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Atlanta-Urologists can add one more alternative, plant-based medication to the list of intriguing possibilities for treating urologic disease. This one is a rye-pollen extract called Cernilton that showed promising results in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in a preliminary, placebo-controlled study from Germany.
This formulation, or similar ones, combining rye and other grass pollen extracts have been studied in the lab, in a few controlled studies of BPH, and even in uncontrolled studies of CP/CPPS with encouraging results.
The chemical make-up of the extract isn't really known, nor is the mechanism of action clear, lead author Wolfgang Weidner, MD, professor of urology at Justus-Liebig University in Giessen, told Urology Times.
In vitro and animal model studies seem to indicate that inhibition of prostaglandin and leukotriene synthesis may be responsible for the extract's anti-inflammatory effect. In other studies, a soluble fraction reduced the size of the prostate in the rat and inhibited testosterone-induced BPH in castrated animals. A few double-blind, placebo controlled studies showed statistically significant but modest improvements in frequency, nocturia, and sensation of residual urine in BPH patients.
Quality of life improved
The current study, presented at the AUA annual meeting here, included 123 patients whose symptoms, NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) scores, and Meares-Stamey four-glass test indicated they had inflammatory (type IIIa) CP/CPPS. They were pretreated with azithromycin (Zithromax) and were then randomized to Cernilton, three tablets twice daily (59 men), or placebo (63 men). The men's progress is being judged based on changes in NIH-CPSI scores.
The investigators will be following their patients for 6 months and hope to see the results published later this year or in 2007. Preliminary 12-week data, however, are encouraging. Although urinary symptoms did not change appreciably, pain and quality of life did improve significantly in the men taking Cernilton compared with those taking placebo. In the Cernilton group, NIH-CPSI pain scores improved by about 5 points and quality of life by about 2.5 points, whereas in the placebo group, pain scores improved only about 3 points and quality of life, only about 1 point.
That's edging up to the "treatment effect" hurdle that J. Curtis Nickel, MD, spoke about in his plenary session presentation on CP/CPPS. He noted that many controlled studies of CP/CPPS treatments have demonstrated significant improvements, but so have placebos. The better assessment may be a 4-to 6-point difference in NIH-CPSI scores between the results of treatment and placebo, said Dr. Nickel, who is professor of urology at Queen's University in Kingston, ON, Canada. He is looking forward to the more complete results to see if this potential treatment passes the bar of peer review, and then "we could add it to the list," he said.
Dr. Weidner also told Urology Times that he and his colleagues are considering comparing results of Cernilton treatment with those of alpha-blockers in men with CP/CPPS, medications that have surpassed that "treatment effect" mark. In addition, they may also look at combination therapy with these two agents.
"I think this combination could work," Dr. Weidner said.
Dr. Weidner has received support from Strathmann GmbH.