Journal Article

Eviprostat has an identical effect compared to pollen extract (Cernilton) in patients with chronic prostatitis/chronic pelvic pain syndrome: a randomized, prospective study

Yoneyama, Takahiro, Iwamura, Hiromichi, Matsumoto, Teppei, Koie, Takuya, Imai, Atsushi, Hatakeyama, Shingo, Ohyama, Chikara, Soma, Osamu, Hashimoto, Yasuhiro

2015

Overview

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. Conclusion 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. Trial registration The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan ( UMIN000019618 ); registration date: 3 November 2015.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Administration, Oral / Adult / Aged / Aged, 80 and over / Chronic Disease / Chronic Pain - diagnosis / Chronic Pain - drug therapy / Chronic Pain - etiology / Clinical trials / Comparative analysis / Complications and side effects / Cytokines / Dose-Response Relationship, Drug / Drug Combinations / Ethamsylate - administration & dosage / Hospitals / Humans / Internal Medicine / Male / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Mens health / Middle Aged / Oxidative stress / Pain / Pain Measurement - drug effects / Patients / Pelvic pain / Pelvic Pain - diagnosis / Pelvic Pain - drug therapy / Pelvic Pain - etiology / Phytotherapy - methods / Plant Extracts - administration & dosage / Pollen / Prospective Studies / Prostate / Prostatitis - complications / Prostatitis - diagnosis / Prostatitis - drug therapy / Quality of life / Research Article / Secale / Sexually transmitted diseases / Statistical analysis / STD / Studies / Urine / Urology / Voiding dysfunction / Young Adult