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Debating the Ups and Downs of Bioidentical Hormones by Wenda Reed

Pam Harkins was an executive in a demanding job, just turning 50 and approaching menopause when she started feeling joint stiffness and began putting on a little weight. “I felt like I needed to do something proactive, so that I wouldn’t have to take drugs or strong hormones,” the Edmonds woman said. She went to Seattle naturopath Dr. Rebecca Wynsome, a national expert on bioidentical hormones.

Bioidentical hormones are manufactured by pharmaceutical companies or customized by compounding pharmacies to replace or balance the hormones a woman may be lacking earlier in life or those she may lose due to menopause. They are formulated to be identical on the molecular level to hormones produced in a woman’s body, using a natural base, usually soy or yam. They are contrasted with synthetic hormones, which contain additives and fillers to make them patentable, and which are similar to — but not identical to — a woman’s own hormones.

Estrogen, progesterone, testosterone and/or DHEA (dehydroepiandrosterone) are the most commonly prescribed “sex hormones.”

Wynsome did not prescribe Harkins hormones in a vacuum. She took a complete medical history, including addressing gastrointestinal issues, before prescribing estrogen, progesterone and, sometimes, testosterone. Wynsome also addressed the adrenal gland, which is affected by stress (“I flat-lined that baby,” Harkins remembers). Over the next 10 years, Wynsome tested Harkins every six months to assess the need for any adjustments to kinds of hormones or dosages.

“I made it through the transition of menopause like a dream — I had hot flashes and insomnia, but managed it,” Harkins says. She was able to maintain energy, sleep and clarity of mind. Now 60, Harkins continues to take replacement hormones, but has decreased the dosage, as a three-month sabbatical from work has reduced her stress level. “I am a participant (in the decision-making),” Harkins says, “intellectually responsible for myself.”

Harkins is typical of women who have turned to bioidentical hormones as an alternative to synthetically manufactured hormones, such as Premarin (PREgnant MARe urINe), Provera and Prempro. These were found to increase the risk of coronary heart disease, stroke, pulmonary embolism and breast cancer according to the seminal 2002 Women’s Health Initiative Study conducted by the National Institutes of Health. After the study was released, women turned away from Hormone Replacement Therapy in droves, but now the pendulum has swung back toward carefully monitored use of the hormones.

“[Menopausal] women have a poor quality of life — they’re miserable, they can’t function normally, they’re depressed, they don’t have energy and they’re not sleeping well,” notes Kirkland naturopath Dr. Amanda Brimhall. She routinely prescribes bioidentical hormones to pre- and post-menopausal women as part of a complete health and lifestyle examination. “We are living longer than we used to —– never before have we lived half of our lives without hormones,” she notes. “After menopause, we only make 10 percent of the estrogen we used to make, and so we do need to replace it for quality of life.”

Gone are the days when women were “mindlessly put on estrogen,” says Matthew Davies, M.D., Ph.D., an endocrinologist affiliated with Swedish Medical Center in Seattle. He prescribes both synthetic and bioidentical hormones, depending on which works best for each patient, but only after scheduling an hour to review a woman’s medical history and talk about life changes. “Is an estrogen deficiency really the reason for their symptoms, or are their problems with pre-diabetes or thyroid or other issues?” he asks.

“My policy is to prescribe hormones only with a general medical evaluation, using minimal dosages, with eyes wide open regarding potential risk.”

SAFER AND MORE EFFECTIVE?

The concern about risk raises the million dollar question: Do bioidentical hormones avoid the life-threatening side effects of synthetic hormones, particularly estrogen/progesterone combinations, as reported in the Women’s Health Initiative study?

Absolutely, say naturopaths like Brimhall, Wynsome, and Michael Platt, author of The Miracle of Bio-Identical Hormones (Clancy Lane Publishing, 2006), as well as compounding pharmacists and the International Hormone Society.

Absolutely not, say many traditional endocrinologists, including Davies, the Endocrine Society, the American Medical Association (AMA) and the Food and Drug Administration (FDA).

Wynsome and Brimhall point to their own experiences over the last two decades and to dozens of studies showing that bioidentical hormones do not increase the risks of breast cancer or coronary problems. For example, a 2007 study of 80,377 post-menopausal women by A. Fornier, et al, published in Breast Cancer Research, found an increase in the incidence of breast cancer in women taking synthetic estrogen and progesterone, but no change with natural estrogen and progesterone, and a decrease in incidence with bioidentical products using estriol, the weakest and safest form of estrogen.

The body makes three forms of estrogen: estrone (sometimes known as “the bad estrogen” because it is most often associated with an increased incidence of breast cancer), estrodial (known as the “workhorse” because it is involved in many of the hormone’s functions in the body) and estriol (which binds more weakly to the receptors and may be protective of breast tissue). Brimhall and Wynsome often prescribe Bi-est, a bioidentical compound that is 80 percent estriol and 20 percent estrodial.

“There’s a difference between saying there’s no data and not reading the data,” Brimhall says.

“Bioidentical hormones are on a circular ring — exactly as the body makes them — so the body is used to processing them,” Wynsome elaborates. Synthetic hormones with their fillers and additives bind much more securely to receptor sites than do bioidentical hormones, and that makes them less safe. Still, she says, “It’s not correct to say, ‘I’m on bioidenticals and so I’m safe.’” Dosages must always be monitored and balanced by a health care professional with expertise in hormone therapy, she says.

“There’s no evidence that bioidentical hormones are safer — people who say so are just making it up,” Davies asserts. “They may be more dangerous because they’re not as well studied. These (hormones) are hard-core, highly pharmaceutical interventions, not benign supplements.” He does mention that it is easier to measure the levels of bioidentical hormones in the body than it is to measure synthetic hormones with their multiple ingredients.

“You have to completely accept the risk of side effects, whichever one of the estrogen therapies you choose,” he says.

Experts on all sides agree that there are fewer studies on bioidentical hormones than there have been on synthetic hormones because the natural substances are not patentable and thus do not draw research dollars. The concern of the medical establishment, including the AMA and the Endocrine Society, is that there is no reason to suppose that it’s the additives and fillers that caused the dangerous side effects reported in the Women’s Health Initiative study. According to the Endocrine Society’s Position Statement on Bio-Identical Hormones published in October 2006, “If dosage and purity were equal, then all estrogen-containing hormone therapies, ‘bioidentical’ or ‘traditional’ would be expected to carry essentially the same risk and benefits.”

They are most concerned with customized hormones formulated by compounding pharmacists because those are not regulated by the FDA. “The public has no way of knowing precisely what they’re getting or what effect it will have on an individual’s body,” summarized the AMA in a 2006 position paper echoing the Endocrine Society’s position.

In January 2008, the FDA announced enforcement actions against seven compounding pharmacies that made false and misleading claims about the safety and effectiveness of bioidentical hormones. The AMA, the Endocrine Society and others are urging more FDA oversight.

A MATTER OF BALANCE

Despite the diametrically opposing viewpoints on the safety of bioidentical hormones, there are areas of agreement among traditional and alternative health providers:

First is that both pre- and post-menopausal symptoms — including hot flashes, night sweats, insomnia, weight gain, “brain fog,” increased breast size, vaginal dryness, carbohydrate craving, dry hair and skin and decreased interest in sex — are often so debilitating that hormone replacement is necessary to maintain quality of life.

Second is that usage should be limited to the lowest doses possible to bring relief. Brimhall starts with herbal remedies first to see if they will take care of symptoms, but finds that at least half of the time, her patients do need hormones. After six to eight weeks of trying low doses of hormones, she will take urine test readings for a full day to measure the free, available hormones actually circulating in the body, and will check back at least once a year to evaluate whether dosages need to be changed.

Wynsome uses the same careful approach, emphasizing that she tests the endocrine, gastrointestinal and immune systems as an integrated entity. She finds that she can often use lower doses of hormones if women go through metabolic detoxification to first take care of any digestive problems. She also looks at how the individual woman’s body is actually metabolizing the hormones.

Davies starts with trials of low-dose hormones and adjusts the dosage based on how the woman is feeling. In line with the recommendations of the American Association of Clinical Endocrinologists, he generally limits the administration of estrogen to women 60 and younger who are no more than 10 years past menopause. After that, he reduces the dose as the woman’s body adjusts to having less and less estrogen.

Third, the various hormones must be balanced, as changing the levels of one hormone can affect the actions of others (most commonly progesterone is often prescribed to counteract the harmful effects on the uterus of too much estrogen). Wynsome uses the analogy of a mobile — if one branch is out of balance, it affects all of the other branches. “If we push too hard on the female hormones (i.e., estrogen and progesterone), we may throw the others out of balance.” She says it’s important to take into account the hormones secreted by the thyroid, adrenal glands, pancreas and ovaries.

Brimhall is a proponent of adding low doses of testosterone to hormone formulations because it is a strong antidepressant, and she believes it helps promote bone density, lean muscle mass, exercise endurance, libido and breast protection.

All three local providers, as well as the mainline medical organizations, emphasize the importance of customizing testing, dosage levels and the way of delivering hormones to the individual woman, who must be an active participant in the decision-making.

“ I decide on dosages anecdotally: Is it helping the woman?” Davies summarizes. Deciding on hormone therapy is “like tailoring a suit of clothing to a person.” ?

Wenda Reed is a Seattle-area medical writer and frequent contributor to Seattle Woman.

FREQUENTLY ASKED QUESTIONS

How will a health care provider decide whether I need hormone therapy?
He or she will test the blood, urine and/or saliva to measure the levels of hormones in your body.

Which hormones might he or she prescribe?
• Estrogen is the most commonly prescribed hormone because ovarian production drops sharply after menopause. Lack of estrogen is implicated in many symptoms, including hot flashes, insomnia, loss of concentration and vaginal dryness. Some health care providers say that it reduces the chances of osteoporosis or colon cancer, but others say such claims cannot be verified.
• Progesterone also declines at menopause and is often prescribed to balance the effects of estrogen. It may also have beneficial effects on brain and nerve tissue, blood vessels and bones. It often acts as an antidepressant, but may be a sedative if doses are too high.
• Testosterone is present in women as well as in men, but at much lower levels, and it drops as the ovaries shut down. It is an antidepressant and believed to help with bone density, breast protection, libido, exercise endurance and lean muscle mass.
• DHEA (dehydroepiandrosterone) is a balancing hormone that helps in the production of estrogen and testosterone and declines as we age. It is produced mainly by the adrenal glands and may help prevent heart disease, osteoporosis and breast cancer, as well as enhance mood, energy and mental acuity.
• Other hormones, including thyroid and insulin, will often be tested and adjusted.

How will the hormones be delivered to my body?
Traditional hormones were usually administered orally as pills, going through the liver to be metabolized. That method is still common, but compounded bioidentical hormones are often administered directly to the skin (transdermally) as a cream, gel or patch, so that they are absorbed directly into the bloodstream. Sometimes a vaginal cream is used for maximum absorption and to concentrate on vaginal symptoms, if they are the main problem. Other patients may take dosages under their tongues.

©2008 Caliope Publishing Company