TABLE 1.
Y | Study design | Sample sizes | Participant characteristics | Details of HT (/d) | Control | Duration | Sleep outcomes | |
Brunner et al20 | 2005 | RCT | 10,739 | postmenopausal women with hysterectomy, mean age 63.6 y | o-CEE 0.625 mg | placebo | 12 mo | WHIIRS |
Cintron et al16 | 2018 | RCT | 727 | postmenopausal women, mean age 52.6 y | o-CEE 0.45 mg + micronized progesterone 200 mg, t-17β-E2 50 μg + micronized progesterone 200 mg | placebo | 48 mo | PSQI |
Ensrud et al25 | 2015 | RCT | 339 | menopause, postmenopausal or undergone hysterectomy women, mean age 54.6 y | o-17β-E2 0.5 mg | placebo | 8 wk | PSQI |
Hachul et al26 | 2008 | RCT | 33 | postmenopausal women, mean age 55.9 ± 4.5 y | o-CEE 0.625 mg | placebo | 24 wk | polysomnography |
Hays et al21 | 2003 | RCT | 8,506 | postmenopausal women, mean age 63.2 y | o-CEE 0.625 mg + MPA 2.5 mg | placebo | 12 mo | WHIIRS |
Heinrich and Wolf17 | 2005 | RCT | 51 | postmenopausal women with hysterectomy, mean age 64.1 ± 0.6 y | o-EV 2 mg, o-EV 2 mg + micro-micronized progesterone 200 mg | placebo | 24 wk | Sleep item from ADSK and from Menopausal Index |
Kagan et al27 | 2018 | RCT | 1,835 | postmenopausal women, mean age 55 y | oral TX-001HR (1 mg E2/ 100 mg P4, 0.5 mg E2/ 100 mg P4, 0.5 mg E2/50 mg P4, 0.25 mg E2/50 mg P4) | placebo | 12 mo | MOS-sleep questionnaire |
Kalleinen et al28 | 2008 | RCT | 18 | postmenopausal women, mean age 62.9 y | o-EV 2 mg + norethisterone 0.7 mg | placebo | 6 mo | BNSQ and polysomno-graphy |
LeBlanc et al29 | 2007 | RCT | 37 | late menopausal or early postmenopause women, mean age 52.3 y | o-E2 2 mg | placebo | 8 wk | OHSU SL sleep dairy |
Leeangkoonsathian et al30 | 2017 | RCT | 100 | perimenopause, early menopause or late menopause women, mean age 52.1 ± 4.1 y | o-EV 1 mg + micronized progesterone 10 mg, o-EV 1mg + dydrogesteron 100 mg | none | 3 mo | PSQI |
Meeuwsen et al31 | 2002 | RCT | 85 | postmenopausal women, mean age 54.2 ± 4.7 y | o-tibolone 2.5 mg | placebo | 12 mo | NHP questionnaire |
Polisseni et al32 | 2013 | RCT | 130 | postmenopausal women, mean age 52.6 ± 3.6 y | tibolone 2.5 mg, estradiol 1mg + norethindrone acetate 0.5 mg | calcium carbonate 50 mg + VitD3 200IU | 12 wk | WHQ sleep item |
Polo-Kantola et al33 | 1999 | RCT | 71 | postmenopausal women, mean age 56.4 ± 4.4 y | estrogel 2.5 g, estrogen patch 50 ug | placebo | 3 mo | polysomnography |
Saletu-Zyhlarz et al22 | 2003 | RCT | 55 | insomniac postmenopausal women, mean age 58 ± 5y | o-EV 2 mg + dienogest 3 mg, o-EV 2 mg | placebo | 8 wk | PSQI and polysomnography |
Savolainen-Peltonen et al23 | 2014 | RCT | 150 | postmenopausal women, mean age 53.2 y | t-E2 1 mg, o-EV 2 mg, o-EV 2mg + MPA 5 mg | placebo | 6 mo | WHQ sleep item |
Shulman et al34 | 2002 | RCT | 845 | postmenopausal women≥45 y | t-17β-E2/LNG (0.045 mg + 0.015 mg, 0.045 mg + 0.030 mg, 0.045 mg + 0.040 mg), t-17β-E2 | none | 1y | WHQ sleep item |
Silva et al35 | 2011 | RCT | 12 | postmenopausal women, mean age 49.7 ± 4.4 y | 0.045 mg o-E2 1mg + trimegestone .125 mg | placebo | 4 wk | polysomnography |
Tansupswatdikil et al24 | 2015 | RCT | 40 | insomniac postmenopausal women, mean age 54.4 y | t-17β-E2 50 μg | placebo | 2 mo | ISI |
Welton et al36 | 2008 | RCT | 3,721 | postmenopausal women with or without subtotal hysterectomy, mean age 63.8 y | o-CEE 0.625 mg + MPA2.5 mg, o-CEE 0.625 mg + MPA 5mg | placebo | 12 mo | WHQ sleep item |
17β-E2,17β-estradiol; ADSK, German short version of the Center for Epidemiological Studies Depression Scale; BNSQ, Basic Nordic Sleep Questionnaire; CEE, conjugated equine estrogens; E2, estradiol; EV, estradiol valerate; HT, hormone therapy; ISI, Insomnia Severity Index; LNG, levonorgestrel; MOS, Medical Outcomes Study; MPA, medroxyprogesterone acetate; NHP, Nottingham Health Profile; o-, oral; o-CEE, oral conjugated equine estrogen; OHSU SL, Oregon Health and Science University Sleep Laboratory; P4, progesterone; PSQI, Pittsburgh Sleep Quality Index; RCT, randomized controlled trials; t-, transdermal; TX-001HR, a single, oral softgel capsule that contains hormones that are biologically identical to endogenous 17β-estradiol and progesterone; VitD3, vitamin D3; WHIIRS, Women's Health Initiative Insomnia Rating Scale; WHQ, Women's Health Questionnaire.