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A Pollen Extract (Cernilton) in Patients with Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome: A Multicentre, Randomised, Prospective, Double-Blind, Placebo-Controlled Phase 3 Study
European Urology, 08/07/09

Wagenlehner FME et al. – Twelve weeks of a pollen extract (Cernilton) in men diagnosed with inflammatory National Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) resulted in a significantly higher symptom improvement compared to placebo and was well tolerated. Pollen extract can therefore be recommended for patients with CP/CPPS in the dosage and duration studied.

Methods

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.
Participants were randomised to receive oral capsules of the pollen extract (two capsules q8 h) or placebo for 12 wk.
The 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

139 men were randomly allocated to the pollen extract (n = 70) or placebo (n = 69).
The individual domains pain and quality of life as well as the total NIH–CPSI score 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%, respectively.
Adverse events were minor in all patients studied.

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