Trial reportContemporary clinical trials2013
Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience.
Trial report in Contemporary clinical trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01178892 (MsFLASH-02), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
Who cites it
15 citing papers in PubMed.
- Confirmatory factor analysis of the Insomnia Severity Index (ISI) and invariance across race: a pooled analysis of MsFLASH data.Menopause (New York, N.Y.) · 2019Trial
- Effects of Yoga and Aerobic Exercise on Actigraphic Sleep Parameters in Menopausal Women with Hot Flashes.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017Trial
- Daily salivary cortisol patterns in midlife women with hot flashes.Clinical endocrinology · 2016Trial
- Is heart rate variability associated with frequency and intensity of vasomotor symptoms among healthy perimenopausal and postmenopausal women?Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2016Trial
- Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms.Obstetrics and gynecology · 2015Trial
- MsFLASH participants' priorities for alleviating menopausal symptoms.Climacteric : the journal of the International Menopause Society · 2015Trial
- Low-dose estradiol and the serotonin-norepinephrine reuptake inhibitor venlafaxine for vasomotor symptoms: a randomized clinical trial.JAMA internal medicine · 2014Trial
- Efficacy of exercise for menopausal symptoms: a randomized controlled trial.Menopause (New York, N.Y.) · 2014Trial
- Efficacy of yoga for vasomotor symptoms: a randomized controlled trial.Menopause (New York, N.Y.) · 2014Trial
- Menopausal quality of life: RCT of yoga, exercise, and omega-3 supplements.American journal of obstetrics and gynecology · 2014Trial
- Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020Review
- Validity, cut-points, and minimally important differences for two hot flash-related daily interference scales.Menopause (New York, N.Y.) · 2017Article
- Female Sexual Function Index Short Version: A MsFLASH Item Response Analysis.Archives of sexual behavior · 2016Article
- Confirmatory factor analysis of the Pittsburgh Sleep Quality Index in women with hot flashes.Menopause (New York, N.Y.) · 2015Article
- Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis.Sexual medicine · 2015Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundBehavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. PURPOSE: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids.
methodsWomen from three geographic areas with a weekly average of ≥14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected.
resultsOf 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2%
conclusionsConducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.
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