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Revisiting the duration of vasomotor symptoms of menopause: a meta-analysis.

ABSTRACT: Treatment decisions about menopause are predicated on a transient duration of vasomotor symptoms. However, evidence supporting a specific duration is weak.To estimate the natural progression of vasomotor symptoms during the menopause transition by systematically compiling available evidence using meta-analytic techniques.We searched MEDLINE, hand searched secondary references in relevant studies, book chapters, and review papers, and contacted investigators about relevant published research.English language, population-based studies reporting vasomotor symptom prevalence among women in menopausal transition in time intervals based on years to or from final menstrual period were included. Two reviewers independently assessed eligibility and quality of studies and extracted data for vasomotor symptom prevalence.The analyses included 10 studies (2 longitudinal, 8 cross sectional) with 35,445 participants. The percentage of women experiencing symptoms increased sharply in the 2 years before final menstrual period, peaked 1 year after final menstrual period, and did not return to premenopausal levels until about 8 years after final menstrual period. Nearly 50% of all women reported vasomotor symptoms 4 years after final menstrual period, and 10% of all women reported symptoms as far as 12 years after final menstrual period. When data were examined according to symptom severity ('any' vs. 'bothersome'), bothersome symptoms peaked about 1 year earlier and declined more rapidly than symptoms of any severity level.Our findings suggest a median symptom duration of about 4 years among symptomatic women. A longer symptom duration may affect treatment decisions and clinical guidelines. Further prospective, longitudinal studies of menopausal symptoms should be conducted to confirm these results.

SUBMITTER: Politi MC

PROVIDER: S-EPMC2518020 | biostudies-other | 2008 Sep

REPOSITORIES: biostudies-other

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Project description:ImportanceAlthough premenstrual disorders (PMDs) end at menopause, it is unclear whether they are associated with the timing and symptom severity of menopause.ObjectiveTo prospectively examine whether women with PMDs have increased risks of early menopause and menopause-related vasomotor symptoms (VMS).Design, setting, and participantsThis population-based cohort study was nested in the Nurses' Health Study II (data collected from questionnaire sent between June 1991 and June 2017). Analysis of menopause timing included participants who did not have natural or surgical menopause before study entry, while the analysis of VMS was restricted to women who provided information on VMS. Data were analyzed from August 2022 to March 2023.ExposuresPMDs were identified by self-reported diagnosis and confirmed with symptom questionnaires from 1991 to 2005. Participants were age-matched to women without PMD diagnoses and confirmed absence of or minimal premenstrual symptoms.Main outcomes and measuresDuring follow-up through 2017, timing of natural menopause was assessed biennially, and VMS were assessed in 2009, 2013, and 2017. The association of PMDs with early menopause was assessed by Cox proportional hazards models and with VMS by logistic regression models.ResultsOf 1220 included women with PMDs, the median (IQR) age was 40.7 (37.3-43.8) years; of 2415 included women without PMDs, the median (IQR) age was 41.7 (38.3-44.8) years. The median (IQR) follow-up in this study was 20.3 (17.8-22-2) years. Early natural menopause (menopause before age 45 years) was reported by 17 women with PMDs (7.1 per 1000 person-years) and 12 women without PMDs (2.7 per 1000 person-years; adjusted hazard ratio, 2.67; 95% CI, 1.27-5.59). In addition, 795 women with PMDs (68.3%) and 1313 women without PMDs (55.3%) reported moderate or severe VMS (adjusted odds ratio, 1.68; 95% CI, 1.32-2.14). There was no observed association between PMDs and mild VMS (adjusted odds ratio, 0.99; 95% CI, 0.76-1.28).Conclusions and relevanceIn this cohort study of US women, PMDs were associated with increased risks of early menopause and moderate or severe VMS. PMDs may be indicative of underlying physiology linked to early menopause and VMS, suggesting a phenotype observable during the reproductive years that may allow clinicians to target women at risk of earlier menopause and subsequent health risks later in the life course.

Project description:ObjectiveTo evaluate the safety, tolerability, and effect of fezolinetant on endometrial health over 52 weeks.MethodsWe conducted a phase 3, randomized, double-blind, 52-week safety study (SKYLIGHT 4 [Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause]) of placebo, fezolinetant 30 mg, and fezolinetant 45 mg once daily (1:1:1). Participants were postmenopausal and seeking treatment for vasomotor symptoms associated with menopause. Primary endpoints were treatment-emergent adverse events, percentage of participants with endometrial hyperplasia, and percentage with endometrial malignancy. Endometrial hyperplasia or malignancy was evaluated according to U.S. Food and Drug Administration guidance (point estimate of 1% or less with an upper bound of one-sided 95% CI of 4% or less). Secondary endpoints included change in bone mineral density (BMD) and trabecular bone score. A sample size of 1,740 was calculated to enable observation of one or more events (≈80% probability for events with background rate of less than 1%).ResultsA total of 1,830 participants were randomized and took one or more medication dose (July 2019-January 2022). Treatment-emergent adverse events occurred in 64.1% (391/610) of the placebo group, 67.9% (415/611) of the fezolinetant 30-mg group, and 63.9% (389/609) of the fezolinetant 45-mg group. Treatment-emergent adverse events leading to discontinuation were similar across groups (placebo, 26/610 [4.3%]; fezolinetant 30 mg, 34/611 [5.6%]; fezolinetant 45 mg, 28/609 [4.6%]). Endometrial safety was assessed in 599 participants. In the fezolinetant 45-mg group, 1 of 203 participants had endometrial hyperplasia (0.5%; upper limit of one-sided 95% CI 2.3%); there were no cases in the placebo (0/186) or fezolinetant 30 mg (0/210) group. Endometrial malignancy occurred in 1 of 210 in the fezolinetant 30-mg group (0.5%; 95% CI 2.2%) with no cases in the other groups. Liver enzyme elevations more than three times the upper limit of normal occurred in 6 of 583 placebo, 8 of 590 fezolinetant 30 mg, and 12 of 589 fezolinetant 45 mg participants; no Hy's law cases were reported (ie, no severe drug-induced liver injury with alanine aminotransferase or aspartate aminotransferase more than three times the upper limit of normal and total bilirubin more than two times the upper limit of normal, with no elevation of alkaline phosphatase and no other reason to explain the combination). Changes in BMD and trabecular bone score were similar across groups.ConclusionResults from SKYLIGHT 4 confirm the 52-week safety and tolerability of fezolinetant and support its continued development.Funding sourceAstellas Pharma Inc.Clinical trial registrationClinicalTrials.gov , NCT04003389.

Project description:Menopause is a critical stage in every woman's life. It can cause a distressing time for women by creating various vasomotor symptoms (VMS). Phytoestrogens can potentially exert various favourable effects and alleviate VMS in postmenopausal women. The hop (Humulus lupulus L.) contains 8-prenylnaringenin (8-PN), the most potent phytoestrogen known to date. The hop is eight times stronger than any other herbal oestrogens. This study aims to conduct a comprehensive systematic review and a meta-analysis survey of the effects of hop in the management of VMS in postmenopausal women.Only randomised controlled clinical trials, with cluster randomisation and crossover, blinded and non-blinded designs, conducted between 2000 and 2015, will be included in this review. Quasi-experimental and observational studies as well as case reports will be excluded. The studies will be selected if their participants were aged 40-60 years, had elevated follicle-stimulating hormone (FSH) levels and/or menstrual irregularities, and experienced discomforting VMS (at least hot flashes or night sweats). The primary outcome will be the rate of response to treatment, such as changes in frequency and intensity of symptoms in the intervention and placebo groups. 'Hop', 'Humulus', 'menopause', 'vasomotor', 'hot flashes', 'phytoestrogen' and 'night sweats' will be used as search key words. Prior to their inclusion in the review, the selected papers will be assessed by two independent reviewers for methodological validity. Any disagreements will be resolved through a third reviewer. The risk of bias will be independently determined using the Cochrane Risk of Bias Tool. The quality of the papers will be assessed based on the CONSORT checklist.Results will be disseminated through traditional academic literature. Dissemination of results will occur by peer-reviewed publications. The results of our project can help reproductive health researchers when evaluating the discomforts of research procedures described in study protocols or when designing a study. Information on experiences of menopausal women involved in previous studies may also help in future research. The expected dissemination actions are effective treatment in designing strategies that aim to develop women's health and healthcare providers when offering treatment for women with vasomotor symptoms.

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Revisiting the duration of vasomotor symptoms of menopause: a meta-analysis.

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