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

Abstract

BackgroundPreviously 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.MethodsThe 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.ResultsIn 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.ConclusionBoth 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 registrationThe study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618); registration date: 3 November 2015.

The role of flower pollen extract in managing patients affected by chronic prostatitis/chronic pelvic pain syndrome: a comprehensive analysis of all published clinical trials

“…1989 [23]Prospective trial (phase II)15 (86.6)--- pollen extract effective in the treatment of chronic prostatitis and prostatodynia.Cai T. 2013 [11]Prospective trial (phase II)20 (90.0)--- pollen extract significantly improved total symptoms, pain, and QoL in patients with non-inflammatory CP/CPPS without severe side effects.Cai T, 2014 [27]Randomized controlled trial41 (75.6)46 (41.3)ibuprofen- pollen extract significantly improved quality of life of patients when compared with those treated with ibuprofen (treatment difference in the NIH-CPSI pain domain, -2.14 ± 0.51, P < 0.001; QoL scores, P = 0.002).Elist J. 2006 [28]Randomized controlled trial30 (73.3)28 (64.2)Placebo- pollen extract is superior to placebo in providing symptomatic relief in men with chronic nonbacterial prostatitis/chronic pelvic pain syndrome.Iwamura H, 2015 [29]Randomized placebo-controlled trial50 (78.1)50 (88.2)Eviprostat (phytotherapeutic agent)- pollen extract significantly reduced the symptoms of category III CP/CPPS without any adverse events, in terms of NIH-CPSI, IPSS, and QoL.Jodai A, 1988 [24]Prospective trial (phase II)32 (75.0)--- pollen extract significantly reduced the symptoms in 75.0% of all treated patients.Monden K. 2002 [25]Prospective trial (phase II)24 (91.6)--- pollen extract significantly reduced the symptoms of chronic prostatitis groupRugendorff EW. 1993 [10]Prospective trial (phase II)90 (62.2)--- pollen extract significantly reduced the symptoms of category III CP/CPPS without any adverse events, in terms of urinary symptoms and QoL.Suzuki T. 1992 [26]Prospective trial (phase II)25 (96.0)--- pollen extract significantly reduced the symptoms of prostatitis patients without any adverse events.Wagenlehner FM.…”

The effects of Cernitin® on inflammatory parameters and benign prostatic hyperplasia: An in vitro study

“…The recognized Cernitin T60 and GBX pollen extract (identified as active pharmaceutical ingredients and hereinafter referred to as Cernitin®). Cernitin® is one of the herbal pharmaceutical drugs widely used in the treatment of CP/chronic pelvic pain syndrome (CPPS) in Japan and some European countries (Iwamura et al, ; Wagenlehner, Bschleipfer, Pilatz, & Weidner, ). Cernitin® is developed and manufactured by AB Cernelle, Sweden.…”

Chronic pelvic pain syndrome: Highlighting medicinal plants toward biomolecules discovery for upcoming drugs formulation

“…In addition to antibiotic treatment, some plants, with anti‐inflammatory and antibacterial properties, can be also useful (Morgia et al, ). Of these, the most effective ones are as follows: Achillea millefolium L. (yarrow), Alchemilla plants from the family Rosaceae (Lady's Mantle); Geranium robertianum L. (crow's foot, death come quickly, fox geranium, herb‐Robert, red robin, Roberts geranium, squinter‐pip, stinking Bob, or stork's bill), white dead‐nettle (white dead nettle), Reynoutria japonica Houtt., Equisetum arvense L. (horsetail), Calendula officinalis L. (marigold) (Iwamura et al, ; Morgia et al, ). Besides, essential oils are also recommended.…”

“…After the set time, 24 patients in Group A showed reduction in the NIH‐CPSI score as compared to 8 patients from Group B. Interleukin (IL8) level was also lower in Group A from the time of initiation of the study (Cai, Verze, Rocca, Anceschi, et al, ; Cai, Verze, Rocca, Palmieri, et al, ). Iwamura et al () carried out a comparative study between Eviprostat and pollen extract on patients with category III CP/CPPS. The outcome showed a significant reduction of symptoms of category III CP/CPPS by both Eviprostat and pollen extract, indicating that pollen extract has an identical effect as Eviprostat on category III CP/CPPS (Iwamura et al, ).…”

“…Iwamura et al () carried out a comparative study between Eviprostat and pollen extract on patients with category III CP/CPPS. The outcome showed a significant reduction of symptoms of category III CP/CPPS by both Eviprostat and pollen extract, indicating that pollen extract has an identical effect as Eviprostat on category III CP/CPPS (Iwamura et al, ).…”