It has been 10 years since researchers with the Women's Health Initiative, a large randomized, controlled trial on hormone therapy sponsored by the National Institutes of Health, announced its 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 lead investigators and a professor of medicine at Harvard Medical School, is president of the North American Menopause Society. She spoke about what women need to know.
Q: Millions of women stopped taking hormones 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. 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 the biggest takeaway from the study?
A: WHI deserves credit for stopping what was becoming common practice of starting hormone therapy in older women 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?
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 have you 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 benefit most?
A She is newly menopausal, within five years of onset of menopause, and in generally good health, with few risk factors for heart disease or breast cancer. She would be a non-smoker, not obese and does not have diabetes or poorly controlled blood pressure. She 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 these genes have a higher risk of developing breast 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.
Q: How long is safe for HT?
A: We usually advise women and clinicians to avoid more than five years of estrogen plus progestin because of breast cancer risk. Estrogen alone did not increase the risk of breast cancer in the WHI over seven years and may be used for that time period, even longer if needed.
Q: Could a woman with mild menopause symptoms take it for bone protection?
A: We don't generally recommend a woman start or continue on HT just for bone protection. The reason is, once you discontinue estrogen, there is accelerated bone loss. If a woman is taking estrogen in her 50s, by the time she gets to her 70s or 80s, when risk of osteoporotic fracture is greatest, she'll retain only a limited benefit (from HT). And we wouldn't recommend using estrogen plus progestin for 20-30 years for bone benefit because that would put women at increased risk for breast cancer and stroke. Other strategies are available to protect bones.
Q: If a woman wants to re-evaluate her decision about HT, how does she get started?
A: The website for the North American Menopause Society (menopause.org) provides a great deal of information for patients and clinicians. Finding a good clinician who is up to date on HT research and has experience prescribing these medications can be a challenge. The site lists clinicians by ZIP code area who have extra training and interest in menopausal issues and are NAMS-certified.
Q: What important research is in the pipeline?
A: The results of the Kronos Early Estrogen Prevention Study will be presented at the North American Menopause Society meeting in October. KEEPS is a study of 727 women within three years of menopause onset (ages 42 to 58) when enrolled. It looks at a number of outcomes, including whether early estrogen prevents or delays atherosclerosis and improves cognitive function or quality of life. It's also comparing different formulations of treatment.
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