Our Bodies, Ourselves (114 page)

If you are taking bisphosphonates, be sure to inform your dentist before any dental surgery (but don't delay if you have a toothache or abscess or another urgent need); also, report new jaw, hip, or thigh pain to your health care provider. If you are considering starting on bisphosphonates, compare the latest data on their risks with the risks of other forms of osteoporosis prevention and treatment, including a bone-healthy lifestyle and monitoring of bone density. Understanding the risks and benefits of these drugs is definitely a work in progress. No one who is now eighty took bisphosphonates in her fifties, for example, since they were not approved until the 1990s.

Selective estrogen receptor modulators (SERMs), such as the drug raloxifene (sold as Evista), can prevent bone loss and reduce the risk of spine (but not hip) fracture without the increased risk of breast or uterine cancer that HT has. However, raloxifene may increase hot flashes and creates a risk of blood clots similar to the risk with pill estrogens. It is not a good choice for women with high risk of blood clot or stroke.

A mixed estrogen-progestin-testosterone-derived steroid called tibolone is widely used in European countries to treat hot flashes and night sweats and to increase bone density. Tibolone has a side effect similar to estrogen in pill form: it increases the risk of stroke in older women. The “Million Women” British study has shown that it increases the risks of endometrial cancer,
24
and it has been shown to increase recurrence in women with breast cancer.
25
Whether tibolone increases or decreases new cancers is still being debated. Unless there is conclusive reassuring evidence on this point, tibolone is unlikely to be approved for use in the United States.

Since the risk of debilitating fractures becomes significant after age seventy, women who start taking any of these drugs during perimenopause or in early postmenopause will probably have to take them for decades for the benefit of reduced fractures to become apparent. Further research into the long-term effects of these medications is needed.

Some women turn to alternative therapies for help during and after perimenopause, including herbs or botanicals, such as black cohosh, and food supplements, such as soy products.

The same questions we ask about drugs need to be posed for any complementary and alternative therapy: What is the specific reason to take it? Are there well-designed, sufficiently large randomized trials showing that it is effective for the recommended purpose? What are the side effects and harms associated with it? Has it been recommended to you by someone who may earn money from its sales?

Often these products are touted as a natural way to cope with discomforts without studies that adequately demonstrate their value. These remedies may not be produced in consistent strengths or doses because they are not regulated the way FDA-approved drugs are. They may not be safe for everyone. Be sure to tell your health care providers if you are taking alternative remedies; seemingly harmless remedies such as Saint-John's-wort or valerian can interact with other medications.

A plant extract called black cohosh is one of the most widely sold menopause treatments (it is found in over-the-counter products such as Remifemin). It appears to be reasonably safe for those who don't have liver problems,
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and some studies show benefits, but a large study by the National Center for Complementary and Alternative Medicine (NCCAM) found it no more effective than a placebo.
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Ginseng, evening primrose oil, dong quai, and vitamin E do not appear to reduce hot flashes.
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A full review of the evidence can be found on the NCCAM menopause page (nccam.nih.gov/health/menopause). NCCAM summarizes a 2005 National Institutes of Health (NIH) State-of-the-Science conference on the management of menopause-related symptoms by saying, “There is very little high-quality scientific evidence about the effectiveness and long-term safety of CAM (complementary and alternative medicine) therapies for menopausal symptoms. More research is needed.”
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One thing researchers agree on is that soy in food has weak estrogenic effects; these phytoestrogens have shown mixed results in studies of hot flashes and vaginal dryness—probably because of the diversity of products as well as individual variations in how women respond to soy. Some oncologists have concerns about soy for breast cancer survivors. Although the data are not clear, food-based soy (rather than supplements) is most likely safe. For more information on how to evaluate CAM therapies, see “Complementary and
Alternative Therapies.”

In much of U.S. culture, natural biological transitions such as childbirth or menopause are considered by many in the medical field to be medical conditions likely to need treatment through drugs or surgery. Ironically, this medicalization can lead to both overtreatment and undertreatment in perimenopause. Overtreatment comes when providers prescribe (and we ask for) medications for every kind of perimenopausal or postmenopausal problem, when in many cases a healthful lifestyle and self-care are safer and may well be more effective. When joints stiffen and ache, for example, this may be a result of aging or lack of adequate stretching and exercise, not just hormone imbalances. On the other hand, undertreatment is likely when we and our providers attribute almost every symptom we experience to perimenopause, rather than thoroughly investigating symptoms that may point to serious conditions.

One of the most important things you can do to improve your health care is to establish a relationship with a health care practitioner or clinician whose philosophy resembles yours, who
has pertinent up-to-date expertise, and who is open-minded. If possible, do so
before
perimenopause begins. Women's physical needs are as varied and individual as their personalities. You need a provider who will listen to what you know and feel and who will take the time to answer questions completely and without prejudice. If your current practitioner won't do that, ask friends, coworkers, and other health care providers to recommend someone else. If you can't change practitioner, at least speak up, ask questions, and insist on participating fully in all decisions concerning your care.

For those of us who have a particularly difficult menopause transition, finding a clinician who specializes in perimenopause and post-menopause can be helpful. The North American Menopause Society (NAMS) has a certification process for such clinicians, and its website (menopause.org) can give you more information. NAMS clinicians tend to be practitioners of mainstream medicine. Some CAM providers have experience helping women navigate the menopause transition with other approaches. If alternative practitioners suggest non-FDA-approved and otherwise less conventional treatments, be sure to request evidence of dependable research to back up the recommendation before making your decisions.

National health care legislation enacted in 2010—the Patient Protection and Affordable Care Act—has led to better coverage of certain services used by peri- and postmenopausal women. Many midlife women in the United States have experienced a gap in health care insurance coverage, being too young for Medicare (under age sixty-five) and not quite poor enough for Medicaid. The United States is the only industrialized country in the world that does not provide access to basic health care for all. Because most health care insurance is tied to benefits offered on a voluntary basis by employers, unemployed people and even many workers are uninsured. Many women lose health care insurance coverage after divorce. It is increasingly difficult to keep jobs as we grow older. Then we are faulted for needing so-called entitlements such as Social Security, Medicare, and disability benefits, though we may have been contributing to these funds for many years. Medicare is criticized as being too expensive, when it should be considered a model for a universal, single-payer health care insurance system. See
Chapter 21
, “Our Later Years,” and
Chapter 26
, “The Politics of Women's Health,” for more.

For those of us who have tried the nonmedical approaches, choose not to use hormone therapy (HT), and still have problems that seriously disrupt our work, sleep, or relationships, there are nonhormonal treatments that address many of the discomforts of perimenopause and beyond. Some of these are FDA-approved and others are considered off-label, which means clinicians may prescribe them for unapproved uses.

Drug companies now heavily market several nonhormonal medications to treat many conditions that were previously treated with estrogen. These include bisphosphonates for bone loss (see above for serious risks of bisphosphonates); anti-inflammatory drugs for joint pain, heavy flow, and cramps; antidepressants for hot flashes and mood problems; sleeping pills for insomnia; statins for high cholesterol; and so on. Many of these medications are even less well understood than HT for long-term use. If you have distressing symptoms but decide to forgo hormone therapy, ask a knowledgeable clinician for other options—but be aware of what else is in your
medicine cabinet and the potential interaction risks.

For many women, nonmedical self-help approaches can alleviate the discomforts of perimenopause and beyond. For others, a balance of nonmedical and medical solutions is needed, and well-informed health care providers can be important partners in thinking through the options. We need to be well informed as consumers, because there are many unanswered questions about the safety of hormone therapy, which is one of the primary medical treatments offered.

What follow are sections on the history and politics of hormone therapy, what we know so far about research on safety issues, and a discussion of the options that may be presented to you.
*

You may have heard about the Women's Health Initiative (WHI), a large study of HT use by women during and after the menopausal transition. The WHI study ended three years early (in 2002), because it had already documented serious health risks to women from certain commonly used forms of HT. Since that time, there have been ongoing discussion and controversy about what the WHI study actually proved about the dangers of hormone therapy and what it didn't. To understand what the WHI study can mean for health care decisions before and after menopause, the following history may be helpful. The hormone therapy story illustrates many lessons about medical care, science, business, and profit making in medicine and women's health. For study findings, visit the National Institutes of Health (
www.nhlbi.nih.gov/whi
).

In 1942, the FDA approved Premarin, an estrogen product made from pregnant mare's urine, for treatment of hot flashes. Drug companies soon began marketing estrogen as a magic pill not only for short-term relief from
hot flashes, night sweats, and vaginal dryness but also for maintaining youthfulness, preventing diseases associated with aging, and keeping women “feminine forever”—without adequate evidence about longer-term effects.
*
Then, in 1975, it became clear that estrogen administered without progesterone caused a dramatic increase in cancer of the uterine lining (endometrial cancer)—the first big shock about hormone therapy. After that time, progestins (synthetic forms of progesterone) were added to standard hormone therapy for women with a uterus, to prevent overgrowth of the uterine lining that can lead to cancer.

Barbara Seaman's 1977 book
Women and the Crisis in Sex Hormones
suggested that the hormone treatment currently in use for menopause could cause breast cancer, stroke, and blood clots. Although Seaman and the growing women's health movement warned against the overpromotion of hormones, flawed research and drug company marketing efforts through the 1990s pushed HT for the prevention of a variety of ills, from cardiovascular disease and osteoporosis to Alzheimer's disease, colon cancer, tooth loss, and macular degeneration. Estrogen-based HT for perimenopause and menopause became the most prescribed drug treatment in the country.

In the 1990s, some observational studies (in which women who chose to take or not take HT were followed over time) suggested that HT prevented heart disease, while other studies suggested that HT increased the risk of breast cancer and blood clots. Most medical professionals, including many who received funding from the pharmaceutical industry, advocated hormones for all women, reasoning that many more women died from heart disease than from breast cancer. (In the observational studies, healthier women were more likely to take hormones, and that could skew the results; this also biased physicians' prescribing practices.)

The first randomized control trial to challenge the theory that HT was beneficial for heart disease was the Heart and Estrogen/Progestin Replacement Study (HERS), a study of women with cardiovascular disease in which older women with heart disease took HT or a placebo. In 1998, HERS found no benefit of the top-selling HT formulation for preventing cardiovascular events.
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There remained a critical absence of dependable research to tell us whether or not HT prevented heart disease and should be recommended to all women.