Bioidentical hormone therapy: An assessment of provider knowledge
Introduction
Following publication of the Women’s Health Initiative (WHI) in 2002 [1], [2], interest in Bioidentical Hormone Therapy (BHT) has grown. Prior to the WHI findings, hormone therapy was believed to not only relieve menopausal symptoms, but also improve overall health [3]. However, the WHI Combined Estrogen and Progestin replacement trial revealed potential risks of combination hormone replacement therapy, reporting that oral combination hormone therapy, specifically 0.625 mg of conjugated equine estrogen daily with 2.5 mg of medroxyprogesterone acetate daily, was associated with increased risk for cardiovascular disease and breast cancer. Subsequently, this led many women to seek what they perceived to be “safer” alternative therapies for relief of menopausal symptoms [4], [5]. Aided by direct-to-consumer marketing, BHT has become a popular alternative and a multi-billion dollar industry in the United States (US), despite lack of evidence-based data on its safety and efficacy [6]. A recent study estimated that up to 2.5 million women over the age of 40 years old in the US use BHT annually [7].
The terminology surrounding BHT can be confusing to both providers and patients. The Endocrine Society defines bioidentical hormones as compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body [8]. This definition does not include how the medication is manufactured, source of hormones or method of delivery. In the US, bioidentical hormones are available in both Food and Drug Administration (FDA)-approved and non-FDA-approved formulations. Examples of FDA-approved bioidentical hormones include oral estradiol and oral micronized progesterone. There are also bioidentical products that are custom compounded in compounding pharmacies under the direction of a prescriber and are referred to as custom-compounded bioidentical hormone therapy (CC-BHT) [9]; currently no CC-BHT products are approved by the US FDA.
Proponents of CC-BHT assert improved efficacy, safety, and tolerability of these products compared with FDA-approved regimens. However these claims lack supporting evidence in the existing medical literature and often do not address concerns regarding lack of FDA oversight, efficacy, and variability of dosing seen in compounded products [10]. Patients are sometimes advised as well that dosing of CC-BHT should be based on the use of salivary hormone level testing, which as a form of testing has several limitations and cannot be reliably used for optimal dosing of sex hormones [11]. Unfortunately, patients are frequently presented with information conveying these messages through marketing tactics utilizing media, celebrity endorsements, web-based resources, and social networking platforms that target symptomatic peri- and postmenopausal women [6], and providers caring for this patient population are challenged to address and respond to these claims. Studies have shown that health care providers desire an improved understanding of the efficacy and safety of CC-BHT, as well as a practical but evidence-based approach toward patient requests for compounded bioidentical hormones [4], [6], [9], [12].
In an attempt to address the confusion surrounding BHT, multiple medical organizations and professional societies, including the Endocrine Society, the North American Menopause Society and the European Menopause and Andropause Society, have issued position statements refuting many of the claims made by CC-BHT advocates [8], [13], [14]. In spite of these attempts however, there continues to be misperceptions and uncertainty, with one study of pharmacists in Canada demonstrating varying beliefs on CC-BHT safety and efficacy [15]. Thus, there appears to be a need to improve provider knowledge and understanding of CC-BHT in order to help dissipate myths and better facilitate a fruitful shared decision-making process with patients.
We recognize that in order to improve provider knowledge, there needs to be improved understanding as to why providers are currently prescribing non-FDA approved BHT. To evaluate and characterize the knowledge, beliefs, and prescribing practices of BHTs among healthcare providers, we designed a survey study of primary care providers attending continuing medical education (CME) conferences in the United States. Our goal was to identify knowledge gaps regarding both BHT and CC-BHT, and to try to better understand why providers may prescribe CC-BHT.
Section snippets
Study design
This was a cross-sectional survey study of health care providers attending primary care Continuing Medical Education (CME) conferences conducted by the Mayo Clinic throughout the United States from May 2, 2012 to April 30, 2013. The primary care conferences encompassed the following medical specialties: internal medicine, family medicine, women’s health, and obstetrics-gynecology (OB-GYN). Health care providers were defined as physicians with medical (MD) or osteopathic (DO) degrees, nurse
Results
At the conclusion of the study period, 7 CME conferences had participated in subject recruitment: 2 were OB-GYN conferences, 2 were women’s health-primary care conferences, and 3 were general internal medicine or family practice conferences. All conferences were mainly targeted at physicians but also provided the opportunity for attendance by other health care providers such as nurses, NPs and PAs. In total, 1629 conference attendees were invited to participate and 400 surveys were collected,
Discussion
The treatment of women with peri- and postmenopausal symptoms is an important aspect of primary care medicine that crosses a number of specialties including internal medicine, obstetrics and gynecology and family medicine. The use of BHT in the treatment of menopausal women has markedly increased since the publication of the Women’s Health Initiative in 2002 [1]. To our knowledge, this is the first survey assessing knowledge, beliefs and prescribing practices around BHT amongst MDs/DOs, NPs and
Conclusions
Health care providers often encounter patients requesting prescriptions for BHT. The findings of this study underscore the confusion that exists regarding BHT, in particular CC-BHT, and the potential for patient safety concerns. Increasing patient demand for the products may be encouraging providers to write prescriptions for which they acknowledge unfamiliarity and discomfort. Our survey revealed that many practitioners are unaware that bioidentical hormones are available in FDA-approved
Disclosure of competing interests
All authors declare no conflict of interest.
Contributors
JAF was responsible for the conception of the study design, administration of the study, and writing and review of the manuscript.
LNK was responsible for the statistical analysis, and writing and review of the manuscript.
MK was responsible for the conception of the study design, administration of the study, and writing and review of the manuscript.
JMK was responsible for the conception of the study design, and writing and review of the manuscript.
PSD was responsible for the conception of the
Funding
The authors have received no funding for this article.
Ethical approval
This study was approved by the Institutional Review Board of the Mayo Clinic, Arizona, USA.
Conflict of interest
The authors declare that they have no conflict of interest.
Provenance and peer review
This article has undergone peer review.
Acknowledgements
We thank Dawn Bergen for her invaluable assistance in manuscript preparation. We also thank Meng-Ru Cheng, MSPH, for her assistance with the statistics.
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