Looking to the Pharmacist for the Truth about Bioidentical Hormone Replacement Therapy
Thanks to celebrities like Angelina Jolie Pitt, women’s issues such as breast cancer and menopause are getting much needed media attention. Many women owe their treatment success to hormone replacement therapy (HRT) while others tout HRT’s bioidentical counterpart for their healthy lives. While the benefits of HRT are numerous, much is still unknown about bioidentical hormone therapy (BHT), which is largely dispensed through compounding pharmacies. What is fact and what still needs to be studied?
What Is Hormone Replacement Therapy?
Hormone replacement therapy is a medication that contains female hormones—estrogen and progesterone—used to treat common symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness. Treatment can be delivered in many forms, such as a pill, topical cream, injection, patch, or ring.
Discussion about the benefits and risks of HRT has been long and controversial. A comprehensive NIH-sponsored Women’s Health Initiative (WHI) study looked at the effects of HRT on over 16,000 women for a period of 8.5 years. The results, reported in 2002, indicated that HRT put women at risk for heart disease, blood clots, stroke, and cancer. More recently, however, a follow-up has shown that the benefit to risk analysis has reversed. Robert Langer, the principal investigator at the WHI center at University of California, San Diego, said, “Information that has emerged over the last decade shows that, for most women starting treatment near the menopause, the benefits outweigh the risks, not just for relief of hot flashes, night sweats and vaginal dryness, but also for reducing the risks of heart disease and fractures.”
How Is BHT Different?
Following the WHI’s initial report, many researchers and patients turned to natural remedies as an alternate therapy. BHT is comprised of natural products whose chemical structures are identical to the hormones women make in their bodies. BHT treatments are delivered through the same mechanism as HRT, but are most likely compounded.
Dr. Charla Blacker, a reproductive endocrinologist at Henry Ford Hospital in Detroit, said, “Unlike conventional hormone therapy that uses synthetic hormones or animal-based hormones that are slightly different from a woman’s own hormones, bio-identical hormones are biochemically the same as those made by the ovaries during a woman’s reproductive years.”
Proponents of BHT, including some celebrities, claim they feel younger because the natural version of HRT is safer and more efficacious. However, many medical organizations disagree, including the FDA, the Mayo Clinic, and the American College of Obstetricians and Gynecologists. So what information do patients need to consider?
Disseminating Data for Compounding Pharmacies
Many people automatically assume that just because something is natural, it must be good for you. Sometimes this is true and sometimes it is not. As many BHT treatments come from compounding pharmacies, pharmacists should consider that:
- The ingredients in BHT are not approved by the FDA;
- The efficacy of BHT is still largely unknown, partly because dosage levels, efficacy standards, and quality controls are not in place;
- Safety through large, controlled studies has not yet been studied; and
- Though some compounders use a saliva-based test to assess patient hormone levels, such tests are insensitive to the large changes in hormone levels throughout the day.
Additionally, many insurance plans do not cover BHT, meaning patients could be paying hefty sums for a treatment not yet well studied. However, that is not the whole story—clearly some patients benefit from BHT, so we need to keep all options available.
How Can We Help Patients Determine Which Therapy Is Right for Them?
As always, the primary steps are to ask patients what they expect from BHT and to educate them about what you know. Why is the patient more interested in BHT than the standard hormone replacement treatment? If she is still under the impression that HRT puts her at risk for cancer and other health problems, pharmacists need to educate her with more recent studies. If she is truly invested in BHT, a different type of education is appropriate before we should compound her medication.
First, patients must understand what BHT provides relative to HRT, and what is still unknown. A good resource to turn patients onto is the myth and fact sheet put out by the FDA. While the FDA tends to be disinclined towards BHT, citing facts such as:
- “Bioidentical” hormone products can prevent or cure heart disease, Alzheimer’s disease, and breast cancer, all of which are untrue;
- If “bio-identical” products were unsafe, there would be a lot of reports of bad side effects, again untrue because individually compounded drugs do not have an effective reporting mechanism in place; and
- FDA wants all compounded hormone therapies off the market, which is patently false as the FDA wants individual therapies that work available for all patients.
The organization still does not acknowledge the enormous benefit BHT has given many patients. BHT may be as efficacious and safe as HRT, and may provide further benefit—it is simply not as well studied as HRT. Current anecdotal and after-use data show that BHT works—studies are needed to investigate this undeniable result. In the mean time, we need to educate our patient with what we know, including patient testimony, and help the patient determine what treatment is best for her.
Pharmaceutica North America is committed to providing you with compounded pharmaceuticals that have been quality tested and approved. Contact us today to see how we can provide you with the safe and effective compounding ingredients you need.