What are the considerations and recommendations for bioidentical hormone replacement therapy (BHRT)?

Bioidentical Hormone Replacement Therapy: Considerations and Recommendations

Bioidentical hormone replacement therapy (BHRT) is not recommended for the prevention of chronic diseases in postmenopausal women due to lack of FDA approval and insufficient evidence regarding safety and efficacy. 1

What are Bioidentical Hormones?

• According to the FDA, "bioidentical hormone replacement therapy" is a marketing term rather than a formally defined drug classification 1
• Bioidentical hormones are compounds that have a molecular structure identical to endogenous hormones found in a woman's body 2
• Compounded bioidentical hormones are often marketed as "natural" and supposedly safer than FDA-approved hormone therapies, but these claims lack scientific evidence 3

Safety and Efficacy Concerns

• The FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women 1
• No randomized trials have studied the potential benefits or harms of bioidentical hormones for the prevention of chronic conditions in postmenopausal women 1
• The safety and effectiveness of these products have not been evaluated through the FDA's drug approval process 1
• There are documented cases of unexplained endometrial cancer in otherwise healthy bioidentical hormone therapy users 4

FDA-Approved vs. Compounded Bioidentical Hormones

FDA-Approved Bioidentical Hormones:

• Some bioidentical hormones (estradiol, progesterone) are available as FDA-approved formulations 5
• These have undergone rigorous testing for safety, efficacy, and manufacturing quality 5
• Estradiol is FDA approved for menopausal symptoms and may have fewer adverse effects on blood pressure than conjugated equine estrogens 5
• Progesterone is FDA approved for managing menopausal symptoms and preventing endometrial hyperplasia 5

Compounded Bioidentical Hormones:

• Compounded bioidentical hormones lack standardization and quality control 5
• The American College of Obstetricians and Gynecologists (ACOG) advises that compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist 3
• Salivary hormone testing used to "customize" compounded bioidentical hormones is not standardized and should be avoided 5

Risks Associated with Hormone Therapy

• The Women's Health Initiative (WHI) study demonstrated that hormone therapy (estrogen plus progestin) was associated with increased risks of:

  • Breast cancer 1
  • Coronary heart disease 1
  • Stroke 1
  • Venous thromboembolism 1
  • Gallbladder disease 1

• These risks must be considered when discussing any form of hormone therapy, including bioidentical hormones 1

Recommendations for Clinical Practice

• For management of menopausal symptoms, FDA-approved hormone therapies are recommended over compounded bioidentical hormone therapy 3
• If hormone therapy is prescribed, use the lowest effective dose for the shortest duration consistent with treatment goals 6
• Patients should be reevaluated periodically (every 3-6 months) to determine if treatment is still necessary 6
• For women with an intact uterus, estrogen therapy should always be combined with progesterone to reduce the risk of endometrial cancer 6

Patient Education Points

• Inform patients that claims about the superior safety of bioidentical hormones are not supported by scientific evidence 1, 3
• Discuss that FDA-approved bioidentical hormone options exist and have undergone rigorous testing 5
• Explain that hormone therapy of any kind is not recommended for the prevention of chronic conditions such as cardiovascular disease, osteoporosis, or dementia 1
• The North American Menopause Society, American Heart Association, and American Congress of Obstetricians and Gynecologists all recommend against using hormone therapy for primary or secondary prevention of cardiovascular disease 1

Common Pitfalls to Avoid

• Relying on celebrity endorsements or media claims about bioidentical hormones 5, 4
• Using salivary hormone testing to guide therapy, as this method lacks standardization 5
• Assuming that "natural" or "bioidentical" automatically means safer 3
• Prescribing hormone therapy for prevention of chronic conditions rather than for symptom management 1
• Failing to discuss both the potential benefits and risks of any hormone therapy with patients 1

When discussing hormone therapy options with patients, focus on FDA-approved formulations, evidence-based approaches, and individualized risk assessment based on medical history and symptom severity 1.