Are compounded bioidentical hormones (BH) safe?

From the Guidelines

The safety of compounded bioidentical hormones is uncertain and they generally aren't recommended as first-line therapy. Unlike FDA-approved hormone products, compounded bioidentical hormones lack standardized testing for safety, efficacy, and quality control. These preparations, which include estrogens, progesterone, and testosterone, are custom-made by pharmacists and marketed as being identical to hormones naturally produced by the human body. However, they haven't undergone rigorous clinical trials to establish appropriate dosing, side effects, or long-term risks. Potential risks include blood clots, stroke, certain cancers, and heart disease—similar to conventional hormone therapy. If considering hormone therapy, FDA-approved bioidentical hormones provide better consistency and known risk profiles. Patients should discuss their symptoms, medical history, and treatment goals with their healthcare provider to determine the most appropriate hormone therapy option, starting with the lowest effective dose for the shortest duration necessary to manage symptoms.

Some key points to consider:

• The FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women, and the safety and effectiveness of these products have not been evaluated through the FDA's drug approval process 1.
• The USPSTF did not identify any randomized trials that have studied the potential benefits or harms of bioidentical hormones for the prevention of chronic conditions in postmenopausal women 1.
• Other expert groups, such as 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.
• Patients should be informed of the potential risks and benefits of hormone therapy and should discuss their symptoms, medical history, and treatment goals with their healthcare provider to determine the most appropriate hormone therapy option 1.

It is essential to prioritize the patient's health and well-being when considering hormone therapy, and to use the most effective and safest treatment options available. The use of compounded bioidentical hormones should be approached with caution, and patients should be closely monitored for potential side effects and risks.

From the FDA Drug Label

The safety and efficacy of estradiol tablets in geriatric patients has not been established. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2. 5 mg) relative to placebo. Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer.

The FDA drug label does not answer the question about the safety of compounded bioidentical hormones. The provided text discusses the risks associated with estrogen therapy, but it does not specifically address compounded bioidentical hormones 2, 2.

From the Research

Safety of Compounded Bioidentical Hormones

• The safety of compounded bioidentical hormones is a topic of ongoing debate, with some studies suggesting that they may be associated with fewer side effects and improved symptom relief compared to conventional hormone therapies 3, 4.
• However, other studies have raised concerns about the lack of standardization and regulation of compounded bioidentical hormones, which can lead to variable purity and potency, and a lack of efficacy and safety data 5, 6.
• A systematic review and meta-analysis of randomized controlled trials found that compounded bioidentical hormone therapy was not associated with adverse changes in lipid profile or glucose metabolism, and may be beneficial for vaginal atrophy symptoms 7.
• Another study found that compounded transdermal bioidentical hormone therapy was associated with significant favorable changes in menopausal symptoms, cardiovascular biomarkers, and health outcomes, with no adverse events reported 4.

Efficacy of Compounded Bioidentical Hormones

• Some studies have reported that compounded bioidentical hormones are effective in relieving menopausal symptoms, such as hot flashes, night sweats, and vaginal dryness 3, 4.
• A survey study found that 71.8% of women reported better relief of menopausal symptoms when using bioidentical hormone replacement therapy, and 57.7% reported fewer side effects 3.
• However, other studies have noted that the evidence for the efficacy of compounded bioidentical hormones is limited, and that more research is needed to fully understand their effects 5, 6.

Risks and Uncertainties

• The use of compounded bioidentical hormones is not without risks and uncertainties, including the potential for variable purity and potency, and a lack of efficacy and safety data 5, 6.
• Some studies have raised concerns about the potential for compounded bioidentical hormones to increase the risk of breast cancer, endometrial cancer, and cardiovascular disease, although the evidence is limited and inconclusive 5, 7.
• The American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine have recommended that patients be counseled about the potential risks and uncertainties associated with compounded bioidentical hormones 6.