A Pollen Extract (Cernilton) In Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome - Phase III Study

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 26 Oct 2009 - 2:00 PDT

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UroToday.com - The prostatitis syndrome is a remarkably prevalent condition, frequently seen by urologists, and with a high impact on life quality. This study investigated the safety and efficacy of Cernilton, a standardized pollen extract, versus placebo, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS, National Institutes of Health (NIH) type IIIA).

The pathophysiology of CP-CPPS is currently not well understood. A variety of possible etiologies are proposed, which makes the patients suffering from CP-CPPS a very heterogenous population. The clinical studies conducted in patients with CP-CPPS so far have shown rather limited effects of the tested medications compared to placebo or were statistically underpowered. Despite the unknown pathophysiology in patients with CP-CPPS, almost all patients show one or another phenotype of symptoms or signs, such as for example inflammation. Until further knowledege of the exact pathophysiology allows for exact stratification of patients in clinical studies, a phenotypical approach might be better than no stratification at all.

Cernilton, a standardized pollen extract, is known to have an antiinflammatory capacity and therefore in this study only patients with an inflammatory phenotype were included. An infectious phenotype was excluded by antibiotic pretreatment before baseline. Compared to placebo, Cernilton significantly improved total symptoms, pain and quality of life in patients with inflammatory CP-CPPS without severe side effects. Up to date there exists no standardized treatment for this very prevalent condition. This study was able to show that in a specific patient cohort, namely patients with inflammatory CP-CPPS, a pollen-extract might be a useful treatment option.

Written by Florian M.E. Wagenlehner, MD, PhD as part of Beyond the Abstract on UroToday.com

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