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 stated by the USPSTF 1. The use of bioidentical hormone therapy is a topic of debate, with some proponents claiming it is a safer alternative to conventional hormone therapy. However, the FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women, and there is no convincing evidence to assert that the ultimate balance of benefits and harms might be substantially altered by using different approaches 1. Some key points to consider when evaluating bioidentical hormone therapy 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 recommend against the use of hormone therapy in postmenopausal women for the prevention of chronic conditions 1.
• The safety and effectiveness of bioidentical hormone therapy have not been evaluated through the FDA's drug approval process, and there are no randomized trials that have studied the potential benefits or harms of bioidentical hormones for the prevention of chronic conditions in postmenopausal women 1. In terms of treatment, women experiencing moderate to severe menopausal symptoms may be considered for conventional hormone therapy, which has a more established safety and efficacy profile, under the guidance of a healthcare provider. It is essential to prioritize the patient's quality of life, morbidity, and mortality when making decisions about hormone therapy, and to carefully weigh the potential benefits and risks of any treatment approach.

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.