Recommended Approach for Functional Medicine Bioidentical Hormone Replacement Therapy (BHRT)
Bioidentical hormone replacement therapy should not be routinely recommended due to insufficient evidence of safety and efficacy compared to conventional hormone therapy, with the same cardiovascular risks potentially applying to both approaches. 1, 2
Evidence-Based Evaluation Before Initiating Hormone Therapy
Before considering any hormone therapy, a thorough hormonal evaluation should include:
- Morning cortisol and ACTH levels
- TSH and free T4 levels
- Comprehensive electrolyte panel
- Sex hormone levels (FSH, estradiol, and progesterone for females; LH and testosterone for males)
- DHEA levels for patients with low libido or energy concerns
- Bone mineral density testing for patients with estrogen deficiency 1
Recommended Hormone Therapy Approach
First-Line Therapy Options
For menopausal symptoms requiring hormone therapy:
Preferred estrogen: 17β-estradiol (bioidentical) via transdermal delivery
- Dosage: 0.025-0.0375 mg/day patch
- Particularly recommended for patients with hypertension 1
Preferred progestogen (for women with intact uterus):
Monitoring and Follow-up
- Initial follow-up at 3 months after starting therapy
- Annual clinical review thereafter
- Monitor: blood pressure, weight, lipid profile, symptom control, and bleeding patterns 1
Limitations of Compounded BHRT
Despite claims of superiority, compounded BHRT products have significant limitations:
Lack of quality evidence: Few well-designed studies compare compounded BHRT with conventional HRT 3
Unproven safety profile: The same cardiovascular risks associated with conventional HRT may apply to oral BHRT 2
Questionable testing methods: Little evidence supports individualized hormone dosing based on saliva hormone concentrations 3
Variable preparation standards: Compounded products lack standardized manufacturing and quality control 4
Limited efficacy data: While some observational studies suggest improvement in mood symptoms, evidence for relief of vasomotor symptoms is less robust 5
Evidence-Based Benefits and Risks
Benefits
- Relief of menopausal symptoms
- Potential bone protection benefits 1
Risks
- Increased risk of adverse events including headache, vaginal bleeding, breast tenderness, and skin reactions 6
- Potential for endometrial hyperplasia when estrogen is used without progestogen in women with intact uterus 6
- Possible increased risk of venous thromboembolism (RR 2.14), with highest risk in first year of use (RR 3.49) 1
- Long-term safety data regarding heart attack, stroke, and breast cancer are lacking for BHRT 6
Contraindications to Hormone Therapy
Hormone therapy (including BHRT) is contraindicated in patients with:
- Active liver disease
- History of breast cancer
- Coronary heart disease
- Previous venous thromboembolism or stroke 1
Key Pitfalls to Avoid
Assuming "natural" means safer: Despite marketing claims, bioidentical hormones carry similar risks to conventional HRT 2, 3
Relying on unvalidated testing: Saliva hormone testing for dosage determination lacks scientific validation 3
Using compounded products without evidence: FDA-approved bioidentical hormone products should be preferred over compounded formulations 1
Neglecting endometrial protection: Women with intact uterus require progestogen therapy when taking estrogen to prevent endometrial hyperplasia 6
Long-term use without monitoring: Use the lowest effective dose for the shortest duration needed 7, 1