• Florian M E Wagenlehner, Henning Schneider, Martin Ludwig, Jörg Schnitker, Elmar Brähler, and Wolfgang Weidner.
• Clinic for Urology, Paediatric Urology and Andrology, Justus-Liebig-University of Giessen, Giessen, Germany. Wagenlehner@AOL.com
• Eur. Urol. 2009 Sep 1; 56 (3): 544-51.

BackgroundNational Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent condition for which no standardised treatment exists.ObjectivesTo assess the safety and efficacy of a standardised pollen extract in men with inflammatory CP/CPPS.Design, Setting, And ParticipantsWe conducted a multicentre, prospective, randomised, double-blind, placebo-controlled phase 3 study comparing the pollen extract (Cernilton) to placebo in men with CP/CPPS (NIH IIIA) attending urologic centres.InterventionParticipants were randomised to receive oral capsules of the pollen extract (two capsules q8h) or placebo for 12 wk.MeasurementsThe primary endpoint of the study was symptomatic improvement in the pain domain of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI individual domains and total score, the number of leukocytes in post-prostatic massage urine (VB3), the International Prostate Symptom Score (IPSS), and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 wk.Results And LimitationsIn the intention-to-treat analysis, 139 men were randomly allocated to the pollen extract (n=70) or placebo (n=69). The individual domains pain (p=0.0086) and quality of life (QoL; p=0.0250) as well as the total NIH-CPSI score (p=0.0126) were significantly improved after 12 wk of treatment with pollen extract compared to placebo. Response, defined as a decrease of the NIH-CPSI total score by at least 25% or at least 6 points, was seen in the pollen extract versus placebo group in 70.6% and 50.0% (p=0.0141), respectively. Adverse events were minor in all patients studied.ConclusionsCompared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects.

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