Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Iliodromiti, Stamatina; Wang, Weilin; Lumsden, Mary Ann; Hunter, Myra; Bell, Robin J.; Mishra, Gita D.; Hickey, Martha

doi:10.1111/1471-0528.15990

Cited by 23 publications

(34 citation statements)

References 244 publications

(244 reference statements)

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“…Given the novelty of this study, we included two primary outcomes: group difference in hot flush score change from baseline to treatment end (week 4), and group difference in problem rating change measured with the Hot Flush Rating Scale (HFRS 54 ). The hot flush score (frequency × severity), measured with a diary, is the most often used outcome in hot flush trials 57 . The diary is considered a gold standard to assess hot flushes 58 .…”

Section: Discussionmentioning

confidence: 99%

Open-label placebos for menopausal hot flushes: a randomized controlled trial

Pan

Meister

Löwe

et al. 2020

Sci Rep

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This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: − 0.32, 95% CI [− 0.43; − 0.21], p < 0.001, Cohen’s d = 0.86), hot flush frequency (− 1.12 [− 1.81; − 0.43], p = 0.02, Cohen’s d = 0.51), and improved overall menopause-related quality of life (− 2.53 [− 4.17; − 0.89], p = 0.02, Cohen’s d = 0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: − 0.04 [− 0.06; 0.14], p = 0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [− 0.17; 0.25], p = 0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.

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Section: Discussionmentioning

confidence: 99%

Open-label placebos for menopausal hot flushes: a randomized controlled trial

Pan

Meister

Löwe

et al. 2020

Sci Rep

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“…Randomized trials of interventions for menopausal symptoms report many different outcomes and assess these outcomes in many different ways. 5 , 6 This prevents researchers, clinicians and patients from combining and comparing results from different studies, limits the ability of meta-analyses to reach firm conclusions, and complicates clinical decision-making. The development of a COMMA will address this by ensuring that future trials report outcomes that are important for all stakeholders in a consistent and meaningful way.…”

Section: Discussionmentioning

confidence: 99%

“…Two systematic reviews of randomized trials evaluating treatments for vasomotor and genitourinary symptoms have been undertaken. 5 , 6 Outcomes identified in each of these reviews were compiled into comprehensive lists. In consultation with the steering group (including consumer representatives), similar outcomes were merged and lay definitions and appropriate terminology for the outcome names and descriptors were developed.…”

Section: Methodsmentioning

confidence: 99%

“…The systematic review component has already been completed. 5 , 6 COMMA is actively collaborating with researchers developing measurement tools for Genitourinary Syndrome of Menopause. 20 …”

Section: Methodsmentioning

confidence: 99%

“…Randomized trials evaluating interventions for the same menopausal symptoms tend to report different outcomes and in different ways. 5 , 6 For example, randomized trials have reported the severity, frequency and interference with daily life due to vasomotor symptoms. Further, each of these outcomes can be measured in different ways.…”

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Protocol for development of a core outcome set for menopausal symptoms (COMMA)

et al. 2020

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Objective: Menopause is the natural cessation of menstruation and may be accompanied by troublesome symptoms including hot flushes and night sweats (vasomotor symptoms) and genitourinary symptoms. Randomized trials evaluating the safety and effectiveness of interventions for these symptoms have reported a wide range of outcomes and used inconsistent measures. This variation precludes comparing and combining data from different trials. To overcome this limitation, we will develop a Core Outcome Set for Menopausal Symptoms. Methods: We will systematically review the literature to identify the outcomes reported in the interventional trials for vasomotor and genitourinary symptoms. This list will be entered into a two-round modified Delphi survey to be completed by clinicians, researchers, and consumers (women who have experienced menopause). Participants will score outcomes on a nine-point scale from “not important” to “critically important.” Representatives from each stakeholder group will then meet to discuss the results and finalize the Core Outcome Set. Ethics approval was not required as this was considered service evaluation and development. The study is registered with the Core Outcome Measures in Effectiveness Trials Initiative ( http://www.comet-initiative.org/studies/details/917 ). Results: An agreed upon set of minimum outcomes and outcome measures will facilitate combining and comparing findings from future trials of treatments for menopausal symptoms. Conclusions: This Core Outcome Set will better enable women and clinicians to select effective treatments, improve the quality of trial reporting, reduce research wastage, and improve care for women with troublesome menopausal symptoms. Video Summary:

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Vasomotor Symptoms

Geraghty¹

2021

Each Woman’s Menopause: An Evidence Based Resource

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Menopausal symptoms are experienced by 70-85% of women worldwide with geographic and cultural variations (see Chap. 1). Along with myalgia/arthralgia and sleep disruption, VMS are the most commonly experienced symptoms [1, 2] (see Chap. 1). Vasomotor symptoms include a mild feeling of heat, or a moderate to severe feeling of heat with flushing, cold sweats, and night sweats. The sensation may be limited to a consistent body region such as the chest and face or the legs. There is sometimes a detectible prodrome. A woman may first awaken during the night with a feeling of dread or increased heart rate, and a subsequent sensation of hot flush or sweating. Women describe VMS differently and the nature of VMS may vary over the course of the menopause transition [3,4].An interplay of social and genetic variables illustrate the complex influences that result in the lived experience of the individual woman. Among women in North America and Europe, VMS are the most common menopausal experience, while women in Japan report a "chilliness" but have no word for "hot flashes" in the Japanese language [5,6]. Within geographic regions, the experience of VMS is influenced by the interplay of race/ethnicity and socioeconomic factors. In the United States culture, the incidence and severity of clustered VMS, sleep disruption, and psychological distress were correlated with lower educational level and African American race [2]. The reporting of vasomotor and other symptoms within populations also varies over time. The incidence of VMS in a review of five studies from multiple countries within the African continent increased from 39% of women surveyed in 2009 to 77% of women in 2012 [1].

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Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Cited by 23 publications

References 244 publications

Open-label placebos for menopausal hot flushes: a randomized controlled trial

Open-label placebos for menopausal hot flushes: a randomized controlled trial

Protocol for development of a core outcome set for menopausal symptoms (COMMA)

Vasomotor Symptoms

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