Eviprostat Has an Identical Effect Compared to Pollen Extract (Cernilton) in Patients with Chronic Prostatitis/chronic Pelvic Pain Syndrome: a Randomized, Prospective Study

Overview

Journal BMC Urol

Publisher Biomed Central

Specialty Urology

Date 2015 Dec 9

PMID 26643109

Citations 9

Authors

Hiromichi Iwamura

Takuya Koie

Osamu Soma

Teppei Matsumoto

Atsushi Imai

Shingo Hatakeyama

Takahiro Yoneyama

Yasuhiro Hashimoto

Chikara Ohyama

Affiliations

Soon will be listed here.

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.

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.

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References

Propert K, Alexander R, Nickel J, Kusek J, Litwin M, Landis J . Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002; 59(6):870-6. DOI: 10.1016/s0090-4295(02)01601-1. View

Fu W, Zhou Z, Liu S, Li Q, Yao J, Li W . The effect of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) on semen parameters in human males: a systematic review and meta-analysis. PLoS One. 2014; 9(4):e94991. PMC: 3990624. DOI: 10.1371/journal.pone.0094991. View

Homma Y, Tsukamoto T, Yasuda K, Ozono S, Yoshida M, Shinji M . [Linguistic validation of Japanese version of International Prostate Symptom Score and BPH impact index]. Nihon Hinyokika Gakkai Zasshi. 2002; 93(6):669-80. DOI: 10.5980/jpnjurol1989.93.669. View

Nickel J, Pontari M, Moon T, Gittelman M, Malek G, Farrington J . A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis. J Urol. 2003; 169(4):1401-5. DOI: 10.1097/01.ju.0000054983.45096.16. View

Nickel J, Downey J, Clark J, Casey R, Pommerville P, Barkin J . Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomized placebo-controlled multicenter trial. Urology. 2003; 62(4):614-7. DOI: 10.1016/s0090-4295(03)00583-1. View

Nickel J, Narayan P, McKay J, Doyle C . Treatment of chronic prostatitis/chronic pelvic pain syndrome with tamsulosin: a randomized double blind trial. J Urol. 2004; 171(4):1594-7. DOI: 10.1097/01.ju.0000117811.40279.19. View

Bjerklund Johansen T, Gruneberg R, Guibert J, Hofstetter A, Lobel B, Naber K . The role of antibiotics in the treatment of chronic prostatitis: a consensus statement. Eur Urol. 1998; 34(6):457-66. DOI: 10.1159/000019784. View

Krieger J, Nyberg Jr L, Nickel J . NIH consensus definition and classification of prostatitis. JAMA. 1999; 282(3):236-7. DOI: 10.1001/jama.282.3.236. View

Bates S, Hill V, Anderson J, Chapple C, Spence R, Ryan C . A prospective, randomized, double-blind trial to evaluate the role of a short reducing course of oral corticosteroid therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome. BJU Int. 2007; 99(2):355-9. DOI: 10.1111/j.1464-410X.2007.06667.x. View

10.

Tugcu V, Tasci A, Fazlioglu A, Gurbuz G, Ozbek E, Sahin S . A placebo-controlled comparison of the efficiency of triple- and monotherapy in category III B chronic pelvic pain syndrome (CPPS). Eur Urol. 2006; 51(4):1113-7. DOI: 10.1016/j.eururo.2006.09.036. View

11.

Nickel J . Treatment of chronic prostatitis/chronic pelvic pain syndrome. Int J Antimicrob Agents. 2007; 31 Suppl 1:S112-6. PMC: 2245867. DOI: 10.1016/j.ijantimicag.2007.07.028. View

12.

Nickel J . Role of alpha1-blockers in chronic prostatitis syndromes. BJU Int. 2008; 101 Suppl 3:11-6. DOI: 10.1111/j.1464-410X.2008.07496.x. View

13.

Jeong C, Lim D, Son H, Lee S, Jeong H . Treatment for chronic prostatitis/chronic pelvic pain syndrome: levofloxacin, doxazosin and their combination. Urol Int. 2008; 80(2):157-61. DOI: 10.1159/000112606. View

14.

Nickel J, Krieger J, McNaughton-Collins M, Anderson R, Pontari M, Shoskes D . Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008; 359(25):2663-73. PMC: 2815340. DOI: 10.1056/NEJMoa0803240. View

15.

Oka M, Ueda M, Oyama T, Kyotani J, Tanaka M . Effect of the phytotherapeutic agent Eviprostat on 17beta-estradiol-induced nonbacterial inflammation in the rat prostate. Prostate. 2009; 69(13):1404-10. DOI: 10.1002/pros.20985. View

16.

Wagenlehner F, Schneider H, Ludwig M, Schnitker J, Brahler E, Weidner W . 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. Eur Urol. 2009; 56(3):544-51. DOI: 10.1016/j.eururo.2009.05.046. View

17.

Anothaisintawee T, Attia J, Nickel J, Thammakraisorn S, Numthavaj P, McEvoy M . Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA. 2011; 305(1):78-86. DOI: 10.1001/jama.2010.1913. View

18.

Sugimoto M, Oka M, Tsunemori H, Yamashita M, Kakehi Y . Effect of a phytotherapeutic agent, Eviprostat®, on prostatic and urinary cytokines/chemokines in a rat model of nonbacterial prostatitis. Prostate. 2011; 71(4):438-44. DOI: 10.1002/pros.21299. View

19.

Tsunemori H, Sugimoto M, Xia Z, Taoka R, Oka M, Kakehi Y . Effect of the phytotherapeutic agent Eviprostat on inflammatory changes and cytokine production in a rat model of nonbacterial prostatitis. Urology. 2011; 77(6):1507.e15-20. DOI: 10.1016/j.urology.2011.02.017. View

20.

Thakkinstian A, Attia J, Anothaisintawee T, Nickel J . α-blockers, antibiotics and anti-inflammatories have a role in the management of chronic prostatitis/chronic pelvic pain syndrome. BJU Int. 2012; 110(7):1014-22. DOI: 10.1111/j.1464-410X.2012.11088.x. View