Growing numbers of peri- and post-menopausal girls request “bioidentical” hormones slightly than the hormones accessible in generally used FDA-approved hormone substitute therapies.
What Precisely is a Bioidentiacal Hormone?
The time period “bioidentical” implies that a hormone is chemically and structurally equivalent to the hormone that the physique naturally produces. Bioidentical hormone remedy used to deal with menopausal signs sometimes incorporates estradiol which is, in reality, equivalent to the estradiol utilized in conventional hormone remedy. Thus, the time period bioidentical hormone remedy could be complicated; there are bioidentical hormones accepted by the FDA, however there are additionally compounded bioidentical hormone therapies.
FDA-approved bioidentical hormones embody estradiol, estrone, and micronized progesterone, that are regulated and monitored for purity and efficacy in response to FDA tips. The efficacy and security of those merchandise have been established by way of rigorous testing in randomized managed trials. These merchandise require a prescription.
Compounded bioidentical hormone therapies are ready by a compounding pharmacy in response to a supplier’s specs. These therapies are custom-blended and sometimes mix a number of hormones together with estradiol, estrone, estriol, DHEA, testosterone, and progesterone. The efficacy of those preparations haven’t been assessed in randomized managed trials and infrequently include untested mixtures and dosages of hormones. These formulations may additionally be administered by nonstandard or untested routes, reminiscent of topical lotions, subdermal implants or pellets, injections, or oral lozenges. Bioidentical hormone remedy is mostly really helpful by naturopathic medical doctors.
Is Bioidentical Hormone Remedy Safer or Extra Efficient?
Within the media, girls are sometimes given the message that bioidentical hormones are safer and simpler than artificial hormones; nevertheless, the underside line is that we’ve got no proof to recommend that bioidentical hormones are any safer or extra advantageous for girls than conventional hormone therapies.
Though there’s a tendency to consider bioidentical hormones as “all-natural”, they, just like the hormones utilized in conventional hormone therapies, are manufactured within the laboratory. Thus, bioidentical hormone remedy carries most of the similar dangers as conventional estrogen substitute remedy, together with elevated threat of blood clots, stroke, endometrial most cancers and breast most cancers. As a result of there’s not constant bundle labeling for these compounded merchandise, customers might not be absolutely conscious of the potential for severe unwanted side effects.
Up to now, there have been no randomized, managed trials evaluating compounded bioidentical hormone remedy with placebo or FDA-approved hormone therapies for menopausal signs. Moreover, there isn’t any scientific proof to help the notion that bioidentical hormone remedy has fewer dangers than FDA-approved hormone therapies. In truth, {many professional} organizations are involved that these compounded preparations could carry extra dangers. There may be the potential for dose variability (both overdosing or underdosing), inconsistent bioavailability, and contamination. Whereas compounding pharmacies are anticipated to adjust to USP Requirements for the preparation of those hormone therapies, compounded merchandise aren’t routinely examined, and pharmacies aren’t required to gather info on antagonistic occasions.
With out FDA oversight and regulation, there isn’t any assure that custom-made compounded preparations containing bioidentical hormones present predictable therapeutic ranges of hormones.
Not sufficient Knowledge, Oversight for the Use of Bioidentical Hormone Remedy
The North American Menopause Society (NAMS) and different medical organizations have cautioned towards using bioidentical hormones: “Little or no scientific or medical proof helps claims that bioidentical hormones are safer or simpler than extra conventional FDA-approved therapies. As well as, many custom-compounded “bioidentical hormone” formulations aren’t topic to FDA oversight and could be inconsistent in dose and purity.”
We agree. We would not have sufficient info to help using these bioidentical preparations for the therapy of menopausal signs.
Ruta Nonacs, MD PhD
