title: Eviprostat has an identical effect compared to pollen extract (Cernilton) in patients with chronic prostatitis/chronic pelvic pain syndrome: a randomized, prospective study.
abstract: BACKGROUND
  Previously reported results of a prospective, randomized placebo-controlled study showed that the pollen extract (Cernilton) significantly improved total symptoms, pain, and quality of life in patients with inflammatory prostatitis/chronic pelvic pain syndrome (CP/CPPS) without severe side effects. A phytotherapeutic agent, Eviprostat, is reportedly effective in a rat model of nonbacterial prostatitis. The aim of the present study was to compare the efficacy and safety of Eviprostat to that of the pollen extract in the management of CP/CPPS.
  
  
  METHODS
  The patients with category III CP/CPPS were randomized to receive either oral capsules of Eviprostat (two capsules, q 8 h) or the pollen extract (two capsules, q 8 h) for 8 weeks. The primary endpoint of the study was symptomatic improvement in the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks.
  
  
  RESULTS
  In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat (n = 50) or the pollen extract (n = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There was no significant difference in the total, pain, urinary, and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8 weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study.
  
  
  CONCLUSIONS
  Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat may have an identical effect on category III CP/CPPS compared the pollen extract.
  
  
  BACKGROUND
  The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618); registration date: 3 November 2015.
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. hiro_hiro388@yahoo.co.jp.
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Iwamura
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. goodwin@cc.hirosaki-u.ac.jp.
authors.forename: Takuya
authors.initials: T
authors.lastname: Koie
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. osamiiiii.0325@gmail.com.
authors.forename: Osamu
authors.initials: O
authors.lastname: Soma
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. ewigkeit.arzt@gmail.com.
authors.forename: Teppei
authors.initials: T
authors.lastname: Matsumoto
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. tsushi.imai@gmail.com.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Imai
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. shingorilla2@gmail.com.
authors.forename: Shingo
authors.initials: S
authors.lastname: Hatakeyama
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. uroyone@cc.hirosaki-u.ac.jp.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Yoneyama
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. bikkuri@opal.plala.or.jp.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hashimoto
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan. coyama@cc.hirosaki-u.ac.jp.
authors.forename: Chikara
authors.initials: C
authors.lastname: Ohyama
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004979:Ethamsylate / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects; D017699:Pelvic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000008:administration & dosage*; D011446:Prospective Studies; D011472:Prostatitis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D012434:Secale; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D010936:Plant Extracts; D004979:Ethamsylate; C010152:eviprostat; C010070:cernilton