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.
BACKGROUND
National Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent condition for which no standardised treatment exists.


OBJECTIVE
To assess the safety and efficacy of a standardised pollen extract in men with inflammatory CP/CPPS.


METHODS
We 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.


METHODS
Participants were randomised to receive oral capsules of the pollen extract (two capsules q8h) or placebo for 12 wk.


METHODS
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.


CONCLUSIONS
In 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.


CONCLUSIONS
Compared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects.
Wagenlehner
Florian M E
FM
Clinic for Urology, Paediatric Urology and Andrology, Justus-Liebig-University of Giessen, Giessen, Germany. Wagenlehner@AOL.com
Schneider
Henning
H
Ludwig
Martin
M
Schnitker
Jörg
J
Brähler
Elmar
E
Weidner
Wolfgang
W
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D011472:Prostatitis / Q000188:drug therapy*; D012434:Secale; D055815:Young Adult
D010936:Plant Extracts; C010070:cernilton