Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome

Cai,Tommaso; Wagenlehner,Florian  M.E.; Luciani,Lorenzo  Giuseppe; Tiscione,Daniele; Malossini,Gianni; Verze,Paolo; Mirone,Vincenzo; Bartoletti,Riccardo

doi:10.3892/etm.2014.1861

Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome

Authors:
- Tommaso Cai
- Florian M.E. Wagenlehner
- Lorenzo Giuseppe Luciani
- Daniele Tiscione
- Gianni Malossini
- Paolo Verze
- Vincenzo Mirone
- Riccardo Bartoletti
View Affiliations

Affiliations: Department of Urology, Santa Chiara Regional Hospital, Trento, Italy, Clinic and Polyclinic for Urology, Child Urology and Andrology, University Hospital of Giessen und Marburg, Justus‑Liebig University, Giessen, Germany, Department of Urology, University Federico II, Naples, Italy, Department of Urology, University of Florence, Florence, Italy
Published online on: July 24, 2014 https://doi.org/10.3892/etm.2014.1861
Pages: 1032-1038

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

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.

View Figures

View References

1	Collins MM, Stafford RS, O’Leary MP and Barry MJ: How common is prostatitis? A national survey of physician visits. J Urol. 159:1224–1228. 1998. View Article : Google Scholar : PubMed/NCBI
2	Barbalias GA: Clinical and therapeutical guidelines for chronic prostatitis. from bacteriological importance to neuromuscular considerations. Eur Urol. 37:116–117. 2000. View Article : Google Scholar : PubMed/NCBI
3	Workshop Committee of the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK). Chronic Prostatitis Workshop; Bethesda, MD. 7–8 December, 1995;
4	Schaeffer AJ: Classification (traditional and National Institutes of Health) and demographics of prostatitis. Urology. 60(6 Suppl): 5–7. 2002. View Article : Google Scholar : PubMed/NCBI
5	Nickel JC: Role of alpha1-blockers in chronic prostatitis syndromes. BJU Int. 101(Suppl 3): 11–16. 2008. View Article : Google Scholar
6	Tuğcu V, Taşçi AI, Fazlioğlu A, et al: A placebo-controlled comparison of the efficiency of triple- and monotherapy in category III B chronic pelvic pain syndrome (CPPS). Eur Urol. 51:1113–1118. 2007.PubMed/NCBI
7	Herati AS and Moldwin RM: Alternative therapies in the management of chronic prostatitis/chronic pelvic pain syndrome. World J Urol. 31:761–766. 2013. View Article : Google Scholar : PubMed/NCBI
8	Shoskes DA, Zeitlin SI, Shahed A and Rajfer J: Quercetin in men with category III chronic prostatitis: a preliminary prospective, double-blind, placebo-controlled trial. Urology. 54:960–963. 1999. View Article : Google Scholar : PubMed/NCBI
9	Rugendorff EW, Weidner W, Ebeling L and Buck AC: Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol. 71:433–438. 1993. View Article : Google Scholar : PubMed/NCBI
10	Cai T, Luciani LG, Caola I, et al: Effects of pollen extract in association with vitamins (DEPROX 500^®) for pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome: results from a pilot study. Urologia. 80(Suppl 22): 5–10. 2013.PubMed/NCBI
11	Kamijo T, Sato S and Kitamura T: Effect of cernitin pollen-extract on experimental nonbacterial prostatitis in rats. Prostate. 49:122–131. 2001. View Article : Google Scholar : PubMed/NCBI
12	Wagenlehner FM, Schneider H, Ludwig M, Schnitker J, Brähler E and 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. 56:544–551. 2009. View Article : Google Scholar
13	Propert KJ, Alexander RB, Nickel JC, et al; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 59:870–876. 2002. View Article : Google Scholar : PubMed/NCBI
14	Grabe M, Bjerklund-Johansen TE, Botto H, et al: Guidelines on Urological Infections. European Association of Urology; Arnhem, The Netherlands: pp. 662012
15	Lee CB, Ha US, Lee SJ, Kim SW and Cho YH: Preliminary experience with a terpene mixture versus ibuprofen for treatment of category III chronic prostatitis/chronic pelvic pain syndrome. World J Urol. 24:55–60. 2006. View Article : Google Scholar : PubMed/NCBI
16	Fiamegos YC, Nanos CG, Vervoort J and Stalikas CD: Analytical procedure for the in-vial derivatization-extraction of phenolic acids and flavonoids in methanolic and aqueous plant extracts followed by gas chromatography with mass-selective detection. J Chromatogr A. 1041:11–18. 2004. View Article : Google Scholar
17	Giubilei G, Mondaini N, Crisci A, et al: The Italian version of the National Institutes of Health Chronic Prostatitis Symptom Index. Eur Urol. 47:805–811. 2005. View Article : Google Scholar : PubMed/NCBI
18	Badía X, García-Losa M and Dal-Ré R: Ten-language translation and harmonization of the International Prostate Symptom Score: developing a methodology for multinational clinical trials. Eur Urol. 31:129–140. 1997.PubMed/NCBI
19	Kaplan RM, Bush JW and Berry CC: Health status: types of validity and the index of well-being. Health Serv Res. 11:478–507. 1976.PubMed/NCBI
20	Ernst EJ, Ernst ME, Hoehns JD and Bergus GR: Women’s quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment. Health Qual Life Outcomes. 3:452005.
21	Nickel JC, Downey J, Hunter D and Clark J: Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 165:842–845. 2001. View Article : Google Scholar
22	Mazzoli S, Cai T, Rupealta V, et al: Interleukin 8 and anti-chlamydia trachomatis mucosal IgA as urogenital immunologic markers in patients with C. trachomatis prostatic infection. Eur Urol. 51:1385–1393. 2007. View Article : Google Scholar : PubMed/NCBI
23	Elist J: Effects of pollen extract preparation Prostat/Poltit on lower urinary tract symptoms in patients with chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a randomized, double-blind, placebo-controlled study. Urology. 67:60–63. 2006. View Article : Google Scholar
24	Jolivalt CG, Mizisin LM, Nelson A, et al: B vitamins alleviate indices of neuropathic pain in diabetic rats. Eur J Pharmacol. 612:41–47. 2009. View Article : Google Scholar : PubMed/NCBI
25	Yu CZ, Liu YP, Liu S, Yan M, Hu SJ and Song XJ: Systematic administration of B vitamins attenuates neuropathic hyperalgesia and reduces spinal neuron injury following temporary spinal cord ischaemia in rats. Eur J Pain. 18:76–85. 2014. View Article : Google Scholar
26	Wang ZB, Gan Q, Rupert RL, Zeng YM and Song XJ: Thiamine, pyridoxine, cyanocobalamin and their combination inhibit thermal, but not mechanical hyperalgesia in rats with primary sensory neuron injury. Pain. 114:266–277. 2005. View Article : Google Scholar
27	Hung KL, Wang CC, Huang CY and Wang SJ: Cyanocobalamin, vitamin B12, depresses glutamate release through inhibition of voltage-dependent Ca²⁺ influx in rat cerebrocortical nerve terminals (synaptosomes). Eur J Pharmacol. 602:230–237. 2009. View Article : Google Scholar : PubMed/NCBI
28	Mäder R, Deutsch H, Siebert GK, et al: Vitamin status of inpatients with chronic cephalgia and dysfunction pain syndrome and effects of a vitamin supplementation. Int J Vitam Nutr Res. 58:436–441. 1988.PubMed/NCBI