What is the recommended approach for a Bioidentical Hormone Therapy (BHT) hormone assessment?

Bioidentical Hormone Therapy (BHT) Assessment

For BHT hormone assessment, baseline evaluation should include morning total testosterone (measured twice for confirmation), FSH, LH, estradiol, prolactin, PSA with digital rectal examination (in testosterone candidates), hematocrit/hemoglobin, and lipid profile, with symptom assessment using standardized questionnaires rather than saliva testing, which lacks evidence-based support. 1, 2

Baseline Hormone Assessment

Essential Laboratory Tests

• Morning testosterone levels: Obtain at least two separate morning measurements to confirm any deficiency before initiating testosterone therapy 1, 2
• Gonadotropins: Measure FSH and LH to distinguish between primary and secondary hypogonadism 1, 2
• Estradiol: Particularly important in patients with breast symptoms or gynecomastia before initiating any testosterone-based therapy 2
• Prolactin: Essential component of comprehensive hormonal evaluation, especially with low testosterone 2

For Estrogen-Based BHT (Women with POI)

• FSH levels: A serum FSH ≥10 U/L at age 10 years or older indicates ovarian impairment requiring hormone replacement 1
• Baseline estradiol: Document deficiency state 1
• No routine saliva testing: Saliva hormone testing lacks scientific validation and contradicts evidence-based guidelines 3, 4

Additional Baseline Assessments

Cardiovascular and Metabolic Screening

• Blood pressure: Baseline measurement required, as transdermal estradiol is preferred in hypertensive women 1
• Lipid profile: Optional but recommended for cardiovascular risk stratification 1
• Fasting glucose and HOMA-IR: Baseline metabolic assessment 5

Cancer Screening (Testosterone Therapy)

• PSA measurement: Mandatory baseline test 1
• Digital rectal examination: Required before initiating testosterone therapy 1
• Prostate biopsy: Indicated if PSA >4.0 ng/mL or abnormal digital rectal examination 1

Hematologic Assessment

• Hematocrit or hemoglobin: Essential baseline measurement before testosterone or estrogen therapy 1, 2

Symptom Assessment Tools

• Standardized questionnaires: Use validated instruments rather than individualized saliva-based dosing 1, 3, 4
  • For women: Greene Climacteric Scale for menopausal symptoms 1, 5
  • For men: International Prostatic Symptoms Score for voiding symptoms 1
• Sleep apnea history: Document any history before initiating therapy 1

Critical Pitfalls to Avoid

Do Not Use Saliva Testing for Dosing

Saliva hormone testing to individualize compounded BHT prescriptions directly contradicts evidence-based guidelines and lacks scientific validation. 3, 4 Multiple studies demonstrate no proven advantage of individualized hormone dosing based on saliva concentrations 3, 4.

Confirm Deficiency Before Treatment

• Single abnormal testosterone value is insufficient: Fluctuating levels require confirmation with at least two measurements 2
• Normal testosterone on one occasion with low on another: Suggests fluctuation requiring further confirmation before diagnosing deficiency 2

Endometrial Protection

• Women with intact uterus: Must receive progestogen with estrogen therapy to prevent endometrial hyperplasia, regardless of whether using bioidentical or conventional preparations 1, 6

Monitoring Schedule After Initiation

Initial Follow-up (1-2 months)

• Assess treatment efficacy and symptomatic response 1
• Consider dose escalation for inadequate clinical response with suboptimal hormone levels 1

Ongoing Monitoring (Every 3-6 months first year, then annually)

• Repeat hormone levels: Testosterone, estradiol as appropriate 1
• Hematocrit/hemoglobin: Monitor for polycythemia 1, 2
• PSA and digital rectal examination: For testosterone therapy 1
• Clinical review: Symptom assessment, compliance, adverse effects 1
• No routine monitoring tests required for estrogen therapy beyond annual clinical review once established 1

Evidence Quality Note

The evidence supporting compounded BHT lacks well-controlled studies examining pharmacokinetics, safety, and long-term outcomes compared to FDA-approved bioidentical hormones (which exist as regulated pharmaceuticals). 3, 6, 4 Current scientific uncertainties make FDA-approved bioidentical hormone preparations preferable to compounded formulations, as they have been assessed by clinical trials for both benefits and risks. 3