Many women take estrogen plus progestin, a form of hormone replacement therapy, to combat the negative side effects associated with menopause. That may not be the case in the near future, however.

After health risks were determined to exceed benefits, earlier this year, the safety monitoring board for the Women's Health Initiative (WHI) halted an eight-and-a-half-year study on postmenopausal women taking estrogen plus progestin.

The WHI, which seeks to define risks and prevention strategies for heart disease, cancer, and fractures in postmenopausal women, enrolled women ages 50-79 in a set of studies between 1993 and 1998. One study of nearly 17,000 women compared estrogen plus progestin in one daily tablet to a placebo tablet (i.e., sugar pill).

Just over five years into the study, however, the risk for invasive breast cancer exceeded the "stopping boundary" for the study, and risks from taking the estrogen plus progestin were deemed too high to continue the trial. Compared to women taking placebo, women taking hormones were significantly more likely to suffer a stroke, breast cancer, or heart disease.

Although progestin plus estrogen is intended in part as a primary prevention for heart disease and death, it actually may increase risk for the condition. If the study had continued for several more years, the risks from taking these combined hormones may have been much worse.

Reference:

Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. Journal of the American Medical Association 2002:288(3), pp. 321-333.

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