheimer's disease. Breast cancer is the remaining controversy even if recent data imply that estrogens could be given to women operated on for breast cancer without increasing the risk of a relapse.
Hormone replacement therapy and the breast cancer issue.
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Is HRT indicated for the prevention of cardiovascular disease?
There is compelling evidence to suggest that estrogen administration to women of climacteric age reduces subsequent myocardial infarction by some 50%. Accumulating data also suggests estrogens confer substantial protection from stroke. Given this rationale, it is prudent to suggest to regulatory bodies that estrogen treatment would have this indication. Estrogens have other well-defined, and less well-defined, effects on various diseases; but observational studies suggest a decrease also in the overall mortality in estrogen users compared to nonusers. The critique of this concept is mainly that there is but one small clinical trial, and that observational data may be subject to confounders and biases. Questions have been raised whether the estrogen user comes from a preselected healthier population. Several of the observational studies are large enough to control for preexisting morbidity, including risk factors of cardiovascular disease. If anything, it would seem that women carrying risk factors inclusive of a sustained myocardial infarction are even better off (yielding a relative risk of 0.2) than those without risk factors. In order to protect the endometrium from malignant transformation and to ensure an acceptable bleeding pattern, a progestogen co-medication must be given with the estrogen. Observational data are based almost exclusively on estrogen-alone preparations, and concern has been expressed that progestogen addition may attenuate or even eliminate cardioprotection. Different estrogens at different doses, with different modes of administration, may also have an impact in this respect. The large variety of existing schedules for the administration of the progestogen adds to the difficulty in interpretation of the data with regard to cardiovascular disease.(ABSTRACT TRUNCATED AT 250 WORDS)
Coagulation and anticoagulation effects of contraceptive steroids.
Epidemiologic data support the notion that first-generation high-dose oral contraceptives (containing > 80 micrograms of estrogen) increased the incidence of thromboembolic events. The quantitative interpretation of these data is difficult because results were often confounded by life-style factors and inadequate diagnostic procedures. With the introduction of modern low-dose combination oral contraceptives, the incidence of thromboembolic events decreased markedly. Although all combined oral contraceptives induce statistically significant changes in hemostatic factors, these changes are generally within normal ranges, and their clinical significance is questionable. Overall, increased activity in hemostatic mechanisms appears to remain in balance. Progestin-only formulations seem to affect hemostatic parameters to a much lesser degree, and their use has not led to an increased risk of thrombosis. Interindividual variations in pharmacokinetics and pharmacodynamics of contraceptive steroids are great and could tentatively explain why certain persons may be at an increased risk of thrombosis. Although most studies have looked at steady-state conditions during contraceptive steroid intake, it would seem prudent to investigate further the hemostatic system during a non-steady-state condition, such as that occurring during the first few days of the pill-free interval.
Transdermal oestradiol and cardiovascular risk factors.
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