An increasing number of peri- and post-menopausal women are seeking “bioidentical” hormones as an alternative to FDA-approved hormone replacement therapies. Unfortunately, the use of hormonal therapy for menopausal symptoms is surrounded by myths and misconceptions. In an era marked by growing distrust of the healthcare system and pharmaceutical industry, many individuals turn to the internet for information rather than consulting their healthcare providers. This online landscape, often dominated by persuasive advertising, promotes false claims and exaggerated promises. As a result, consumers may forgo effective treatments or unknowingly opt for therapies that are unproven and potentially harmful. Thus, it is crucial to prioritize evidence-based research to ensure safe and effective care.

What Are Bioidentical Hormones?

  1. True or False: Bioidentical hormones are identical to the hormones naturally produced by the body.
     True. The term “bioidentical” refers to hormones that are chemically and structurally identical to those produced by the human body. 
  2. True or False: All bioidentical hormones are FDA-approved.
     False. While some bioidentical hormones, such as estradiol and micronized progesterone, are FDA-approved, compounded bioidentical hormone therapies are not regulated by the FDA.

Safety and Efficacy

  1. True or False: Compounded bioidentical hormones are safer than FDA-approved hormone therapies.
     False. There is no scientific evidence to support that compounded bioidentical hormones are safer or more effective than FDA-approved therapies. In fact, compounded formulations may carry additional risks, such as inconsistent dosing, contamination, and lack of oversight.
  2. True or False: Compounded bioidentical hormone therapy has undergone rigorous testing in clinical trials.
     False. Compounded bioidentical hormone therapies have not been assessed in randomized controlled trials, making their efficacy and safety uncertain.
  3. True or False: FDA-approved bioidentical hormones carry fewer risks than traditional hormone therapies.
     False. FDA-approved bioidentical hormones carry similar risks as traditional hormone replacement therapy, including increased risks of blood clots, stroke, breast cancer, and endometrial cancer.

Claims and Misconceptions

  1. True or False: Hormone testing is necessary to guide dosing for bioidentical hormone therapy.
     False. The FDA recommends against using hormone levels to guide dosing because hormone levels naturally fluctuate and salivary tests are unreliable.
  2. True or False: Bioidentical hormones can help maintain youth and promote weight loss.
     False. Claims that bioidentical hormones can maintain youth or aid in weight loss are unsubstantiated and often used as marketing tactics rather than evidence-based recommendations.

Regulation and Oversight

  1. True or False: Compounded bioidentical hormones are subject to the same regulatory standards as FDA-approved medications.
     False. Compounded bioidentical hormones lack FDA oversight, meaning their purity, potency, and safety are not guaranteed.
  2. True or False: Pharmacies that compound bioidentical hormones must report adverse events to the FDA.
     False. Unlike manufacturers of FDA-approved drugs, compounding pharmacies are not required to report adverse events to the FDA.

Clinical Recommendations

  1. True or False: Professional organizations recommend compounded bioidentical hormone therapy for menopausal symptoms.
     False. Organizations such as The North American Menopause Society caution against using compounded bioidentical hormones due to insufficient evidence supporting their safety and efficacy.
  2. True or False: Hormones are more effective than non-hormonal treatments for managing menopausal symptoms.
     False. While bioidentical hormones can be effective for some women, non-hormonal treatments, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin, and lifestyle modifications, have also been shown to effectively manage menopausal symptoms like hot flashes, mood changes, and sleep disturbances. Non-hormonal options are particularly valuable for women who cannot or prefer not to use hormonal therapies.

The Bottom Line

Bioidentical hormone therapy is often misunderstood due to marketing claims and misinformation about its safety and effectiveness compared to traditional hormone replacement therapy. While FDA-approved bioidentical hormones may be a viable option for some women, compounded versions lack rigorous testing and regulation, posing potential risks that should be carefully considered with a healthcare provider167.

 Ruta Nonacs, MD PhD

 

References

Kauffman RP, MacLaughlin EJ, Courtney LA, Vineyard DD. Fear, misinformation, and pharmaceutical messianism in the promotion of compounded bioidentical hormone therapy. Front Reprod Health. 2024 Feb 29;6:1378644.

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