What is bioidentical hormone replacement therapy (BHRT)?

From the Guidelines

Bioidentical hormone therapy should not be used for the primary prevention of chronic conditions in postmenopausal women due to the lack of evidence on its safety and effectiveness, as noted by the USPSTF 1. When considering bioidentical hormone therapy, it's crucial to understand that the FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women, and there are no randomized trials studying its potential benefits or harms for this purpose 1. Key points to consider include:

• The American Heart Association and the American Congress of Obstetricians and Gynecologists recommend against the use of menopausal hormone therapy for the primary or secondary prevention of cardiovascular disease 1.
• The Canadian Task Force on Preventive Health Care and the American Academy of Family Physicians also recommend against the use of hormone therapy in postmenopausal women for the prevention of chronic conditions 1.
• The use of bioidentical hormones may carry risks similar to conventional hormone therapy, including potential increased risk of blood clots, stroke, and certain cancers.
• Women with a history of hormone-sensitive cancers, liver disease, or blood clotting disorders should generally avoid hormone therapy.
• A thorough discussion with a healthcare provider about individual risks and benefits is essential before starting any hormone therapy. Given the current evidence, the safest approach is to avoid bioidentical hormone therapy for the primary prevention of chronic conditions in postmenopausal women, as recommended by the USPSTF and other professional organizations 1.

From the Research

Bio-Identical Hormone Therapy

• Bio-identical hormone therapy (BHT) uses bioidentical hormones, derivatives of plant extracts chemically modified to be structurally indistinguishable from human endogenous hormones 2.
• BHTs are available commercially or can be compounded into different dosages and for different routes of administration, typically including estriol, estrone, estradiol, testosterone, micronized progesterone, and occasionally dehydroepiandrosterone (DHEA) 2.
• The efficacy and safety of BHT are still being researched, with some studies suggesting that it may have similar benefits and risks to conventional hormone therapy (CHT) 3, 2.

Benefits and Risks

• Menopausal hormone therapy (MHT) is the most effective treatment for vasomotor symptoms, with benefits including decreased risk of osteoporotic fractures and vaginal atrophy, improved glycemic control, and decreased vasomotor symptoms 3.
• However, recent research on risks associated with MHT has shown increased risk of venous thromboembolism and breast cancer 3.
• The decision to start MHT should be made on an individual basis after a thorough evaluation and counseling, with the goal of using the lowest dose for the shortest time that effectively manages symptoms 3.
• Bio-identical HRT (BHRT) may have the same cardiovascular risks as oral hormone replacement therapy (HRT), and its use cannot be promoted until further evidence is available to demonstrate its safety 4.

Studies on Bio-Identical Hormone Therapy

• A prospective, cohort, closed-label study examined the long-term effects of compounded bioidentical transdermal sex steroid therapy on cardiovascular biomarkers, hemostatic, inflammatory, immune signaling factors, quality-of-life measures, and health outcomes in peri/postmenopausal women 5.
• The study found significant favorable changes in menopausal symptoms, cardiovascular biomarkers, inflammatory factors, immune signaling factors, and health outcomes, with no adverse events reported 5.
• Another study reviewed the literature related to compounded BHT and found a dearth of scientific evidence to support claims of greater efficacy and safety, with many advocates of compounded BHTs customizing prescriptions based on saliva tests or blood sera levels in direct contradiction to evidence-based guidelines 2.

Treatment Approach

• Hormone therapy (HT) is an effective treatment for menopausal symptoms, including vasomotor symptoms and genitourinary syndrome of menopause, with randomized trials demonstrating positive effects on bone health and age-stratified analyses indicating more favorable effects on coronary heart disease and all-cause mortality in younger women 6.
• The timing of HT initiation, type and route of administration, and patient-specific considerations should be weighed when prescribing HT, with the goal of using the lowest dose for the shortest time that effectively manages symptoms 6.