Hormone therapy with estrogen and progesterone started soon after menopause may relieve many of the symptoms experienced by menopausal women and also improve mood and markers of cardiovascular risk, according to new findings presented at the North American Menopause Society (NAMS) Annual Meeting in October, 2012. The Kronos Early Estrogen Prevention Study (KEEPS) investigated the risks and benefits of hormone therapy in women aged 42-58 who recently entered menopause. KEEPS was undertaken because the Women’s Health Initiative (WHI) found that the incidence of cardiovascular disease increased by 29% in older women (age 50-79) who were treated with oral conjugated equine estrogens (CEE) and medroxyprogesterone acetate. The WHI contradicted previous studies that suggested hormone therapy was associated with a high degree of protection against heart disease and a favorable benefit-risk ratio, so KEEPS studied a younger popular than the WHI to determine if age is a factor.
KEEPS was a four-year randomized, double-blinded, placebo-controlled clinical trial involving 727 women who were within three years after menopause when the study began. Women at nine major medical centers received low-dose oral conjugated equine estrogens (CEE), transdermal estradiol (E2) or placebo. All women also received cyclic micronized progesterone orally.
KEEPS researchers concluded:
- 48 months of hormone treatment in this healthy, recently menopausal population neither significantly reduced nor accelerated progression of atherosclerosis.
- Improvements in hot flashes, night sweats, mood, sexual function, and bone density were observed with hormones but not placebo.
- Transdermal estradiol appeared to improve insulin sensitivity (lowered insulin resistance).
- Hormone therapy improves symptoms of depression and anxiety in recently menopausal women, without adverse effects on cognition.
- No significant differences in adverse events (breast cancer, endometrial cancer, heart attack, stroke, or venous blood clots) were found between different hormones or placebo.
- There is a need for individualized decision making about hormone therapy, given that each woman has a unique symptom profile and priorities for treatment.
- Additional research on hormone therapy in newly menopausal women, including differences in effects according to route of delivery, dose, and formulation of hormone therapy, is needed.
For more information about the KEEPS study results, visit www.keepstudy.org. Researchers noted that the KEEPS preliminary findings presented at NAMS are not yet peer- reviewed and will be submitted for publication in a medical journal.