10 years after hormone therapy study: What doctors know now

It's been 10 years since researchers of the Women's Health Initiative, a large randomized, controlled trial on hormone therapy sponsored by the National Institutes of Health, announced their first findings: that the health risks outweighed the benefits of estrogen plus progestin hormone therapy (HT) in postmenopausal women. Since then, additional research has advanced the understanding of the benefits and risks. JoAnn Manson, one of the study's lead investigators and a professor of medicine at Harvard Medical School, is the president of the North American Menopause Society. She spoke with USA TODAY's Janice Lloyd about what women need to know to get through the challenging time and to protect their health.

Q: Millions of women stopped taking hormone therapy as a result of the study 10 years ago. Was that a good thing?

A: Although the pendulum may have swung too far, it was a good thing that many women who were inappropriate candidates for HT stopped taking the medications. For example, it was fortunate that many women at high risk of heart attack, stroke, and breast cancer stopped taking HT. However, even young, newly menopausal, and healthy women with significant hot flashes and other symptoms became afraid to seek treatment. Also, many, many clinicians no longer prescribe, or know how to prescribe. This isn't a good situation for young women who are having severe menopausal symptoms. They're going to have trouble finding clinicians who will help them make the most informed decision.

Q: Critics fault the Women's Health Initiative (WHI) for using mostly older women who wouldn't benefit from hormone therapy. But what do you think was one of the biggest takeaways from that study?

A: WHI deserves credit for stopping what was becoming common practice of starting hormone therapy in older women who were at high risk for heart disease because we found it failed to protect them from heart disease, stroke or dementia, and actually increased their risk. We also learned there are major differences in the benefit-risk profile of estrogen alone - used by women who have had a hysterectomy - and estrogen plus progestin, used by women who have an intact uterus. The balance of benefits and risk was more favorable with estrogen alone.

Q: Was the study flawed in any way?

A: It's fortunate there was a broad range of age groups so we could assess differences by age, but unfortunate there were not more women in the younger age group so we'd have a clearer understanding of the results for younger women seeking relief from menopausal symptoms. Q: What has been learned since 2002 about who is most likely to benefit from hormone replacement therapy?

A: It's become very clear that a "one size fits all" approach is not appropriate. The WHI has pointed the way to more individualized decision making and health care.

Q: Can you describe a woman likely to get the most benefit?

A She is newly menopausal, within five years of onset of menopause, and in generally good health and with few risk factors for heart disease or breast cancer. For example, she would be a nonsmoker, not obese and does not have diabetes or poorly controlled blood pressure. That is the optimal candidate. But an optimal candidate would also have moderate or severe hot flashes or other menopausal symptoms, so she'd have a clear indication for treatment. From a breast cancer standpoint, she would not have first-degree relatives (mother, sister) with breast cancer and would not be known to have the BRCA1 or BRCA2 gene. (Women who have inherited mutations in these genes have a higher risk of developing breast cancer and ovarian cancer.) Even though that's the optimal candidate, I don't want to suggest that these are the only women who would benefit from HT or be considered for treatment.

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10 years after hormone therapy study: What doctors know now