Clinical Review

“Bioidentical” hormones: What you (and your patient) need to know

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Here’s the skinny on compounded “bioidentical” hormone therapy—popular among women but absolutely data-free


 

References

OBG Management Senior Editor Janelle Yates contributed to this article.

Hear Dr. Pinkerton discuss this article

The Women’s Health Initiative (WHI) caused a sea change in women’s attitudes toward menopausal hormone therapy and aroused many fears—not always rational—that remain almost palpable today. One study of the aftermath of the WHI found that 70% of women who were taking hormone therapy discontinued it, and 26% of women lost confidence in medical recommendations in general.1

Into the chaos stepped Suzanne Somers, Michael Platt, and other celebrities, touting the benefits of a new kind of hormone: bioidentical. You don’t have to read Somers’ bestseller, The Sexy Years, to encounter the claims it makes on behalf of bioidenticals; the cover itself makes them clear: Discover the Hormone Connection—The Secret to Fabulous Sex, Great Health and Vitality, for Women and Men. Since publication of the book, the demand for bioidentical hormones has only increased, as women remain fearful about conventional hormone therapy.

Many ObGyns regularly field requests from patients for specially compounded bioidentical regimens. In most cases, the women who ask for these drugs are poorly informed about their risks and willing to pay out of pocket to acquire them. JoAnn V. Pinkerton, MD, sees many of these patients at The Women’s Place Midlife Health Center in Charlottesville, Virginia. OBG Management recently sat down with Dr. Pinkerton to discuss her concerns about the growing ubiquity of compounded bioidentical hormones. In the Q&A that follows, we talk about what “bioidentical” actually means, whether these hormones are ever justified, common misconceptions about them, and other issues.

In a special accompanying commentary, former Food and Drug Administration (FDA) Senior Medical Officer Bruce Patsner, MD, JD, also weighs in on the issue.

10 erroneous beliefs patients have about compounded hormones
  • “They’re identical to the hormones in my body”
  • “They occur naturally”
  • “They are safer and more effective than conventional hormone therapy”
  • “They’re risk-free”
  • “They are monitored by the FDA”
  • “They are the fountain of youth”
  • “They prevent breast cancer”
  • “Celebrities know more about them than physicians and menopause and hormone experts do”
  • “Doctors oppose bioidentical hormone therapy because they are in the pocket of Big Pharma”
  • “Bioidentical hormones are not a huge money-making enterprise”

What is “bioidentical”?

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OBG MANAGEMENT: Let’s start with the basics. What does the word “bioidentical” mean? Is it a legitimate medical term?

DR. PINKERTON: Bioidentical hormones are exogenous hormones that are biochemically similar to those produced endogenously by the body or ovaries. These include estrone, estradiol, estriol, progesterone, testosterone, dehydroepiandrosterone (DHEA), and cortisol. The FDA has approved many prescription products that contain bioidentical hormones. However, the term “bioidentical” is often used to refer to custom-compounded hormones. The major difference between the FDA-approved prescription bioidentical hormone products and custom-compounded products is that the former are regulated by the FDA and tested for purity, potency, efficacy, and safety.

Bioidenticals are not “natural” hormones, although many consumers think they are. In reality, compounded bioidentical hormones and FDA-approved bioidentical hormones all come from the same precursors. They begin as soy products or wild yam and then get converted to the different hormones in a laboratory in Germany before finding their way to the various world markets.

The claim that all bioidentical hormones are bioengineered to contain the same chemical structure as natural female sex hormones is false. As one expert noted, “the term ‘bioidentical’ has become inappropriately synonymous with ‘natural’ or ‘not synthetic’ and should be redefined to correct patient misconceptions.”2

Common misconceptions

OBG MANAGEMENT: What are some of the other false impressions you encounter among patients who ask for bioidenticals?

DR. PINKERTON: That the hormones are safer or more effective than hormone therapy, that they carry no risks, and that they are as well-monitored as FDA-approved products, to name a few. (For more, see “10 erroneous beliefs patients have about compounded hormones”).

OBG MANAGEMENT: Where do these ideas originate?

DR. PINKERTON: They are propagated by self-proclaimed experts and celebrities or by laypersons and physicians who devote the bulk of their time to promoting these hormones, usually at considerable cost to the patient.

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