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Title: Patients Want Alternative Medicines, Despite Proof of Efficacy: Presented at AUA

"Patients Want Alternative Medicines, Despite Proof of Efficacy: Presented at AUA"

By Sophie Bainbridge ATLANTA, G.A. -- May 29, 2006 -- Patients with urologic disease say they want to take alternative medicines despite a lack of proof of efficacy from randomized, controlled trials, and even if these products might cause them harm, according to research presented here at the annual meeting of the American Urological Association (AUA). Alternative medicines are presumed to be safe, are easy to obtain, and can provide their users with a positive attitude about their condition, said Franklin C. Lowe, MD, professor of clinical urology, Columbia University College of Physicians and Surgeons, and associate director, department of urology, Luke's Roosevelt Hospital, New York City, New York. Usage of alternative medicines increases with higher education and socioeconomic status, and users are very active in their own health management, said Dr. Lowe, who is also chairman of the AUA Complementary and Alternative Medicine committee. "Over 70% of the US population uses some form of vitamins or supplements on a regular basis, Dr. Lowe said during a presentation on May 22[^nd. "In my personal practice, we've identified 90% of newly referred BPH [benign prostatic hyperplasia] patients who have already used some form of supplementation, and it's also been shown that over 80% of high-risk prostate cancer patients who have already been treated for initial localized therapy are using some form of alternative medicine."

Alternative products are permitted to be sold in the U.S. without any testing being required and without Food and Drug Administration approval.

Dr. Lowe examined the quality of evidence for the efficacy of 3 popular alternative agents used for urologic disease: saw palmetto, cranberry products, and supplements for prostate cancer prevention, in particular selenium and vitamin E.

Cranberry products are widely believed to be effective in treating urinary tract infections. However, the results of 2 randomized, controlled trials indicate that cranberry does not treat urinary tract infections, but that it might prevent them. There is uncertainty about which specific cranberry products might be effective for this purpose, and what the optimum dosage should be, Dr. Lowe said.

However, cranberry products might increase the risk of kidney stones in people who already at high risk of kidney stones, he added.

Saw palmetto is the most commonly used product for BPH. "While there have been numerous trials, we still do not know what the active component in saw palmetto berry is, and the clinical data are often contradictory," Dr. Lowe said.

The one randomized trial of 225 patients which was supported by the National Institutes of Health found no difference between placebo and saw palmetto berry for treatment of BPH. In fact, patients on placebo actually had greater improvements of their symptoms during the 1-month lead-in phase of the trial, Dr. Lowe said.

"For the consumer, the most important fact from this trial was that there was no difference in serious and non-serious adverse events. So we are uncertain about the mechanism of action, there is significant variability between products, and the efficacy of saw palmetto is still unproven," he said.

With regard to prostate cancer prevention with selenium and vitamin E, Dr. Lowe said there is no definitive proof that supplements have any impact on prostate cancer or its development, "although we certainly have a lot of noise that they might."

"There have been a lot of negative clinical trials, but they've had very little impact on consumer behavior," he said. "We must continue to educate our patients about the risks of taking these vitamins and supplements and continue to develop appropriate clinical trials to help answer our questions, because right now, it's really difficult to discern fact from fiction."

[Presentation title: Evidence-Based Results From Complementary And Alternative Medicine in Urology.]

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