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Notes on Women's Health
Notes on Women's Health

Bioidentical Hormone Replacement Therapy For Menopause

The truth is that there is no scientific evidence supporting the safety or effectiveness of compounded bioidentical hormones. There is also no scientific support for the use of hormone assays from salivary, urine or blood for the adjustment of hormone replacement dosage.

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Patients occasionally ask me about the safety and effectiveness of  Bioidentical Hormone Replacement Therapy (“BHRT”). They point out that they can get natural hormones in personalized doses based upon levels of hormones in their saliva. They are told by compounding pharmacies and their marketers that BHRT

  • is a safer, natural alternative to dangerous prescription drugs
  • is superior to FDA-approved hormone therapies
  • can slim you down by reducing hormone imbalances
  • can prevent senility, Alzheimer’s disease, stroke, and various cancers

It sounds great, doesn’t it?

The truth is that there is no scientific evidence supporting the safety or effectiveness of compounded bioidentical hormones. There is also no scientific support for the use of hormone assays from salivary, urine or blood for the adjustment of hormone replacement dosage.

With the approach of menopause, decreasing estrogen levels may be associated with hot flashes, vaginal dryness, poor memory, insomnia and osteoporosis. Treatment with estrogen and progesterone (HRT) can relieve these symptoms and help prevent osteoporosis. The benefits of HRT are accompanied by an increase in the risk of cardiovascular disease and breast cancer. Because of these risks, the FDA requires that pharmaceutical companies manufacturing HRT include appropriate warning labels within the packaging of all these medications. The American College of Obstetricians and Gynecologists (ACOG) recommends that HRT should only be used for relief of severe menopausal symptoms that do not respond to natural methods or non-hormonal medications. HRT should be used at the lowest effective dosage for the shortest possible period of time.

In order to get initial FDA approval for sale and marketing of HRT preparations, pharmaceutical companies were required to produce scientific evidence supporting the safety and efficacy of their product. The FDA also mandates ongoing monitoring of the manufacturing processes and reporting of adverse drug events. BHRT, on the other hand, is not made by pharmaceutical companies; it is made by compounding pharmacies that are not subject to the rigors of FDA regulation. The bottom line is that because BHRT preparations have not undergone rigorous clinical testing for safety or efficacy, we really do not know if these preparations are either safe or efficacious. Important decisions about one’s health should not be based on what seems like a good idea. Safety and efficacy claims must be based on the best available scientifically derived evidence and must be reevaluated in the light of emerging data.

Your decision of whether or not to take hormone therapy for menopausal symptoms is highly individualized, based on your health, risk factors, and personal wishes. You should be sure to have all the information you need in order to make an informed decision.

For more information on bioidentical hormones:

Click here for an article from the FDA   http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm

For more information about salivary testing for hormone levels:

Fugh-Berman A et al. Bioidentical Hormones for Menopausal Hormone Therapy: Variation on a Theme. J. Gen. Internal Med. 22: 2007.  http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2219716

Chatterton RT Jr, Mateo ET, Hou N, et al. Characteristics of salivary profiles of oestradiol and progesterone in premenopausal women. J Endocrinol 2005;186:77-84.  http://www.ncbi.nlm.nih.gov/pubmed/16002538

John M. Garofalo, MD