Rising numbers of peri- and post-menopausal girls request “bioidentical” hormones slightly than the hormones out there in generally used FDA-approved hormone alternative therapies.
What Precisely is a Bioidentiacal Hormone?
The time period “bioidentical” signifies that a hormone is chemically and structurally identical to the hormone that the physique naturally produces. Bioidentical hormone remedy used to deal with menopausal signs sometimes accommodates estradiol which is, actually, equivalent to the estradiol utilized in conventional hormone remedy. Thus, the time period bioidentical hormone remedy may be complicated; there are bioidentical hormones accepted by the FDA, however there are additionally compounded bioidentical hormone therapies.
FDA-approved bioidentical hormones embrace estradiol, estrone, and micronized progesterone, that are regulated and monitored for purity and efficacy in accordance with FDA pointers. The efficacy and security of those merchandise have been established by rigorous testing in randomized managed trials. These merchandise require a prescription.
Compounded bioidentical hormone therapies are ready by a compounding pharmacy in accordance with 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 sometimes include untested combos and dosages of hormones. These formulations may additionally be administered by nonstandard or untested routes, resembling 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 more practical than artificial hormones; nonetheless, the underside line is that we have now no evidence to suggest that bioidentical hormones are any safer or more advantageous for girls than conventional hormone remedies.
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 alternative remedy, together with elevated threat of blood clots, stroke, endometrial most cancers and breast most cancers. As a result of there may be not constant bundle labeling for these compounded merchandise, shoppers might not be totally 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 a scientific proof to assist the notion that bioidentical hormone remedy has fewer dangers than FDA-approved hormone therapies. Actually, {many professional} organizations are involved that these compounded preparations might carry further 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 are usually not routinely examined, and pharmacies are usually not required to gather data on antagonistic occasions.
With out FDA oversight and regulation, there isn’t a assure that custom-made compounded preparations containing bioidentical hormones present predictable therapeutic ranges of hormones.
Not sufficient Information, Oversight for the Use of Bioidentical Hormone Remedy
The North American Menopause Society (NAMS) and different medical organizations have cautioned towards the usage of bioidentical hormones: “Little or no scientific or medical proof helps claims that bioidentical hormones are safer or more practical than extra conventional FDA-approved therapies. As well as, many custom-compounded “bioidentical hormone” formulations are usually not topic to FDA oversight and may be inconsistent in dose and purity.”
We agree. We wouldn’t have ample data to assist the usage of these bioidentical preparations for the remedy of menopausal signs.
Ruta Nonacs, MD PhD
