An ethical assessment of compounded bioidentical hormone therapy

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.

摘要

尽管美国食品药品监督管理局批准了许多不同配方和剂量的激素产品, 但复合生物同质激素疗法(cBHT)的使用仍然日益普及。cBHT的支持者提出的许多主张没有经过适当设计的研究证实。关于cBHT的纯度、有效性、生物利用度和安全性的问题引起了有效的关注。由于病人福利是医疗专业人员的首要责任, 将cBHT作为一线疗法推广和开处方违反了医学和药学实践的多项伦理原则, 应在没有令人信服的理由的情况下加以阻止。

Keywords:

• Bioidentical hormone therapy
• compounding
• drug safety
• ethics
• menopause