Sleep disturbances in women with early-onset menopausal transition: a population-based study.

OBJECTIVE: The aim of this study was to investigate sleep disturbances in 46-yr-old women and their association with early-onset menopausal transition. METHODS: The women of this cross-sectional birth cohort study were divided into climacteric (n = 359) and preclimacteric (n = 2,302) groups by their menopausal status, defined by follicle-stimulating hormone levels and menstrual history. Sleep disturbances were evaluated with Athens Insomnia Scale 5. We performed univariable and multivariable logistic regression models in which sleep parameters were dependent variables and climacteric status, hot flashes, smoking, and education level were independent variables. The use of hormone therapy was also evaluated in women suffering from sleeping disturbances. RESULTS: On the basis of the scale questions, climacteric women experienced significantly delayed sleep induction (12.2% vs 8.7%, P = 0.047), more problems with awakenings during the night (23.4% vs 14.6%, P < 0.001), earlier final awakening (13.8% vs 9.9%, P = 0.039), and more unsatisfying sleep quality (11.9% vs 7.9%, P = 0.023). Climacteric women who were experiencing hot flashes reported unsatisfactory sleep quality more frequently compared with climacteric women who did not experience hot flashes (17.0% vs 9.2%, P = 0.047). In the univariable and multivariable logistic regression models, being climacteric was independently associated with different impaired sleeping parameters. Most climacteric women who had a scale score of 4 or greater were not using hormone therapy, according to their medicine purchases over the past year. CONCLUSIONS: Being climacteric was associated with sleep disturbances in women in their mid-40s. However, this association seemed to be particularly driven by hot flashes. Most climacteric women with clinically significant sleeping disturbances were not using hormone therapy.

Evaluation and Comparison of Citalopram and Venlafaxine for Management of Hot Flashes in Women with Breast Cancer.

BACKGROUND: Breast cancer is the most common cancer in women worldwide. Premature menopause and hot flashes are the main complications of breast cancer treatments. About 40 to 50 percent of breast cancer women who undergo chemotherapy are experiencing premature menopause symptoms, including hot flashes. Some endocrine therapies such as tamoxifen and aromatase inhibitors are associated with induction or aggravating hot flashes. Hot flashes are often debilitating and significantly impair daily functions. Therefore many therapeutic options have been studied so far for the management of this adverse effect. However, there are still some clinical challenges in managing hot flashes in patients with breast cancer. OBJECTIVE: We aimed to evaluate and compare the efficacy of venlafaxine and citalopram on hot flashes in breast cancer women receiving tamoxifen. DESIGN: We conducted a double-blind, placebo-controlled trial in forty-one, 35 to 65 years old female patients. The study lasted for four weeks, and the follow-up was for two months. Venlafaxine and citalopram treatments started with doses of 37.5 mg or 10 mg, respectively. Venlafaxine and citalopram dosages were increased in the second week to 75 and 20 mg, respectively. The study was conducted during the year 2017. KEY RESULTS: The results indicated that the total efficacy was significantly different in groups receiving citalopram, venlafaxine, and placebo. Total efficacy in the placebo group, venlafaxine, and citalopram was 14.3, 53.8, and 64.3%, respectively (p=0.02). During the second week, the efficacy in groups receiving citalopram, venlafaxine, and placebo was 57.1, 53.8, and 14.3%, respectively (p=0.04). Generally, both citalopram and venlafaxine were well tolerated. The associated adverse effects were mild to moderate in both groups. CONCLUSIONS: Although citalopram was associated with more adverse effects, including constipation, it was more effective in reducing the frequency of hot flashes when compared to venlafaxine or placebo.

Association between vasomotor symptom frequency and weight gain in the Study of Women's Health Across the Nation.

OBJECTIVE: The menopause transition is associated with weight gain in women. We examined whether changes in vasomotor symptom (VMS) frequency precede weight changes. METHODS: This longitudinal retrospective analysis included data from the multisite, multiethnic Study of Women's Health Across the Nation. Women in premenopause or perimenopause aged 42 to 52 years at baseline self-reported VMS frequency (hot flashes/night sweats) and sleep problems at up to 10 annual visits. Menopause status, weight, body mass index, and waist circumference were compared across visits. The primary objective was to measure the association between VMS frequency and weight gain using a lagged approach with first-difference regression models. Secondary objectives were to statistically quantify mediation by sleep problems and moderation by menopause status and explore the association between cumulative, 10-year VMS exposure and long-term weight gain. RESULTS: The primary analysis sample included 2,361 participants (12,030 visits; 1995-2008). Increased VMS frequency across visits was associated with subsequently increased weight (0.24 kg), body mass index (0.08 kg/m 2 ), and waist circumference (0.20 cm). Cumulative exposure to a high frequency of VMS (≥6 d/2 wk) over 10 consecutive annual visits was associated with increases in weight measures, including a 3.0-cm increase in waist circumference. Contemporaneous sleep problems mediated no more than 27% of waist circumference increases. Menopause status was not a consistent moderator. CONCLUSIONS: This study demonstrates that increases in VMS, onset of a high frequency of VMS, and persistent VMS symptoms over time may precede weight gain in women.

Does self-compassion explain variance in sleep quality in women experiencing hot flushes?

OBJECTIVES: With poor sleep highly prevalent during the menopause transition, there is a need to better understand modifiable psychological resources that may be associated with improved sleep. Hence, we investigated whether self-compassion can explain variance in self-reported sleep quality in midlife women, over and above vasomotor symptoms. METHODS: This cross-sectional study (N = 274) used questionnaire data from self-report measures of sleep, hot flushes and night sweats, hot flush interference, and self-compassion, with analyses conducted using sequential (hierarchical) regression. RESULTS: Poor sleep, as measured by the Pittsburgh Sleep Quality Index, was prevalent and significantly worse in the subsample of women with hot flushes and night sweats, g = 0.28, 95 % CI [0.04, 0.53]. The interference of hot flushes in everyday life (ß = 0.35, p < .01), but not their frequency, predicted self-reported sleep quality. Once self-compassion was added to the model it was the only predictor of poor sleep (ß = -0.32, p < .01). When positive self-compassion and self-coldness were considered separately, the effect on sleep quality appeared to be attributable to self-coldness scores alone (ß = 0.29, p < .05). CONCLUSIONS: Self-compassion may have a stronger relationship with self-reported sleep quality in midlife women than vasomotor symptoms. Future intervention-based research could test the efficacy of self-compassion training for midlife women experiencing sleep disturbances, as this may be an important and modifiable psychological resilience factor.

Optimizing sleep across the menopausal transition.

Women frequently experience sleep disturbances, particularly night-time awakenings, as they transition menopause and enter postmenopause. Sleep is essential for optimal functioning and health. Persistent and distressing sleep disturbances across menopause can negatively impact daytime functioning and productivity, and increase risk for mental and physical health conditions. While multiple factors can disturb sleep, two unique factors in the context of menopause are vasomotor symptoms and the changing reproductive hormone environment. Vasomotor symptoms are associated with sleep disturbances and contribute significantly to awakenings and amount of time spent awake during the night. Even after accounting for vasomotor and depressive symptoms, lower estradiol and higher follicle stimulating hormone levels, indicative of menopause, are associated with sleep disturbance, particularly awakenings, suggesting that the hormone environment may directly affect sleep. Management strategies for clinically significant menopausal sleep disturbances include cognitive behavioral therapy for insomnia, which is effective and durable in treating menopausal insomnia. Hormone therapy alleviates sleep disturbances, particularly in the presence of disruptive vasomotor symptoms. Sleep disturbances have a significant impact on women's functioning and health, and there is a need for further research of the underlying mechanisms to advance effective preventative and treatment strategies that ensure optimal health and well-being of midlife women.

Vasomotor symptoms and risk of cardiovascular disease in peri- and postmenopausal women: A systematic review and meta-analysis.

INTRODUCTION: Vasomotor symptoms (VMS) are the symptoms most frequently experienced by women transitioning to menopause and are a primary indication for menopausal hormone therapy. A growing body of evidence has associated the presence of VMS with future risk for cardiovascular disease (CVD) events. This study aimed to systematically evaluate, qualitatively and quantitatively, the possible association between VMS and the risk for incident CVD. METHODS: This systematic review and meta-analysis included 11 studies evaluating peri- and postmenopausal women in a prospective design. The association between VMS (hot flashes and/or night sweats) and the incidence of major adverse cardiovascular events, including coronary heart disease (CHD) and stroke, was explored. Associations are expressed as relative risks (RR) with 95 % confidence intervals (CI). RESULTS: The risk for incident CVD events in women with and without VMS differed according to the age of participants. Women with VSM younger than 60 years at baseline had a higher risk of an incident CVD event than women without VSM of the same age (RR 1.12, 95 % CI 1.05-1.19, I2 0%). Conversely, the incidence of CVD events was not different between women with and without VMS in the age group >60 years (RR 0.96, 95 % CI 0.92-1.01, I2 55%). CONCLUSION: The association between VMS and incident CVD events differs with age. VMS increases the incidence of CVD only in women under 60 years of age at baseline. The findings of this study are limited by the high heterogeneity among studies, pertaining mainly to different population characteristics, definitions of menopausal symptoms and recall bias.

Effects of Chicory and Fumitory on Hot Flashes Among Breast Cancer Survivors: A Randomized, Double-Blind Placebo-Controlled Trial.

Objectives: Hot flashes are unpleasant long-term complications of breast cancer. This study aimed to evaluate the effects of a traditional Persian medicine containing extracts of Cichorium intybus L. (chicory) and Fumaria parviflora L. (Fumitory) extract syrup (CFS) compared with placebo when used as intended. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting/Location: The Oncology Ward of Shahid Modarres Hospital (Tehran, Iran). Subjects: Breast cancer survivors undergoing hormone deprivation therapy. Interventions: Patients were randomly allocated to receive 5 mL CFS or placebo syrup three times a day, for 4 weeks. Outcome measures: The co-primary outcomes were self-reported daily hot flashes frequency and severity scores assessed using self-reported daily dairies, including 1 week of baseline data. Results: Of the 148 patients screened, 137 were eligible, and 96 were randomly allocated to receive either CFS (n = 48) or placebo (n = 48). All participants who returned their dairies were compliant and analyzed as randomized in the a priori per-protocol analysis. After 4 weeks of treatment, both the mean daily hot flashes frequency and severity score had reduced by 57% in the CFS group and 10% in the placebo group. The overall weekly mean daily hot flashes frequency (effect size ηp2 0.221, p < 0.001, n = 66) and severity scores (effect size ηp2 0.160, p = 0.001, n = 66) were significantly lower in the CFS group compared with the placebo group (one-within one-between repeated-measures analysis of variance adjusted for baseline). CFS was well tolerated, with similar proportions of serious and nonserious adverse events occurring in both groups. Conclusions: This is the first study to report the effects of chicory or fumitory for the treatment of hot flashes. The findings provide preliminary evidence that CFS can improve hot flashes in breast cancer survivors undergoing hormone deprivation therapy. More research is warranted to confirm its effectiveness, safety, and mechanisms of action. Clinical Trial Registration: IRCT20210226050506N1.

Vasomotor symptoms of menopause, autonomic dysfunction, and cardiovascular disease.

Cardiovascular disease (CVD), the leading cause of death among US adults, is more prevalent in menopausal females compared with age-matched males. Vasomotor symptoms of menopause (VMS; hot flashes/flushes and night sweats) are common among females undergoing menopausal transition and have been associated with elevated blood pressure (BP) and increased CVD risk. Autonomic dysregulation of BP has been posited as a contributing factor to the elevated CVD risk in menopausal females with VMS. This review includes 1) a brief overview of the relationship between VMS and CVD, 2) mechanisms of hot flushes and their potential impact on short- and long-term BP regulation, and 3) how the disruption of autonomic function associated with VMS might provide a mechanistic pathway to CVD development. Finally, this review will highlight knowledge gaps and future directions toward better understanding of hot flush physiology and VMS contributions to CVD.

Limited evidence of a threshold effect for increasing adiposity on risk of symptoms at midlife.

OBJECTIVE: To assess the nature of relationships between increasing body mass index (BMI) and the prevalence of midlife symptoms in a population with high adiposity. METHODS: In the cross-sectional Study of Women's Health in Qatar, 841 participants aged 40 to 60 years were recruited from nine primary health centers in Doha. Face-to-face interviews collected demographic, menopause, and symptom information. BMI (kg/m 2 ) was categorized as healthy, overweight, or class I, II, or III obesity. Multivariate logistic regression models were used to examine aches/stiffness in joints, trouble sleeping, shortness of breath, urinary incontinence, and hot flashes with BMI categories. Restricted cubic splines (RCSs) were used to estimate relationships between continuous BMI and each symptom and to conduct formal tests of nonlinearity. RESULTS: Mean BMI was 34.3 kg/m 2 (SD, 6.0 kg/m 2 ). Women with class II and III obesity had higher odds of reporting aches/stiffness than women with a healthy BMI, and the odds of reporting urinary incontinence were three times higher among women with class III obesity (odds ratio, 3.08; 95% confidence interval, 1.17-8.14). Using restricted cubic spline models, a significant nonlinear association ( P = 0.002) was observed between aches/stiffness and BMI with an apparent threshold of 38 kg/m 2 . Linear relationships were observed with BMI for urinary incontinence ( P < 0.001 for linear trend) and shortness of breath ( P = 0.005 for linear trend). Trouble sleeping and hot flashes were not associated with BMI. CONCLUSIONS: Even at very high levels of BMI, likelihood of urinary incontinence and shortness of breath increases with BMI. In contrast, likelihood of aches/stiffness has a nonlinear relationship with BMI, increasing to a threshold level.

Menopausal vasomotor symptoms and adiponectin among midlife women.

OBJECTIVE: Vasomotor symptoms (VMS) are prevalent symptoms that can have a negative impact on quality of life. VMS have also been linked to cardiovascular disease risk, yet the mechanisms underlying these associations have not been elucidated. Some initial works link VMS to adverse adipokine profiles or cytokines produced by adipose tissue. However, results are not entirely consistent and are based entirely on self-report VMS, which is influenced by a range of memory and reporting biases. The aim of this work was to test whether physiologically assessed VMS are associated with lower adiponectin, the most abundant adipokine in the body, controlling for confounding factors. We also consider whether adiponectin explains previously documented relationships between VMS and carotid atherosclerosis. METHODS: A total of 300 peri- and postmenopausal nonsmoking women aged 40 to 60 years enrolled in the MsHeart study comprised the analytic sample. Women were free of hormone therapy or other medications impacting VMS, insulin-dependent diabetes, and cardiovascular disease. Participants underwent ambulatory physiologic VMS monitoring, physical measures, a carotid ultrasound, and fasting phlebotomy. RESULTS: More frequent physiologically assessed VMS were associated with lower adiponectin ( B [SE] = -0.081 [0.028], P = 0.004; or 0.081 lower µg/mL in adiponectin for each additional VMS over 24 hours), controlling for age, race/ethnicity, education, insulin resistance, and waist circumference. Associations were not explained by endogenous estradiol. Adiponectin did not explain associations between VMS and carotid atherosclerosis. CONCLUSIONS: Physiologic VMS were associated with lower adiponectin after considering potential confounders. The role of adipokines in VMS and in links between VMS and health warrants further attention.

Menopausal Symptoms and Sleep Quality in Women Aged 40-65 Years.

The study examined the relationship between menopausal symptoms and sleep disturbances and the related influencing factors. Methods. We recruited women aged 40-65 years who attended the menopause clinic at Shanghai Jiao Tong University's Sixth People's Hospital from February 2011 to November 2019. The Menopause Rating Scale (MRS) was used to collect women's menopausal symptoms, and the Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the subjects' sleep condition. We used logistic regression models to identify the relationship between menopausal symptoms and sleep quality. Results. A total of 1341 participants were recruited in this study. The most frequent three symptoms assessed by MRS were fatigue (72.9%), sleep disturbance (67%), and hot flashes with night sweats (65%). Participants' age was significantly associated with the severity of menopausal syndrome (P < 0.01). According to the PSQI sleep evaluation, 66.9 percent of participants had sleep disturbances (PSQI > 5). Logistic regression analysis revealed that women with mild, moderate, or severe menopausal syndrome had a 3-, 7-, and 17-fold increased chance of having sleep disturbances compared to women without menopausal syndrome. Conclusion. Women aged 40-65 years were found to have a significantly higher risk of menopausal syndrome and sleep disturbances.

Results of a pilot study of a cooling mattress pad to reduce vasomotor symptoms and improve sleep.

OBJECTIVE: This single-arm pilot study was designed to generate pilot data on the use of a cooling mattress pad system on vasomotor symptoms (VMS; hot flashes and/or night sweats), self-assessed sleep, and daily hot flash interference among perimenopausal and postmenopausal women. METHODS: A total of 15 perimenopausal and postmenopausal women aged 45 to 59 years experiencing four or more VMS per day were recruited from the community. After completion of baseline questionnaires and a 2-week daily diary to confirm VMS eligibility, all women received a cooling mattress pad system to use at night for 8 weeks, during which time they continued to complete their daily diaries to record VMS frequency and severity. The primary study outcome was change from baseline in VMS frequency. Secondary outcomes were sleep quality, measured by the Pittsburgh Sleep Quality Index, and hot flash interference with daily life, assessed by the Hot Flash Related Daily Interference Scale, where higher sores indicate worse sleep quality and higher interference, respectively. We used repeated-measures methods (analysis of covariance, paired t tests, and McNemar test) to evaluate outcomes. RESULTS: VMS frequency significantly declined by 52% at 8 weeks ( P < 0.0001). Mean total Pittsburgh Sleep Quality Index score significantly declined 3.27 points from 11.14 at baseline to 7.87 at follow-up ( P = 0.011). The total Hot Flash Related Daily Interference Scale score significantly declined from 4.16 at baseline to 1.92 at follow-up ( P = 0.011). CONCLUSIONS: Women who used a cooling mattress pad system experienced significant and clinically meaningful reductions in VMS frequency, sleep disturbance, and hot flash interference with daily activities over an 8-week period. These results provide preliminary evidence suggesting that a cooling mattress pad used while sleeping can provide a nonpharmacological option to reduce VMS and sleep disturbance for women experiencing menopausal hot flashes.

Clinical Update in Women's Heart Disease.

The goal in selecting these recent articles was to help identify literature that may change the clinical practice of women's health for practitioners in the primary care setting. Articles were identified by reviewing high-impact medical and women's health journals, national guidelines, ACP JournalWise, and NEJM Journal Watch. In this clinical update, we selected recent publications relevant to the prevention, risk assessment, and diagnosis of cardiovascular disease (CVD) in women. Breastfeeding now has data suggesting a robust reduction in subsequent CVD, and migraine with aura and severe and early- and late-onset hot flashes can now be considered risk factors for CVD. The decision to initiate menopausal hormone therapy is influenced by estimation of underlying vascular risk, and new data suggest that CVD risk scores are more accurate in predicting CVD risk than the traditionally used age and years since menopause and should be incorporated into counseling. Finally, new data support the growing belief that breast arterial calcification on mammography is a promising noninvasive marker that can enhance CVD risk prediction in women.

Menopausal symptom management in women with cardiovascular disease or vascular risk factors.

Women with preexisting cardiovascular disease (CVD) or vascular risk factors commonly experience bothersome symptoms of menopause, including vasomotor symptoms (VMS) and genitourinary syndrome of menopause (GSM). Due to confusion surrounding the safety of menopausal hormone therapy (HT) in symptomatic women with CVD, evidence-based guidelines should be followed regarding identifying candidates for treatment and HT decision making. This review summarizes best practices in the evaluation and treatment of VMS and GSM in women with preexisting CVD, based on international expert consensus guidelines and/or expert opinion when data are scarce. For women with preexisting CVD or vascular risk factors who are candidates for HT, guidelines often address the appropriate formulation, dose, and route of delivery. For women who are not candidates for HT, non-hormonal options are reviewed, and their safety and efficacy in treating VMS and GSM are discussed. Due to increased knowledge of the role that pregnancy-related complications play in maternal risk for future CVD, these conditions are considered when addressing the use of systemic HT. Women at increased risk for future CVD without the use of HT, such as women with premature or early menopause, are also discussed, as well as the safely profile of HT in these special populations. With worldwide rates of CVD increasing among women in midlife, it is important for clinicians to have clear guidelines for identifying candidates for hormonal and nonhormonal treatments for symptom management to safeguard the health and quality of life of these patients through the menopause transition and post-menopause.

The relationship between sleep quality and menopausal symptoms among postmenopausal women in Saudi Arabia.

OBJECTIVES: To assess sleep quality and examine its relationship with menopausal symptoms among Saudi postmenopausal women. METHODS: We carried out a cross-sectional study of 410 postmenopausal women, aged 50-60 years, visiting Prince Mutaib bin Abdulaziz Hospital, Maternity and Children Hospital, and primary health care clinics, Sakaka, Jouf, Saudi Arabia. The menopause rating scale (MRS) was used to assess menopause symptoms and severity, while the Pittsburgh sleep quality index (PSQI) was used to assess sleep quality. RESULTS: The participants' age was 53.04±4.15 years, their mean age at natural menopause was 49.14±3.07, and the meantime since their menopause was 6.50±3.84 years. The PSQI total mean score was 6.10±4.17, classified into good versus poor sleepers; 65.4% scored ≤5, and 34.6% scored >5. The Mann-Whitney analysis revealed that somatic and urogenital symptoms, and total MRS score were associated with poor sleep quality (p<0.001). CONCLUSION: The study findings revealed that more than one-third of Saudi postmenopausal women had poor sleep quality.

Hot Flashes: Common Side Effect.

For hot flashes, standards of care are based on established evidence-based practice. Hot flashes are a sensation of heat that can be accompanied by facial flushing, perspiration, chills, heart palpitations, night sweats, and anxiety. Hot flashes occur in 51%-82% or women treated for breast cancer and 80% of men treated for prostate cancer with surgical or chemical castration.

Relationship between vasomotor symptoms and metabolic syndrome in Chinese middle-aged women.

PURPOSE: This study aimed to find the associations between vasomotor symptoms (VMS) and metabolic syndrome (MetS) in Chinese middle-aged women in a cross-sectional study. METHODS: A total of 675 participants were recruited from an urban Chinese community. MetS was defined by the 2009 criteria of the Joint Interim Statement. VMS including hot flashes and sweats, blood pressure, weight, height, waist circumference (WC), serum glucose, triglycerides, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), estradiol, and follicle-stimulating hormone (FSH) were collected. RESULTS: The presence of hot flashes was independently associated with the risk of MetS after adjusting for age, menopausal status, FSHlog, estradiollog, and physical activity (odds ratio: 1.98, 95% confidence interval: 1.21-3.24, p = 0.006). Both hot flashes and sweats were also independently associated with WC (for hot flashes, p = 0.016; and for sweats, p = 0.007) and triglycerides (for hot flashes, p = 0.041; and for sweats, p = 0.014) significantly. However, VMS were not significantly associated with blood pressure, glucose, HDL, and LDL. CONCLUSION: Women with hot flashes had a higher risk of MetS. Both hot flashes and sweats were related to a higher amount of central fat indicated by WC and higher triglycerides, but were not related to blood pressure, glucose, and HDL in Chinese women.

Effects of forehead cooling and supportive care on menopause-related sleep difficulties, hot flashes and menopausal symptoms: a pilot study.

OBJECTIVE/BACKGROUND: This pilot study explored the efficacy of a novel forehead cooling device for perceived sleep difficulties and hot flashes in menopausal-age women. PARTICIPANTS: 20 women (55.1 ± 4.2 years; 19 post-menopausal) with insomnia symptoms and self-reported two or more hot flashes per day. METHODS: Participants completed daily assessments of sleep and hot flashes (via diaries) across 1 baseline week and 4 weeks of open-label, in-home, nightly treatment with a forehead cooling device (15-18°C) along with sleep hygiene instructions. They also completed ratings of insomnia and menopausal symptoms using standardized questionnaires. RESULTS: Women reported reductions in sleep onset latency (SOL), wakefulness after sleep onset (WASO), and nocturnal hot flash severity during the first week of treatment (SOL: 25.7 ± 18.4 min; WASO: 36.3 ± 27.3 min; hot flash severity: 3.0 ± 2.8) compared with baseline (SOL: 38 ± 26.3 min; WASO: 52.2 ± 35.6 min; hot flash severity: 6.8 ± 3.7), with further improvements after 2-4 weeks of use (p < .001). There were also clinically meaningful reductions in insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores on the Greene climacteric scale after treatment (all p's<0.001). CONCLUSIONS: This exploratory, naturalistic, pilot study shows that nightly use of a forehead cooling device produces improvements in self-reported sleep and reductions in insomnia, hot flash, and other menopausal, symptoms. Controlled studies are warranted to determine the role of this therapy in the management of sleep difficulties and menopausal symptoms in women. Further mechanistic studies are needed to understand the physiological impact of forehead cooling on sleep and menopausal symptoms.

The association between severe menopausal symptoms and engagement with HIV care and treatment in women living with HIV.

Using data from the PRIME Study, an observational study of the menopause in women living with HIV in England, we explored the association between menopausal symptoms and: (i) antiretroviral therapy (ART) adherence and (ii) HIV clinic attendance. We measured menopausal symptom severity with the Menopause Rating Scale (MRS, score ≥17 indicating severe symptoms), adherence with the CPCRA Antiretroviral Medication Adherence Self-Report Form, and ascertained HIV clinic attendance via self-report. Odds ratios were obtained using logistic regression. Women who reported severe menopausal symptoms had greater odds of suboptimal ART adherence (adjusted odds ratio (AOR) 2.22; 95% CI 1.13, 4.35) and suboptimal clinic attendance (AOR 1.52; 95% CI 1.01, 2.29). When psychological, somatic and urogenital domains of the MRS were analysed individually there was no association between adherence and severe symptoms (all p > 0.1), however there was an association between suboptimal HIV clinic attendance and severe somatic (AOR 1.98; 95% CI 1.24, 3.16) and psychological (AOR 1.76; 95% CI 1.17, 2.65) symptoms. Severe menopausal symptoms were significantly associated with sub-optimal ART adherence and HIV clinic attendance, however we cannot infer causality, highlighting the need for longitudinal data.

Tamoxifen related side effects and their impact on breast cancer incidence: A retrospective analysis of the randomised IBIS-I trial.

BACKGROUND: Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial. METHODS: Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation. RESULTS: Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed. CONCLUSIONS: Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.