| Washington A supplement containing four herbal and antioxidant agents improved key symptoms of benign prostatic hyperplasia, Dr. Harry Preuss reported at the annual meeting of the American College of Nutrition.
The supplement contains 378 mg of Cernitin, a proprietary flower-pollen extract; 286 mg of a phytosterol/saw palmetto and beta-sitosterol complex; and 100 1U of Vitamin E.
Dr. Preuss and his colleagues at Georgetown University Medical Center, Washington, tested the compound in a multi-center clinical trial that involved 127 patients who had confirmed benign prostatic hyperplasia (BPH), maximal flow rates between 5 and 15 ml/second, and no evidence of cancer.
The active therapy was randomly assigned to 70 patients; 57 others took a placebo for 90 days.
The patients were evaluated using the American Urological Association index of symptom severity, urinary flow rate, prostate-specific antigen measurements, and residual bladder volumes, Dr. Preuss said.
The placebo effect was quite strong. But at 12 weeks follow-up, a significantly greater proportion of patients who received the active compound had symptom reductions compared with patients taking placebo, including nocturia (60% vs. 13%), urinary frequency (35% vs. 10%), and overall scores on the severity index (49% vs. 22%). These are generally viewed as the key symptoms of BPH, he commented.
Active treatment and placebo produced comparable improvements in other symptoms. Patients taking the compound or placebo improved in terms of symptoms of emptying (50% vs. 42%), hesitancy when urinating (58% vs. 30%), urgency (32% vs. 10%), weak stream (46% vs. 30%) and straining (70% vs. 52%), respectively. These improvements were significant compared with baseline, but the differences between the compound and placebo were not considered significant. |
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The supplement appeared to have no effect on prostate-specific antigen levels, maximal and average urinary flow rates, and residual bladder volumes, he said at the meeting.
The side effect profile was similar for the compound and for the placebo, Dr. Preuss added.
Its generally thought that Cernitin-which is believed to have anti-inflammatory and antiedematous effects-may be the most active agent in the compound. The next step is to look at Cernitin separately in head-to-head trials with other agents, Dr. Preuss said.
Sundown Vitamins of Boca Raton, Fla., manufactures the study compound and funded the study.
Another company, Graminex of Saginaw, Mich., along with the pharmaceutical firm, Bigmar, Inc., plans on filing an Investigational New Drug application with the FDA to conduct studies specifically on Cernitin for the treatment of BPH and to pursue approval.
"In Europe, as much as they use agents like Hytrin, they use natural means," Dr. Preuss said.
Consumers in Europe look to natural agents in part because of their more favorable side effect profile. Proscar, one of the most commonly used drugs in the United States for BPH, is associated with gastrointestinal distress and impotency Hytrin is used even less frequently for BPH because of side effects such as hypotension, edema, dizziness, nasal congestion, chest pain, and impotency, he noted.
Cernitin is sold as a dietary supplement under the name Cernilton in the United States. It is a prescription drug in Japan and Europe, according to Cynthia May, President of Graminex.

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