From: 7, The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
There is a dearth of high-quality evidence—data from studies that would meet FDA's requirements for granting regulatory approval to a drug product—available to establish whether compounded bioidentical hormone therapy preparations are safe and effective for their prescribed uses.
Conclusion 7-4
Well-designed and properly controlled clinical trials are needed to provide reliable evidence about the safety and effectiveness of compounded bioidentical hormone therapy preparations.
Conclusion 7-5
The majority of marketing claims about the safety and effectiveness of compounded bioidentical hormone therapy preparations, whether in absolute terms or in comparison to FDA-approved bioidentical hormone therapy, are not supported by evidence from well-designed, properly controlled studies.
From: 7, The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.