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Objective: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects., Methods: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome., Results: A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice., Conclusions: We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes., Competing Interests: Financial disclosure/conflicts of interest: V.P. received past funding from Sigvaris AG. M.P. received institutional funding from University of Melbourne (Internal Grant Schemes), Royal Women's Hospital (Internal grant scheme), and Cancer Council NSW Project Grant RG 21-06, Centre for Research Excellence in Women's Health in Reproductive Life (CREWHiRL) Seed Funding and Project Support Grant, NHMRC (APP1163202), and Royal Children's Hospital Foundation. She received past funding from FertilityIQ webinar honorarium. She has received fee registration fees as an invited speaker by the Pacific Society of Reproductive Medicine 2023 Conference and had subsidized flights and accommodations as an invited speaker for the European Society of Human Reproduction and Embryology 2022 Conference. She was also given free registration as an invited speaker for the Annual Scientific Meeting of Breast Cancer Trials 2021. D.A. has consulted for Evestra, Exeltis, Lupin, Mithra, ObsEva, and TherapeuticsMD, received industry support for research from AbbVie, Mithra, Myovant, and ObsEva, and has stock holdings in Agile Therapeutics, InnovaGyn, Inc. N.A. receives ongoing institutional funding from the National Cancer Institute. J.C. is owner of JSCarpenter, LLC which received scale licensing fees from Mapi Research Trust (2022), consulting fees from the University of Wisconsin (spring 2022), and consulting fees from Simumetrix SMX Health (spring 2022). M.C. has been paid for developing and delivering educational presentations for Alliance Chicago, received fees for an educational video and speaking engagements with Fertility IQ, wrote a White Paper on GSM for Materna (no financial reimbursement), and is a member of The Menopause Society Board of Trustees. M.D. receives current institutional funding from National Institute of Health Research. She serves as a chief investigator on POISE study (research relevant to HRT) and a chief investigator for BLUSH study (research on treatment of menopause). She received past institutional funding from Best Practice & Research Clinical Obstetrics & Gynaecology as editor of volume on menopause management published 2022. She is an elected member of the Medical Advisory Council of the British Menopause Society, is a member of the ESHRE guideline update group on Premature Ovarian Insufficiency, is a member of the British Endocrine Society working group producing clinical guidelines on estrogen treatment, and is a member of the British Gynaecological Cancer Society working group producing clinical guidelines on HRT. T.H. received past funding from Besins and Astellas. M.H. receives ongoing funding from Rightsteps and current funding from Hello Therapeutics. L.K. has lectured and/or acted in an advisory capacity for Gedeon Richter, Dr. KADE Besins and Mithra. P.M. has received compensation as a member of the scientific advisory board of Astellas, Bayer, and Johnson & Johnson; compensation from AbbVie and Pfizer for consulting; and serves as a member of the scientific advisory board and has/had equity in Alloy, Estrigenix, and MidiHealth. She has received speaking fees and travel support from Mithra. R.E.N. has ongoing relationships with Abbott, Astellas, Bayer HealthCare AG, Besins Healthcare, Exeltis, Fidia, Gedeon Richter, HRA Pharma, Merck Healthcare, Novo Nordisk, Shionogi Limited, Theramex, and Viatris. N.P. has lectured and/or acted in an advisory capacity for Abbott, Lawley, Mithra, Novo, SeCur, and Viatris. S.R. has lectured and/or acted in an advisory capacity or conducted studies for Abbott, Bayer, Gedeon Richter, Mylan, Amgen, UCB, Theramex, and Viatris. J.S. receives grant/research support from AbbVie, Inc., Bayer Healthcare LLC., Dare´ Bioscience; Ipsen, Mylan/Viatris Inc., Myovant Sciences, Sebela Pharmaceuticals Inc. He acts as a consultant is on advisory boards for Bayer HealthCare Pharmaceuticals Inc., Besins Healthcare, California Institute of Integral Studies (CIIS), Dare´ Bioscience, Femasys Inc., Khyria, Madorra Pty Ltd., Mayne Pharma, Inc., and Vella Bioscience Inc. He serves on speaker's bureaus for Astellas Pharma, Inc., Mayne Pharma, Inc., Myovant Sciences, Inc., Pfizer Inc., Pharmavite LLC., Scynexis Inc. He is a stockholder (direct purchase) of Sermonix Pharmaceuticals. P.S. has received fees for giving educational presentations, participating in advisory boards and conducting research by Besins Healthcare, Astellas, Mylan, Labatec, Exeltis, Effik, Theramex, and Gedeon-Richter. A.J.V. has received fees for presentations and participation in an advisory board from Besins and Theramex. W.W. has received institutional support with an unrestricted grant from Pfizer and sits on the advisory boards of Pfizer, Lupin, and Biosyent. She has received fees for educational presentations for Lupin, Astellas, Bayer and Pfizer, and Biosyent. She is a board member of the International Menopause Society and the President of the Canadian Menopause Society. M.H. has received funding from Madorra for a study of a device to manage GU symptoms and is a clinical expert for the NICE Menopause Guidelines. J.T.G. is a speaker for NurtureMed Pharma, Bayer Phils, Corbridge Phils, and Zuellig Pharma. P.S. has a research consultancy relationship with Chugai Pharmaceuticals. H.J. receives grant funding from the National Institutes of Health, Merck, and Pfizer and is a consultant to Bayer, Merck, and Hello Therapeutics. She receives in kind support from Sage to her institution (drug provided to support NIH-funded trial), funds from Bayer support a pilot grant program she lead within an NIH-funded Center grant. Her spouse is employed by Arsenal Biosciences and receives equity from Merck Research Labs. N.J. is on the advisory board of Vira Health, UK. All other authors report no conflicts of interest., (Copyright © 2024 by The North American Menopause Society.)

Objective: This study aimed to evaluate the association between the intensity of menopausal symptoms and highly active antiretroviral therapy (HAART) adherence in middle-aged women with human immunodeficiency virus (HIV) infection. Methods: In this cross-sectional study, 313 Peruvian women with HIV infection (age 40-59 years) were surveyed and classified as adherent or non-adherent to HAART based on the Antiretroviral Treatment Adherence Evaluation Questionnaire. The intensity of menopausal symptoms was assessed with the Menopause Rating Scale, and categorized as none, mild, moderate, and/or severe. Age, sexual orientation, used HAART scheme, time since HIV diagnosis, menopausal status, risk of depression, and presence of comorbidities were also assessed. Poisson generalized linear models with robust variance were performed in order to estimate crude prevalence ratios (PRs) and adjusted PRs using statistical (a 1 PR) and epidemiological criteria (a 2 PR). Results: A total of 19.9%, 32.6%, and 15.0% of all women presented mild, moderate, and severe menopausal symptoms, respectively. Overall, 70.6% women were non-adherent to HAART. The probability of non-adherence was higher in women with mild, moderate, and severe symptoms as compared to asymptomatic women in the non-adjusted model (PR: 1.79, 95% confidence interval [CI]: 1.39-2.29; PR: 1.76, 95% CI: 1.38-2.23; and PR: 2.07, 95% CI: 1.64-2.61, respectively) and the adjusted model. Conclusion: The severity of menopausal symptoms was associated with HAART non-adherence in HIV-infected middle-aged women.

Objective: To analyze the short-term efficacy and safety over menopausal symptoms of three low-dose continuous sequential 17β-estradiol (E)/progesterone (P) parental monthly formulations using novel non-polymeric microspheres., Methods: This was a multicenter, randomized, single blinded study in which peri- and postmenopausal women were assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24) or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Primary efficacy endpoints included mean change in the frequency and severity of hot flushes and the effect over urogenital atrophy symptoms at 3 and 6 months. Safety variables included changes in the rate of amenorrhea, endometrial thickness and histopathology, and local and systemic adverse events., Results: Compared to baseline at month 6, the three treatment schemes significantly decreased the rate of urogenital atrophy symptoms and the frequency (mean number per day) and severity (mean number graded as moderate and severe per month) of hot flushes. No differences in studied efficacy parameters were observed between studied groups at baseline or at the end of the study. For all groups the most frequent adverse event was pain at the injection site; however they were all rated as mild. At the end of the study peri- and postmenopausal women displayed no significant changes in endometrial thickness or histopathology in all treated groups. The rate of amenorrhea at the end of the study decreased for all studied groups yet was less evident among postmenopausal women as compared to perimenopausal ones., Conclusions: The three low-dose continuous sequential intramuscular monthly treatments of E/P using novel microsphere technology were effective at reducing menopausal symptoms at short-term with a low rate of adverse events. More long-term and comparative research is warranted to support our positive findings.

Background: The majority of instruments used to evaluate menopausal symptoms are long and complex. In this sense, more simple tests are being designed to rapidly obtain a snapshot of the global clinical picture., Objective: To assess menopausal symptoms in mid-aged women using the short 10 item version of the original menopause Cervantes Scale (CS-10)., Method: This was a cross sectional study in which a total of 451 Ecuadorian women (40-59 years) were surveyed with the CS-10 and a general socio-demographic questionnaire containing personal and partner data., Results: Median age of the whole sample was 48 years. A 41.2% were postmenopausal, 44.3% abdominally obese (waist circumference >88cm), 6% diabetic, 16.9% hypertense, 11.5% smoked, 6.9% currently used hormone therapy, 9.5% phytoestrogens and 6.7% psychotropic drugs. For the entire sample, median [interquartile range] CS-10 global scores were 10.0 [9.5], and for pre-, peri- and postmenopausal women: 5.0 [7.0], 11.0 [9.0] and 13.5 [8.0], respectively. The CS-10 displayed good internal consistency (Cronbach's alpha 0.87). According to the CS-10, the three most prevalent menopausal symptoms were: muscle and joint pains (88.5%), hot flushes (77.6%) and skin dryness (71.4%). Multiple linear regression analysis found that postmenopausal status, parity, unhealthy perceived status, psychotropic drug use, partner erectile dysfunction, lower coital frequency and living at high altitude were related to higher CS-10 global scores., Conclusion: In this mid-aged Ecuadorian female sample severity of menopausal symptoms, as determined by the CS-10, were related to environmental and female/partner personal and socio-demographical aspects., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Menopausal hormone therapy (HT) has shown benefits for women; however, associated drawbacks (i.e. risks, costs, fears) have currently determined its low use., Objective: To determine the prevalence of current HT use among mid-aged women and describe the characteristics of those who have never used, have abandoned or are currently using HT. In addition, reasons for not using HT were analyzed., Method: This was a cross-sectional study that analyzed a total of 6731 otherwise healthy women (45-59 years old) of 15 cities in 11 Latin American countries. Participants were requested to fill out the Menopause Rating Scale (MRS) and a questionnaire containing sociodemographic data and items regarding the menopause and HT use., Results: The prevalence of current HT use was 12.5%. Oral HT (43.7%) was the most frequently used type of HT, followed by transdermal types (17.7%). The main factors related to the current use of HT included: positive perceptions regarding HT (odds ratio (OR) 11.53, 95% confidence interval (CI) 9.41-14.13), being postmenopausal (OR 3.47, 95% CI 2.75-4.36) and having a better socioeconomic level. A total of 48.8% of surveyed women had used HT in the past, but abandoned it due to symptom improvement or being unconcerned; fear of cancer or any other secondary effects were also reported but in less than 10%. Among women who had never used HT, 28% reported the lack of medical prescription as the main reason, followed by the absence of symptoms (27.8%). Among those reporting lack of prescription as the main reason for not using HT, 30.6% currently had severe menopausal symptoms (total MRS score > 16); 19.5% of women were using alternative 'natural' therapies, with 35.1% of them displaying severe menopausal symptoms as compared to a 22.5% observed among current HT users., Conclusion: The use of HT has not regained the rates observed a decade ago. Positive perceptions regarding HT were related to a higher use. Lack of medical prescription was the main reason for not using HT among non-users, many of whom were currently displaying severe menopausal symptoms.

Background: The prevalence of the metabolic syndrome (METS) increases after the menopause. Reports indicate that the METS and its components, especially obesity, enhance the intensity of menopausal symptoms., Objective: Assess the frequency and severity of menopausal symptoms in postmenopausal women. Factors related to the symptom severity were also analyzed including depressive and metabolic status., Methods: A total of 204 natural postmenopausal women (40-65 years) participating in a METS screening program were asked to fill out the Menopause Rating Scale (MRS), the Hospital Anxiety and Depression Scale (HADS), and a general socio-demographic questionnaire containing personal and partner data. Criteria of the American Heart Association were used to define the METS., Results: Median age of the whole sample was 56 years. A 52.9% presented the METS, with 37.3% presenting hyperglycemia, 51.5% hypertension, 58.3% abdominal obesity, 45.6% high triglyceride and 56.4% low HDL-C levels. Total and subscale MRS scores did not differ in accordance to the presence or not of the METS. The three top prevalent menopausal symptoms were muscle and joint problems (87.2%), physical and mental exhaustion (72%) and depressive mood (64.7%). A 19.6% of women presented total MRS scores above 16 defined as severe. Multivariate linear regression analysis determined that anxiety (higher HADS anxiety subscale scores) was significantly and positively correlated with all components of the MRS (Total and subscale scores). Higher total MRS scores correlated positively with abdominal perimeter and higher parity. Somatic scores correlated inversely with female education and positively with psychotropic drug use; and psychological MRS scores positively correlated depressed mood (higher HADS depressive subscale scores) and abdominal perimeter., Conclusion: In this postmenopausal sample, severity of menopausal symptoms correlated to abdominal obesity, mood and other personal aspects.

Objective: To examine the relationship between climate (including altitude, temperature, humidity and annual range of temperature) and experience of hot flushes and night sweats amongst Spanish-speaking mid-aged women living in five urban centers., Methods: A total of 896 peri- and postmenopausal women from centers in Chile (Santiago de Chile), Ecuador (Guayaquil and Quito), Panama (Panama City) and Spain (Madrid) completed questionnaires eliciting information about sociodemographics, hot flushes (prevalence, frequency and problem-rating), health and lifestyle (body mass index, diet, exercise, alcohol use) and mood (Women's Health Questionnaire)., Results: There was a wide range of altitude and temperature in the participating centers. Of the sample, 58.5% (524/896) were currently experiencing vasomotor symptoms. Prevalence was associated with higher temperatures, while hot flushes were more frequent and problematic for women living in higher temperature and lower altitudes. Hot flush variables were not associated with seasonal variation in temperature. When health and lifestyle variables were included as covariates in regression analyses, prevalence was best predicted by age (younger), poor general health, more depressed mood and anxiety; hot flush frequency by anxiety, temperature, life satisfaction (lower), age (higher), regular strenuous exercise (more strenuous exercise more frequent), and a diet including regular hot spicy food intake. Hot flush problem-rating was best predicted by anxiety, life satisfaction, altitude (lower more problematic), any regular exercise (more exercise less problematic), and depressed mood., Conclusions: In this study of Spanish-speaking women, those living in countries with higher temperatures and lower altitudes reported more frequent and problematic hot flushes.

Background: Assessing sexuality is a difficult task, hence used tools should be straight forward and easy to use., Objective: To assess sexual function in mid-aged Ecuadorian women., Method: In this cross sectional study, 904 otherwise healthy women 40-59 years completed the short 6-item Female Sexual Function Index (FSFI-6) and a general socio-demographic questionnaire containing personal/partner data. Internal consistency of the tool was also assessed., Results: Median age of the whole sample was 49 years, 51.1% were postmenopausal, 43.8% lived at high altitude, 12.6% used hormone therapy (HT), 58.5% presented hot flushes, 43.5% were abdominally obese and 80.8% had a partner. Overall, 72.4% of surveyed women reported sexual activity (n=655/904) with 65% of these presenting total FSFI-6 scores equal or below 20 the calculated median (lower sexual function). A 10.2% of those having a partner were sexually inactive. Internal consistency of tool was high (Cronbach's alpha=0.91). Total FSFI-6 scores positively correlated with coital frequency and female and partner educational level and inversely with female age, waist circumference, hot flush intensity and partner age (bivariate analysis). Multiple linear regression analysis determined that lower scores (lower sexual function) were related to high altitude, history of sexual abuse, sedentarism, hot flush intensity, partner age and sexual dysfunction whereas partner educational level, coital frequency and female parity were significantly related to higher scores (better sexual function)., Conclusion: As assessed with a consistent, short, and easy to use tool lower sexual function of this mid-aged series was related to several female and partner factors. More research with this tool is warranted., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate the effect of red clover isoflavone supplementation over vasomotor and overall menopausal symptoms in postmenopausal women., Methods: One hundred and nine postmenopausal women aged 40 or more were assigned to randomly receive either two daily capsules of the active compound (80 mg red clover isoflavones, Group A) or placebo of equal appearance (Group B) for a 90-day period. After a washout period of 7 days, medication was crossed over and taken for 90 days more. Daily hot flush and night sweat frequency and overall menopausal symptom intensity (Kupperman Index) were measured at baseline, 90, 97 and 187 days., Results: Daily hot flush/night sweat frequency and Kupperman Index values were similar in both studied groups at baseline. All indices significantly decreased after red clover phase in Group A, corresponding, respectively to a 73.5%, 72.2% and 75.4% average decrement. These decrements were significantly higher than those observed for Group B after placebo phase (8.2%, 0.9% and 6.7% respectively). In Group A, after washout and placebo phases all values significantly increased. In Group B, all indices remained similar after placebo and washout phases, however significantly dropping after red clover treatment. These values were also significantly lower than those observed in Group A after placebo phase. No side effects were encountered after treatment with the active compound or placebo., Conclusion: Red clover isoflavone supplementation was more effective than placebo in reducing daily vasomotor frequency and overall menopausal intensity in postmenopausal women.

Objective: The aim of this study was to determine vasomotor symptom (VMS) prevalence, duration, and impact on quality of life in middle-aged women using a validated menopausal tool., Methods: The Menopause Rating Scale (MRS) and an itemized questionnaire containing personal sociodemographic data were used to examine 8,373 women aged 40 to 59 years from 22 healthcare centers in 12 Latin American countries., Results: Less than half (48.8%) of all women studied were postmenopausal, 14.7% used hormone therapy (HT), 54.5% presented VMS of any degree, and 9.6% presented severe/bothersome symptoms. The rate of VMS (any degree) significantly increased from one menopausal stage to the next. HT users presented more VMS (any degree) than did nonusers (58.6% vs 53.8%, P = 0.001). When surgical postmenopausal women were compared, non-HT users displayed a higher prevalence of severe VMS (16.1% vs 9.0%, P = 0.0001). The presence of VMS of any degree was related to a more impaired quality of life (higher total MRS score; odds ratio, 4.7; 95% CI, 4.1-5.3). This effect was even higher among women presenting severe VMS. Logistic regression analysis determined that the presence of severe psychological/urogenital symptoms (MRS), lower educational level, natural perimenopause-postmenopause status, nulliparity, surgical menopause, and living at high altitude were significant risk factors for severe VMS. HT use was related to a lower risk. A second regression model determined that surgical menopause, intense psychological/urogenital symptoms, and a history of psychiatric consultation were factors related to severe VMS persisting into the late postmenopausal stage (5 or more years)., Conclusions: In this Latin American middle-aged series, VMS prevalence was high, persisting into the late postmenopausal phase in a high rate and severely impairing quality of life. HT use was related to a lower risk of severe VMS.

Background: Although the menopause associates to poor sleep quality, insomnia severity data in the menopausal transition is scarce or lacking., Objective: To assess insomnia prevalence, severity and related factors in mid-aged women., Methods: In this cross-sectional study 340 women (40 to 59 years) completed the Insomnia Severity Index (ISI) and a general questionnaire containing personal/partner data. Hot flush presence and intensity was also assessed with the Menopause Rating Scale (MRS)., Results: Median age of the sample was 48.0 years, with 63.5% having lower education and 52.9% being postmenopausal. At the moment of the survey 7.1% were on hormone therapy, 8.2% on phytoestrogens and 2.1% on psychotropic drugs. A 63.8% were abdominally obese (waist circumference > 88 cm) and 65.5% sedentary. According to item 1 of the MRS, 60.9% presented hot flushes, graded in 17.4% as severe-very severe. Regarding the partner (n=255), erectile dysfunction was present in 23.9%, premature ejaculation 37.6%, 35.3% abused alcohol and 42.4% were faithful. The ISI tool displayed a high internal consistency (alpha Cronbach coefficient=0.87), identifying 41.5% of women with some degree of insomnia (Total ISI score ≥8) further categorized as sub-threshold or mild (32.0%), moderate (7.4%) and severe (2.1%). Multiple linear regression analysis obtained two best fit models predicting total ISI scores, one not including and one including partner data. In the first model, hot flush severity, psychotropic use and sedentarism displayed significant positive correlations with total ISI scores. In the second, hot flush intensity, psychotropic drug use and male erectile dysfunction positively correlated whereas partner faithfulness inversely with ISI scores., Conclusion: In this mid-aged series insomnia severity was related to female and partner factors; several of which are susceptible of intervention., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause. Despite this, data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk populations is still lacking., Objective: To evaluate the effect of soy derived isoflavones over hot flushes, menopausal symptoms and mood in climacteric women with increased body mass index (BMI)., Methods: Fifty symptomatic climacteric women aged 40 to 59 with increased BMI (≥ 25) were recruited to receive oral 100 mg/day of soy derived isoflavones (Climasoy) for 3 months. Hot flushes (frequency/intensity), menopausal symptoms (Menopause Rating Scale [MRS]) and mood (Hamilton Depressive Rating Scale [HDRS]) were evaluated at baseline and at 90 days., Results: A total of 45 women completed the study. After 3 months of soy isoflavone supplementation hot flushes significantly decreased in percentage, number and severity (100% to 31.1%; 3.9 ± 2.3 to 0.4 ± 0.8 and 2.6 ± 0.9 to 0.4 ± 0.8, respectively, p < 0.001). MRS scores (total and for subscales) reflecting general menopausal symptoms also significantly decreased compared to baseline. Regarding mood, after three months total HDRS scores and the rate of women presenting depressed mood (scores ≥ 8) significantly decreased (16.3 ± 5.4 to 6.9 ± 5.2 and 93.3% to 28.9%, respectively, p < 0.05). There was no effect on blood pressure levels or BMI values after treatment., Conclusion: In this high risk climacteric population, soy derived isoflavone treatment improved mood as well as vasomotor and general menopausal symptoms. More research is required to determine if the positive effect over mood is a direct or an indirect one through hot flush alleviation.

Background: Hot flushes (HFs) and night sweats are frequent complaints among both peri- and postmenopausal women. Perceived control of this complaint may vary from one population to another., Objective: To assess perceived control over menopausal HFs and determinant factors among mid-aged Ecuadorian women., Methods: In this cross-sectional study healthy women aged 40-59 years, seeking healthcare centres of eight main cities of Ecuador with more than 100,000 inhabitants, were assessed with the Menopause Rating Scale (MRS) and those presenting HFs were requested to fill out the Perceived Control Index (PCI) and a questionnaire containing socio-demographic data (female and partner)., Results: A total of 1154 women participated in this study of which 56% presented HFs (n = 646). According to the MRS, 29.1% and 9.1% of these HFs were graded as severe and very severe, respectively. Mean age of women presenting HFs was 49.5 +/- 5.2 years, with 51.9% having 12 years or less of education, 61.5% being postmenopausal and 47.2% living in high altitude. At the moment of the survey 13.9% were on hormone therapy, 12.8% on phytoestrogens and 7.1% on psychotropic drugs. There was a significant decreasing trend for PCI scores (total and difficulty in control items) from one menopausal stage to the next, with no differences observed for time since menopause onset. Despite this, logistic regression analysis determined that HF severity, as determined with the MRS, was the only single predictive factor related to lower HF perceived control (total PCI score <38) (OR: 1.83 CI 95% [1.15-2.90], p < 0.01)., Conclusion: As determined with the PCI, HF severity was related to a lower perceived control among mid-aged women.

Background: Hot flushes (HFs) and night sweats are frequent complaints among both peri- and postmenopausal women. Beliefs regarding these complaints may vary from one population to another., Objective: To assess HF beliefs and factors related to negative beliefs in a climacteric Hispanic population using the Hot Flush Beliefs Scale (HFBS)., Methods: A total of 1154 healthy women (40-59 years) were assessed with the Menopause Rating Scale (MRS), those presenting HFs were requested to fill out the HFBS and a questionnaire containing socio-demographic data (female and partner)., Results: A total of 646 presented HFs (56%) graded according to the first item of the MRS as mild (28.6%), moderate (33.2%), severe (29.1%) and very severe (9.1%). Mean age of these women was 49.5+/-5.2 years, with 51.9% having 12 or less years of education, 61.5% being postmenopausal and 47.2% living in high altitude. At the moment of the survey 13.9% were on HT, 12.8% on phytoestrogens and 7.1% on psychotropic drugs. Women strongly disagreed in more negatively oriented items of those contained in subscale one (beliefs about self in social context). Contrary to this, women strongly agreed in more negative oriented items contained in subscale two which assesses beliefs about coping with HFs. Women presenting with severe-very severe HFs displayed higher HFBS total and subscale scores indicating a more negative belief regarding HFs. Logistic regression analysis determined that HF severity was related to higher HFBS scores for the total and subscales one and two. Current smoking, higher parity, lower female education, female psychiatric consultation, time since menopause and partner unhealthiness and alcohol consumption were also related to higher HFBS scorings. Postmenopausal status and church attendance were related to lower scores., Conclusion: In this mid-aged Ecuadorian female series negative beliefs regarding HFs were related to the severity of HFs and individual female or partner characteristics. Data provided from clinical research using this tool, alone or in combination with other tests, is warranted., (Copyright 2010 Elsevier Ireland Ltd. All rights reserved.)

Background: Gabapentin (GPT), a widely used drug in neurology, has been proposed as a non-hormonal option for the management of hot flushes in menopausal women with contraindications for estrogen therapy., Objective: To compare GPT versus low-dose transdermal estradiol (E(2)) for treating post-menopausal women with moderate to very severe hot flushes., Methods: A total of 45 post-menopausal women with moderate to very severe hot flushes were prospectively and single-blinded randomised to receive oral GPT 600 mg/night or transdermal 25 microg/day E(2) per week. Hot flush intensity and frequency were assessed with the Menopause Rating Scale and a numeric scale respectively at baseline and at 1, 4 and 8 weeks. Side effects were also assessed., Results: Hot flush intensity and frequency significantly decreased for both groups at 1, 4 and 8 weeks of treatment as compared to baseline; however, this decrease was statistically more evident for the E(2) group. Although the percentage of hot flush intensity and frequency reduction at the end of the treatment was higher for E2, this was not statistically significant (68.2% vs. 60.6% for intensity and 70.1% vs. 58.9% for frequency, respectively, p > 0.05, NS). Encountered side effects included: drowsiness, dizziness, fatigue (GPT group) and mastodynia, vaginal spotting and a local allergic reaction (E(2) group). Compliance to treatment was 95.6% (GPT group) as compared to 90.9% for the E(2) group., Conclusion: Despite statistical significant differences, from a clinical point of view oral GPT 600 mg was as effective as low-dose transdermal E(2) in controlling moderate to severe hot flushes in post-menopausal women, and should be recommended as an alternative option in those with contraindications to estrogen therapy. More research is warranted in this regard.

Background: Several studies drawn from the Ecuadorian population have previously reported that more than half of mid-aged women present hot flushes, which can impair their quality of life. However up-to-date risk factors for their presence and severity have not been assessed., Objective: To assess hot flush frequency and intensity and related risk factors among middle-aged Ecuadorian women., Methods: In this cross-sectional study, 1154 healthy women aged 40-59 years, visiting healthcare centers of eight main cities of Ecuador with more than 100,000 inhabitants, were assessed with the first item of the Menopause Rating Scale (MRS) and a questionnaire containing female and partner socio-demographic data., Results: Mean age of the entire sample was 48.8+/-5.6 years (median 48), a 48.7% had 12 or less years of schooling, 52.8% were postmenopausal, 43.6% lived at high altitude, 56.8% were married and 10% were on hormonal therapy (HT). Hot flushes accounted for 56% (n=646) of the whole sample, of which 29.1% and 9.1% were respectively graded as severe and very severe. Logistic regression determined that female sedentarism (OR: 2.42, CI 95% [1.63-3.59]), accessing a free healthcare system (OR: 1.96, CI 95% [1.30-2.96]), living at high altitude (OR: 1.82, CI 95% [1.14-2.90]) and having a partner abusing alcohol (OR: 1.92, CI 95% [1.09-3.35]) were significant risk factors related to the presence of hot flushes. The regression model also determined that among women with hot flushes (n=646), sedentarism (OR: 1.73, CI 95% [1.14-2.62]) and having a partner with erectile dysfunction (OR: 2.57, CI 95% [1.44-4.59]) were significant risk factors related to severe/very severe hot flushes whereas married status (OR: 0.53, CI 95% [0.32-0.86]), living at high altitude (OR: 0.46, CI 95% [0.26-0.78]) and partner healthiness (OR: 0.59, CI 95% [0.36-0.95]) were not., Conclusion: To the best of our knowledge this is the first and largest study assessing hot flushes in a mid-aged Ecuadorian population. We found that the presence and severity were not significantly related to age and hormonal status yet to other individual female/male characteristics and the demography of the studied population., (Copyright 2009 Elsevier Ireland Ltd. All rights reserved.)

Objective: To assess the female quality of life (QoL) during the menopausal transition and determine factors (personal and partner) related to its impairment. The frequency of menopausal symptoms was also assessed., Methods: In this cross-sectional study, healthy women aged 40-59 years were asked to fill out the Menopause Rating Scale (MRS) and a questionnaire assessing personal and partner demographic data., Results: During the study period, a total of 409 women were surveyed. Mean age was 47 +/- 5.3 years (median 46). Mean educational level was 13.2 +/- 4.1 years (median 14), with 28.1% having 12 or less years of schooling; premenopausal (42.1%), perimenopausal (24.4%) and postmenopausal (33.5%). At the time of the survey, 9.8% were receiving hormonal therapy (HT) for the menopause, 1.5% were on psychotropic drugs and 1.2% on alternative treatments for the menopausal. Regarding partner profile, 10.3% had erectile dysfunction, 11.2% had precocious ejaculation and 7.3% had abused alcohol. Mean total MRS score was 9.1 +/- 6.4 (median 9); for the somatic subscale, 4 +/- 2.7; the psychological subscale, 3 +/- 2.8 and the urogenital subscale, 2.1 +/- 2.5. Of the surveyed women, 50.6% presented a total MRS scoring of 9 or more (moderate to severe intensity). The four most frequently found symptoms of those composing the MRS were hot flushes (68.9%), sleeping problems (68.4%), depressive mood (55.2%) and irritability (51.6%). After adjusting for confounding factors, logistic regression analysis determined that female age, menopause and partner precocious ejaculation increased the risk for presenting higher total MRS scores (impaired female QoL) whereas HT use, church assistance and partner faithfulness decreased this risk., Conclusions: A high rate of middle-aged women in this series presented impaired QoL associated to female age and hormonal status and additionally to partner's health and sexual behavior.

Background: The frequency and intensity of menopausal symptoms within a given population, as assessed by several tools, vary and depend on several factors among them age, menopausal status, chronic conditions and socio-demographic profile., Objective: Determine the frequency and intensity of menopausal symptoms as well as associated risk factors among healthy middle aged Ecuadorian women., Design: In this cross-sectional study healthy women aged 40 or more, with intact uterus and ovaries, working at the Luis Vernaza Hospital, Guayaquil, Ecuador, were asked to fill out the Menopause Rating Scale (MRS) questionnaire. Symptom frequency and intensity, as well as obtained scores, were assessed and correlated to demographic data., Results: During the study period, 300 subjects were surveyed. Mean age was 45.1+/-3.1 years (median 45). According to menopausal status women were premenopausal (40.6%); perimenopausal (48%) and postmenopausal (11.4%). A 62% of women were not sexually active and 8.3% had less than 12 years of schooling. The 5 most frequent symptoms of the 11 composing the MRS (n=300) were: muscle and joint problems (77%), depressive mood (74.6%), sexual problems (69.6%), hot flushes (65.5%) and sleeping disorders (45.6%). In general, peri- and postmenopausal women significantly presented higher rates of menopausal symptoms when compared to premenopausal women. Total and subscale MRS scores significantly increased in relation to age and the menopausal stage. Women with lower educational level presented higher somatic and psychological scorings in comparison to their counterparts. Sexually inactive women presented higher total as well as somatic, psychological and urogenital scorings. Logistic regression analysis confirmed significant associations found during univariate analysis., Conclusion: In this specific healthy population, age, the menopause, sexual inactivity and educational level were independent risk factors predicting more severe menopausal symptoms.