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Biomedical subjects

G Samsioe

Publications and source records attributed to G Samsioe.

At least 19 recordsLinked to original sources
PubMed2006

Endometrial safety, overall safety and tolerability of transdermal continuous combined hormone replacement therapy over 96 weeks: a randomized open-label study.

OBJECTIVES: To establish whether transdermal continuous hormone replacement therapy (HRT) with estrogen/progestogen provides adequate long-term endometrial protection in postmenopausal women over a period of 96 weeks. METHODS: This multicenter, randomized, open-label, parallel-group study evaluated the endometrial effects and overall safety and tolerability of a transdermal matrix patch delivering estradiol (E2) 50 microg/day and norethisterone acetate (NETA) 140 microg/day (Estalis; patches applied twice weekly without intermediate breaks) and a once-daily oral comparator (Kliogest; one tablet containing E2 2 mg/NETA 1 mg) in postmenopausal women. A total of 406 women with an intact uterus, aged 44-69 years, were randomized in the 48-week core phase of the study, and 239 continued into the 48-week extension phase. Subjects were randomized in the ratio 3 : 1 to transdermal or oral E2/NETA treatment. RESULTS: No cases of endometrial hyperplasia or endometrial cancer were reported with either treatment during the core or extension phase. Both treatments were generally well tolerated, with most adverse events (>90%) being mild to moderate, although minor differences in the tolerability profile were observed between treatments. CONCLUSIONS: Continuous combined transdermal HRT with E2/NETA shows no evidence of an increased endometrial hyperplasia or endometrial cancer risk over a 96-week period.

Administration, Cutaneous↗
PubMed2004

Bone mineral density changes in young women: a two year study.

Achievement of a high peak bone mass is considered a pivotal preventive strategy against future osteoporotic fractures. The ostensible interaction between physiology and lifestylefor the development of bone mass over time is sparsely outlined among young women. The aim of this study was to follow bone density and bone resorption over time among healthy young women in relation to lifestyle factors and to evaluate the perceived influence of other factors. Data were collected in 1999 and in 2001. Healthy young women (n=152) were given a structured questionnaire, a heel bone scanner (dual X-ray absorptiometry) performed bone mineral density measurements and deoxypyridinoline was measured in urine. Data were analyzed by linear, multiple and logistic regression analysis. Mean bone mineral density (BMD) was 0.562 g/cm2 (+/-0.090). Bone density at baseline was the best predictorfor the bone density atfollow-up. Bone density at baseline together with smoking and alcohol (dichotomized) accounted for 86.5% of the variation in bone density 2 years later. Of the participants 62% had decreased/unchanged bone density and 38% had increased their bone density from 1999 to 2001. Use of oral contraceptives or alcohol at baseline was associated with an increased risk of belonging to the group who decreased their bone density. Deoxypyridinoline was not a strongpredictor to bone density and all potential predictors of deoxypyridinoline had a minor influence (<10%). In conclusion, lifestyle behaviors such as use of oral contraceptives, smoking and alcohol consumption seem to have a negative influence on BMD development among young women and warrant further scrutiny.

Absorptiometry, Photon↗
PubMed2004

Low-dose oral combination of 17beta-estradiol and norethisterone acetate in postmenopausal women decreases factor VII, fibrinogen, antithrombin and plasminogen activator inhibitor-1.

OBJECTIVE: Controversies still persist concerning hormone replacement therapy (HRT) and its effects upon blood coagulation and fibrinolysis. This study was carried out to evaluate possible effects of continuously administered low-dose 17beta-estradiol (E2) and norethisterone acetate (NETA) on coagulation and fibrinolytic factors. METHODS: We conducted a randomized double-blind, placebo-controlled, 1-year study in 120 healthy postmenopausal women. The three groups consisted of a placebo group (n = 40), a group receiving oral continuous combined E2 1 mg and NETA 0.25 mg (n = 40) and a group receiving oral continuous combined E2 1 mg and NETA 0.5 mg (n = 40). RESULTS: The two low doses of E2-NETA induced significantly lower plasma levels of factor VII, fibrinogen, antithrombin and plasminogen activator inhibitor-1 (PAI-1), compared with placebo treatmen CONCLUSIONS: Low-dose E2 (1 mg) in combination with NETA resulted in favorable changes of factor VII activity and fibrinogen, compared with placebo. The lower plasma levels of PAI-1 may lead to increased fibrinolytic activity. These findings suggest a decreased risk of developing coronary heart disease. Antithrombin activity was also reduced, which may increase the risk of developing venous thromboembolism. The clinical significance of the lower levels of these factors remains to be clarified.

Administration, Oral↗
PubMed2004

Cardiovascular risk factors in middle-aged women and the association with use of hormone therapy: results from a population-based study of Swedish women. The Women's Health in the Lund Area (WHILA) Study.

OBJECTIVE: Cardiovascular diseases in women are multifactorial. Women carry different risk factors compared to men and these specific risk factors need to be delineated, particularly in relation to the hormonal situation, and effects of diet and lifestyle. METHODS: Out of the total cohort of 10,766 women born 1935-1945 living in the Lund area of southern Sweden, 6917 women completed a generic questionnaire and underwent a physical and laboratory assessment. According to hormonal status, 492 women were premenopausal (PM), 3600 were postmenopausal without hormone therapy (HT) (PM0) and 2816 were postmenopausal with ever-use of HT (PMT). Major cardiovascular risk factors as well as level of education, diet, and degree of physical activity were assessed in relation to hormonal status. RESULTS: Compared to the PM0 group, the women in the PMT group had a higher level of education, more often worked full time, more often had sedentary work and lived a more regular life. They also had a lower rate of cigarette consumption, lower waist-to-hip ratio and lower body mass index than women in the PM0 group. The PMT group had lower levels of serum total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides than the PM0 group and also had lower systolic and diastolic blood pressures, a lower prevalence of type II diabetes mellitus, of deep venous thrombosis and of coronary artery disease. Low-risk factors for cardiovascular disease and high level of education were still associated with HT, after adjustment by multiple logistic regression. Major risk factors for coronary heart disease were similar between the PM and the PMT groups. CONCLUSION: Use of HT is accompanied by a lower risk profile for cardiovascular disease and also by several factors indicating a healthier lifestyle.

Aged↗
PubMed2004

Transdermal hormone therapy: gels and patches.

Hormone therapy (HT) in the climacteric has a number of beneficial effects including mitigation of climacteric symptoms and prevention of osteoporosis. Administration of HT via the transdermal route avoids hepatic first-pass metabolism and therefore the high plasma levels of estrogen metabolites that are associated with oral administration. Patch formulations have traditionally been the most common form of transdermal HT. However, as patches may be associated with local skin reactions, gel formulations have been developed in an attempt to improve acceptability and compliance with transdermal HT. Patch and gel formulations are equally as effective in treating climacteric symptoms and improving bone mineral density, and the effects are comparable to those achieved by oral HT.

Administration, Cutaneous↗
PubMed2003

Influence of smoking and oral contraceptives on bone mineral density and bone remodeling in young women: a 2-year study.

The objective of the study was to explore the influence of menstrual irregularities, oral contraceptives and smoking on bone mineral density (BMD) development and bone turnover with time. Healthy young women (n = 118) were divided into four categories: (a) women neither smoking nor using oral contraceptives; (b) women who were smokers; (c) women using oral contraceptives; (d) women who were smoking and using oral contraceptives. They responded to a validated questionnaire with 34 questions concerning lifestyle and the Sense of Coherence scale (SOC). BMD was measured by dual energy x-ray absorptiometry (DEXA). Deoxypyridinoline (DPD) was measured in urine. Data were analyzed by multiple linear regression analysis. Among smokers, BMD level decreased during a 2-year period and smoking was associated with a larger negative change in BMD. Use of oral contraceptives moderated the negative impact of smoking. Women using oral contraceptives at baseline and with regular bleeding induced by contraceptive pills had a significantly higher BMD at baseline and at follow-up. They also had lower SOC than women who had natural regular bleedings. Use of oral contraceptives in combination with smoking was linked to high alcohol consumption and higher frequency of self-reported body weight reduction, which reduced the negative BMD change in this category. DPD level and difference were strongly associated with estrogen influence. It is concluded that smokers without OCs had a negative BMD development and BMD in young women with irregular menstruations seems to be improved by OC.

Absorptiometry, Photon↗
PubMed2003

Socio-demographic and psychosocial factors are associated with features of the metabolic syndrome. The Women's Health in the Lund Area (WHILA) study.

AIM: The aim was to analyse any associations between socio-demographic and psychosocial factors and different features of the metabolic syndrome in a geographically well-defined population of middle-aged women. METHODS: A population of 10 766 Caucasian women aged 50-59 years was investigated regarding biological and socio-demographic conditions, physical activity, dietary habits, aspects of quality of life, and subjective physical and mental symptoms. The screening instrument was used to discriminate subjects as positive or negative on one or more of a total of eight variables considered to be linked to the metabolic syndrome. The cut-off values for positive screening were non-fasting capillary blood glucose >/= 8.0 mmol/l and serum triglycerides >/= 2.3 mmo/l, BMI >/= 30 kg/m2, WHR >/= 0.90, blood pressure >/= 160 and/or 95 mmHg, a family history of diabetes, and pharmacological treatment for hypertension or hyperlipidaemia. RESULTS: Altogether 6805 women (63.2%) participated: 3535 with positive and 3270 with negative screening. Multiple logistic regression analyses showed that comprehensive (OR 1.62, 95% CI 1.41-1.87) and upper secondary (1.40, 1.24-1.57) school, low physical quality of life (1.41, 1.23-1.61) and high sum of subjective physical symptoms (1.06, 1.04-1.08) were positively associated with one or more features of the metabolic syndrome, while high leisure-time exercise and healthy diet (0.84, 0.71-0.99), and low (</= 83 g/week) (0.71, 0.63-0.81) and moderate (84-167 g/week) (0.78, 0.65-0.93) alcohol consumption were negatively associated. CONCLUSIONS: To identify middle-aged women with cardiovascular risk factors and high risk for diabetes, it is important to consider not only biological, but also socio-demographic and psychosocial conditions.

Alcohol Drinking↗
PubMed2002

Bone mineral density and lifestyle among female students aged 16-24 years.

The objective of the study was to investigate bone mineral density and bone turnover among female students aged 16-24 years in relation to lifestyle factors, such as dietary habits and physical activity, as well as physiological factors, such as age, body weight, and menstrual pattern. Female college and university students (n = 218) were given a validated questionnaire with 34 questions concerning diet, recreational physical activity, alcohol, smoking, menstrual pattern, weight gain and loss. Bone mineral density (BMD) measurements were performed using a heel bone scanner (DEXA). Deoxypyridinoline (DPD) levels were measured in urine samples. The data were analyzed by linear regression and multiple regression analysis. The mean BMD was 0.568 g/cm2. Multiple regression showed that hormonal age was a better predictor of high BMD and low bone mineral turnover than chronological age. The best model predicting high BMD was composed of physical activity, regular menstruation, hormonal age and body weight. Smoking, alcohol consumption and current calcium intake did not contribute to the model. A negative association between BMD and DPD was found, indicating an enhanced bone remodeling. A correlation was found between DPD and hormonal age, chronological age, sugar intake and time with irregular menses. In multiple regression analysis, hormonal age, high sugar intake and weight loss were the factors best predicting DPD. BMD was positively influenced by a healthy lifestyle, including a physically active life and healthy dietary habits without dieting. Our study shows that hormonal age is a stronger BMD predictor than chronological age. Menstrual disturbances might be an indication of a risk for low BMD and might therefore be a reason for measuring BMD among young females.

Absorptiometry, Photon↗
PubMed2002

Effects of tamoxifen and estradiol on estrogen binding sites in the urogenital tract: an experimental study in the rabbit.

The aim of the study was to investigate the effects of estradiol and tamoxifen alone and in combination on the estrogen binding site status of the urogenital tract in the rabbit. Bilaterally ovariectomized rabbits were divided into four groups of six. Whereas the control group received no treatment, the remaining rabbits were treated with estrogen or/and tamoxifen. Cytosolic and nuclear fractions were isolated from the uterus, vagina, urethra and urinary bladder and used for binding site assay, by radioligand binding. The total weight of the rabbit vagina and uterus was increased significantly by both estradiol, tamoxifen and the combination of the two. The total weight of the urethra was increased only in the combination group. The cytosol binding site was downregulated by estradiol, tamoxifen and combination in the uterus, and in the vagina. Cytosol binding site in the urethra was not detected. The combination of estrogen-tamoxifen markedly reduced the nuclear binding site in the urethra and decreased affinity of the nuclear binding sites in all three tissues. The data suggest that tamoxifen has a specific ability to modulate the transcriptional activity of the estrogen binding sites in the rabbit urogenital tract.

Animals↗
PubMed2001

A screening procedure detecting high-yield candidates for OGTT. The Women's Health in the Lund Area (WHILA) study: a population based study of middle-aged Swedish women.

The objective was to evaluate a screening procedure for detecting high-yield candidates for an OGTT, in a population of middle-aged Swedish women. A two-step screening procedure was performed in 6917 subjects. Women with a positive screening outcome, i.e. increased non-fasting capillary blood glucose, serum triglycerides, BMI, WHR, blood pressure or a family history of diabetes, pharmacological treatment of hypertension or hyperlipidaemia at the primary screening underwent a 75-g OGTT. A control group of women with negative screening outcome (n = 221) also underwent an OGTT. In 2923 women with positive screening outcome, 517 (17.7%) had NFG/IGT (normal fasting venous blood glucose <5.6 mmol/l and 2h-glucose 6.7-9.9 mmol/l), 109 (3.7%) IFG/IGT (fasting 5.6-6.0 and 2h 6.7-9.9 mmol/l) and 223 (7.6%) diabetes (fasting > or = 6.1 or 2h > or = 10.0 mmol/l). These figures were three, five and four times higher, respectively, than in the control group with negative screening outcome (p < 0.001 for all); no differences were found for IFG/NGT (fasting 5.6-6.0 and normal 2h < 6.7 mmol/l) (4.6% vs. 7.2%). For predicting impaired glucose metabolism (IFG/NGT, NFG/IGT, IFG/IGT, diabetes), the screening instrument showed an estimated sensitivity of 70%, specificity of 55%, positive predictive value of 34% and negative predictive value of 85%, based on findings in the control sample. The odds ratio for NFG/IGT increased with the numbers of risk factors from 2.8 to 7.7, for IFG/ IGT from 5.7 to 55.0 and for diabetes from 2.5 to 18.1. High B-glucose, WHR and BMI were the three most important factors associated with an increased risk for NFG/IGT, IFG/IGT and diabetes. In subjects with IFG/NGT, none of the screening variables was associated with an increased risk. In summary, the results show a population screening method focused on features of the metabolic syndrome that discloses high-yield candidates for OGTT. A high prevalence of unknown impaired glucose metabolism was found in middle-aged women with a positive screening profile.

Analysis of Variance↗
PubMed2000

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

Administration, Cutaneous↗
PubMed2000

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.

Analysis of Variance↗
PubMed1999

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.

Adult↗
PubMed1999

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.

Aged↗
PubMed1999

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.

Cohort Studies↗
PubMed1998

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.

Antioxidants↗