Health-related quality of life in women with or without hot flashes

Savolainen-Peltonen, Hanna; Hautamäki, Hanna; Tuomikoski, Pauliina; Ylikorkala, Olavi; Mikkola, Tomi S.

doi:10.1097/gme.0000000000000120

Cited by 42 publications

(31 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Authors were contacted for 23 trials; the remaining 10 did not provide contact information. Two of 23 contacted authors provided the requested data [24, 25]. Thereafter, a total of nine trials had complete report of sleep quality.…”

Section: Resultsmentioning

confidence: 99%

“…Seven of the nine trials included a placebo treatment arm [15, 24–29], while 2 had parallel comparisons of MHT formulations [30, 31]. Therefore, the seven RCTs with placebo arm as comparator had similar interventions and reported sufficient quantitative data to allow for statistical pooling (Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…These covariates should help guide the design of future comparative effectiveness trials. Following the WHI, the use of low-dose transdermal estrogen increased more than tenfold [4], yet only three trials [24, 33, 34] had a direct comparison between routes of administration. Additionally, there is still a need for a standard definition of menopause, given that both age and years from menopause have shown to be important indicators of the benefit-risk ratio of MHT [35].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

et al. 2016

View full text Add to dashboard Cite

Sleep complaints are reported by 40–60 % of menopausal women. Poor sleep is a risk factor for cardiovascular disease, diabetes, and obesity. The effect of menopausal hormone therapy on sleep quality is unclear. A systematic review and meta-analysis were conducted to summarize the efficacy of menopausal hormone therapy on self-reported sleep quality. Electronic databases (PubMed, Scopus, Ovid MEDLINE, EMBASE, EBM Reviews CENTRAL, and Psyclnfo) were searched from 2002 to October 2015. Randomized trials assessing the effect of menopausal hormone therapy with a minimum follow up of 8 weeks were included. Titles, abstracts, and full texts were screened independently and in duplicate. Primary outcome included sleep items within a questionnaire, scale or diary. Standardized mean differences across trials were pooled using random-effects models. The search identified 424 articles, from which 42 trials were included. Seven trials at a moderate to high risk of bias enrolling 15,468 women were pooled in meta-analysis. Menopausal hormone therapy improved sleep quality in women who had vasomotor symptoms at baseline [standardized mean difference −0. 54 (−0. 91 to −0. 18), moderate quality evidence]. No difference was noted when women without such symptoms were analyzed separately or combined. Across 31 sleep quality questionnaires, daytime dysfunction was the most evaluated sleep domain. Menopausal hormone therapy improves sleep in women with concomitant vasomotor symptoms. Heterogeneity of trials regarding study population, formulations, and sleep scales; limit overall certainty in the evidence. Future menopausal hormone therapy trials should include assessment of self-reported sleep quality using standardized scales and adhere to reporting guidelines.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

et al. 2016

View full text Add to dashboard Cite

show abstract

“…Vasomotor symptoms (VMS) have been shown to negatively affect quality of life, increase sleep disturbances, impair social relationships, interfere with mood, and decrease work productivity, and are especially bothersome when severe. 1-9 For example, women with moderate to severe VMS have increased frequency of nighttime wakefulness 10-12 and chronic insomnia. 13 They are also more than three times more likely to report impaired quality of life than those with mild or moderate VMS.…”

mentioning

confidence: 99%

Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone

Mirkin

Graham

Revicki³

et al. 2019

Menopause

View full text Add to dashboard Cite

Objective: To characterize the impact of TX-001HR on the relationship between vasomotor symptom (VMS) improvement and quality of life and sleep. Methods: REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, which evaluated four daily doses of 17β-estradiol and progesterone (E2/P4) combined in a single, oral, softgel capsule in postmenopausal women (40-65 years) with a uterus and moderate to severe VMS (≥7/day or ≥50/week). In post hoc analyses, growth models were used to examine relationships between linear changes in VMS frequency and severity over 12 weeks and changes from baseline in the Menopause-Specific Quality of Life (MENQOL; total score and VMS domain) and the Medical Outcomes Study-Sleep (total score, sleep problems indices I and II) questionnaire outcomes at 12 weeks with treatment compared with placebo. Results: Outcomes with all four E2/P4 doses were combined (n = 591) and compared with placebo (n = 135). In all 5 growth models, the effects of TX-001HR on MENQOL total score and vasomotor domain were significantly associated with changes in VMS frequency and severity observed over 12 weeks (all, P < 0.001). Treatment-mediated effects on MENQOL via VMS frequency and severity models were significant. Similar results were found with Medical Outcomes Study-Sleep total score and sleep problems indices. Conclusions: TX-001HR improvements in quality of life and sleep outcomes are associated with and may be mediated through improvements in VMS frequency and severity.

show abstract

“…7 A smaller study specifically reported an association between hot flushes and poor sleep. 11 Chronic insomnia has been reported in approximately 50% to 55% of peri- and postmenopausal women versus approximately 35% of premenopausal women, with 81.3% of women with severe hot flushes experiencing symptoms of chronic insomnia. 6 Because VMS and associated symptoms, particularly sleep disruption, can lead to substantial physical and psychosocial impairment among postmenopausal women, addressing these symptoms is clinically important.…”

mentioning

confidence: 99%

Improvement in sleep outcomes with a 17β-estradiol–progesterone oral capsule (TX-001HR) for postmenopausal women

Kagan¹,

Constantine²,

Kaunitz

et al. 2018

Menopause

View full text Add to dashboard Cite

Objective: The aim of the study was to evaluate the effects of TX-001HR, a single-capsule 17β-estradiol–progesterone on sleep parameters in postmenopausal women with vasomotor symptoms (VMS) using the Medical Outcomes Study (MOS)-Sleep scale questionnaire in the REPLENISH trial. Methods: In the REPLENISH trial (NCT01942668), women were randomized to one of four doses of TX-001HR or placebo, and the 12-item MOS-Sleep questionnaire (secondary endpoint) was self-administered at baseline, week 12, and months 6 and 12. Changes from baseline in the MOS-Sleep total score and 7 subscale scores were analyzed for treatment groups versus placebo at all time points. Somnolence was also collected as an adverse event. Results: Women (mean age 55 y) were randomized to TX-001HR (estradiol/ progesterone [E2/P4] [mg/mg]) doses: 1/100 ( n = 415), 0.5/100 ( n = 424), 0.5/50 ( n = 421), 0.25/50 ( n = 424), or placebo ( n = 151). TX-001HR significantly improved MOS-Sleep total score, Sleep Problems Index II subscale, and sleep disturbance subscale versus placebo at all time points, except with 0.25 mg E2/50 mg P4 at week 12. Differences in LS mean changes between TX-001HR and placebo for MOS-Sleep total scores ranged from −6.5 to −7.6 at 12 months (all; P ≤ 0.001). All doses of TX-001HR significantly improved the Sleep Problems Index I subscale at all time points. The sleep somnolence subscale significantly improved from baseline with 0.5 mg E2/100 mg P4 and 0.5 mg E2/50 mg P4 at month 12. The incidence of somnolence as a treatment-emergent adverse event ranged from 0.2% to 1.2% versus 0% with placebo. Conclusion: TX-001HR significantly improved MOS-Sleep parameters from baseline to week 12, which was sustained for up to 12 months, and was associated with a very low incidence of somnolence.

show abstract

Health-related quality of life in women with or without hot flashes

Cited by 42 publications

References 36 publications

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone

Improvement in sleep outcomes with a 17β-estradiol–progesterone oral capsule (TX-001HR) for postmenopausal women

Contact Info

Product

Resources

About