The Clinical Utility of Compounded Bioidentical Hormone Therapy A Review of Safety, Effectiveness, and Use (2020) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-28
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, a comprehensive, prospective study, to test whether hormone t herapy would prevent heart disease and to examine overall health risks and benefits of FDA-approved hormone therapy (Hays et al., 2003; Stefanick et al., 2003)
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The resulting Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy was charged to review the uses of cBHT preparations and the available evidence that would support marketing 1 As a consequence of cBHT marketing strategies, the term bioidentical is often mis nterpreted i by the general public. The committee intentionally includes the term when referencing certain types of hormone therapies, with the rationale that bioidentical serves as an important identifier for many compounded hormone therapies, and including the term may be a useful means of more effectively communicating the report conclusions to the general public.
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; • Review and assess the available evidence (or lack of evidence) regarding the safety and effectiveness of compounded BHRT drug products; and • Based on the available evidence, summarize findings and make recommendations with respect to: o The clinical utility of compounded BHRT drug products; o Whether the available evidence of safety and effectiveness supports use of compounded BHRT drug products to treat patients; and o The patient populations that might need a compounded BHRT drug product in lieu of a U.S.
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Additionally, the report focuses on the use of cBHT resulting from traditional prescriber– pharmacist–patient triads, although there is limited discussion of online purchases and office stock where pertinent. Based on the physiological effects and indications of the steroid hormones the committee reviewed, the primary focus of this report is on the use of cBHT preparations to treat menopause or male hypogonadism symptoms.
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. The committee met in person five times and held four halfday virtual meetings.
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on topic areas relevant to the study's charge. In recognition of the limited information available addressing the use, safety, effectiveness, and patient perspectives of cBHT, the committee also made concerted efforts to collect and review relevant anecdotal, survey, and
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s Chapter 3 provides an overview of the regulatory framework for compounded mediations and includes a discussion on the development, evaluation, and approval of FDA-approved drug products to highlight differences in regulatory processes to ensure safety and effectiveness. Chapter 4, serving as important context for the remainder of the report, provides an overview of the synthesis, structure, and biochemistry of steroid hormones, and clarifies the term bioidentical hormone.
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Public Information-Gathering Sessions -- Discussion Panels • Discussion of the Committee's Charge • Background on Compounding • Marketing and Use • Context for the Current Study • Consumer Engagement, Education, and Medical Care • Pharmaceutical Sciences and Compounding • Common Formulations • Difficult to Compound List • National Perspectives on the Behalf of Compounding Professionals • Provider Education and Medical Care • Pharmaceutical Sciences and Compounding Pharmacies • 503B Outsourcing Facilities Chapter 6 examines the available evidence on the bioavailability of the hormones included in cBHT preparations. Chapter 7 outlines the key findings and conclusions that resulted from the committee's literature review on the safety and effectiveness of hormone ingredients commonly used in cBHT preparations.
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2020a. Approved drug products with therapeutic equivalence evaluations (Orange Book)
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2003. The Women's Health Initiative postmenopausal hormone trials: Overview and baseline characteristics of participants.
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2017. Why women choose compounded bioidentical hormone therapy: Lessons from a qualitative study of menopausal decision making.
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