Severity Of Hot Flashes Research Articles

Alliance A222001: A randomized, double-blind, placebo controlled phase II study of oxybutynin versus placebo for the treatment of hot flashes in men receiving androgen deprivation therapy.

LBA12004 Background: Hot flashes are among the most common adverse events impacting quality of life reported by patients receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. Oxybutynin is an effective therapy for reducing frequency and severity of hot flashes in women. Pilot information supports that this drug may also benefit men with hot flashes related to ADT. Methods: Patients with prostate cancer receiving a stable regimen of ADT with at least 28 hot flashes per week were randomized to receive either oral oxybutynin 2.5 mg twice a day, oxybutynin 5 mg twice a day, or matching placebo doses for 6 weeks. The primary endpoint was the change in patient-reported hot flash scores (determined by multiplying the number of hot flashes by the mean hot flash severity [grade 0: none, 1: mild, 2: moderate, 3: severe, and 4: very severe]) from baseline to 6 weeks, as measured by a daily hot flash diary. A total of 87 patients provided 76% power to reject the null hypothesis of no between-arm mean difference in hot flash score reduction from baseline to 6 weeks, when comparing each oxybutynin arm to the combined placebo arms. This was based on a two-sided contrast estimated from a generalized linear mixed model, α= 0.10, intraclass correlation of 0.50, population standardized mean difference of 0.50, and 10% missing data rate. Results: 88 patients were accrued between 10/28/21 and 12/02/23. Six patients cancelled before starting treatment and one was ineligible, leaving 81 analyzed patients with a median age of 68. Baseline characteristics were balanced between arms with patients reporting an average of 10.15 (SD = 5.55) hot flashes per day and an average daily hot flash score of 18.23 (SD = 13.48) at enrollment. On average, patients on the placebo arm, low dose oxybutynin arm, and high dose oxybutynin arm had reductions of 2.15, 4.77, and 6.89 hot flashes/day, respectively. Compared to placebo arm patients, high dose oxybutynin arm patients had a greater reduction in hot flashes/day (p < 0.001), as did low dose oxybutynin arm patients (p = 0.02). Daily hot flash scores for the same three protocol arms reduced by an average of 4.85, 9.94, and 13.95 points, respectively. Compared to placebo arm patients, high dose oxybutynin arm patients had a greater reduction in daily hot flash scores (p = 0.002), as did low dose oxybutynin arm patients (p = 0.07). No treatment-related grade 3+ adverse events occurred. The most commonly reported oxybutynin-related grade 2 adverse event was dry mouth. Conclusions: Oxybutynin is superior to a placebo for the management of hot flashes in men associated with androgen deprivation therapy and appears to be well tolerated. Support: UG1CA189823; https://acknowledgments.alliancefound.org . Clinical trial information: NCT04600336 .

Abstract PO5-12-07: Analyzing Patient Experiences with Adjuvant Hormone Therapy for Early Breast Cancer Treatment via NLP/ML on Social Media: Symptoms and Their Mitigation

Abstract Understanding the early breast cancer (eBC) patient experience of disease and treatment is critical to addressing unmet patient needs, improving outcomes, and informing the next wave of drug development. Traditional approaches, such as interviews or focus group studies, are resource intensive and have limitations in reflecting the diverse experiences of patients with different disease characteristics, treatments, and sociodemographic backgrounds, and in detecting rare severe events that could potentially lead to therapy discontinuation. To overcome these limitations, we have developed a semi-automated approach utilizing Natural Language Processing (NLP) and Machine Learning (ML) methods in application to public patient forums to extract patient insights. Specifically, we analyzed 500,000 anonymized posts from the BreastCancer.org forum, utilizing Transformer-based methods to identify posts related to eBC patient experiences treated with standard hormonal therapies (HT). First, a novel ML-based model identified posts related to eBC adjuvant HT. For those, patient demographics, symptoms and their severity, and symptom management strategies such as exercise and yoga were subject to further analysis. Out of 362,074 relevant eBC posts, 32 symptoms and 9 impacts were significantly associated with at least one of the six hormonal therapies we considered. Hot flushes (relative risk [RR]: 6.70; 95% CI: 3.36–13.36), arthralgia (RR: 6.67; 95% CI: 3.53–12.59), weight increase (RR: 4.83; 95% CI: 3.20–7.28), mood swings (RR: 7.36; 95% CI: 5.75–9.42), insomnia (RR: 4.76; 95% CI: 3.14–7.22), and depression (RR: 3.05; 95% CI: 1.71–5.44) demonstrated the strongest associations. Severe headache, dizziness, back pain, and muscle spasms showed significant associations with ≥1 HT despite their low overall prevalence in eBC posts. Notably, posts contained a wide range of symptoms severity, including rarely seen symptoms in smaller patient pools, such as severe night hot flashes leading to treatment discontinuation. Symptoms/impacts mentioned in association with exercise and yoga as a way for symptom mitigation included hot flashes, arthralgia, fatigue, anxiety, depression, and pain. Of those posts, 53.3% to 82.5% reported positive or neutral sentiments for exercise, and 22.2% to 100.0% for yoga. For posts specifically mentioning the management of side effects of HT, between 50.0% and 63.5% had a positive sentiment associated with exercise concerning each of the symptoms/impacts with a lower positive impact related to yoga (between 11.1% and 43.0% of posts). Posts discussing pain management and exercise included a higher proportion of negative feedback, versus positive sentiment for depression. Posts related to yoga as an HT symptom mitigation strategy had a higher prevalence of negative sentiments for anxiety and depression. Our proposed ML/NLP-based approach to collecting patient feedback from publicly available forums complements standard qualitative methods by enabling the scalable extraction of insights from hundreds of thousands of online conversations that could span a broad diversity of symptoms and well-being reflections. Furthermore, our findings suggest the potential value of informing clinical outcome assessment (COA) measurement for clinical trials, alone and in combination with standard qualitative research approaches to guide the next clinical development. Overall, our study highlights the significant potential of NLP and ML to address the critical need to better understand the eBC patient experience of disease and treatment to improve outcomes for patients. Citation Format: Sameet Sreenivasan, Chao Fang, Emuella Flood, Natasha Markuzon, Jasmine Sze. Analyzing Patient Experiences with Adjuvant Hormone Therapy for Early Breast Cancer Treatment via NLP/ML on Social Media: Symptoms and Their Mitigation [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-12-07.

Abstract PS15-06: Results of the window-of-opportunity PIONEER trial evaluating addition of the progesterone receptor (PR) agonist megestrol to letrozole for early stage estrogen receptor (ER) positive breast cancer: exploiting ER-PR interaction

Abstract Background: Pre-clinical data suggest that combining anti-estrogen treatment with a progesterone receptor agonist leads to greater inhibition of tumor proliferation, due to molecular interactions between ER and PR [1]. A high dose of the PR agonist megestrol (160mg daily) is approved as monotherapy for the treatment of ER positive metastatic breast cancer. A lower dose of megestrol (20-40mg daily) can be an effective treatment for severe hot flashes associated with endocrine therapy [2] but whether this dose has anti-tumor activity is unknown. The PIONEER trial evaluated the potential anti-proliferative effect of low and high dose megestrol in combination with letrozole, relative to letrozole alone, using a short-term preoperative ‘window’ trial design assessing the direct effects of the trial treatment on tumor tissue before and after treatment. Methods: Eligible patients were post-menopausal women with histologically confirmed ER+ (Allred ≥ 3) HER2 negative breast cancer at least 10mm in size, with an ECOG performance status ≤ 2, planned for primary surgery or endocrine therapy. Enrolled patients were randomised 2:3:3 to Arm A: letrozole alone, Arm B: letrozole + lower-dose megestrol (40mg) or Arm C: letrozole + higher-dose megestrol (160mg). Treatment was given for 15 (13-19) days prior to surgery or end of treatment (EOT) core biopsy. The primary endpoint was change in tumor proliferation between baseline and EOT in Arm A vs (Arms B+C combined), measured by Ki67 immunohistochemistry (IHC). Secondary endpoints were comparison of Ki67 change in high versus low dose megestrol arms, absolute Ki67 at EOT, and change in tumor apoptosis (cleaved caspase 3 IHC), proliferation (Aurora Kinase A IHC), PR and androgen receptor expression. Exploratory analysis of ER chromatin binding (ChIP-Seq) was conducted on paired fresh-frozen samples from a subset of patients. Results: A total of 243 patients were randomised from July 2017 to October 2022 with recruitment paused for 3 months at onset of the COVID pandemic. 198 patients completed treatment and had evaluable tissue samples at baseline and EOT (Arm A: n = 51, Arm B: n = 74, Arm C: n = 73). Baseline mean Ki67 values were well balanced. Therapy was well tolerated and adverse events ≥ grade 3 were similarly rare across arms (A: 3.3%, B+C: 3.5%). The mean % reduction in Ki67 for each arm was: Arm A (letrozole): 71%, Arm B (letrozole + 40mg megestrol): 79%, Arm C (letrozole + 160mg megestrol): 80%. There was a statistically significantly greater reduction in Ki67 with megestrol combinations (B+C) versus letrozole alone (A) (P = 0.013). Analyses of secondary IHC endpoints and ER ChIP-Seq are ongoing and will be presented. Conclusion: Addition of the PR agonist megestrol enhanced the anti-proliferative effect of letrozole in this window-of opportunity trial. Megestrol combinations were well tolerated, and the anti-proliferative effect was observed in both low and high dose arms. These data support the potential use of low-dose megestrol as an inexpensive and well-tolerated means of improving aromatase inhibitor efficacy. Low dose megestrol can also ameliorate hot flashes and therefore might be a strategy to improve both treatment adherence and clinical outcomes for patients taking adjuvant endocrine therapy.

Blood pressure responses to isometric handgrip exercise and post-exercise ischemia in females with no/low or high severity hot flash symptoms

Introduction: Severe menopausal hot flash symptoms are linked to the development of cardiovascular disease. Exaggerated blood pressure responses to exercise are also associated with an increased risk of hypertension and cardiovascular disease. It is unclear if females with more severe hot flash symptoms exhibit greater blood pressure responses to exercise compared to those with minimal menopausal hot flashes. We aimed to determine if there is a difference in the pressor response to isometric exercise between females with severe hot flash symptoms compared to females with no/low hot flash symptoms. We hypothesized that there will be exaggerated blood pressure responses to isometric handgrip exercise (IHG) and post-exercise ischemia (PEI) in females who have severe menopausal hot flashes compared to females with no/low hot flashes. Methods: We studied 19 female participants (age: 51±5yrs) with no history of cardiovascular disease or hypertension. The Menopausal Rating Scale (MRS) was used to assess the hot flash symptom severity and to group the participants into no/low (no-or-mild on MRS) or high (moderate-or-severe on MRS) hot flash symptom groups. Continuous blood pressure (BP) was measured via photoplethysmography and calibrated relative to a brachial arm cuff pressure. After 2 minutes of quiet rest, participants performed 2 minutes of IHG at 30% of maximal voluntary contraction, followed by 2 minutes of PEI on the exercising arm to isolate the metaboreflex. The severity groups were compared via independent samples t-tests. Results: There were 13 females in the no/low group and 6 females in the high group. Baseline heart rate (HR, no/low: 60±11 vs high: 58±8bpm), systolic (SBP, no/low:129±18 vs high: 120±14mmHg), diastolic (DBP, no/low: 72±12 vs high: 63±7mmHg) and mean BP (MBP, no/low: 91±11 vs high 82±9mmHg) were not different between groups. There were no differences in the pressor responses to IHG between groups (HR: no/low: Δ6±5 vs high: 5±4bpm, p=0.425; SBP: no/low: Δ9±5 vs high: 11±6mmHg, p=0.408; DBP: no/low: Δ5±3 vs high: 7±4mmHg, p=0.182; MBP: no/low: Δ6±3 vs high: 8±4mmHg, p=0.253). There was also no difference in the pressor response to PEI between groups (HR: no/low: Δ6±6 vs high: 4±2bpm, p=0.554; SBP: no/low: Δ11±6 vs high: 16±9mmHg, p=0.191; DBP: no/low: Δ5±3 vs high: 8±6mmHg, p=0.298; MBP: no/low: Δ7±4 vs high: 11±7mmHg, p=0.280). Conclusion: The current data show no differences in the blood pressure responses to IHG or PEI between females with different menopausal hot flash symptom severities. This suggests that pressor responses to an IHG exercise and the metaboreflex may not be notable contributors to the increased cardiovascular risk in females with severe menopausal hot flashes. NIH: K01 HL148144, NCATS UL1 TR000135, UL1 TR002377; AHA: 898649. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Physical Activity Influences the Relationship between Objectively Measured Hot Flashes and Endothelial Function in Perimenopausal Women

Hot flashes (HF) are disruptive symptoms experienced by approximately 80% of women undergoing menopause. The transition to menopause is associated with increases in CVD risk factors. The frequency and severity of HF have been associated with poorer cardiovascular health but most of these studies have quantified HF by self-report and have not considered physical activity (PA), known for its cardiovascular benefits. The association between HFs and CVD risk may be through their effect on endothelial health. The objective of this study was to evaluate the relationship between objectively measured HF and endothelial function and determine the effect of physical activity on the relationship in healthy perimenopausal women. We hypothesized that more HF would be associated with lower endothelial function and PA would influence this relationship. Healthy perimenopausal women (n=52, age 43-54) were included in this analysis. Perimenopause was defined as ≥7d difference in the length of consecutive cycles to <12 months of amenorrhea. Hot flashes were measured objectively using sternal skin conductance for 24 hours. The number of HF experienced and HF rate (normalized to actual wear time) were quantified. Endothelial function was assessed with measures of brachial artery flow mediated dilation (FMD, %) on the non-dominant arm. Moderate to vigorous physical activity (MVPA) was assessed with 7-days of actigraphy monitoring on the non-dominant wrist. The R package GGIR and Hildebrand (2016) cut points were used to quantify PA intensity and reported as sum of the average minutes of moderate and vigorous physical activity per day. Pearson correlations and multiple regression analyses were used to evaluate relationships between variables. Data met all assumptions for statistical tests. Modeling was performed to evaluate whether HFs were predictors of the main outcome of FMD (R version 4.2.3 and RStudio version 2023.06.2+561). Age and BMI were included in all models. Lower FMD was significantly correlated with a higher objective HF rate ( r (52) =-0.27, p=0.05). Objective HF rate predicted FMD (β=-3.91, p=0.04) when controlling for age and BMI (adj R2=0.100, F(3,48) =2.892, p=.05). When MVPA was added to the model, MVPA alone was not a significant predictor but the interaction between MVPA and HF was (β=0.12, p=0.04; adj R2=0.147, F(5,46) =2.761, p<0.03). This interaction was such that higher levels of MVPA were related to a less strongly negative relationship between objective HF rate and FMD. A simple slopes analysis found that the HF rate effect at one SD below the mean MVPA was significantly negative, (β=-8.64, p=0.004), whereas the HF rate effect at one SD above the mean MVPA was not significant, (β=0.18, p=0.95). These data provide strong evidence that support the hypothesis that a greater number of objectively-assessed hot flashes is associated with lower endothelial function in perimenopausal women and that higher amount of physical activity serves as a buffer against the negative relation between hot flashes and FMD. NIH NHLBI R15 Grant 1R15HL145650-01A1 (Witkowski); Smith College McKinley s Honors Fellowship (Tha Ra Wun); Smith College STRIDE (Buszkiewicz). This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Menopausal Hot Flashes Are Not Associated with Pressor Responses to Cold Stress

Menopausal females who experience frequent hot flashes (episodes of increased body temperature and sweating) have a greater risk of hypertension and cardiovascular disease than females without hot flashes. Individuals with exaggerated blood pressure (BP) responses to cold stress have a higher risk of hypertension than those with lower responses. It is unknown if females who experience hot flashes have exaggerated pressor responses to cold stress, indicating their greater risk of hypertension. The aim of this study was to determine the pressor responses to cold stress in females who experience hot flashes and those who do not. An additional goal was to understand the relation between daily hot flash frequency and pressor responses. We hypothesized that females with hot flashes would have exaggerated pressor responses to cold stress compared to females without hot flashes. We also hypothesized that pressor responses would be positively correlated to daily hot flash frequency. We recruited 17 females, ages 45-60 years, without hypertension or cardiovascular disease, who did and did not have hot flashes. They reported hot flash frequency in a 3-day written diary. On the study day, continuous BP (finger photoplethysmography, calibrated to brachial cuff BP) and heart rate (HR; 3-lead ECG) were recorded while the participant rested during a 2-minute baseline period, then subsequently had an ice-water pack placed on their forehead for 3 minutes. The changes in mean BP (MBP) and HR are calculated as the change in MBP or HR during the cold pressor test minus the average MBP or HR during baseline. Data were analyzed using the Student’s t-test and Pearson correlation. Twelve females reported hot flashes (age: 51±4 years; average number of hot flashes: 3 per day) and five did not (age: 49±5 years). These groups did not differ in age, body mass index, resting MBP, or resting HR (p>0.05 for all). The change in MBP from baseline to the cold pressor test did not differ between females with and without hot flashes (Δ17±10 vs. Δ19±14 mmHg, respectively; p=0.860). The change in HR with the cold pressor test also did not differ between females who did and did not report hot flashes (Δ10±6 vs. Δ12±8 mmHg, respectively; p=0.647). In females with hot flashes, the number of hot flashes reported per day (range: 1-12 per day) was not correlated with the change in MBP (p=0.824) or HR (p=0.460) during the cold pressor test. These current data show that menopausal females who experience hot flashes do not exhibit exaggerated BP or HR responses to cold stress in comparison to females who do not experience hot flashes. In addition, BP and HR responses are not correlated with daily hot flash frequency. There are likely other vascular mechanisms that place menopausal females with hot flashes at an increased risk for hypertension. In addition, incorporating information on the age at which hot flashes began, as well as hot flash severity, might help us to further understand cardiovascular risk in this population. AHA 898649, NIH T32 DK07352, K01 HL148144, NCATS UL1 TR002377. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Association between sleep complaints with the presence and severity of hot flashes in Colombian postmenopausal women: assessment with the Jenkins Sleep Scale

Association between sleep complaints with the presence and severity of hot flashes in Colombian postmenopausal women: assessment with the Jenkins Sleep Scale

Stellate ganglion block with procaine in breast cancer survivors with hot flashes and sleep disturbances undergoing Endocrine Therapy.

Breast cancer survivors under endocrine therapy (ET) suffer from side effects such as hot flashes and sleep disturbance accompanied by poor quality of life. Many quit ET early and reduce their survival rate. Guidelines recommend gabapentin next to yoga or acupuncture. The role of side effects related to compliance with ET over years require new and effective therapies. Stellate ganglion block (SGB) has shown evidence of safety and efficacy and was found to be more effective than pregabalin without side effects. However, practical guidelines for the long-term use of SGB are still missing. We primarily used procaine instead of bupivacaine presuming effectiveness paired with lower toxic risks. Twenty-nine breast cancer survivors with severe hot flashes and sleep disturbance under ET received SGB with Procaine. Diaries recorded hot flashes and sleep quality scores up to week 24. All patients took part and none refused SGB. Each Patient received one SGB every 4 weeks without any side effects observed. Weekly scores were reduced from baseline by -33.6% (P < .01) (hot flashes) and -22.3% (P < .01) (sleep disturbances) after 4, and by -58.8% (P < .01) (hot flashes) and -50.8% (P < .01) (sleep disturbances) after twenty-for weeks. A wavelike reduction indicated a limited effect of a single SGB during continuous ET. We showed, that procaine in SGB is as effective as bupivacaine with lower risks and costs. High significant reductions in hot flashes and sleep disturbances after 1 and 6 months were found. We conclude that breast cancer survivors need individual treatment with SGB due to her personal impact. Hence, SGB should find its way to guidelines and daily routines as a valuable method for treating side effects in breast cancer survivors undergoing ET.

Counseling in menopausal women: How to address the benefits and risks of menopause hormone therapy. A FIGO position paper.

Menopause marks the end of menstrual cyclicity and, depending on individual vulnerability, has several consequences related to gonadal steroid deprivation, especially if it is premature. Menopause may be more burdensome for some women than for others. Individual factors, such as personal history, socioeconomic status, ethnicity, and current health conditions, affect symptomatology and, thereby, the menopausal experience. In addition, some menopausal symptoms, such as severe hot flashes, sleep disorders, and depression, are markers of future health risks. Counseling is a fundamental part of health care in the peri- and postmenopause periods. It must include an assessment of the patient's symptoms, needs, desires, and risk profile to address the benefits and risks of menopausal hormone therapy (MHT) on an individual basis and promote a healthy lifestyle. Indeed, healthcare practitioners can and must protect the health and lives of mid-life women by increasing awareness of menopausal symptoms and ensuring healthcare options, especially MHT. The type and duration of MHT should be tailored based on the patient's history, menopausal age, physical characteristics, and current health status so that the benefits always outweigh the risks. This FIGO position paper focuses on the benefits and risks of MHT on health domains, target organs, and systems, and on systemic and vaginal MHT regimens, to provide indications that can be used in the clinical practice for menopausal counseling. Moreover, it offers insights into what FIGO considers the mainstay for the healthcare management of women in peri- and postmenopause, worldwide.

Feasibility of a novel wearable thermal device for management of bothersome hot flashes in patients with prostate cancer

BackgroundThis single-arm prospective study evaluated the feasibility of a novel wrist-worn thermal device that applies cooling to the inside of the wrist for management of bothersome hot flashes in prostate cancer survivors.Methods57 individuals were enrolled and instructed to use the thermal device as needed for management of hot flashes for 4 weeks. The primary outcome was thermal device usage (hours and sessions per day). Additional outcomes included the change in Hot Flash Related Daily Interference Scale (HFRDIS, range 0–10) and Patient Reported Outcomes Measurement Information System Sleep Disturbance 4a (PROMIS SD T-score, range 0–100) and Sleep-Related Impairment 8a (PROMIS SRI T-score, range 0–100). Study procedures were conducted remotely from May to Dec 2021 in the US.Results44 participants completed the study and 39 had retrievable usage data. The mean ± SD age was 67 ± 6 years and 5 ± 5 years since cancer diagnosis. The baseline mean ± SD HFRDIS score of 4.3 ± 2.0 indicated moderate hot flash interference in this population. During the study, participants used the thermal device (mean ± SD) 3.2 ± 2.5 hours/day and 7.6 ± 3.6 sessions/day. Most (67%) participants reported using the device 7 days and 7 nights each week. Statistically significant improvements from baseline at Week 4 were observed for HFRDIS (mean ± SE change: −1.1 ± 0.3), PROMIS SD (−6.0 ± 1.0), and PROMIS SRI (−5.5 ± 1.2) scores (all p < 0.001). The majority (69%) of participants reported that the thermal device was effective at helping them manage hot flashes. No adverse events were reported.ConclusionsResults support the feasibility of using the thermal device for management of bothersome hot flashes in prostate cancer survivors. Future randomized controlled studies are warranted to evaluate the impact of the thermal device on frequency and severity of hot flashes, sleep quality, fatigue, and overall quality of life.

PERBEDAAN EFEKTIFITAS PEMBERIAN MINYAK ZAITUN (OLIVE OIL) DAN MINYAK KELAPA MURNI (VIRGIN COCONUT OIL) TERHADAP PENYEMBUHN RUAM PADA POPOK BAYI DI KLINIK TAHUN 2023

Babies will be sensitive to everything around them. Babies have relatively thin skin, making them susceptible to infection, inflammation and allergies. One of the most common skin problems is diaper rash. Diaper rash appears on the baby's thighs and buttocks. Causes of diaper rash include poor skin hygiene, severe hot flashes, and diarrhea. OBJECTIVE: To find out whether there is a difference in the effect between olive oil and coconut oil in healing diaper rash in babies. METHODS: This study used a two-group design with a quasi-experimental style, before and after a test-control design. The study population consisted of babies aged 0-12 months who suffered from diaper rash in Kasih Ibu, Deli Tua District, Deli Serdang Regency, who had an average of 17 visits. Non-random sampling and targeted sampling using the Federer formula were used in this sample, with a total sample size of 16 people. An observation sheet with the Mann-Whitney test was used as an instrument. RESULTS: The results of the bivariate analysis test using Mann-Whitney showed that the average value for giving olive oil was (1.75) from 8 samples and for giving pure coconut oil, it was (1.25) with an average difference of (50). ) with Z count for giving olive oil (2.936) and giving muri coconut oil (0.3032). Based on the results of the Mann-Whitney test, the p-value was 0.023. Because the p-value &lt;0.05, it can be concluded that there is a significant difference between the use of olive oil and pure coconut oil for healing diaper rash in babies at the Kasih Ibu Clinic, Deli Tua District, Deli Serdang Regency in 2023 Suggestion: In the future, it is hoped that research will be more advanced and the results will be enriched by looking for other treatments that can be used to reduce the severity of diaper rash, such as giving aloe vera or honey.

Interleukin-17, C-reactive protein, Neutrophil-to-Lymphocyte ratio, Lymphocyte-to-Monocyte ratio, and lipid profiles in healthy menopausal women with or without hot flashes: A cross-sectional study.

The reciprocation between systemic inflammatory markers (SIMs), dyslipidemia, and hot flashes (HFs) can play a part in the pathogenesis of endothelial dysfunction through menopause. This study intended to determine the association between some SIMs, lipids, and HFs in healthy menopausal women. We designed a cross-sectional study in which 160 healthy menopausal women aged 40-60 were enrolled. Concerning their HFs status, they were stratified into two groups by consecutive sampling: without HFs (n = 40) and with HFs (n = 120). In addition to clinical variables and HFs experience, we measured the fasting serum levels of SIMs and lipid profiles (LPs), including Interleukin-17 (IL-17), high- sensitivity C-Reactive Protein (hs-CRP), Total Cholesterol (TC), Triglycerides (TG), Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) in each group. Then, we calculated TC/HDL-C concerning the related variables and determined Neutrophil-to-Lymphocyte Ratio (NLR), and Lymphocyte-to-Monocyte Ratio (LMR), according to Complete Blood Count (CBC) quantitative parameters in each group. Furthermore, we used logistic regression analysis to assess the association between SIMs, LPs, and HFs. We performed this study in a governmental teaching hospital, Guilan/Rasht, Iran, from April to September 2021. The two groups of menopausal women without and with HFs were not significantly different regarding the median of IL-17, hs-CRP, NLR, LMR, TG, HDL-C, and TC/HDL-C, and the mean of TC and LDL-C. Based on multiple logistic regression, TG levels appeared to be associated with the incidence of HFs (B = 0.004, P = 0.040, Odds Ratio:1.004, 95%CI:1.000-1.009). NLR seemed to have an increasing impact on the HFs severity, according to ordinal logistic regression (B = 0.779, P = 0.005, Odds Ratio = 2.180, 95%CI:1.270-3.744). Furthermore, hs-CRP negatively correlated with TG (r = -0.189, P = 0.039) and TC/HDL-C (r = -0.268, P = 0.003) in menopausal women with HFs. This study indicated an association between SIMs, lipids, and HFs. These connections may suggest HFs as links between SIMs/LPs alterations and their outcomes.

A dietary intervention for postmenopausal hot flashes: A potential role of gut microbiome. An exploratory analysis

ObjectiveThis study examined the role of gut microbiome changes in mediating the effects of a dietary intervention on the frequency and severity of postmenopausal vasomotor symptoms MethodsPostmenopausal women (n = 84) reporting ≥2 moderate-to-severe hot flashes daily were randomly assigned, in 2 successive cohorts, to an intervention including a low-fat, vegan diet and cooked soybeans (½ cup [86 g] daily) or to stay on their usual diet. Over a 12-week period, frequency and severity of hot flashes were recorded with a mobile application. In a subset of 11 women, gut microbiome was analyzed at baseline and after 12 weeks of the dietary intervention (low-fat vegan diet with soybeans), using deep shotgun metagenomic sequencing. Differences in the microbiome between baseline and 12 weeks were assessed by comparing alpha diversity with Wilcoxon signed rank tests, beta diversity with permanovaFL, and taxon abundance with Wilcoxon signed rank tests. Pearson correlations were used to assess the association between changes in hot flashes and gut bacteria. ResultsIn the subset for which microbiome testing was done, total hot flashes decreased by 95 % during the dietary intervention (p = 0.007); severe hot flashes disappeared (from 0.6 to 0.0/day; p = 0.06); and moderate-to-severe hot flashes decreased by 96 % (p = 0.01). Daytime and nighttime hot flashes were reduced by 96 % (p = 0.01) and 94 % (p = 0.004), respectively. Alpha and beta diversity did not significantly differ in the intervention group between baseline and 12 weeks. Two families (Enterobacteriaceae and Veillonellaceae), 5 genera (Erysipelatoclostridium, Fusicatenibacter, Holdemanella, Intestinimonas, and Porphyromonas), and 6 species (Clostridium asparagiforme, Clostridium innocuum, Bacteroides thetaiotaomicron, Fusicatenibacter saccharivorans, Intestinimonas butyriciproducens, Prevotella corporis, and Streptococcus sp.) were differentially abundant, but after correction for multiple comparisons, these differences were no longer significant. Changes in the relative abundance of Porphyromonas and Prevotella corporis were associated with the reduction in severe day hot flashes both unadjusted (r = 0.61; p = 0.047; and r = 0.69; p = 0.02), respectively), and after adjustment for changes in body mass index (r = 0.63; p = 0.049; and r = 0.73; p = 0.02), respectively). Changes in relative abundance of Clostridium asparagiforme were associated with the reduction in total severe hot flashes (r = 0.69; p = 0.019) and severe night hot flashes (r = 0.82; p = 0.002) and the latter association remained significant after adjustment for changes in body mass index (r = 0.75; p = 0.01). ConclusionsThis exploratory analysis revealed potential associations between changes in vasomotor symptoms in response to a diet change and changes in the gut microbiome. Larger randomized clinical trials are needed to investigate these findings.

Pomegranate effects on the health aspects of women during peri- and postmenopause: A systematic review and meta-analysis.

Pomegranate is widely used to preserve human health and help prevent many kinds of diseases. This study aims to review and assess the effects of pomegranate on women's health during and after menopause. PubMed, Web of science, Cochrane, Scopus, and Google Scholar were searched up to the end of 2022 with no language or study type restriction. All types of clinical research studies (randomized clinical trial [RCT], pre-post, case report, and case series) were included. The Cochrane RoB 2.0 tool was used for quality assessment of RCTs. A summary of intervention's effects for each study was provided by calculating standardized mean differences and accompanying 95% confidence interval using random effect model. Weighted mean differences and heterogeneity between studies were assessed using Hedges's method and Cochran's Q test, respectively. Pomegranate can significantly improve hot flashes severity and menopause symptoms and decrease FSH. It significantly improves high-density lipoprotein but not low-density lipoprotein, body mass index, and weight. Most of our results are inconclusive, and the small sample sizes and the lack of blinding and randomization have led to an increased risk of bias. Pomegranate can decrease menopause symptoms, but more well-designed studies, with bigger sample sizes are needed to establish its other clinical benefits for menopausal women.

Associations of adverse childhood and lifetime experiences with sleep quality and duration among women in midlife

ObjectivesMany women experience sleep problems during midlife. Associations of adverse lifetime experiences—more common among women—with sleep outcomes are understudied. MethodsWe studied 476 women enrolled in Project Viva 1999-2002. At enrollment, participants reported any lifetime history of abuse and/or financial hardship. At midlife follow-up ∼20 years later, they reported a history of up to 10 adverse childhood experiences (ACEs); 7-day sleep quality (patient-reported outcomes measurement information system sleep disturbance and sleep-related impairment T-scores); and past month average sleep duration. We examined associations of adverse experiences with sleep outcomes, adjusted for childhood sociodemographic variables. We also explored mediation by current depression and anxiety symptoms, hot flash severity, general health, and body mass index. ResultsACEs were common: 301 women (63%) reported one or more. Each additional ACE was associated with higher midlife sleep disturbance (adjusted β = 0.65 points, 95% confidence interval [CI]: 0.27, 1.02) and sleep-related impairment (0.98, 95% CI: 0.54, 1.41) T-scores, and with sleep duration <6 hour/night (odds ratio 1.19, 95% CI: 1.00, 1.42), but not with continuous sleep duration (−2 minutes, 95% CI: −5, 1). Adverse experiences in adulthood were less consistently associated with sleep quality but were associated with sleep duration, for example, financial hardship during the index pregnancy was associated with 75 minutes (95% CI: −120, −29) shorter sleep duration 2 decades later. Associations of ACEs with sleep disturbance and sleep-related impairment were mediated by midlife depression anxiety and physical health but not by hot flash severity or body mass index. ConclusionsAdverse lifetime experiences have deleterious associations with sleep duration and quality in midlife women.

Acupuncture Reduces Severity of Hot Flashes in Breast Cancer: A Randomized Single-Blind Trial.

This study evaluated the effectiveness of traditional Chinese medicine-based therapeutic acupuncture (TA) in reducing the severity of hot flashes (HFs) in breast cancer patients and compared the effectiveness of TA to "sham" placebo acupuncture (SA). Subjects experiencing more than 10 episodes of HF/week were randomly assigned to TA or SA. The response was assessed by the Menopause-specific Quality of Life (MenQoL) scale, scoring the subject's perception of the severity of HFs. HFs were scored at baseline, after treatment, and 1-month follow-up. A total of 54 subjects enrolled (28 TA and 26 SA). Seven women withdrew from the study. A hot flash diary documented the number of HFs a subject experienced. Analysis included 47 subjects (27 TA and 20 SA). A statistically significant response in HF scores was noted in the TA group compared with the SA group (P = .0064.) On average HF scores dropped by 1.89 with TA, and only 0.16 with SA. At follow-up, TA subjects had a sustained response. TA is effective in reducing the intensity and severity of HF. With SA, no relative response/change in HF scores was noted. Larger studies and longer follow-up to assess durability of response to TA are needed.

The effect of genetic variation in estrogen transportation and metabolism on the severity of menopause symptoms: A study from the RIGHT 10K cohort.

The severity of menopause-related symptoms varies considerably among women. The determinants of this variation are incompletely understood. The aim of this study was to assess the association between genetic variation in estrogen metabolism and transport pathways and the severity of menopause symptoms. This was a cross-sectional study of 60 peri- and postmenopausal women in the Mayo Clinic RIGHT study (which involved sequencing of genes involved in drug metabolism and transport), who had also been evaluated in the Women's Health Clinic at Mayo Clinic in Rochester, MN. All participants completed the Menopause Rating Scale (MRS) for assessment of menopause symptoms, including hot flashes. The association between severity of menopause symptoms and the variation in genes encoding 8 enzymes and transporters involved in estrogen metabolism was evaluated. Lower CYP3A4 activity and higher COMT activity were associated with lower severity of somatic menopause symptoms (p=0.04 and 0.06, respectively). These associations did not persist after adjustment for hormone therapy use. No differences in MRS scores or hot flash severity were noted among other genetic variant groups. Age at natural menopause was not affected by variations in the genes studied. The current study did not show an association between genetic variation in estrogen metabolism and transport pathways and the severity of menopause symptoms. Further studies with larger sample sizes may be required to understand this potentially complex association.

Estro G-100 herbal extract and hot flashes in postmenopausal women: A randomized double-blinded controlled trial

ObjectiveThe present study aimed to determine the efficacy of EstroG-100 herbal extract on hot flashes in postmenopausal women. Material and methodsThis randomized, double-blind, placebo-controlled trial was performed on postmenopausal women recruited from two university hospitals complaining of hot flashes. The intervention group received two extract capsules (daily for 12 weeks), and the control group received two placebo capsules (daily for 12 weeks). Finally, the frequency and severity of hot flashes (F&S) were subjectively reported and compared weekly during the treatment for 12 weeks. ResultsOut of 120 randomized participants, 35 entered the final analysis for each group. In the third week, participants of the control group significantly reported more moderate hot flashes than other group (MD=1.00, P = 0.004). However, in terms of mild (MD=0.74, P = 0.057) and severe (MD=0.60, P = 0.064) hot flashes, the groups did not differ. In the sixth week, mild (MD=1.51, P<0.001), moderate (MD=1.54, P<0.001), and severe (MD=1.22, P<0.001) hot flashes were significantly reported more in the control group compared with another group. ConclusionThe present study revealed that EstroG-100 herbal extract could improve hot flashes in postmenopausal women.

Fezolinetant: First Approval.

Fezolinetant (VEOZAH™) is an oral, small molecule, neurokinin 3 receptor (NK3R) antagonist, which is being developed by Astellas Pharma Inc. for the treatment of moderate to severe vasomotor symptoms (VMS) or hot flashes due to menopause. Inhibiting NK3R-mediated signalling in the central nervous system is a non-hormonal strategy to modulate the activity of neurones that are associated with thermoregulation, thereby reducing the frequency and severity of VMS. Fezolinetant received its first approval in the USA in May 2023 for the treatment of moderate to severe VMS due to menopause. This article summarizes the milestones in the development of fezolinetant leading to this first approval in this indication.

The Effect of Salvia Officinalis on Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis.

The experience of hot flashes during menopause has a negative effect on quality of life and can cause disturbance in the workplace and disrupt daily activities. Phytoestrogens in Salvia officinalis reduce menopause symptoms due to their anti-dopaminergic effects. This study was conducted to systematically review and summarize the results of clinical trials on the effect of Salvia officinalis on hot flashes in postmenopausal women. In this systematic review, databases including Pubmed, Web of Science, Cochrane library, Scopus, SID, and Magiran were searched using keywords such as menopause, hot flashes, Salvia officinalis, and herbal medicines; all possible combinations of these words were used with the Boolean operators of "OR" and "AND". To evaluate the quality of articles, we used Cochrane's Risk of bias tools. After eliminating the duplicates, a total of 148 articles were found. Following the exclusion of irrelevant articles, 4 studies with number of 310 people were examined. Among them, 3 out of 4 studies examined the effect of Salvia officinalis on the frequency of hot flashes, 3 out of 4 studies examined the severity of hot flashes, and only 1 out of 4 studies examined the effect of Salvia officinalis on the duration of hot flashes. All 4 reviewed studies indicated that the use of Salvia officinalis reduced the frequency and severity of hot flashes in postmenopausal women. Meta-analysis results showed that the effect of Salvia Officinalis on the frequency [ES=-1.12 (%95 CI:-2.37; 0.14), I2=71%] of hot flashes in postmenopausal women was significant compared to placebo, but severity [ES=-2.05 (%95 CI:-6.53; 2.43), I2=70%] was not significant. Salvia officinalis can be used to reduce the frequency of menopausal hot flashes. Expansive use of this plant can be suggested in case it is confirmed in further investigations.