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Authors: Boston Women's Health Book Collective

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In addition, there is recent randomized controlled trial evidence that Prometrium in a dose of 300 mg just before bed decreases hot flashes in healthy normal-weight postmenopausal women more than a placebo.
36
The Centre for Menstrual Cycle and Ovulation Research is just starting a similar trial for hot-flash treatment in perimenopausal women.

When taken by mouth, Prometrium acts as a sedative and is helpful for increasing sleep time and reducing night waking. (For this purpose, one practitioner recommends a 300-mg dose, which keeps the blood level in the normal range for the progesterone-rich second half of the cycle; another recommends trying the 100-mg dose first.) Take it right before bed to avoid dizziness—the sedative effects usually wear off by morning. If you are sleep-deprived when you start it, you may feel sluggish or tired in the morning because your body is trying to catch up on lost sleep.

Use with More Caution:
Progesterone Cream

BIOIDENTICAL HORMONES AND COMPOUNDING PHARMACIES

The term “bioidentical” has been used to refer to hormones that are the chemical equivalent of those made by women's bodies—notably estradiol, estrone, and estriol (instead of horse estrogens) and progesterone (instead of the chemically altered progestins). Although chemically synthesized in a lab from plant-based building blocks, these hormones can be considered more natural to women than horse estrogens or progestins that have been chemically altered to make them digestible and patentable. The oral micronized progesterone called Prometrium is an example of a bioidentical hormone.

Many bioidenticals are made by compounding pharmacists, who mix hormones into gelcaps, gels, or creams. The hormones in many compounded products (estradiol and progesterone) are also found in FDA-approved products, whereas additional hormones such as estriol and testosterone are found only in compounded products.

Theoretically, both compounded and pharmaceutical industry products are acceptable options; however, the quality control of compounded products varies widely. In the United States, an industry has arisen to promote and commercialize bioidentical hormones and a particular approach to HT that includes compounded products that are not FDA-approved. Promoters of compounded products often recommend frequent monitoring of hormone levels with saliva or blood tests. However, hormone level tests are not a particularly useful way of judging how a therapy is working. A better gauge is how a person feels in response to the therapy.

If you choose to use compounded hormones because your provider suggests a hormone such as estriol or testosterone that is not available in a commercial product or because you need a different dose than is commercially available, choose a licensed pharmacist who has taken the Professional Compounding Centers of America course in compounding of medications and who is registered with the Pharmacy Compounding Accreditation Board.

Progesterone creams made in compounding pharmacies (see sidebar) are made with natural progesterone, which may have a better safety/risk profile than progestin. However, it's difficult to know the right dose because blood levels do not reflect the actual exposure of tissues. When used as part of estrogen-progesterone hormone therapy, progesterone creams used instead of oral progesterone may not be in a high enough dose to balance the estrogen and protect the vaginal lining from cancer, so they are not a particularly safe option. It's possible, however, that progesterone cream used alone can be effective for hot-flash treatment in menopause.
37

When progesterone creams are sold over the counter and not prescribed, there is no quality control, and the cream may contain anywhere from too much progesterone to none at all.

Combination Products

There are several combination HT products with both estrogen and progestin (none contains progesterone). Although they seem convenient, they provide clinicians with less opportunity for careful individual dosing of each hormone.

Use with More Caution: PremPro

PremPro, the most widely used HT in the United States for many years, is a combination of Premarin (conjugated horse estrogens) and Provera (a progestin). The WHI trials showed that women taking estrogens with progestins by mouth significantly increased their risk of strokes and blood clots in the lungs or legs, with a trend toward increased breast cancer. A memory substudy of the WHI found that women sixty-five and older taking PremPro had a heightened risk of developing dementia.
38

Convenient Though Not
Proved Safer: Patches

Combination estrogen/progestin patches, such as CombiPatch and Climara Pro, contain a synthetic male hormone—derived progestin (norethindrone acetate or levonorgestrel) with transdermal estrogen. Though they have not been proved to be safer than oral combinations of estrogen with progestin, some women use patches because of convenience and because continuous absorption may provide more effective control of the discomforts for which the therapy is being used.

IT'S YOUR DECISION IN THE END

It's your decision whether to take hormones. Consider your own history, values, health status, and preferences, as well as what's known and not known about harms and benefits. Keep up with new research findings. Women can have quite different reactions to the same hormonal regimen and what is good for some women may not be good for others. Furthermore, what is best for a population of women may not be best for an individual—thus the importance of each woman weighing both the knowns and the unknowns in making her own decision.

Keep the risks in perspective. For most women, smoking, poor diet, and lack of exercise are the most important risk factors for heart disease and osteoporosis. You can change those. Ask for help from your friends, family, and health care provider to support better habits.

If you decide to stop taking hormones, tapering off slowly may minimize the return of discomfort.

RESEARCH ON MIDLIFE WOMEN'S HEALTH

Until recently, medical research paid little attention to the health concerns of aging women. Even today, it focuses on the medical aspects of peri- and postmenopause, as though reproductive organs were the center of a woman's life. It continues to overlook the basic biology of aging, occupational and environmental damage, racial and ethnic differences, and the influence of socioeconomic factors on our health. Studies are often designed and funded by corporate interests rather than objective researchers, and tend to focus on drugs rather than nonmedical interventions. They often neglect the needs of women of color, undermining the ability of health care practitioners to provide appropriate care. Three important studies are under way to remedy this long-standing neglect.

The Study of Women's Health Across the Nation (SWAN) (
www.swanstudy.org
) is the first major longitudinal study of women of different racial and ethnic backgrounds as they transition through menopause. Since 1994, about 3,300 U.S. women from diverse backgrounds—white, African American, Hispanic, Chinese, and Japanese—have participated in SWAN at seven centers around the United States. The study examines psychological, social, and economic factors, in addition to health and medical components, including ovarian aging, its effects on bone and body composition, and risk factors for cardiovascular disease.

KEEPING UP WITH NEW RESEARCH

To keep up with new information and research findings on perimenopause and menopause, visit the websites of the following organizations. For more on how to understand study findings, see
Chapter 23
, “Navigating the Health Care System.”

The Centre for Menstrual Cycle and Ovulation Research: cemcor.ubc.ca

National Institutes of Health (NIH): nih.gov

National Women's Health Information Center: womenshealth.gov/menopause

American Menopause Foundation: americanmenopause.org

National Women's Health Network: nwhn.org

The North American Menopause Society
*
(NAMS): menopause.org

Society for Menstrual Cycle Research: menstruationresearch.org

*
The North American Menopause Society has strong ties to the pharmaceutical industry, but many of its members have tried to minimize the direct influence of drug companies over the content of NAMS educational programs.

SWAN has generated a wealth of information about how women age. In 2010, the women in SWAN were fifty-six to sixty-six years old, and most had transitioned into postmenopause. By following various health issues, including diabetes, osteoporosis and fractures, osteoarthritis, heart disease, and depression, SWAN will continue to deepen our understanding of how menopause and other factors may play a role in later disease, disability, and quality of life, with the goal of finding better ways to prevent disease and maintain the health of older women.
39

The Black Women's Health Study (BWHS) (bu.edu/bwhs), funded by the National Cancer Institute and administered by the Slone Epidemiology Center at Boston University School of Medicine, enrolled 59,000 African-American women in 1995. The focus of the study is to identify and evaluate causes and preventives of cancers and other serious illness for African-American women. Although it focuses primarily on younger women, it is also looking at conditions more typical of midlife and older women, such as cardiovascular disease, diabetes, and breast cancer, which affect black women earlier.

The BWHS has identified modifiable risk factors for both breast cancer
40
and type 2 diabetes.
41
Mortality rates of breast cancer are greater in black women than white women. The BWHS found that the use of menopausal hormones was associated with an increased risk of breast cancer, as has also been found in white women. A high intake of vegetables, especially cruciferous vegetables such as broccoli and collard greens, was associated with a reduced risk of breast cancer. Future research in the BWHS will address the causes of urinary incontinence, another condition that affects older women. BWHS has been funded through 2013.
42

JERILYNN PRIOR

The endocrinologist and clinician-scientist Jerilynn Prior, M.D., is founder and director of the Centre for Menstrual Cycle and Ovulation Research at the University of British Columbia. She is a key contributor to recent research exploring the significance of higher estrogen and declining progesterone levels in perimenopause. She studies the use of progesterone in its bioidentical, oral micronized form to treat severe hot flashes and other disruptive discomforts experienced by women in perimenopause and beyond. She works to counter the commonly held belief that perimenopause is a time of estrogen deficiency and questions the appropriateness and safety of estrogen therapy during this time. Her work, much of which you can find at cemcor.ubc.ca, runs counter to many of the conventional views of peri- and postmenopause.

In speaking out for “a newer, clearer meaning” for the word “menopause” and arguing against use of the term “postmenopause” for the last third of a woman's life, Jerilynn offers insight into what might motivate a scientist and clinician to swim so hard against the tides of established thinking.

What we currently have is outdated language about women that reenforces our “deficiencies” as women. Why not, as women, start making language that fits our experiences and isn't disease-oriented? Why subject ourselves to those physicians who want to give us routine estrogen treatment in perimenopause and beyond, treatment we may not need at all?

It is long past time for a revision of outmoded language about midlife. I could cite instances from at least a dozen scientific articles that use the terms—menopause, menopausal transition, perimenopause and FMP—in mutually contradictory ways. That is not science—it is confusion. Who does confusion serve? Certainly not women
.

The actual final menstrual flow can't be determined to be final for a further year, so why give it a name or initials? I remember my final, final flow very well because it came 14 months after my last “final” flow. I had cramps and sore breasts for weeks on end and began to wonder what on earth was happening to me. But, nevertheless, that flow was a non-event. I celebrated being menopausal when one further full year had passed. I don't want to be POST a non-event for the rest of my life
.

Though this edition of
Our Bodies, Ourselves
sticks with the words and usages currently in practice—perimenopause, menopause, and postmenopause—Jerilynn Prior's scientific work on behalf of women has a passion and intelligence that suggests that these changes may yet come.

The Kronos Early Estrogen Prevention Study (KEEPS) (keepstudy.org) includes 729 newly menopausal women of ethnic makeup intentionally similar to the women in the WHI study, with 70 percent non-Hispanic Caucasian, 8 percent African American, and 7 percent Hispanic. This large randomized study is comparing a low dose of the estrogen pills used in the WHI study (Premarin), a transdermal estrogen (a patch), and a placebo. (Those receiving active estrogen will also be given oral micronized progesterone to avoid increasing the risk of uterine cancer.) In effect, KEEPS is trying HT using what many now believe to be the safest approach.

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