Bioidentical hormones are intended to offer a more natural option for hormone replacement therapy. Unlike synthetic hormones, which may have a slightly different chemical structure from the hormones produced by the body, bioidentical hormones are chemically identical to the hormones naturally produced by the human body.
Bioidentical hormones can be made from plant estrogens or progesterone and are available in various forms, including pills, patches, creams, gels, and injections. It is important to differentiate between formulations that are approved by regulatory authorities such as the Swissmedic, European Medicines Agency (EMA) or the US Food and drug administration (FDA) and compounded bioidentical hormones.
Compounded bioidentical hormones are mixtures of bioidentical hormones that can be prepared individually by pharmacists according to a prescription by a physician. They are tailored to an individual's specific hormonal needs and are therefore sometimes seen as a more personalized form of treatment. However, they don’t offer the same quality standard as approved bioidentical hormones.
Chemical structures of estradiol, estriol, and progesterone.
Formulations of bioidentical hormones, that are approved by regulatory authorities, are subject to the same regulatory requirements as synthetic hormone formulations. Therefore, they offer a similar standard for efficacy and safety. They are often marketed and perceived as a more natural and safer alternative to synthetic hormones. However, clinical data supporting this claim is limited.
While some studies found, that approved bioidentical hormones are safer than their synthetic counterparts, others did not show any significant difference between the two. In both cases, side effects may vary depending on the dosage and duration of the treatment making it important to find the best individual dose.
Safety and efficacy of approved vs compounded bioidentical hormones
Proponents of compounded bioidentical hormones claim that their individual preparation allows a natural therapy perfectly tailored to individual needs which is supposed to be especially safe and efficacious. However, there are a few major drawbacks of compounded preparations:
- Since these preparations are not approved by regulatory authorities, they are not subject to thorough clinical examination and their efficacy and safety has not been tested to the same standards as approved hormone formulations (synthetic or bioidentical)
- Manufacturing of bioidentical hormones used for compounded preparations may not fulfill quality standards similar to those of approved drugs. Therefore, quality and composition of the ingredients may vary a lot. The dosage of the ingredients might not be accurately determined, which may lead to more side effects.
- The composition of compounded bioidentical hormone preparations is often chosen based on salivary hormone tests with questionably accuracy as described in an earlier blog post.
Despite these drawbacks, compounded bioidentical hormone therapy might be indicated for people who cannot tolerate available approved formulations. It is advisable to consult a hormone specialist to figure out the right composition. To assure a constant level of quality, practitioners should carefully choose the compounding pharmacy they wish to work with.
The Swiss Menopause Society advises to use Swissmedic approved bioidentical hormone formulations whenever possible. In case of intolerance to existing formulations, a compounded preparation can be used, but the person must be informed about the lack of safety data for individual preparations.
In conclusion, approved bioidentical hormones are a valuable alternative to synthetic hormones, offering similar efficacy and maybe a slightly superior safety profile. The use of compounded preparations of bioidentical hormones, however, should be carefully evaluated since quality may vary and no safety data is available for individual preparations.
It's important for individuals to consult with healthcare professionals to understand the potential risks and benefits of all hormone therapy options. Decisions should be based on individual health needs, preferences, and the best available scientific evidence.
