Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial.

BACKGROUND: Hot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice. METHODS: Qualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs. RESULTS: BCNs (n = 10), managers (n = 2), surgeons (n = 3) and trial participants (n = 8) across six recruiting sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments and organisational priorities. CONCLUSIONS: Both healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support. TRIAL REGISTRATION: NCT02623374 - Last updated 07/12/2015 on ClinicalTrials.gov PRS.

A sex/age anomaly in thermal comfort observed in an office worker field study: A menopausal effect?

In a field study conducted in office settings in Sydney, Australia, background survey and right-here-right-now thermal comfort questionnaires were collected from a sample of office workers. Indoor environmental observations, including air temperature, mean radiant temperature, air velocity, and relative humidity, were also recorded and matched with each questionnaire according to the time and location. During exploratory data analyses, we observed that female subjects aged over 40 and 50 or younger registered significantly warmer sensations than other subjects, male and female, from other age ranges. To further explore this phenomenon, the sample of building occupants was classified into two groups-women of perimenopausal age (over 40 and 50 or younger) while the remaining respondents served as a reference group for comparison. Women in the perimenopausal age range demonstrated an increased perception of warmth (p < 0.01) and expressed thermal dissatisfaction more frequently (p < 0.01) than the reference group respondents who were exposed to the same indoor environmental conditions. Furthermore, women of perimenopausal age also expressed preference for cooler thermal environments, that is, lower air temperature (p < 0.01) and greater air movement (p<0.01) than the reference group, and their thermal neutrality (ie, the room temperature corresponding to a neutral thermal sensation) was approximately 2°C cooler than that of the reference group (20.7°C vs 22.4°C). A potential physiological explanation for the distinct thermal perception of women aged over 40 and 50 or younger observed in this study could stem from menopausal symptoms-the presence of hot flushes and dysregulation of the thermoregulatory system.

Relation between blood pressure and genito-urinary symptoms in the years across the menopausal age.

OBJECTIVES: This study aimed to evaluate the relation between blood pressure (BP) or heart rate and genito-urinary symptoms in 504 women across the menopausal age (40-55 years old). METHODS: In this multicenter, cross-sectional study, data of office systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate were related to the presence of vaginal dryness, dyspareunia, vaginal atrophy (VA), recurrent urinary infection (RUI), hot flushes (HF) or menopausal status. RESULTS: Vaginal dryness (coefficient of linear regression ß = 5.45, 95% confidence interval [CI] 2.01-8.89; p = 0.0001), VA (ß = 3.79, 95% CI 0.84-6.74; p = 0.002) and RUI (ß = 3.91, 95% CI 0.72-7.09; p = 0.0163) were independently related to SBP. Vaginal dryness (ß = 3.28, 95% CI 0.95-5.61; p = 0.0058), and HF (ß = 2.29, 95% CI 0.29-4.28; p = 0.025) were independently related to DBP. Dyspareunia (ß = 2.11, 95% CI 0.50-3.72; p = 0.010) was independently related to heart rate. Hypertension was present in 17% of women. When corrected for body mass index (BMI), risk factors for hypertension were VA (OR 2.50, 95% CI 1.43-4.40; p = 0.0014), RUI (OR 1.94 95% CI 1.06-3.52; p = 0.0302) and HF (OR 2.01, 95% CI 1.15-3.50; p = 0.0141). CONCLUSIONS: In women across the menopausal age, genito-urinary symptoms, more than HF, are associated with higher values of SBP, DBP, heart rate and hypertension.

Consumption of a soy drink has no effect on cognitive function but may alleviate vasomotor symptoms in post-menopausal women; a randomised trial.

PURPOSE: Cognitive decline is commonly reported during the menopausal transition, with memory and attention being particularly affected. The aim of this study was to investigate the effects of a commercially available soy drink on cognitive function and menopausal symptoms in post-menopausal women. METHODS: 101 post-menopausal women, aged 44-63 years, were randomly assigned to consume a volume of soy drink providing a low (10 mg/day; control group), medium (35 mg/day), or high (60 mg/day) dose of isoflavones for 12 weeks. Cognitive function (spatial working memory, spatial span, pattern recognition memory, 5-choice reaction time, and match to sample visual search) was assessed using CANTAB pre- and post-the 12 week intervention. Menopausal symptoms were assessed using Greene's Climacteric Scale. RESULTS: No significant differences were observed between the groups for any of the cognitive function outcomes measured. Soy drink consumption had no effect on menopausal symptoms overall; however, when women were stratified according to the severity of vasomotor symptoms (VMS) at baseline, women with more severe symptoms at baseline in the medium group had a significant reduction (P = 0.001) in VMS post-intervention (mean change from baseline score: - 2.15 ± 1.73) in comparison to those with less severe VMS (mean change from baseline score: 0.06 ± 1.21). CONCLUSIONS: Soy drink consumption had no effect on cognitive function in post-menopausal women. Consumption of ~ 350 ml/day (35 mg IFs) for 12 weeks significantly reduced VMS in those with more severe symptoms at baseline. This finding is clinically relevant as soy drinks may provide an alternative, natural, treatment for alleviating VMS, highly prevalent among western women.

Managing vasomotor symptoms effectively without hormones.

Vasomotor symptoms (hot flushes and/or night sweats) affect approximately 80% of women over the menopause transition and can affect quality of life, productivity, and relationships. Vasomotor symptoms are the main reason for seeking treatment during the menopausal transition. Although menopausal hormone therapy (MHT) is effective for symptom management, the majority of symptomatic women do not take MHT. In this article, we review the evidence for non-hormonal treatments for vasomotor symptoms, including pharmacological and non-pharmacological approaches, and provide a clinical algorithm for managing symptomatic women.

Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.

OBJECTIVES: Two identical 12-week, randomized, double-blind, placebo-controlled, multi-arm, parallel-group Phase III studies (Study P012, NCT00560833; Study P013, NCT00535288) evaluated the efficacy and safety of esmirtazapine, an investigational medicine, for the treatment of moderate to severe vasomotor symptoms (VMS) in postmenopausal women. METHODS: Participants were randomized to placebo or esmirtazapine (2.25, 4.5, 9.0, or 18.0 mg). Co-primary efficacy endpoints (daily frequency and severity of moderate to severe VMS, both at weeks 4 and 12) were based on participative LogPad daily diaries. Adverse events (AEs) were recorded. RESULTS: In Studies P012 and P013, 942 and 946 participants were randomized, respectively. Compared with placebo, esmirtazapine significantly reduced the mean daily frequency by 1.4-2.2 moderate to severe VMS at weeks 4 and 12 (both ≥4.5 mg) and mean daily severity by 0.06-0.08 symptoms at weeks 4 (≥4.5 mg) and 12 (9.0 mg P012; 18.0 mg P013 only). Esmirtazapine was generally well tolerated with a more favorable safety profile at lower doses. Somnolence and fatigue were the most frequently reported AEs. CONCLUSIONS: Esmirtazapine reduced the frequency and severity of moderate to severe VMS associated with menopause and was generally well tolerated in the study population.

Novel effect of α-lactalbumin on the yohimbine-induced hot flush increase of the tail skin temperature in ovariectomized rats.

5-Hydroxytryptamine (5-HT) and noradrenaline have been thought to play important roles in the mechanism of hot flush. Then, to clarify the relation between serotonergic and adrenergic nervous systems on the mechanism of hot flush, the effect of paroxetine, 5-HT reuptake inhibitor (SSRI) was evaluated on the yohimbine-induced hot flush increase of tail skin temperature in ovariectomized female rats. Yohimbine (adrenaline α2 antagonist) significantly increased the tail skin temperature in course of time. Clonidine (adrenaline α2 agonist) significantly attenuated this effect. Paroxetine also significantly inhibited the increase of tail skin temperature by yohimbine. α-Lactalbumin having SSRI activity in vitro study also significantly inhibited the increase of tail skin temperature, but not significantly decreased the initial temperature. This difference may explain the different mechanism between paroxetine (SSRI) and α-lactalbumin, suggesting new mechanism of hot flush.

Etiologies and management of cutaneous flushing: Nonmalignant causes.

The flushing phenomenon may represent a physiologic or a pathologic reaction. Although flushing is usually benign, it is prudent that the physician remains aware of potentially life-threatening conditions associated with cutaneous flushing. A thorough investigation should be performed if the flushing is atypical or not clearly associated with a benign underlying process. The diagnosis often relies on a pertinent history, review of systems, physical examination, and various laboratory and imaging modalities, all of which are discussed in the 2 articles in this continuing medical education series. This article reviews flushing associated with fever, hyperthermia, emotions, menopause, medications, alcohol, food, hypersensitivity reactions, rosacea, hyperthyroidism, dumping syndrome, superior vena cava syndrome, and neurologic etiologies.

Effects of imparting planned health education on hot flush beliefs and quality of life of climacteric women.

OBJECTIVE: The aim of the present study was to determine the effect of imparting planned health education to climacteric women on their beliefs related to hot flushes and on their quality of life. METHODS: The research was conducted using pretest and post-test semi-experimental models along with a control group. Of 450 women, 255 were randomly selected and invited to participate in the study. Five people did not agree to participate in the study. Three people were also excluded from the study because they did not complete training. The research sample was comprised of 247 climacteric women (121 women in the experimental group and 126 women in the control group) who were <65 years (the average ages of the participants in the experimental group were 50.61 ± 5.54 years and in the control group 50.94 ± 6.03 years), had experienced hot flushes within the past month, were going through the menopause and postmenopause, were not using hormone replacement therapy, and had agreed to participate in the study. Participants were asked to complete a Sociodemographic Questionnaire, the Hot Flush Beliefs Scale, and The Menopause-Specific Quality of Life Questionnaire. Three educational sessions at 2-week intervals were given to the women in the experimental group. The research was supported with an educational booklet prepared by the researchers. Training was not given to the women in the control group. After the education of the experimental group (after about 6 months), women in both groups recompleted the data collection forms, and post-test data were collected. RESULTS: On all the subscales, the total of the Hot Flush Beliefs Scale, and the average post-test score, the women in the experimental group scored lower than the women in the control group (the average post-test total score in the experimental group was 26.22 ± 10.09 and in control group it was 52.25 ± 15.04; p < 0.001). While the women in the experimental group developed positive beliefs about their hot flushes, the beliefs of the women in the control group remained unchanged. The average post-test score on all the subscales of the Menopause-Specific Quality of Life Questionnaire for the women in the experimental group was lower than that for the women in the control group (p < 0.001; the average post-test score in the experimental group for the vasomotor subscale was 1.78 ± 0.88, for the psychosocial subscale 1.50 ± 0.75, for the physical subscale 1.69 ± 0.63, and for the sexual subscale 2.91 ± 2.06; the average post-test score in the control group for the the vasomotor subscale was 3.80 ± 1.88, for the psychosocial subscale 2.79 ± 1.08, for the physical subscale 3.10 ± 1.04, and for the sexual subscale 2.25 ± 2.11). While the quality of life of the women in the experimental group showed an upward trend, that of the women in the control group remained the same. CONCLUSION: It was found that planned health education about the climacteric period reduced women's negative beliefs about hot flushes and enhanced their quality of life.

The menopausal hot flush: a review.

The hot flush is the most characteristic and often the most distressing symptom of the menopause. It is a unique feature and yet the mechanism and health implications are still not fully understood. This review summarizes some of the current thoughts on factors contributing to flushing, the physiological, vascular and neuroendocrine changes associated with flushing and the possible cardiovascular and other health implications for women experiencing hot flushes. Therapy is not discussed.

A negative view of menopause: does the type of symptom matter?

OBJECTIVES: To assess the association between the type of symptom and women's self-reported view of menopause. METHODS: The study was conducted at Mayo Clinic, Rochester MN, between January 2006 and October 2014. Women aged 40-64 were included. Data from 1420 women were analyzed in a cross-sectional design. The Menopause Health Questionnaire was used for symptom assessment. Odds ratios (ORs) and population attributable risk (PAR) (OR × percent frequency) were calculated for each symptom. Logistic regression analyses were performed with the view of menopause as the dependent variable. RESULTS: Anxiety (2.34), depressed mood (2.24), irritability (2.22), vaginal itching (2.27), crying spells (2.1) and breast tenderness (2.08) were associated with highest odds of having a negative view of menopause. Highest PAR (population impact) symptoms were anxiety (22.27), weight gain (20.66), fatigue (20.28) and irritability (19.41). Hot flushes and night sweats, although common, were not associated with a negative view of menopause (OR 1.3 and 1.16; PAR 3.85 and 4.42, respectively). CONCLUSION: Mood symptoms, vaginal itching, weight gain, breast tenderness and fatigue, although less common than hot flushes, were noted to have greater association with a negative view of menopause. Specifically addressing these symptoms during menopausal consultation may improve patient satisfaction and outcomes.

Efficacy of phytoestrogens for menopausal symptoms: a meta-analysis and systematic review.

OBJECTIVE: To perform a meta-analysis examining the efficacy of phytoestrogens for the relief of menopausal symptoms. METHODS: Medline, Cochrane, EMBASE, and Google Scholar databases were searched until September 30, 2013 using the following key words: vasomotor symptoms, menopausal symptoms, phytoestrogens, isoflavones, coumestrol, soy, red clover. Inclusion criteria were (1) randomized controlled trial (RCT), (2) perimenopausal or postmenopausal women experiencing menopausal symptoms, (3) intervention with an oral phytoestrogen. Outcome measures included Kupperman index (KI) changes, daily hot flush frequency, and the likelihood of side-effects. RESULTS: Of 543 potentially relevant studies identified, 15 RCTs meeting the inclusion criteria were included. The mean age of the subjects ranged from 49 to 58.3 and 48 to 60.1 years, respectively, in the placebo and phytoestrogen groups. The number of participants ranged from 30 to 252, and the intervention periods ranged from 3 to 12 months. Meta-analysis of the seven studies that reported KI data indicated no significant treatment effect of phytoestrogen as compared to placebo (pooled mean difference = 6.44, p = 0.110). Meta-analysis of the ten studies that reported hot flush data indicated that phytoestrogens result in a significantly greater reduction in hot flush frequency compared to placebo (pooled mean difference = 0.89, p < 0.005). Meta-analysis of the five studies that reported side-effect data showed no significant difference between the two groups (p = 0.175). CONCLUSION: Phytoestrogens appear to reduce the frequency of hot flushes in menopausal women, without serious side-effects.

Relation between oxidative stress and climacteric symptoms in early postmenopausal women.

OBJECTIVES: To evaluate the relation between climacteric symptoms or other risk factors for cardiovascular disease and oxidative status of postmenopausal women. METHODS: Cross-sectional investigation performed at the outpatient service for the menopause at the University Hospital, on 50 apparently healthy women in physiological postmenopause. The whole-blood free oxygen radical test (FORT), free oxygen radical defence (FORD), age, months since menopause, weight, body mass index, waist circumference, waist-to-hip ratio, estradiol, lipids, glucose, insulin, insulin resistance (glucose/insulin and HOMA-IR), and fibrinogen were evaluated. The Greene Climacteric Scale with its subscales was used to evaluate climacteric symptoms. The pulsatility index, an index of downstream blood flow resistance, was determined for both the internal carotid artery and the brachial artery. RESULTS: The waist-to-hip ratio (r = 0.540; p = 0.0001), estradiol (r = 0.548; p = 0.0004) and waist circumference (r = 0.345; p = 0.02) were independently related to blood FORT. The score in the Greene vasomotor subscale was the only parameter independently related to blood FORD (r = 0.554; p = 0.0001). FORT was not related to the artery pulsatility index, while FORD was negatively related to the pulsatility index of both the internal carotid (r = 0.549; p = 0.0001) and the brachial (r = 0.484; p = 0.0001) arteries. DISCUSSION: In postmenopausal women, abdominal adiposity and hypoestrogenism increase oxidative stress. Climacteric symptoms, particularly vasomotor symptoms, markedly reduce antioxidant defences. Lower antioxidant defences are associated with higher resistance to blood flow in the great arteries. In women early after the menopause, visceral fat, hypoestrogenism and climacteric symptoms may increase the risk for cardiovascular disease.

Are climacteric complaints associated with risk factors of cardiovascular disease in peri-menopausal women?

Recent studies indicate that metabolic risk for cardiovascular disease is increased in post-menopausal women suffering from disturbances, such as hot flushes. In order to evaluate whether this is also true in peri-menopausal women, we performed an observational study on 590 peri-menopausal women of an outpatient center at a University Hospital. Each cardiovascular risk factor, such as blood pressure, fasting glucose, fasting lipids and the 10-year risk for cardiovascular disease was tested for its relation to climacteric complaints. Greene's climacteric scale, and its subscales were used to evaluate climacteric symptoms. Analyses were corrected for confounders derived by personal history and anthropometric measures. When corrected for confounders, Greene's score was a positive determinant of triglycerides (R(2 )= 0.249; p = 0.0001), triglycerides/HDL-cholesterol (R(2 )= 0.316; p = 0.0001), glucose (R(2 )= 0.101; p = 0.0003), and the 10-year risk for cardiovascular disease, calculated by the Framingham formula (R(2 )= 0.081; p = 0.0001). Greene's vasomotor sub-score was an independent determinant of LDL-cholesterol (R(2 )= 0.025; p = 0.01), and LDL/HDL-cholesterol (R(2 )= 0.143; p = 0.0001), while Greene's depression sub-score was a negative determinant of HDL-cholesterol (R(2 )= 0.179; p = 0.0001). The data also indicate that in peri-menopausal women, menopausal symptoms evaluated by a validated climacteric scale are associated with biochemical risk factors for atherosclerosis and cardiovascular disease.

The Sleepio After Cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial.

AIMS: This study will assess the efficacy of digital CBT for insomnia (dCBT-I) compared to sleep hygiene education (SHE) for the management of insomnia in women with cancer. BACKGROUND: 30% of patients with cancer meet insomnia diagnostic criteria and this can be detrimental to health outcomes. Insomnia disorder comprises a dissatisfaction with sleep quantity or quality characterized by difficulty initiating sleep, frequent awakenings, or early morning wakening without the ability to return to sleep, at least 3 nights per week, for at least 3 months, causing significant impairment or distress in areas of functioning. METHODS: We will recruit 308 women with a current or prior cancer diagnosis who are currently experiencing insomnia; defined as a score of 16 or less on the Sleep Condition Indicator (SCI). Participants will be randomised to dCBT-I or SHE. dCBT-I will be delivered online via 6 sessions. SHE will be provided in an online format. Assessments of sleep and other related parameters, through validated questionnaires, will be taken at 12 and 24 weeks following intervention. Once 24 week assessments are completed, participants will crossover to the alternate arm (either SHE or dCBT-I) and undergo a final assessment at week 36. OUTCOMES: The primary outcome will be the mean continuous change in SCI score in the intervention arm compared to the control arm at 24 weeks. Additionally, the proportion of women with an SCI > 16 at 24 weeks will be assessed. Secondary outcomes include fatigue, sleep related quality of life, depression, anxiety, and hot flush interference. REGISTRATION: This study is registered on ClinicalTrials.gov with number NCT05816460.

Menopausal hot flushes do not associate with changes in heart rate variability in controlled testing: a randomized trial on hormone therapy.

OBJECTIVE: To compare in controlled cardiovascular autonomic function tests the effects of hormone therapy (HT) on heart rate variability (HRV) responses in postmenopausal women with and without pretreatment hot flushes. DESIGN: A randomized placebo-controlled trial. SETTING: Finland, Helsinki University Central Hospital. POPULATION: A total of 150 recently postmenopausal and healthy women with prospectively evaluated hot flushes. METHODS: Women (72 with and 78 without hot flushes) were randomized to receive estradiol alone or in combination with medroxyprogesterone acetate or placebo for 6 months. Time and frequency domain measures of HRV were assessed at baseline and after HT with short-term recordings during paced quiet and deep breathing and with active orthostatic tests, both under carefully controlled laboratory conditions to avoid confounding factors present in long-term ambulatory HRV measurements. MAIN OUTCOME MEASURES: Responses of time and frequency domain measures of HRV to HT. RESULTS: At baseline HRV was similar in women with and without hot flushes. Pretreatment hot flushes did not associate with changes in time domain parameters of HRV during controlled quiet or deep breathing or active orthostatic tests after different types of HT. However, HT reduced HRV in very low frequency power in women with pretreatment hot flushes (from 371 ± 40 to 258 ± 28 ms(2) , p = 0.018). HT did not have an effect on other frequency domain measures during quiet breathing or active orthostatic tests. CONCLUSIONS: Hormone therapy did not significantly modify the HRV responses in women with or without hot flushes under controlled short-term measurements of the cardiovascular autonomic nervous system.

The impact of 17ß-estradiol on the estrogen-deficient female brain: from mechanisms to therapy with hot flushes as target symptoms.

Sex steroids are essential for whole body development and functions. Among these steroids, 17ß-estradiol (E2) has been known as the principal "female" hormone. However, E2's actions are not restricted to reproduction, as it plays a myriad of important roles throughout the body including the brain. In fact, this hormone also has profound effects on the female brain throughout the life span. The brain receives this gonadal hormone from the circulation, and local formation of E2 from testosterone via aromatase has been shown. Therefore, the brain appears to be not only a target but also a producer of this steroid. The beneficial broad actions of the hormone in the brain are the end result of well-orchestrated delayed genomic and rapid non-genomic responses. A drastic and steady decline in circulating E2 in a female occurs naturally over an extended period of time starting with the perimenopausal transition, as ovarian functions are gradually declining until the complete cessation of the menstrual cycle. The waning of endogenous E2 in the blood leads to an estrogen-deficient brain. This adversely impacts neural and behavioral functions and may lead to a constellation of maladies such as vasomotor symptoms with varying severity among women and, also, over time within an individual. Vasomotor symptoms triggered apparently by estrogen deficiency are related to abnormal changes in the hypothalamus particularly involving its preoptic and anterior areas. However, conventional hormone therapies to "re-estrogenize" the brain carry risks due to multiple confounding factors including unwanted hormonal exposure of the periphery. In this review, we focus on hot flushes as the archetypic manifestation of estrogen deprivation in the brain. Beyond our current mechanistic understanding of the symptoms, we highlight the arduous process and various obstacles of developing effective and safe therapies for hot flushes using E2. We discuss our preclinical efforts to constrain E2's beneficial actions to the brain by the DHED prodrug our laboratory developed to treat maladies associated with the hypoestrogenic brain.

Comparing the effects of face-to-face versus phone counseling based on cognitive-behavioral therapy for vasomotor symptoms in postmenopausal women: a randomized controlled trial.

Purpose: Menopause is associated with complications that may affect quality of life, such as hot flashes, night sweats, and mood swings. This study aimed to compare the effects of phone versus face-to-face counseling based on cognitive-behavioral therapy (CBT) for vasomotor symptoms in postmenopausal women. Methods: In this study, 40 eligible postmenopausal women were randomly assigned to face-to-face (n = 20) and phone counseling methods (n = 20). Six counseling sessions were held weekly for each person, and the women were requested to record their hot flashes (HF) and night sweats (NS) in a diary. HF and NS were measured at baseline, and 6 and 8 weeks after the completion of intervention. Data were analyzed using χ2, repeated measures ANCOVA, and independent t-test. Results: Means of weekly hot flashes and night sweats decreased after intervention in both groups (face-to-face group: HF frequency from 31.92 ± 7.98 to 18.83 ± 7.35, HF severity from 2.24 ± 0.28 to 1.21 ± 0.23, HF duration from 4.22 ± 1.17 min to 2.79 ± 0.91 min, NS frequency from 2.34 ± 0.31 to 1.21 ± 0.24 and NS severity from 1.70 ± 0.34 to 1.03 ± 0.29; and also in the phone counseling group: HF frequency from 33.32 ± 7.77 to 19.53 ± 7.7, HF severity from 2.23 ± 0.24 to 1.20 ± 0.18, HF duration from 4.29 ± 1.23 min to 2.68 ± 0.95 min, NS frequency from 2.33 ± 0.31 to 1.14 ± 0.16 and NS severity from 1.59 ± 0.34 to 1.01 ± 0.30). Although the differences within each group were significant (p < 0.001), there was no significant difference between the groups after the intervention in terms of HF frequency, severity, and duration, as well as NS frequency and severity (p > 0.05). Conclusions: Face-to-face and phone counseling methods based on CBT had a similar effect on reducing hot flashes and night sweats. Both methods can be used for women with postmenopausal complications such as hot flashes and night sweats.

The effect of oral vitamin E and omega-3 alone and in combination on menopausal hot flushes: A systematic review and meta-analysis.

This systematic review was conducted to investigate the effects of vitamin E and omega-3 used alone and in combination on the frequency and intensity of hot flushes (primary outcomes) and adverse effects (secondary outcome) in menopausal women. English and Persian databases were searched until March 18, 2021. The quality of the published papers was evaluated using Cochrane Handbook and the meta-analysis was conducted in RevMan 5.3. Heterogeneity was assessed using I2. In cases with substantial heterogeneity, a random effects model was used instead of a fixed effects model. A total of 387 papers were obtained from the databases. Finally, 10 papers with a sample size of 1100 participants entered the systematic review and a meta-analysis was conducted on nine of them. The results of the meta-analysis of two studies indicated that using vitamin E and omega-3 in combination significantly reduced the intensity of hot flushes compared to the placebo (mean difference (MD): -0.35; 95% CI: -0.48 to -0.21). The mean frequency (MD: -0.50; 95% CI: -1.58 to 0.58) and intensity (SMD: -0.61; 95% CI: -1.50 to 0.29) of hot flushes in the omega-3 group and the frequency of hot flushes (SMD: -0.21; 95% CI: -0.47 to 0.04) in the vitamin E group showed no significant differences with the placebo. No serious adverse effects were reported in the studies. Given the low number of RCTs, more clinical trials with larger sample size are required.

Transcriptomic changes in the hypothalamus of ovariectomized mice: Data from RNA-seq analysis.

BACKGROUND: Menopausal symptoms can affect the physical and mental health of females and are often related to abnormal function of the hypothalamus. In this study, we evaluated changes in the hypothalamus transcriptome in ovariectomized mice to identify key mRNAs, and systematically elucidated the possible molecular mechanisms underlying the menopausal syndrome to provide a theoretical basis for clinical diagnosis and treatment. METHODS: Forty-six adult female C57BL/6 J mice were randomly divided into SHAM and OVX groups, 23 mice per group. Eight weeks after the procedure, differentially expressed genes (DEGs) in the hypothalamus were identified through RNA-sequencing. DEGs were analyzed using Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genome (KEGG) analyses. Key DEGs were then evaluated using quantitative reverse transcription-polymerase chain reaction (qRT-PCR) and immunohistochemical staining. RESULTS: Compared with SHAM group, 7295 genes were upregulated, and 8979 genes were downregulated in the hypothalamus of OVX mice with a fold change of 1.5 (log2 fold change ≥0.585). GO and KEGG analyses suggested these key genes were involved in thermoregulation, food intake, glucose and lipid metabolism, cardiovascular regulation, biological rhythm, and endocrine regulation. CONCLUSIONS: Differential expression of genes in the hypothalamus of OVX mice involved in thermoregulation, eating, sleeping, homeostasis, and endocrine regulation 8 weeks after ovariectomy suggest potential roles in the pathogenesis of climacteric syndrome.