Hormone Misuse

Little evidence for “low T” or “adrenal fatigue.”

BOSTON – Recent years have witnessed an unprecedented rise in the off-label use of hormones and supplements for the treatment of common and non-specific symptoms such as fatigue, low energy, poor sleep, weight gain and lower libido. In a statement released by the American Association of Clinical Endocrinologists, by a team of clinical endocrinologists – led by AACE Member, Michael S. Irwig, MD, FACE, of Beth Israel Deaconess Medical Center (BIDMC), outlined the dangers of the practice and urging physicians and their patients to have honest conversations about the risks associated with the inappropriate use of testosterone, growth hormone, thyroid hormone and so-called adrenal supplements. The statement was published in the journal Endocrine Practice.

“The off-label use and misuse of hormones and supplements in individuals without an established endocrine diagnosis carries risks that are both known and unknown,” said Irwig, an Endocrinologist & Director of Transgender Medicine at BIDMC, who chaired the expert committee responsible for the statement. “In addition to these health risks, the inappropriate use of the hormones and supplements generates billions in unnecessary costs to patients and the health care system. Worse, off-label hormone and supplement use may delay the diagnosis and treatment of a legitimate medical condition for months to years, possibly allowing otherwise treatable conditions to progress untreated.”

Linking the surge in consumer interest in hormone therapy to well-funded marketing campaigns orchestrated by pharmaceutical companies and for-profit clinics promoting therapies for anti-aging and men’s health, the authors emphasized the lack of scientific evidence to back these claims. The position statement strongly recommended that providers prescribe hormones only to patients with clearly established diagnoses for conditions where hormone therapy is medically indicated – fewer than five percent of men tested meet the criteria for low testosterone, for example, even as U.S. sales of the drug quadrupled from 2000 to 2011.

The authors also note:

• Patients should be aware that dietary supplements – which are not regulated or tested by the U.S. Food and Drug Administration – may be spiked with substances not listed as ingredients such as anabolic steroids or thyroid hormone.
• Adrenal fatigue is not a legitimate medical diagnosis and supplements marketed as adrenal support often contain steroids which can cause a host of side effects including bone loss, muscle weakness and weight gain.
• Patients should be wary of clinics that promote testosterone or growth hormone for anti-aging purposes or for common symptoms such as weight gain, low energy or low sexual desire. Testosterone can cause infertility, hypertension and lower good cholesterol, while growth hormone may cause leg swelling, joint pain and diabetes.
• Physicians should discuss this topic with their patients and patients should honestly disclose off-label hormone use as it may affect their overall health, diagnostic testing and treatment plan.

“Unfortunately, aggressive marketers lead people to believe their symptoms are caused by a hormone deficiency and treatment with this hormone will improve or eliminate their complaints,” Irwig said. “There’s no scientific evidence to support that. This position statement seeks to raise awareness in the general public as well as among the medical community concerning the risks of off-label use and misuse of hormones and supplements.”

Co-authors included Maria Fleseriu, MD, FACE, of Oregon Health and Science University; Jacqueline Jonklaas, MD, of Georgetown University; Nicholas A. Tritos, MD, DSc, FACE, of Massachusetts General Hospital; Kevin C.J. Yuen, MD, FRCP, FACE, of Barrow Neurological Institute; Ricardo Correa, MD, FACE, of University of Arizona College of Medicine-Phoenix; George Elhomsy, MD, FACE, of Kansas University School of Medicine-Witchita; Vishnu Garla, MD, of University of Mississippi; Sina Jasim, MD, of Washington University in St. Louis; Kyaw Soe, MD, of University of Texas Southwestern Medical Center and VA Medical Center; Stephanie E. Baldeweg, MD, of University College London Hospitals; Cesar Luiz Boguszewski, MD, PhD, of Federal University of Parana; and Irina Banco, MD, of Mayo Clinic College of Medicine and Science.