MsFLASH

Findings From Studies

Below are links to the published findings and methodologies from previous studies.

Escitalopram/Lexipro | Yoga, Excercise and Omega-3 | Venlafaxine-XR and Low-Dose Estradiol | Methodology

Study 01: Escitalopram (also known as Lexipro) for Menopausal Symptoms in Midlife Women

Efficacy of Escitalopram for Hot Flashes in Healthy Women published in the Journal of the American Medical Association (JAMA), January 2011.

Main trial report: Among healthy women, the use of escitalopram (10-20 mg/day), compared with placebo, resulted in fewer and less severe menopausal hot flashes at 8 weeks of follow-up.

Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial published in Menopause, August 2012.

Escitalopram intervention reduced both day and night flashes, as well as hot flash interference scores, over eight weeks of follow-up.

Effect of escitalopram on hot flash interference: a randomized, controlled trial published in Fertility and Sterility, April 2012.

Among healthy menopausal women with hot flashes, escitalopram at 10-20 mg/day, compared with placebo, reduced insomnia symptoms and improved subjective sleep quality at eight weeks of follow-up.

Sexual Function in Nondepressed Women Using Escitalopram for Vasomotor Symptoms: A Randomized Controlled Trial published in Obstetrics and Gynecology, March 2012.

Escitalopram did not worsen sexual function among non-depressed women with bothersome VMS but did adversely affect lubrication among a small percentage of sexually active womem.

Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: A randomized controlled trial published in Maturitas, December 2012.

Treatment with escitalopram 10–20 mg/day in healthy women with vasomotor symptoms significantly improved menopause-related quality of life and pain.

Relapse of vasomotor symptoms after discontinuation of the selective serotonin reuptake inhibitor escitalopram: results from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health Research Network published in Menopause: The Journal of The North American Menopause Society, March 2013.

Among women whose VMS improved with escitalopram, approximately one third relapsed swiftly after discontinuation of the medication. Those with pretreatment insomnia and those with a weaker response to escitalopram may be at greatest risk for VMS relapse after treatment discontinuation. Women should be educated about the likelihood of VMS symptom relapse when they discontinue SSRIs after receiving benefits from short-term treatment.

Effects of escitalopram on markers of bone turnover: a randomized clinical trial published in The Journal of Clinical Endocrinology & Metabolism, July 2014

Recent studies have suggested that the use of SSRI medications may be associated with increased fracture risk and bone loss, although conflicting results have been reported. The purpose of this study was to assess the impact of the SSRI medication escitalopram on bone metabolism. Results suggest that escitalopram does not lead to bone loss in the short term (i.e., after 8 weeks of use).
 

Study 02: Interventions for Relief of Menopausal Symptoms: Yoga, Exercise, and Omega-3

Efficacy of exercise for menopausal symptoms: a randomized controlled trial published in Menopause, April 2014.

This study assessed the efficacy of exercise training for alleviating vasomotor (VMS) and other menopausal symptoms. Findings provide strong evidence that 12 weeks of moderate-intensity aerobic exercise do no alleviate VMS, but may result in small improvements in sleep quality, insomnia, and depression in midlife sedentary women.

Efficacy of yoga for vasomotor symptoms: a randomized controlled trial published in Menopause, April 2014.

This study assessed the efficacy of yoga in alleviating vasomotor (VMS) and other menopausal symptoms. Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, did not improve VMS frequency or bother, but did reduce insomnia symptoms.

Efficacy of Omega-3 treatment for vasomotor symptoms: a randomized controlled trial published in Menopause, April 2014.

This study assessed the efficacy of omega-3 fatty acids in reducing vasomotor (VMS) symptoms. Among healthy peri-menopausal and post-menopausal women, a 12-week treatment with omega-e did not improve VMS frequency, VMS bother, sleep, or mood, compared with placebo.

Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience published in Contemporary Clinical Trials, May 2013 (E-pub ahead of print).

Conducting 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.

Menopausal quality of life: a RCT of yoga, exercise, and omega-3 supplements published in The American Journal of Obstetrics and Gynecology, March 2014.

The purpose of this study was to assess the efficacy of 3 non-hormonal therapies (yoga, exercise, and omega-3 supplements) for the improvement of menopause-related quality of life in women with vasomotor symptoms. The study found that, among healthy sedentary menopausal women, yoga appears to modestly improve menopausal quality of life.
 

Study 03: Comparison of Venlafaxine-XR and Low-Dose Estradiol for Treatment of Menopausal Symptoms

Randomized Controlled Trial of Low-Dose Estradiol and the SNRI Vanlafaxine for Vasomotor Symptoms published in JAMA Internal Medicine, July 2014.

Estrogen therapy (estradiol) is the gold standard hormonal treatment for hot flashes, but has associated risks for some women, while the SNRI venlafaxine is a widely used non-hormonal treatment. The purpose of this study was to evaluate these two medications in the same trial. Study findings suggest that both low-dose oral estradiol and venlafaxine are effective treatments for vasomotor symptoms in women during midlife.

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial published in Obstetrics & Gynecology, August 2014.

The purpose of this study was to evaluate sexual function in midlife women taking low-dose estradiol or venlafaxine for hot flashes. Findings were that overall sexual function among non-depressed women experiencing hot flashes did not change over 8 weeks with estradiol or venlafaxine (compared with placebo), although a small increase in desire (with estradiol) and decreases in orgasm and pain (with venlafaxine) may exist.

Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes published in Sleep, January 2015.

The purpose of this study was to determine the effects of low-dose estradiol or venlafaxine on self-reported sleep in menopausal women with hot flashes. Findings suggest that both estradiol and venlafaxine, compared with placebo, modestly reduced insomnia symptoms and improved subjective sleep quality.

Effects of estrogen and vanlafaxine on menopause-related symptoms and quality of life in healthy postmenopausal women with hot flashes: a randomized controlled trial published in Menopause, November 2014.

This study evaluated the effects of low-dose estradiol and venlafaxine on menopause-related quality of life and associates symptoms in healthy midlife women with hot flashes. They found that both estradiol and venlafaxine (compared with placebo) were effective in improving menopause-related quality of life, but did not improve pain, anxiety, or depression.
 

Methodology

Methods for the design of vasomotor symptom trials: the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network published in Menopause, January 2014.

Trial designs of the first three MsFLASH trials are presented, including the descriptions of and rationale for criteria used for interventions and study selection, common eligibility and exclusion criteria, common primary and secondary outcome measures, establishment of biorepository, trial duration, screening and recruitment, statistical methods, and quality control.

Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network published in Menopause, June 2012.

This study evaluated various monitors for assessing vasomotor symptoms (VMS) in laboratory and ambulatory settings. The Bahr Monitor and Biolog were found to be suitable for use in controlled laboratory conditions; however, the current versions of these monitors may not be suitable for ambulatory clinical trials.

Using an FSDS-R Item to Screen for Sexually Related Distress:A MsFLASH Analysis published in Sexual Medicine, December 2014.

The Female Sexual Distress Scale-Revised (FSDS-R) was created to assess distress due to impaired sexual function in women, but it is rather long for use in clinical practice. This study found that a single item from the FSDS-R could be a useful screening tool to quickly identify sexually-related distress when it is not possible to administer the entire scale.

Placebo Improvement in Pharmacologic Treatment of Menopausal Hot Flashes: Time Course, Duration and Predictors published in Psychosomatic Medicine, February/March 2015.

Data from two MsFLASH studies were combined to see if there was a clinically significant response to the placebo (inactive treatment), i.e., to see if women taking the inactive treatment had a reduction in hot flashes. The results showed that women reported fewer hot flashes while taking the placebo than they had at the beginning of the study.