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Reuters, CanWest - Two seeking to boost sexual performance and grow bigger muscles instead ended up with advanced prostate cancer after taking “herbal” supplements, US doctors said.

They said many supplements marketed as “safe” and “natural” could contain unknown and potentially dangerous ingredients, and noted that the US Food and Drug Administration has little authority to regulate them.

“Physicians need to ask their patients not only about the prescription drugs they may be taking, but — perhaps even more importantly — about the over-the-counter drugs and supplements, which may have a profound impact on certain health conditions,” Claus Roehrborn, chairman of urology at the University of Texas Southwestern medical school, said yesterday.

Dr Roehrborn’s team became concerned about what it calls herbal/hormonal dietary supplements, or HHDSs, after two developed aggressive prostate within months of taking the same supplement.

For legal reasons the researchers won’t name the supplement, which was removed from the market, and say they have no direct proof that the product caused the highly suspicious prostate cancers.

The team analysed the product and found it contained two hormones — testosterone and estradiol. When the product was tested on tumour cells in the lab, it fuelled the growth of prostate cells more potently than testosterone alone, the team reported in the journal Clinical Research.”We filed an adverse event report with the FDA, who issued a warning letter. The manufacturer responded by removing this HHDS product from the market,” the researchers wrote.

“Individuals use HHDS for self-improvement, failure or distrust of conventional medicine, and because they believe that these natural products are safe and drug-free.”

The researchers searched websites promoting such products and found they promised maintenance of a “youthful” heart, relief of stress, and improvements in stamina, energy, strength and virility.

The patients, a 67-year-old and a 51-year-old, have both survived but has spread throughout their bodies.

“Unlike prescription and over-the-counter drugs, the law does not require nutritional supplements to undergo pre-market approval for safety and efficacy,” the researchers wrote, with manufacturers allowed to assume the sole responsibility.

“Thus, the current Food and Drug Administration regulatory system provides little oversight or assurance that HHDS will have predictable pharmacological effects or even that product labels provide accurate information to consumers.”

A leading Canadian urologist warns that who take nutritional supplements advertised as having male hormones are “really playing with fire.”

“Many are on androgen replacement therapy or some kind of male replacement and there’s always been a concern this may stimulate the growth of prostate cells,” says Dr. Laurence Klotz, chief of the division of urology at Toronto’s Sunnybrook Health Science Centre.

“It’s a very controversial question and the answer is still not clear.”

A separate study, this one the latest to look at the risk of therapy for , found that taking an estrogen-plus-progesterone combination for as little as three years significantly increases the risk of certain breast cancers.

It was thought only who use these hormones for at least five years have an increase in breast risk.

The study involved more 1,500 postmenopausal , age 55 to 74, in western Washington. Researchers at the Fred Hutchinson Research Center in Seattle found that who used the combined regimen had a three- to four-fold relative increased risk of lobular , but only if they used the hormones for three or more years.

Lobular accounts for about only 15 per cent of all invasive breast cancers. It’s hard to detect and its incidence soared 52 per cent in the U.S. between 1987 and 1999, according to the researchers.

“These findings are still of considerable public-health importance considering the estimated 57 million prescriptions for menopausal therapy that continue to be filled in the United States,” lead author Dr. Christopher Li said in a release issued with the new study, published in the journal Epidemiology, Biomarkers and Prevention.

[Clinical Cancer Research 14, 607-611, January 15, 2008]

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