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 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 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 healthcare.
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, night sweats 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.
Q: What length of time is safe for HT? A: We usually advise women and their clinicians to avoid more than five years of estrogen plus progestin because of the risk of breast cancer. Estrogen alone did not increase the risk of breast cancer in the WHI over seven years and may be used for that time period, or even longer if needed.
Q: What if a woman has mild menopause symptoms but wants to also 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 for bone protection.
Q: If a woman wants to re-evaluate her decision about HRT, how does she get started? A: The website for the North American Menopause Society (NAMS) provides a great deal of information for patients and their clinicians. Finding a good clinician who is up to date on HT research and has experience prescribing these medications can be a challenge. The NAMS website (menopause.org) lets people know which clinicians in their zip code area have extra training and interest in menopausal issues and are NAMS certified menopause practitioners (NCMPS).
Q: What important research is in the pipeline? A: We need more information on different formulations and doses of HT. 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 who were within three years of the onset of menopause (42 to 58 years old) when they enrolled in the HT trial. KEEPS is looking 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.