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. 2022 Jan 31;29(5):627–635. doi: 10.1097/GME.0000000000001945

TABLE 1.

Characteristics of included trials

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.