For the majority of these women, hot flashes are an inconvenience and nothing more. But about 10 to 15 percent of women have severe hot flashes so frequently that they have trouble sleeping at night and making it through the day without a shower and a change of clothes. Until a few years ago, the most widely prescribed remedy for hot flashes was estrogen. However, in 2002, a huge federally funded study called the Women’s Health Initiative (WHI) found that women taking a combination of estrogen and progesterone had a higher risk of heart disease and breast cancer. Women threw out their pills, and tried a variety of alternatives, including “natural” hormones that haven’t been approved by the Food and Drug Administration. In our last column, we talked about the risks of these individually prepared drugs , which are usually derived from plants.
But there’s another side to the hormone story. Since the WHI, researchers have been learning much more about the risks and possible benefits of estrogen at midlife. One of the most prominent of those scientists is Dr. JoAnn Manson, a professor at Harvard Medical School and chief of preventative medicine at Brigham and Women’s Hospital in Boston. She was also a lead investigator on the WHI. In her recently published book, " Hot Flashes, Hormones & Your Health ," (McGraw-Hill) Manson and co-author Shari Bassuk explain the latest science on hormones and provide guidelines for women who need hot flash relief. We talked to Manson about some of the highlights:
NEWSWEEK: Many doctors now say women should try lifestyle changes (losing weight, lowering stress, getting exercise) before hormone therapy. Do you agree? If so, how long should you try these changes to see if they work before moving on to another solution?
MANSON: Before considering hormone therapy or other drug treatment, most women should first try lifestyle approaches for at least three months to see whether these strategies relieve hot flashes or night sweats. But if hot flashes and night sweats are debilitating and disruptive of sleep and quality of life, women need not wait that long before trying hormone therapy. Lifestyle changes generally help with mild symptoms of menopause but provide less benefit for moderate to severe symptoms.
Do you believe the WHI results have been misinterpreted? If so, how?
The WHI results have been generally translated into an inappropriate “one-size-fits-all” conclusion—namely, that hormone therapy is bad for all women. While the pendulum of public opinion has swung from the pre-WHI position that hormone therapy is good for all women to the post-WHI position that it’s harmful for all women, both views are oversimplifications that have confused and alarmed women, not to mention their doctors. Research from our group and others suggests that a woman’s age and time since menopause, as well as her health profile, powerfully influence the benefit-risk equation. Indeed, after the maelstrom surrounding the initial WHI publication in 2002, which concluded that hormone therapy increased cardiovascular disease risk in the WHI study population as a whole, my colleagues and I took a closer look at the data from the WHI and other studies, focusing on the ages of the participants. We found that, for heart disease, estrogen therapy tends to be beneficial when started early after menopause and harmful when started late after menopause. The average age of the women participating in the WHI hormone trials was 63 years. Because most were many years past menopause, which occurs on average at age 51 in this country, their benefit/risk profile tended to be more adverse than for most recently menopausal women.
How can a woman tell whether she is an appropriate candidate for hormone
therapy? What questions should she be thinking about?
First, she must have moderate to severe hot flashes or night sweats as a treatment indication, because relief of these symptoms is the only compelling reason to take menopause hormones. Women with vaginal dryness or other local symptoms may be candidates for topical, rather than systemic, estrogen. Second, she must have an acceptable health profile. Key factors to consider are her age, where she is in the menopausal transition, and whether she is in good cardiovascular health.
A younger, recently menopausal woman—one whose last menstrual period occurred less than five years ago and who is not at high risk of heart disease, stroke, or blood clots in the legs or lungs—is the best candidate for hormone therapy. An older woman many years past menopause, who is at higher risk of these cardiovascular conditions, is not a good candidate. A woman with a history of breast or uterine cancer, or who is at high risk of these cancers, should also avoid hormone therapy. [Provided she is an appropriate candidate to start hormones, a woman will need to weigh a possible increase in risk of breast cancer against a decrease in risk of osteoporotic fracture to determine how long she can stay on hormone therapy.] And, of course, she must also have a personal preference for hormone therapy; no one who is reluctant to take hormones should feel pressure from her healthcare provider to do so.
Obviously, women need to be partners with their doctors. However, since the WHI, many women express distrust of the medical community as a whole. What is your answer to that?
This distrust is an unfortunate consequence of a trend that developed in the late 1980s and into the 1990s when doctors began to prescribe hormone therapy to older women at high risk of cardiovascular disease, a group we now know to be inappropriate candidates for hormone therapy. Due largely to the results of the WHI and other clinical trials, our current understanding of the health consequences of hormone therapy is actually a triumph of what researchers call “evidence-based” medicine—that is, using the results of scientific studies to shape healthcare practice and policy. That said, women need to realize that their doctors may be predisposed toward or against the use of menopause hormones, so women need to have knowledge of recent study results in order to discuss with their doctors the pros and cons of hormone therapy for their particular situation. My book provides the necessary information for women who want to take an active role in partnering with their doctors to make informed decisions about hormone therapy and, if this treatment is chosen, to maximize the benefits while minimizing the risks.
That distrust has opened the door to the huge market in bioidenticals—supposedly more “natural” than FDA-approved drugs. What should women know about these preparations? Are they more natural? Are they safe or effective?
Bioidentical hormones refer to hormone preparations containing hormones that are an exact molecular match to those made naturally by our bodies. It’s possible that bioidentical products provide a more favorable balance of long-term benefits and risks than other hormone options, but we simply don’t know whether this is the case, because large-scale scientifically rigorous studies of bioidentical hormones have not been done.
I’d like to point out an often misunderstood distinction between bioidentical hormones and custom-compounded hormones. The term “bioidentical,” as I’ve just mentioned, refers to the chemical structure of the hormones. Such hormones can be prescribed by doctors and
purchased at conventional pharmacies in a range of standard doses, or, alternatively, at compounding pharmacies in individually prepared doses.
In the latter situation, the hormone preparations are known as “custom-compounded” bioidentical hormones. My advice to women who wish to use bioidentical hormones is to stick with commercially available preparations, which are regulated by the federal government, rather than custom-compounded preparations, which are not. Surveys of custom-compounded products find that a significant percentage of these medications, including hormone preparations, do not meet standard quality benchmarks. In some cases, the advertised potency is not the same as the actual potency of these drugs and contamination is possible.
Women who use bioidenticals say they like them because the dosage is individually prepared based on blood or saliva tests. Is there any scientific basis to these tests? How accurate are they?
Some healthcare providers and popular writers recommend blood or saliva tests to determine whether a woman has the “right amount” or “right balance” of hormones and whether to adjust her dose. However, the value of these tests is highly questionable, and there are little scientific data to support their use. Also, hormone levels can fluctuate throughout the day and a single measurement may be misleading. Moreover, the tests can be expensive and are rarely covered by insurance.
Some scientists think that we may ultimately find that estrogen is indeed cardio-protective. What are your thoughts on that?
I think it is possible that estrogen may indeed protect the heart if it is started early enough after menopause, but women and their doctors need to take into account the full set of benefits and risks of hormone therapy when deciding whether to use this treatment. Hormone therapy, particularly estrogen plus progestogen, has been linked to an increased risk of blood clots, stroke, and breast cancer-and the risk of breast cancer rises with duration of hormone use. To achieve lasting heart benefits, estrogen would likely need to be taken for many years. In the long run, the heart benefit may be offset by breast cancer or other risks.
In terms of heart disease, what would you tell a woman who wants to lower her risk of heart problems but doesn’t want to take hormones?
Lifestyle factors have a powerful role in preventing cardiovascular disease. Indeed, research has shown that 80 percent of heart disease cases can be prevented through lifestyle modification. Rather than relying on hormone therapy, women of all ages should renew their focus on eating healthy foods; abstaining from smoking; getting regular physical activity; maintaining a healthy weight; and controlling cholesterol, blood pressure, and diabetes (with prescription medications as needed), as these remain the best strategies for long-term cardiovascular disease prevention.
If you’ve tried diet and exercise to reduce your cholesterol and it’s still high, do you think midlife women should consider statins on a long-term basis?
Yes. Statins can be very effective in lowering cholesterol and reducing the likelihood that a woman will experience a heart attack or stroke, especially if she has other risk factors for cardiovascular disease in addition to a high cholesterol level. That said, not every midlife woman needs to take statins—these drugs shouldn’t be added to the water supply! We don’t yet have data from very long-term studies on the safety and the balance of benefits and risks of statins among people who have taken these medications for many decades.
