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Risks of Hormones in Early Menopause Challenged

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WebMD Medical Reference

Oct. 5, 2012 -- Is it possible to safely take hormone replacement therapy (HRT)? That question is at the heart of a small new study testing whether better timing and refined delivery may help early menopausal women get the benefits of hormones relatively safely and without long-term risks.

For some women, menopause brings mental and physical symptoms that can make life a misery.

Replacing estrogen and progestin may help relieve complaints like hot flashes, irritability, brain fog, and vaginal dryness. But studies show that taking hormones, even temporarily, has risks.

In a large, government-funded trial called the Women’s Health Initiative (WHI) that was released about a decade ago, postmenopausal women who took HRT had higher risks of blood clots, strokes, heart disease, and breast cancer.

But the WHI enrolled women ages 50-79, many of whom started hormones when they were over age 65 and well past menopause.

Many doctors have wondered if replacement hormones might be safer if they are given as soon as they start to drop naturally in the body, around age 50 or so. It’s a theory called the timing hypothesis.

Testing the Timing Hypothesis

Preliminary results from the new four-year study, called the Kronos Early Estrogen Prevention Study (KEEPS), were presented Wednesday at the annual meeting of the North American Menopause Society in Orlando, Fla.

The study tested two forms of estrogen, in either a patch or a pill, along with progesterone, against a placebo in 737 women who were near menopause. The average age of women in the KEEPS study was 52, or within three years of entering menopause, and none had any evidence of heart disease.

Along with looking at two different ways to deliver estrogen, doctors lowered the usual dose, from 0.625 milligrams to 0.45 milligrams a day. The progesterone used in the study was taken for just 12 days of the month.

“We tried to simulate as much as we could the normal menstrual cycle hormonal changes,” says researcher Sanjay Asthana, MD, director of the Geriatric Research, Education and Clinical Center at the University of Wisconsin in Madison.

For four years, doctors have kept an eye on the participants' mental and physical health, watching for changes in heart, brain, bone, and sexual health.

The study was funded by the Kronos Longevity Research Institute in Phoenix, Ariz. An arm of the study that looked at mental function and memory was funded by the National Institute on Aging, which is a part of the National Institutes of Health.

Weighing Benefits and Risks

The study found that both forms of hormone therapy relieved menopausal symptoms like hot flashes and night sweats better than the placebo. Hormones also showed significant benefits for sexual health. Both pain with intercourse and vaginal dryness improved in women taking estrogen. Women on the patch, but not the pill, saw increases in their libido.

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