Compounded Bioidentical Hormones in Endocrinology Practice

Custom compounded hormone therapy might seem attractive to your patient but the recent statement from the US Endocrine Society sounds a warning! This scientific statement finds that there is no rationale for prescribing of unregulated, untested, and potentially harmful compounded “bioidentical” hormones.

The Australasian Menopause Society (AMS), together with the Endocrine Society of Australia, endorses this new position statement on compounded hormone therapy.

The AMS does not support the prescribing of compounded hormones for menopause hormone therapy (MHT).

It should be noted that "bioidentical" can equally be applied to many of the TGA approved pharmaceutically produced therapies for use in the menopause.

Abstract

This Scientific Statement finds that there is no rationale for routine prescribing of unregulated, untested, and potentially harmful custom compounded bioidentical hormone therapies.

Context:

Custom-compounded bioidentical hormone therapy (HT) has become widely used in current endocrine practice, which has led to unnecessary risks with treatment.

Objective:

This scientific statement reviews the pharmacology and physiology of popular compounded hormones and the misconceptions associated with these therapies. The hormones reviewed include: estradiol and estrogens, progesterone and progestins, testosterone, dehydroepiandrosterone, levothyroxine, and triiodothyronine.

Results:

Overall, there is a general lack of standardization and quality control regarding how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, or contamination. There is also recent evidence of patient harm and death associated with treatment, as seen with fungus-contaminated glucocorticoid preparations. With estrogen, progestin, and dehydroepiandrosterone treatments, the practice of baseline hormone measurements to replace "abnormal" hormone deficiencies has no basis in medical practice. Furthermore, there is no evidence that monitoring compounded HT with serial salivary or blood testing is effective, except in the case of thyroid hormone. Finally, no evidence supports the popularized notion that custom-compounded bioidentical hormones have fewer risks when compared with Food and Drug Administration (FDA)-approved hormone treatments.

Conclusion:

The widespread availability of FDA-approved bioidentical hormones produced in monitored facilities demonstrates a high quality of safety and efficacy in trials; therefore, there is no rationale for the routine prescribing of unregulated, untested, and potentially harmful custom-compounded bioidentical HTs. Clinicians are encouraged to prescribe FDA-approved hormone products according to labeling indications and to avoid custom-compounded hormones. 

Reference

Santoro N, Braunstein GD, Butts CL, Martin KA, McDermott M, Pinkerton JV. J Clin Endocrinol Metab. 2016 Apr;101(4):1318-43. doi: 10.1210/jc.2016-1271. Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement.

http://press.endocrine.org/doi/10.1210/jc.2016-1271

Content updated April 2016