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Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry

Editor-in-Chief

ISSN (Print): 1871-5230
ISSN (Online): 1875-614X

Clinical Trial

Flower Pollen Extract in Association with Vitamins (Deprox 500®) Versus Serenoa repens in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Comparative Analysis of Two Different Treatments

Author(s): Nicola Macchione*, Paolo Bernardini, Igor Piacentini, Barbara Mangiarotti and Alberto Del Nero

Volume 18, Issue 2, 2019

Page: [151 - 161] Pages: 11

DOI: 10.2174/1871523018666181128164252

Abstract

Objective: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is reported in the literature ranging from 1 to 14.2%. The aim of the present study was to assess the impact on patient’s quality of life and symptoms of Flower pollen extract in association with vitamins (Deprox 500®) in comparison with Serenoa repens 320 mg (Permixon 320 mg® by Pierre Fabre) in patients with CP/CPPS.

Methodology: All consecutive patients, with a diagnosis of CP/CPPS, referred to our center from January to August 2016, were screened to be enrolled in this single-center, randomized, controlled trial. The main outcome measure was the evaluation of IPSS/NIHCPSI (International Prostatic Symptom Score/NIH-Chronic Prostatitis Symptom Index) score variation and the assessment of the quality of life and symptoms at the end of the therapy. The second outcome measure was the evaluation of the comorbidity role in the CP/CPPS therapy. 63 patients were analyzed; patients were randomized into two groups: 29 patients were treated with Deprox 500® 2 tablets/day for 6 weeks and 34 patients with Serenoa repens 320 mg, 1 tablet/day for 6 weeks.

Results: The mean score variation for IPSS was -12.7 ± 4.3 in the Deprox 500® group and -7.8 ± 4.7 in the Serenoa repens group (p=0.0005) while for NIH-CPSI was -17.3±3.1 in the Deprox 500® group and -13.6±4.8 in the Serenoa repens group (p=0.0016). By accounting only the symptoms part of NIH-CPSI questionnaire, the mean score variation reported was -11.5±2.5 in the Deprox 500® group and -9.02±4.0 in the Serenoa repens group (p=0.009321). Furthermore, analyzing the comorbidity subgroups, in patients with hypertension, the mean IPSS score variation was -14.3±3.2 in the Deprox 500® group and - 9.02±4.0 in the Serenoa repens group.

Conclusion: In conclusion, in patients with CP/CPPS, Deprox 500® improves IPSS and NIH-CPSI scores up to 74.5% and 84.5% respectively. Furthermore, in patients with hypertension, the antioxidant effect of Deprox 500® reduces the mean IPSS score of 82.7%.

Keywords: Chronic pelvic pain syndrome, chronic prostatitis, CP/CPPS, deprox, flower pollen extract, prostatitis, Serenoa repens, vitamins.

Graphical Abstract
[1]
Krieger, J.N.; Lee, S.W.; Jeon, J.; Cheah, P.Y.; Liong, M.L.; Riley, D.E. Epidemiology of prostatitis. Int. J. Antimicrob. Agents, 2008, 31(Suppl. 1), S85-S90.
[2]
Mehik, A.; Hellström, P.; Lukkarinen, O.; Sarpola, A.; Järvelin, M. Epidemiology of prostatitis in Finnish men: A population-based cross-sectional study. BJU Int., 2000, 86(4), 443-448.
[3]
Collins, M.M.; Stafford, R.S.; O’Leary, M.P.; Barry, M.J. How common is prostatitis? A national survey of physician visits. J. Urol., 1998, 159(4), 1224-1228.
[4]
Barry, M.J.; Link, C.L.; McNaughton-Collins, M.F.; McKinlay, J.B. Overlap of different urological symptom complexes in a racially and ethnically diverse, community-based population of men and women. BJU Int., 2008, 101(1), 45-51.
[5]
Roberts, R.O.; Jacobson, D.J.; Girman, C.J.; Rhodes, T.; Lieber, M.M.; Jacobsen, S.J. Low agreement between previous physician diagnosed prostatitis and national institutes of health chronic prostatitis symptom index pain measures. J. Urol., 2004, 171(1), 279-283.
[6]
Krieger, J.N.; Nyberg, L., Jr; Nickel, J.C. NIH consensus definition and classification of prostatitis. JAMA, 1999, 282(3), 236-237.
[7]
Murphy, A.B.; Macejko, A.; Taylor, A.; Nadler, R.B. Chronic prostatitis: Management strategies. Drugs, 2009, 69(1), 71-84.
[8]
de la Rosette, J.J.; Hubregtse, M.R.; Meuleman, E.J.; Stolk-Engelaar, M.V.; Debruyne, F.M. Diagnosis and treatment of 409 patients with prostatitis syndromes. Urology, 1993, 41(4), 301-307.
[9]
Krieger, J.N.; Ross, S.O.; Deutsch, L.; Riley, D.E. The NIH Consensus concept of chronic prostatitis/chronic pelvic pain syndrome compared with traditional concepts of nonbacterial prostatitis and prostatodynia. Curr. Urol. Rep., 2002, 3(4), 301-306.
[10]
Curtis Nickel, J.; Baranowski, A.P.; Pontari, M.; Berger, R.E.; Tripp, D.A. Management of men diagnosed with chronic prostatitis/chronic pelvic pain syndrome who have failed traditional management. Rev. Urol., 2007, 9(2), 63-72.
[11]
Liu, Y.J.; Song, G.H.; Zhang, C. Roles of substance P and transient receptor potential vanilloid 1 in neuralgia in rats with chronic nonbacterial prostatitis. Zhonghua Nan Ke Xue, 2015, 21(2), 107-112.
[12]
Rees, J.; Abrahams, M.; Doble, A.; Cooper, A. Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: A consensus guideline. BJU Int., 2015, 116(4), 509-525.
[13]
Murphy, A.B.; Nadler, R.B. Pharmacotherapy strategies in chronic prostatitis/chronic pelvic pain syndrome management. Expert Opin. Pharmacother., 2010, 11(8), 1255-1261.
[14]
Engeler, D.; Baranowski, A.P.; Borovicka, J.; Cottrell, A.M.; Dinis-Oliveira, P.; Elneil, S.; Hughes, J.; Messelink, E.J. Guideline on chronic pelvic pain; European Association of Urology, 2014.
[15]
Cai, T.; Luciani, L.G.; Caola, I.; Mondaini, N.; Malossini, G.; Lanzafame, P.; Mazzoli, S.; Bartoletti, R. 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, 2013, 80(Suppl. 22), 5-10.
[16]
Cai, T.; Wagenlehner, F.M.; Luciani, L.G.; Tiscione, D.; Malossini, G.; Verze, P.; Mirone, V.; Bartoletti, R. Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome. Exp. Ther. Med., 2014, 8(4), 1032-1038.
[17]
Morgia, G.; Mucciardi, G.; Galì, A.; Madonia, M.; Marchese, F.; Di Benedetto, A.; Romano, G.; Bonvissuto, G.; Castelli, T.; Macchione, L.; Magno, C. Treatment of chronic prostatitis/chronic pelvic pain syndrome category IIIA with Serenoa repens plus selenium and lycopene (Profluss) versus S. repens alone: An Italian randomized multicenter-controlled study. Urol. Int., 2010, 84(4), 400-406.
[18]
International conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice. ICH Harmonised tripartite guideline, Jeneva, Switzerland 1997.
[19]
World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 2013, 310(20), 2191-2194.
[20]
Penugonda, K.; Lindshield, B.L. Fatty acid and phytosterol content of commercial saw palmetto supplements. Nutrients, 2013, 5(9), 3617-3633.
[21]
Avins, A.L.; Bent, S. Saw palmetto and lower urinary tract symptoms: What is the latest evidence? Curr. Urol. Rep., 2006, 7(4), 260-265.
[22]
Rugendorff, E.W.; Weidner, W.; Ebeling, L.; Buck, A.C. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br. J. Urol., 1993, 71(4), 433-438.
[23]
MacDonald, R.; Ishani, A.; Rutks, I.; Wilt, T.J. A systematic review of Cernilton for the treatment of benign prostatic hyperplasia. BJU Int., 2000, 85(7), 836-841.
[24]
Iwamura, H.; Koie, T.; Soma, O.; Matsumoto, T.; Imai, A.; Hatakeyama, S.; Yoneyama, T.; Hashimoto, Y.; Ohyama, C. Eviprostat has an identical effect compared to pollen extract (Cernilton) in patients with chronic prostatitis/chronic pelvic pain syndrome: A randomized, prospective study. BMC Urol., 2015, 15, 120.
[25]
Wagenlehner, F.M.; Schneider, H.; Ludwig, M.; Schnitker, J.; Brähler, 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), 544-551.
[26]
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, 2006, 67(1), 60-63.
[27]
Jolivalt, C.G.; Mizisin, L.M.; Nelson, A.; Cunha, J.M.; Ramos, K.M.; Bonke, D.; Calcutt, N.A. B vitamins alleviate indices of neuropathic pain in diabetic rats. Eur. J. Pharmacol., 2009, 612(1-3), 41-47.
[28]
Yu, C.Z.; Liu, Y.P.; Liu, S.; Yan, M.; Hu, S.J.; Song, X.J. Systematic administration of B vitamins attenuates neuropathic hyperalgesia and reduces spinal neuron injury following temporary spinal cord ischaemia in rats. Eur. J. Pain, 2014, 18(1), 76-85.
[29]
Wang, Z.B.; Gan, Q.; Rupert, R.L.; Zeng, Y.M.; Song, X.J. Thiamine, pyridoxine, cyanocobalamin and their combination inhibit thermal, but not mechanical hyperalgesia in rats with primary sensory neuron injury. Pain, 2005, 114(1-2), 266-277.
[30]
Hung, K.L.; Wang, C.C.; Huang, C.Y.; Wang, S.J. Cyanocobalamin, vitamin B12, depresses glutamate release through inhibition of voltage-dependent Ca2+ influx in rat cerebrocortical nerve terminals (synaptosomes). Eur. J. Pharmacol., 2009, 602(2-3), 230-237.
[31]
Mäder, R.; Deutsch, H.; Siebert, G.K.; Gerbershagen, H.U.; Grühn, E.; Behl, M.; Kübler, W. Vitamin status of inpatients with chronic cephalgia and dysfunction pain syndrome and effects of a vitamin supplementation. Int. J. Vitam. Nutr. Res., 1988, 58(4), 436-441.
[32]
Cai, T.; Verze, P.; La Rocca, R.; Anceschi, U.; De Nunzio, C.; Mirone, V. 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. BMC Urol., 2017, 17(1), 32.
[33]
Latil, A.; Pétrissans, M.T.; Rouquet, J.; Robert, G.; de la Taille, A. Effects of hexanic extract of Serenoa repens (Permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Prostate, 2015, 75(16), 1857-1867.
[34]
MacDonald, R.; Tacklind, J.W.; Rutks, I.; Wilt, T.J. Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): An updated Cochrane systematic review. BJU Int., 2012, 109(12), 1756-1761.
[35]
Fu, Y.; Zhou, Z.; Yang, B.; Zhang, K.; He, L.; Zhang, X. The relationship between the clinical progression of benign prostatic hyperplasia and metabolic syndrome: A prospective study. Urol. Int., 2016, 97(3), 330-335.
[36]
Zhao, S.; Tang, J.; Shao, S.; Yan, Y. The relationship between benign prostatic hyperplasia/lower urinary tract symptoms and mean platelet volume: The role of metabolic syndrome. Urol. Int., 2016, 96(4), 449-458.
[37]
Locatelli, M.; Macchione, N.; Ferrante, C.; Chiavaroli, A.; Recinella, L.; Carradori, S.; Zengin, G.; Cesa, S.; Leporini, L.; Leone, S.; Brunetti, L.; Menghini, L.; Orlando, G. Graminex pollen: Phenolic pattern, colorimetric analysis and protective effects in immortalized Prostate Cells (PC3) and rat prostate challenged with LPS. Molecules, 2018, 23(5)E1145

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