Professor of medicine at Harvard Medical School and Brigham and Women's Hospital told that, they generally agree with the approvals of the Task Force against the use of menopausal hormone therapy for the express purpose of trying to prevent cardiovascular disease or other chronic conditions. They have heard from many clinicians and patients that that's the case and that this is leading to confusion. This report was published in JAMA.
One of the issues is that the Task Force report didn't make as clear a distinction as it could have about the use of hormone therapy for treatment of symptoms versus use for prevention of chronic disease. The report does not apply to hormone therapy for management of symptoms. We've also seen that there is a signal that supports the timing hypothesis that the younger women do better than the older women in terms of the risk for myocardial infarction and all-cause mortality. The ELITE trial did directly test the timing hypothesis and did provide support for this theory.
Although it did not look at clinical events, it looked at the surrogate endpoint of carotid intima-media thickness. Another key point is that we now have many formulations of hormone therapy, and many have lower risk, such as lower doses and transdermal formulations, that would not be expected to have the same risk for venous thrombosis. That needs to be taken into account—not for making a case to use hormone therapy for prevention of cardiovascular disease or other chronic diseases, but when looking at the likelihood of adverse events and the overall balance of benefits and rest.
It's also of some concern that the recommendations regarding bone health may be an overall generalization and may really be a too-simple, one-size-fits-all type of answer. We know that for bone health, the decisions are complex. They need to be individualized. Some women may be candidates, especially if they started in early menopause and have very high risk for osteoporosis, or low risk for cardiovascular disease or breast cancer. Another point is that the Task Force did not address some special populations, as they admitted.
They conclude menopausal hormone therapy is an appropriate treatment for hot flashes and other menopausal symptoms, including dyspareunia and some of the genitourinary symptoms. The professional societies that focus on women's health all endorse its use for those purposes in appropriate candidates. They didn't address early menopause, premature menopause, and women who are at particularly high risk for bone health problems. This was not given detailed evaluation within the report.
It is FDA approved for that purpose and also for prevention of osteoporosis in appropriate candidates. These are complex decisions where clinicians really need to individualize decision-making, and it is very important that women share in the decision-making process and have the opportunity to express their personal preferences.