A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative

Lensen, Sarah; Archer, David F.; Bell, Robin J.; Carpenter, Janet S.; Christmas, Monica; Davis, Susan R.; Giblin, Karen; Goldstein, Steven R.; Hillard, Tim; Hunter, Myra; Iliodromiti, Stamatina; Jaisamrarn, Unnop; Joffe, Hadine; Khandelwal, Sunila; Kiesel, L.; Kim, Bobae V; Lambalk, Cornelis B.; Lumsden, Mary Ann; Maki, Pauline M.; Nappi, Rossella E.; Panay, Nick; Roberts, Helen; Shifren, Jan L.; Simon, James A.; Vincent, Amanda; Wolfman, Wendy; Hickey, Martha

doi:10.1097/gme.0000000000001787

Cited by 28 publications

(29 citation statements)

References 25 publications

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“…To enable comparison of SNRI and NK3Ra outcomes, while studies may include different outcome measures [19], each qualifying study was assessed for the specific key efficacy outcomes of HF frequency, HF severity and, if stated, night-time awakenings due to HFs, plus safety/tolerability outcomes including common adverse events (AEs), serious adverse events (SAE) and discontinuation due to AEs. Since SNRI studies were phase 3 whereas NK3Ra trials were phase 2, a systematic qualitative review rather than a meta-analysis was considered the most appropriate.…”

Section: Methodsmentioning

confidence: 99%

Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review

Menown

Tello

2021

Adv Ther

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Introduction: Hot flushes/flashes (HFs) or other vasomotor symptoms affect between 45 and 97% of women during menopause. Hormone replacement therapy (HRT) is effective at alleviating menopausal symptoms, but some women cannot or prefer not to take HRT. Since current non-hormonal options have suboptimal efficacy/tolerability, there is a pressing need for an effective, well-tolerated alternative. The neurokinin 3 receptor (NK3R) has recently been implicated in the generation of menopausal HFs and represents a novel therapeutic target to ameliorate HF symptoms. This review aims to assess if NK3R antagonists (NK3Ras) are more effective than Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)-currently a common choice for non-hormonal treatment of menopausal HFs. Methods: Studies were identified after systematically searching Ovid MEDLINE and EMBASE databases based on PRISMA guidelines. Trial quality and bias were assessed. Key efficacy outcomes (HF frequency, HF severity and number of night-time awakenings/nightsweats) and selected safety outcomes were extracted and analysed. Results: Seven SNRI and four NK3Ra placebocontrolled randomised trials (plus four followup reports) were included in this review. NK3Ra administration resulted in a larger reduction from baseline in HF frequency, HF severity and night-sweats compared to SNRIs. Five of seven SNRI trials showed a reduction in HF frequency that was statistically significant (by 48-67% from baseline at weeks 8 or 12) whereas all NK3Ra trials showed a statistically significant reduction in HF frequency (by 62-93% from baseline at weeks 2, 4 or 12). While SNRI trials reported poor tolerability, particularly nausea, NK3Ra trials reported good tolerability overall, although two trials reported elevation in transaminases. Conclusion: NK3Ras trials show encouraging efficacy and tolerability/safety. Completion of phase 3 NK3Ra trials are required to confirm efficacy and uphold safety/tolerability data but

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Section: Methodsmentioning

confidence: 99%

Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review

Menown

Tello

2021

Adv Ther

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“…The Core Outcomes in Menopause group have recently clarified which aspects of vasomotor symptoms should be measured in clinical studies. 59 This research, including our findings, will enable improved standardization of study design to assess the treatment appropriately.…”

Section: Placebo Response In Studies Of Hot Flashesmentioning

confidence: 80%

Factors associated with high placebo response in clinical studies of hot flashes: a meta-analysis

2021

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Importance: High placebo response can often mask the evaluation of active treatment in clinical studies for women with hot flashes and potentially undermine the evaluation of new treatments.Objective: The aim of this meta-analysis was to determine the factors associated with high placebo response (defined as the reduction in the mean number of hot flash frequency from baseline) in randomized, controlled, double-blind studies enrolling women with hot flashes.Evidence Review: To identify eligible studies, Embase, MEDLINE, and BIOSIS Previews were searched for English-language articles published between April 1975 and August 2020. Placebo-controlled, double-blind, randomized studies that assessed changes in hot flash frequency were included if they satisfied the defined criteria. We conducted univariate and multivariate analyses using categorical and numerical data. Categorical data included the following variables and levels in brackets: active treatment type (hormone therapy /non-hormone therapy / complementary and alternative medicine), administration route (oral/non-oral), study region (in/excluded the US), breast cancer population (in/excluded), entry criteria of hot flash severity (moderate to severe only/all included), parallel or crossover study, placebo run-in period before treatment (yes/no), and menopausal status (postmenopausal only/include perimenopausal/include premenopausal). Numerical data included published year, pretreatment period duration, treatment period duration, number of sites, number of total participants, number of placebo participants, number of treatment arms, mean age, BMI, and hot flash frequency at baseline.Findings: Forty-three of the 802 identified publications were included in the review. Multivariate analysis identified three individual factors associated with high placebo response: treatment period duration, number of treatment arms, and BMI.Conclusions and Relevance: We identified several factors associated with high placebo response in clinical studies of women with hot flashes. Knowing these factors may enable proactive implementation of operational and analytic strategies that further aid in determining the true treatment effect of an intervention.

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“…28 In COMMA developed in collaboration researchers, clinicians, and women to elucidate and propagate a Core Outcome Set related to the symptoms of menopause, hot flashes, and night sweats. 29 Core Outcome Set to date remains to be developed and validated. Such scales will, in the future, be used by women experiencing symptoms, clinicians, and researchers.…”

Section: Discussionmentioning

confidence: 99%

Validation of the Menopause Transition Scale (MTS)

et al. 2022

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ObjectiveAll women will experience menopause transition, and a majority will experience symptoms that negatively affect their quality of life. Current validated menopause symptom scales are time consuming, phrased in clinical language, and difficult to adopt for digital use. This study seeks to validate a short novel survey which can be reliably completed without coaching and accurately represents the experience of the menopause transition.MethodsWe developed a patient-centric questionnaire (Menopause Transition Scale, MTS) to examine for symptoms of menopause. Survey responders represented a total of 144 women with at least one symptom of menopause. Survey responders included women affected by cancer aged 30 to 65 (n = 72) and women not affected by cancer aged 45 to 60 (n = 72). Cronbach Alpha was used to examine for internal consistency and dimensionality was assessed using exploratory factor analysis. The cross-validation was analyzed against established patient scales using Spearman correlations or Chi-Square analysis, as appropriate.ResultsThe MTS questions showed internal consistency with a Cronbach Alpha of 0.63. The individual questions loaded into three unique domains. The MTS overall correlated with validated scales for menopause symptoms, the Menopause-Specific Quality of Life Questionnaire (r = –0.86, P < 0.0001) and Greene Climacteric Scale (r = –0.65, P < 0.0001). Libido correlated with scales (P = 0.0150) and subscales (r = –0.70, P < 0.0001) relating low sexual desire. Energy (r = –0.62, P < 0.0001), Mood (r = –0.48, P < 0.0001), and Hot Flashes/Night Sweats (r = –0.77, P < 0.0001) correlated with scales and subscales related to mood, depression, and vasomotor symptoms. The majority of our responders expressed mild vaginal bleeding. The highest frequency of severe symptoms were low libido and poor energy.ConclusionsThe MTS is a short thorough patient-centric survey that is readily amenable to digital adoption to measure symptoms of menopause as women transition in the out-patient setting. Further study is needed for the longitudinal assessment of symptoms through the transition process and the response of women to therapeutic options.Video Summary: http://links.lww.com/MENO/A938.

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A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative

Cited by 28 publications

References 25 publications

Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review

Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review

Factors associated with high placebo response in clinical studies of hot flashes: a meta-analysis

Validation of the Menopause Transition Scale (MTS)

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