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Bioidenticals Popular Among American Women, Though Experts Skeptical
After a federal study found risks from traditional hormone replacement therapy, or HRT, women began to try out the custom-compounded hormones or herbal supplements like black cohosh and red clover since 2002.
Previously the scientific medical community believed that hormone replacement therapy (HRT) at any age would reduce the risk of heart attack and stroke. This hope was dashed by the Women's Health Initiative Study, which found that taking estrogen plus progestin for more than five years places postmenopausal women at risk for heart attacks, strokes, and several other serious problems. Since the study bioidenticals have come to the fore.
"Women need to understand there's no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there's much less evidence for efficacy and very little research on long-term safety," said Dr.Joann Manson, the preventive medicine chief at Harvard-affiliated Brigham and Women's Hospital in Boston. She was a key researcher in the 2002 study.
Also in 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Dr. Manson writes in her book, Hot Flashes, Hormones and Your Health.
Compounded "bioidentical hormones" are plant-derived hormones that pharmacists prepare and label as drugs. The products are claimed to be biochemically similar or identical to those produced by the ovaries or body. However, the relevant chemicals (steroids) in plants are not identical to those in humans. To make products that work in humans, raw materials from the plants must be converted to human hormones synthetically. Thus, to the extent that they are potent, the "bioidentical" products would pose the same risks as those of standard hormones—plus whatever problems might be introduced during compounding, says Stephen Barrett, writing on Pharmwatch.
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