title: Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome.
abstract: The therapeutic efficacy for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is currently unsatisfactory. The aim of the present study was to assess the safety and efficacy of pollen extract in association with vitamins (DEPROX 500®) in males with CP/CPPS. All patients with a diagnosis of CP/CPPS attending the same urologic centre between March and October 2012 were enrolled in this randomised controlled phase III study. Participants were randomised to receive oral capsules of DEPROX 500®(two capsules every 24 h) or ibuprofen (600 mg, one tablet three times a day) for four weeks. The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), International Prostate Symptom Score and Quality of Well-Being (QoL) questionnaires were used. In the intention-to-treat analysis, 87 males (25 class IIIa and 62 class IIIb) with a mean age of 33.6±5.9 years were randomly allocated to the DEPROX 500®(n=41) or ibuprofen (n=46) treatment groups. At the follow-up examination (following one month of treatment), in the DEPROX 500®group, 31/41 patients (75.6%) reported an improvement in quality of life, defined as a reduction of the NIH-CPSI total score by ≥25%, compared with 19/46 (41.3%) in the control group (P=0.002). The greater improvement in the DEPROX 500®group compared with the ibuprofen group was statistically significant (treatment difference in the NIH-CPSI pain domain, -2.14±0.51, P<0.001; QoL scores, P=0.002). All patients were negative at the Meares-Stamey test evaluation. Adverse events were less frequent in the DEPROX 500®group than in the ibuprofen group. The DEPROX 500®treatment significantly improved total symptoms, pain and quality of life compared with ibuprofen in patients with CP/CPPS, without severe side-effects.
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Cai
authors.affiliation: Clinic and Polyclinic for Urology, Child Urology and Andrology, University Hospital of Giessen und Marburg, Justus-Liebig University, Giessen, Germany.
authors.forename: Florian M E
authors.initials: FM
authors.lastname: Wagenlehner
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
authors.forename: Lorenzo Giuseppe
authors.initials: LG
authors.lastname: Luciani
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Tiscione
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Malossini
authors.affiliation: Department of Urology, University Federico II, Naples, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Verze
authors.affiliation: Department of Urology, University Federico II, Naples, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
authors.affiliation: Department of Urology, University of Florence, Florence, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bartoletti
keywords: chronic pelvic pain syndrome; chronic prostatitis symptom index; pollen extract; prostatitis syndrome; quality of life