Custom-compounded bioidentical hormone therapy: why so popular despite potential harm? The case against routine use

Area of Science:

• Endocrinology
• Pharmacology
• Women's Health

Background:

• The Women's Health Initiative (WHI) study led to widespread avoidance of conventional hormone therapy (HT).
• This resulted in increased use of unregulated, custom-compounded bioidentical hormones in the USA.
• Custom compounding lacks manufacturing oversight, leading to false claims and potential harm.

Purpose of the Study:

• To evaluate the risks and benefits of custom-compounded hormone therapy (HT) versus conventional HT.
• To highlight the safety concerns associated with unregulated compounded hormones.
• To advocate for preferred, regulated HT preparations.

Main Methods:

• Review of adverse events and risks associated with custom-compounded HT.
• Comparison of oral versus non-oral administration routes for hormone therapy.
• Analysis of estrogen/progestogen imbalance risks in compounded preparations.

Main Results:

• Custom-compounded hormones have led to severe harm, including deaths from infected products and renal failure.
• Oral estrogens increase risks of venous thromboembolism and stroke, risks mitigated by non-oral routes like transdermal estradiol.
• Estrogen/progestogen imbalance in compounded HT may increase endometrial cancer risk.

Conclusions:

• Unregulated custom-compounded hormone therapy presents significant safety concerns and should be avoided.
• Regulated, registered preparations, especially those using transdermal estradiol with progesterone, offer a safer and more physiological approach.
• Custom compounding is rarely justified, primarily for allergies or specific, scientifically acceptable formulations not available through registered products.