Vasomotor Scores Research Articles

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.

Serum 25-hydroxyvitamin D and cancer-related fatigue: associations and effects on depression, anxiety, functional capacity and health-related quality of Life in breast cancer survivors during adjuvant endocrine therapy

BackgroundThe adjuvant treatment with Aromatase Inhibitor (AI) is considered standard of care for postmenopausal breast cancer (BC) women with hormone receptor-positive (HR +), however, it often causes adverse effects such as cancer-related fatigue (CRF). The high prevalence of vitamin D deficiency in postmenopausal women who start adjuvant AI supports the hypothesis that hypovitaminosis D would be one of the biological explanations for toxicity of AI. This study aimed to identify the relationship between 25-hydroxyvitamin D [25(OH)D] and CRF, and to analyze their associations and effects on depression, anxiety, functional disability, muscle/joint aches and HRQL.MethodsThis prospective study included 89 postmenopausal women diagnosed with HR + early BC in adjuvant endocrine therapy with AI. Anthropometric and body composition assessments were performed, as well as dietary assessments by application of 24-h dietary recall, at three time points, totaling 24 months of follow-up. The women completed the Cervantes Scale (CS), Hospital Anxiety and Depression Scale (HADS) and Health Assessment Questionnaire (HAQ). The CRF was determined from the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F). The serum 25(OH)D was determined by electrochemiluminescence, with cut-off point above 75 nmol/L adopted as sufficiency. Generalized Linear Model (GLzM) and Generalized Mixed Model (GMM) analysis were used.ResultsAt baseline, 36% (n = 32) of the women presented CRF and 39.3% (n = 35) had 25(OH)D below 75 nmol/L. None of the women reached the Estimated Average Requirements (EAR) of vitamin D. The causality between 25(OH)D and CRF was not significant. Longitudinally, lower levels of 25(OH)D had a negative effect on anxiety (p = 0.020), Menopause and Health (p = 0.033) and Vasomotor scores (p = 0.007). Also, the CRF had a negative effect on anxiety (p = 0.028); depression (p = 0.027); functional disability (p = 0.022); HRQL (p = 0.007); Menopause and Health (p = 0.042), Psychological (p = 0.008) and Couple Relations (p = 0.008) domains; and on Health (p = 0.019) and Aging (p = 0.036) subdomains. Vasomotor subdomain (β = -2.279, p = 0.045) and muscle/joint aches (β = -0.779, p = 0.013) were significant with CRF only at baseline.ConclusionsThis study found negative effect of body adiposity on CRF. Still, the clinical relevance of 25(OH)D and CRF is highlighted, especially that of CRF, considering the consistent impact on several adverse effects reported by BC survivors during adjuvant endocrine therapy.

Effects of Lactobacillus gasseri CP2305 on Mild Menopausal Symptoms in Middle-Aged Women.

Lactobacillus gasseri CP2305 (CP2305) is a paraprobiotic that exhibits beneficial effects on the intestinal function and microbiota, and increases resistance to psychological stress. The stress response mechanism mainly involves the hypothalamic–pituitary–adrenal axis, which is influenced by the gut–brain axis. Furthermore, the gut–brain axis also communicates bidirectionally with the intestinal microbiota. Additionally, the hypothalamic–pituitary–adrenal and hypothalamic–pituitary–gonadal axes share a common route that affects both mental and health aspects in women. This double-blind, placebo-controlled, parallel-group clinical trial aimed to analyze the influence of the intake of CP2305 on mild symptoms associated with menopause. Eighty women aged 40–60 years ingested CP2305 or placebo tablets for six consecutive menstrual cycles. Assessment was based on the observation of climacteric symptoms with two validated questionnaires—the Simplified Menopausal Index (SMI) and the Greene Climacteric Scale (GCS). The results showed that CP2305 provided significant relief in the SMI total score, SMI vasomotor score, SMI psychological score, GCS total score, GCS somatic score, and GCS vasomotor score compared to the placebo. The percentage of women with symptom relief for the SMI total score was 75.0%, with 30 of 40 women in the CP2305 group, and 55.0%, with 22 of 40 women in the placebo group (p = 0.0594). These findings provide new insights into the function of paraprobiotic CP2305 in relieving mild climacteric symptoms in women.

Abstract PD3-06: Biomarker modulation by bazedoxifene and conjugated estrogen (Duavee®) in women at high risk for development of breast cancer

Abstract Agents which both reduce risk for development of breast cancer and relieve vasomotor symptoms are likely to have good uptake and adherence. We conducted a pilot study with 6 months of the tissue selective estrogen complex bazedoxifene (20 mg) and conjugated estrogen (0.45 mg) (Duavee®) to assess feasibility and effects on biomarkers. Risk biomarkers for postmenopausal breast cancer included fully automated mammographic volumetric density (Volpara®), benign breast tissue Ki-67, and serum levels of progesterone, IGF-1 and IGFBP3, bioavailable estradiol and testosterone. Exploratory biomarkers included selected estrogen and progesterone responsive gene expression in benign breast tissue. 28 peri- and post-menopausal women at increased risk for breast cancer were enrolled; 13 in Cohort A with baseline Ki-67 &amp;lt; 1% and 15 in Cohort B with baseline Ki-67 of 1-4%. All completed the study with &amp;gt; 85% drug adherence. An improvement in median hot flash score from 15 at baseline to 0 at 6 months, and menopause specific quality of life total, vasomotor and sexual domain scores were also observed (p&amp;lt; 0.001). Significant changes in risk biomarkers, uncorrected for multiple comparisons, were a decrease in mammographic fibroglandular volume (p=0.043); decreases in serum progesterone, bioavailable testosterone, and IGF-1 (p&amp;lt;0.01); and for women from Cohort B, a reduction in Ki-67 (p=0.017) despite an increase in serum bioavailable estradiol. Unsupervised cluster analysis of RT-qPCR results indicated two clusters with differences in change in early estrogen response genes including ERS1, TFF1, GREB1a, PGR and AREG. The 10 women in one cluster tended to have increased expression of two or more of early estrogen response genes, but not increased expression of CCND1 (cyclin D1) or genes downstream of activated progesterone receptor such as STAT5a, PdK4, and STK. A trend towards decrease in several genes with predominant stromal expression implicated in breast cancer development including FASN, LEP, CXCL12, SDF1a and B, and CYP19A1 was observed. The 17 women in cluster 2 by contrast exhibited predominately decreased expression of early estrogen response genes. Given the favorable effects on vasomotor symptoms and risk biomarkers, a placebo-controlled Phase IIB trial is warranted. This study was supported in part by grants from the Breast Cancer Research Foundation (BCRF-16-049, BCRF-17-049, BCRF-18-049); and an NIH Clinical and Translational Science Award grant (UL1 TR000001, formerly UL1RR033179) awarded to the University of Kansas Medical Center, and an internal clinical pilot grant program of the KUMC Research Institute. Citation Format: Carol J Fabian, Lauren Nye, Teresa A Phillips, Onalisa Winblad, Carola M Zalles, Christy R Hagan, Merit L Goodman, Byron J Gajewski, Devin C Koestler, Prabhakar Chalise, Bruce F Kimler. Biomarker modulation by bazedoxifene and conjugated estrogen (Duavee®) in women at high risk for development of breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD3-06.

Predictors of Frequency and Severity of Vasomotor Symptoms: Results from the REPLENISH Trial [19M

INTRODUCTION: The objective of this analysis was to determine whether baseline characteristics can predict the frequency and severity of hot flushes (HF) in postmenopausal women. METHODS: REPLENISH was a phase 3, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of TX-001HR (17β-estradiol/progesterone oral capsule) in 767 postmenopausal women, who had ≥50 moderate to severe HF/week at baseline. Post hoc associations of baseline characteristics (age, race, BMI, smoking, time since last menstrual period [LMP], age at LMP, tubal ligation, parity, estradiol levels, and menopause-specific quality of life [MENQOL] total and vasomotor domain scores) with frequency and severity of hot flushes were evaluated. RESULTS: Baseline predictors for having ≥50 moderate to severe HF/week were BMI (P=.0299), MENQOL total score (P<.0001), and MENQOL Vasomotor domain score (P<.0001). For every unit increase in BMI, the odds of having ≥50 moderate to severe HF decreased by 12.6% while a one-point increase in MENQOL total and vasomotor scores increased the odds by 20.9% and 110.9%, respectively. Baseline predictors for HF severity were current smoking (P=.0042), and MENQOL overall (P<.0001) and vasomotor (P<.0001) scores. Multiple regression analyses showed that the MENQOL vasomotor score was the best predictor of severity (R2=0.1876; P<.0001), followed by MENQOL total score + smoking (R2=0.0325; P<.0001). Other baseline characteristics evaluated were not predictors of HF frequency and/or severity. CONCLUSION: In REPLENISH, baseline BMI, smoking, and MENQOL total and vasomotor scores were predictors for moderate to severe HF frequency and/or severity. These characteristics could potentially be used to predict women's HF frequency and severity at menopause.

Oral 17β-estradiol/progesterone (TX-001HR) and quality of life in postmenopausal women with vasomotor symptoms

Objective:The aim of the study was to describe the effects of TX-001HR (17β-estradiol [E2] and natural progesterone [P4] in a single oral capsule) on menopause-specific quality of life in women with moderate to severe vasomotor symptoms (VMS).Methods:The REPLENISH study (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial which evaluated four E2/P4 doses in postmenopausal women with VMS and a uterus. Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were included in a VMS substudy. Participants self-administered the Menopause-Specific Quality of Life (MENQOL) questionnaire. Baseline changes in MENQOL overall and domains were determined as well as correlations between changes in MENQOL scores and VMS frequency or severity.Results:In the VMS substudy, women treated with E2/P4 had significantly greater improvements from baseline in their MENQOL overall score at week 12, and months 6 and 12, compared with placebo (all, P < 0.05, except the lowest E2/P4 dose at months 6 and 12). Improvements from baseline for the MENQOL vasomotor domain score were significantly greater with TX-001HR doses versus placebo at all time points (all, P < 0.01). Changes in MENQOL vasomotor scores moderately correlated with changes in VMS frequency (r = 0.56, P < 0.0001) and severity (r = 0.55, P < 0.0001).Conclusion:In the REPLENISH trial, women with moderate to severe VMS treated with most E2/P4 doses reported significant improvements in quality of life from baseline to 12 weeks compared with placebo, which were maintained up to 12 months. TX-001HR, if approved, may provide the first oral hormone therapy formulation in a single capsule containing E2 and P4 for the treatment of VMS in postmenopausal women with a uterus.

The effect of a randomized 12-week soy drink intervention on everyday mood in postmenopausal women.

Dietary soy may improve menopausal symptoms, and subsequently mediate mood. This novel study examines various doses of dietary soy drink on everyday mood stability and variability in postmenopausal women. Community-dwelling women (n = 101), within 7 years postmenopause, consumed daily either a low (10 mg, n = 35), medium (35 mg, n = 37), or high (60 mg, n = 29) dose of isoflavones, for 12 weeks. Menopausal symptoms and repeated measures of everyday mood (positive [PA] and negative [NA] affect) (assessed at four time points per day for 4 consecutive days, using The Positive and Negative Affect Schedule) were completed at baseline and follow-up. The dietary soy intervention had no effect on everyday mood stability (for PA [F{2,70} = 0.95, P = 0.390] and NA [F{2,70} = 0.72, P = 0.489]) or variability (for PA [F{2,70} = 0.21, P = 0.807] and for NA [F{2,70} = 0.15, P = 0.864]), or on menopausal symptoms (for vasomotor [F{2,89} = 2.83, P = 0.064], psychological [F{2,88} = 0.63, P = 0.535], somatic [F{2,89} = 0.32, P = 0.729], and total menopausal symptoms [F{2,86} = 0.79, P = 0.458]). There were between-group differences with the medium dose reporting higher PA (low, mean 24.2, SD 6; and medium, mean 29.7, SD 6) and the low dose reporting higher NA (P = 0. 048) (low, mean 11.6, SD 2; and high, mean 10.6, SD 1) in mood scores. Psychological (baseline M = 18 and follow-up M = 16.5) and vasomotor (baseline M = 4.2 and follow-up M = 3.6) scores declined from baseline to follow-up for the overall sample. Soy isoflavones had no effect on mood at any of the doses tested. Future research should focus on the menopause transition from peri to postmenopause as there may be a window of vulnerability, with fluctuating hormones and increased symptoms which may affect mood.

Assessment of Quality of Life in Post − Menopausal Women: A Questionnaire Study

Background: Menopausal women may experience vasomotor, urogenital and psychological symptoms as well as sexual dysfunction. These problems are often attributed to hormonal changes during midlife and are projected as health risk. The present study was conducted to assess the quality of life (QOL) and determinants in postmenopausal women. Materials & Methods: The present study was conducted on 140 postmenopausal women age ranged 45- 60 years of age. All women were provided with a pre-designed questionnaire containing 24 questions about quality-of-life in menopause. Scores for vasomotor aspect ranged from 0 to 6, for psychosocial aspect from 0 to 18, for physical aspect from 0 to 42 and for sexual aspects from 0 to 6. Results: 60 women were 50 years. Psychosocial score of 5-15 was observed in 42 women, vasomotor score of 2-5 was seen in, physical score of 24-33 was seen in 12 and sexual score of 2-4 was seen in 32 women. 65 women had more than 5 years of menopause while 75 had less than 5 years. 110 women exercise in the form of brisk walking while 30 do not. In 90 women, relation with husband deteriorated after menopause and 50 women never complained of this. 80 were living with their children while 60 not. 50 women had support from their children while 90 had not. 75 women had good perception of her heath while 65 had average perception. All domain showed significant difference in QOL. Conclusion: Post-menopausal women who fall in a transitional population between the reproductive age group and geriatric population need special attention. Their quality of life is highly determined by physical domain and psychosocial domain

Abstract P6-12-22: Sexual health in long-term breast cancer survivors

Abstract Background Significant sexual dysfunction is reported in women with breast cancer (BC) in the years following diagnosis. It is unclear whether symptoms persist over time in BC survivors (BCS) as long-term data compared to healthy controls is lacking. We compared sexual functioning in long-term BCS to controls and explored the impact of adjuvant therapy on sexual health. Methods A cohort of women with localized BC recruited from 1989 to 1996 was prospectively followed as previously described. BCS without recurrence and controls without BC were contacted between 2005 and 2007 and answered self-reported quality of life questionnaires. Sexual health was measured with the Sexual Activity Questionnaire (SAQ). Vasomotor, gynecological and bladder symptoms were scored using the Menopausal Symptom Scale (scale ranges 0-4) based on the Breast Cancer Prevention Trial Symptom Checklist. Regression analysis was used to compare groups, with and without adjustment for age (quadratic) and menopausal status. P values &amp;lt;0.05 were considered significant. Results 248 of 285 BCS and 159 of 167 controls completed the SAQ. The median time from diagnosis of BCS was 12.5 years. BCS were slightly older (61.9 vs 59.1 years, p=0.0004) and somewhat more likely to be post-menopausal (94.4 vs 85.5%, p=0.0025) than controls. Overall, fewer BCS were sexually active than controls (45.2 vs 59.7%, p=0.0041). This difference was no longer significant when adjusted for age and menopausal status (odds ratio 0.68, p=0.075). In those sexually active, no significant differences were noted on the SAQ Pleasure and Discomfort scales.Differences in adjuvant treatment were not significantly associated with being sexually active or the SAQ subscales. BCS scored higher (worse) on the gynecological and bladder symptom scale than controls (0.66 vs 0.43, p=0.0036, adjusted difference 0.24, p=0.0029; 0.60 vs 0.41, p=0.02, adjusted difference 0.18, p=0.029 respectively), but no difference was seen in vasomotor scores. Gynecological symptom scores were greatest in BCS who received adjuvant chemotherapy. Conclusion Despite more frequent long-term gynecological and bladder symptoms, sexual health is similar in BCS and controls. Adjuvant chemotherapy is associated with persistent gynecological symptoms and interventions aimed at improving these could improve quality of life. Citation Format: Soldera SV, Ennis M, Lohmann AE, Goodwin PJ. Sexual health in long-term breast cancer survivors [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-12-22.

Impact of Menopause on Quality of Life in Community-based Women in China: 1 Year Follow-up

Quality of life (QOL) throughout menopause has become an outcome variable requiring measurement in clinical care. Staff nurses can provide earlier nursing during the menopausal transition (MT) stage. The purpose of this study was to describe the changes of QOL in different stages of the MT according to The Stages of Reproductive Aging Workshop (STRAW) in Chinese women in community settings. Prospective longitudinal study design was used to analyze QOL of 327 community women age 30–65years old. They were followed up at 1-year. An instrument including the Chinese version of the Menopause-Specific Quality of Life Questionnaire was used to obtain data. A gradual decline in QOL was seen from premenopausal to menopausal transition (MT) and in postmenopausal women. Significant differences were observed in vasomotor, physical and sexual scores at baseline and follow-up (P<0.05). Significant differences in vasomotor scores were observed between baseline and follow-up for women in the premenopausal and Late MT stages (P<0.05). There were significant differences in psychosocial and physical scores between baseline and follow-up in the Late MT stage (P<0.05). Menopause might have a negative impact on QOL independent of age in community-based women in China. There seemed to be a potential model of the relationship of menopause status to change in QOL, but this needs supporting evidence from longer longitudinal studies.

Melatonin in perimenopausal and postmenopausal women

Melatonin synthesis and secretion are partly modulated by estrogen and progesterone. Changes in melatonin concentrations, possibly related to the menopausal transition, may be associated with climacteric mood, sleep, and vasomotor symptoms. The aims of this study were to compare the serum concentrations of melatonin in perimenopausal and postmenopausal women and to evaluate melatonin's influence on mood, sleep, vasomotor symptoms, and quality of life. We analyzed the data of 17 healthy perimenopausal women (aged 43-51 y) and 18 healthy postmenopausal women (aged 58-71 y) who participated in a prospective study. On study night (9:00 pm-9:00 am), serum melatonin was sampled at 20-minute (9:00 pm-12:00 midnight; 6:00-9:00 am) and 1-hour (12:00 midnight-6:00 am) intervals. Questionnaires were used to assess depression (Beck Depression Inventory), anxiety (State-Trait Anxiety Inventory), insomnia and sleepiness (Basic Nordic Sleep Questionnaire [BNSQ]), subjective sleep quality, vasomotor symptoms, and quality of life (EuroQoL). Postmenopausal women had lower nighttime serum melatonin concentrations than perimenopausal women. The duration of melatonin secretion tended to be shorter in postmenopause, whereas melatonin peak time did not differ. Mean melatonin concentrations and exposure levels did not correlate with follicle-stimulating hormone level, estradiol level, body mass index, Beck Depression Inventory score, State-Trait Anxiety Inventory score, BNSQ insomnia score, BNSQ sleepiness score, subjective sleep score, climacteric vasomotor score, or quality of life. In perimenopause, the later is the melatonin peak, the higher is the level of anxiety (P = 0.022), and the longer is the melatonin secretion, the better is the quality of life (P < 0.001). Longitudinal research is needed to better understand the possible contributory role of menopause in lower melatonin levels.

A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause

The aim of this study was to conduct a pilot study for the feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) with sham acupuncture (SA) and waiting control (WC) on menopause-related vasomotor symptoms (VMS), quality of life, and the hypothalamic-pituitary-adrenal axis in perimenopausal and postmenopausal women. Thirty-three perimenopausal and postmenopausal women with at least seven VMS daily were randomized to TA, SA, or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, Menopause-Specific Quality of Life Questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24-hour urine cortisol and metabolites, and adrenocorticotropic hormone stimulation testing. Both the TA and SA groups demonstrated improved VMS trends compared with the WC group (Δ -3.5 ± 3.00 vs -4.1 ± 3.79 vs -1.2 ± 2.4, respectively; P = 20) and significantly improved Menopause-Specific Quality of Life Questionnaire vasomotor scores (Δ -1.5 ± 2.02 vs -1.8 ± 1.52 vs -0.3 ± 0.64, respectively; P = 0.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA versus the SA or WC group in total cortisol metabolites (4,658.9 ± 1,670.9 vs 7,735.8 ± 3,747.9 vs 5,166.0 ± 2,234.5, P = 0.03; respectively) and dehydroepiandrosterone (41.4 ± 27.46, 161.2 ± 222.77, and 252.4 ± 385.40, respectively; P = 0.05). The response data on adrenocorticotropic hormone stimulation cortisol also trended in the hypothesized direction (P = 0.17). Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared with WC; however, TA alone may impact the hypothalamic-pituitary-adrenal axis. This association is viewed as preliminary and hypothesis generating and should be explored in a large clinical trial.

Quality of life after the menopause in Iran: a population study

Quality of life (QoL) decreases after the menopause as it has been assessed by several designed tools. The aim of the present research was to assess QoL and determine factors related to its impairment among postmenopausal Iranian women. This cross-sectional study was conducted through cluster sampling among 480 postmenopausal women in Yazd, Islamic Republic of Iran, in 2008. Data were collected using the menopause quality of life questionnaire (MENQOL) by interviewing. Content validity and Cronbach's alpha were used, respectively, to ensure the validity and reliability of the questionnaires. Inferential and descriptive statistics via SPSS.15 software was used for data analysis. The results showed that the menopausal women have worse QoL scores in vasomotor dimension and higher QoL scores in physical dimension. Univariate analysis showed that there were significant differences in the MENQOL scores by age, number of children, education, postmenopausal stage, employment status, and BMI. Women aged 60-65 (P < 0.05), with a university level of education (P < 0.01), who had employment (P < 0.01), who had postmenopausal stage 5 or more years (P < 0.05), with a body mass index <or=18.5 kg m(-2) (P < 0.05), and who had significantly lower scores indicating better quality of life. Logistic regression determined that vasomotor score decreased with age. Employment and number of children decreased the risk of having psychosocial scores above the median. Postmenopausal stage >or=5 increased the risk for higher scores within the sexual domain, respectively. Menopause causes a decrease in quality of life, which is dependent to work and other socio-demographic variables. Therefore, it is necessary to develop effective intervention programs to improve quality of life after menopause.

Changes in circulating cytokine levels in midlife women with psychological symptoms with selective serotonin reuptake inhibitor and Japanese traditional medicine

Objective The aim of the present study was to compare the effects on serum cytokine concentrations of paroxetine, a selective serotonin re-uptake inhibitor, and kamishoyosan, a Japanese traditional medicine, in midlife women with psychological symptoms. Methods Seventy-six women with psychological symptoms such as anxiety and mild depression as menopausal symptoms were enrolled in this study. Thirty-eight women received oral administration of 10 mg paroxetine every day, and 38 women received oral administration of kamshoyosan every day for 6 months. Overall climacteric symptoms were assessed using Greene's climacteric scale. Serum levels of cytokines were measured using a multiplexed human cytokine assay. Results Greene's total scores in both women treated with paroxetine and in women treated with kamishoyosan decreased significantly. Percentage decreases in Greene's total, psychological and vasomotor scores during the 6-month period in the paroxetine group were significantly greater than those in the kamishoyosan group. Serum IL-6 concentration in women treated with paroxetine decreased significantly. Serum concentrations of IL-8, IL-10, macrophage inflammatory protein (MIP)-1β and monocyte chemoattractant protein-1 in women treated with paroxetine decreased significantly. On the other hand, serum IL-6 concentration in women treated with kamishoyosan decreased significantly, but other serum concentrations did not change significantly. Conclusion Decrease in IL-6 concentration may be involved in the mechanism of the actions of both paroxetine and kamishoyosan in women with psychological symptoms, and IL-6 may therefore be useful as a marker of treatment. The action of paroxetine may also be associated with decreases in IL-8, IL-10, MIP-1β.

Gabapentin for the treatment of menopausal hot flashes

To compare the effectiveness and tolerability of gabapentin with placebo for the treatment of hot flashes in women who enter menopause naturally. A randomized, double-blind, placebo-controlled trial was conducted across the greater Toronto area between March 2004 and April 2006 in the community and primary care settings. Eligible participants were 200 women in natural menopause, aged 45 to 65 years, having at least 14 hot flashes per week. Study participants were randomized to receive gabapentin 300 mg oral capsules or placebo three times daily for 4 weeks. The primary outcome measure was the mean percentage change from baseline to week 4 in daily hot flash score, determined from participant diaries. Secondary outcome measures included changes in weekly mean hot flash scores and frequencies, quality of life, and adverse events. Of the 197 participants, 193 (98%) completed the study. Analysis was by intention to treat. Hot flash scores decreased by 51% (95% CI: 43%-58%) in the gabapentin group, compared with 26% (95% CI: 18%-35%) on placebo, from baseline to week 4. This twofold improvement was statistically significant (P < 0.001). The Menopause-Specific Quality-of-Life vasomotor score decreased by 1.7 (95% CI: 1.3-2.1; P < 0.001) in the gabapentin group. These women reported greater dizziness (18%), unsteadiness (14%), and drowsiness (12%) at week 1 compared with those taking placebo; however, these symptoms improved by week 2 and returned to baseline levels by week 4. Gabapentin at 900 mg/day is an effective and well-tolerated treatment for hot flashes.

Treatment of menopausal symptoms by qualified herbal practitioners: a prospective, randomized controlled trial

To assess the effectiveness of professional herbal practice in the treatment of menopausal symptoms. To generate pilot data for future sample size calculations. A pilot prospective, randomized, waiting list controlled trial was conducted in primary care at one urban UK GP practice. Participants were 45 women aged 46-59, experiencing self-defined menopausal symptoms and no menstrual bleeding for 3 months. Exclusion criteria included use of hormone replacement therapy. Participants were block randomized into a treatment group (n = 15) who received a course of individualized treatment from one of three herbal practitioners, and control group (n = 30) offered treatment after waiting 4 months. Treatment was six consultations over 5 months including discussion of nutrition, lifestyle and individualized herbal prescription. Change in menopausal symptoms was measured in both groups using the validated Greene Climacteric Scale. Measure Yourself Medical Outcome Profile recorded changes in self-defined most troublesome symptoms. Forty-four participants completed the study. The treatment group demonstrated a statistically and clinically significant reduction in menopausal symptoms compared to the control group. Total scores for menopausal symptoms reduced for both groups. Reduction for the treated group was 9.05 points greater than that for the control group, CI 5.08-13.03, as were changes in vasomotor scores (mean 1.81, CI 1.00-2.62). Libido increased (mean 0.69, CI 0.38-0.99) in the group receiving herbal treatment. The treatment package from herbal practitioners improved menopausal symptoms, particularly hot flushes and low libido. This offers evidence to support herbal medicine as a treatment choice during the menopause.

The Association between Soy Nut Consumption and Decreased Menopausal Symptoms

Epidemiological studies suggest a low incidence of hot flashes in populations that consume dietary soy. The present study examined the effect of soy nuts on hot flashes and menopausal symptoms. Sixty healthy postmenopausal women were randomized in a crossover design to a therapeutic lifestyle changes (TLC) diet alone and a TLC diet of similar energy, fat, and protein content in which one-half cup soy nuts divided into three or four portions spaced throughout the day (containing 25 g soy protein and 101 mg aglycone isoflavones) replaced 25 g of nonsoy protein. During each 8-week diet period, subjects recorded the number of hot flashes and amount of exercise daily. At the end of each 8-week diet period, subjects filled out the menopausal symptom quality of life questionnaire. Compared to the TLC diet alone, the TLC diet plus soy nuts was associated with a 45% decrease in hot flashes (7.5 +/- 3.6 vs. 4.1 +/- 2.6 hot flashes day, respectively, p < 0.001) in women with >4.5 hot flashes/day at baseline and 41% in those with <or=4.5 hot flashes/day (2.2 +/- 1.2 vs. 1.3 +/- 1.1, respectively, p < 0.001). Soy nut intake was also associated with significant improvement in scores on the menopausal symptom quality of life questionnaire: 19% decrease in vasomotor score (p = 0.004), 12.9% reduction in psychosocial score (p = 0.01), 9.7% decrease in physical score (p = 0.045), and a trend toward improvement in the sexual score, with a 17.7% reduction in symptoms (p = 0.129). The amount of exercise had no effect on hot flash reduction. Substituting soy nuts for nonsoy protein in a TLC diet and consumed three or four times throughout the day is associated with a decrease in hot flashes and improvement in menopausal symptoms.

Quality of life among postmenopausal Ecuadorian women participating in a metabolic syndrome screening program

Background Quality of life decreases after the menopause as it has been assessed by several designed tools. Despite this, few studies have reported correlations between quality of life and the metabolic syndrome and its determinants. Objective Evaluate quality of life and determine factors related to its impairment among postmenopausal Ecuadorian women. Methods Postmenopausal women that participated in a metabolic syndrome screening and educational program at the Institute of Biomedicine of the Universidad Católica of Guayaquil, Ecuador were interviewed using the Menopause-Specific Quality of Life Questionnaire (MENQOL). Mean domain scores as well as factors associated to higher scores within each of the domains of the questionnaire (vasomotor, psycho-social, physical and sexual) were determined. Results Three hundred twenty-five postmenopausal women ( n = 325) were surveyed. Mean age of participants was 55.9 ± 8.1 years (median: 54 years). Women presented metabolic syndrome, hypertension, hyperglycemia, hypertriglyceridemia and abdominal obesity in 41.5%, 38.8%, 16.6%, 56.9% and 54.2% respectively. Mean scores obtained for each domain were: vasomotor: 3.5 ± 2.5 (median 3); psycho-social: 3.7 ± 1.5 (median 3.6); physical: 3.8 ± 1.2 (median 3.8); sexual: 4.9 ± 2.3 (median 5.3). More than 50% of women had scores above the median for each domain of the questionnaire. Logistic regression determined that vasomotor score decreased with age. Abdominal obesity increased the risk of having vasomotor, psycho-social and physical scores above the median. Hypertension and hyperglycemia increased the risk for higher scores within the psycho-social and sexual domain respectively. Conclusion In this postmenopausal Ecuadorian population, impairment of quality of life was found to be associated to age and related conditions such as abdominal obesity, hypertension and hyperglycemia.

Duration not severity of the climacteric syndrome predicts resumption of hormone therapy after discontinuation: a prospective cohort study

Predictive factors of women who are unable to quit prolonged hormonal therapy (HT) are largely unknown. We sought to identify predictors for the resumption of HT after the discontinuation of treatment. A cohort prospective study was conducted allocating menopausal women treated with HT for over 3 years. Menopausal symptoms were monitored periodically after HT cessation by the Greene climacteric scale. Eighty-two women participated in the study. Age, the age of menopause, BMI, HT duration, the type of regimen, reasons cited to discontinue HT and the method of discontinuation did not differ between the subjects who successfully discontinued HT and those who failed to quit HT. Only the prevalence of vasomotor symptoms when HT was first prescribed significantly differed between the groups (P = 0.03). Comparable maximal Greene score was recorded in both groups. Over time, the subjects who returned to HT had higher Greene score [Hazard ratio 1.25, confidence interval (CI) 95% (1-1.07)] and significantly higher vasomotor score [Hazard score 1.22, CI 95% (1.02-1.46)]. The history of hot flashes and the duration of menopausal symptoms upon HT discontinuation predict the resumption of HT. Thus, the return to HT is expected in individuals who are intolerant of prolonged climacteric syndrome.

Effects of low-dose, continuous combined hormone replacement therapy on sleep in symptomatic postmenopausal women

Sleep disturbances in peri- and postmenopausal women may result from hormonal changes, vasomotor symptoms, and possibly psychological factors. Hormone replacement therapy (HRT) seems to diminish the disruption of sleep in climacteric women. The aim of this study was to determine the effects of a low dose of conjugated equine estrogens (CE) in combination with different progestins (LD-HRT) and evaluate differences between regimens on sleep in symptomatic postmenopausal women. Postmenopausal women were recruited and assigned to calcium–vitamin (control group) or to LD-HRT with 0.3 mg of CE associated with a daily administration at bedtime of a progestin (2.5 mg MPA, CE + MPA, n = 20), or 100 mg natural micronized progesterone (CE + P, n = 20). Subjective symptoms were evaluated by the Greene climacteric scale, and by a visuoanalogic graduated scale (0–10) at baseline and after 4, 8, and 12 weeks of study. Greene’s scores for the control group were similar to those in LD-HRT group at baseline, and showed no significant modification at all subsequent measurements. Conversely, in LD-HRT group, a significant ( P < 0.05) reduction in the scores of all Greene’s domains was evident versus corresponding baseline and control group values. Conversely, in LD-HRT group, a significant ( P < 0.05) reduction in the scores of all Greene’s domains was evident with no difference in the scores of the two treated group. Both CE + MPA and CE + P significantly ( P = 0.05) reduced the HF and sleep visuanalogic score in comparison to the control group. The score of sleep was significantly ( P = 0.05) lower in the CE + P group in comparison to that measured in the CE + MPA group. No significant correlation between sleep and vasomotor score was found. In conclusion, low estrogen dose may have a value in the treatment of menopausal women in which sleep disturbances may be a symptom of estrogen deprivation. Low-dose estrogen associated with low-dose micronized progesterone may especially benefit women who complain of disturbed sleep.