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Hormonal dietary supplements might promote prostate cancer progression
Date:1/14/2008

tosterone. Additionally, attempts to stop the cancer-cell growth with increasing concentrations of the anti-cancer drug bicalutamide proved to be futile.

Bicalutamide is an oral nonsteroidal anti-androgen used to treat prostate cancer, Dr. Shariat said. The fact that this supplement caused the drug to be less effective is very troubling.

Based on the clinical data and cell culture experiments, the researchers filed an adverse event report with the Food and Drug Administration. The government agency in turn issued a warning letter to the manufacturers, which led to the removal of the product from the market.

Unlike prescription and over-the-counter drugs, the law does not require nutritional supplements to undergo pre-market approval for safety and efficacy, Dr. Shariat said. The current FDA regulatory system provides little oversight or assurances that dietary supplements will have predictable pharmacological effects or even that product labels provide accurate information for consumers.

The researchers say expanded research is needed to define the mechanism, safety and efficacy of common herbal and hormone dietary supplements.

For most supplements efficacy is not established in randomized, controlled trials. What is worse, safety is often equally poorly established, said Dr. Roehrborn, who directs the Sarah M. and Charles E. Seay Center for Pediatric Urology.

An estimated 42 percent to 69 percent of U.S. adults use dietary supplements, at an estimated out-of-pocket expenditure of about $34.4 billion, according to published reports cited in the study. Individuals often use supplements because they believe these natural products are safe and drug-free. The sale of androgenic steroids is exponentially increasing. In 2004, U.S. expenditures on testosterone supplements were estimated to be $425 million.

Given that testosterone supplements are in high demand, there is significant concern that supplements, i
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Contact: Erin Prather Stafford
erin.pratherstafford@utsouthwestern.edu
214-648-3404
UT Southwestern Medical Center
Source:Eurekalert  

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