Menopause-specific Quality Of Life Research Articles

Study protocol for the ROLEX-DUO randomised placebo-controlled trial: ROmosozumab Loaded with EXercise – DUal effects on bone and muscle in postmenopausal Osteoporosis and Osteopenia

IntroductionNovel strategies are needed to address the rising burden of osteoporosis and fragility fractures. High-intensity resistance and impact (HiRIT) exercise has shown benefit in improving bone density in postmenopausal women...

The prevalence and severity of vasomotor and sexual symptoms among refugee women in Australia

Objective This study aimed to document the prevalence and severity of vasomotor symptoms (VMS) and sexual symptoms among refugee women in Melbourne, Australia. Methods This cross-sectional study included refugee women, aged 18–63 years, recruited from community centers and social media between February and July 2023. The Menopause-specific Quality of Life (MENQOL) questionnaire measured VMS and sexual symptoms. The scores were compared between different menopausal states. Results Of 333 participants, 62.8% were premenopausal, 8.0% perimenopausal and 29.2% postmenopausal, with a median age of 40 years (range 18–63 years). Moderate–severe VMS was most prevalent amongst perimenopausal (20.8%; 95% confidence interval [CI]: 8.9–41.4%) versus postmenopausal (9.5%; 95% CI: 5.0–17.3%) and premenopausal (0%) women. Moderate–severe sexual symptoms affected 15.8% (95% CI: 5.2–39.3%) of perimenopausal and 16.9% (95% CI: 10.4–26.1%) of postmenopausal women versus 1.4% (95% CI: 0.3-5.3%) of premenopausal women. Perimenopausal and postmenopausal women had higher VMS and sexual symptom scores than premenopausal women (both p < 0.0001); the scores were also higher in perimenopausal women than postmenopausal women (p = 0.016 and p = 0.013, respectively). Conclusion While perimenopausal and postmenopausal VMS and sexual symptoms are not uncommon amongst refugee women, these symptoms were less prevalent in postmenopausal refugees than in the non-refugee population. Further research is warranted to confirm and expand on these findings.

Menopausal stages and overactive bladder symptoms in middle-aged women: A cross-sectional study.

To examine the prevalence of overactive bladder (OAB) according to menopausal stages in middle-aged women. Cross-sectional study. Total Healthcare Center in South Korea. Middle-aged Korean women (n=3469, mean age, 49.5 ± 2.9 years). Menopausal stages were defined according to the Stages of Reproductive Aging Workshop +10 criteria, and menopausal symptoms were assessed using the Korean version of Menopause-Specific Quality of Life (MENQOL). Logistic regression models were used to estimate prevalence ratios with 95% confidence intervals for OAB according to menopausal stage and to assess the associations with menopausal symptoms. OAB symptoms were evaluated using the Overactive Bladder Symptom Score (OABSS). The prevalence of OAB increased with menopausal stage; however, the multivariable-adjusted prevalence ratios for women in menopausal transition and postmenopausal stage were insignificant (ptrend = 0.160) compared to those for premenopausal women. Among individual OAB symptoms, the multivariable-adjusted prevalence ratios for nocturia increased with menopausal stage in a dose-response manner (ptrend = 0.005 for 1 time/day; ptrend < 0.001 for ≥2 times/day). The association between menopausal stages and nocturia occurring ≥2 times/day was evident in women without OAB and with relatively high MENQOL scores, vasomotor symptoms and difficulty sleeping. The prevalence of OAB, particularly nocturia, increased with menopausal stage, and the association was obvious in women with other menopausal symptoms. This finding underscores the importance of addressing nocturia as a potential menopausal symptom in middle-aged women. Further studies are required to understand the mechanisms linking OAB with menopausal symptoms in middle-aged women.

Examining the Quality of Life among Working Women in Agartala During the Menopausal Transition: An In-Depth Analysis

Menopause is a critical phase in a woman’s life characterized by hormonal changes that can impact various aspects of health, including the quality of life. Despite the increasing number of women in the workforce, there is a noticeable gap in specific challenges and experiences of working women during the menopausal transition. The study aims to analyze the quality of life among working women in Agartala during the menopausal transition. The study includes N=30 working women from diverse professional backgrounds in Agartala. Data were collected through the MENQOL (Menopause-Specific Quality of Life) Questionnaire developed by John R Hilditch et.al, (1996). Descriptive statistics and percentage analysis were employed to interpret the data. The researcher has concluded that the quality of life of the working women of Agartala seems to experience greater physical, vasomotor, and sexual changes during this prolonged phase. The findings can contribute to developing targeted interventions and support systems aimed at enhancing the quality of life for this demographic group. Additionally, the study may serve as a foundation for further research in other geographical regions, fostering a broader understanding of menopausal experiences among working women.

Role of estradiol and C-reactive protein levels on genitourinary syndrome in menopausal women

Menopause leads to decreased estradiol levels affecting tissue health and causing local inflammation in the genital organs and urinary tract. The rise of blood C-reactive protein (CRP) levels in menopausal women may indicate systemic inflammation associated with estradiol decline. The aim of this study was to determine the relationship between serum estradiol and CRP levels on genitourinary syndrome in menopausal women. A cross-sectional study was conducted among menopausal women who had not experienced menstruation for at least 12 consecutive months at Prof. dr. Chairuddin P. Lubis Hospital, Medan, Indonesia, in 2023. Estradiol and CRP levels were measured using enzyme-linked immunosorbent assay (ELISA) and the presence of genitourinary syndrome was assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire. The mean levels of estradiol and CRP were compared to menopausal women with and without genitourinary syndrome with the Mann-Whitney test. To assess the correlation between estradiol and CRP levels, and between their levels with the presence of genitourinary symptoms, the Spearman correlation test was used. The genitourinary syndrome was reported in 25% of the total included menopausal women. Our data indicated that the mean estradiol levels were not significantly different between menopausal women with and without genitourinary syndrome (9.13±2.47 pg/mL vs 18.96±31.23 pg/mL, p=0.881). The mean serum CRP level of menopausal women with genitourinary syndrome (9.72±6.30 mg/L) was higher than that of women without the syndrome (2.09±1.26 mg/L) with p&lt;0.001. In addition, serum CRP level, not estradiol, was correlated with the symptom score of genitourinary syndrome. This study highlights that to identify and manage genitourinary syndrome, monitoring of CRP levels is essential in menopausal women.

Features, measurements, determinants, treatments, and outcomes of musculoskeletal symptoms in postmenopausal women: A scoping review

BackgroundThe literature lacks a consistent review of musculoskeletal symptoms in postmenopausal women. AimTo identify features, measurements, determinants, treatments, and outcomes of musculoskeletal symptoms in postmenopausal women. MethodA scoping review was completed using six databases: Embase, Medline, Cochrane, CINAHL, Web of Science, and Scopus up to December 2022. Sixty-three articles were identified. ResultsMusculoskeletal symptoms in postmenopausal women include somatic symptoms of non-specific origin, upper and lower limb symptoms, spinal pain, and decline in physical performance. Measurements were categorized into four groups: musculoskeletal symptoms for menopause, general musculoskeletal symptoms, menopause-specific quality of life, and general quality of life questionnaires. The determinants were grouped into four themes: demographics, physical determinants, psychosocial determinants, and lifestyle. Pharmacological interventions, supplementation options, and exercise regimens exist for postmenopausal women with musculoskeletal symptoms. ConclusionA comprehensive policy is needed to address musculoskeletal symptoms in postmenopausal women, promoting diverse treatments for improved quality of life.

Effects of pilates exercise on quality of life and menopausal symptoms in menopausal women: A quasi experimental study

Background: Menopause is an unspoken, unattended, reality of life, the cause of which is still undeciphered completely by human. Women can enjoy good quality of life after menopause even without hormones as exercise works by improving muscle mass, strength, flexibility and coordination. Pilates exercise has grown in popularity as a result of profound effects that it has had on both healthy and injured bodies. Nowadays Pilates exercise more formally into rehabilitation from more medical perspective. Aim: To assess the effect of Pilates exercises on quality of life and menopausal symptoms in menopausal women. Materials and Methods: A Study was performed on a total of 30 women. Subjects matching the inclusion criteria with age group 45-55 years were included for the study. They performed pilates exercise, 3 times a week for 8 weeks. Menopause Rating Scale and Menopause-specific Quality of Life were used as outcome measures to assess the pre and post effect of exercises. Data was analyzed using SPSS software 28. Results and Discussion: There is a statistically significant difference in the outcomes of pre and post intervention. Paired t test was performed. Conclusion: It is concluded that the Pilates training program in menopausal women helps to improve their quality of life and also beneficial in reducing the symptoms of menopause.

Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2).

The aims of the study were to further characterize the efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause using responder analysis and to investigate whether efficacy, not adjusted for placebo, resulted in clinically meaningful within-patient change. This prespecified analysis used pooled data from two phase 3, randomized, double-blind, placebo-controlled studies (SKYLIGHT 1 and 2). Responders were those experiencing ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. Responder analysis was performed for patient-reported outcome (PRO) measures to evaluate participants achieving a clinically meaningful within-patient change (not placebo adjusted) at week 4 and 12 versus baseline. Single responders were based on outcomes of VMS frequency, Patient-Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b Total Score, Menopause-Specific Quality of Life (MENQoL) Total Score, and MENQoL VMS Domain Score. Double and triple responder analyses combined VMS frequency plus one or more of the PRO. Patient Global Impression of Change VMS was deemed a suitable anchor measure for meaningful within-patient change in VMS frequency. A greater proportion of fezolinetant-treated versus placebo-treated participants had ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. A greater proportion of responders were observed in the fezolinetant groups versus placebo at week 12 in all four single responder analyses. In the double and triple responder analyses, odds ratios were supportive of a beneficial effect for both doses of fezolinetant versus placebo. Fezolinetant was associated with significantly higher within-patient clinically meaningful improvement in important PRO, including VMS frequency, PROMIS SD SF 8b Total Score, MENQoL Total Score, and MENQoL VMS Domain Score.

Efficacy and safety of fezolinetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials.

Vasomotor symptoms (VMS), such as hot flashes and night sweats, are highly prevalent and burdensome for women experiencing menopausal transition. Fezolinetant, a selective neurokinin 3 receptor (NK3R) antagonist, is a potential therapeutic option for mitigating VMS. Our aim is to assess the efficacy and evaluate the safety profile of fezolinetant compared with placebo in post-menopausal women suffering from VMS, by pooling all the relevant data and reflecting the most current evidence. An extensive literature search was performed in the PubMed, Medline and Cochrane Library databases from inception until June 2023 to identify relevant trials. Mean differences (MDs) and 95% confidence intervals (CIs) were calculated for continuous outcomes. Risk ratios (RRs) were calculated for dichotomous outcomes. All statistical analyses were performed using R Statistical Software. A total of six randomized controlled trials were added. For the frequency of daily VMS, the combined pooled result favored the fezolinetant group over placebo (MD -2.38, 95% CI -2.64 to -2.12; P < 0.001, I2 = 0%). For the severity of daily VMS, fezolinetant was again found to be superior to the placebo group (MD -0.40, 95% CI -0.51 to -0.29; P < 0.001, I2 = 70%). Fezolinetant (120 mg) consistently demonstrated a significant reduction in the severity of daily moderate/severe VMS compared with other doses at both 4 and 12 weeks. Patient-reported outcomes (PROs) of Greene Climacteric Scale (GCS), PROMIS the Sleep Disturbance Short Form 8b and Menopause-Specific Quality of Life (MENQoL) scores indicated significant improvement with fezolinetant. No significant difference in efficacy of fezolinetant at 4 and 12 weeks were observed in any outcome. As for safety, no significant differences in the treatment emergent adverse events at 12 weeks were found between fezolinetant and placebo. Our study significantly favors fezolinetant over placebo regarding the primary efficacy outcomes of daily moderate to severe VMS frequency and severity, including PROs, while both the groups are comparable in terms of treatment emergent adverse events. Further studies are needed to confirm these findings.

A Case Report of a Medial Medullary Infarction Patient with Menopausal Hot Flashes

This case study reports on the effectiveness of Korean medicine treatment for menopausal hot flashes in stroke patients. During hospitalization, a female patient with medial medullary infarction was diagnosed with menopausal hot flashes and received treatment with traditional Korean medicine and acupuncture. The assessment was performed by monitoring daily habits to relieve hot flashes. The hot flash index, menopause rating scale (MRS), menopause-specific quality of life (MENQoL) questionnaire, and Kupperman index (KI) were also used. After 28 days of treatment, the hot flash index improved from 27 to 2, MRS improved from 11 to 2, MENQoL improved from 40 to 21, and KI improved from 22 to 6. Thus, this case suggests that Korean medicine treatment may be effective for menopausal hot flashes in stroke patients.

Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause.

Vasomotor symptoms (VMS) associated with menopause can negatively affect health-related quality of life (HRQoL). The Menopause-Specific Quality of Life (MENQOL) questionnaire has been developed to assess QOL specific to menopause. The objective of the current study was to assess the psychometric properties, sensitivity to change, and clinically meaningful within-patient change of the MENQOL using data from the fezolinetant SKYLIGHT1 and 2 studies in individuals with VMS. Individuals aged ≥ 40 to ≤ 65years with moderate-to-severe VMS (≥ seven hot flashes/day) were enrolled. In addition to MENQOL, eight patient-reported outcome (PRO) measures were used for the psychometric evaluation. All PRO assessments were completed at weeks4 and 12 during the treatment period, and most were completed at baseline. Psychometric analyses included factor analysis and reliability, construct validity, and sensitivity to change assessments. The within-patient threshold for a clinically meaningful change in MENQOL was derived. In total, 1022 individuals were included from SKYLIGHT1 and 2. Mean MENQOL total score at baseline was 4.30, improving to 3.16 at week12. The confirmatory factor analysis supported established MENQOL domain structure, including the overall score. The internal consistency of the MENQOL overall and domain scores was supported using Cronbach's alpha and McDonald's omega, and MENQOL construct validity was supported for overall and domain scores. Item-to-item and item-total correlations were generally sufficient, and moderate test-retest reliability was noted. The scales against which construct validity and responsiveness for MENQOL domains were examined were moderately related to the MENQOL domains in general, providing additional support for acceptable measurement properties of MENQOL in this population. A reduction in MENQOL overall score of ≥ 0.9 points was identified as responding to treatment (a clinically important threshold). Thresholds of 2.0 points for the vasomotor domain and 0.9 for the psychosocial domain were estimated, in addition to distribution-based threshold estimates of 0.8 and 1.2 for the physical and sexual domains, respectively. The psychometric properties of the MENQOL overall and domain scores support use of this instrument to capture experiences among individuals with moderate-to-severe VMS associated with menopause and assess related endpoints in clinical trials. ClinicalTrials.gov identifiers NCT04003155 and NCT04003142.

Fezolinetant impact on health-related quality of life for vasomotor symptoms due to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled trials.

To assess the effect of fezolinetant treatment on health-related quality of life using pooled data from SKYLIGHT 1 and 2 studies. Prespecified pooled analysis. USA, Canada, Europe; 2019-2021. 1022 women aged ≥40 to ≤65 years with moderate-to-severe vasomotor symptoms (VMS; minimum average seven hot flushes/day), seeking treatment for VMS. Women were randomised to 12-week double-blind treatment with once-daily placebo or fezolinetant 30 or 45 mg. Completers entered a 40-week, active extension (those receiving fezolinetant continued that dose; those receiving placebo re-randomised to fezolinetant received 30 or 45 mg). Mean changes from baseline to weeks 4 and 12 on Menopause-Specific Quality of Life (MENQoL) total and domain scores, Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS) domain scores, Patient Global Impression of Change in VMS (PGI-C VMS); percentages achieving PGI-C VMS of 'much better' (PGI-C VMS responders). Mean reduction was estimated using mixed model repeated measures analysis of covariance. Fezolinetant 45 mg mean reduction over placebo in MENQoL total score was -0.57 (95% confidence interval [CI] -0.75 to -0.39) at week 4 and -0.47 (95% CI -0.66 to -0.28) at week 12. Reductions were similar for 30 mg. MENQoL domain scores were also reduced and WPAI-VMS scores improved. Twice as many women receiving fezolinetant reported VMS were 'much better' than placebo based on PGI-C VMS assessment. Fezolinetant treatment was associated with improvement in overall QoL, measured by MENQoL, and work productivity, measured by WPAI-VMS. A high proportion receiving fezolinetant felt VMS were 'much better' based on PGI-C VMS responder analysis.

Efficacy and Safety of Fezolinetant for the Treatment of Menopause-Associated Vasomotor Symptoms: A Meta-analysis.

To evaluate the efficacy and adverse events of fezolinetant for treating vasomotor symptoms (VMS) of menopause. PubMed/MEDLINE, ClinicalTrials.gov , EMBASE, Cochrane Database, Scopus, and WHO International Clinical Trials Registry Platform were searched through June 2023 for publications and randomized controlled trials on fezolinetant compared with placebo in menopausal women who experienced moderate-to-severe VMS. Our literature search identified 330 articles, of which five studies with six reports were included in our meta-analysis per our eligibility criteria. The risk of bias was evaluated using Cochrane's RoB 2 (Risk of Bias version 2) tool, quality of evidence was graded using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, and outcome measures data for effect size were pooled in random-effects model and rated. A total of 2,168 participants from five randomized clinical trials (six reports) were included. Fezolinetant significantly lowered VMS frequency, with pooled mean difference of 2.62 (95% CI, 1.84-3.41). The pooled mean difference for fezolinetant compared with placebo for the MENQOL (Menopause-Specific Quality of Life) measure was -0.60 (95% CI, -0.92 to -0.28), and the mean percentage improvement in VMS frequency was 22.51% (95% CI, 15.35-29.67). Fezolinetant was associated with improvement in sleep quality when compared with placebo. Fezolinetant is effective in lowering moderate-to-severe VMS frequency and sleep disturbances in postmenopausal women. PROSPERO, CRD42023427616.

Comparative Benefit of Evening Primrose Oil and Soybean Oil on Treatment Satisfaction and Quality of Life among Postmenopausal Women

Background: Medicinal herbs as alternative therapies, commonly used to treat menopausal symptoms, and some studies have shown that they can be useful in treating menopausal syndrome, which have been linked to worse self-rated health, and decreased work productivity.&#x0D; Aim of the study: This study compared the effectiveness of EPO and Soybean Oil herbal supplement in a sample of Iraqi postmenopausal women on treatment satisfaction and their quality of life.&#x0D; Patients and methods: This prospective study conducted on 20 post-menopausal women who received 500 mg EPO compared to other 20 received 233 mg soybean oil extract, as a capsule twice a day for 8 weeks. The subjective and clinical assessments of Menopause Symptom Treatment Satisfaction, and Menopause-Specific Quality of Life. Data was collected by the researcher via face-to-face interviews with women at baseline and after 2 months of treatment.&#x0D; Results: In this study, Menopause Symptoms Treatment Satisfaction score was not significant within each group post treatment (P&gt;0.05). While after 2 months of treatment, EPO significantly improved the quality of life by decreasing all MEN-QoL domains more than soybean oil, except for the sexual domain (P&lt;0.01).&#x0D; Conclusions: This study revealed that both EPO and soya bean oil supplements had the beneficial effect in improving the postmenopausal quality of life with less treatment satisfaction.

Efficacy and safety of fezolinetant, a neurokinin-3 antagonist, in treating vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis.

Menopause causes a variety of symptoms such as hot flashes and night sweats. While menopausal hormonal therapy has been used for managing postmenopausal vasomotor symptoms (VMS) for quite a while, it has a considerably poor safety profile. To review and analyze existing data to evaluate the efficacy of the neurokinin-3 antagonist, fezolinetant, in treating postmenopausal VMS and to assess its safety profile. A thorough literature search was performed on PubMed, Cochrane Library, and Google Scholar in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020, to find publications on the efficacy of fezolinetant for postmenopausal VMS. Changes in the frequency and severity scores of moderate/severe VMS and changes in the Hot Flash-Related Daily Interference Scale (HFRDIS), Greene Climacteric Scale (GCS), and Menopause-Specific Quality of Life (MENQoL) were the efficacy outcomes. Adverse events, drug-related treatment-emergent adverse effects (TEAEs), drug-related dropouts, hepatotoxicity, endometrial hyperplasia or tumor, and uterine bleeding were all safety outcomes. We used Review Manager 5.4 for pooling risk ratios (RRs) and mean differences (MDs) for dichotomous and continuous outcomes, respectively. A P value of < .05 was considered significant. There was a significant reduction in mean daily VMS frequency at weeks 4 and 12 (MD, -2.36; 95% confidence interval [CI], -2.85 to -1.87; P < .00001, for week 12) and also a significant decrease in VMS severity scores in the treatment group. Furthermore, improvements in MENQoL, HFRDIS, and GCS scores were observed. There was no significant difference in adverse events while drug-related TEAEs (RR, 1.21; 95% CI, 0.90-1.63; P = .21) showed a slight increase with fezolinetant. Drug-related dropouts were again similar across the 2 groups. Uterine bleeding had a lower incidence while endometrial events and hepatotoxicity showed a statistically insignificant, increasing trend in the fezolinetant group. Fezolinetant can be a treatment option for postmenopausal VMS but warns of a risk increase in endometrial hyperplasia or tumors. The heterogeneity in the data being analyzed, short follow-up period, and small sample size in most of the included randomized controlled trials were the greatest limitations, which must be considered in further research and safety profile exploration.

The validity and reliability of the Turkish version of the Postmenopause Sexuality Questionnaire.

To translate and to validate the Postmenopause Sexuality Questionnaire (PMSQ) for Turkish women in the climacteric. The study included 356 menopausal women with a mean age of 60.2 ± 7.6 years. First, the demographic characteristics and obstetric information of the women were recorded. Then, the PMSQ was adapted into Turkish. In order to determine the sexual activity and menopause-specific quality of life, the Female Sexual Function Index (FSFI), The Menopause Specific Quality of Life Questionnaire (MENQOL), and the PMSQ were administered. The reliability and validity of the PMSQ were assessed with internal consistency, test-retest, and criterion validity analyses. According to the results of the study, the internal consistency (Cronbach's α = 0.97) and test-retest reliability (r = 0.95) of the PMSQ were found to be high (P < 0.001). Criterion validity was established based on the relationship of PMSQ scores with FSFI (r = 0.76; P < 0.001) and MENQOL (r = -0.47, P < 0.001) scores. According to this study, it was determined that the Turkish version of the PMSQ can be a valid and reliable scale to evaluate sexual activity in Turkish menopausal women.

Electroacupuncture for hot flashes in early postmenopause: A study protocol for a randomized sham-controlled trial

IntroductionMany early postmenopausal women experience hot flashes (HFs). Electroacupuncture (EA) is a safe and effective therapy for menopause-related symptoms. However, there are few rigorous clinical trials on this topic. This randomized controlled trial is designed to explore the feasibility and efficacy of EA in the treatment of early postmenopausal HF. MethodsThis study is a randomized, controlled trial involving 72 early postmenopausal patients. Patients will be randomized 1:1 to the EA or sham acupuncture (SA) group. The acupuncture points that will be used are Hegu (LI4), Fuliu (KI7), Taixi (KI3), Shenshu (BL23), Guanyuan (CV4), and Sanyinjiao (SP6). Participants in each group will receive 18 acupuncture sessions over 6 weeks (three times per week). The primary outcome is the hot-flash score at the end of the 6 week of intervention. Secondary outcome measures are the Pittsburgh Sleep Quality Index, Menopause-Specific Quality of Life, Menopause Rating Scale, Traditional Chinese Medicine Syndrome Score Scale, and estradiol, follicle-stimulating hormone, luteinizing hormone, and anti-Mullerian hormone levels. Safety will be assessed at every visit. ConclusionThis prospective trial will evaluate the efficacy of EA in the treatment of HFs among early postmenopausal women. Our results will provide additional knowledge for clinicians in the treatment of HFs.

Effect of Electroacupuncture Versus Cognitive Behavioral Therapy for Perimenopausal Insomnia: Protocol for a Noninferiority Randomized Controlled Trial.

Perimenopausal insomnia (PMI) has a high global incidence, which is common in middle-aged women and is more severe than nonmenopausal insomnia. Effective treatments with fewer side effects and more consistent repeatable results are needed. Acupuncture, a therapy based on traditional Chinese medicine, is safe and may be effective for PMI. It is widely accepted in Western countries, and evidence supports the use of acupuncture as a main or supplementary therapy. Cognitive behavioral therapy is also used to improve sleep quality. It has structured sessions and has been recommended as a first-line treatment for insomnia (cognitive behavioral therapy for insomnia [CBT-I]) by the American Association of Physicians. However, few randomized controlled trials have been conducted to compare the effectiveness of these 2 therapies. This study will be performed in perimenopausal women with insomnia to determine the efficacy of electroacupuncture (EA) versus CBT-I. This study aimed to compare the preliminary effectiveness and safety of EA and CBT-I for PMI through a randomized controlled noninferiority study design. This study is designed as an assessor-blinded, noninferiority, randomized controlled trial. A total of 160 eligible participants with PMI will be randomly divided into 2 groups to receive either EA or CBT-I. Participants in the EA group will receive electroacupuncture for 8 weeks. The intervention will be delivered 3 times weekly for a total of 12 sessions and 2 times weekly for the next 4 weeks. Meanwhile, participants in the control group will undergo CBT-I (once a week) for 8 weeks. Treatment will use 7 main acupoints (GV20, DU24, EX-HN3, EX-HN18, EX-CA1, RN6, and RN4) and an extra 4 acupoints based on syndrome differentiation. The primary outcome is the Insomnia Severity Index. The secondary outcome measures are the Pittsburgh Sleep Quality Index; Menopause-Specific Quality of Life; Menopause Rating Scale; Hamilton Depression Scale; Hamilton Anxiety Scale; hot flash score; and the level of estradiol, follicle-stimulating hormone, and luteinizing hormone in serum. Sleep architecture will be assessed using polysomnograms. Participants are currently being recruited. The first participant was enrolled in January 2023, marking the initiation of the recruitment phase. The recruitment process is expected to continue until January 2025, at which point data collection will commence. This trial represents a pioneering effort to investigate the efficacy and safety of EA and CBT-I as interventions for PMI. It is noteworthy that this study is conducted solely within a single center and involves Chinese participants, which is a limitation. Nonetheless, the findings of this study are expected to contribute valuable insights for clinicians engaged in the management of PMI. Chinese Clinical Trial Registry ChiCTR2300070981; https://www.chictr.org.cn/showprojEN.html?proj=194561. DERR1-10.2196/51767.

Effects of Eurycoma longifolia Jack standardised water extract (Physta) on well-being of perimenopausal and postmenopausal women: protocol for a randomised, double-blinded, placebo-controlled, parallel group study

IntroductionEurycoma longifolia Jack (EL), profoundly recognised as ‘Tongkat Ali’, is a medicinal herb originating from Southeast Asia. It is commonly used in traditional ‘antiageing’ treatments to address decreased energy, mood,...

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.