On Your Health

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Bioidentical Hormone Replacement Therapy

For years, women have turned to hormone replacement therapy to help balance the effects of menopause. Bioidentical hormone replacement therapy (BHRT) has become trendy in recent times, marketed as a more natural solution to hormone replacement therapy. We’re here to help explain exactly what BHRT is and how it compares to standard hormone replacement therapy.

Standard hormone replacement therapy

As you age, your body produces fewer hormones, most commonly estrogen and progesterone. Standard hormone replacement therapy replaces the lost estrogen and progesterone made by our ovaries. “Estrogen replacement, in natural forms of estradiol, estriol and estrone, helps with hot flashes, night sweats and vaginal dryness,” says Dr. Julie Hansen, an OB/GYN at INTEGRIS Women’s Health Edmond. “Estrogen naturally tends to act like fertilizer on the lining of the uterus and will make it grow unless it is counterbalanced by progesterone, which is why a woman with a uterus needs to take both hormones for HRT.

Bioidentical hormone replacement therapy

Bioidentical hormones are plant-derived hormones that are similar or identical in molecular and chemical structure to the hormones women make in their ovaries during their reproductive years. Bioidentical hormones are made, or synthesized, from a plant chemical extracted from yams and soy. Some women who are looking for an alternative hormone therapy believe bioidentical hormones are better because they are “natural.”

Bioidentical hormones have been made into a range of products, some of which are commercially available and FDA-approved as well as compounded preparations that are not regulated by the FDA.

The two most commonly prescribed FDA-approved medicines are estradiol and micronized progesterone. Estradiol is found in pill form, like Estrace. Micronized progesterone is marketed most commonly under the name Prometrium. Also, estrone, found in Premarin or other synthetically conjugated estrogen preparations, is also a bioidentical hormone available for prescription.

Is bioidentical hormone replacement therapy safe?

The term “bioidentical” has been used by compounding pharmacies to imply their products are more natural and are therefore safer. Both the FDA and the Endocrine Society recognize the term “bioidentical” as a marketing term and not one based on scientific evidence.

“The bottom line is bioidentical hormones can promote the same side effects as commercially manufactured hormones and thus are not safer,” Dr. Hansen says. “A hormone is a chemical messenger that stimulates specific cells or tissue into a prescribed action. It kind of acts like a key that fits into a lock. Your body does not care what the source is, as long as it structurally matches the hormone produced by your ovary for the mechanism that produces the hormonal action.”

In 2002, a national study conducted by the Women’s Health Initiative (WHI) examined the side effects of taking artificial hormones. Researchers discovered an increased risk of breast cancer, heart attack, stroke and other problems in postmenopausal women taking hormone replacement therapy. However, not all postmenopausal women have the same risks of developing one of these problems, which is why discussing your personal risk factors with your doctor is the best way to determine if using HRT is beneficial for you.

While considering what your best option for HRT may be, remember when considering medication safety, the use of bioidentical hormones does not prevent women from being exposed to any of these risky side effects of standard hormone replacement,” says Dr. Hansen. 

Compound pharmacies and BHRT

“One advantage of compounded medications is that they can be made available in several different forms for administration, including oral, sublingual, transdermal, implants, injections or suppositories,” says Dr. Hansen. “They can also be custom-made for a patient based on her provider’s prescription. This is helpful for people with allergies.” However, the main concern is that compounded preparations are not regulated by the FDA.

“We worry about underdosage and overdosage in non-FDA regulated compounded meds,” Dr. Hansen says. “As far as a safety concern, unless you know your pharmacist has strict quality controls for potency and dosing, what you are prescribed by your doctor may not be what you are actually getting in your compounded product. This is especially important for women on combination estrogen and progesterone who have a uterus in place, as there may be a risk of developing hyperplasia or uterine cancer if their hormones are not appropriately balanced.”  

To combat unregulated dosages, the FDA passed the Compounding Quality Act. This law allows an entity that compounds sterile drugs to register as an outsourcing facility. Once registered, an outsourcing facility must meet certain conditions to comply. Before you buy compounded hormones from a pharmacy or online distributor, make certain they participate in some type of nationally recognized quality verification program.

Is BHRT right for you?

A health care provider can help you decide whether BHRT is right for you based on your current health and medical history.I encourage patients considering BHRT to read this practice bulletin, published by the American Congress of Obstetricians and Gynecologists, to weigh all the options,” says Dr. Hansen.

The North American Menopause Society is also an excellent source of information to help you learn more about hormones and menopause.


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