Hormone treatment options in the aged population continue to be a source of debate among the medical community. Education is key was the common theme of three presentations given during yesterday’s press conference on hormones and aging.
Targeting the largely unregulated custom-compound prescription boom, one study found that among prescriptions filled for menopausal hormone therapy (HRT) in the United States, almost half now are custom-compounded “bioidentical” hormones. The problem with these prescriptions, which are mixed for an individual according to a doctor’s prescription, is that they are not well-regulated or monitored by the Food and Drug Administration (FDA), said lead investigator JoAnn Pinkerton, MD, professor of obstetrics and gynecology at the University of Virginia Health System.
Prescriptions for FDA-approved HRT were numbered at 36 million in 2012, down 61 percent since 2002, while custom-compounded HT prescriptions have grown to an estimated 26 to 36 million filled last year.
Pharmacists in the study expect those numbers to continue to grow in the next two years.
“Health providers and their patients should understand the differences in and the risk associated with less-regulated treatments of compounded HRT,” said Dr. Pinkerton, who cited lack of safety and efficacy data along with the possible presence of contaminants and concerns of overdosing or underdosing as possible dangers. “There are many bioidentical products that are FDA approved. There is a need for education.”
Another study addressed the mortality risk of menopausal hormone therapy, and found that its use does not affect the risk of dying.
Researchers reviewed medical literature published over the past 30 years, including clinical trials of postmenopausal women in studies that last more than six months.
According to lead investigator, Khalid Benkhadra, MD, a research fellow at Mayo Clinic, researchers found no statistically significant relationship between HRT use and all-cause mortality or death due to heart attack, breast cancer, or stroke. There was also no significant association between HRT use and death when researchers performed a subgroup analysis based on hormone type: estrogen alone or estrone plus progesterone, said Dr. Benkhadra.
The results, he said, should allay women’s concerns about taking HRT for debilitating menopause symptoms.
The final presentation addressed hormone replacement in men, specifically looking at the link between borderline testosterone levels and depression.
Research conducted by Michael S. Irwig, MD, FACE, and associates found that men with borderline testosterone levels have higher rates of depression and depressive symptoms than the general population, as well as high prevalence of obesity, overweight, and physical inactivity.
“Clinicians need to be aware of the clinical characteristics of this sample population and manage their comorbidities such as depression and obesity,” said Dr. Irwig, who is associate professor of medicine and director of the Center for Andrology in the division of endocrinology at George Washington University.
The number of men having their testosterone levels checked has increased dramatically, largely due to pharmaceutical advertising. However, in some cases treatment of comorbidities, including encouraging better diet and exercise, carries less risk than testosterone therapy and can improve testosterone levels.
“The study underscores the utility of a validated instrument to screen for depression, especially as some subjects may deny signs and symptoms during the interview,” said Dr. Irwig, who noted that many in the study claimed no depressive symptoms, but were found to have them during the assessment by the validated Patient Health Questionnaire 9 (PHQ-9). “Appropriate referrals should be made for formal evaluation and treatment of depression.”