ClimactericPub Date : 2024-10-01Epub Date: 2024-07-30DOI: 10.1080/13697137.2024.2380364
Qi Yu, John C Stevenson, Tetiana Tatarchuk, Rossella E Nappi, Marcelo Graziano Custodio, Elke Kahler, Tommaso Simoncini, Junyi Yang, Mulan Ren
{"title":"Ultra-low-dose estradiol and dydrogesterone for treatment of vasomotor symptoms in Europe and China.","authors":"Qi Yu, John C Stevenson, Tetiana Tatarchuk, Rossella E Nappi, Marcelo Graziano Custodio, Elke Kahler, Tommaso Simoncini, Junyi Yang, Mulan Ren","doi":"10.1080/13697137.2024.2380364","DOIUrl":"10.1080/13697137.2024.2380364","url":null,"abstract":"<p><strong>Objective: </strong>Among postmenopausal women, oral, ultra-low-dose continuous combined estradiol (E0.5 mg) plus dydrogesterone (D2.5 mg) reduces vasomotor symptoms (VMS).</p><p><strong>Methods: </strong>This study was a <i>post hoc</i> 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.</p><p><strong>Results: </strong>Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, <i>n</i> = 288; placebo, <i>n</i> = 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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"494-500"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-10-01Epub Date: 2024-07-22DOI: 10.1080/13697137.2024.2376190
Luis Fernando Vidal-Neira, José Luis Neyro, Genessis Maldonado, Osvaldo Daniel Messina, Mario Moreno-Alvarez, Carlos Ríos
{"title":"Climacteric and fibromyalgia: a review.","authors":"Luis Fernando Vidal-Neira, José Luis Neyro, Genessis Maldonado, Osvaldo Daniel Messina, Mario Moreno-Alvarez, Carlos Ríos","doi":"10.1080/13697137.2024.2376190","DOIUrl":"10.1080/13697137.2024.2376190","url":null,"abstract":"<p><p>Fibromyalgia (FM) and climacteric conditions share common epidemiological and clinical features, with FM symptoms often beginning during menopause. Musculoskeletal pain, arthralgia, myalgia and other symptoms are frequently seen in both conditions. Some research suggests a link between the cessation of sex hormones and FM symptoms. Women with FM tend to experience more severe symptoms after menopause, and the severity of FM symptoms can worsen in women who have had a hysterectomy with or without oophorectomy. Despite these similarities, it is essential to treat FM and climacteric conditions separately and follow established guidelines for management. However, it is also important to recognize that both conditions can coexist in the same patient. It is crucial to note that there is limited evidence supporting the effectiveness of menopausal hormone therapy for primary FM management. Therefore, menopausal hormone therapy should not be recommended for FM unless the patient also has climacteric syndrome.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"458-465"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-10-01Epub Date: 2024-07-18DOI: 10.1080/13697137.2024.2376189
Salvatore Giovanni Vitale, Stefano Angioni, Maurizio Nicola D'Alterio, Carlo Ronsini, Stefania Saponara, Pasquale De Franciscis, Gaetano Riemma
{"title":"Risk of endometrial malignancy in women treated for breast cancer: the BLUSH prediction model - evidence from a comprehensive multicentric retrospective cohort study.","authors":"Salvatore Giovanni Vitale, Stefano Angioni, Maurizio Nicola D'Alterio, Carlo Ronsini, Stefania Saponara, Pasquale De Franciscis, Gaetano Riemma","doi":"10.1080/13697137.2024.2376189","DOIUrl":"10.1080/13697137.2024.2376189","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate characteristics of endometrial surveillance in women treated for breast cancer to build a clinical prediction model.</p><p><strong>Design: </strong>A multicentric retrospective cohort study was conducted at two tertiary-care university hospitals from January 2020 to June 2023. Perimenopausal and postmenopausal women treated for breast cancer were categorized into two groups: patients with and without diagnosis of endometrial malignancy (endometrial carcinoma) or premalignancy (atypical endometrial hyperplasia). Characteristics of breast cancer and ultrasonographic and hysteroscopic examinations were compared. A prediction model for endometrial malignancy was built using logistic regression. Predictive accuracy was assessed using the receiver operating characteristic (ROC) curve and goodness of fit using the Hosmer-Lemeshow test.</p><p><strong>Results: </strong>One hundred and thirty-two (28 with premalignancy or malignancy and 104 without malignancy) women were analyzed. A nomogram was produced for prediction model development utilizing the presence and duration in months of abnormal uterine (BL)eeding, ultrasound (US) vascular pattern and echogenicity and (H)ysteroscopic appearance of endometrium (BLUSH) as determined by logistic regression. Sensitivity and specificity were 79.17% and 95.19%, respectively, with an area under ROC curve of 0.965, indicating good accuracy. Good goodness of fit and prediction stability were indicated by the calibration curve and Hosmer-Lemeshow test (<i>χ</i><sup>2</sup> = 26.36; <i>p</i> = 0.999).</p><p><strong>Conclusions: </strong>Breast cancer survivors undergoing endometrial surveillance might benefit from a potentially useful prediction model based on hysteroscopic appearance, ultrasonographic uniformity of endometrium, Doppler flow and presence of abnormal uterine bleeding.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"482-488"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-10-01Epub Date: 2024-07-22DOI: 10.1080/13697137.2024.2376185
Peyman Hadji, Jens-Olaf Schmeißer, Klaus Peters, Erwin Göckeler-Leopold
{"title":"Use of an estradiol transdermal spray in women with menopausal symptoms: a non-interventional study.","authors":"Peyman Hadji, Jens-Olaf Schmeißer, Klaus Peters, Erwin Göckeler-Leopold","doi":"10.1080/13697137.2024.2376185","DOIUrl":"10.1080/13697137.2024.2376185","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate the effectiveness, tolerability and application of estradiol metered-dose transdermal spray (EMDTS) in postmenopausal women during real-world use.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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 (<i>p</i> < 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 (<i>n</i> = 6), nausea (<i>n</i> = 4), dizziness (<i>n</i> = 4) and pruritus (<i>n</i> = 3).</p><p><strong>Conclusions: </strong>EMDTS is an effective, well tolerated and easily applied hormone replacement therapy for women experiencing postmenopausal symptoms.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"473-481"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"COVID-19 vaccination and postmenopausal bleeding: a retrospective cohort study.","authors":"Lucía Pastor-Goutherot, Ester Miralpeix, Berta Fabregó, Laia Serrano, Adrián Vizoso, Josep-Maria Solé-Sedeño, Gemma Mancebo","doi":"10.1080/13697137.2024.2385360","DOIUrl":"10.1080/13697137.2024.2385360","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> < 0.005). No increase in endometrial malignant pathology was observed among the vaccinated group (<i>p</i> = 0.189). Multivariable analysis that correlates factors associated with PMB suggests COVID-19 vaccine and malignant endometrial biopsy as independent risk variables.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"489-493"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-10-01Epub Date: 2024-07-30DOI: 10.1080/13697137.2024.2380363
Vonda J Wright, Jonathan D Schwartzman, Rafael Itinoche, Jocelyn Wittstein
{"title":"The musculoskeletal syndrome of menopause.","authors":"Vonda J Wright, Jonathan D Schwartzman, Rafael Itinoche, Jocelyn Wittstein","doi":"10.1080/13697137.2024.2380363","DOIUrl":"10.1080/13697137.2024.2380363","url":null,"abstract":"<p><p>Fifty-one percent of humans are born with ovaries. As the ovarian production of estrogen diminishes in midlife and ultimately stops, it is estimated that more than 47 million women worldwide enter the menopause transition annually. More than 70% will experience musculoskeletal symptoms and 25% will be disabled by them through the transition from perimenopause to postmenopause. This often-unrecognized collective of musculoskeletal symptoms, largely influenced by estrogen flux, includes arthralgia, loss of muscle mass, loss of bone density and progression of osteoarthritis, among others. In isolation, it can be difficult for clinicians and patients to adequately appreciate the substantial role of decreasing estrogen, anticipate the onset of related symptoms and actively treat to mitigate future detrimental processes. Thus, in this review we introduce a new term, the musculoskeletal syndrome of menopause, to describe the collective musculoskeletal signs and symptoms associated with the loss of estrogen. Given the significant effects of these processes on quality of life and the associated personal and financial costs, it is important for clinicians and the women they care for to be aware of this terminology and the constellation of musculoskeletal processes for which proper risk assessment and prophylactic management are of consequence.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"466-472"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141791999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-09-27DOI: 10.1080/13697137.2024.2404574
Andrea Etrusco, Antonio D'Amato, Vittorio Agrifoglio, Vito Chiantera, Giuseppe Russo, Tullio Golia D'Augè, Marco Monti, Gaetano Riemma, Antonio Simone Laganà, Andrea Giannini
{"title":"Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age.","authors":"Andrea Etrusco, Antonio D'Amato, Vittorio Agrifoglio, Vito Chiantera, Giuseppe Russo, Tullio Golia D'Augè, Marco Monti, Gaetano Riemma, Antonio Simone Laganà, Andrea Giannini","doi":"10.1080/13697137.2024.2404574","DOIUrl":"https://doi.org/10.1080/13697137.2024.2404574","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to assess the efficacy of randomly started oral dienogest/ethinylestradiol (DNG/EE) for swift endometrial preparation prior to outpatient hysteroscopic polypectomy in perimenopausal women.</p><p><strong>Method: </strong>A multicenter, prospective, randomized controlled trial was conducted in university hospitals. Eighty perimenopausal women scheduled for outpatient hysteroscopic polypectomy between January 2023 and March 2024 were randomly assigned to either intervention (<i>n</i> = 40) or control (<i>n</i> = 40) groups. Exclusion criteria included concomitant endometrial pathologies, recent therapy and adnexal diseases. The intervention group received oral DNG/EE 2 mg/0.03 mg/day started on any day of the menstrual cycle for 14 days. The control group underwent polypectomy between menstrual cycle days 8 and 11 without pharmacological treatment.</p><p><strong>Results: </strong>Pre-procedure (<i>p</i> < 0.001) and post-procedure (<i>p</i> < 0.001) endometrial thickness were significantly reduced in the intervention group, along with a higher incidence of hypotrophic/atrophic endometrial patterns (<i>p</i> < 0.001). Surgical parameters also differed significantly between groups.</p><p><strong>Conclusion: </strong>DNG/EE treatment offers rapid, cost-effective endometrial preparation, enhancing surgical outcomes and patient satisfaction during outpatient polypectomy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06316206.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"1-7"},"PeriodicalIF":2.9,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-09-26DOI: 10.1080/13697137.2024.2401369
Chen Zhu, Elizabeth H X Thomas, Qi Li, Shalini Arunogiri, Caroline Gurvich
{"title":"Cut-off point development for the Everyday Memory Questionnaire - Revised in perimenopausal women.","authors":"Chen Zhu, Elizabeth H X Thomas, Qi Li, Shalini Arunogiri, Caroline Gurvich","doi":"10.1080/13697137.2024.2401369","DOIUrl":"https://doi.org/10.1080/13697137.2024.2401369","url":null,"abstract":"<p><strong>Objective: </strong>Subjective cognitive complaints have been reported in women during perimenopause and the Everyday Memory Questionnaire - Revised (EMQ-R) has been recently evaluated as a standardized instrument to measure subjective cognitive changes. The purpose of this study was to identify potential cut-off points for the EMQ-R retrieval subscale and attentional subscale, and to assess the validity of these cut-off points in detecting objective cognitive changes associated with reported subjective cognitive complaints.</p><p><strong>Method: </strong>After screening, 232 perimenopausal women were included in the analyses. The supervised classification and regression tree was applied to identify optimal cut-off points. Its performance was evaluated by the value of the receiver operating characteristics curve, sensitivity and specificity.</p><p><strong>Results: </strong>Findings revealed that the optimal cut-off point for the attentional subscale was 7, and for the retrieval subscale was 13. Both cut-off points presented acceptable discrimination performance. An independent <i>t</i>-test indicated that both cut-off points were associated with significant differences in scores on neuropsychological measures of retrieval (episodic memory and verbal fluency) as well as neuropsychological measures of higher-level attention (working memory).</p><p><strong>Conclusion: </strong>The identified cut-off points may be helpful for women to track or quantify their subjective experiences of brain fog or cognitive symptoms during the menopause transition.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"1-10"},"PeriodicalIF":2.9,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ClimactericPub Date : 2024-09-16DOI: 10.1080/13697137.2024.2393128
Rachel A Schroeder, Kristen L Mordecai, Susan M Resnick, Antonio Terracciano, Adrian Dobs, Samuel C Durso, Paul T Costa, Pauline M Maki
{"title":"Effect of hormone therapy on personality traits: preliminary evidence in older men and women.","authors":"Rachel A Schroeder, Kristen L Mordecai, Susan M Resnick, Antonio Terracciano, Adrian Dobs, Samuel C Durso, Paul T Costa, Pauline M Maki","doi":"10.1080/13697137.2024.2393128","DOIUrl":"https://doi.org/10.1080/13697137.2024.2393128","url":null,"abstract":"<p><strong>Objective: </strong>Findings concerning the effects of hormone therapy (HT) on cognition and dementia are mixed, with some trials suggesting increased harm at older ages. Personality, like cognition, changes with dementia, but no clinical trials to date have examined the effects of HT on personality traits. This study aimed to determine the effects of HT on personality traits in older men and women.</p><p><strong>Method: </strong>Secondary data analysis was performed from randomized, double-blind, placebo-controlled cross-over studies of menopausal HT in women and testosterone therapy (TT) in men. Participants were community-dwelling cognitively normal adults (mean age = 75.2 years), including 29 men and 22 women. Three months of hormone intervention (for women, 0.625 mg/day conjugated equine estrogen with or without 2.5 mg/day medroxyprogesterone acetate; for men, 200 mg intramuscular testosterone enanthate every 2 weeks) were crossed over with 3 months of identical placebo with a 3-month washout between intervention phases. The main outcome measure was neuroticism and conscientiousness personality domains and facets assessed with the Revised NEO Personality Inventory (NEO-PI-R) after the active and placebo intervention phases.</p><p><strong>Results: </strong>In linear mixed-effect models, HT in women decreased conscientiousness (<i>p</i> < 0.01) and the conscientiousness facet of achievement striving (<i>p</i> < 0.01), and increased vulnerability, a facet of neuroticism (<i>p</i> < 0.05). Testosterone in men decreased conscientiousness (<i>p</i> < 0.05) and the conscientiousness facet of dutifulness (<i>p</i> < 0.05), and increased vulnerability (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>In a preliminary study of healthy older adults, HT and TT formulations produced adverse changes in vulnerability and conscientiousness facets that parallel personality changes in dementia.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"1-8"},"PeriodicalIF":2.9,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}