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Back pain lifetime incidence is 60%–70%, while 12%–20% of older women have vertebral fractures (VFs), often with back pain. We aimed to provide objective evidence, currently lacking, regarding whether back pain and VFs affect physical activity (PA). We recruited 69 women with recent back pain (age 74.5 ± 5.4 years). Low- (0.5 < g < 1.0), medium- (1.0 ≤ g < 1.5), and high-impact (g ≥ 1.5) PA and walking time were measured (100 Hz for 7 days, hip-worn accelerometer). Linear mixed-effects models assessed associations between self-reported pain and PA, and group differences (VFs from spine radiographs/no-VF) in PA. Higher daily pain was associated with reduced low (β = −0.12, 95% confidence interval, [−0.22, −0.03], p =.013) and medium-impact PA (β = −0.11, 95% confidence interval, [−0.21, −0.01], p =.041), but not high-impact PA or walking time (p >.11). VFs were not associated with PA (all p >.2). Higher daily pain levels but not VFs were associated with reduced low- and medium-impact PA, which could increase sarcopenia and falls risk in older women with back pain. [ABSTRACT FROM AUTHOR]

STUDY QUESTION: What is the association between reproductive health history (e.g. age at menarche, menopause, reproductive lifespan) with abdominal adiposity in postmenopausal women? SUMMARY ANSWER: Higher visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) tissue levels were observed among women with earlier menarche, earlier menopause, and greater parity. WHAT IS KNOWN ALREADY: Postmenopausal women are predisposed to accumulation of VAT and SAT. Reproductive health variables are known predictors of overall obesity status in women, defined by BMI. STUDY DESIGN, SIZE, DURATION: This study is a secondary analysis of data collected from the baseline visit of the Womens Health Initiative (WHI). The WHI is a large prospective study of postmenopausal women, including both a randomized trial and observational study. There were 10 184 women included in this analysis. PARTICIPANTS/MATERIALS, SETTING, METHODS: Data were collected from a reproductive health history questionnaire, dual-energy x-ray absorptiometry scans, and anthropometric measures at WHI baseline. Reproductive history was measured via self-report, and included age at menarche, variables related to pregnancy, and age at menopause. Reproductive lifespan was calculated as age at menopause minus age at menarche. Statistical analyses included descriptive analyses and multivariable linear regression models to examine the association between reproductive history with VAT, SAT, total body fat, and BMI. MAIN RESULTS AND THE ROLE OF CHANCE: Women who reported early menarche (15 years had 23 cm2 less VAT (95% CI: -31.4, -14.4) and 47 cm2 less SAT (95% CI: -61.8, -33.4) than women who experienced menarche at age 10 years or earlier. A similar pattern was observed for age at menopause: compared to women who experienced menopause 3 pregnancies) was also associated with VAT and SAT. For example, adjusted beta coefficients for VAT were 8.36 (4.33, 12.4) and 17.9 (12.6, 23.2) comparing three to four pregnancies with the referent, one to two pregnancies. LIMITATIONS, REASONS FOR CAUTION: The WHI reproductive health history questionnaire may be subject to poor recall owing to a long look-back window. Residual confounding may be present given lack of data on early life characteristics, such as maternal and pre-menarche characteristics. WIDER IMPLICATIONS OF THE FINDINGS: This study contributes to our understanding of reproductive lifespan, including menarche and menopause, as an important predictor of late-life adiposity in women. Reproductive health has also been recognized as a sentinel marker for chronic disease in late life. Given established links between adiposity and cardiometabolic outcomes, this research has implications for future research, clinical practice, and public health policy that makes use of reproductive health history as an opportunity for chronic disease prevention. STUDY FUNDING/COMPETING INTEREST(S): HRB and AOO are supported by the National Institute of Health National Institute of Aging (R01AG055018-04). JWB reports royalties from ACSMS Body Composition Assessment Book and consulting fees from the WHI. The remaining authors have no competing interests to declare. TRIAL REGISTRATION NUMBER: N/A.

BACKGROUND: Individuals with inflammatory bowel disease (IBD) who lack traditional cardiovascular disease (CVD) risk factors, such as young females, are observed to experience adverse CVD outcomes. Whether women with IBD have increased CVD risk after the menopause transition is unclear. METHODS: We conducted a survival analysis of Womens Health Initiative (WHI) participants and excluded those with missing IBD diagnosis, model covariate data, follow-up data, or a baseline history of the following CVD outcomes: coronary heart disease (CHD), ischemic stroke, venous thromboembolism (VTE), peripheral arterial disease (PAD). Risk of outcomes between IBD and non-IBD women was performed using Cox proportional hazard models, stratified by WHI trial and follow-up. Models were adjusted for age, socio-demographics, comorbidities (e.g., hypertension, diabetes, hypercholesterolemia, etc.), family history, and lifestyle factors (e.g., smoking, alcohol, physical activity, body mass index, etc.). RESULTS: Of 134,022 WHI participants meeting inclusion criteria, 1367 (1.0%) reported IBD at baseline. Mean baseline age was 63.4 years. After adjusting for age and other confounders, no significant difference was observed between IBD and non-IBD women for the risk of CHD (HR 0.96, 95% CI 0.73-1.24), VTE (HR 1.11, 95% CI 0.81-1.52) or PAD (HR 0.64, 95% CI 0.28-1.42). After adjusting for age, risk of ischemic stroke was significantly higher (HR 1.41, 95% CI 1.06-1.88) in IBD than non-IBD women. With further adjustment, the excess risk of ischemic stroke among IBD women was attenuated and no longer statistically significant (HR 1.31, 95% CI 0.98-1.76). CONCLUSIONS: Among postmenopausal women with IBD, risk of ischemic stroke may be higher than in non-IBD women.

UNLABELLED: Long-term physical functioning trajectories following distal forearm fracture are unknown. We found that women with versus those without distal forearm fracture were more likely to experience a 5-year decline in physical functioning, independent of initial physical functioning level. This association was most evident among women 80 years and older. INTRODUCTION: Physical functioning trajectory following lower arm or wrist fracture is not well understood. PURPOSE: This study is to evaluate physical functioning trajectory before vs. after lower arm or wrist fracture, stratified by age. METHODS: We performed a nested case-control study of prospective data from the Womens Health Initiative Study (n = 2097 cases with lower arm or wrist fracture, 20,970 controls). Self-reported fractures and the physical functioning subscale of the RAND 36-item Short-Form Health Survey were assessed annually. We examined three physical functioning trajectory groups: stable, improving, and declining. RESULTS: Mean (SD) number of physical functioning measurements was 5.2 (1.5) for cases and 5.0 (1.4) for controls. Declining physical functioning was observed among 20.4% of cases and 16.0% of controls. Compared to women without lower arm or wrist fracture, women with lower arm or wrist fracture were 33% more likely to experience declining physical functioning (adjusted odds ratio [aOR] 1.33 95% confidence interval [CI] 1.19-1.49, reference group stable or improving physical functioning trajectory). Associations varied by age: age ≥ 80 years aOR 1.56 (95% CI 1.29-1.88); age 70-79 years aOR 1.29 (95% CI 1.09-1.52); age

BACKGROUND: Sedentary behavior (SB) is a recognized risk factor for many chronic diseases. ActiGraph and activPAL are two commonly used wearable accelerometers in SB research. The former measures body movement and the latter measures body posture. The goal of the current study is to quantify the pattern and variation of movement (by ActiGraph activity counts) during activPAL-identified sitting events, and examine associations between patterns and health-related outcomes, such as systolic and diastolic blood pressure (SBP and DBP). METHODS: The current study included 314 overweight postmenopausal women, who were instructed to wear an activPAL (at thigh) and ActiGraph (at waist) simultaneously for 24 hours a day for a week under free-living conditions. ActiGraph and activPAL data were processed to obtain minute-level time-series outputs. Multilevel functional principal component analysis (MFPCA) was applied to minute-level ActiGraph activity counts within activPAL-identified sitting bouts to investigate variation in movement while sitting across subjects and days. The multilevel approach accounted for the nesting of days within subjects. RESULTS: At least 90% of the overall variation of activity counts was explained by two subject-level principal components (PC) and six day-level PCs, hence dramatically reducing the dimensions from the original minute-level scale. The first subject-level PC captured patterns of fluctuation in movement during sitting, whereas the second subject-level PC delineated variation in movement during different lengths of sitting bouts: shorter (< 30 minutes), medium (30 -39 minutes) or longer (> 39 minute). The first subject-level PC scores showed positive association with DBP (standardized β ^ : 2.041, standard error: 0.607, adjusted p = 0.007), which implied that lower activity counts (during sitting) were associated with higher DBP. CONCLUSION: In this work we implemented MFPCA to identify variation in movement patterns during sitting bouts, and showed that these patterns were associated with cardiovascular health. Unlike existing methods, MFPCA does not require pre-specified cut-points to define activity intensity, and thus offers a novel powerful statistical tool to elucidate variation in SB patterns and health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03473145; Registered 22 March 2018; https://clinicaltrials.gov/ct2/show/NCT03473145 ; International Registered Report Identifier (IRRID): DERR1-10.2196/28684.

This case report discusses a diagnosis of uterine torsion in an 84-year-old woman who presented with five days of right lower quadrant abdominal pain, nausea, vomiting, constipation, and poor intake. Computed tomography (CT) imaging demonstrated a whorled configuration at the junction of the cervix and lower uterine segment, with the left gonadal vein crossing midline, and two previously known right leiomyomas now appearing on the left. These findings were consistent with the diagnosis of uterine torsion. She then underwent an urgent exploratory laparotomy, and the uterus was found to be dextroverted 270 degrees, with dark mottled purple tissue and engorged vessels. A supracervical hysterectomy and bilateral salpingo-oopherectomy were performed. Final pathology demonstrated extensive necrosis. This case reviews the classic presentation and imaging findings for the rare diagnosis of uterine torsion and options for management of both non-gravid and gravid patients.

BACKGROUND: Although gestational diabetes mellitus and delivering high-birthweight infants are known to predict a higher risk of future type 2 diabetes mellitus, the association of hypertensive disorders of pregnancy and other adverse pregnancy outcomes with type 2 diabetes mellitus is not well established. OBJECTIVE: This study aimed to examine the associations between different types of adverse pregnancy outcomes and incident type 2 diabetes mellitus among postmenopausal women. STUDY DESIGN: The Womens Health Initiative, a nationwide cohort of postmenopausal women, collected self-reported history of adverse pregnancy outcomes, including gestational diabetes mellitus, hypertensive disorders of pregnancy, preterm birth, and delivering low- birthweight (4500 g) infants. Participants were followed up annually for self-reported incident type 2 diabetes mellitus treated with medication from baseline (1993-1998) to March 2021. This study used logistic regression to examine the associations of any and individual adverse pregnancy outcomes with diabetes mellitus. Stratified analyses were performed to assess effect modification by body mass index, race and ethnicity, education, parity, breastfeeding, and age at first birth. RESULTS: This analysis included 49,717 women without a history of diabetes mellitus at enrollment who had a least 1 pregnancy and responded to the questionnaire about adverse pregnancy outcomes. After adjusting for body mass index, demographic, lifestyle, and reproductive factors, gestational diabetes mellitus (odds ratio, 2.26; 95% confidence interval, 1.94-2.63), high birthweight (odds ratio, 1.30; 95% confidence interval, 1.18-1.44), and hypertensive disorders of pregnancy (odds ratio, 1.18; 95% confidence interval, 1.08-1.30) were independently associated with higher odds of type 2 diabetes mellitus, whereas preterm birth and low birthweight were not associated with diabetes mellitus risk. A history of ≥2 adverse pregnancy outcomes was associated with higher odds of type 2 diabetes mellitus (odds ratio, 1.55; 95% confidence interval, 1.28-1.88). This study further observed higher odds of type 2 diabetes mellitus (odds ratio, 3.69; 95% confidence interval, 2.38-5.70) among women with a history of both gestational diabetes mellitus and hypertensive disorders of pregnancy than those without any adverse pregnancy outcomes. CONCLUSION: Postmenopausal women with a history of gestational diabetes mellitus, those delivering high-birthweight infants, or those with hypertensive disorders of pregnancy are at risk of future type 2 diabetes mellitus. In addition, women with ≥2 conditions had an augmented risk and might be prioritized for screening and prevention efforts for type 2 diabetes mellitus.

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Summary: This 78-week (18-month) study conducted in 479 postmenopausal women with osteoporosis evaluated the efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of candidate biosimilar CT-P41 relative to US reference denosumab. CT-P41 had equivalent efficacy and pharmacodynamics to US-denosumab, with similar pharmacokinetics and comparable safety and immunogenicity profiles. Purpose: To demonstrate equivalence of candidate biosimilar CT-P41 and US reference denosumab (US-denosumab) in postmenopausal women with osteoporosis. Methods: This 78-week (18-month), double-blind, randomized, active-controlled Phase 3 study (NCT04757376) comprised two treatment periods (TPs). In TPI, patients (N = 479) were randomized 1:1 to 60 mg subcutaneous CT-P41 or US-denosumab. At Week 52, those who had received CT-P41 in TPI continued to do so. Those who had received US-denosumab were randomized (1:1) to continue treatment or switch to CT-P41 in TPII. The primary efficacy endpoint was percent change from baseline in lumbar spine bone mineral density at Week 52. Efficacy equivalence was concluded if associated 95% confidence intervals (CI) for least squares (LS) mean group differences fell within ± 1.503%. The primary pharmacodynamic (PD) endpoint was area under the effect curve for serum carboxy-terminal cross-linking telopeptide of type I collagen through the first 26 weeks, with an equivalence margin of 80–125% (for 95% CIs associated with geometric LS mean ratios). Results: Equivalence was demonstrated for CT-P41 and US-denosumab with respect to primary efficacy (LS mean difference [95% CI]: − 0.139 [− 0.826, 0.548] in the full analysis set and − 0.280 [− 0.973, 0.414] in the per-protocol set) and PD (geometric LS mean ratio [95% CI]: 94.94 [90.75, 99.32]) endpoints. Secondary efficacy, PD, pharmacokinetics, and safety results were comparable among all groups up to Week 78, including after transitioning to CT-P41 from US-denosumab. Conclusions: CT-P41 was equivalent to US-denosumab in women with postmenopausal osteoporosis, with respect to primary efficacy and PD endpoints. [ABSTRACT FROM AUTHOR]

Background Sex hormone changes during menopausal transition contribute to declining skin health. However, how menopause and its treatment by hormone replacement therapy (HRT) impact the skin barrier and immune system is unclear. Objectives To examine how menopause and HRT affect the skin barrier and immune cell composition in postmenopausal women following irritant challenge. Methods Two cohorts of postmenopausal women were recruited to the study. The first cohort consisted of 10 untreated women [HRT–; mean (SEM) age 56.5 (1.6) years (range 48–63)] and the second was composed of 8 women receiving HRT [HRT+; mean (SEM) age 54.0 (2.1) years (range 48–63)]. Skin irritation was induced by applying topical sodium lauryl sulfate (SLS) 1.25% to occluded buttock skin for 48 h. Clinical assessment was conducted after 24 h, followed by biopsy of both SLS-challenged and unchallenged skin for analysis of skin barrier proteins and immune cell distribution using immunofluorescence. Results Clinically, there were no significant differences in skin irritant responses between those taking or not taking HRT (including increased skin redness and blood flow). In response to SLS challenge a significant increase in transepidermal water loss (P < 0.05), filaggrin deposition and cytokeratin 10 (K10)+ cell layers (P < 0.01) was observed in individuals receiving HRT compared with the HRT– group. Following SLS challenge in individuals taking HRT, a significant (P < 0.01) reduction in CD207+ cells in the epidermis was observed, accompanied by an increase of CD207+ cells in the dermis, indicative of migrating Langerhans cells (LCs). Significantly fewer migrating LCs were found in those who were not receiving HRT (P < 0.01). Furthermore, the numbers of dermal dendritic cells (DCs), macrophages, and CD11c+CD206– and CD68+CD206– subsets were found to be significantly (P < 0.05) higher in those taking HRT following SLS challenge. Conclusions Individuals receiving HRT displayed enhanced skin barrier response to SLS challenge with thicker filaggrin and increased K10+ epidermal cell layers. Following challenge, HRT users exhibited elevated LC, inflammatory DC and macrophage counts in the dermis. These may render skin both more prone to inflammation and more capable of resolving it, while also promoting skin repair. [ABSTRACT FROM AUTHOR]

Female hypogonadism (FH) is a relatively common endocrine disorder in women of premenopausal age, but there are significant uncertainties and wide variation in its management. Most current guidelines are monospecialty and only address premature ovarian insufficiency (POI); some allude to management in very brief and general terms, and most rely upon the extrapolation of evidence from the studies relating to physiological estrogen deficiency in postmenopausal women. The Society for Endocrinology commissioned new guidance to provide all care providers with a multidisciplinary perspective on managing patients with all forms of FH. It has been compiled using expertise from Endocrinology, Primary Care, Gynaecology and Reproductive Health practices, with contributions from expert patients and a patient support group, to help clinicians best manage FH resulting from both POI and hypothalamo‐pituitary disorders, whether organic or functional. [ABSTRACT FROM AUTHOR]

• Biopsy for asymptomatic postmenopausal women if endometrial thickness is ≥8 mm. • For 4-8 mm, consider biopsy after evaluating risk factors and blood flow signals. To determine the cutoff value for endometrial thickness (ET) that prompts a biopsy in asymptomatic postmenopausal women with an incidental finding of thickened endometrium, and to develop a risk prediction model. This is a retrospective cohort analysis of the clinical records of the Hysteroscopic Center of Fu Xing Hospital, Capital Medical University, Beijing, China. We collected asymptomatic postmenopausal women who presented with an ET of ≥4 mm (double-layer) as an incidental finding. We stratified the participants into non-malignant and malignant groups based on pathology results and assessed differences between the two groups. A receiver operating characteristic curve (ROC) was used to identify the cutoff value of ET for predicting endometrial malignancy. Logistic regression models were also constructed to predict the risk of malignancy. A total of 581 consecutive eligible cases were included. The optimal cutoff value for ET was 8 mm, with a maximum area under the curve (AUC) of 0.755 (95 % CI: 0.645–0.865). In addition to ET, the regression model incorporated diabetes, blood flow signal, BMI, and hypertension to predict the risk of malignancy. A ROC curve constructed for the model yielded an AUC of 0.834 (95 % CI: 0.744–0.924). It is reasonable to offer hysteroscopy and visually-directed endometrial biopsy for asymptomatic postmenopausal women when ET is 8 mm or above. For those with an ET between 4 and 8 mm, further decision to perform biopsy should be determined on an individual basis, considering risk factors and blood flow signals of the endometrium. [ABSTRACT FROM AUTHOR]

Various foods and nutrients are linked with higher or lower risk of rheumatoid arthritis (RA), yet these associations are inconsistent across studies. Limited research has been done evaluating the association between diet quality and RA in a larger-scale prospective study on postmenopausal women. The objective of this study was to evaluate the association between dietary quality and risk of incident RA in postmenopausal women. This was a prospective cohort study as part of the Women's Health Initiative (WHI), with an average follow-up time of 8.1 years. Baseline diet was measured using a food frequency questionnaire (FFQ). Diet quality was evaluated by the Healthy Eating Index (HEI)-2015 total score. In addition, intake of food groups and nutrients that align with HEI-2015 components was assessed. Postmenopausal women (N = 109 591) were included in this study, which was conducted at various clinical centers across the United States with recruitment from 1993 to 1998. Women's Health Initiative participants who were missing outcome data, had unreliable/missing FFQ data, or had RA at baseline were excluded. The primary outcome measure was incident RA. Statistical analyses performed Multivariable Cox proportional regression analysis was performed evaluating the association of diet quality with self-reported physician-diagnosed RA after adjusting for age, race, ethnicity, education status, income, and body mass index (BMI). During 857 517 person-years of follow-up, 5823 incident RA cases were identified. After adjustment for multiple comparisons, compared with quartile 1, quartiles 2, 3, and 4 of the HEI-2015 total scores were associated with lower RA risks of 1%, 10%, and 19%, respectively (P -trend <.001). Greater consumption of total fruits (P -trend =.014), whole fruits (P -trend <.0002), total vegetables (P -trend =.008), greens and beans (P -trend <.0002), whole grains (P -trend =.008), and dairy (P -trend =.018) were significantly associated with lower rates of incident RA. Conversely, higher consumption of saturated fat (P -trend =.002) was significantly associated with higher rates of incident RA. A higher-quality diet reflected by higher HEI-2015 total scores was inversely associated with incident RA in postmenopausal women. [ABSTRACT FROM AUTHOR]

In the Women's Health Initiative Dietary Modification randomized trial, the dietary intervention reduced breast cancer mortality by 21% (P =.02) and increased physical activity as well. Therefore, the aim was to examine whether or not these lifestyle changes attenuated age-related physical functioning decline. In a randomized trial, the influence of 8 years of a low-fat dietary pattern intervention was examined through 20 years of cumulative follow-up. From 1993 to 1998, 48,835 postmenopausal women, ages 50 to 79 years with no prior breast cancer and negative baseline mammogram were randomized at 40 US clinical centers to dietary intervention or usual diet comparison groups (40 out of 60). The intervention significantly reduced fat intake and increased vegetable, fruit, and grain intake. In post hoc analyses, physical functioning, assessed using the RAND 36-Item Short Form Health Survey, evaluated quality or limitations of 10 hierarchical physical activities. Longitudinal physical functioning, reported against a disability threshold (when assistance in daily activities is required) was the primary study outcome. Semiparametric linear mixed effect models were used to contrast physical functioning trajectories by randomization groups. Physical functioning score, assessed 495,317 times with 11.0 (median) assessments per participant, was significantly higher in the intervention vs comparison groups through 12 years of cumulative follow-up (P =.001), representing a reduction in age-related functional decline. The intervention effect subsequently attenuated and did not delay time to the disability threshold. Among women in the dietary intervention vs comparison groups, aged 50 to 59 years, who were physically inactive at entry, a persistent, statistically significant, favorable influence on physical functioning with associated delay in crossing the disability threshold by approximately a year was seen (P value for interaction =.007). In the Women's Health Initiative Dietary Modification randomized trial, a dietary intervention that significantly reduced breast cancer mortality also significantly reduced age-related functional decline through 12 years, which was attenuated with longer follow-up. [ABSTRACT FROM AUTHOR]

Clinical studies have reported the beneficial effects of unfermented soy product consumption on blood lipids in various populations. However, contradictory results have been reported regarding the influence of unfermented soy product consumption on blood lipids in postmenopausal women. The aim of this systematic review and meta-analysis was to evaluate the effects of diets with unfermented soy products compared with diets without unfermented soy products on blood lipids in postmenopausal women. The Cochrane Library, PubMed, Scopus, Web of Science, and Embase electronic databases were searched for eligible randomized controlled trials (RCTs) published up to February 21, 2023. RCTs were included if they were published in English and investigated the effect of unfermented soy product consumption on blood lipids in postmenopausal women who had discontinued hormone replacement therapy at least 3 months before randomization. A random-effects model was used to calculate the overall effect size of the mean difference (MD) and 95% CI. Risk of bias was assessed using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 2. Twenty-nine RCTs involving 2,457 participants were included. The results showed that, compared with the control group that did not consume unfermented soy products, consumption of unfermented soy products significantly reduced total cholesterol (TC) (MD, −9.46 mg/dL [to convert mg/dL cholesterol to mmol/L, multiply mg/dL by 0.0259; to convert mmol/L cholesterol to mg/dL, multiply by 38.7]; 95% CI −15.04 to −3.89 mg/dL; P =.001) and triglycerides (TGs) (MD, −10.86 mg/dL [to convert mg/dL TGs to mmol/L, multiply mg/dL by 0.0113; to convert mmol/L TGs to mg/dL, multiply mmol/L by 88.6]; 95% CI −19.70 to −2.02 mg/dL; P =.016), while significantly increasing high-density lipoprotein cholesterol (MD, 2.32 mg/dL; 95% CI 0.87 to 3.76 mg/dL; P =.002) in postmenopausal women, but had no significant effect on low-density lipoprotein cholesterol (MD, −4.55 mg/dL; 95% CI −10.90 to 1.80 mg/dL; P =.160). Results of soy preparation subgroup analysis showed that soy isolate protein significantly reduced TC and soy protein–containing isoflavones significantly reduced TC and low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol. Furthermore, unfermented soy product consumption significantly reduced TC, low-density lipoprotein cholesterol, and TG levels in postmenopausal women with lipid disorders and TGs in healthy postmenopausal women. The results showed that unfermented soy product consumption reduced TC and TG levels significantly, and increased high-density lipoprotein cholesterol levels in postmenopausal women. The findings of this review contribute to the evidence-base for dietary management of blood lipids in postmenopausal women. [ABSTRACT FROM AUTHOR]

The Women's Health Initiative (WHI) has been a major contributor to diet and chronic disease research among postmenopausal US women over its 30+ year history (1993 to present). The WHI program included full-scale randomized trials of a low-fat dietary pattern high in fruits, vegetables, and grains, and of calcium and vitamin D supplementation, each with designated primary and secondary chronic disease outcomes. The history of these trials will be briefly reviewed here, along with principal findings that included evidence for breast cancer-related benefits for each of the 2 interventions. In recent years, WHI investigators have developed an active research program in nutritional biomarker development and in the application of these biomarkers in WHI cohorts, among various other nutritional epidemiology uses of WHI observational study resources. The intake biomarker work, which primarily relies on blood and urine metabolomics profiles, lends support to the low-fat dietary pattern trial results, and supports chronic disease benefits of higher carbohydrate diets more generally, especially through the fiber component of carbohydrate. [ABSTRACT FROM AUTHOR]

Type 2 diabetes is a major public health concern in the United States and worldwide. The dietary inflammatory index (DII) and the energy-adjusted DII (E-DII) are tools that assess dietary inflammation. Previous evidence suggests that obesity can modify the association between inflammation and disease. The aim of this study was to evaluate the association between the DII/E-DII and incident diabetes in self-identified Hispanic women from the Women's Health Initiative (WHI). The secondary aim was to evaluate whether obesity modifies the association between the DII/E-DII scores and incident diabetes. Participants were from the WHI Observational Study and the Clinical Trial Components (except women from the treatment arm in the Dietary Modification Trial) conducted among postmenopausal women in the United States. DII/E-DII scores were calculated from a self-administered food frequency questionnaire at baseline that included 122 food items, of which 12 are representative of Hispanic eating patterns. Participants included 3,849 postmenopausal women who self-identified as Hispanic that were recruited for the WHI from 1993 to 1998 at 40 US clinical centers. The outcome was incident diabetes. Cox regression models were used to assess the association between DII/E-DII and incident diabetes. Models were adjusted for age at baseline, lifestyle-related risk factors, known type 2 diabetes mellitus (T2DM) risk factors, and neighborhood socioeconomic status. Interaction was tested between the DII/E-DII scores and obesity. The incidence of diabetes was 13.1% after a median follow-up of 13 years. Higher E-DII scores were associated with a higher risk of incident diabetes (hazard ratio [HR], 1.09; 95% confidence interval [CI], 1.04–1.14). There was no interaction between E-DII scores and obesity (P = 0.73). Pro-inflammatory diets, as measured by higher E-DII scores, were associated with a higher risk of incident diabetes. Future research is needed for understanding how the inflammatory potential of diets can be decreased. [ABSTRACT FROM AUTHOR]

Background: Burning mouth syndrome (BMS) is a chronic pain condition affecting the oral cavity. This condition mostly affects peri‐ or postmenopausal women; for this reason, sexual hormonal changes have been implicated in BMS pathogenesis. Methods: A systematic review was performed in MEDLINE/PubMed, Scopus, Web of Science, Cochrane Library and EMBASE without restriction for language or year. Eligibility criteria were controlled studies addressing the PICO question: (P) patients with BMS; (I) detection of the sex hormones; (C) patients without BMS; (O) changes on sexual hormones as a risk factor for BMS severity. Risk of bias was performed with Newcastle‐Ottawa Quality Assessment Scale. Results: Four studies were included. Salivary levels were evaluated in three studies and serum blood was used in one. Three studies analysed oestradiol and/or dehydroepiandrosterone (DHEA), two assessed progesterone and one evaluated follicle‐stimulating hormone (FSH). Oestradiol results were contradictory, with two studies reporting lower levels in BMS patients compared to controls and one finding the opposite. DHEA was statistically lower in the BMS group in one study. Progesterone showed opposite results in two studies, although none with statistical significance. FSH was statistically higher in the BMS group compared to controls. Correlation of hormones with quality of life was performed in three studies and there was no significant correlation with self‐perceived symptoms severity. Conclusion: Sexual hormones can be altered in BMS, especially oestradiol. Despite these changes, we did not find correlation between hormone fluctuation and BMS symptoms intensity affecting quality of life. These findings suggested the need for further investigation on hormonal alterations, which may be a promising target on BMS management. [ABSTRACT FROM AUTHOR]

Context Bone marrow adiposity (BMAT) alterations in patients with type 2 diabetes mellitus (T2DM) may contribute to adverse bone effects. Objective Characterization of BMAT content and composition in patients with well-controlled T2DM. Methods This cross-sectional study included 2 groups of postmenopausal women: one with T2DM and the other without. The proton density fat fraction (PDFF) of the lumbar spine and proximal femur, comprising the femoral head, neck, and diaphysis, was assessed using chemical shift-based water-fat separation imaging (WFI). Magnetic resonance imaging with spectroscopy (1H-MRS) was performed in a subgroup of participants to confirm the PDFF measurements and determine the apparent lipid unsaturation level (aLUL) at the L3 vertebrae and femoral neck. The association of imaging-based PDFFs and aLUL between diabetes groups was investigated by adjusting for confounding factors using a linear mixed model. Results Among 199 participants, patients with T2DM (n = 29) were significantly heavier (P <.001) and had a higher bone mineral density (BMD) (P <.001 for all sites) than nondiabetic patients (n = 170). When PDFFs were compared after adjusting for age, body mass index (BMI), and BMD, the femoral head WFI-based PDFF was lower in patients with T2DM (mean [standard error] 88.0% [0.7] vs 90.6% [0.3], P <.001). Moreover, the aLUL at the L3 vertebrae was lower in patients with T2DM (n = 16) than in without (n = 97) (mean [standard error] 3.9% [0.1] vs 4.3% [0.1], P =.02). Conclusion The content and composition of BMAT are modified in postmenopausal women with T2DM and these changes occur at specific sites. [ABSTRACT FROM AUTHOR]

Current therapeutic approaches for osteoporosis predominantly involve antiresorptive agents, but the emergence of bone anabolic therapy, such as romosozumab, presents a promising alternative. Romosozumab, a monoclonal antibody targeting sclerostin, exhibits both bone anabolic and antiresorptive effects, offering the potential to enhance bone mineral density and mitigate fracture risk. Evidence from several studies demonstrating the efficacy of romosozumab is now established in improving bone mineral density and reducing fracture rates in postmenopausal women and men. This review critically evaluates the role of romosozumab in osteoporosis management, emphasizing findings from real-world studies to facilitate its practical application in clinical settings. Adverse effects, comparative effectiveness with other osteoporotic agents, and challenges in sequential therapy are also discussed, providing insights for informed decision-making by physicians, particularly in the context of pre-treatment considerations. Additionally, the review examines global prescribing guidelines and highlights challenges associated with romosozumab utilization in special patient subgroups, aiming to optimize its clinical use. [ABSTRACT FROM AUTHOR]

AbstractIntroductionMethodsResultsConclusionsThe diagnostic workflow for endometrial carcinoma in postmenopausal asymptomatic women remains an ongoing dilemma. Whereas an ultrasonographic endometrial thickness greater than 4.0 or 5.0 mm is adequate for warranting further investigations in women with postmenopausal vaginal bleeding, there is still no unanimous consensus on what the ideal endometrial thickness cut-off should be, justifying additional inspection through endometrial sampling when bleeding is absent.A comprehensive overview of the most recent literature to summarize the clinical pathway necessary for the diagnostic assessment of a postmenopausal asymptomatic woman with increased ultrasonographic endometrial thickness.An endometrial thickness cut-off between 3.0 and 5.9 mm seems to show the lowest specificity while also reducing the chances of missing malignancy. If endometrial thickness can be a valid starting point, a careful evaluation of the other ultrasonographic endometrial features and a thorough scrutiny of patients’ risk factors are pivotal to standardizing the diagnostic process while avoiding overtreatment. Although preventing unnecessary procedures is crucial, stratifying the risk and proceeding with further investigations (preferably through outpatient or office hysteroscopically-guided targeted biopsies) should be the goal.Closer collaboration between different fields of medicine (ultrasonography, hysteroscopy, and oncology) is strongly encouraged to facilitate early diagnosis of asymptomatic postmenopausal women at risk of developing endometrial malignancy. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion To evaluate Hyuganatsu oranges (Citrus tamurana Hort. Ex Tanaka) derived arabinogalactan for bone turnover, we performed a randomized placebo‐controlled trial.Sixty‐three postmenopausal women were age‐stratified and randomly assigned to receive arabinogalactan‐rich hyuganatsu juice (study group) or a placebo drink (control group) for 90 days. We measured blood tartrate‐resistant acid phosphatase 5b (TRACP5b), type I procollagen N‐terminal propeptide (P1NP), and other bone turnover biomarker levels at baseline, days 45 and 90 (T90) of the intervention, and day 30 of recovery. Cumulative effects were compared between groups using repeated‐measures linear mixed model analysis. The primary endpoint was the difference between the pre‐ and post‐intervention TRACP5b and P1NP levels.Using repeated measures linear mixed model analysis, the study group had significantly lower TRACP5b and P1NP levels at day 90 than the control group (mean [95% confidence interval]; TRACP5b: 310.0 [269.2–350.9] vs. 386.4 [341.2–431.6] mU/dL; P1NP: 53.7 [48.6–58.7] vs. 70.3 [64.1–76.4] ng/mL), whereas other biomarker levels showed no change.Arabinogalactan‐rich Hyuganatsu juice suppressed bone mineral turnover and potentially improved ovarian hormone deficiency‐induced osteoporosis in postmenopausal women. [ABSTRACT FROM AUTHOR]

Background/Objectives: Renal function influences bone metabolism, as kidney failure can increase the risk of fractures. Denosumab is an approved osteoporosis treatment, but its efficacy in relation to renal function has not yet been studied in real-life scenarios. This study aimed to investigate the denosumab-induced change in bone mineral density (BMD) according to kidney function. Methods: A retrospective analysis was conducted at the outpatient clinic in postmenopausal women receiving denosumab (60 mg subcutaneously administered every 6 months). The glomerular filtration rate (eGFR) was measured by the 2021 CKD-EPI equation and patients were stratified for eGFR categories. BMD was measured by dual-energy X-ray absorptiometry. Results: 128 women (mean age 70.3 ± 9.4 years) were recruited. The mean denosumab treatment duration was 3.9 ± 1.4 years and all the participants had improved BMD values. In stepwise multiple regression analysis—after controlling for age, BMI, and treatment duration—the eGFR value (ß = −0.11, SE 0.04, p = 0.01) was independently associated with the lumbar spine BMD change. The same association remained when the eGFR categories were considered (ß = 3.564, SE 1.29, p = 0.007). In addition, after controlling for BMI and the duration of denosumab treatment, age (ß = −0.7915, SE 0.37, p = 0.03) and eGFR (ß = −0.3257, SE 0.1567, p = 0.04) were found to be associated with femoral neck BMD change. The association remained when considering eGFR categories (ß = 8.7339, SE 4.29, p = 0.04). Conclusions: This retrospective study suggests that eGFR is associated with denosumab efficacy in postmenopausal women treated for osteoporosis. [ABSTRACT FROM AUTHOR]

Background: Resistance training is hardly recommended for postmenopausal women to counteract negative effects of hormonal changes. However, some concern exists about the marked hemodynamic responses caused by high-load resistance exercises. In this regard, studies on young, healthy, physically active individuals suggest that set configuration can modulate acute cardiovascular, metabolic, and cardiac autonomic responses caused by resistance training sessions, but this has not yet been explored in postmenopausal women. Methods: A sample of 60 physically active postmenopausal women (30 normotensive, 30 hypertensive) will participate in this crossover study. After a medical exam, ergometry, familiarization session, and two testing sessions, participants will complete three experimental sessions and one control session in a randomized order. Each experimental session includes 36 repetitions of four exercises (horizontal leg press, bench press, prone leg curl, and lat pull-down) differing in set configuration: 9 sets of 4 repetitions (i.e., 33% intensity of effort) with 45 s of inter-set recovery, 6 sets of 6 repetitions (50% intensity of effort) with 72 s, and 4 sets of 9 repetitions (75% intensity of effort) with 120 s; with 4 min rest between exercises. Before and immediately after each session, arterial stiffness, hemodynamic variables, cardiac autonomic modulation, baroreflex sensitivity, sympathetic vasomotor tone, and resting oxygen uptake will be evaluated. Furthermore, perceived effort, mechanical performance (e.g., power, velocity), heart rate, and lactatemia will be collected throughout sessions. The impact of set configuration on these variables will be analyzed, along with comparisons between normotensive and hypertensive women. Discussion: Cardiovascular responses to resistance exercise have been scarcely studied in females, particularly postmenopausal women. The results of this study will provide information about the modulating role of set structure on metabolic and cardiovascular responses of normotensive and hypertensive postmenopausal women to resistance training. Clinical trial registration: NCT05544357 on 7 December 2022. [ABSTRACT FROM AUTHOR]

PurposeMethodsResultsConclusionAlthough fragility hip fractures (HF) in the South African (SA) population are among the lowest worldwide, the incidence of HF is expected to more than double over the next few decades. Little is known about the contributors to increased hip fracture risk, including low bone mineral density (BMD), in our unique population. In addition, the ability of the recently calibrated SA Fracture Risk Assessment Tool (FRAX) to identify high fracture risk in the SA population accurately has not been validated.A retrospective, descriptive, cohort study of SA postmenopausal women and men ≥ 50 years who presented with fragility HFs was conducted. The ability of clinical risk factors (CRFs) and BMD measured by dual-energy X-ray absorptiometry (DXA), as well as calculated FRAX probability scores, to identify the known high fracture risk in SA patients were evaluated. The SA FRAX tool was used, and a high fracture risk defined if the United States (US) fixed thresholds for major osteoporotic (MOF) and/or HF risk were exceeded (≥ 20% and ≥ 3% over 10 years respectively).A total of 163 patients were included. The most useful predictive CRFs were age and gender, recreational toxins in men, and a history of falls. Most were females (71%), who were older than males. DXA-BMD and FRAX-HF calculations best identified the known high fracture risk in the study cohort. FRAX-MOF calculations performed poorly.Fracture risk assessment tools did not identify the known high fracture risk in all of the elderly study cohort with HF. Clinicians must continue to appreciate the important role of a good clinical assessment to ensure optimal fracture risk prediction. [ABSTRACT FROM AUTHOR]

Polycystic ovary syndrome (PCOS) exhibits high prevalence and heritability despite causing negative impacts on fertility and fecundity. Previous hypotheses have postulated that some PCOS-associated traits, especially above-average levels of testosterone, were associated with benefits in ancestral environments. As such, PCOS would represent, in part, a maladaptive extreme of adaptations related to relatively high testosterone. To evaluate this hypothesis, we conducted a series of systematic literature reviews on the associations of testosterone levels, and prenatal testosterone metrics, with measures of strength, robustness, muscularity, and athleticism in females. We also systematically reviewed the literature on associations of testosterone with dominance in females and reviewed archaeological evidence concerning female strength and muscularity and its correlates. The main findings were fivefold: (1) elevated testosterone levels were generally associated with higher strength, muscularity and athleticism in females; (2) females with PCOS showed notable evidence of increased strength, muscularity, and athleticism compared to controls; (3) females with higher testosterone levels exhibited clear evidence of high dominance, (4) despite evidence that higher testosterone is linked with higher bone mineral density in healthy females, PCOS was not clearly associated with this phenotype; and (5) archaeological evidence from osteology, and data from some current small-scale societies, indicated that females often exhibit substantial levels of muscularity. Overall, the hypothesis that relatively high levels of testosterone are associated with benefits to females in some contexts was largely supported. These results provide evidence for the "maladaptive extremes of adaptation" model, with implications for treatment of females with PCOS and for future research. [ABSTRACT FROM AUTHOR]

To investigate the conventional ultrasound (US), contrast-enhanced ultrasound (CEUS) manifestations and the corresponding histopathological characteristics of patients diagnosed with breast encapsulated papillary carcinoma (EPC) and to explore the value of CEUS in diagnosis of EPC.The clinical, pathological, US, and CEUS features of 16 patients (17 lesions) with EPC confirmed by postoperative histopathology were retrospectively analyzed.EPC was prevalent in the postmenopausal women. The majority of conventional US images of EPC showed complex cystic and solid masses with circumscribed margins (70.6%), enhanced posterior echo (94.1%), no sonographic calcification (88.2%), rich blood flow in the solid components within lesions (70.6%) on Color Doppler flow imaging, and high resistance index of blood flow (94.1%). Moreover, CEUS showed mainly centripetal hyperenhancement of the solid components within the lesions with irregular outline, and the enhancement area of the whole masses was essentially the same as the B-mode US area.EPC typically presents as a complex cystic and solid mass. CEUS is helpful to clarify the extent of the solid component and facilitate preoperative core-needle biopsy. A comprehensive evaluation by CEUS is valuable for diagnosing EPC and combining it with clinical features are helpful to further improve the diagnosis of this rare kind of breast cancer. [ABSTRACT FROM AUTHOR]

This study aims at improving the lower-limb muscle segmentation accuracy of deep learning approaches based on Magnetic Resonance Imaging (MRI) scans, crucial for the diagnostic and therapeutic processes in musculoskeletal diseases. In general, segmentation methods such as U-Net deep learning neural networks can achieve good Dice Similarity Coefficient (DSC) values, e.g. around 0.83 to 0.91 on various cohorts. Some generic post-processing strategies have been studied to incorporate connectivity constraints into the resulting masks for the purpose of further improving the segmentation accuracy. In this paper, a novel mean shape (MS) based post-processing method is proposed, utilizing Statistical Shape Modelling (SSM) to fine-tune the segmentation output, taking into consideration the muscle anatomical shape. The methodology was compared to existing post-processing techniques and a commercial semi-automatic tool on MRI scans from two cohorts of post-menopausal women (10 Training, 8 Testing, voxel size 1.0x1.0x1.0 mm3). The MS based method obtained a mean DSC of 0.83 across the different analysed muscles and the best performance for the Hausdorff Distance (HD, 20.6 mm) and the Average Symmetric Surface Distance (ASSD, 2.1 mm). These findings highlight the feasibility and potential of using anatomical mean shape in post-processing of human lower-limb muscle segmentation task and indicate that the proposed method can be popularized to other biological organ segmentation mission. [ABSTRACT FROM AUTHOR]

Background: The association between Estradiol (E2) levels and abdominal aortic calcification (AAC) in postmenopausal women remains unclear. Methods: 614 postmenopausal women from the 2013-2014 NHANES survey cycle were included in this study. The study population was divided into 3 groups according to E2 tertiles: Tertile1 (2.12-3.57pg/mL), Tertile2 (3.60-7.04pg/mL), and Tertile3 (7.06-38.4pg/mL). Estrogen concentration data were natural logarithmically transformed. A Kauppila score > 5 was regarded as prominent arterial calcification and was used to define (EAAC). Logistic regression models were used to assess the association between E2 levels and EAAC prevalence. Subgroup analyses were performed to test whether the association between E2 levels and EAAC prevalence was consistent in different groups. Sensitivity analyses tested the stability of the model in women older than 45 years. Results: EAAC prevalence was significantly higher in Tertile1 (16.6%) than in Tertile2 (9.8%) and Tertile3 (8.3%). On a continuous scale, the adjusted model showed a 58% [OR (95%CI), 1.58 (1.02, 2.54)] increase in the risk of EAAC prevalence for per unit decrease in ln(E2). On a categorical scale, the adjusted model showed that Tertile1 and Tertile2 were 2.55 [OR (95%CI), 2.55 (1.10, 5.92)] and 1.31[OR (95%CI), 1.31(1.03, 2.57)] times higher risk of suffering from EAAC than Tertile3, respectively. Conclusion: This study found that a higher prevalence of AAC in postmenopausal women is closely associated with lower serum E2 levels. Our research further underscores the importance of E2 in maintaining cardiovascular health in postmenopausal women and suggests that monitoring E2 levels may aid in the early prevention and management of AAC and related cardiovascular diseases. [ABSTRACT FROM AUTHOR]

Key content: Urethral caruncle is a common post‐menopausal finding.This common benign lesion can be mistaken as a malignancy.Management should be based on the patient's symptoms.Vaginal estrogen should be considered as first‐line management before surgical excision. Learning objectives: To evaluate the symptomatic presentation of urethral caruncle.To establish the differential diagnosis of a mass in the urethra.To review the management options of urethral caruncle including medical and surgical excision.To highlight primary care management of urethral caruncle. Ethical issues: Owing to poor recognition of urethral caruncle, many patients are put through the emotional distress of referral to cancer pathways.Surgery should be considered first line for large urethral caruncle or in symptomatic patients. [ABSTRACT FROM AUTHOR]

Purpose: Bone mineral density (BMD) measured with dual x‐ray absorptiometry (DXA) is the clinical standard for the diagnosis of osteoporosis and prediction of bone fracture risk. In the aging skeleton, osteoporosis is often concomitantly present with degenerative joint disease (DJD). Methods: In this study, we evaluated tissue‐level changes in the differentially loaded concave (CC) and convex (CV) sides of the lumbar spine in a sample of postmenopausal women with scoliosis. We used a cumulative degeneration score to assess osteophyte formation, the severity of sclerotic morphology, and marrow changes as markers of DJD in the lumbar spine and examined the correlation between markers of DJD and BMD. Results: More severe osteophyte growth and sclerosis were present on the CC side of the spine. The degenerative score (DS) was higher on the CC side of the lumbar spine compared with the CV side. While CC BMD was positively correlated with CC DS and marrow, CV DS was not correlated with CV BMD. Marrow changes were correlated with DS on the CC lumbar spine. Conclusion: These results highlight the importance of mechanoadaptive as well as broader inflammatory processes in the manifestation of degenerative changes and local mineral deposition at the lumbar spine. DXA‐based BMD measurement of osteoporosis need to be contextualized within the biomechanical and degenerative conditions of a joint rather than using a strict threshold cutoff. [ABSTRACT FROM AUTHOR]

Most previous studies found an elevated risk of endometrial cancer among women with polycystic ovary syndrome (PCOS). However, these had highly varying methods for ascertainment of PCOS diagnoses and limitations such as few exposed women and short follow-up. In this cohort study, we investigated the association between PCOS and endometrial cancer among women born in Denmark between January 1, 1940, and December 31, 1993 (n  = 1 719 121). Data in this study, including PCOS and endometrial cancer diagnoses and covariates, were derived from nationwide registers. We used Cox proportional hazards regression models to calculate hazard ratios (HRs) and 95% CIs. A total of 7862 endometrial cancer cases were identified during 23.7 years of follow-up (IQR, 37.7-61.9). We found an increased risk of endometrial cancer among women with PCOS compared with women without PCOS (HR = 3.02; 95% CI, 2.03-4.49). The risk was increased for premenopausal women (HR = 5.82; 95% CI, 3.64-9.30), whereas no marked association was seen for postmenopausal women. However, for postmenopausal women, results were limited by few cases and young age at the end of follow-up. Mounting evidence of an increased risk for endometrial cancer among women with PCOS reinforces the need for prevention and early detection. This article is part of a Special Collection on Gynecological Cancers. [ABSTRACT FROM AUTHOR]

Background/Objectives: Osteoporosis and periodontal disease (PD) are associated with significant morbidity and mortality especially among post-menopausal women. The attributable causes of mortality include bone fragility, hip fractures, surgical risks, complications associated with immobility/disability, and mental health issues. This cross-sectional study aims to investigate the association between oral health and bone diseases along with the factors that predict this association. Methods: This study included post-menopausal women undergoing routine bone density evaluation. Following informed consent, case histories were collected using an investigator-administered questionnaire. The oral cavity was inspected for the health of the oral structures and periodontium. Bone density data, interpreted by a radiologist, were also collected. Data were analyzed using chi-square and logistic regression tests with the significance level set at 5%. Results: Among 100 eligible participants, mean age and body mass index (BMI) were 68.17 ± 8.33 years and 29.59 ± 6.13 kg/m2, respectively. A total of 23 participants (23.0%) had T2DM, 29 (29.0%) had < 20 natural teeth, and 17 (17.0%) had normal bone mineral density. Except for age (aOR 1.171, p < 0.001), BMI (aOR 0.763, p < 0.001), and past osteoporotic fractures (aOR 21.273, p = 0.021), all other factors were insignificant predictors of bone loss. Conclusions: Although the unadjusted results suggest a relationship between oral health indicators and bone loss, these relationships were not present when other factors were included in an adjusted model. Our findings suggest PD by itself may not be a risk factor for bone loss but that the two conditions may have similar risk factors. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is associated with subclinical atherosclerosis and endothelial dysfunction, which can be assessed non-invasively through flow-mediated dilation (FMD). In this study, we evaluated the potential impact of inhaled corticosteroid (ICS) therapy on FMD of COPD patients undergoing pulmonary rehabilitation (PR). Methods: Medical records of COPD patients undergoing FMD assessment upon admission to our Pulmonary Rehabilitation Unit were reviewed in this retrospective post hoc analysis. Results: A total of 46 patients with COPD (median age 71.5 years, 28.3% postmenopausal females) were included in the final analysis. Among these, 27 participants were currently receiving ICS therapy, while 19 were not. At baseline, the two groups showed no difference in the main clinical and functional variables. Similarly, no significant difference was observed in vascular reactivity parameters, with a median FMD of 3.12% (IQR: 2.23–4.45) in ICS users and 3.39% (IQR: 2.45–4.08) in ICS nonusers (p = 0.544). After PR, a significant improvement in the main rehabilitation and patient-reported outcomes was observed in all groups, with a significant improvement in FMD documented in both patients treated with steroids (from 3.12%; IQR: 2.23–4.45 to 4.77%; IQR: 3.25–5.63, p = 0.022) and in those who were not (from 3.39%; IQR: 2.45–4.08 to 5.04%; IQR: 3.98–6.06, p = 0.005). FMD changes were of comparable magnitude among groups. Conclusions: Our preliminary findings do not indicate a significant impact of medications containing ICS on the endothelial function of COPD patients, suggesting that the potential beneficial effect of PR on this surrogate marker of cardiovascular risk is independent of inhaled therapy. [ABSTRACT FROM AUTHOR]

Menopause is characterized by many physiologic changes due to decreasing hormone levels. Genitourinary syndrome of menopause causes vulvovaginal symptoms, urinary symptoms, and sexual symptoms. This systematic review evaluated the effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers with regard to patient-reported outcomes. Background: Postmenopausal women commonly experience vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM). Purpose: To evaluate effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM symptoms. Data Sources: Medline, Embase, and CINAHL through 11 December 2023. Study Selection: Randomized controlled trials (RCTs) of at least 8 weeks' duration enrolling postmenopausal women with at least 1 GSM symptom and reporting effectiveness or harms of hormonal interventions or vaginal moisturizers. Data Extraction: Risk of bias and data extraction were performed by one reviewer and verified by a second reviewer. Certainty of evidence (COE) was assessed by one reviewer and verified by consensus. Data Synthesis: From 11 993 citations, 46 RCTs evaluating vaginal estrogen (k = 22), nonestrogen hormones (k = 16), vaginal moisturizers (k = 4), or multiple interventions (k = 4) were identified. Variation in populations, interventions, comparators, and outcomes precluded meta-analysis. Compared with placebo or no treatment, vaginal estrogen may improve vulvovaginal dryness, dyspareunia, most bothersome symptom, and treatment satisfaction. Compared with placebo, vaginal dehydroepiandrosterone (DHEA) may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and vaginal moisturizers may improve dryness (all low COE). Vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene may provide no benefit (low COE) or had uncertain effects (very low COE). Although studies did not report frequent serious harms, reporting was limited by short-duration studies that were insufficiently powered to evaluate infrequent serious harms. Limitations: Most studies were 12 weeks or less in duration and used heterogeneous GSM diagnostic criteria and outcome measures. Few studies enrolled women with a history of cancer. Conclusion: Vaginal estrogen, vaginal DHEA, oral ospemifene, and vaginal moisturizers may improve some GSM symptoms in the short term. Few long-term data exist on efficacy, comparative effectiveness, tolerability, and safety of GSM treatments. Primary Funding Source: Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684) [ABSTRACT FROM AUTHOR]

Menopause is characterized by many physiologic changes from declining hormone levels. Genitourinary syndrome of menopause includes vulvovaginal, urinary, and sexual symptoms. This evidence map describes the 39 complementary and alternative medicine or therapies that have been studied in 57 randomized controlled trials. Background: Women seeking nonhormonal interventions for vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM) may seek out complementary and alternative medicine or therapies (CAMs). Purpose: To summarize published evidence of CAMs for GSM. Data Sources: Ovid MEDLINE, EMBASE, and CINAHL from inception through 11 December 2023. Study Selection: Randomized controlled trials (RCTs) 8 weeks or more in duration that evaluated the effectiveness or harms of CAMs for postmenopausal women with GSM and reported 1 or more outcomes of interest, with sample sizes of 20 or more participants randomly assigned per group. Data Extraction: Data were abstracted by 1 reviewer and verified by a second. Data Synthesis: An evidence map approach was used to organize and describe trials. Studies were organized by type of intervention, with narrative summaries for population, study characteristics, interventions, and outcomes. Fifty-seven trials were identified that investigated 39 unique interventions. Studies were typically small (n  < 200), and most were done in Iran (k = 24) or other parts of Asia (k = 9). Few trials evaluated similar combinations of populations, interventions, comparators, or outcomes. Most studies (k = 44) examined natural products (that is, herbal or botanical supplements and vitamins), whereas fewer reported on mind and body practices (k = 6) or educational programs (k = 7). Most studies reported 1 or 2 GSM symptoms, mainly sexual (k = 44) or vulvovaginal (k = 30). Tools used to measure outcomes varied widely. Most trials reported on adverse events (k = 33). Limitations: Only English-language studies were used. Effect estimates, risk of bias, and certainty of evidence were not assessed. Conclusion: There is a large and heterogeneous literature of CAM interventions for GSM. Trials were small, and few were done in North America. Standardized population, intervention, comparator, and outcomes reporting in future RCTs are needed. Primary Funding Source: Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684) [ABSTRACT FROM AUTHOR]

Menopause is associated with reduced endothelial‐dependent vasodilation and increased cardiovascular disease (CVD) risk. Dietary nitrate, a non‐pharmacological approach, may increase vasodilatory capacity consequentially reducing CVD risk. We investigated macro‐ and microvascular function after acute nitrate supplementation in postmenopausal females (PMF). Vascular function was studied with flow‐mediated vasodilation (FMD) and near‐infrared post occlusive reactive hyperemia (PORH). Incremental handgrip exercise was performed to investigate blood flow and tissue oxygenation. We hypothesized acute dietary nitrate would not impact resting endothelial measures but would increase post ischemic vasodilation and incremental exercise blood flow. Late‐phase PMF (n = 12) participated in a randomized crossover design with 140 mL of nitrate‐rich (NR) beetroot juice or nitrate‐poor black currant juice. Testing included a 5‐min FMD, a 3‐min ischemic exercise FMD, and incremental exercise at 10%, 15%, and 20% maximal voluntary contraction to measure blood flow and pressure responses. A p ≤ 0.05 was considered significant. One‐way ANOVA indicated lower resting pressures, but no change to FMD, or PORH in either protocol. Two‐way repeated measures ANOVA indicated NR supplementation significantly reduced mean arterial pressure at rest and during incremental exercise at all intensities without changes to blood flow. Acute nitrate is effective for resting and exercising blood pressure management in PMF. [ABSTRACT FROM AUTHOR]

The present cross-sectional study aimed to compare climacteric symptoms and arterial stiffness indices between perimenopausal and postmenopausal women. The study sample comprised 70 healthy female participants, including 27 perimenopausal (49.8 ± 3.8 years) and 43 postmenopausal (55.7 ± 4 years) individuals. Validated methods were used to assess physical activity level, quality of life, climacteric symptoms, and anthropometric data. Arterial stiffness parameters were measured using Mobil-O-Graph. Pulse wave velocity (PWV) had a higher mean in the postmenopausal group than in the perimenopause group [8.04 m/s (SD 0.79) vs 7.01 m/s (SD 0.78), p <.001). PWV was strongly correlated with peripheral (r = 0.619) and central (r = 0.632) Systolic Blood Pressure (SBP) in postmenopausal group and an even stronger correlation was observed in perimenopausal group (r = 0.779 pSBP and 0.782 cSBP). BMI was a risk predictor in the perimenopausal group contributing positively to increase Pulse Pressure Amplification (PPA) (0.458, p <.05). In postmenopausal women, heart rate (HR) was a stronger predictor for central SBP, cardiac output, and total vascular resistance, whereas perimenopausal women HR influenced central diastolic blood pressure and PPA. Vascular changes initiating during perimenopause may contribute to the development of cardiovascular pathologies in the postmenopausal period. Further research with larger, representative samples is warranted to corroborate these findings. [ABSTRACT FROM AUTHOR]

Introduction: Females suffer greater lifetime risk of stroke and greater morbidity and mortality from stroke compared with males. This study's objective was to identify differences in metabolomic profiling of females and males with stroke and which differences were associated with neurological outcome. Methods: Females and males with acute ischemic stroke enrolled in the Emergency Medicine Specimen Bank at a comprehensive stroke center provided whole blood samples upon arrival for mass spectrometry-based metabolomics. We used descriptive statistics to characterize the cohort. A linear regression model was fit for individual metabolites to determine differences in relative abundance between males and females while controlling for covariates (age, race/ethnicity, postmenopausal status, cardiovascular risk factors, depression, time between sample collection and last known well, and initial National Institutes of Health Stroke Scale [NIHSS] score). For each differentially expressed metabolite, a linear regression model was fit to determine the association between the metabolite and NIHSS at 24 hours after admission while controlling for the covariates and acute treatments. Results: After adjusting for covariates, eight metabolites differed in females and males with a stroke. These included amino acids or their metabolites (proline and tryptophan), nucleotides (guanosine diphosphate [GDP], and inosine-3′,5′-cyclic monophosphate), citrate, dehydroascorbate, choline, and acylcarnitine-(5-OH). GDP and dehydroascorbate were significantly associated with 24-hour NIHSS (p = 0.0991). Conclusions: Few metabolites were differentially abundant in blood after a stroke when comparing females with males and controlling for confounders, but the interactions between biological sex and GDP, as well as biological sex and dehydroascorbate, were associated with 24-hour neurological function. This has important implications for future studies that evaluate the therapeutic potential of these metabolites in ischemic stroke. [ABSTRACT FROM AUTHOR]

Objective: Uterine-sparing surgery for pelvic organ prolapse (POP) repair has shown good results, but the potential negative implications of leaving the uterus in place are yet to be fully defined. We aimed to assess the risk of unanticipated abnormal gynecological pathology at the time of reconstructive pelvic surgery. Methods: A retrospective consecutive case series including women who underwent vaginal hysterectomy for POP repair at a tertiary medical center in 2006–2020. All patients were offered a free Pap smear test at the age of 65 years as part of a national screening program. Transvaginal ultrasound was routinely performed preoperatively. Standard 3 pedicle hysterectomy was performed with/without bilateral salpingo-oophorectomy (BSO). Results: The study comprised 462 women of mean age 63 ± 9.3 years without previous known malignant or premalignant pathology. Benign pathology was observed in 286 patients (61.9%). Endometrial malignancy was found in three patients (0.7%) and significant premalignant pathology in 15 patients (3.2%), including cervical intraepithelial neoplasia stage 2–3 in seven patients (1.5%) and complex hyperplasia with atypia in eight patients (1.7%). All these pathologies were found in postmenopausal women. None had preoperative clinical symptoms or endometrial thickness of ≥5 mm on preoperative ultrasound. In the 35 patients after BSO, adnexal findings were normal (77.2%) or benign (22.8%). Conclusions: Premenopausal women with uterovaginal prolapse and normal preoperative evaluation have a minimal risk of significant abnormal uterine pathology. In postmenopausal women, the risk of unanticipated malignant uterine pathology is 0.7% and 3.2% for significant premalignancy. [ABSTRACT FROM AUTHOR]

Independently, both prolonged uninterrupted sitting and the onset of menopause negatively impact markers of cardiovascular risk. Whether their combination augment these responses additively remains unknown. This study assessed whether prolonged uninterrupted sitting causes greater central and peripheral cardiovascular dysfunction in post-menopausal women compared to pre-menopausal women. To address this, 23 healthy women (13 pre-menopausal [43.77 ± 4.30 years] and 10 post-menopausal [57.20 ± 8.55 years]) sat uninterrupted for 2-h. Carotid-femoral pulse wave velocity (cf-PWV), pulse wave analysis (PWA), lower limb venous pooling (HHb), and calf circumference were assessed pre-and post-sitting using general linear mixed models, with age as a covariate. Changes in MAP over time (both between and within groups) was assessed using a two-way repeated-measures-ANOVA. There were no significant interactions for any outcome measures. However, for cf-PWV, there was a significant main effect of group (Δ = 0.854 ± 0.354 m s−1; p = 0.026, ηp2 = 0.707). For PWA, only heart rate (HR) and pressure forwards (Pf) showed significant main effects 13 of time [Δ = 6 ± 1 bts-min−1, p < 0.001, ηp2 = 0.861] and group [Δ = 3.893 ± 1.450 mmHg, p = 0.016, ηp2 = 0.271], respectively. Both HHb (Δ = 2.737 ± 0.952, p = 0.009, ηp2 = 0.742) and calf circumference (Δ = 0.812 ± 0.128 cm, p < 0.001, ηp2 = 0.863) significantly increased over time. Whilst post-menopausal women demonstrated greater overall arterial stiffness (increased cf-PWV at baseline), there was no difference in cardiovascular response (central or peripheral) to 2-h of prolonged sitting between the pre- and post-menopausal women. [ABSTRACT FROM AUTHOR]

Objective: Postmenopausal changes in bone mass and structure compromise the mechanical properties of proximal humerus, predisposing it to low‐energy fractures with complex morphology. The aim of the study is to investigate associations of bone quality and estimated bone strength of the surgical neck with age after menopause. Methods: A total of 122 healthy postmenopausal women were recruited from December 2016 to December 2022 and assigned to three groups: the 50–59 years group, the 60–69 years group, and the older than 70 years group. Bone properties of the surgical neck, including volumetric bone mineral density (vBMD), cortical thickness (CTh), the periosteal and medullary size, and estimated indices of bone strength were evaluated by quantitative computed tomography. Results: Compared to the 50–59 years group, postmenopausal women aged over 70 years were characterized by lower cortical thickness (13.9%) and vBMD (6.65%), as well as reduced strength indices including the minimum and maximum section modulus (Zmin 18.11%, Zmax 21.71%), polar section modulus (Zpol 20.21%), and the minimum and maximum second moments of area (Imax 21.01%, Imin 21.43%). Meanwhile, the difference in periosteal diameter and perimeter, total area in three groups did not reach statistical significance. Both cortical thickness and vBMD value were inversely associated with age, showing 10.56% and 23.92% decline. Imax showed the greatest age‐related decrease between age of 54 and 86 years (39.08%), followed by Zmax (−35.77%), Imin (−35.73%), Zpol (−34.90%) and Imin (−23.92%).The strength indices had stronger correlations with cortical thickness than with bone size or density. Conclusion: In postmenopausal women, aging is associated with a significant decline in cortical bone thickness and mechanical strength of the proximal humerus, especially over the age of 70 years. [ABSTRACT FROM AUTHOR]

Objective: Malondialdehyde (MDA), a by-product of lipid peroxidation, is considered one of the biological markers for oxidative stress. Oxidative stress increases with age, especially after menopause. The aim is to evaluate the oxidative stress levels in pre-, peri-, and postmenopausal women by measuring salivary malondialdehyde levels. Methods: The study included 45 participants, who were categorized into premenopausal, perimenopausal, and postmenopausal groups. Salivary MDA levels were measured biochemically using the thiobarbituric acid method. Results: A statistically significant rise (P < .001) in the mean salivary MDA level was observed in postmenopausal women (0.94 ± 0.18 nmol/mL) when compared to perimenopausal (0.78 ± 0.08 nmol/mL) and premenopausal women (0.48 ± 0.09 nmol/mL). Salivary MDA levels were also positively correlated with the age of the participants (r = 0.79; P < .00) and the duration of menopause (r = 0.609; P = .015). Conclusion: Salivary MDA levels were highest in postmenopausal women, followed by perimenopausal and premenopausal women. The changes observed in salivary MDA levels could be probably due to the oxidative stress during menopause. [ABSTRACT FROM AUTHOR]

Purpose: The Functional Assessment of Cancer Therapy item (FACT-GP5) has the potential to provide an understanding of global treatment tolerability from the patient perspective. Longitudinal evaluations of the FACT-GP5 and challenges posed by data missing-not-at-random (MNAR) have not been explored. Robustness of the FACT-GP5 to missing data assumptions and the responsiveness of the FACT-GP5 to key side-effects are evaluated. Methods: In a randomized, double-blind study (NCT00065325), postmenopausal women (n = 618) with hormone receptor-positive (HR+), advanced breast cancer received either fulvestrant or exemestane and completed FACT measures monthly for seven months. Cumulative link mixed models (CLMM) were fit to evaluate: (1) the trajectory of the FACT-GP5 and (2) the responsiveness of the FACT-GP5 to CTCAE grade, Eastern Cooperative Oncology Group (ECOG) Performance Status scale, and key side-effects from the FACT. Sensitivity analyses of the missing-at-random (MAR) assumption were conducted. Results: Odds of reporting worse side-effect bother increased over time. There were positive within-person relationships between level of side-effect bother (FACT-GP5) and severity of other FACT items, as well as ECOG performance status and Common Terminology Criteria for Adverse Events (CTCAE) grade. The number of missing FACT-GP5 assessments impacted the trajectory of the FACT-GP5 but did not impact the relationships between the FACT-GP5 and other items (except for nausea [FACT-GP2]). Conclusions: Results support the responsiveness of the FACT-GP5. Generally speaking, the responsiveness of the FACT-GP5 is robust to missing assessments. Missingness should be considered, however, when evaluating change over time of the FACT-GP5. Trial Registration: NCT00065325. Trial Registration Year: 2003. [ABSTRACT FROM AUTHOR]

Background: Women who reach menarche and menopause at earlier ages have been shown to be at increased risk for numerous conditions including cardiovascular disease, cancer, depression, and obesity; however, risk factors for earlier ages of menarche and menopause are not fully understood. Therefore, we aimed to perform a retrospective investigation of the associations between a personal birthweight and/or being born preterm and the age of and menarche and menopause and related events in the Women's Health Initiative, a large, racially and ethnically diverse cohort of postmenopausal women. Methods: At study entry, women reported their birthweight by category (< 6 lbs., 6–7 lbs. 15 oz, 8–9 lbs. 15 oz, or ≥ 10 lbs.) and preterm birth status (4 or more weeks premature). Ages at events related to menarche and menopause were also self-reported. Linear regression and logistic regression models were used to estimate unadjusted and adjusted effect estimates (β) and odds ratios (OR), respectively (n ≤ 86,857). Individuals born preterm were excluded from all birthweight analyses. Results: After adjustments, individuals born weighing < 6lbs. were more likely to reach natural menopause at an earlier age (adjusted β=-0.361, SE = 0.09, P = < 0.001) and have a shorter reproductive window (adjusted β = -0.287, SE = 0.10, p < 0.004) compared to individuals weighing 6–7 lbs. 15 oz. Individuals born preterm were also more likely to reach natural menopause at an earlier age (adjusted β=-0.506, SE = 0.16, P = 0.001) and have a shorter reproductive window (adjusted β = -0.418, SE = 0.17, p < 0.006). Conclusions: These findings raise concerns that, as more preterm and low birthweight individuals survive to adulthood, the prevalence of earlier-onset menarche and menopause may increase. Clinical counseling and interventions aimed at reducing the incidence of preterm and low birthweight births, as well as intensification of lifestyle modifications to reduce CVD risk among women with these early-life risk factors, should be prioritized. [ABSTRACT FROM AUTHOR]

Disordered eating refers to a range of eating behaviours and attitudes towards weight and food that can negatively influence physical and psychosocial well-being. The menopausal transition could be a vulnerable period for disordered eating due to major hormonal fluctuations, menopausal symptoms, common body composition shifts, and an increased risk of psychological challenges. This systematic review aimed to summarize evidence on the associations between the menopausal transition and disordered eating. Records published before October 2023 were identified through MEDLINE, PsycINFO, Scopus, Embase, and CINAHL. Studies investigating associations between menopausal status, menopausal symptoms, or reproductive hormone levels, and disordered eating during the menopausal transition were sought. A total of 1301 non-duplicate records were screened, with 10 studies deemed eligible for inclusion. Most included studies used a cross-sectional design (n = 9). Findings include potentially higher levels of binge eating during the perimenopausal stage, whereas restrictive eating behaviours appeared more common during postmenopause compared to premenopause. Both studies investigating menopausal symptoms found strong positive associations with disordered eating. Nonetheless, findings are equivocal with contrasting results and limited methodological quality across studies. Further research is needed to verify these findings and better assist health professionals in supporting healthy eating behaviours in menopausal women during this complex transition. (PROSPERO ID: CRD42021290736) [ABSTRACT FROM AUTHOR]

Summary: Long-term glucocorticoids (GCs) treatment is associated with osteoporosis and fractures. We investigated whether low-dose GC treatment also increased the risk of osteoporotic fractures, and the results showed that even low-dose GC treatment increased the risk of osteoporotic fractures, especially spine fractures. Purpose: The effect of low-dose glucocorticoid (GC) therapy on the fracture risk in postmenopausal women with low bone mass was investigated. Methods: 119,790 66-year-old postmenopausal women with low bone mass based on bone mineral density (BMD) results were included. GC group consisted of patients who had been prescribed oral GCs within 6 months of BMD testing. In GC group, GCs dosage was calculated by a defined daily dose (DDD), and divided into five groups according to GC usage (Group 1[G1]; < 11.25 DDDs, G2; ≥ 11.25, < 22.5 DDDs, G3; ≥ 22.5, < 45 DDDs, G4; ≥ 45, < 90 DDDs, G5; ≥ 90 DDDs). The risk of major osteoporotic fractures (MOF) and non-MOF was analyzed and compared with that of the control group during the 1-year follow-up. Results: The risk of total fracture was higher in G3–G5 than in the control group (G3, hazard ratio (HR) 1.25, 95% confidence interval [CI] 1.07–1.46; G4, 1.37 [1.13–1.66]; G5 1.45 [1.08–1.94]). The risk of MOF was higher in all groups except G2 than in the control group (G1, 1.23 [1.05–1.45]; G3, 1.37 [1.11–1.68]; G4, 1.41 [1.09–1.83]; G5, 1.66 [1.14–2.42]). The risk of spine fracture was significantly higher in all GC groups except G2 than in the control group. The risk of non-MOF was higher only in G4 than in the control group (G4, 1.48 [1.13–1.94]). Conclusion: Low-dose GC therapy can increase the risk of osteoporotic fractures, particularly spine fractures, in postmenopausal women with low bone mass. [ABSTRACT FROM AUTHOR]

Objective: COVID-19 vaccination has been related to menstrual irregularities; however, the effect on postmenopausal women is unknown. The aim of this study was to analyze the prevalence of postmenopausal bleeding (PMB) after COVID-19 vaccination. Methods: A retrospective study was conducted in the Department of Gynecology in Hospital del Mar. Consecutive postmenopausal women with data available and endometrial biopsy were included between February 2021 and January 2022. Patients were stratified between COVID-19 vaccinated and unvaccinated groups. PMB after 30 days from last vaccine dose was considered unrelated to vaccine. Endometrial pathology diagnoses were stratified into benign or malignant. Univariable and multivariable of regression analysis on variables potentially associated with PMB was performed. Results: A total of 381 patients were included, 91 in the vaccinated group and 290 in the unvaccinated group. Prevalence of PMB in the vaccinated group was 75.8% compared to 59.0% in the unvaccinated group (p < 0.005). No increase in endometrial malignant pathology was observed among the vaccinated group (p = 0.189). Multivariable analysis that correlates factors associated with PMB suggests COVID-19 vaccine and malignant endometrial biopsy as independent risk variables. Conclusions: A higher prevalence of PMB was associated with COVID-19 vaccine. Endometrial histological results showed no association with COVID-19 vaccination, but endometrial biopsy should be performed for PMB. [ABSTRACT FROM AUTHOR]

Objective: Among postmenopausal women, oral, ultra-low-dose continuous combined estradiol (E0.5 mg) plus dydrogesterone (D2.5 mg) reduces vasomotor symptoms (VMS). Methods: This study was a post hoc analysis of data from two phase 3, double-blind studies. Postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg, E1 mg/D5 mg (not included in this analysis) or placebo for 13 weeks (European study), or randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks (Chinese study). Endpoints assessed in ethnicity subgroups (European and Chinese) included changes from baseline in number of hot flushes, number of moderate-to-severe hot flushes and Menopause Rating Scale (MRS) score. Results: Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, n = 288; placebo, n = 291). European and Chinese women receiving E0.5 mg/D2.5 mg experienced greater reductions from baseline in mean daily number of hot flushes and mean daily number of moderate-to-severe hot flushes at week 4, week 8 and end of treatment versus those receiving placebo. Significant improvements in the 'hot flushes, sweating' MRS item score were reported in both European and Chinese women. Conclusion: Oral, ultra-low-dose continuous combined 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone improved VMS compared with placebo in European and Chinese postmenopausal women, with a positive impact on health-related quality of life. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate the effectiveness, tolerability and application of estradiol metered-dose transdermal spray (EMDTS) in postmenopausal women during real-world use. Methods: This was a prospective, non-interventional, multicenter, observational phase IV cohort study. The Menopause Rating Scale II (MRS II) was used to assess symptoms and clinical response. Safety was assessed by the occurrence of adverse events and adverse drug reactions (ADRs). Results: A total of 451 postmenopausal women were enrolled at 52 gynecological practices across Germany; 383 patients were evaluated for effectiveness and 430 patients for safety. Mean age was 54.3 ± 7.4 years. In total, 228 patients (59.5%) received EMDTS monotherapy and 155 patients (40.5%) received EMDTS plus progestogens. Significant improvements (p < 0.0001) from baseline in symptom severity were recorded for all 11 items of the MRS II at 3, 6 and 12 months of treatment. At 12 months, 81.4% of patients reported improvement in hot flushes/sweating. At final visit, 73% of patients and 77% of physicians were 'satisfied/very pleased' with EMDTS. Most common ADRs were headache (n = 6), nausea (n = 4), dizziness (n = 4) and pruritus (n = 3). Conclusions: EMDTS is an effective, well tolerated and easily applied hormone replacement therapy for women experiencing postmenopausal symptoms. [ABSTRACT FROM AUTHOR]