Women's Bodies, Women's Wisdom (121 page)

Further, Rowan Chlebowski, M.D., Ph.D., a medical oncologist at Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, assembled a team of researchers to determine if the significant drop in breast cancer cases seen after 2003 was due to women halting their hormone therapy or to more vigilant mammography practices.
²²
Their research, published in 2009, showed that getting regular mammograms didn’t affect the drop in breast cancer cases. But it also showed that the decline in breast cancer wasn’t related to all types of hormone therapy. The women who took only estrogen (mainly Premarin) without the progestin were no more likely to develop breast cancer than women who took no hormones at all, which points to synthetic progestin as the likely culprit.

All the evidence combined makes it more clear that the science supporting hormone therapy is still evolving and that hormone therapy decisions need to be individualized.

The Case for Bioidentical Hormones

Despite data suggesting a decrease in heart disease if Premarin is started early, and also despite the data indicating that Premarin probably doesn’t cause an increase in the risk of breast cancer, I’m still concerned that Premarin isn’t the best choice of estrogen. And synthetic progestin clearly isn’t the best choice, either. Back in 1994, concerned about the type of hormone therapy used in the WHI study, I wrote, “In view of the concerns regarding breast cancer associated with estrogen replacement therapy (ERT), the use of synthetic sex com pounds with which the human body is not designed to cope would appear to be the equivalent of conducting a vast experiment on the human female population. It is ironic, in this light, that treatment using natural hormones bioidentical to those in a woman’s body is designated as ‘alternative’ medicine.”

Now here we are, nearly twenty years later, and most people, including health care practitioners, still don’t comprehend the difference between a hormone that is identical to one that is native to the female human body and one that isn’t. It’s crucial to understand that it is the three-dimensional structure of a hormone that determines how it acts in the body. You can’t possibly get an optimal physiologic response from a hormone if its structure is foreign to the human body. And that is the case with many of the hormones available today. The reason for the continued use of synthetic hormones is that naturally occurring compounds cannot be patented. Therefore, using them has not been in the financial interest of drug companies. Instead, they have altered the compounds so that they can obtain patents on them. (This is also why substances such as iodine, magnesium, vitamin D, and omega-3 fats, for example, have been so slow to catch on as the therapeutic powerhouses that they are. There’s little financial profit in producing them.)

Because the hormones in Premarin are derived from horses, they clearly don’t match those found in women’s bodies.
²³
As Joel Hargrove, M.D., a pioneer in the use of natural hormones and former medical director of the Menopause Center at Vanderbilt University Medical Center, quips, “Premarin is a natural hormone if your native food is hay.”

Finding Middle Ground:
The Individualized Hormone Solution

Though many of my colleagues and I were disturbed by the way in which the Women’s Health Initiative study was stopped and the distress it caused for so many women, the good news is that it changed the hormone therapy paradigm completely. Almost overnight, we went from a “one size fits all,” “magic bullet” approach to understanding the need to individualize our approach to hormone therapy. And that is likely to remain the standard of care from now on—regardless of what new studies are done in the future. This updated thinking about hormones also led to new terminology. Taking hormones is now called hormone therapy (HT), not hormone replacement therapy (HRT). This change reflects the fact that menopause is now finally viewed as a normal life stage, not as a deficiency state. Hallelujah!

For those women who require hormone therapy by virtue of their symptoms, this is very good news. The field of individualized natural hormone support has positively blossomed since the first edition of this book was published. And instead of reducing the entire hormone question simply to estrogen, it is now clear that HT may require the two other classes of hor mones that the ovaries also produce: progesterone and androgens.

First, a word about that confusing and much-debated word
natural
. The hormone components of Premarin are indeed natural for horses, but the word is more commonly applied to plant hormones (phytohormones) found in foods such as soybeans and wild yams. The human body utilizes plant hormones very well, because we have been ingesting them for millions of years. But plant hormones are sterols, not steroids. And though they have slight hormonal effects, they are simply not the same thing as bioidentical human hormones. (See also the phytoestrogen discussion in chapter 10, page 352.)

I use the word
natural
to refer to a hormone that, while derived from the plant sterols found in soybeans and yams, has a molecular structure that is modified in the laboratory to be an exact match for those found in the human body. That is why they are also referred to as bioidentical hormones. The issue is not whether or not a hormone is produced in a laboratory; if it matches the hormones found in the human body, then it’s a bioidentical hormone. The bioidentical estrogens, progesterone, and testosterone that are used for hormone therapy have been available for years and are listed in the United States Pharmacopeia. Any licensed pharmacist or physician can use them, and they can be produced at strengths that can be standardized, so their effects are measurable and predictable. They do not require FDA approval because, as naturally occurring substances, they do not fall under the jurisdiction of the FDA.

Natural hormone therapy using bioidentical hormones provides no single, uniform program. Prescriptions must be tailored to the individual patient, with adjustments made regularly for the first year or so until an optimal dose is reached. This dose may continue to require readjustment as a woman moves through perimenopause and menopause and her body, lifestyle, and diet undergo changes.

The goal of natural hormone therapy is to provide symptomatic relief of a woman’s menopausal symptoms. How much of what hormone is needed to do this varies widely depending on the woman. In general, symptom relief is reached when hormones are at about the same level a woman had in her late thirties or early forties.

An integrated approach including all three hormone types (estrogen, progesterone, and androgen) is optimal, even in women whose uteruses have been removed. Currently, most women who have had hysterectomies are offered only estrogen, without any consideration for the role of progesterone or androgens.

Virtually hundreds of combinations of hormones, including estrogen, progesterone, DHEA, and testosterone, are possible and may be administered by various routes, including orally, transdermally, or vaginally. (Transdermal and vaginal routes are the physiologically best way to take hormones because they don’t have to go through the gastrointestinal system and then be processed by the liver. This allows the body to get maximal benefit from a minimal dose.) Because the choices are so numerous and often confusing, I recommend beginning with a hormone profile for every woman who expresses con cern about menopause or who is exhibiting menopausal symptoms. Ideally this baseline hormone profile should be done in one’s early to mid-forties, when a woman is symptom-free. Then her own normal levels will be known beforehand, making it much easier to create a hormone therapy regimen that is tailor-made for her should she require it. That said, there is still a great deal we don’t know about how hormones are metabolized in the body and what ideal hormone levels are. Ultimately, relief of symptoms and an overall sense of well-being, not necessarily hormone levels, are the best ways to assess the success of hormone therapy. Since the climacteric can last as long as thirteen years, it will be necessary to vary regimens or to reevaluate the need for continued hormone replacement over the course of the menopausal transition. Happily, a growing number of health care practitioners are offering women the kind of individualized hormone replacement regimens that I consider ideal. A number of laboratories and independent formulary pharmacies located throughout the United States and Canada specialize in customized care. (See Resources.)

No one knows the ideal length of time to stay on hormone therapy. Short-term is considered five years or less. I suggest annually remaking the decision about whether to stay on hormones. Research on the potential long-term benefits of hormone therapy is ongoing. For example, the Kronos Longevity Research Institute, a nonprofit organization in Phoenix that does research on aging, is conducting a multicenter prospective trial known as the Kronos Early Estrogen Prevention Study (KEEPS;
www.keepstudy.com
) that is comparing the use of bioidentical hormone therapy to conjugated estrogen therapy (Premarin) in newly menopausal women. The placebo-controlled study, which began in 2006 and is slated to be complete in 2012, is designed to address the issue of whether either of these types of estrogen therapy, if begun within a couple years of menopause, decreases the risk of heart disease in women. Similarly, the National Institute on Aging is sponsoring a study on estrogen and heart disease called the Early Versus Late Intervention Trial with Estradiol (ELITE) study. In this study, which started in 2004 and is expected to end in 2012, researchers at the Keck School of Medicine at the University of Southern California are testing whether natural estrogen therapy will reduce the progression of early atherosclerosis if started soon after menopause. Many other aspects of HT are also being studied. Stay tuned.

Remember, hormone therapy is as much an art as it is a science. Most formulary pharmacists have a great deal of experience working with health care providers to individualize optimal hormone solutions. For additional information and guidance that will help you make the right decisions about bioidentical hormones for you, visit the website of the Bioidentical Hormone Initiative at
www.bioidenticalhormoneinitiative.org
.

Are Bioidentical Hormones the Secret of Youth?

Some doctors who practice antiaging medicine feel that lifelong hormone therapy with levels matching those of a twenty-year-old is the secret of youth. This school of thought also recommends that a woman’s hormones be cycled in such a way that she gets her period every month. This is the approach that has been widely publicized by actress and breast cancer survivor Suzanne Somers in her book
The Sexy Years
(Crown, 2004). Though I love the idea of all of us looking as sexy and young as possible for our entire lifetimes, there are other ways to do this that don’t involve artificially keeping hormone levels at the level of a twenty-year-old. The jury is still out on the wisdom of taking high-dose hormones for life in order to stay young forever. Besides, I know precious few women past the age of fifty who want to continue having periods. That said, I applaud Somers for her work in letting women know about the many benefits of bioidentical hormones as opposed to synthetic ones. They have helped millions of women who would otherwise have suffered needlessly with insomnia, intolerable hot flashes, low sex drive, and no energy.

A HORMONE PRIMER

Estrogen

There are three types of estrogen that occur naturally in the female body: estrone (E1), estradiol (E2), and estriol (E3). Estrone is produced in significant amounts in body fat, which is one reason why anorexic women cease menstruating and get premature osteoporosis. They simply don’t have enough body fat to sustain normal hormone function. Estrogen acts as a growth hormone for breast, uterine, and ovarian tissue. Overstimulation of these organs by estrogen is associated with excessive cell growth that may lead to cancer. On the positive side, estrogen elevates HDL (the good cholesterol) and has a beneficial effect on blood vessel walls; these were the main reasons why a large number of studies, but not the Women’s Health Initiative, have shown a decreased risk for heart disease for those taking estrogen. Estrogen also helps to prevent osteoporosis by inhibiting the activity of bone cells known as osteoclasts, which are involved in the recycling and breakdown of old bone. It also ameliorates hot flashes, prevents vaginal thinning and dryness, and enhances the collagen layer of the skin, which improves elasticity and helps to prevent wrinkles.

The most effective and most commonly used estrogens are estradiol and estrone. These are available in a wide variety of preparations, in cluding transdermal patches and creams, vaginal rings, or oral preparations.

With the exception of estriol, estrogen from any source, natural or otherwise, can be potentially dangerous if the dose used is too high or if it’s not balanced by progesterone. The rule for estrogens is this: Use the lowest possible dose that gives symptom relief.

The ideal preparations match the hormones found naturally in the female body. These would include any combination of estrone and estradiol from a formulary pharmacy; Estrace, the Estraderm or Climara patch, or any other type of estradiol; or Ortho-Est, a type of estrone.

Note that estrogen given through the skin by patch or cream often results in much higher levels than oral preparations. In some cases, a woman will need only a tenth of the estrogen on her skin that she was taking as a pill. This is one of the reasons why monitoring blood hormone levels can be important.

Estriol

Women who have had breast cancer or an estrogen-associated neo plasia of any kind, as well as any women with concerns about breast cancer, are usually not considered suitable candidates for HT, although some women will still want to take it. Among them are Suzanne Somers, who has described her very positive experience with bioidentical hormones. An alternative bioidentical hormone for these women may be estriol, a somewhat weaker estrogen that seems to have a protective effect against breast cancer.
²⁴
Henry Lemon, M.D., demonstrated this in a study of women with metastatic breast cancer. In a test group receiving estriol in dosages ranging from 2.5 to 15 mg per day, 37 percent experienced either remission or arrest of the cancer. A later study from Hebrew University of Jerusalem showed that in sufficient dosages, estriol actually has an antiestrogenic effect, preventing estradiol from binding to estrogen-sensitive tissue (such as breast and endometrium), which then doesn’t form tumors.
²⁵
The most recent study is from Berkeley, where researchers found that rats receiving a three-week treatment of estriol with progesterone had a significantly reduced incidence of breast cancer.
²⁶
Clearly, more research is required in this area.