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

Objective: To investigate the pharmacokinetic profile of estradiol delivery after the subcutaneous insertion of a 25 mg estradiol bioabsorbable implant in hysterectomized women presenting with menopause-associated symptoms.

Methods: This was a prospective, open-label, single-arm study conducted at a single center between December 2023 and October 2024. Twenty hysterectomized participants received a 25 mg subcutaneous estradiol implant and were followed at weeks 4, 12, and 24 for clinical assessments, symptom evaluation, and safety monitoring. Hormone levels were measured using liquid chromatography-tandem mass spectrometry and electrochemiluminescence immunoassay. Adverse events were recorded, and menopause symptoms were assessed using the Menopause Rating Scale (MRS).

Results: Serum estradiol levels increased after treatment, rising from 31.6±7.0 pg/mL preinsertion to 105.2±10.7 pg/mL (mean±SD) at week 1, remaining stable (~80 pg/mL) through Week 20 and above pre-insertion levels until week 24. Estrone had a similar profile. Follicle-stimulating hormone and luteinizing hormone levels decreased throughout the treatment. Sex hormone-binding globulin, total and free testosterone, and prolactin showed minimal variation throughout the study. Subcutaneous estradiol delivery resulted in a sustained pharmacokinetic profile characterized by a Tmax of 75.6 hours and a 6439 hours notably extended half-life (T1/2). Vasomotor and psychological symptoms decreased significantly after 4 weeks of treatment, and the reduction in Menopause Rating Scale score was observed until Week 24. No serious adverse event was reported.

Conclusion: The 25 mg estradiol implant provided sustained serum concentration of estradiol over a 24-week period of treatment, effective symptom relief, and an acceptable safety profile in hysterectomized women, thereby offering a novel therapeutic option for hormone therapy.

Importance: Black cohosh (BC) is a herbal medicine being prescribed for the management of climacteric complaints. This is the first review to assess the quality of evidence for BC as measured by adherence to Consolidated Standards of Reporting Trials (CONSORT) extensions for herbal interventions and harms.

Objective: Herbal medicines such as Actaea racemosa (A. racemosa; synonym Cimicifuga racemosa, BC) are commonly being used by women seeking relief from menopausal (climacteric) complaints. Our objective is to evaluate the quality of reporting of clinical trials investigating A. racemosa for climacteric complaints, by grading their adherence to both the CONSORT extensions for herbal interventions, and for reporting adverse events (harms).

Evidence review: A systematic search of the databases: AMED, CINAHL, EBSCO, Academic Search Ultimate, Google Scholar, PubMed and Science Direct, was conducted in April 2023 and another search done March 2024. The search phrase employed included relevant herbal or herbal product keywords ["black cohosh," "actaea racemosa," "cimicifuga racemosa," "BNO 1055," "remifemin," "Ze 450"] combined using the Boolean operator term AND with keywords regarding climacteric complaints ["menopausal symptoms," "menopause," "climacteric complaints"]. Additional citation searching was conducted to identify any other published studies. Articles were included if they were clinical trials of oral use of A. racemosa in humans. Quality assessment of included articles was undertaken to review adherence to the CONSORT Statement Extensions for reporting on herbal interventions, and harms (adverse events).

Findings: Fourteen records were included in the final analysis. Adherence to the herbal extension for the CONSORT ranged between 39% and 87%, with four of them receiving an adherence rating of 50% or less. Adherence to the Harms Extension for the CONSORT ranged between 6% and 90%, with three of the articles receiving an adherence rating of 50% or less.

Conclusions and relevance: This is the first time a systematic review of the quality of clinical trial reports of BC, using the CONSORT herbal extension and harms checklists, has been conducted. The wide range of ratings found in our quality assessment suggests the need for further high-quality investigation of this widely used herbal preparation.

Objective: Approximately 75% of women aged between 45 and 55 years suffer from symptoms of menopause. Hormone therapies used in breast cancer treatment can induce the same symptoms. Current medications for menopausal symptoms are not suitable for everyone. Here, we describe a case of a woman whose menopausal vasomotor symptoms decreased after starting lamotrigine.

Methods: We report a case of a woman whose menopausal vasomotor symptoms disappeared with lamotrigine and returned after stopping the medication. We did not find any reports of lamotrigine in regards to menopausal symptoms.

Results: A 53-year-old woman with menopausal symptoms and migraine had tried different medications for migraine. She could not use estradiol 1 mg p.o. regularly, because it worsened her headache. Then, lamotrigine was started for the migraine as a preventive medication. Lamotrigine's official indication is epilepsy and bipolar disorder. It is also used off-label, for example, for migraine. In a few days the nighttime hot flashes, night sweats and sleeping problems disappeared. Then she developed a rash. Because the rash induced by lamotrigine can be severe, the medication had to be stopped. In 2 weeks, the menopausal symptoms returned.

Conclusions: Menopausal vasomotor symptoms disappeared with lamotrigine and returned after stopping the medicine in this case. The precise action mechanism(s) of lamotrigine is unknown. Lamotrigine has interactions with estrogen and progesterone medicines. So, this effect we describe might not have been just a coincidence. Lamotrigine could be worth further research in regards to menopausal symptoms.

Objective: The primary objective of this study was to determine whether women with and without a history of endometriosis experience menopause differently, in terms of their satisfaction with quality of life.

Methods: This study was conducted at Fondazione IRCCS Ca' Granda Policlinico Hospital, Milan, from October 2022 to April 2024. The total sample included 394 postmenopausal women aged 48-55 years: 197 with a clinical history of endometriosis (group 1) and 197 without (group 2). All participants were required to complete a series of validated questionnaires assessing quality of life (Short-Form Health Survey 12, SF-12), sexual function (Female Sexual Function Index [FSFI]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), climacteric symptoms (Menopause-Specific Quality of Life Questionnaire [MENQOL]), and satisfaction with their clinical condition using a 5-point Likert scale.

Results: The SF-12 scores were significantly higher in group 2 than in group 1 (physical score: P=0.01; mental score: P<0.001). Group 1 reported lower satisfaction levels than group 2; however, this difference was not statistically significant (OR = 0.78, 95% CI: 0.5-1.2, P=0.26). The FSFI, HADS, and MENQOL scores were not significantly different between the two groups (FSFI score, P = 0.20; HADS anxiety score, P=0.11; HADS depression score, P=0.48; MENQOL score, P = 0.91).

Conclusion: Postmenopausal women with a history of endometriosis appear to have a similar quality of life compared with those without such a history. While the overall quality of life scores were higher in women without endometriosis, both groups reported comparable climacteric symptoms, sexual functioning, and anxiety and depression levels.

Objectives: This study explores how women in a UK workplace discuss their menopause experiences and respond to their organization's menopause policy. It aims to understand the value, limitations, and implications of workplace menopause policies from the perspectives of women undergoing this life transition.

Methods: Data were drawn from a workshop involving 11 participants who were perimenopausal and postmenopausal women. Participants shared personal experiences and collectively reviewed their employer's menopause policy. Reflexive thematic analysis was employed to identify key themes reflecting participants' emotional, cognitive, and practical responses to menopause at work and to organizational support.

Results: Three main themes were developed from the data: (1) "I thought I was going mad": the emotional and cognitive toll of going through the menopause at work; (2) "It reads like it's been written for HR, not for us": the gap between policy and reality; and (3) "Not the policy, not HR, just knowing you're not alone": support beyond policy. Participants expressed that menopause at work is not only a biological process but also a deeply social and professional experience. While menopause policy was welcomed, participants felt it often lacked grounding in employees' real needs and contexts.

Conclusions: Workplace menopause policies must move beyond symbolic gestures to offer meaningful, flexible support that respects women's dignity and professional contributions during menopause. Genuine inclusion requires policies shaped by women's lived experiences and organizational practices that facilitate recognition and practical support, fostering a truly inclusive work environment during this significant life stage.

Importance: Sexual concerns are commonly reported by perimenopausal and postmenopausal women. Nonpharmacological treatments, including psychological-based treatments, may serve as an alternative and/or complementary option for those who cannot, or choose not, to take medication or who continue to experience symptoms despite their use.

Objective: This systematic review and meta-analysis examined psychological interventions that directly targeted and/or assessed sexual functioning in perimenopausal and postmenopausal women using standardized measures.

Evidence review: Web of Science, MEDLINE, and PubMed were searched for studies that evaluated the effects of psychological interventions for sexual concerns during perimenopause and postmenopause. Risk of bias assessments were done using the Cochrane Risk-of-Bias Tool and the Newcastle-Ottawa Scale. Data were pooled in a primary meta-analysis using the Female Sexual Function Index (FSFI), as well as subgroup analyses based on psychological intervention type, with effects reported separately for each subgroup.

Findings: Sixteen articles (n=1,445) met the eligibility criteria and were included in the systematic review and meta-analysis. Overall, nine randomized controlled trials (n=738) containing FSFI data were pooled in a meta-analysis showing psychological interventions were associated with significant improvements in sexual concerns (standardized mean difference [SMD]=1.37, 95% CI=1.17-1.58, P<0.00001; n=475). Subgroup analysis based on type of psychological intervention revealed that cognitive-behavioral therapy (SMD =-0.00, 95% CI=-0.26 to 0.25; n=233; I2=0%) and mindfulness-based interventions (SMD =0.02, 95% CI=-0.40 to 0.45; n=86; I2=0%) had no to small effect on the sexual function in perimenopausal and postmenopausal women, while education programs (SMD=2.53, 95% CI=-2.19 to 2.86; P<0.00001; n=268; I2=94%) and counseling (SMD=2.43, 95% CI=1.92-2.94; P<0.00001; n=106; I2=0%) had a large effect. Only one motivational interviewing study (effect size of 0.72) was included, but it revealed a large effect on sexual functioning. Overall risk of bias ranged from low to some concerns, with one study scoring high.

Conclusions and relevance: This systematic review and meta-analysis suggests that psychological interventions are an effective nonpharmacological treatment option for addressing sexual concerns in perimenopausal and postmenopausal women. Although cognitive-behavioral therapy and mindfulness-based approaches showed small to no effects on sexual concerns, these findings should be interpreted with caution, as the included studies did not directly target sexual concerns but instead assessed them as secondary outcomes. Psychological interventions should be considered when discussing treatment options for sexual concerns in perimenopausal and postmenopausal women.

Objective: Around 70% of women experience vasomotor symptoms (VMS) over the menopause transition. These are a leading patient priority for treatment. To robustly evaluate treatment effectiveness, validated tools are needed. VMS diaries are widely used in clinical trials, but their content validity and acceptability for symptomatic women is not established. The objective of this study is to evaluate acceptability, content validity and face validity of available hot flash diaries.

Methods: We conducted semi-structured interviews to explore acceptability, content, interpretation and experience of completion of three widely used hot flash diaries: Sloan, Guttuso, Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) with English speaking symptomatic peri/postmenopausal women in Australia, recruited through social media (Facebook groups), a registry of previous trial participants, and through Menopause clinics. Content analysis was used to analyze findings.

Results: Of 33 women who completed screening questions, 25 provided contact details and consented to being interviewed. Women were aged 40-69 years, most reported menopause between 50 and 59 years, and 18 experienced moderate-severe VMS. Participants considered daily reporting of VMS acceptable, preferred diaries reporting VMS in real-time or twice daily (rather than once daily) and found descriptions for severity categories helpful in assigning severity of their VMS.

Conclusion: Two diaries (Guttuso and MsFLASH) were found to be acceptable and valid measures of VMS severity and frequency. However, adding descriptions for severity categories to the MsFLASH diary and distinguishing between day and night-time VMS in the Guttuso diary were recommended improvements. Real-time data collection may be preferable.

Importance: Currently, many postmenopausal women experience symptoms related to the cessation of hormone production, and hormone therapy is the most commonly used treatment to alleviate these symptoms. However, it is contraindicated in several situations, which highlights the importance of alternative therapies such as royal jelly (RJ), particularly given the limited number of studies demonstrating its effectiveness.

Objective: To evaluate the effects of RJ supplementation on postmenopausal symptoms in women.

Evidence review: We developed a search strategy using "royal jelly" and "menopause" with their synonyms. Terms were combined using Boolean operators (OR for synonyms, AND between concepts). We searched MEDLINE (PubMed), LILACS (BVS), Embase (Elsevier), and Cochrane Library through May 2025. Studies were included if they evaluated interventions for postmenopausal symptoms, with outcomes including genitourinary symptoms and quality of life measures.

Findings: A total of 281 studies were identified; 262 were excluded. Of the remaining 19, 14 were selected for full-text reading, and 6 studies involving 471 postmenopausal women were included in the final analysis. The studies were published between 2011 and 2021. RJ supplementation significantly improved postmenopausal symptoms compared with placebo (standardized mean difference=0.73; 95% confidence interval=0.50-0.96; P <0.00001; I2=0%, two studies, 312 participants, moderate-quality evidence).

Conclusions and relevance: RJ supplementation may offer a promising nonhormone option for managing menopausal symptoms and supporting bone and genitourinary health, especially for women who cannot or prefer not to use hormone therapy.

Objective: Hot flashes are a hallmark symptom of menopause and are often implicated in sleep disturbance. Although hot flash severity has been linked to insomnia, the cognitive model of hot flashes suggests that negative beliefs about hot flashes may also influence symptom perception and distress. However, the relationship between hot flash beliefs and insomnia remains understudied. We examined whether hot flash beliefs are uniquely associated with insomnia symptom severity.

Methods: This study is a cross-sectional design utilizing secondary data from participants recruited for a longitudinal study. A total of 102 perimenopausal and postmenopausal women were included in this study. Participants completed measures assessing hot flash severity, hot flash beliefs, and insomnia symptom severity. Hierarchical linear regression was used to examine whether hot flash beliefs were associated with insomnia symptoms above and beyond hot flash severity.

Results: Hot flash beliefs were positively associated with insomnia symptom severity (β=0.12, P<0.05), accounting for 24% of the variance. When hot flash severity was added to the model, both hot flash severity (β=0.80, P<0.05) and hot flash beliefs (β=0.10, P<0.05) were significantly positively associated with insomnia symptoms. Together, hot flash severity and hot flash beliefs explained 27% of the variance in insomnia symptom severity.

Conclusion: Cognitive appraisals of hot flashes are associated with greater insomnia symptom severity in perimenopausal and postmenopausal women. It is possible that negative beliefs about hot flashes may heighten arousal and interfere with sleep, independent of hot flash severity. These findings have implications for cognitive-behavioral interventions targeting insomnia and vasomotor symptoms in this population.

Objective: This pilot cross-sectional study aimed to determine the prevalence of sarcopenia among older women with obesity and to compare anthropometric parameters, body composition, and physical function between older women with nonsarcopenic obesity and those with sarcopenic obesity. In addition, sarcopenia-associated factors were explored.

Methods: In total, 141 older women with obesity (mean age 64.84 y) participated. Obesity was defined by a body mass index ≥30 kg/m², and sarcopenia was determined using handgrip strength (<0.56 kgf/BMI) and low appendicular lean mass (<0.512 kg/BMI). Independent t tests were used to compare differences between groups, and multivariate logistic regression analyses to assess sarcopenia-associated factors.

Results: Sarcopenic obesity was observed in 28% of the participants with obesity. Women with sarcopenic obesity were shorter, but had a higher body mass index, waist circumference, and body fat percentage (total, android, and gynoid). These women also presented lower appendicular lean soft tissue and handgrip strength values. Logistic regression analysis showed that body fat percentage was associated with sarcopenia (5-unit increase in body fat: odds ratio: 4.25, 95% CI: 2.26-8.76, P<0.001).

Conclusion: In this pilot sample of older women with obesity, 28% exhibited sarcopenic obesity. Elevated body fat appeared to be associated with sarcopenia, highlighting a potential relationship that warrants further investigation in longitudinal studies.