Many women taking compounded bioidentical hormone therapy are not aware that these products have not been evaluated or approved by the US Food and Drug Administration (FDA). A new study has found that the use of these products is on the rise. The findings were published in the September issue of the journal Menopause by researchers at the University of Virginia Health System, Charlottesville, VA; and University of Colorado School of Medicine, Aurora, CO.
The study authors note that hormone replacement therapy (HRT) is effective for the treatment of vasomotor symptoms (hot flashes), vaginal atrophy, and prevention of postmenopausal osteoporosis in women who are entering or beyond the menopause. The use of commercially manufactured HRT to treat menopausal symptoms has decreased during the past 12 years in response to the findings of the Women’s Health Initiative trials; however, the use of custom compounded hormone therapy (CHT; bioidentical hormone therapy) appears to have increased. The researchers note that, apparently do not apply their concerns about the risks of HRT to CHT products.
The researchers explain that, fueling the increase in usage of CHT appears to be the absence of regulation governing product advertising, which allows manufacturers of CHT to make unsubstantiated claims about their safety and effectiveness. In addition, high-profile celebrities such as Oprah Winfrey and Suzanne Somers have promoted CHT to postmenopausal women. In addition, doctors and pharmacists who derive economic benefits from the sales of CHT may also have encouraged its use.
The authors note that two surveys, the Harris and Rose surveys, were conducted to quantify the use of CHT among perimenopausal and postmenopausal women in the US, to examine women’s knowledge of CHT versus FDA–approved hormone therapy, and to compile information on menopausal experience. The Harris survey was administered to 801 women aged 45 to 60 years who had experienced at least one menopausal symptom. The Rose survey was administered to 2,044 women aged 40 years or older who had used hormone therapy on at least one occasion. The women were asked about menopausal symptoms, hormone therapy use, and knowledge of CHT. Findings from the Rose survey were expanded by the use of US Census Bureau data and prescription claims for FDA-approved hormone therapy to estimate the prevalence of CHT use.
The researchers found that, according to expansion of the Rose data, up to 2.5 million US women aged 40 years or older may use CHT annually, accounting for 28% to 68% of prescriptions for hormone therapy. The Harris data revealed that 86% of women surveyed were unaware that CHT products are not FDA-approved. The Rose survey asked a subgroup of 1,771 women whether their hormone therapy had been personalized based on hormone levels; 378 (21%) answered “yes”, and 476 (27%) did not know. In both surveys, most hormone therapy users responded that their doctor had recommended the treatment.
The authors estimated that 1 million to 2.5 million US women aged 40 years or older use CHT. They concluded that the study suggests that many women are unaware that compounded hormones have not been evaluated or approved by the FDA. They stressed that healthcare providers should ensure that women considering hormone therapy understand the risks and benefits of inadequately regulated CHT.