COMMENTARY

Compounded Hormone Therapy: What Should We Tell Our Patients?

Andrew Kaunitz, MD

Disclosures

March 09, 2011

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Hello, I'm Andrew Kaunitz, Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine in Jacksonville, Florida. Today I'd like to discuss "Compounded Hormone Therapy: What Should We Tell Our Patients?"

Since the 2002 publication of initial findings from the Women's Health Initiative,[1] many women have lost confidence in our recommendations in regard to menopause and use of hormone therapy (HT). Not surprisingly, use of HT has declined substantially. Riding this wave of skepticism, celebrities, including Oprah Winfrey and Suzanne Somers, have recommended the use of compounded and bioidentical menopausal HT.

Among the myths that our patients believe in regard to compounded hormones are that they are more effective and safer than conventional HT, and that they are monitored by the US Food and Drug Administration (FDA).[2]

In my practice, if patients ask, I explain that compounded hormones are not regulated or monitored by the FDA. I also point out that when the FDA has tested compounded hormones, more than one third of samples assessed have failed quality tests. In contrast, fewer than 2% of approved medications fail FDA testing.[2]

Progesterone cream is often prescribed and sold to symptomatic menopausal women who consult compounding clinicians. However, a double-blind, randomized trial in the United Kingdom found that progesterone cream is no more effective than placebo in treating menopausal symptoms.[3]

Another concern with compounded hormones is that they are characteristically sold without FDA-mandated patient information. Furthermore, ethical concerns exist: Many practitioners who prescribe compounded hormones also sell them, posing a conflict of interest and violating standards of professional ethical conduct.[2]

Clinicians who sell compounded hormones often recommend salivary hormone testing. I have 2 concerns here: First, menopausal hormones should be individualized with a dose that is based on patient symptoms rather than on laboratory testing. A second concern is that salivary testing has not been found to correlate with serum steroid levels,[2,4] and the American College of Obstetricians and Gynecologists (ACOG) advises against salivary hormone testing.[5]

When our patients use the term "bioidentical," they are often referring to compounded hormones. However, FDA-approved formulations of the native ovarian hormones estradiol and progesterone are available. If patients ask, I point out that most of the HT that I prescribe is indeed bioidentical, including transdermal, oral, and vaginal estradiol as well as oral micronized progesterone.

To conclude, treatment of vasomotor symptoms and genital atrophy as well as prevention of osteoporosis can be accomplished with FDA-approved, bioidentical HT formulations. This approach avoids the safety, efficacy, and ethical concerns associated with prescription of compounded HT. Thank you.

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