We have been discussing testosterone replacement therapy and the unknown outcomes associated with this treatment among healthy men. Due to the absence of information regarding the long-term risks and benefits of testosterone replacement therapy, caution seems to be warranted.
It is also important to remind ourselves that we have been here before.
In the 1990s the most frequently prescribed class of medication was for the purpose of hormone replacement (estrogen alone or estrogen plus progestin) in postmenopausal women. Its popularity was due to the long-standing argument that hormone replacement therapy not only improved quality of life among women but also served to reduce risk for cardiovascular disease, osteoporosis, and cancer. Despite this therapy being available to women since the 1960s, it was not until 1998 that the first large-scale randomized clinical trial investigating hormone replacement was completed. This study, the Hormone Estrogen/progestin Replacement Study (HERS), found that hormone replacement treatment provided no benefit and, in fact, served to increase risk for heart disease among women. Subsequent investigations also began to challenge the value of hormone replacement.
The final nail in the hormonal coffin arose in 2002 during the Women’s Health Initiative (WHI) studies. One of the clinical trials within the WHI reviewed estrogen plus progestin hormone replacement therapy among healthy women. This trial, however, was halted early due to an accumulation of evidence indicating that the risks associated with this therapy were too high. Hormone replacement did provide a protective benefit against hip fracture and colon cancer. Yet, this treatment also served to increase risk for breast cancer, heart attacks, stroke, and blood clots. Prescriptions for hormone replacement therapy in the US soon dropped from 30 million in 1999 to 10 million by 2005. The risks associated with hormone replacement therapy were deemed sufficiently dire that the US Food and Drug Administration required a black box warning to be prominently displayed on hormone replacement medication.
Hormone replacement therapy for postmenopausal women was no longer risk-free. And the risks it possessed were significant.
- Herrington, D. M. (2003). Hormone replacement therapy and heart disease: replacing dogma with data. Circulation, 107, 2-4.
- Postmenopausal Hormone Therapy: US Department of Health and Human Services
- Macdougall, C., Udkow, T., Guglielmo, B. J., Vittinghoff, E., & Martin, J. (2010). National estimates and predictors of prescription medication sample use in the United States, 1999-2005. Journal of the American Pharmacists Association, 50, 677-685.