Related Experiment Video
Updated: May 21, 2025

Establishment of Rat Models Mimicking Gender-affirming Hormone Therapies
Published on: January 10, 2025
Legal Considerations in Bioidentical Hormone Replacement Therapy: Anticipating Future Challenges in Medical Liability
F Del Duca1, G Santangelo2,3, G Bogani2,3
1Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Viale Regina Elena 336, 00161 Rome, Italy.
Compounded Bioidentical Hormone Replacement Therapy (cBHRT) lacks safety studies and personalized efficacy, despite user claims. Prescribing cBHRT carries significant medico-legal risks due to unstudied drug interactions and preparation errors.
Area of Science:
- Endocrinology
- Pharmacology
- Women's Health
Background:
- Rise of compounded Bioidentical Hormone Replacement Therapy (cBHRT) formulations.
- Driven by misinformation and fears surrounding traditional hormone replacement therapy.
- cBHRT utilizes plant-derived active pharmaceutical ingredients (APIs).
Purpose of the Study:
- Review the impact of cBHRT on post-menopausal syndrome.
- Address physician and patient questions regarding cBHRT.
- Evaluate the safety, efficacy, and risks of cBHRT.
Main Methods:
- Literature research on cBHRT.
- Analysis of common questions from clinicians and patients.
- Review of medico-legal aspects and risks associated with compounded preparations.
Main Results:
- No safety or security studies exist for individual cBHRT formulations.
- Personalized cBHRT treatment appears ineffective.
- High costs of galenic preparations outweigh efficacy and safety.
- Generic risks (preparation errors, hygiene) and specific risks (drug-to-drug interactions) are present.
- Lack of scientific data exposes physicians to legal risks.
Conclusions:
- Caution is warranted when prescribing cBHRT.
- The efficacy and safety of cBHRT are not scientifically established.
- Prescribing physicians face potential medico-legal repercussions due to insufficient evidence.
More Related Videos
06:26Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
Published on: January 24, 2025
06:18An In Vivo Estrogen Deficiency Mouse Model for Screening Exogenous Estrogen Treatments of Cardiovascular Dysfunction After Menopause
Published on: August 13, 2019
Related Concept Videos
Bioequivalence: Overview
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Factors Affecting Drug Biotransformation: Biological
Species differences: Variations in enzyme systems across species can cause disparities in drug metabolism. For instance, humans may metabolize certain drugs faster than rodents, altering therapeutic effects.
Strain differences: Genetic variations within a species can result in differing enzyme activity, impacting drug response and toxicity. For example, some mouse strains may...
Drug Biotransformation: Overview
Standards of Care II
Target Cell Response to Hormones
Notably, the cellular response can be regulated by altering the number of receptors expressed in the cell. For example, prolonged exposure to elevated hormone levels results in a gradual decline or down-regulation in the number of receptors for that specific hormone on the cell surface. Conversely, in response to low hormone levels, cells may use up-regulation, producing an...