June 7, 2010

The Buzz About Bioidenticals
By Lindsey Getz
For The Record
Vol. 22 No. 11 P. 24

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) early last year and Suzanne Somers began touting the hormones in her best-selling books on aging and wellness, the dialogue on this subject 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, the term bioidentical means that the structure of the compound in question is an exact match. For example, 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 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.

BHRT, on the other hand, generally uses chemicals derived from plants such as soybeans and wild yams. The plant estrogen is extracted and then chemically altered to human estrogen or progesterone that would be an exact match to the hormones the ovaries were making prior to menopause. “Synthetic hormones have a very different molecular structure than the hormones that are produced in the body,” explains C. W. Randolph, Jr, MD, an internationally recognized medical expert in the field of BHRT and cofounder of the Natural Hormone Institute of America. “When these hormones come into the body, they do not fit perfectly into the body’s hormone receptor locks. Consequently, their bad fit triggers side effects at a cellular level. Some of these side effects are uncomfortable, such as weight gain, while others are truly dangerous.”

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
However, the idea that BHRT is safer or more effective than traditional HRT is where much of the controversy lies. The FDA has warned consumers that these claims are unproven. “The implication seems to be that if a hormone is bioidentical, and therefore identical to what is made in the body, that it is safe,” explains James Liu, MD, chairman of the obstetrics and gynecology department at University Hospital’s Case Medical Center in Cleveland. “But that’s not true. What people don’t understand is that it’s the amount and the duration of the hormone that makes it risky, not the structure. People have this magical thinking that if they take something that’s a natural compound, it can’t hurt them. They think if it comes from soy, a food product, how can it be dangerous? But that logic doesn’t add up. Consider the fact that certain mushrooms can be poisonous, so natural products can definitely still be dangerous.”

Liu says he’s not claiming bioidentical hormones are less safe or safer than synthetics but that it’s important to remember they are still drugs and should be treated that way. In fact, he adds, bioidentical hormones can have the same side effects and should have the same warnings as other hormones. “A hormone is a hormone, and the reasons that standardized hormones may be unsafe are the same reasons why bioidentical hormones would be unsafe,” agrees Suzanne Steinbaum, DO, director of women and heart disease at Lenox Hill Hospital in New York City.

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 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 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
Still, BHRT proponents continue to believe these hormones are safer and point to the fact that they’ve been used effectively for a long time in Europe and that data in the United States are building. “Clinical studies in this country and across the globe have found BHRT to be safe and effective while the data continues to roll in that synthetic hormone replacement drugs are dangerous,” says Randolph. “Recent studies have even shown synthetic hormones to cause brain shrinkage and an increase in the risk of lung cancer.”

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 says. “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 cautions. “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.