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Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions (continued)

Appendix Table. Randomized, Controlled Trials Included in This Update

Trial (Reference) Intervention Participants Outcomes
WHI estrogen plus progestin trials
Main trial (3, 14, 17, 20, 22, 23, 25, 27, 29, 30, 32, 35, 36, 38, 39, 40) CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo (8506 vs. 8102 participants) for 5.2 y Postmenopausal women without hysterectomies, aged 50–79 y, recruited across the United States Invasive breast, colorectal, lung, or endometrial cancer; all-cause mortality; fractures; thromboembolic events (deep venous thrombosis or pulmonary embolism); coronary heart disease events; stroke; diabetes; gallbladder disease; cognitive function; and urinary incontinence
Postintervention phase (21, 28, 26) CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo for 8.6 years of cumulative use 95% of women from the main trial who provided follow-up information Invasive breast, colorectal, lung, or endometrial cancer; all-cause mortality; fractures; thromboembolic events; coronary heart disease events; and stroke
Extension phase (18) CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo for 11 y of cumulative use 83% of women from the main trial who consented for the extension phase Invasive breast cancer
WHIMS (41, 43, 45) CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo (2229 vs. 2303 participants) for 4.1 y WHI trial participants aged >65 y and free of probable dementia Cognitive function
WHISCA (46, 48) CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo (690 vs. 726 participants) for 1.4 y WHIMS trial participants at 1 of 14 WHIMS centers Cognitive function
WHI estrogen-only trials
Main trial (2, 15, 16, 19, 23, 24, 30, 31, 33, 37, 38) CEE, 0.625 mg/d, vs. placebo (5310 vs. 5429 participants) for 6.8 y Postmenopausal women with hysterectomies, aged 50–79 y, recruited across the United States Invasive breast, colorectal, or lung cancer; all-cause mortality; fractures; thromboembolic events; coronary heart disease events; stroke; diabetes; gallbladder disease; cognitive function; and urinary incontinence
Extension phase (18, 34, 63) CEE, 0.625 mg/d, vs. placebo for 10.7 y of cumulative use 78% of women from the main trial who consented for the extension phase Invasive breast cancer or colorectal cancer, all-cause mortality, fractures, thromboembolic events, coronary heart disease events, and stroke
WHIMS (42, 44) CEE, 0.625 mg/d, vs. placebo (1464 vs. 1483 participants) for 4.1 years WHI trial participants aged >65 y and free of probable dementia Cognitive function
WHISCA (46, 47) CEE, 0.625 mg/d, vs. placebo (434 vs. 452 participants) for 1.4 years WHIMS trial participants at 1 of 14 WHIMS centers Cognitive function
HERS
Main trial (50, 54–56) CEE, 0.625 mg/d, plus MPA, 2.5 mg, vs. placebo (1380 vs. 1383 participants) for 4.1 years Postmenopausal women with established coronary artery disease but no hysterectomies, aged ≤ 80 y, recruited across the United States Invasive breast, colorectal, lung, or endometrial cancer; all-cause mortality; fractures; diabetes; cognitive function; and urinary incontinence
Follow-up (HERSII) (52, 53) CEE, 0.625 mg/d, plus MPA, 2.5 mg, vs. placebo (1156 vs. 1165 participants) for 6.8 years cumulative use 93% of women from the HERS trial who consented for follow-up Invasive breast, colorectal, lung, or endometrial cancer and all-cause mortality
ESPRIT (57) Estradiol valerate, 2 mg/d, vs. placebo (513 vs. 504 participants) for 2 y Women aged 50–60 y admitted to coronary care units or general medical wards, met diagnostic criteria for initial myocardial infarction, and were discharged from the hospital within 31 d of admission Invasive breast cancer
EMS (49) 17-ß estradiol, 1 mg/d, for 4 days then 17-β estradiol, 1 mg, plus norethindrone, 0.35 mg/d, for 3 days, repeated every week vs. placebo (70 vs. 72 participants) for 2 y Postmenopausal women both with and without hysterectomies, age >60 y Invasive breast cancer and cognitive function
ULTRA (58–61) Transdermal estradiol, 0.014 mg/d, vs. placebo (208 vs. 209 participants) for 2 y Postmenopausal women without hysterectomies who had normal bone mineral density Fractures, cognitive function, and urinary incontinence
WISDOM (62) CEE, 0.625 mg/d, plus MPA, 2.5–5.0 mg/d, vs. placebo (2196 vs. 2189 participants) for 11.9 mo Postmenopausal women age 50–69 y Invasive breast cancer

CEE = conjugated equine estrogen; EMS = Estrogen Memory Study; ESPRIT = Oestrogen in the Prevention of Reinfarction Trial; HERS = Heart and Estrogen/progestin Replacement Study; MPA = medroxyprogesterone acetate; ULTRA = Ultra–Low-Dose Transdermal Estrogen Assessment; WHI = Women’s Health Initiative; WHIMS = Women’s Health Initiative Memory Study; WHISCA = Women’s Health Initiative Study of Cognitive Aging; WISDOM = Women's International Study of Long-Duration Oestrogen After Menopause.

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