Monday, August 17, 2009

Bioidentical Hormones

Hormone therapy is a frequent topic of discussion with my patients. The media coverage of bioidentical hormones including Oprah, Suzanne Somers and Dr. Christiane Northrup have empowered women to seek a better quality of life and relief from menopausal symptoms such as hot flashes, night sweats, impaired sleep, vaginal dryness, decreased libido, painful intercourse, loss of memory and weight gain. This has caused quite a stir in the medical community. Why? Because women are asking questions they’ve not asked before – especially about bioidentical hormones.

What are bioidentical hormones? Bioidentical hormones are prescribed hormones that are identical to the hormones produced in a women’s body prior to the onset of menopause. The most commonly prescribed include three different types of estrogen (estrone, estradiol and estriol), progesterone, testosterone and dehydroepiandosterone (DHEA).

There are two categories of bioidentical hormones: compounded and manufactured.

Compounded bioidentical hormones are pills, creams, gels, suppositories, injectables, sublingual drops or lozenges that are prescribed by health care providers who tailor the dose to a woman’s individual symptoms and concerns. They are literally assembled in the pharmacy by a certified compounding pharmacist and are available through mail-order and some local pharmacies. Compounded bioidentical hormones are generally not covered by insurance and therefore are an out-of-pocket expense.

Manufactured bioidentical hormones are pills, creams, gels, sprays and injectable medications manufactured and marketed by large pharmaceutical companies. They come in standard doses and, therefore, are not available as tailor-made medications. There are other limitations with manufactured hormones. For instance, bioidentical estrogen is only manufactured as estradiol – the most potent of the three types manufactured in a woman’s body. Manufactured bioidentical hormones may be covered by insurance.

The alternative to bioidentical hormone therapy is synthetic hormone therapy. They include manufactured hormones that are similar to but intentionally different than the chemical structure as those hormones produced in a woman’s body. Premarin (conjugated equine estrogen) and Provera (a synthetic progestin) are the most commonly prescribed conventional hormones. They are the suspect hormones studied in the Women’s Health Initiative (WHI) Study that raised concerns about all hormone replacement therapy due to increased risks of blood clot formation, stroke, heart attack and cancer. Upon release of this information in 2002, many women abruptly stopped hormone usage and many physicians stopped or significantly limited prescribing hormone therapy.

The American College of Obstetricians and Gynecologist (ACOG) and the North American Menopause Society (NAMS) have recently issued statements supporting the use of manufactured bioidentical or conventional hormone therapy when necessary. They have also issued statements against compounded bioidentical hormones due to their unproven safety and efficacy.

The debate in the medical community continues regarding the safety and effectiveness of the bioidentical hormones as they have not been studied in large standardized controlled trials such as the WHI. However, it is difficult to undertake such studies when medications are tailor-made for individual women. Small European studies from the 1980’s suggest an improved safety profile with bioidentical hormones. However, this has yet to be proven.

A review article published in January of 2009 in the Journal of Postgraduate Medicine states that patients report greater satisfaction with bio-identical hormone therapies. Clinical outcomes and physiologic data support that bio-identical hormones are more effective than synthetic hormones and are associated with lower risks, including the risk of breast cancer, stroke and heart attack. Further randomized controlled trials are needed to further expound upon the differences.

References:

1. Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, striol and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgraduate Medicine 2009:121(1). doi: 10.3810/pgm.2009.01.1949

2. Compounded bioidentical hormones. ACOG Committee Opinion No. 322. American College of Obstricians and Gynecologists. Obstet Gynecol 2005;106:1139-40.

3. North American Menopause Society Statement on Bioidentical Hormones Therapy