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North American Menopause Society. Estrogen and progesterone use in postmenopausal women: 2010 position statement of the North American Menopause Society
Abstract
Objective: To update for both clinicians and the lay public the evidence-based position statement published by The North American Menopause Society (NAMS) in July 2008 regarding its recommendations for menopausal hormone therapy (HT) for postmenopausal women, with consideration for the therapeutic benefit-risk ratio at various times through menopause and beyond.
Methods: An Advisory Panel of clinicians and researchers expert in the field of women's health was enlisted to review the July 2008 NAMS position statement, evaluate new evidence through an evidence-based analysis, and reach consensus on recommendations. The Panel' s recommendations were reviewed and approved by the NAMS Board of Trustees as an official NAMS position statement. Also participating in the review process were other interested organizations who then endorsed the document.
Results: Current evidence supports a consensus regarding the role of HT in postmenopausal women, when potential therapeutic benefits and risks around the time of menopause are considered. This paper lists all these areas along with explanatory comments. Areas that vary from the 2008 position statement are noted. A suggested reading list of key references published since the last statement is also provided.
Conclusions: Recent data support the initiation of HT around the time of menopause to treat menopause-related symptoms; to treat or reduce the risk of certain disorders, such as osteoporosis or fractures in select postmenopausal women; or both. The benefit-risk ratio for menopausal HT is favorable for women who initiate HT close to menopause but decreases in older women and with time since menopause in previously untreated women.
... The menopausal transition marks a time of great variability in reproductive hormones [1]. Natural menopause is defined after 12 consecutive months of amenorrhea without any self-evident, pathologic reason [2]. ...
Background. In recent decades, the frequency of surgical interventions on reproductive system organs has been steadily increasing. In gynecological practice, preference is given to minimally invasive surgery and precision treatments, especially involving ovaries. Despite the modern approach, it is not always possible to preserve this endocrine organ, which leads to post-surgical menopause (PSM). The relatively high incidence of total hysterectomy-associated PSM and primary hypothyroidism in late reproductive age often leads to their combination. Clinical manifestations aggravating each other form an unfavorable vicious circle. Aim. To study the features of the PSM course with concomitant primary hypothyroidism. Materials and methods. A prospective clinical study included 130 women aged 45 to 55 years with a history of PSM. The main group consisted of 70 patients with PSM with subclinical primary hypothyroidism. A control group included 60 PSM patients without thyroid disorders. We assessed the effect of hypothyroidism on the PSM course by comparing several indicators in the main and control groups. Results. It was found that in the main group patients, severe 26.5% and moderate 38.8% menopausal syndrome prevailed, while in the control group patients, such forms were twice as common. In the women of the main group, the levels of triglycerides were higher than those in the control group by 1.3 times (2.6±0.86 mmol/L and 1.43±0.33 mmol/L, respectively). The total serum alkaline phosphatase activity in patients in the study groups was 29.8% higher than in healthy women. Conclusion. It can be concluded that the severity of menopausal disorders depends on the thyroid status, with more severe in patients of the main group with hypothyroidism. In addition, in patients of the main group with hypothyroidism, dyslipidemia is more pronounced, which predisposes them to severe diseases in the future, in particular cardiovascular disorders, the unfavorable course of metabolic syndrome, and the development of postmenopausal osteoporosis.
Aims:
To assess the correlation between calf circumference and cardiac metabolic risk factors such as hypertension, abnormal blood glucose and dyslipidaemia among middle-aged and elderly women.
Methods:
The cross-sectional study population consisted of 476 female participants aged 40-80 years, including 304 perimenopausal and 172 postmenopausal women. Calf circumference, body mass index (BMI), blood pressure, blood glucose and blood lipids were measured. Logistic regression analysis was used to evaluate the study aims.
Results:
Calf circumference was lower in postmenopausal than perimenopausal women, and postmenopausal women had the highest rates of hypertension, abnormal blood glucose and abnormal blood lipids. Pearson correlation coefficients showed that calf circumference was positively correlated with triglycerides (TGs), BMI, fasting plasma glucose (FPG),2-h plasma glucose, glycated haemoglobin (HbA1C), systolic blood pressure and diastolic blood pressure; and negatively correlated with high-density lipoprotein cholesterol (HDL-C) and total cholesterol (TC). The group with the lowest quantile of calf circumference had higher rates of hypertension (odds ratio (OR)2.14,95% confidence interval (CI)1.67-2.74),dysglycaemia (OR1.40,95%CI1.03-1.90) and dyslipidaemia (OR2.14,95%CI 1.86-2.46).
Conclusion:
In perimenopausal women, measurements of calf circumference can be used to predict the presence of cardiac metabolic risk factors, which can be detected by observing blood pressure, blood glucose, and blood lipids.
We evaluated the efficacy of minodronic acid for osteoporosis prevention after bilateral oophorectomy for gynaecologic disease in premenopausal women. Bone mineral density (BMD) and young adult mean (YAM) data from the lumbar vertebrae and femur and bone alkaline phosphatase (BAP)/tartrate-resistant acid phosphatase 5 b (TRACP 5 b) data were obtained for 101 patients. The primary endpoint was the efficacy of minodronic acid for osteoporosis prevention. Fifty-five and 31 patients were assigned to medication and no medication groups, respectively. The decrease in BMD and YAM and the increase in BAP/TRACP-5b were significantly more suppressed in the medication group. There were no significant between-group differences in age at oophorectomy, cancer type, body mass index (BMI), and adjuvant therapy. There were no adverse events due to minodronic acid. Minodronic acid may prevent osteoporosis after oophorectomy in premenopausal women with gynaecologic disease, independent of age at oophorectomy, cancer type, BMI, or adjuvant therapy.
• Impact statement
• What is already known on this subject? Although the current strategy for osteoporosis prevention after premenopausal bilateral oophorectomy (b-OVX) is hormone therapy (HT), there is no consensus on the treatment duration or adverse events.
• What do the results of this study add? Therefore, we planned a prospective study to evaluate the efficacy of prophylactic treatment for osteoporosis after b-OVX in premenopausal women with gynaecologic disease using minodronic acid, an oral bisphosphonate, which have a strong evidence of the treatment for osteoporosis. The result showed minodronic acid significantly suppressed the decrease in bone mineral density (BMD) and young adult mean (YAM) and the increase in bone alkaline phosphatase (BAP)/tartrate-resistant acid phosphatase 5b (TRACP 5b). Minodronic acid may prevent osteoporosis after oophorectomy in premenopausal women with gynaecologic disease, independent of age at oophorectomy, cancer type, BMI, or adjuvant therapy.
• What are the implications of these findings for clinical practice and/or further research? Minodronic acid treatment for osteoporosis prevention after premenopausal b-OVX may be effective as a therapeutic agent after the cessation of HT, or alternative for patients who are contraindicated for HT in breast cancer and thrombosis and should be administered with caution with a history of uterine or ovarian cancer.
Objectives:
This study aims to assess the effect of ultralow dose 0.005% estriol vaginal gel in women with genitourinary syndrome of menopause (GSM).
Methods:
In this prospective and multicenter single-arm study, efficacy was assessed by the evaluation of the epithelial maturation value (MV), vaginal pH, symptoms and signs of vulvovaginal atrophy. Tolerability, acceptability, and the effect on intimate relationships were also evaluated.
Results:
We included 35 postmenopausal women with moderate-to-severe vaginal dryness. The most bothering symptom reported was vaginal dryness. The mean increase in the MV after 7 and 14 days of treatment were 22.1 (P < 0.001) and 39.9 (P < 0.001) points, with an increase in the superficial cells of 17.7 percentage points (pp) (95% confidence interval [CI], 7.9-27.4; P < 0.001) and 41.4 pp (95% CI, 28.2-54.6; P < 0.001) observed at the timepoints. Additionally, the pH decreased by 0.6 ± 0.7 (mean ± SD) at 7 days (P < 0.0001) and by 1.1± 0.8 at 14 days (P < 0.0001) from a baseline mean value of 6.3 ± 0.8. The severity of vaginal dryness (range, 0 [none] to 3 [severe]) was significantly reduced by a mean of 1.4 points (P < 0.0001) at 7 days and 2 points (P < 0.0001) at 14 days.
Conclusions:
Ultralow dose 0.005% estriol vaginal gel produced a rapid improvement of most relevant symptoms and signs of GSM. This clinically meaningful response was observed from the initial days of treatment, confirming a fast onset and a progressive action.
Objectives:
This study aimed to further explore the efficacy and safety of Danggui Buxue Tang (DBT), a simple herbal formula, for improving the quality of life of women suffering from menopausal symptoms.
Methods:
A third clinical trial to determine the clinical efficacy of high-dose DBT for a period of 12 weeks was carried out. The standard Menopause-Specific Quality of Life (MENQOL) assessment chart was used for the evaluation. Safety was defined as an absence of direct estrogenic effects, serum inflammatory cytokines. Notably, interleukin IL-6, IL-8 and tumor necrosis factor TNF-α, known to be directly related to estrogenic reactions in menopause studies, were monitored.
Results:
The third clinical trial indicated an overall improvement in the four domains of MENQOL, offering further proof of the efficacy of DBT demonstrated in the two previous trials. The serial checks of the three cytokines related to estrogen activities did not show either upward or downward trends. The haphazard behavior reactions of the three cytokines offered indirect indications that DBT improved the MENQOL independently from estrogen activities.
Conclusions:
The three clinical trials using DBT to relieve menopausal syndrome have offered solid evidence for its efficacy. The uncertainty regarding whether the "phytoestrogen" contained in DBT had bioactivities similar to estrogen was alleviated through the confirmation that no strict estrogenic bioactivities were observed. The issue of safety was further clarified via laboratory platform studies on DBT, which not only showed the lack of similarity with estrogen actions but also confirmed the value of combining the two herbs in the classic formula.
Introduction:
The impact of menopausal hormone therapy (HT) on age-associated Alzheimer's and neurodegenerative diseases (NDDs) remains unresolved. To determine the effect of HT, formulation, type, and duration on risk of NDDs, a retrospective analysis was performed using a 10-year Humana claims dataset.
Methods:
Study population included women aged 45 years or older with or without claim records of HT medications. Patients diagnosed with NDDs including Alzheimer's disease (AD), Parkinson's disease (PD), dementia, multiple sclerosis (MS), and amyotrophic lateral sclerosis (ALS) were identified. Relative risk (RR) ratios and 95% confidence intervals (CI) for combined NDDs, or AD, PD, dementia, MS, and ALS were determined. Cumulative hazard ratios were determined to investigate the association between HT and NDDs at different age groups.
Results:
In 379,352 women with or without claim records of HT, use of HT was associated with significantly reduced risk for combined NDDs (RR 0.42, 95% CI 0.40-0.43, P < 0.001). Average follow-up time was 5.1 [2.3] years. Formulations containing natural steroids 17β-estradiol and/or progesterone were associated with greater reduction in NDD risk. Oral- HT users showed significantly reduced RRs (0.42, 0.41-0.44, P < 0.001) for combined NDDs compared to non-HT users. The RRs for transdermal-HT users were significantly decreased for all-cause dementia (0.73, 0.60-0.88, P = 0.001) and MS (0.55, 0.36-0.84, P = 0.005). Greatest reduction in risk of NDD, AD, and dementia emerged in patients aged 65 years or older. Further, the protective effect of long-term therapy (>1 year) on combined NDDs, AD, PD, and dementia was greater compared to short-term therapy (≤1 year).
Discussion:
HT was associated with reduced risk of all NDDs including AD and dementia, with greater duration of therapy and natural steroid formulations associated with greater efficacy. These findings advance precision HT to prevent NDDs including AD.
Background
Hearing loss leads to impairments in communication, social interactions, and cognitive functions. This renders early treatment particularly important. A causal therapy is not yet available. Human and animal studies have shown that certain hormones can have a positive effect on hearing.Objective
This review provides an overview of the effects of various hormones on hearing and describes the potential benefit for future therapeutic approaches.Materials and methodsA systematic literature review of reviews dealing with the effects of various hormones on hearing in humans and animals published in PubMed between 2015 and 2020 was conducted.ResultsHormones may mediate antiapoptotic effects on structure-relevant cells of the cochlea and auditory pathway, and may influence hair cell functionality or the electrolyte balance of the endo- and perilymph. Current research focuses on glucocorticoids; the mineral corticoid aldosterone; the sex hormones estrogen, progesterone, and testosterone; the growth hormones GH (growth hormone) and IGF‑1 (insulin-like growth factor 1); thyroid hormones; and insulin. Study results are still inconsistent at this time, but various hormones appear to represent a possible future treatment option for acute hearing loss. Long-term hormone treatment, which would be necessary particularly in the case of age-related hearing loss, does not currently represent a sensible course of action due to the side effect profile of the systemic treatment/lack of practicable topical application options.Conclusion
The mode of action of hormones is complex. Whether they can be used in the future for individualized treatment of patients with acute hearing impairment requires further investigation.
Objective
The study aimed to evaluate the degree of menopausal hormonal therapy (MHT) use and the related trends, as well as the characteristics of Korean women who used MHT by type of hormone therapy.
Methods
Women aged ≥40 years were selected using data from the Korea National Insurance Service-National Sample Cohort 2002–2013 database. MHT entailed either estrogen therapy or estrogen plus progestogen therapy, as categorized by the Anatomical Therapeutic Chemical system. The prevalence of MHT use was calculated as the number of women with prescriptions annually and the level of hormone consumption was calculated using the defined daily dose (DDD).
Results
The proportion of MHT users among women aged ≥40 years was 7.8% in 2002, which decreased to 6.3% in 2013. The overall MHT consumption level in 2002 was 27.5 DDDs/1000 inhabitants/day. There was a sharp decline in the first few years after 2002 and this value decreased to 12.5 DID in 2013; however, the decrease had lessened from 2006 to 2013 and differed by HT type, administration route, age, and income level. During the 11-year follow-up, over 70% of women were prescribed MHT for less than 1 year, while only 11.8% had a prescription for 3 years or more, and women who started treatment at age 45–59 years showed longer treatment duration.
Conclusions
Since 2002, MHT use among Korean women, especially overall MHT consumption, has declined remarkably. Regarding the pattern of use among women who took hormone preparations during 2002–2013, MHT was used around menopause, over the short term only, and at low dose.
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