Hormone replacement therapy found its basis using synthetic hormones. The most profitable and mass-marketed form of HRT is synthetic hormones. This led to a push against bioidentical

hormones as inferior, dangerous, and unsafe.

But, is it true?

As doctors, it is our responsibility to do the proper research and make our own decisions for the best health and safety of our patients. Being educated by the marketing department of pharmaceutical companies should always be met with constructive skepticism.

Definitions A Synthetic Versus Bioidentical Hormone Replacement Therapy

The female body naturally produces various levels of estrogens estriol, estradiol, and estrone. Proponents of HRT may prescribe estriol alone, estriol and estradiol (known as Bi-Est), or estriol, estradiol, and estrone (Tri-Est). They may combine these estrogen derivatives with other hormones, particularly progestin. These hormones behave in the female body very similar, but not identical to it.

They are capable – taking the place of natural hormones, however, have a few unanticipated side effects. The side effects have included an increased risk of breast cancer, endometriosis, and dementia.

Estradiol is the popular choice in brand name pharmaceuticals – as pills (Estrace®, Gynodiol®, and generics), patches (Climara®, Alora®, Estraderm®, Vivelle®, and generics), vaginal creams (Estrace® and generics), and vaginal rings (Estring®). These are all set standard doses for easy distribution by a doctor.

Proponents of bioidentical hormones prepare each dose based on a person’s need, rather than a mass-marketed, easy to pass out-group. Bioidentical hormones derive from plant material, such as wild yams.

But, the main constructive criticism against bioidentical hormones is that they are manufactured in a lab, the same as synthetic hormones. This is true.  However, they derive from the natural source material.

The chemical structure of bioidentical hormones is identical to natural hormones. That means the estrogen and testosterone replacement is the balance of the different estrogens and testosterone in quantities required by the body. The balance of testosterone within the man’s body matches his need for it, as well.

These hormones are effective, taking the place of natural hormones. Additionally, because they are chemically identical to our natural hormones, they have not produced side effects.

It’s a fine distinction. Synthetic hormones differ from bioidentical hormones by chemical structure and effectiveness in the body. Not by being natural, naturally-derived, or any other buzzword.

Why The FDA & Other Organizations Don’t Support Bioidentical Hormones

If bioidentical hormones have fewer side effects and are chemically identical to natural hormones, why does the FDA recommend against them?

The answer has nothing to do with the hormones. Currently, bioidentical hormones cannot be patented, removing the majority of the financial incentive to produce them. Therefore, smaller companies produce hormones using unique and innovative delivery methods, which can be patented.

HTCA partners compounding pharmacists to provide a variety of dosages of bioidentical pellets to accommodate our array of individualized dosages based on the individual biological need. The FDA has a longstanding antagonistic relationship with compounding pharmacists, driving many of them out of business. Most of this is based on old studies (>20 years) or one that only sampled 29 compounded prescriptions 18 years ago.

As we move back to the money discussion, the FDA drives a substantial portion of its budget from fees and donations made by large companies that undergo large drug trials.

Bioidentical hormones lack large-scale testing for one, very precise reason: Compounded hormone therapy is unique to each person. It is impossible to test each unique compound in a random, double-blind study because no two doses are the same.

Please read about other myths.

Research on Bioidentical Hormones

First, there needs to be a separation of bioidentical hormones and “natural” hormones. In some arena, especially the commercial sphere, these two terms are the same. Many customers are confused by the two terms. Good marketers play upon this confusion, enticing people to want more of the natural hormones.

You should know that when your patients come in for the more natural hormone therapies, they are asking about bioidentical treatment. Here is where things get tricky for doctors. When a patient comes in already having researched a topic, if the doctor unknowledgeable or unwilling to talk about that topic, chances are your patient will go elsewhere. This increases the likelihood you will not be aware of your patient using this bioidentical hormone replacement therapy – three-quarters will not tell you everything, and almost half will not tell you anything at all!

This is why you need to keep the lines of communication open and avoid disregarding what your patients say.

Now, you need to create a discussion. Patients that want bioidentical hormones will not be swayed by past research, especially since the current research show women fare better in various health metrics and feel better using bioidentical hormones.

Bioidentical hormones provide the same benefits to the body as synthetic hormones, yet have far fewer side effects. In terms of cardiovascular health, bone density, and the prevention of colorectal cancer, bio-identical hormones equal standardized synthetic hormones.

The side effects are different. Synthetic hormones, particularly progestins, are associated with an increased risk of breast cancer. In contrast, bioidentical progesterone is associated with a decreased risk of breast cancer and potentially is more cardio-protective.

Again, the main argument against bioidentical hormones is from the FDA approval standpoint. Compounding pharmacists make each dose individually, most of the time, without any direct FDA supervision. Although there is a slight risk of under-dosing or contamination, the risk is negligible for the control and precision to match a patient’s need with the correct medication.

Compounding Unique Doses – Why It’s Just as Safe to Produce and Safer for your Patient

Although persecuted heavily, compounding pharmacists operate under the same stringent procedures that regular pharmacists operate under. The quality and ethics of compounding pharmacists are equal to, and often higher because they know people directly depend on the outcome of their work.

HTCA’s unique dose-specific recommendations for each bioidentical pellet are based on the individual doctor-patient relationship and calculated from test results derived from the patient. For example, some women may need a higher percentage of estriol over progesterone. The compounding pharmacist would be able to match that unique requirement.

Using pellet therapy, the individual compounded dose is delivered in a consistent, measurable amount over several months. As you can see in the chart below, it is the only long-term consistent method of delivery.

Add chart

Injected under the skin, pellets reliably release their dose. This eliminates inconsistencies that may arrive in your patience day-to-day life. Compared to taking a daily hormone replacement pill, it can increase compliance and reliability.

Additionally, pellet therapy has a lower infection rate, averaging 0.3% versus other forms of treatment which average 1.4%. It also consistently shows a sustained rate of release over 4-6 months.

Consistent BHRT Use (link)

Conclusion and Discussion

We encourage you to read the research on bioidentical hormones listed above. We understand that it might be difficult in some situations to switch over to bioidentical hormones, especially if you are dealing with contracts, hospital systems, and other providers. We encourage you to talk to one of our HTCA representatives and learn about how other doctors incorporated HTCA pellet therapy, into their practices.