title: 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.
abstract: 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.
authors.affiliation: Clinic for Urology, Paediatric Urology and Andrology, Justus-Liebig-University of Giessen, Giessen, Germany. Wagenlehner@AOL.com
authors.forename: Florian M E
authors.initials: FM
authors.lastname: Wagenlehner
authors.forename: Henning
authors.initials: H
authors.lastname: Schneider
authors.forename: Martin
authors.initials: M
authors.lastname: Ludwig
authors.forename: Jörg
authors.initials: J
authors.lastname: Schnitker
authors.forename: Elmar
authors.initials: E
authors.lastname: Brähler
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Weidner
mesh_terms: 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
chemical_list: D010936:Plant Extracts; C010070:cernilton