Severity Of Hot Flashes Research Articles

MON-418 Symptomatic Pituitary Metastasis: Two Case Reports with Contrasting Clinical Presentations

Introduction: Pituitary metastases (PM) are a rare occurrence with a poor prognosis. The most common cancers to metastasize to the pituitary are breast and lung. Most PMs are asymptomatic, but when symptoms occur the most commonly reported presentation is central DI. Clinical Cases: Case 1. An 86 year old male presented to the hospital with progressive weakness, fatigue and low appetite. He had a history of widely metastatic papillary thyroid cancer treated with thyroidectomy, repeated doses of RAI and repeated neck dissections. Most recent TG was 27,405 ng/mL (nl 2.8-40.9). An 8AM cortisol was checked and found to be low at 0.8 mcg/dL (nl 10-20). Further hormonal workup showed low ACTH, TSH <0.01uIU/mL (nl 0.3-5), FT4 1.43 ng/dL (nl 0.76-1.46) while on LT4, prolactin 38.94ng/mL (nl 2.1-17.7), low LH and FSH consistent with panhypopituitarism. Pituitary MRI showed an infiltrative process enlarging the pituitary gland, with extension into the stalk and hypothalamus concerning for metastatic disease. He was started on steroid replacement. He underwent systemic tyrosine kinase inhibitor therapy as well as pituitary radiation, but unfortunately, he died 7 months after presenting with central AI. Case 2. A 56 year old male was referred to endocrine clinic for polydipsia, polyuria and nocturia. Initial labs showed normal glucose, Na 145 mmol/L (nl 136-145), serum Osm 299mOsm/kg (nl 276-305), and urine Osm 92mOsm/kg (nl 500-800). Water deprivation test confirmed central DI. Further labs showed intact anterior pituitary function. Pituitary MRI showed an infiltrative process in the pituitary gland, affecting stalk and hypothalamus concerning for metastatic disease. Imaging was obtained and showed masses in the lung, kidney, spine, and mediastinal lymph nodes. The patient had a remote history of colon cancer and underwent biopsy of the lymph and renal masses, both showing metastatic colorectal cancer. He was started on DDAVP and symptoms improved. Three weeks later he presented with severe fatigue, dizziness, and hot flashes. Workup showed panhypopituitarism. Repeat MRI showed interval growth of the pituitary lesion. He underwent pituitary radiation and chemotherapy. He did not tolerate the side effects of systemic therapy and enrolled in hospice care. Conclusions: The most commonly reported symptomatic presentation of PM is central DI, however the reported incidence of anterior pituitary dysfunction is rising and clinicians should be aware. Pituitary metastases should remain on the differential in any case of anterior or posterior pituitary dysfunction, particularly in patients with any history of malignancy.

PT119 - A phase 2, dose finding, placebo-controlled, study of zuclomiphene citrate to alleviate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer

PT119 - A phase 2, dose finding, placebo-controlled, study of zuclomiphene citrate to alleviate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer

A phase II, dose finding, placebo-controlled, study of zuclomiphene citrate to amerliorate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer.

TPS338 Background: Androgen deprivation therapy (ADT) is the mainstay of treatment for advanced prostate cancer. ADT not only lowers testosterone, but also decreases estrogen levels which can cause significant side effects including hot flashes, loss of bone and bone fractures, and decreases in libido. Up to 80% of the men on ADT report hot flashes and 30-40% of men have moderate to severe hot flashes. Concern over hot flashes make patients less likely to begin ADT and can lead to early discontinuation of ADT. While the off-label use of potent steroidal estrogens has demonstrated efficacy, the appropriate dose as well as dosing route or schedule of these potent estrogens, has not been established. Furthermore, the potential for safety issues with potent steroidal estrogens remains a significant limitation to their clinical utility. Zuclomiphene citrate, is novel weak nonsteroidal estrogenic agent that should ameliorate hot flashes caused by ADT, and as one of the isomers of clomiphene, has a 50 year safety history of being well tolerated in men. Methods: The Phase 2, placebo controlled, dose finding clinical trial (V72203) evaluating zuclomiphene citrate (VERU-944) capsules, oral daily dosing, for the treatment of moderate to severe hot flashes in men with prostate cancer on ADT is in progress. Men are randomized to daily doses of placebo or zuclomiphene 10mg, 50mg or 100mg. V72203 is enrolling approximately 36 men per arm in 10 sites in the United States. The primary efficacy endpoint is the mean change in frequency of moderate and/or severe hot flashes from baseline to week 4 and maintained until week 12. Secondary endpoints include changes from baseline in bone turnover markers, free and total testosterone, SHBG, PSA, and safety. Hot flashes are being measured in real time utilizing an electronic data capture device (ePRO) provided to each subject. We anticipate completion of enrollment by the end of 2018 with study results by second quarter of 2019. Clinical trial information: NCT03646162.

Abstract P1-11-16: Efficacy and safety of acupuncture for the hot flashes in breast cancer patients taking adjuvant tamoxifen: A multicenter study in Korean women

Abstract Background : Tamoxifen is widely used in premenopausal patients with estrogen receptor positive (ER+) breast cancer. Among the side-effects of tamoxifen, hot flashes is a common and challenging one. Previous pilot study suggested the effectiveness of acupuncture for relief of symptoms. This study was performed to evaluate the efficacy and safety of acupuncture for treatment of hot flashes in Korean women breast cancer patients taking tamoxifen as adjuvant endocrine therapy. Methods : Thirty(30) breast cancer patients taking tamoxifen and reported moderate to severe hot flashes were enrolled from two institutes. Patients were randomly assigned into acupuncture group(n=15) and control group(n=15). The acupuncture group received acupuncture 3 times a week for 4 consecutive weeks, at 5 predefined points(GV 20, M-HN-3, HT 8, KI 10 and LV 2) for 20 ± 5minutes at each session. Control group received no treatment. The score of hot flash visual analogue scale(VAS) and total hot flash score, EORTC QLQ-C30 and QLQ-BR 23 questionnaire were recorded before treatment, once every treatment week and 4 weeks after treatment for both groups. Results : Acupuncture group showed significantly reduced severity of hot flashes during treatment assessed with either VAS and total hot flash score (p=0.000 and p=0.008, respectively). Also, acupuncture group showed improvement of global health status and physical functioning score assessed with EORTC QLQ-C30 (p=0.004 and p=0.027, respectively). Four weeks after the treatment, these trends were retained. No adverse events were notified Conclusion : Acupuncture may have feasibility and safety for alleviate hot flashes of Korean women breast cancer patients taking tamoxifen as an adjuvant endocrine therapy. Long-term follow up results and further study with a larger sample size is required. Citation Format: Choi H, Jeong Y-j, Park S-H, Kwak M-A, Kim K-S, Lee Y, Park S. Efficacy and safety of acupuncture for the hot flashes in breast cancer patients taking adjuvant tamoxifen: A multicenter study in Korean women [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-16.

Health Characteristics Associated With Hot Flashes in Women With HIV During Menopause: An Integrative Review.

Hot flashes (HFs) are a prominent symptom of menopause known to unfavorably influence mood, sleep, and quality of life. More women living with HIV are entering menopause and may experience a greater prevalence of HFs and more severe HFs compared with uninfected women. This integrative review evaluated existing evidence on potential health characteristics associated with HFs in women living with HIV during menopause. A search strategy was conducted within 6 databases. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guided the review, and the Johns Hopkins Nursing Evidence-Based Practice model was used to evaluate methodological quality and appraisal of the evidence. Five articles met the review eligibility criteria. Three content categories emerged from the key findings of the 5 articles: HIV-specific characteristics, mental health and cognitive characteristics, and quality of life and social characteristics. Implications for research and clinical care were identified.

Equol Decreases Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Soy isoflavones may benefit some, but not all, menopausal women, and the ability of the women to produce equol may be the major determinant of effectiveness. We assessed the efficacy of soy isoflavones and equol for alleviating menopausal symptoms, especially vasomotor symptoms, in postmenopausal women who were equol producers and nonproducers by using systematic review and meta-analysis of randomized clinical trials (RCTs). We searched 12 English, Korean, and Chinese language scientific and medical databases. We selected all available RCTs that assessed the effect of equol, either equol itself or soy isoflavone in equol producers, on menopausal symptoms in peri- or postmenopausal women. The primary outcome was the effect on hot flashes. The severity of hot flashes was determined by the scores, and sensitivity and risk of bias analyses were conducted. Other outcomes of the review, but not meta-analysis, included depression and adverse events. Six studies (779 total subjects) met all criteria for the systematic review, 5 of those could be included in the meta-analysis (728 total subjects). Two studies included in the meta-analysis reported no statistically significant benefits of equol; the other three did report significant benefits of equol. Meta-analysis revealed a significant benefit of equol for lowering hot flash scores and revealed a generally low risk of bias. In conclusion, this study found that supplementing equol to equol nonproducers significantly lowered the incidence and/or severity of hot flashes in menopausal women.

Effect of Vitamin E Supplementation on Plasma Nitric Oxide in Menopausal Women with Hot Flashes: A Cross-Over, Randomized Clinical Trial

Background: Vitamin E serves a major role in increasing nitric oxide (NO) and reducing lipoperoxidation progression during the menopause transition. Objectives: This study aimed to determine the effect of Vitamin E on plasma nitric oxide in menopausal women with hot flashes (HFs). Methods: In this double-blind, randomized, cross-over clinical trial performed in a teaching hospital, 83 eligible menopausal women with HFs were randomly block allocated to Vitamin E (n = 42) and placebo (n = 41) groups. In phase I of the intervention, they were administered 400 IU per day of Vitamin E or placebo for 4- weeks. In the phase II, the group receiving Vitamin E was subsequently given placebo and vice versa after wash-out. Primary outcomes were the number and severity of hot flashes per day as determined by the recorded values by the women and using Modified Kupperman Index, respectively. The secondary outcome was plasma nitric oxide measured before and after the intervention in the two phases. Both outcomes were analyzed within and between placebo-vitamin E (P-E) and Vitamin E-placebo (E-P) groups, and in general by gathering Vitamin E and placebo groups in the two phases, separately. Data were analyzed using the Chi-Square test, independent t-test, Wilcoxon test, Mann-Whitney test, and Spearman’s correlation coefficient. Results: The mean number of HFs indicated a significant decreasing trend from week II of the phase I to the end of the phase II within P-E and E-P groups compared to before the intervention. Median (interquartile range [IQR]) of HFs number changes was 2.03 (2.57) in the P-E group and 1.21 (2.21) in the E-P group at the end of the first week of phase II (P = 0.043). There was a very low significant positive correlation between changes in HFs and plasma nitric oxide level in weeks I (r = 0.262, P = 0.029) and ΙΙ (r = 0.256, P = 0.034) in the Vitamin E group. Conclusions: Vitamin E and placebo were both effective in reducing HFs in menopausal women. It seems that the subjective effect of placebo contributed to this decline. Vitamin E had no effect on reducing HFs via increasing plasma level of nitric oxide. These results were not in line with our hypothesis. Further research is needed to understand this issue.

Psychometric properties of the Menopause Specific Quality of Life questionnaire among Thai women with a history of breast cancer

This study evaluated the psychometric properties of the Thai Menopause Specific Quality of Life Questionnaire (MENQOL) instrument in menopausal Thai women with a history of breast cancer. Two hundred and ninety women with a history of breast cancer who reported hot flashes completed the Thai MENQOL. Internal consistency reliability and item analysis were used to evaluate the reliability of the Thai MENQOL. Construct validity was evaluated by examining the correlations between the self-reported hot flash frequency and severity with the vasomotor MENQOL subscale (convergent validity); and assessed using exploratory factor analysis (structural validity). The Cronbach's alpha coefficient for the MENQOL total scale was 0.86 and for the vasomotor, psychosocial, physical, sexual domains were 0.73, 0.78, 0.81, and 0.83, respectively. Self-reported frequency and severity of hot flashes were correlated significantly with the vasomotor subscale (r's ≥ 0.50, p's < 0.001). The single item "increased facial hair" was poorly correlated with most items (r = 0.13). Confirmatory factor analysis supported four factors explaining 42.35% of the total variance. Item-domain correlation analysis showed that all items correlated more strongly with their own domains than with other domains. The Thai version of the MENQOL demonstrates good psychometric properties (internal consistency reliability, convergent validity, and structural validity). We recommend removal of the single item, "increased facial hair" from the Thai version due to low correlations with most items. The Thai MENQOL can be used to measure menopause-related quality of life in Thai women with a history of breast cancer experiencing menopausal symptoms.

Neurokinin 3 receptor antagonism rapidly improves vasomotor symptoms with sustained duration of action.

Objective:Seventy percent of postmenopausal women experience vasomotor symptoms, which can be highly disruptive and persist for years. Hormone therapy and other treatments have variable efficacy and/or side effects. Neurokinin B signaling increases in response to estrogen deficiency and has been implicated in hot flash (HF) etiology. We recently reported that a neurokinin 3 receptor (NK3R) antagonist reduces HF in postmenopausal women after 4 weeks of treatment. In this article we report novel data from that study, which shows the detailed time course of this effect.Methods:Randomized, double-blind, placebo-controlled, single-center, crossover trial of an oral NK3R antagonist (MLE4901) for vasomotor symptoms in women aged 40 to 62 years, experiencing ≥7 HF/24 hours some of which were reported as bothersome or severe (Clinicaltrials.gov NCT02668185). Thirty-seven women were randomized and included in an intention-to-treat analysis. To ascertain the therapeutic profile of MLE4901, a post hoc time course analysis was completed.Results:By day 3 of treatment with MLE4901, HF frequency reduced by 72% (95% CI, −81.3 to −63.3%) compared with baseline (51 percentage point reduction compared with placebo, P < 0.0001); this effect size persisted throughout the 4-week dosing period. HF severity reduced by 38% compared with baseline by day 3 (95% CI, −46.1 to −29.1%) (P < 0.0001 compared with placebo), bother by 39% (95% CI, −47.5 to −30.1%) (P < 0.0001 compared with placebo), and interference by 61% (95% CI, −79.1 to −43.0%) (P = 0.0006 compared with placebo); all continued to improve throughout the 4-week dosing period (to −44%, −50%, and −70%, respectively by day 28, all P < 0.0001 compared with placebo).Conclusions:NK3R antagonism rapidly relieves vasomotor symptoms without the need for estrogen exposure.

CYP2D6 genotype and endoxifen plasma concentration do not predict hot flash severity during tamoxifen therapy.

Tamoxifen is frequently prescribed to prevent breast cancer recurrence. Tamoxifen is a prodrug and requires bioactivation by CYP2D6. Tamoxifen use is often limited by adverse effects including severe hot flashes. There is paucity of prospectively collected data in terms of CYP2D6 genotype and measured tamoxifen, 4-hydroxytamoxifen and endoxifen concentrations in relation to hot flash severity during tamoxifen therapy. We conducted a longitudinal prospective study of breast cancer patients on tamoxifen (n = 410). At each visit, blood samples were collected, and patients completed a standardized hot flash survey (n = 1144) that reflected hot flash severity during the 7 days prior to the visit. Plasma concentrations of tamoxifen, 4-hydroxytamoxifen, and endoxifen were measured using liquid chromatography-tandem mass spectrometry and genotyping was carried out for CYP2D6. A linear mixed-effects regression analysis assessed the association of covariates in relation to the hot flash severity score (HFSS). Median age at first assessment was 50years with 61.9% of patients considered peri-menopausal. Most patients (92.2%) experienced hot flash symptoms with 51.0% having low HFSS (0-4) and 7.32% experiencing HFSS > 25. Age was significantly associated with hot flash severity, with patients aged 45-59 more likely to have higher HFSS. Neither duration of tamoxifen therapy nor observed tamoxifen, endoxifen and 4-hydroxy tamoxifen plasma concentration predicted hot flash severity. Genetic variation in CYP2D6 or CYP3A4 was not predictive of hot flash severity. Hot flash severity during tamoxifen therapy can not be accounted for by CYP2D6 genotype or observed plasma concentration of tamoxifen, 4-hydroxytamoxifen, or endoxifen.

Abstract 948: Preventing estrogen receptor alpha-positive breast cancer outgrowth with the use of hormone replacement therapy

Abstract Menopause occurs in all women, usually between the ages of 45 and 55. As a result of menopause, women often experience undesirable vasomotor symptoms, which can be alleviated by hormone replacement therapy (HRT). The Women's Health Initiative (WHI) trial concluded that PremPro, a HRT formulation that combines conjugated equine estrogens (CE) with medroxyprogesterone acetate, increases the risk of breast cancer. Over the years, the number of women taking HRT has dramatically decreased due to the perceived risk based largely on the results of the WHI trial. Follow-up sudies suggest that breast cancer cases from PremPro treatment were primarily due to the outgrowth of occult tumors, not the formation of new disease. Duavee, a more recent form of HRT that combines CE and bazedoxifene (BZA), a selective estrogen receptor modulator (SERM) and degrader (SERD), has been approved by the FDA for treatment of moderate to severe hot flashes and to reduce the risk of osteoporosis. More importantly, this CE+BZA mixture not only relieves symptoms associated with menopause, but it also does not stimulate the breast or uterus. Several preclinical studies suggest that CE+BZA might be protective in the breast, however the mechanism of action of this new combination therapy is not known. Our goal, therefore, is to elucidate the underlying molecular mechanisms by which CE+BZA differentially affects estrogen receptor alpha (ERα) action in the mammary gland, using transcriptome and whole genome occupancy analysis in breast cancer cell lines. RNA-Seq and ChIP-Seq studies suggest that CE+BZA decreases pathways related to S-phase entry, cell cycle regulation and BRCA1. We are also studying the effects of CE+BZA on early mammary cancer progression in the estrogen-sensitive polyoma middle T antigen (PyMT) transgenic mouse model and have observed that treatment with CE+BZA delayed the onset of tumors and decreased their rate of growth. Mice treated with CE+BZA also survived longer. In addition, CE+BZA was able to decrease the rate of tumor growth in an ERα-positive patient-derived xenograft (PDX) mouse model. An improved understanding of the molecular mechanisms of CE+BZA action in hormone sensitive breast cancer cell and animal models should have important implications for women considering HRT. Citation Format: Anna G. Dembo, Emily S. Aledort, Geoffrey L. Greene. Preventing estrogen receptor alpha-positive breast cancer outgrowth with the use of hormone replacement therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 948.

Association between HIV status and psychological symptoms in perimenopausal women.

HIV-infected women are burdened by depression and anxiety, which may impact adherence to antiretroviral therapy and overall quality of life. Yet, little is known about the scope of psychological symptoms in the growing number of HIV-infected women reaching menopause, when affective symptoms are more prevalent in the general population. We conducted a longitudinal study to compare affective symptoms between perimenopausal HIV-infected and non-HIV-infected women. The Center for Epidemiologic Studies Depression Scale (CES-D), and the Generalized Anxiety Disorder scale (GAD-7) were completed at baseline and 12 months among 33 HIV-infected and 33 non-HIV-infected perimenopausal women matched by race, age, menstrual patterns, and BMI. Linear regression models estimated the relationship of baseline GAD-7 and CES-D scores with clinical factors. All women were perimenopausal at baseline, and the vast majority remained perimenopausal throughout follow-up. HIV status was associated with higher baseline CES-D scores (median [interquartile range] 21 [12, 29] vs 10 [5, 14]; P = 0.03) and GAD-7 scores (7 [5, 15] vs 2 [1, 7]; P = 0.01), controlling for smoking, substance use, and antidepressant use. Depressive symptoms and anxiety remained significantly higher in the HIV-infected women at 12 months (P ≤ 0.01). Significant relationships of depressive symptoms (P = 0.048) and anxiety (P = 0.02) with hot flash severity were also observed. Perimenopausal HIV-infected women experienced a disproportionately high level of affective symptom burden over a 12-month observation period. Given the potential for these factors to influence adherence to HIV clinical care and quality of life, careful assessment and referral for treatment of these symptoms is essential.

What's in a name: are menopausal "hot flashes" a symptom of menopause or a manifestation of neurovascular dysregulation?

Hot flashes have typically been classified as "symptoms of menopause" that should be tolerated or treated until they resolve. However, mounting evidence points to hot flashes as a manifestation of one or several underlying pathophysiological processes. Associations exist between the presence, timing of onset, severity, and duration of hot flashes, and the risk of several neurological (affecting sleep, mood, and cognition) and cardiovascular conditions. In addition, four consistent patterns of vasomotor disturbances have been identified across different countries, making it unlikely that these patterns are solely explained by socioeconomic or cultural factors. The changing hormonal environment of menopause may unmask differences in the autonomic neurovascular control mechanisms that put an individual woman at risk for chronic conditions of aging. These differences may have a genetic basis or may be acquired across the life span and are consistent with the variability of the clinical manifestations of aging observed in women after bilateral oophorectomy. It is time to investigate the pathophysiological mechanisms underlying the four patterns of vasomotor symptoms more closely, and to shift from describing hot flashes as symptoms to be tolerated to manifestations of an underlying autonomic neurovascular dysregulation that need to be addressed.

Understanding the complex relationships underlying hot flashes: a Bayesian network approach.

The mechanism underlying hot flashes is not well-understood, primarily because of complex relationships between and among hot flashes and their risk factors. We explored those relationships using a Bayesian network approach based on a 2006 to 2015 cohort study of hot flashes among 776 female residents, 45 to 54 years old, in the Baltimore area. Bayesian networks were fit for each outcome (current hot flashes, hot flashes before the end of the study, hot flash severity, hot flash frequency, and age at first hot flashes) separately and together with a list of risk factors (estrogen, progesterone, testosterone, body mass index and obesity, race, income level, education level, smoking history, drinking history, and activity level). Each fitting was conducted separately on all women and only perimenopausal women, at enrollment and 4 years after enrollment. Hormone levels, almost always interrelated, were the most common variable linked to hot flashes; hormone levels were sometimes related to body mass index, but were not directly related to any other risk factors. Smoking was also frequently associated with increased likelihood of severe symptoms, but not through an antiestrogenic pathway. The age at first hot flashes was related only to race. All other factors were either not related to outcomes or were mediated entirely by race, hormone levels, or smoking. These models can serve as a guide for design of studies into the causal network underlying hot flashes.

Polymorphisms in Estrogen Synthesis Genes and Symptom Clusters During the Menopausal Transition and Early Postmenopause: Observations From the Seattle Midlife Women's Health Study.

During the menopausal transition and early postmenopause, participants in the Seattle Midlife Women's Health Study (SMWHS) experienced one of the three symptom severity clusters identified through latent class analysis: severe hot flashes with moderate sleep, mood, cognitive, and pain symptoms (high-severity hot flash); low-severity hot flashes with moderate levels of all other symptom groups (moderate severity); and low levels of all symptom groups (low severity). In an effort to determine whether gene polymorphisms were associated with these symptom severity classes, we tested associations between gene polymorphisms in the estrogen synthesis pathways (cytochrome P450 19 [CYP 19] and 17 beta hydroxysteroid dehydrogenase [ 17HSDB1]) and the three symptom severity clusters. SMWHS participants ( N = 137) recorded symptoms monthly in diaries and provided buccal smears for genotyping. Multilevel latent class analysis with multinomial regression was used to determine associations between gene polymorphisms and symptom severity clusters. Only the 17HSDB1 polymorphisms ( rs615942 and rs592389) were associated significantly with the high-severity hot flash cluster versus the low-severity symptom cluster. None of the polymorphisms was associated with the moderate-severity cluster versus the low-severity symptom cluster. Findings of associations of the 17HSDB1 polymorphisms with the high-severity hot flash symptom cluster are consistent with those of an association between 17HSDB1 polymorphisms and hot flashes in the Study of Women and Health Across the Nation population and our previous findings of associations between these polymorphisms with greater estrone levels.

A comparative study on the effect of “black cohosh” and “evening primrose oil” on menopausal hot flashes

INTRODUCTION:Hot flashes are considered to be a common experience for menopausal women and they can compromise the quality of life. The objective of this study is to assess the efficacy of Cimicifuga racemosa in comparison with evening primrose oil (EPO) in postmenopausal women with menopause-related symptoms.MATERIALS AND METHODS:This study was performed on 80 postmenopausal women with hot flashes. The participants were randomly divided into two groups by blocked randomization. The participants of one group received black cohosh and the other group received EPO for 8 weeks. The severity and number of hot flashes and quality of life were measured by four-point scale, and the Menopause-Specific Quality of Life (MENQOL) questionnaire at pre-intervention, 1st, 4th, and 8th weeks after treatment. Data were analyzed in SPSS Version 16 using independent t-test, Chi-square, and Fisher's exact test.RESULTS:Average severity of hot flashes in both groups and number of hot flashes in black cohosh group in 8th week were significantly lower than 1st week (P < 0.001), but number of hot flashes in primrose oil group in 8th week showed no significant differences (P = 0.32). The number of hot flashes and quality of life score in black cohosh arm compared to EPO showed a significant decrease in the 8th week (P < 0.05). All MENQOL scores were significantly improved in two groups (P < 0.05), but the percentage of improvement in black cohosh arm was significantly superior to EPO group.CONCLUSION:Both herbs were effective in reduction of severity of hot flashes and improvement of the quality of life, but it seems that black cohosh is more effective than primrose oil because it was able to reduce the number of hot flashes too.

The effect of herbal tea capsule on menopause hot flashes.

Background:Menopause, during which women experience many problems, including hot flashes, is a natural stage in the life of women. One of the duties of midwives is the promotion of women's health during menopause. Herbal remedies are well received and accepted by the community. This study was conducted to determine the effect of herbal tea capsule on hot flashes during menopause.Methods:The present randomized, clinical trial study was conducted on 82 women who complained of hot flashes during their menopause period. The samples were randomly divided into two groups, each including 41 subjects. One group received 450 mg of herbal extracts daily and the other group received starch gelatin capsules daily for 8 weeks. The capsules were similar in appearance. After the intervention, the mean hot flash score was determined using the registration form of the severity, duration, and number of hot flashes before, 4, and 8 weeks after the intervention. Statistical analysis of collected data was conducted using t-test, Chi-square, Friedman, Wilcoxon, and Mann–Whitney tests.Results:The mean score of hot flashes, in the placebo group, was 0.62 ± 0.63 before intervention, 4.24 ± 3.26 four weeks after intervention, and 4.42 ± 1.93 eight weeks after intervention; in the herbal tea group, this rate turned out to be 1.65 ± 1.42 before intervention, 3.8 ± 1.36 four weeks after intervention, and 1.74 ± 4.88 eight weeks after intervention. Hence, there was a significant difference between the groups in terms of severity and duration of hot flashes.Conclusion:Taking herbal tea capsules for at least 1 month is recommended for treating hot flashes of women during pregnancy. It is recommended that these herbs be used as herbal supplement.

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

BackgroundPostmenopausal 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. MethodsA 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. ResultsMean 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). ConclusionThe 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.

Intermittent 96-Hour Auricular Electroacupuncture for Hot Flashes in Patients with Prostate Cancer: A Pilot Study.

Objective: The hot flash is a common vasomotor disorder that causes distress in menopausal women and that can be debilitating in men with prostate cancer who are treated with androgen deprivation therapy (ADT). The utility of auricular electroacupuncture (AEA) was tested exclusively for a small cohort of men with ADT-induced vasomotor symptoms while the men underwent a course of curative radiotherapy. Materials and Methods: Prior to and during radiotherapy treatment, men with vasomotor symptoms were given repeated questionnaires regarding severity and frequency of hot flashes, quality of life (QoL), and sleep over a 6-week span of an AEA protocol. Each subject's heart rate variability (HRV) was obtained repeatedly every week in an ambulatory setting with a BlueCardio device (BlueCardio, Miami, FL). The AEA intervention was given with a Neurova device (Nunka Corporation, CM Wellness Clinic, Pompano Beach, FL) that used three needles at Master points Sympathetic, Shen Men, and Point Zero, which were located precisely with a bipolar point finder. Intermittent microcurrent stimulation was given every other week for 96 hours, using a cyclic programmed output of 2 hours on and 2 hours off. Results: Of 10 men completing the 6-week protocol, all responded with significantly lower frequency, duration, and severity of vasomotor symptoms; QoL and sleep scores improved significantly. The HRV analysis showed significantly lower low-frequency/high-frequency power ratios in each individual, compared to baseline, that were consistent with the subjective responses. Conclusions: Vasomotor disturbance, caused by gender hormone withdrawal-either naturally or in patients treated with ADT, as in this study-is a well-defined neurophysiologic condition. This disorder is a constellation of findings that reflect autonomic disturbances of excessive sympathetic and reduced parasympathetic activity. AEA intervention with the Neurova device is simple to administer, is well-tolerated, and appears to be effective for restoring autonomic balance. Further evaluation of AEA for vasomotor disturbances could provide more insight into the mechanisms of AEA neuromodulation and potentially lead to approaches for treating not only these symptoms but also other neurologic conditions with components of autonomic disturbances.

Circulating interleukin-8 and tumor necrosis factor-α are associated with hot flashes in healthy postmenopausal women.

IntroductionHot flashes have been postulated to be linked to systemic inflammation. This study aimed to investigate the relationship between hot flashes, pro-inflammatory factors, and leukocytes in healthy, non-obese postmenopausal women.Participants and designIn this cross-sectional study, a total of 202 women aged 45–60 years were stratified into one of four groups according to their hot-flash status: never experienced hot flashes (Group N), mild hot flashes (Group m), moderate hot flashes (Group M), and severe hot flashes (Group S). Variables measured in this study included clinical parameters, hot flash experience, leukocytes, and fasting plasma levels of nine circulating cytokines/chemokines measured by using multiplex assays. Multiple linear regression analysis was used to evaluate the associations of hot flashes with these pro-inflammatory factors.SettingsThe study was performed in a hospital medical center.ResultsThe mean values of leukocyte number were not different between these four groups. The hot flash status had a positive tendency toward increased levels of circulating IL-6 (P-trend = 0.049), IL-8 (P-trend < 0.001), TNF-α (P-trend = 0.008), and MIP1β (P-trend = 0.04). Multivariate linear regression analysis revealed that hot-flash severity was significantly associated with IL-8 (P-trend < 0.001) and TNFα (P-trend = 0.007) among these nine cytokines/chemokines after adjustment for age, menopausal duration, BMI and FSH. Multivariate analysis further revealed that severe hot flashes were strongly associated with a higher IL-8 (% difference, 37.19%; 95% confidence interval, 14.98,63.69; P < 0.001) and TNFα (51.27%; 6.64,114.57; P < 0.05).ConclusionThe present study provides evidence that hot flashes are associated with circulating IL-8 and TNF-α in healthy postmenopausal women. It suggests that hot flashes might be related to low-grade systemic inflammation.