Your activity: 14 p.v.
< Back

Comparison of FDA-approved MHT with custom-compounded bioidentical HT

Comparison of FDA-approved MHT with custom-compounded bioidentical HT
  MHT (FDA approved) BIH (unregulated)
Goal of intervention

Treatment: Clinicians prescribe estrogen to treat symptoms (primarily vasomotor)

They add progestin only for women with a uterus to prevent endometrial hyperplasia

Replacement: Clinicians prescribe replacing multiple sex steroids with the goal of restoring levels to the premenopausal range

Progesterone is often recommended for all women, even those without a uterus
Pretreatment testing

No pretreatment testing is required

Baseline hormones do not predict dose requirements		 Extensive salivary or blood testing is required
Biochemical testing for monitoring This is rarely needed Routine salivary or blood testing to monitor and adjust doses is required
FDA approval status and concerns FDA-approved estrogens and progestins, including 17-beta estradiol and progesterone, are required to:
  1. Demonstrate sufficient purity, potency, efficacy, and safety for approval
  2. Have a failure rate of <2% in quality and potency tests
  3. Have indications (hot flashes, vaginal atrophy, prevention of bone loss)
  4. Be supported by well-conducted RCTs
  5. Have package inserts that provide extensive product information, which may include black box warnings
  6. Have all adverse events reported to the FDA both before approval and after marketing
  7. E3 not approved
Compounded bioidenticals have:
  1. No requirement to prove efficacy or safety before use
  2. No requirement for routine monitoring for purity or potency (sporadic assessments indicate high failure rates)
  3. Unsupported claims that the approach is safer and more effective than conventional HT
  4. No requirement for package inserts or black box warnings
  5. No listed concerns about possible overdosing or underdosing or the risk of higher estrogen/inadequate progesterone exposure
  6. No requirement for adverse event reporting
  7. E3 is a commonly included agent
Timing and duration of treatment Perimenopause, ages 50 to 59, or <10 years after menopause is recommended There are no age or duration restrictions
Evidence for efficacy (relief of symptoms) There is 80 to 90% relief with appropriate estrogen doses There is anecdotal evidence for efficacy
Other benefits

Alleviating adverse mood

Reduction in fracture

Energy

Vitality

Increased attractiveness (these are only claims and not supported by RCTs)
Risks
  1. Breast cancer: E + P after five years of use
  2. CVD: Risk of CHD, stroke, particularly in older women (WHI), safer in younger menopausal women because of very low absolute risk (ages 50 to 59)
  3. VTE: Small excess at all ages, but absolute risk small in younger women ages 50 to 59
  4. Gallbladder disease
  5. Urinary incontinence
The lack of evidence for harm (due to overall lack of evidence of any sort) is suggested by some of these products as evidence of safety
MHT: menopausal hormone therapy; FDA: US Food and Drug Administration; BIH: custom-compounded bioidentical hormone therapy; RCT: randomized controlled trial; E3: estriol; HT: hormone therapy; E + P: estrogen plus progestin; CVD: cardiovascular disease; CHD: coronary heart disease; WHI: Women's Health Initiative; VTE: venous thromboembolism.
Republished with permission of The Endocrine Society, from Santoro N, Braunstein GD, Butts CL, et al. Compounded bioidentical hormones in Endocrinology practice: An Endocrine Society Scientific Statement. J Clin Endocrinol Metab 2016; 101:1318. Copyright © 2016; permission conveyed through Copyright Clearance Center, Inc.
Graphic 107768 Version 2.0