Nelson Vergel
Founder, ExcelMale.com
Most members of the this society are paid speakers and consultants to pharmaceutical companies that sell hormone products like Androgel, Testim, Fortesta, Axiron, Testopel, etc
Here they discourage the use of cheaper compounded products. You make your own conclusions!
Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement
Nanette Santoro, Glenn D. Braunstein, Cherie L. Butts, Kathryn A. Martin, Michael McDermott, and JoAnn V. Pinkerton
- See more at: http://press.endocrine.org/doi/10.1210/jc.2016-1271#sthash.tun6bkTb.dpuf
This Scientific Statement finds that there is no rationale for routine prescribing of unregulated, untested, and potentially harmful custom compounded bioidentical hormone therapies.
Context:
Custom-compounded bioidentical hormone therapy (HT) has become widely used in current endocrine practice, which has led to unnecessary risks with treatment.
Objective:
This scientific statement reviews the pharmacology and physiology of popular compounded hormones and the misconceptions associated with these therapies. The hormones reviewed include: estradiol and estrogens, progesterone and progestins, testosterone, dehydroepiandrosterone, levothyroxine, and triiodothyronine.
Results:
Overall, there is a general lack of standardization and quality control regarding how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, or contamination. There is also recent evidence of patient harm and death associated with treatment, as seen with fungus-contaminated glucocorticoid preparations. With estrogen, progestin, and dehydroepiandrosterone treatments, the practice of baseline hormone measurements to replace “abnormal” hormone deficiencies has no basis in medical practice. Furthermore, there is no evidence that monitoring compounded HT with serial salivary or blood testing is effective, except in the case of thyroid hormone. Finally, no evidence supports the popularized notion that custom-compounded bioidentical hormones have fewer risks when compared with Food and Drug Administration (FDA)-approved hormone treatments.
Conclusion:
The widespread availability of FDA-approved bioidentical hormones produced in monitored facilities demonstrates a high quality of safety and efficacy in trials; therefore, there is no rationale for the routine prescribing of unregulated, untested, and potentially harmful custom-compounded bioidentical HTs. Clinicians are encouraged to prescribe FDA-approved hormone products according to labeling indications and to avoid custom-compounded hormones.
Affiliations
Departments of Obstetrics and Gynecology (N.S.) and Medicine (M.M.), University of Colorado School of Medicine, Aurora, Colorado 80045; Department of Medicine (G.D.B.), Cedars-Sinai Medical Center, Los Angeles, California 90048; Program Leadership (C.L.B.), Biogen, Cambridge, Massachusetts 02142; Department of Medicine (K.A.M.), Massachusetts General Hospital, Boston, Massachusetts 02114; and Department of Obstetrics and Gynecology (J.V.P.), Midlife Health, University of Virginia, Charlottesville, Virginia 22908
- See more at: http://press.endocrine.org/doi/10.1210/jc.2016-1271#sthash.lGCpLFZA.dpuf
Here they discourage the use of cheaper compounded products. You make your own conclusions!
Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement
Nanette Santoro, Glenn D. Braunstein, Cherie L. Butts, Kathryn A. Martin, Michael McDermott, and JoAnn V. Pinkerton
- See more at: http://press.endocrine.org/doi/10.1210/jc.2016-1271#sthash.tun6bkTb.dpuf
This Scientific Statement finds that there is no rationale for routine prescribing of unregulated, untested, and potentially harmful custom compounded bioidentical hormone therapies.
Context:
Custom-compounded bioidentical hormone therapy (HT) has become widely used in current endocrine practice, which has led to unnecessary risks with treatment.
Objective:
This scientific statement reviews the pharmacology and physiology of popular compounded hormones and the misconceptions associated with these therapies. The hormones reviewed include: estradiol and estrogens, progesterone and progestins, testosterone, dehydroepiandrosterone, levothyroxine, and triiodothyronine.
Results:
Overall, there is a general lack of standardization and quality control regarding how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, or contamination. There is also recent evidence of patient harm and death associated with treatment, as seen with fungus-contaminated glucocorticoid preparations. With estrogen, progestin, and dehydroepiandrosterone treatments, the practice of baseline hormone measurements to replace “abnormal” hormone deficiencies has no basis in medical practice. Furthermore, there is no evidence that monitoring compounded HT with serial salivary or blood testing is effective, except in the case of thyroid hormone. Finally, no evidence supports the popularized notion that custom-compounded bioidentical hormones have fewer risks when compared with Food and Drug Administration (FDA)-approved hormone treatments.
Conclusion:
The widespread availability of FDA-approved bioidentical hormones produced in monitored facilities demonstrates a high quality of safety and efficacy in trials; therefore, there is no rationale for the routine prescribing of unregulated, untested, and potentially harmful custom-compounded bioidentical HTs. Clinicians are encouraged to prescribe FDA-approved hormone products according to labeling indications and to avoid custom-compounded hormones.
Affiliations
Departments of Obstetrics and Gynecology (N.S.) and Medicine (M.M.), University of Colorado School of Medicine, Aurora, Colorado 80045; Department of Medicine (G.D.B.), Cedars-Sinai Medical Center, Los Angeles, California 90048; Program Leadership (C.L.B.), Biogen, Cambridge, Massachusetts 02142; Department of Medicine (K.A.M.), Massachusetts General Hospital, Boston, Massachusetts 02114; and Department of Obstetrics and Gynecology (J.V.P.), Midlife Health, University of Virginia, Charlottesville, Virginia 22908
- See more at: http://press.endocrine.org/doi/10.1210/jc.2016-1271#sthash.lGCpLFZA.dpuf
