An ethical assessment of compounded bioidentical hormone therapy

Climacteric. 2024 Jun;27(3):326-328. doi: 10.1080/13697137.2024.2306272. Epub 2024 Jan 30.

Abstract

The use of compounded bioidentical hormone therapy (cBHT) continues to grow in popularity despite the availability of many US Food and Drug Administration-approved hormone products produced in different formulations and dosages. Numerous claims made by proponents of cBHT are not substantiated by properly designed studies. Valid concerns about purity, efficacy, bioavailability and safety of cBHT have been raised. Since patient welfare is the first duty of health professionals, promoting and prescribing cBHT as first-line therapy violates a number of ethical tenets of medical and pharmacy practice and should be discouraged without a compelling reason.

Keywords: Bioidentical hormone therapy; compounding; drug safety; ethics; menopause.

MeSH terms

  • Drug Compounding*
  • Estrogen Replacement Therapy*
  • Female
  • Humans
  • Menopause
  • United States
  • United States Food and Drug Administration