Hormone Replacement
Menopause is the time of life when the monthly periods
(menstruation) end. The ovaries, the twin organs that
produce and release an egg during each monthly cycle,
also produce the female hormone estrogen. There are
four primary types of estrogen circulating in the blood—
estrone, estrone-sulfate, estradiol, and estriol. At an
average age of 51, when the ovaries stop producing
estrogen, menopause begins.
Menopause can have mild to severe symptoms including
hot flashes, night sweats, and vaginal dryness. The severity
of symptoms varies from woman to woman and there are
a variety of ways to treat them. The most common and
effective way is to replace the estrogen the body no longer
produces with hormone therapy (HT). Hormone therapy can be
estrogen alone or combined estrogen-progestin (a synthetic form of
progesterone, which is produced after the release of an egg, or ovulation).
In 2002, the Women’s Health Initiative study of postmenopausal women with an average age of 65 found that taking combination HT slightly increased the risk of breast cancer, heart disease, stroke, and blood clots. The results scared women and many stopped taking HT, only to find their symptoms came back. As a result, women and their doctors began looking for alternative ways to treat menopausal symptoms, such as bioidentical hormone therapy. (For more information on the WHI study, see Resources at the end of this fact sheet.)
What is Bioidentical Hormones?
Bioidentical hormones are sometimes called “natural” hormones—even though they are synthesized in a laboratory— because they are identical to the hormones that women make in their bodies. (Conventional hormone therapy uses estrogens or progestins that differ slightly from the hormones made in the body.)
There are two types of bioidentical hormone products:
- Pharmaceutical products: These are compounds that have been approved by
the Health Canada and the U.S. Food and Drug Admini- stration (FDA). Their
quality and safety is regulated so it is the same product every time. These
products (particularly estradiol) are available as pills, patches, gels, and vaginal inserts. - Custom-made products: When many people think of bioidentical hormones, they
think of custom- made products. These are made in a compounding pharmacy
(a pharmacy that mixes medications according to a doctor’s specifications). Often
these contain varying amounts of two or three types of estrogen. Although some
ingredients are approved by the FDA, the compounds (the final product that is
created after all the individual ingredients are combined) are not. And because
these compounds are not regulated by the FDA, they can be of low quality and
the dosage can change with each batch.
Both types can be taken by mouth (pills), through the vagina (creams, rings) or through the skin (patch, gel, injection). Because the quality of custom- made products can vary, it is probably safer to use pharmaceutical products. This way you’ll know exactly what you’re getting and how much.
How do you know what is best for you?
You and your doctor will work together to determine the best treatment option for you. This will be based on your medical history; your risk of side effects such as breast cancer, stroke, heart disease and blood clots; and with clear goals for what you want to get out of the therapy (e.g., treatment of hot flashes, vaginal symptoms, or both).
If hormone therapy is prescribed to treat your menopause symptoms, the FDA recommends that treatment should be the lowest possible dose for the shortest time needed to treat your symptoms. The goal is to avoid taking too much medication for too long because all medications have risks.
Are Bioidentical Hormones safer to use than other forms of hormone therapy?
To date there is no scientific proof to show that bioidentical hormones, whether prepared by a compounding pharmacy or pharmaceutical company, are safer to use than other forms of hor- mone replacement. All forms of HT may have potential risks, whether compound- ed or pharmaceutical, bioidentical or not.
The lack of FDA oversight of compounded hormones means that the dose you get may not be the same from refill to refill. For consistent safety and dose, it is best to take FDA-approved hormone preparations, whether they are bioidentical or synthetic.