HOLLI W. HAYNIE

In recent years, women have increasingly requested bioidentical hormone therapy from their healthcare providers to treat menopause symptoms. Some professionals have speculated the increased interest is due to the media attention bioidentical hormones received after the Women's Health Initiative (WHI) study raised concerns about hormone therapy in 2002.

As explained by the North American Menopause Society (NAMS), bioidentical hormones are defined as compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body. Compounded bioidentical hormones are sometimes used by gynecologists to give patients a custom-tailored hormone mixture. Basically they're used as an additional option to traditional hormone therapy and to individualize treatment options. But there is tremendous confusion about the meaning of the term "bioidentical" and pervading misconceptions about the risks and benefits of traditional and bioidentical hormone therapy.

For decades, menopausal and postmenopausal women were given high doses of estrogen therapy as part of a preventative strategy against osteoporosis. Subsequent studies have shown that high doses of estrogen as well as combined estrogen and progestin can be harmful to the body, especially in postmenopausal women, which is what the WHI study articulated.

Literature from NAMS explains that WHI measured a number of criteria, including the incidence of cardiovascular disease, cancers and bone fractures. The study was discontinued due to the observations of increased risks of CVD and breast cancer in postmenopausal women taking combination hormone therapy. There were positive effects such as a decreased risk of colorectal cancer and bone fracture, but ultimately it was concluded the adverse effects outweighed the benefits of the type and dosage used in the WHI. Many physicians, nevertheless, felt the results of the WHI did not warrant a total discontinuation of hormone therapy.

"The emergence of hormone therapy is back," said Dr. Henry Sullivant, ob/gyn at Ruch Clinic. "The Women's Health Initiative study has been looked at very carefully and we changed our use."

As an ob/gyn at Ruch Clinic for 24 years, Sullivant has seen the changes in hormone therapy and has adjusted his treatment after studies show inherent risks in high hormone doses. He explained there has been some concern about higher levels of estrogen, whether endogenous (made by the body) or exogenous, creating a greater risk for breast cancer. The WHI didn't solve that question, he stressed, but the data motivated physicians to watch hormone therapy carefully.

When hormone therapy was used as prevention, it was discovered that many women were getting too much estrogen. In fact only a small percentage of women with a higher risk of osteoporosis benefited from high dose estrogen as prevention. With the multitude of medications now available for osteoporosis treatment, Sullivant said doctors can be very specific about who needs treatment as opposed to prevention.

"Lower dose therapy seems to make more sense as opposed to higher dose therapy because of concerns about blood clots and stimulating any estrogen-sensitive cancer," Sullivant said. "There is a lot of adjusting and changing of medications to alleviate symptoms. I'm not using it for prevention but that doesn't mean that it doesn't have potentially some benefit for prevention."

The WHI's findings opened a floodgate in the lay media suggesting compounded bioidentical hormones are safer and more effective than traditional hormone therapy, but no such comprehensive study has been conducted to examine the effects of bioidentical hormones.

NAMS defines compounding as the preparation, mixing, assembling, packaging and labeling of a drug or device in accordance with a licensed practitioner's prescription. Compounding pharmacies are not subject to Food and Drug Administration (FDA) monitoring for dose, purity, safety, or efficacy.

The medical community currently recommends that a menopausal or postmenopausal woman discuss her individual risks and benefits of hormone therapy with her physician, who can prescribe and closely monitor an individualized regimen. There is a place for compounded bioidentical hormones, but it is variable based on the patient needs.

Ruch Clinic has 10,000 registered patients over 50, Sullivant said, and they have 10,000 different symptoms and needs. Sullivant utilizes both traditional and compounded bioidentical remedies for menopausal patients. He prescribes bioidentical compounds to about 10 percent of patients.

"You want to start out very simple at first rather than just throwing everything you know at a patient all at once," explained Sullivant. "Start out simple and then start adding medication, [being] very target specific about what you're trying to accomplish."

In other words, if a woman is complaining of generalized menopause symptoms, he said, she should be treated with generalized therapy. If she's complaining of a specific symptom such as vaginal dryness she may be given medication for vaginal dryness only.

"Compounded estrogens and progesterone, I use a lot of these medications following the general principle that you've got to be very flexible in how you approach treatment," stressed Sullivant.

His concerns with using bioidentical hormone therapies exclusively are that they tend to be expensive and not covered by all prescription plans, they don't always work as effectively as traditional therapies, and they are not approved by the FDA. Physicians who prescribe compounded bioidentical hormone therapy disclose the benefits and risks of medications not approved by the FDA.

"If I'm getting into an area where it's expensive and I'm not sure of therapeutic success and the FDA has not give full support of their use, I've got to be certain I've chosen the right patient for it," Sullivant said. "If it doesn't work, then we've got to be willing to say this doesn't work and let's try another medication."

Some bioidentical hormones are not compounded and are approved by the FDA for a proven delivery system, the most common of which is estradiol.

While some level of controversy surrounds the method of compounding, it has a place in medicine. Typically it fills the gaps commercial manufacturing creates in specific patient populations such as pediatric age groups or in regard to drug shortage situations.

"Hormone therapy has changed in the last 30 years, from treating everyone the same to really focusing on symptoms, not just hormone levels, [but] the individual patient," said Sullivant. "WHI and all the subsequent studies clarified the use of hormone replacement therapy, in my opinion."


May 2007