Effects of pharmacologic and nonpharmacologic interventions on insomnia symptoms and self-reported sleep quality in women with hot flashes: A pooled analysis of individual participant data from four MsFLASH trials

Katherine A. Guthrie, Joseph C. Larson, Kristine E. Ensrud, Garnet L. Anderson, Janet S. Carpenter, Ellen W. Freeman, Hadine Joffe, Andrea Z. LaCroix, Jo Ann E. Manson, Charles M. Morin, Katherine M. Newton, Julie Otte, Susan D. Reed, Susan M. McCurry

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions’ effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ? 12, and ?14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10–20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8–12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at ?5.2 points (95% CI ?7.0 to ?3.4). Effects on ISI were similar for exercise at ?2.1 and venlafaxine at ?2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at ?2.7 points (?3.9 to ?1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study’s findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.

Original languageEnglish (US)
Article numberY
JournalSleep
Volume41
Issue number1
DOIs
StatePublished - Jan 1 2018

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Hot Flashes
Sleep Initiation and Maintenance Disorders
Sleep
Cognitive Therapy
Yoga
Citalopram
Estradiol
Randomized Controlled Trials
Exercise
Omega-3 Fatty Acids
Menopause

Keywords

  • Insomnia
  • Menopause
  • Vasomotor symptoms

PubMed: MeSH publication types

  • Journal Article
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

Cite this

Effects of pharmacologic and nonpharmacologic interventions on insomnia symptoms and self-reported sleep quality in women with hot flashes : A pooled analysis of individual participant data from four MsFLASH trials. / Guthrie, Katherine A.; Larson, Joseph C.; Ensrud, Kristine E.; Anderson, Garnet L.; Carpenter, Janet S.; Freeman, Ellen W.; Joffe, Hadine; LaCroix, Andrea Z.; Manson, Jo Ann E.; Morin, Charles M.; Newton, Katherine M.; Otte, Julie; Reed, Susan D.; McCurry, Susan M.

In: Sleep, Vol. 41, No. 1, Y, 01.01.2018.

Research output: Contribution to journalArticle

Guthrie, KA, Larson, JC, Ensrud, KE, Anderson, GL, Carpenter, JS, Freeman, EW, Joffe, H, LaCroix, AZ, Manson, JAE, Morin, CM, Newton, KM, Otte, J, Reed, SD & McCurry, SM 2018, 'Effects of pharmacologic and nonpharmacologic interventions on insomnia symptoms and self-reported sleep quality in women with hot flashes: A pooled analysis of individual participant data from four MsFLASH trials', Sleep, vol. 41, no. 1, Y. https://doi.org/10.1093/sleep/zsx190
Guthrie, Katherine A. ; Larson, Joseph C. ; Ensrud, Kristine E. ; Anderson, Garnet L. ; Carpenter, Janet S. ; Freeman, Ellen W. ; Joffe, Hadine ; LaCroix, Andrea Z. ; Manson, Jo Ann E. ; Morin, Charles M. ; Newton, Katherine M. ; Otte, Julie ; Reed, Susan D. ; McCurry, Susan M. / Effects of pharmacologic and nonpharmacologic interventions on insomnia symptoms and self-reported sleep quality in women with hot flashes : A pooled analysis of individual participant data from four MsFLASH trials. In: Sleep. 2018 ; Vol. 41, No. 1.
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abstract = "Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions’ effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ? 12, and ?14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10–20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8–12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at ?5.2 points (95{\%} CI ?7.0 to ?3.4). Effects on ISI were similar for exercise at ?2.1 and venlafaxine at ?2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at ?2.7 points (?3.9 to ?1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study’s findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.",
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AU - Ensrud, Kristine E.

AU - Anderson, Garnet L.

AU - Carpenter, Janet S.

AU - Freeman, Ellen W.

AU - Joffe, Hadine

AU - LaCroix, Andrea Z.

AU - Manson, Jo Ann E.

AU - Morin, Charles M.

AU - Newton, Katherine M.

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AU - Reed, Susan D.

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N2 - Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions’ effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ? 12, and ?14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10–20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8–12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at ?5.2 points (95% CI ?7.0 to ?3.4). Effects on ISI were similar for exercise at ?2.1 and venlafaxine at ?2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at ?2.7 points (?3.9 to ?1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study’s findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.

AB - Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions’ effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ? 12, and ?14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10–20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8–12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at ?5.2 points (95% CI ?7.0 to ?3.4). Effects on ISI were similar for exercise at ?2.1 and venlafaxine at ?2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at ?2.7 points (?3.9 to ?1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study’s findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.

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KW - Menopause

KW - Vasomotor symptoms

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