Bioidentical Hormones



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Editors
Howard Baum, MD
JoAnn Pinkerton, MD
Richard Santen, MD



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Menopause is the time of life when monthly periods end, and production of the female hormones estrogen and progesterone decline. Menopausal symptoms can vary from mild to severe. Symptoms include hot flashes, night sweats, and vaginal dryness. The most effective way to treat symptoms is to replace the estrogen the body no longer makes with hormone therapy (HT). HT can be estrogen alone (for women who have had a hysterectomy) or combined estrogen-progesterone (for women with a uterus). Progesterone protects against uterine cancer.

A large study of women 50 to 79 years old, called the Women’s Health Initiative (WHI), looked at the effect of taking HT on various aspects of health. In 2002, the study found that postmenopausal women taking estrogen plus progesterone HT had a slightly increased risk of breast cancer, heart disease, stroke, and blood clots.

As a result, many women stopped taking these hormones and began looking for other treatments, such as bioidentical hormone therapy. A later reanalysis of the WHI, as well as several other studies, found that most women under age 60 and within 10 years of menopause can safely take HT for symptom relief.

What are bioidentical hormones?

Bioidentical hormones are identical to the hormones that women make in their bodies. Other types of hormone therapy, like the one used in the WHI study, differ slightly from the hormones made in the body. Bioidentical hormones are sometimes called “natural” hormones—even though they are made in a laboratory—because they come from plant sources before being altered to be like human hormones. Not all hormones made from natural sources are bioidentical.

There are two types of bioidentical hormone products:

Pharmaceutical products. These products have been approved by the U.S. Food and Drug Administration (FDA). Their quality and safety is regulated so it is the same high-quality product every time.

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 instructions). These products may contain varying amounts of two or three types of estrogen, often mixed with other hormones. Although the individual ingredients are approved by the FDA (except for estriol), the compounds themselves (the final product after the ingredients are combined) are not. Because these compounds are not regulated by the FDA, they can be of low quality. The amount of hormone can change with each batch.

Most menopause specialists start with FDA-approved products, because they’ve been proven to be safe and effective. For women who cannot take these products due to allergies, or who need a special prescription, custom-made products are an option. Because the quality of custom-made products can vary, however, it is safer to use pharmaceutical products. This way, you’ll know exactly what you’re getting and how much.

If your doctor prescribes HT, the FDA recommends using the lowest possible dose for the shortest time needed to relieve symptoms. The idea is to avoid taking too much medication for too long to reduce potential risks linked to HT. You might also want to consider the wide range of non-hormonal options available to treat menopausal symptoms.

Finding the type of treatment that works best for you may take some time. Whatever you choose, your doctor will monitor your therapy regularly.

Are bioidentical hormones safer to use than other forms of hormone therapy?

To date, there is no scientific proof that bioidentical hormones, whether prepared by a compounding pharmacy or pharmaceutical company, are safer to use than other forms of HT. All forms of HT may have potential risks, whether compounded or pharmaceutical, bioidentical or not.

Questions to ask your doctor

  • Do I need hormone therapy?
  • What are my options for therapy?
  • What are the risks and benefits of each option?
  • How long will I need therapy?
  • Should I consider non-hormonal treatment?
  • Should I see an endocrinologist?