Menopause: The Journal of The North American Menopause Society最新文献

Objective: To evaluate whether effects of oral hormone therapy (HT) on risks of venous and arterial vascular events differ by baseline statin or aspirin use.

Methods: We performed time-to-event analysis using data from the Women's Health Initiative menopausal HT randomized trials to assess risk of thrombotic events. Women were randomized to oral conjugated equine estrogens (CEEs) alone or placebo among women with prior hysterectomy (n = 10,739), and CEE with medroxyprogesterone acetate (MPA) or placebo among women with an intact uterus (n = 16,608), stratified by baseline personal use of statins and aspirin. We evaluated risk of prespecified, adjudicated thrombotic events, including coronary heart disease, stroke, venous thromboembolism, and/or composite major adverse cardiovascular events, at 2 and 5 years.

Results: Baseline statin use (n = 827 in CEE-alone trial; n = 1,115 in CEE+MPA trial) or aspirin use (n = 2,212; n = 3,431) was limited. At 5-year follow-up, coronary heart disease risk for CEE-alone versus placebo was hazard ratio (HR) = 0.81 (95% CI: 0.44-1.49) in statin users, similar to nonusers, HR = 1.07 (95% CI: 0.82-1.40). For CEE+MPA, there was also no difference by statin use, HR = 1.02 (95% CI: 0.55-1.89) and HR = 1.47 (95% CI: 1.13-1.90), respectively. Neither statin nor aspirin exposure significantly modified effects of HT on any arterial or venous thrombotic outcome at 2 or 5 years.

Conclusions: In this secondary randomized clinical trial analysis, neither statins nor aspirin significantly modified effects of oral HT on key arterial or venous thrombotic outcomes at 2 or 5 years. Results, however, may be underpowered given low baseline exposure prevalence for both statins and aspirin.

Objective: There is growing evidence for the benefits of physical activity during the menopause life stage. However, limited research has explored physical activity behavior of UK women. Using a mixed-methods approach, 2 phases of research were undertaken to: (1) assess physical activity levels and examine the relationship with menopausal symptoms, and (2) use the COM-B theoretical framework to understand the influence of "Capability, Opportunity and Motivation" on physical activity Behavior.

Methods: In phase 1, participants completed an online survey (n = 655; mean age = 49.9 y). Descriptive analyses were supplemented with χ 2 tests, with Bonferroni correction. In phase 2, 4 online focus groups (n = 24; mean age = 52.7 y) were undertaken and thematically analyzed.

Results: In phase 1, 75% reported achieving 150 minutes of moderate to vigorous physical activity/week, although 57% reported activity levels had decreased during the menopause life stage. Twelve out of 14 symptoms were experienced by >50%, with changes in mood and brain fog most common (>80%). There was no significant difference in the proportion meeting the moderate to vigorous physical activity guidelines between those women who did or did not experience individual symptoms, although for 10/14 symptoms, >50% indicated a negative impact on likelihood to engage in activity. In phase 2, capability (eg, menopausal symptoms), opportunity (eg, social support), and motivation (eg, low confidence) were all influential on behavior.

Conclusion: These findings enhance our understanding of UK women's experiences of being physically active during the menopause, and provide insight into potential intervention strategies to support women to be active at that time.

Importance: Menopause is characterized by significant physiological changes, including cardiovascular and hormonal alterations. Estrogen therapy is a critical intervention for managing menopausal symptoms and preventing long-term complications. Understanding the differences between the estrogen therapy administration routes is essential for optimizing treatment strategies.

Objective: This study aimed to compare oral and transdermal routes of estrogen therapy among postmenopausal women and assess changes from baseline in key cardiovascular and lipid parameters, including systolic and diastolic blood pressure, heart rate, total cholesterol, low and high-density lipoprotein, and triglyceride levels.

Evidence review: PubMed, Scopus, Web of Science, and ClinicalTrials. gov were searched for randomized clinical trials comparing oral and transdermal estrogen therapy in postmenopausal women. Pooled mean differences (MDs) with 95% CIs were estimated using a random effects model. Statistical analyses were performed using R version 4.3.2.

Findings: Eight randomized clinical trials, with a total of 885 participants, were included. Of these participants, 453 (51.2%) received oral estrogen therapy. Participants receiving oral estrogen therapy had a higher mean change in high-density lipoprotein levels (MD=3.48 mg/dL; 95% CI: 1.54-5.43; P <0.01) coupled with a significant rise in mean triglyceride levels (MD=19.82; 95% CI: 6.85-32.78; P <0.01), compared with participants receiving transdermal estrogen therapy. There were no significant differences in the mean changes from baseline in the systolic and diastolic blood pressure, heart rate, total cholesterol, and low-density lipoprotein levels.

Conclusions and relevance: Compared with transdermal estrogen therapy, oral estrogen therapy was associated with a greater increase in high-density lipoprotein levels in postmenopausal women. However, this was associated with a greater increase in the triglyceride levels. This suggests that the choice of estrogen therapy route should be individualized, considering the patients' baseline hormonal and metabolic parameters, particularly lipid profiles.

Objective: Perimenopause is the time leading up to a woman's last menstrual cycle and includes the 12 months afterward. Studies that systematically compare perimenopause symptoms across diverse cultural and geographic settings are lacking. This study, utilizing data from Flo, an international mobile health application, aimed to assess global knowledge and symptom experiences related to perimenopause.

Methods: This cross-sectional survey was conducted via the Flo application, offered to users aged 18 years and above. The primary endpoints were knowledge of perimenopause symptoms from all survey participants, and self-reported perimenopause symptoms for survey participants aged 35 years and above. Secondary analyses compared knowledge scores and symptoms across geographic regions.

Results: A total of 17,494 women from 158 countries were included. Commonly recognized perimenopause symptoms included hot flashes (71%), sleep problems (68%), and weight gain (65%). Of the participants, 12,681 were aged 35 years or above, with the most common self-reported symptoms being fatigue (83%), physical and mental exhaustion (83%), irritability (80%), depressive mood (77%), sleep problems (76%), digestive issues (76%), and anxiety (75%). This pattern of symptoms was similar among those who self-reported being in perimenopause, though higher than in those not in perimenopause. International variation in perimenopause symptom knowledge and symptoms experienced was noted (P<0.001).

Conclusions: This survey highlights a discordance between perimenopause knowledge and actual symptoms experienced across diverse global populations. While hot flashes were the most widely recognized symptom, respondents aged 35 years or above most commonly reported experiencing fatigue, physical and mental exhaustion, and irritability.

Objective: To investigate the association between changes in body mass index (BMI) from adolescence to middle age and osteoporosis risk among participants in the Japan Nurses' Health Study (JNHS), a nationwide prospective cohort study.

Methods: Data were reviewed for 15,019 participants in the JNHS. After excluding 6,511 participants aged below 40 years or diagnosed with osteoporosis at baseline, 8,508 participants were included. The mean age at baseline was 47.5±5.4 years, and the mean follow-up period was 15.5±6.3 years. Low body weight (L) was defined as BMI <18.5 kg/m2, normal weight (N) as BMI ≥18.5 to <25 kg/m2, and overweight (O) as BMI ≥25 kg/m2.

Results: Age-adjusted hazard ratios for new-onset osteoporosis according to change in BMI from age 18 years to baseline compared with N to N were L to L, 1.65 (95% CI: 1.10-2.47), N to L, 1.44 (1.08-1.91) and N to O, 0.65 (0.54-0.79). Multivariable-adjusted hazard ratios for osteoporosis compared with N to N were L to L, 1.51 (0.98-2.33), N to L, 1.29 (0.95-1.76) and N to O, 0.68 (0.55-0.82). Regarding age at diagnosis of osteoporosis compared with N to N, the HR for L to L was 1.97 (1.04-3.72) for participants in their 50s, and the HR for N to O was 0.56 (0.42-0.76) for participants in their 60s.

Conclusions: Persistent underweight status in women from adolescence to middle age is a risk factor for developing earlier osteoporosis in menopause.

Objective: Mood and anxiety symptoms at the menopause transition are common. However, most cognitive-behavioral treatments focused on perimenopause center on managing physical symptoms such as hot flashes, and not mood symptoms. In this case series, we assessed the impact of a CBT intervention program on anxiety and depressive symptoms among individuals in perimenopause or postmenopause, who reported mood symptoms.

Methods: The intervention included eight 45-minute sessions of individual CBT with a clinical psychologist, and included CBT skills training (eg, behavioral activation, reframing negative automatic thoughts). The intervention was a general CBT intervention not tailored to perimenopause. Chart abstractions were performed for individuals who completed at least one session of the CBT program.

Results: Twenty participants completed at least one session, and sixteen completed all eight sessions. Symptoms of depression (Patient Health Questionnaire 9 scores) decreased by 42.1% from session 1 (M=8.74 [5.48]) to session 8 (M=5.06 [4.77]) (t=3.98, P=0.001). Similarly, symptoms of anxiety (GAD-7 scores) decreased by 56.2% from session 1 (M=6.98 [4.38]) to session 8 (M=3.06 [4.34]) (t=3.39, P=0.004).

Conclusions: A standardized CBT intervention, not tailored to perimenopause, reduced depressive and anxiety symptoms in a small case cohort of women in perimenopause and postmenopause. Further research in a larger sample with a clinical trial design is needed.

Objective: To identify factors associated with climacteric symptoms and quality of life in women with and without a history of gynecological cancer.

Methods: A cross-sectional study was conducted from November 2022 to May 2024 in a tertiary hospital's menopause clinic in Campinas, Brazil. Women aged 30 years or above with climacteric symptoms were included, excluding those undergoing treatment for these symptoms or with debilitating conditions. Climacteric symptoms were assessed using the Menopause Rating Scale (MRS), and quality of life by the Women's Health Questionnaire (WHQ). Statistical analyses included descriptive tests, χ2, Mann-Whitney, and Poisson regression (P<0.05).

Results: A total of 184 women (mean age 49.6±9.5 y) were included, of whom 54.3% had a history of cancer (29.3% breast, 14.1% cervical, 7.6% ovarian, 2.7% endometrial, 0.5% vulvar). The mean age at menopause was 44.2±6.7 years; 58.5% had treatment-induced menopause. Median MRS and WHQ scores were 27 and 0.58, respectively. No association was found between a history of cancer and overall symptom severity or reduced quality of life. In multivariate analysis, worse quality of life was independently associated with higher severity of somatovegetative symptoms (PR: 2.10; 95% CI: 1.16-3.79) and psychological symptoms (PR: 1.90; 95% CI: 1.07-3.36).

Conclusion: A history of gynecological cancer was not associated with increased climacteric symptoms or poorer quality of life. Menopausal symptoms, especially vasomotor and psychological domains, were the main factors related to lower quality of life.

Objective: Individuals with BRCA1/2 pathogenic variants (PV) are recommended risk-reducing salpingo-oophorectomy between 35 and 45 years of age to prevent ovarian cancer. Trials evaluating the oncologic safety of risk-reducing salpingectomy are ongoing. One's decision on the type and timing of surgery has implications for fertility, quality of life, and long-term health. Published literature on patient preferences has focused on White women from North America and Europe; thus, findings are not necessarily generalizable to patients from other backgrounds. To address this gap, we sought to assess decision-making around ovarian cancer risk-reducing surgery among a racially and ethnically diverse population with BRCA1/2 PVs.

Methods: Between February 2023 and November 2023, patients with BRCA1/2 PVs were invited to participate in a one-time, semi-structured, one-on-one interview. Interviews were recorded, transcribed, and analyzed using an inductive approach by two independent coders.

Results: Among 15 participants, the median age was 41 years (range 24-64). Ten participants identified as Hispanic, Black, or Asian. Two identified as gender queer. Six had a history of breast cancer. Ten had undergone risk-reducing surgery for ovarian cancer (seven salpingo-oophorectomy and three salpingectomy). Concerns about surgical menopause were a primary consideration for all participants. Other influencing factors included fertility, oncologic safety, history of breast cancer, sexual function, sense of control, gender identity, and mental health.

Conclusion: This study identified themes that influenced decision-making among BRCA1/2 PV carriers considering or having undergone risk-reducing gynecologic surgery in a racially and ethnically diverse population. These insights can help clinicians better support patients undergoing this process, with the objective of providing patient-centered, culturally sensitive care.

Objectives: Timely identification of endometrial nonbenign lesions led to improved outcomes, but there was a lack of effective predictive models for asymptomatic endometrial thickening. The aim of this study was to develop a strong machine learning (ML) model for assessing the risk of endometrial malignancy in asymptomatic patients after menopause.

Methods: This retrospective study was designed to collect data from 971 postmenopausal asymptomatic women with endometrial thickening. The bootstrap resampling method was used for model training, internal validation, and external validation. With 41 easily accessible characteristics, multifactor regression and least absolute shrinkage and selection operator regression were performed for feature selection. Nine ML algorithms were applied to build a model. To explain the final model and rank feature importance, the SHapley Additive exPlanation (SHAP) method was utilized. Meanwhile, a nomogram was developed to facilitate model interpretation.

Results: The comprehensive methodologies identified parity, Doppler flow signals, endometrial thickness, cancer antigen 125, and D-dimer as significant predictors. The logistic regression (LR) model demonstrated superior performance compared with other ML algorithms, achieving an accuracy of 88%, a sensitivity of 78%, a specificity of 98%, and an area under the receiver operating characteristic curve of 0.81. Furthermore, individualized predictions of endometrial malignancy were visualized through a force plot generated by SHAP analysis. A nomogram based on the LR model was subsequently constructed, showing area under the receiver operating characteristic curve values of 0.82, 0.82, and 0.81 for the training, internal validation, and external validation cohorts, respectively. The calibration curve demonstrated excellent consistency.

Conclusions: We developed an LR-based nomogram model and interpreted using the SHAP method, which provided visual insights for detecting endometrial nonbenign lesions in asymptomatic postmenopausal women. This approach would aid clinicians in providing individualized treatment and help avoid unnecessary invasive surgeries.