The Buzz About Bioidenticals
Controversy surrounds the compelling topic of bioidentical hormone replacement therapy. What’s it all about and is it safe?
Ever since Oprah Winfrey started talking enthusiastically about her bioidentical hormone replacement therapy (BHRT) earlier this year and Suzanne Somers began touting the hormones in her best-selling books on aging and wellness, the dialogue on this topic has been growing. But as with any hot topic, controversy and confusion have followed close behind. Understanding exactly what BHRT means is complicated by the fact that it’s not a term recognized by the FDA. Instead the agency has referred to BHRT as a “marketing term” that’s been used loosely, as often happens with unofficial medical jargon. Essentially, bioidentical means that the structure of the compound in question is an exact match. So in terms of hormones, bioidentical hormones would be exact chemical matches to those made by the body.
As women age and enter menopause, a decrease in hormone production can produce myriad symptoms, including hot flashes, mood swings, forgetfulness, weight gain, and a decreased sex drive. Men can go through similar symptoms as they enter andropause, the male equivalent of menopause. Hormone replacement therapy (HRT) may help alleviate these symptoms by restoring the depleted levels of hormones. The difference, however, between traditional HRT and BHRT is that the chemicals for the former are typically derived from animals. For instance, one of the most well-known synthetic hormones, Premarin, is derived from the urine of pregnant horses.
Randolph is referring to a study led by the National Institutes of Health called the Women’s Health Initiative, which found that synthetic hormones such as Premarin and Provera increased the risk of heart attacks, strokes, and breast cancer in the more than 16,000 women studied. “Bioidentical hormones, however, are synthesized in a laboratory from a precursor molecule called diosgenin to have exactly the same molecular structure as the hormones produced by the ovaries or testes,” continues Randolph. “When bioidentical hormones are introduced into the body, they fit perfectly into the body’s hormone receptor locks. They are the keys that fit.”
Jeanne O’Connell, MD, medical director of the Sylvana Institute for Medical Aesthetics, LLC, in Frederick, MD, agrees with the analogy. “We as humans have receptors, and those receptors know the natural form of the hormone,” she says. “Hormones that are not identical may attach, but they don’t have the same response that the biologically identical form has. The key may fit into the door, but it won’t unlock it.”
O’Connell says she’s seen dramatic results from using BHRT in her practice. “The idea is to replace what our body needs now in order to maintain function,” she says. “My patients are not looking to be 20 years old again or even trying to extend their lives. They just want to mitigate the changes that are occurring from aging. We see patients who have had this treatment will actually have a decrease in the occurrence of lung cancer, especially among previous smokers. Women may also now be able to maintain bone density and strength, as well as mental clarity. Libido often tends to return. The goal is to lessen the occurrence of the symptoms that come with getting older.”
A Hormone Is a Hormone
Richa Sood, MD, a women’s health expert from the Mayo Clinic, adds that consumers should know there is still a lack of knowledge surrounding the long-term effects of BHRT. “Bioidentical hormones have not been subjected to the rigors of the clinical trials as much as their synthetic cousins,” she says. “Hence, there is relatively limited data with these preparations. Lack of information does not amount to proof of safety. We simply need more information to say whether or not they are safer and, until we know that, it may be safest to assume that a ‘hormone is a hormone.’ Thus, if it has the desired effects, it is likely to have the undesirable side effects as well.”A Notable Difference
It’s important to note that there are conventional, FDA-approved bioidentical hormones on the market, which are sold in standard doses. But when talking about the controversy surrounding BHRT, many are referring to hormone preparations that are made at compounding pharmacies. Such bioidentical hormones are handmade on an individual basis for each patient. Because the resulting product is not standardized, the FDA does not approve any compounded products.
That’s not to say compounded products are bad, says Liu. Compounding is very useful for patients who may be allergic to particular additives in FDA-approved products. But many are concerned by the fact that compounded bioidentical hormones come without the literature and warnings that would accompany an FDA-approved product.
In addition, the notion that made-to-order compounded products are safer is another bone of contention. The word “natural” is often used synonymously with these types of products, and some marketers even claim they aren’t drugs. “Natural is sometimes used to convey that something is found in the wild, but the estrogens that are used in compounding pharmacies are made in a laboratory just like other estrogens and then sold to compounding pharmacies,” says Margery Gass, MD, executive director designate of The North American Menopause Society. “And while progesterone is derived from a plant, it must be changed in the laboratory to be active in humans. The diosgenin in wild yam cream has no progesterone activity unless it is transformed in the laboratory.”
The Jury’s Still Out
Though Randolph believes BHRT is safe, he emphasizes that the proper dosing is crucial. “Any approach to hormone replacement must make sure the hormone levels remain in physiologic ranges, meaning the levels that would be normal to the body,” he adds. “Just like any form of medicine, doctors who know what they are doing will use hormone-level testing to ensure they prescribe BHRT within safe and effective ranges.”
Sood says the bottom line is that consumers who choose BHRT should consider using conventional, FDA-approved agents first. “You get the benefit of standardized dosing along with the benefits of bioidentical hormones,” she says. But for those who have sensitivity to the preparations used in conventional products, it’s important to choose an accredited compounding pharmacy. “Remember that the compounded preparations could have variations from one batch to the next, thereby resulting in variable blood levels,” she warns. “And realize that the lack of FDA package insert warnings in compounded preparations does not mean they are safer, it just means they have not been tested.”
— Lindsey Getz is a freelance writer based in Royersford, PA.