Understanding Menopause Bioidentical Hormone Therapy
Written and edited by Sarah Bonza MD, MPH, FAAFP, DipABLM, NBC-HWC
Menopause is a natural biological process that occurs in women, signaling the end of their reproductive years. During this time, the ovaries stop releasing eggs and the production of hormones such as estrogen and progesterone decreases. This hormonal shift can lead to a variety of symptoms, including hot flashes, night sweats, mood swings, fatigue, vaginal dryness, and changes in menstrual patterns (Files et al., 2011). These symptoms can significantly impact a woman’s quality of life and may last for several years. The symptoms can be so burdensome, that women may seek medical attention. Following the Women’s Health Initiative study in 2001, which highlighted potential risks associated with traditional hormone therapy, many women turned to alternative treatments for relief, one of them being compounded bioidentical hormone therapy (Hill et al., 2016).
Bioidentical Hormone Therapy Explained
Bioidentical estrogens arederived from plant sources and then chemically altered to precisely match the molecular structure of estrogens produced by the human ovaries, such as estradiol, estrone, and estriol. They are synthesized from plant sterols, such as soybean or yam sterols, which are chemically converted into bioidentical estradiol. This involves several chemical reactions where the plant-derived sterols are modified to replicate the molecular structure of naturally occurring human estradiol. They differ from conventional HRT, which might use synthetic or animal-derived hormones that are similar, but not identical, to human hormones.
Compounded vs. FDA-Approved Bioidentical Hormone Therapy
The distinction between compounded bioidentical hormones and FDA-approved bioidentical hormones is significant, particularly in terms of regulation, consistency, and safety. FDA-approved bioidentical hormones have been subjected to rigorous testing and quality control processes to ensure their safety, efficacy, and consistency. These products are manufactured in controlled environments and are available in standardized doses that have been scientifically tested in large groups of people (Files et al., 2011).
On the other hand, compounded bioidentical hormones are customized preparations made by pharmacists to fit the specific requirements of an individual patient, often based on hormone levels tested in saliva or blood. While this customization is sometimes viewed as an advantage, it also introduces variability and potential safety concerns. Compounded hormones are not FDA-approved, meaning they do not undergo the same stringent testing for safety and efficacy. This lack of oversight can lead to inconsistencies in dosage, purity, and potency. Consequently, while advocates of compounded bioidentical hormones tout their “natural” qualities and alignment with human biology, medical experts caution against their use due to the absence of standardized evidence proving their safety and effectiveness, compared to well-studied, FDA-approved options. Thus, while bioidentical hormones can be an important therapy, the distinction between FDA-approved and compounded forms is crucial in assessing their potential risks and benefits.
Why my doctor does not recommend compounded bioidentical hormone therapy
There are several reasons why a doctor may not recommend compounded bioidentical hormone therapy:
Lack of Standardization and Regulation
The term “bioidentical” can be misleading. It often refers to hormones that are chemically identical to those produced by the human body, but it is used in marketing both FDA-approved products and compounded hormone therapies. Compounded hormones are not regulated by the FDA as rigorously as commercial products. This lack of standardization can raise concerns about purity, potency, efficacy, and safety.
Insufficient Evidence
Many claims about the superiority of bioidentical hormones over conventional hormone replacement therapy (HRT) lack rigorous scientific backing. The medical community prefers evidence-based practices, and many studies on bioidentical hormones are limited in scale or lack control and long-term follow-up. This makes it difficult for physicians to fully endorse these therapies based on the available evidence.
Safety Concerns
Although proponents claim that bioidentical hormones are safer than synthetic hormones, there is limited large-scale and long-term research to substantiate these claims. Physicians are particularly cautious because of the history of hormone therapy, which has shown potential risks such as increased chances of blood clots, stroke, and certain types of cancer.
Marketing vs. Medical Science:
The term “bioidentical” is sometimes seen as a marketing tool used to imply a “natural” and safer alternative without sufficient medical and scientific backing. Physicians are wary of terms that might be used more for consumer appeal than clinical accuracy.
FDA Approval
Physicians tend to trust and prescribe FDA-approved medications because these have undergone rigorous testing for safety and efficacy. Many bioidentical hormones, especially those that are compounded, do not have FDA approval, leading to skepticism and reluctance among healthcare providers.
Professional Guidelines
Medical organizations and endocrinology experts often provide guidelines based on systematic reviews and consensus, favoring well-studied and standardized treatments. Since bioidentical hormone therapies often fall outside these recommendations due to the reasons mentioned above, physicians may not feel comfortable recommending them without more robust guidelines.
What are the FDA approved bioidentical systemic hormone treatments available in the United States?
This table summarizes the FDA-approved bioidentical hormone therapies available in the United States, providing options in various forms and strengths to accommodate different therapeutic needs.
Conclusion
In conclusion, menopause and perimenopause can cause various symptoms that can significantly impact a woman’s quality of life. The effectiveness of hormone therapy in treating these symptoms is well-established. However, safety concerns and the desire for alternative treatments have led some women to explore compounded bioidentical hormone therapy. While some perceive compounded bioidentical hormone therapy as a natural and potentially safer alternative, it’s important to note that there are significant concerns regarding its regulation, quality, and safety.
FDA-approved bioidentical hormone therapy offers a regulated and carefully tested alternative. These products have undergone rigorous testing and are manufactured under strict standards to ensure their safety and efficacy. They provide a level of assurance that is not present with compounded bioidentical hormone therapy.
When considering hormone therapy, it’s crucial for women to have open and honest discussions with their healthcare providers. Understanding the potential risks and benefits of different treatment options is essential for making well-informed decisions about managing menopausal symptoms.
Talk with your doctor or schedule a consultation to discuss your options.
References
Files, J A., Ko, M G., & Pruthi, S. (2011, July 1). Bioidentical Hormone Therapy. https://doi.org/10.4065/mcp.2010.0714
Hill, D A., Crider, M., & Hill, S R. (2016, December 1). Hormone Therapy and Other Treatments for Symptoms of Menopause.. https://pubmed.ncbi.nlm.nih.gov/27929271
