Real-world clinical evaluation of natural and induced vasomotor symptoms in the USA and Europe.

OBJECTIVE: This study aimed to examine physicians' and patients' perceptions regarding symptom burden and impact in women experiencing natural vasomotor symptoms (nVMS) or vasomotor symptoms induced by endocrine therapy for breast cancer (iVMS). METHODS: The cross-sectional survey based on real-world clinical consultations was conducted in the USA and five European countries. Obstetrician-gynecologists, primary-care physicians and oncologists provided demographic and symptom data for patients experiencing VMS; patients optionally self-reported their experiences via questionnaires, including their symptom profile and work/activity burden through the Menopause Quality of Life (MENQOL) and Work Productivity and Activity Impairment (WPAI) tools. RESULTS: Physicians completed survey forms on 2451 consulting patients; patients completed 1029 questionnaires. nVMS and iVMS severity was significantly associated with the severity of mood symptoms and sleep disturbances (p < 0.0001). However, around half of the patients with mild nVMS/iVMS also experienced moderate-severe mood changes (55.4%/43.7%) or sleep disturbances (42.4%/40.4%). Presence of mood/sleep disturbances alongside nVMS increased MENQOL vasomotor scores (p = 0.004/p < 0.001). Presence of sleep disturbances increased WPAI activity impairment (p < 0.001) but mood changes did not. Similar findings were reported for iVMS patients. CONCLUSION: Significant burden from the triad of natural or induced menopausal symptoms, sleep disturbances and mood changes affected women's daily activities, work and quality of life more than vasomotor symptoms alone.

Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause.

INTRODUCTION: Vasomotor symptoms (VMS) associated with menopause can negatively affect health-related quality of life (HRQoL). The Menopause-Specific Quality of Life (MENQOL) questionnaire has been developed to assess QOL specific to menopause. The objective of the current study was to assess the psychometric properties, sensitivity to change, and clinically meaningful within-patient change of the MENQOL using data from the fezolinetant SKYLIGHT 1 and 2 studies in individuals with VMS. METHODS: Individuals aged ≥ 40 to ≤ 65 years with moderate-to-severe VMS (≥ seven hot flashes/day) were enrolled. In addition to MENQOL, eight patient-reported outcome (PRO) measures were used for the psychometric evaluation. All PRO assessments were completed at weeks 4 and 12 during the treatment period, and most were completed at baseline. Psychometric analyses included factor analysis and reliability, construct validity, and sensitivity to change assessments. The within-patient threshold for a clinically meaningful change in MENQOL was derived. RESULTS: In total, 1022 individuals were included from SKYLIGHT 1 and 2. Mean MENQOL total score at baseline was 4.30, improving to 3.16 at week 12. The confirmatory factor analysis supported established MENQOL domain structure, including the overall score. The internal consistency of the MENQOL overall and domain scores was supported using Cronbach's alpha and McDonald's omega, and MENQOL construct validity was supported for overall and domain scores. Item-to-item and item-total correlations were generally sufficient, and moderate test-retest reliability was noted. The scales against which construct validity and responsiveness for MENQOL domains were examined were moderately related to the MENQOL domains in general, providing additional support for acceptable measurement properties of MENQOL in this population. A reduction in MENQOL overall score of ≥ 0.9 points was identified as responding to treatment (a clinically important threshold). Thresholds of 2.0 points for the vasomotor domain and 0.9 for the psychosocial domain were estimated, in addition to distribution-based threshold estimates of 0.8 and 1.2 for the physical and sexual domains, respectively. CONCLUSIONS: The psychometric properties of the MENQOL overall and domain scores support use of this instrument to capture experiences among individuals with moderate-to-severe VMS associated with menopause and assess related endpoints in clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT04003155 and NCT04003142.

Factor analysis of quality of life among menopausal women attending primary health centers of Jazan city, KSA.

Although it looks reasonable to say menopausal women experience significant changes in quality of life, however the period is filled with anxiety and distress. Women can experience an array of symptoms including hot flushes, night sweats, sleep and mood disorders, impaired memory, lack of concentration, nervousness, depression, insomnia, bone and joint complaints Objectives:1. To assess Quality of life in menopausal women attending primary health care centers of Jazan, KSA 2. To conduct factor analysis for the variables affecting quality of life of menopausal women Methodology: A cross-sectional study conducted in primary health centers located in Jazan city. All menopausal women between age of 40-79 years were considered. A predesigned questionnaire drawn from World Health Organization Quality Of Life BREF (WHO QOL BREF) utilized Results: Mean age was 50.02+4.5 (Age + SD) Physical changes domain mean was 1.42+1.46 (mean + SD), greater than other domains and the participants were experiencing physical changes affecting quality of life more than any domain Sexual changes domain mean + SD was 1.21+1.99 and the participants were extremely bothered with symptoms of this domain. Conclusions: Significant shift in health care services is required for improving QOL of menopausal women which continue to be overlooked.

Bien qu'il semble raisonnable de dire que les femmes ménopausées connaissent des changements significatifs dans leur qualité de vie, cette période est néanmoins remplie d'anxiété et de détresse. Les femmes peuvent ressentir toute une série de symptômes, notamment des bouffées de chaleur, des sueurs nocturnes, des troubles du sommeil et de l'humeur, des troubles de la mémoire, un manque de concentration, de la nervosité, de la dépression, de l'insomnie, des problèmes osseux et articulaires. Objectifs : 1. Évaluer la qualité de vie des femmes ménopausées fréquentant les centres de soins de santé primaires de Jazan, KSA 2. Effectuer une analyse factorielle pour les variables affectant la qualité de vie des femmes ménopausées Méthodologie : Une étude transversale menée dans les centres de santé primaires situés dans la ville de Jazan. Toutes les femmes ménopausées âgées de 40 à 79 ans ont été prises en compte. Un questionnaire prédéfini tiré du BREF sur la qualité de vie de l'Organisation mondiale de la santé (WHO QOL BREF) a utilisé les résultats : L'âge moyen était de 50,02+4,5 (âge + écart-type). La moyenne du domaine des changements physiques était de 1,42+1,46 (moyenne + écart-type), supérieure à celle des autres domaines et les participants subissaient des changements physiques affectant la qualité de vie plus que n'importe quel domaine. La moyenne du domaine des changements sexuels + SD était de 1,21 + 1,99 et les participants étaient extrêmement gênés par les symptômes de ce domaine. Conclusions : Un changement significatif dans les services de soins de santé est nécessaire pour améliorer la qualité de vie des femmes ménopausées, qui continue d'être négligée.

Post-Menopausal Quality of Life Claims: Overlooking the Requirements of Normal Science and Fundamental Measurement in ICER'S Cost-Effectiveness Assessment of Fezolinetant for Moderate to Severe Vasomotor Symptoms.

One of the signal failures in health technology assessment is the absence of consideration given, not only to the standards of normal science, but to those of fundamental measurement. A recent evidence report by the Institute for Clinical and Economic Review (ICER) is emblematic of this failure. Based on a simple linear regression model that translates aggregate scores from the ordinal Menopause-specific Quality of Life Questionnaire (MENQOL) to the ordinal EuroQol EQ-5D-5L, ICER has applied these scores to an assumption driven model simulation to produce preferences, QALYs and incremental cost-per-QALY claims for fezolinetant for moderate to severe symptoms associated with menopause. Unfortunately, the attempt to crosswalk multidimensional or multiattribute ordinal scores is mathematically impossible. The 'created' EQ-5D-5L preferences are, as a result, of no interest. The overall result is that the ICER modelled claims for cost-effectiveness fail the required standards for normal science and fundamental measurement. fundamental are impossible. This is unfortunate, although it might be possible to assess certain domains of the MENQOL for their approximation to an interval score with the application of the Rasch Rating Scale Model, this will not support quality of life claims. A preferred approach would be to consider an alternative latent trait for quality of life in menopause, applying Rasch Measurement Theory (RMT), to develop a polytomous instrument that has the required measurement properties. The purpose of this commentary is to point out, as a number of previous commentaries have done, that this framework for creating assumption driven simulated modelled claims has no role in decisions for product assessment, access to formulary and pricing. This commentary expands upon these previous commentaries in placing RMT is the context of a needed paradigm shift to support the evolution of objective knowledge. This is critical if we are to understand, from the individual's perspective, not only an accurate assessment of the burden of menopause but to see this as part of an on-going research program that has to rely on fundamental measurement.

Comparison of predictive effect of the dietary inflammatory index and empirically derived food-based dietary inflammatory index on the menopause-specific quality of life and its complications.

INTRODUCTION: Menopause, defined as the cessation of menstruation for at least 12 months, is one of the important stages of a woman's life cycle. Some hormonal variations occur during the transition to menopause, which affects women's quality of life. Recently, the role of dietary factors in alleviating symptoms has been investigated. AIM OF THIS STUDY: We tried to investigate the relationship between dietary inflammatory index (DII), food-based dietary inflammatory index (FDII) and quality of life, and menopausal symptoms, comparing their predictive power and suggesting the best cut-off point. METHODOLOGY: One hundred forty-nine postmenopausal women were included in the cross-sectional study. After collecting data by interview, the desired variables were calculated. Logistic regression and ROC curves were used to investigate the relationship and predictive power of DII and FDII with menopausal symptoms. FINDINGS: We observed that both DII and FDII were significantly associated with the severity of sexual symptoms. The first tertile of DII (OR = 0.252, P-value = 0.002) and FDII (OR = 0.316, P-value = 0.014) had a significantly lower odds ratio for severe to moderate symptoms compared to the third tertile. Both inflammatory indices had significant predictive power in predicting the probability of having severe to moderate poor quality of life (FDII (p-value = 0.004) > DII (p-value = 0.006)) and sexual symptoms (DII (p-value = 0.002) > FDII (p-value = 0.003)). Also, regarding the physical subtype, only FDII (p-value = 0.002) results were significant. CONCLUSION: Both dietary inflammatory indices appear to be suitable for predicting quality of life, but FDII had slightly more predictive power. It seems that the quality of life and severity of menopausal symptoms may be improved, particularly with regard to sexual symptoms, by following an anti-inflammatory diet.

The COVID-19 Pandemic Impact on the Psychophysical Health of Post-Menopausal Women: A Cross-Sectional Study.

Background and Objectives: The aim of this study was to investigate lifestyle, menopausal symptoms, depression, post-traumatic stress disorder (PTSD) and sleep disorders in post-menopausal women throughout the first wave of the COVID-19 pandemic, including the impact of menopause hormonal therapy (HT). Materials and Methods: Post-menopausal women were given the following questionnaires: socio-demographic characteristics; lifestyle; history of COVID-19; menopause-specific quality of life (MENQOL), the first part of which refers to the pre-pandemic period ("pre COVID-19") and the second refers to the current period ("during COVID-19"); Beck's depression inventory (BDI); the impact of event scale-revised (IES-R); and the Pittsburgh sleep quality index (PSQI). Results: One hundred and twenty-six women completed all questionnaires, with a mean age of 55.5 ± 6.0 years. The mean menopause duration was 5.7 ± 5.6 years. Twenty-four women were taking HT. A significant mean weight gain, a reduction in physical activity (respectively p < 0.001) and worsened quality of romantic relationships (p = 0.001) were reported during the pandemic. Menopausal symptoms did not vary significantly throughout the pandemic; however, women taking menopausal HT had lower physical (p = 0.003) and sexual (p = 0.049) MENQOL domain scores, lower depressive symptoms (p = 0.039) and better romantic relationships (p = 0.008). Conclusions: The COVID-19 pandemic caused reduced physical activity, worsened food habits and weight gain in post-menopausal women. They also reported a high rate of severe-moderate PTSD and a negative influence on their romantic relationships. Menopausal HT seems to be a potential protective factor for sexual and physical status and for symptoms of depression.

Quality of life of patients with bilateral oophorectomy before the age of 45 for the treatment of endometriosis.

INTRODUCTION: The study aimed to evaluate the quality of life and associated factors among women who underwent bilateral oophorectomy (BO) before the age of 45 for the treatment of deep infiltrating endometriosis (DIE). MATERIALS AND METHODS: This cross-sectional study was carried out in 52 women who were treated from January 2014 to December 2019 in 2 public and private DIE surgical centers in Toulouse. All women answered the Menopausal Quality of Life questionnaire (MenQOL). Mean MenQOL scores were compared according to age at BO, smoking, BMI, level of education, delay between BO and the survey and post-BO hormone replacement therapy (HRT) using Mann-Whitney and Anova tests. Spearman's correlation coefficient was used to analyze the correlations between all the MEnQOL domain scores and clinical variables. The variables associated with the outcomes in univariate analyses with p < 0.2 were jointly evaluated using multiple linear regression. RESULTS: The mean age at the time of the survey was 43.4 ± 3.4 years while the mean age at BO was 40.5 ± 3.4 years. The mean MenQOL score was 3.96 (± 1.45), with the highest scores in the sexual (4.77) and vasomotor (4.01) domains. BMI and smoking were independently and significantly associated with the mean total MenQOL score, all domain scores being significantly higher in overweight/obese women. A trend towards worse MenQOL scores was found in patients who had BO before the age of 41. We did not find any difference according to whether or not they were taking HRT. CONCLUSION: This is a first study evaluating quality of life in a specific population of oophorectomized women under the age of 45 using MenQOL for DIE. While BO is effective in relieving pain in women with severe DIE, the induced premature menopause is associated with a poor quality of life, which deserves further attention.

A Complex of Cirsium japonicum var. maackii (Maxim.) Matisum. and Thymus vulgaris L. Improves Menopausal Symptoms and Supports Healthy Aging in Women.

We evaluated the efficacy and safety of MS-10® for the treatment of menopausal symptoms. A double-blind randomized placebo-controlled clinical trial was performed in 71 premenopausal women for 4 and 12 weeks. A total of 12 individual menopausal symptom scores were assessed using the Kupperman index. MS-10 treatment effectively improved the symptoms by ∼48%. In addition, the quality of life of the women improved by 36% from four perspectives: vasomotor, psychosocial, physical, and sexual symptoms as evaluated using the menopause-specific quality of life (MenQoL) questionnaire. Our results show that MS-10 improves insulin-like growth factor-1 (IGF-1) and estrogen utilization through receptor activation, which are thought to have causative therapeutic effects on menopause and aging inhibition in women. Improvement of Enthotheline-1 (ET-1) in the blood after MS-10 intake led to an improvement in menopausal vascular symptoms. Improvements in bone formation and absorption markers such as osteocalcin, bone-specific alkaline phosphatase (BSALP), C-telopeptides of type I collagen (CTx), deoxypyridinoline (deoxyPYD), and N-telopeptides of type I collagen (NTx) in blood or urine indicate that MS-10 fundamentally improves bone health in women. By confirming the improvement of the psychological well-being index based on the improvement of stress hormone cortisol, MS-10 can solve causative psychological and physical stress-related symptoms. Moreover, various safety tests, such as those for female hormones, were confirmed. Therefore, it can be confirmed that MS-10 is a natural pharmaconutraceutical that causatively and safely improves health of women and aids in antiaging processes.

Community-based appraisal of menopause-specific health problems and quality of life among women of rural Western Maharashtra.

Background: Menopause is an important hormonal transition of women's lifespan which can strike as early as 30-35 years of age. Menopause-specific quality of life (MENQoL) mainly depends upon awareness, frequency, and intensity of menopausal symptoms; sociocultural, lifestyle, and dietary factors; and availability of health services specifically focusing on these issues. As life expectancy increases, women have to spend more years after menopause. So menopause specific quality of life will be a major issue of concern in the near future. The aim of this study was to assess the post-menopausal symptoms and quality of life (QoL) amongst post-menopausal women and their association with various sociodemographic factors. Materials and Methods: A community-based, descriptive, cross-sectional study was undertaken at Sakuri village among 100 postmenopausal women. Information was collected using MENQoL questionnaire. Unpaired t-test and Chi-squared test were used. Results: The mean age of participants and menopause was 51.8 ± 4.54 years and 46.42 ± 4.13 years, respectively. The major symptoms reported were hot flushes (70%), under accomplishment (100%), bloating (100%), decrease in physical strength (95%), and change in sexual desire (78%). Statistically significant association was found between age and psychosocial domain. QoL was associated with age and educational level. Conclusion: More than half of the participants had poor QoL for all four domains. Awareness about post-menopausal changes and available treatment modalities can improve QoL. Accessible and affordable gynaecological and psychiatric health services through channel of primary health care are necessary to alleviate these complaints.

Effect of the fourth generation multi-theory model intervention on the quality of life in Iranian postmenopausal women: A randomized controlled trial.

OBJECTIVES: Menopause is a natural part of women's lives and is associated with a series of complications that can impair their quality of life. This study was conducted to determine the effect of specific educational interventions on the quality of life among postmenopausal women. METHODS: This randomized controlled trial was conducted on 80 menopausal women who met the inclusion and exclusion criteria and were selected through the multi-stage stratified random sampling method. The participants were randomly allocated to either the control or intervention group (40 per group). The intervention comprised 5 × 45-min educational sessions based on the Multi-Theory Model on the predetermined days of the week. The scores of the quality of life level were collected at baseline, immediately, and 3 months after the intervention using the Menopause-Specific Quality of Life questionnaire (MENQOL). The control group received a health advice. RESULTS: Analysis of variance of repeated measures showed a significant interaction between time and intervention. The comparison between the mean score of quality of life of the "before," "immediately after intervention," and "3 months after the intervention" showed a significant difference between the two groups. The intervention group quality of life improved significantly as the intervention went on compared to the control group. CONCLUSION: Structured simple educational programs based on the Multi-Theory Model could be used as a simple and noninvasive intervention that help menopausal women improve their quality of life through menopausal symptoms relief. Further interventions with larger trials may be required to confirm these findings.

Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study.

BACKGROUND: Perimenopause is the period during which many physiological changes mark the transition into the final menstrual period of a woman and these changes are associated with climacteric symptoms. OBJECTIVES: This study aimed to assess the efficacy and tolerability of an Ashwagandha root extract on the climacteric symptoms, quality of life (QoL), and hormonal parameters in perimenopausal women. MATERIALS AND METHODS: In this 8-week, randomized, double-blind, placebo-controlled study, 100 women with climacteric symptoms were randomly allocated to take either a placebo or 300 mg of an Ashwagandha root extract twice daily. Outcomes were measured using the menopause rating scale (MRS), menopause-specific QoL (MENQoL), hot flash score, and hormonal changes in estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone. RESULTS: Among 100 participants enrolled, 91 participants completed the study. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in total MRS score (p < 0.0001), reflected by significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains. Ashwagandha intake demonstrated a statistically significant reduction in total MENQoL scores (p < 0.0001) and was also associated with a statistically significant increase in serum estradiol (p < 0.0001) and a significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05) compared with the placebo. There was no significant between the group differences in the serum testosterone level. CONCLUSION: These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause in women.

The effect of low-dose combined hormone therapy (oestradiol and norethindrone acetate) on serum C-reactive protein levels and life quality in natural menopause women.

INTRODUCTION: To assess the effect of low-dose combined oestradiol and norethindrone acetate hormone therapy (HT) on serum C-reactive protein (CRP) levels and life quality in natural menopause women. MATERIAL AND METHODS: Forty-five natural menopause women admitted to the clinic during a 1-year period and diagnosed as menopause, who planned to have HT for menopausal symptoms, were enrolled in this prospective study. The serum CRP levels were measured, and vasomotor symptoms scores were graded according to the Blatt-Kupperman menopause index, and life quality scores according to the Menopause-Specific Quality of Life Questionnaire (MENQOL) were recorded before and after (3 months later) hormone therapy. RESULTS: The Blatt-Kupperman menopause index and MENQOL scores were significantly decreased after 3 months of low-dose treatment. No significant difference was found between white blood cell counts and serum CRP levels before and after 3 months of hormone therapy. CONCLUSIONS: Considering all HT types and biochemical effects, low-dose HT, which had positive results in terms of quality of life, was a safe treatment and could be preferred to conventional-dose preparations in cases without contraindications. Low-dose combined HT containing oestradiol and norethindrone acetate did not alter the serum CRP level in postmenopausal cases.

Menopausal symptoms in relationship to breast cancer-specific quality of life after adjuvant cytotoxic treatment in young breast cancer survivors.

INTRODUCTIONS: For young premenopausal breast cancer patients, adjuvant chemotherapy may cause menstrual disruptions and premature menopause, which may in turn impair their quality of life (QoL). In this study among young breast cancer survivors who have undergone adjuvant chemotherapy, the objectives were to assess post-treatment menopausal symptoms and their associated factors, and to correlate these symptoms with breast cancer-specific QoL. METHODS: The study population included premenopausal young Chinese women with early-stage breast cancer who had undergone adjuvant chemotherapy between 3 and 10 years prior to enrolling into this study. At study entry, patients' characteristics and clinical features were collected; each patient had detail menstrual history collected and each filled in MENQOL and FACT-B + 4 questionnaires. RESULTS: Two hundred eighty eligible patients were recruited. For adjuvant chemotherapy, 92% received anthracyclines and 28% received taxanes; 76% received adjuvant tamoxifen. At a median of 5.0 years from initial cancer diagnosis, 49 and 11% had become post- and peri-menopausal respectively. MENQOL at study entry revealed that physical domain score was worse in overweight/obese patients (mean scores for underweight/normal vs overweight/obese: 2.65 vs 2.97, p = 0.0162). Vasomotor domain score was worse in those who received taxanes or tamoxifen (taxane vs non-taxane: 2.91 vs. 2.35, p = 0.0140; tamoxifen vs no tamoxifen: 2.75 vs. 2.34, p = 0.0479). Sexual domain score was worse among those who had become peri/post-menopausal (peri/postmenopausal vs premenopausal: 2.82 vs. 2.29, p = 0.0229). On the other hand, patients who utilized traditional Chinese medicine had significantly worse scores for vasomotor, psychosocial and physical domains. Further, there was a significant association between MENQOL scores and FACT-B + 4 scores; less severe symptoms in the MENQOL domains were associated with better QoL scores in FACT-B + 4 physical, functional, psychosocial and emotional well-being, Breast Cancer Subscale, Arm Subscale and FACT-B total score. CONCLUSION: Among premenopausal breast cancer women who had undergone adjuvant chemotherapy, those who had received taxanes or tamoxifen, were overweight/obese and utilized traditional Chinese medicine had more severe menopausal symptoms. Patients who experienced worse menopausal symptoms were found to have worse breast cancer-specific QoL. Interventional studies with an aim to alleviate menopausal symptoms are warranted to assess if overall QoL of these patients could be improved. TRIAL REGISTRATION: Not applicable.

Menopause-Specific Quality of Life among Emirati Women.

To investigate the quality of life (QOL) of menopausal Emirati women aged 40-64 years and determine its relationship with their sociodemographic characteristics. A community-based cross-sectional study was conducted on 70 Emirati women using multistage stratified clustered random sampling. The participants were interviewed face-to-face using a structured questionnaire comprising sociodemographic variables, reproductive characteristics, and the Menopause-Specific Quality of Life (MENQOL) questionnaire. The most common symptom among the study participants was 'aching in the muscles'. The participants had a moderate level of bothersome symptoms; in addition, vasomotor symptoms were reported by 61%, while sexual symptoms were only reported by one-third of the participants. There were no significant differences between the menopausal status in any of the four domains of the MENQOL questionnaire. Additionally, there were no significant differences between the mean scores of the four MENQOL domains and all predictors. This study highlights the importance of educating women about menopause and its symptoms.

Effects of a combination of Nigella sativa and Vitex agnus-castus with citalopram on healthy menopausal women with hot flashes: results from a subpopulation analysis.

The goal of the current study was to evaluate the efficiency of a phytotherapeutic intervention consisting of a combination of Nigella sativa and Vitex agnus-castus with citalopram in the control of hot flashes in healthy menopausal women. An 8 week, double-blind, randomized, placebo-controlled study was performed among 46 women aged between 40 and 60 years experiencing an average of more than four hot flashes per day recruited during July 2016 to June 2017. Data on severity of vasomotor symptoms were collected at the end of the eighth week. Herbal medication or placebo capsules were administered once daily in morning. At the end of the 8-week treatment period, analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including vasomotor (p < .001), physical (p = .036), psychosocial (p = .001) but no significant differences were observed in terms of sexual function (p = .231). Based on the results, the addition of a combination of N. sativa and V. agnus-castus to the citalopram may be a potential clinical application for improving therapeutic outcomes. Larger randomized, controlled trials are also warranted for further investigations of these symptoms.

Quality of life among postmenopausal women enrolled in the Minnesota Green Tea Trial.

BACKGROUND: Postmenopausal symptomatology has not been elucidated in large, long-term human clinical trials. Our objective was to measure quality of life in postmenopausal women aged 50-70 years. METHODS: A Menopause-Specific Quality of Life-Intervention (MENQOL) questionnaire was completed by women enrolled in the Minnesota Green Tea Trial (n=932) to assess vasomotor, physical, sexual, and psychosocial symptoms in the years following menopause. Responses were coded; mean overall and domain scores ranged from 1 to 8. A higher score indicated more severe symptoms. RESULTS: Mean overall MENQOL scores were highest in women aged 50-54.9 years. A pattern of reduced symptom severity with increasing age was observed overall and within each domain. Women aged 50-54.9 years had more severe night sweats and sweating than other age groups (P≤0.001) and more severe hot flashes than women aged≥60years (P≪0.001). No differences between age groups were seen on mean score in the Sexual domain. Compared with women aged 50.0-54.9 years (the reference group), study participants aged 60-64.9 and≥65years had lower MENQOL scores in the Psychosocial domain (P=0.029 and P≪0.001). Women aged 50-54.9 years had more severe symptoms related to negative mood than women ≥65 years (P≤0.009). Compared with women aged 50-54.9 years, those in the age groups 60-64.9 and≥65 years had lower scores for "poor memory" (2.98±1.75 and 2.66±1.68 vs. 3.43±1.87, P≪0.001). Women≥65 years reported lower scores for "feeling tired or worn out", "difficulty sleeping", and "lack of energy" than all other age groups (P≤0.003). CONCLUSION: The findings of this descriptive analysis of postmenopausal women may help clinicians counsel women about expectations and treatment options to address menopause-associated symptoms and the relationship between postmenopausal symptoms and overall health.

Experience of menopause in women with inflammatory bowel disease: pilot study.

OBJECTIVE: Inflammatory bowel diseases (IBD) are debilitating chronic intestinal diseases requiring extensive medical intervention. Little is known how IBD symptoms and treatments affect menopause experience and quality of life. The study's goal was to investigate the relationship between IBD and menopause. METHOD: Women with IBD, between the ages of 30 and 65 years, were recruited from an outpatient IBD clinic. They completed surveys on obstetric, medical, and IBD history and clinical disease activity. Quality of life was assessed using the validated menopause-specific quality of life (MENQOL) questionnaire. RESULTS: Seventy-one women (47 Crohn's disease, 22 ulcerative colitis, and two indeterminate colitis, median age 45 years) enrolled into the study. Younger age of IBD diagnosis was correlated with younger age of last menstrual period (r = 0.697). IBD severity affected menopause-related quality of life in three MENQOL domains (psychosocial, physical, and sexual); the fourth domain (vasomotor) did not appear to be affected by the severity of IBD clinical disease. CONCLUSION: Women with IBD may experience additional challenges when going through the menopause transition. Our findings support the need for further studies to better inform patients and clinicians on the relationship between IBD and menopause to optimize patient care.

Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning.

OBJECTIVE: Conjugated estrogens/bazedoxifene (CE/BZA) has demonstrated benefit in vulvar-vaginal atrophy (VVA, part of genitourinary syndrome of menopause) and the sexual function domain of the Menopause-specific Quality of Life (MENQOL) questionnaire. The study's objective was to determine the relationship of VVA symptoms and clinical parameters with MENQOL sexual functioning in postmenopausal women receiving VVA treatment. STUDY DESIGN: Post hoc analysis data were derived from the 12-week SMART-3 trial, which evaluated CE/BZA's effect on VVA in nonhysterectomized postmenopausal women (aged 40-65 years) experiencing one or more moderate to severe VVA symptoms (dryness, itching/irritation, pain with intercourse) and vaginal pH>5.0 (N=664). MAIN OUTCOME MEASURES: Repeated measures models were used to determine relationships of VVA symptoms and clinical parameters (vaginal pH, parabasal/superficial cells) with sexual functioning; sensitivity analyses were performed to check assumptions of linearity. RESULTS: VVA symptoms showed an approximately linear relationship with sexual functioning. A 1-point improvement in pain on intercourse (which has a large effect size [ES]=0.85) corresponded to medium improvement (ES=0.57) in MENQOL sexual functioning. Equivalent improvements (in terms of ES) in dryness and itching/irritation corresponded to small to medium (ES=0.35) and small (ES=0.27) improvements in sexual functioning, respectively. The same ES improvement in clinical parameters corresponded to small-trivial improvements in sexual functioning. CONCLUSIONS: VVA symptoms have an approximately linear relationship with sexual functioning. Sexual functioning was most improved when pain on intercourse was reduced. Similar magnitudes of improvements in other VVA symptoms were linked with smaller, though potentially beneficial, improvements in sexual functioning. Changes in clinical parameters had only small or trivial associations with sexual functioning. Trial registration number NCT00238732.

Effect of Cupping plus Medication on Quality of Life and Estrogen Level in Perimenopausal Syndrome Patients / 上海针灸杂志

Objective To observe the effect of cupping plus medication on the quality of life and estrogen level in perimenopausal syndrome patients. Method A total of 40 eligible perimenopausal syndrome patients were randomized into a cupping-medication group and a Chinese medication group, 20 cases in each group. The Chinese medication group was intervened by Er Xian decoction, the cupping-medication group was intervened by moving cupping on the back in addition to the treatment given to the Chinese medication group, once a week. Each item of the Menopause-specific Quality of Life (MENQOL), the levels of estradiol (E2), follicle-stimulating hormone (FSH) and luteotropic hormone (LH) in serum were observed before and after the treatment, and the results were analyzed. Result After two treatment courses, the vasomotor symptoms, mental state, physiological state, and sexual life scores in the two groups were significantly improved compared to the scores before the treatment (P0.05). Conclusion Moving cupping on the back plus Er Xian decoction can effectively improve the quality of life of perimenopausal syndrome patients and significantly increase the serum E2 level, superior to using Er Xian decoction alone.

Effect of Soy Milk Consumption on Quality of Life in Iranian Postmenopausal Women.

OBJECTIVE: To find out whether or not soy milk as a phytoestrogen product can improve the quality of life of the Iranian postmenopausal women. MATERIALS AND METHODS: Participants of this randomized clinical trial were 57 healthy postmenopausal women. All eligible women were randomly divided into two groups of soy milk (SG) and control (CG). Individuals in the SG (n = 34) received 500 ml soy milk including genistein (28.86 mg/dl) and daidzein (8.25 mg/dl) per day, while the participants in the CG (n = 23) received 500 ml low fat cow milk per day during 8 months. Both groups also took daily calcium-D capsules (500 mg calcium and 200 IU D3). The quality of life of all participants was examined twice (at the baseline and the end of the eighth month) using the menopause-specific quality of life (MENQOL) questionnaire. RESULTS: A total of 57 healthy postmenopausal women with a mean age of 52.13 (3.05) years were included in this study. Despite the significant but weak difference was observed between SG and CG in the sexual domain score (the mean of percent change: 0.46% vs. 33.94%, respectively; p = 0.031), while significant relationship was found between the soy milk consumption and improvement in the domains studied (vasomotor, psychosocial and physical). CONCLUSION: Overall our findings showed that soy milk does not improve the quality of life in postmenopausal women. But to achieve more reliable results, it is recommended further study to be done with a larger sample size, more prolonged, and with participants having severer vasomotor symptoms.