Think “Bio-identical” is Better? Not Necessarily.

Doctor with female patientCompounded “bio-identical” hormones are not better or safer, according to physicians and leading health organizations.

By Maryann Hammers

Hot flashes, night sweats, mood swings — oh my!

Increasingly, women going through perimenopause or menopause are drawn to compounded “bio-identical hormones” for relief.

Bio-identical hormones are identical in molecular structure to the hormones women make in their bodies, explains Harvard Medical School.[i] Sounds good, right? So it’s little wonder that almost half the prescriptions filled for menopausal hormone therapy are custom-compounded “bio-identical” hormones, according to the Endocrine Society[ii].

But is bio-identical really better, safer, or more natural? And are all bio-identical hormones custom-made in a compounding pharmacy?

The answer is “no” to both questions.

You’re an Experiment of One

Compounded bio-identical hormones have no fewer side effects than synthetic or animal-derived hormones. No studies have shown them to be safer or more effective.

“People who sell non-FDA approved compounded ‘hormones’ imply their product is natural or safe, and what they are selling is neither,” says Diana Bitner, MD, a board-certified OB/GYN in Grand Rapids, Michigan.

Compounded drugs are not FDA-approved, monitored, or regulated, Dr. Bitner points out, so there’s no way to know if the products have the level of hormone stated on the prescription. Quality, preparation methods, and ingredients may vary.

“With [compounded] bio-identicals, there is no metered dosing nor quality control,” Dr. Bitner says.

In other words, “you’re an experiment of one,” according to Harvard Medical School.

Beware of Upsells

Some compounding pharmacies recommend saliva testing to determine the amount of hormones in a woman’s body. But women’s health experts and leading organizations, including The North American Menopause Society, say such tests are a waste of time and money.

Such tests are unreliable because a woman’s hormone levels vary throughout the day, making results meaningless.[iii] Further, saliva hormone levels don’t reflect the levels in your blood or correspond to menopause symptoms, says Mayo Clinic.[iv]

Ask Your Doctor

Want your bio-identical hormones and safety and FDA-approval, too?  You can have it all. Commercially available (as opposed to compounded), FDA-approved bio-identical hormones are available by prescription in forms including creams, patches, gels, pills, and rings. The North American Menopause Society offers a list of FDA-approved bio-identical pharmaceutical products on its website (menopause.org).[v]

“With FDA approval, you get quality control, and most importantly, metered dosing,” says Dr. Bitner. “So when I prescribe a certain dose, I know how much you will get and how long it is likely to last in your body.” (The US Food and Drug Administration has websites and Q&As devoted to bio-identical compounded hormones here[vi] and here.[vii])

But all hormone therapy — bio-identical or otherwise — carries some risk.

“Hormones are powerful agents. I sleep at night by using the safest routes, safest sources, and by following guidelines on who gets them, for how long, and by which route,” Dr. Bitner adds.

If you seek truly natural and completely safe relief from menopausal symptoms, you may decide skip hormones altogether and instead opt for smart lifestyle changes.  “Many of the women who get through entry into menopause without many symptoms are those who have chosen healthy habits before the phase started,” Dr. Bitner notes. “They tend to be at a healthy weight, following a diet with low simple sugar; they are aware of their triggers for symptoms such as stress and alcohol, and they get enough sleep and exercise.”

 

REFERENCES

[i] What are bioidentical hormones? Harvard Health Publications/Harvard Medical School website. Available at http://www.health.harvard.edu/newsweek/What-are-bioidentical-hormones.htm. Accessed March 27, 2015.

[ii] Endocrine Society. Pharmacist Survey Shows Huge Growth in Nonregulated, Custom-Compounded Menopausal Hormone Therapy. Available at https://www.endocrine.org/news-room/current-press-releases/pharmacist-survey-shows-huge-growth-in-nonregulated-custom-compounded-menopausal-hormone-therapy. Accessed March 27, 2015.

[iii] Bioidentical Hormone Therapy. The North American Menopause Society website. Available at http://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy. Accessed March 27, 2015.

[iv] Are “bioidentical” or “natural” hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? Mayo Clinic website. Available at http://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460. Accessed March 27, 2015.

[v] Approved Prescription Products for Menopausal Symptoms in the United States and Canada. The North American Menopause Society. January 30, 2015. Available at http://www.menopause.org/docs/default-source/2014/nams-ht-tables.pdf. Accessed March 27, 2015.

[vi] Bio-Identicals: Sorting Myths from Facts. U.S. Food and Drug Administration. April 8, 2008. Available at http://www.fda.gov/forconsumers/consumerupdates/ucm049311.htm. Accessed March 27, 2015.

[vii] Compounded Menopausal Hormone Therapy Questions and Answers. U.S. Food and Drug Administration. February 5, 2010. Available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Accessed March 27, 2015.