The association of Boswellia resin extract and propolis derived polyphenols can improve quality of life in patients affected by prostatitis-like symptoms.

OBJECTIVES Chronic prostatitis syndrome is a bothering and poorly understood condition. Many patients report genitourinary pain and Lower Urinary Tract Symptoms as a main complaint. Many different pharmacological or behavioural therapies are prescribed in daily clinical practice, but efficacy data are still lacking. The aim of our study was to test the efficacy and safety of a transrectal delivered association of Boswellia resin extract and propolis derived polyphenols for the relief of prostatitis - like symptoms. MATERIALS AND METHODS Patients affected by chronic/recurrent prostatitis - like symptoms were prospectively enrolled in our study from December, 2016 to December, 2018. Patients were screened at baseline through clinical examination and validated questionnaires administration: Chronic Prostatitis Symptom Index (CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF). Inclusion criteria were: age ≥ 18; prostatitis symptoms persisting for at least 3 of the last 6 months; CPSI pain domain score ≥ 5; previous negative Meares-Stamey test. Treatment consisted on the administration of 1 suppository containing Boswellia resin extract and propolis derived polyphenols, once a day for 20 days. The primary endpoint of the study was the improvement of quality of life after treatment, defined by a reduction of ≥ 2 points, or ≥ 25%, of mean CPSI pain domain score, compared to baseline. Secondary endpoints were the improvement of post-treatment CPSI total score and the analysis of treatment - related adverse events. All patients were re-evaluated 1 month after treatment. RESULTS 40 patients were enrolled in our study. Median age (Inter - Quartile Range IQR) was 51.5 (41.5-63.2) years. Mean baseline CPSI scores were: 22.15 (total score), 9.67 (pain domain), 5.15 (micturition domain) and 7.35 (quality of life domain), respectively. No significant adverse events were reported. At 1 month follow-up, CPSI scores appeared modified as follows: 16.40 (total score, p = 0.001); 6.92 (pain domain; p = 0.001; 4.02 (micturition domain, p = 0.09); 5.45 (quality of life domain, p = 0.002). Mean CPSI pain domain score reduction was -2.75 points (-28.5%). Mean CPSI total score reduction was -5.75 points (-26%). CONCLUSIONS The association of Boswellia resin extract and propolis derived polyphenols can reduce genitourinary pain and then improve quality of life of men affected by bothersome prostatitis - like symptoms.

[1]  F. Galeotti,et al.  Chemical Composition and Antioxidant Activity of Propolis Prepared in Different Forms and in Different Solvents Useful for Finished Products , 2018, Foods.

[2]  T. Cai,et al.  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 , 2017, BMC Urology.

[3]  D. Milojković-Opsenica,et al.  Antimicrobial Activity of Serbian Propolis Evaluated by Means of MIC, HPTLC, Bioautography and Chemometrics , 2016, PloS one.

[4]  T. Cai,et al.  Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome , 2014, Experimental and therapeutic medicine.

[5]  A. Salonia,et al.  European Association of Urology guidelines on priapism. , 2014, European urology.

[6]  I. Caola,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 , 2013, Urologia.

[7]  V. Pagliarulo,et al.  [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. , 2012, Minerva urologica e nefrologica = The Italian journal of urology and nephrology.

[8]  L. Estevinho,et al.  Antimicrobial activity, phenolic profile and role in the inflammation of propolis. , 2012, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[9]  J. Tieppo,et al.  Effect of Boswellia serrata on Antioxidant Status in an Experimental Model of Colitis Rats Induced by Acetic Acid , 2012, Digestive Diseases and Sciences.

[10]  J. Nickel,et al.  Quercetin for chronic prostatitis/chronic pelvic pain syndrome. , 2011, The Urologic clinics of North America.

[11]  O. Werz,et al.  Inhibition of microsomal prostaglandin E2 synthase‐1 as a molecular basis for the anti‐inflammatory actions of boswellic acids from frankincense , 2011, British journal of pharmacology.

[12]  E. Brähler,et al.  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. , 2009, European urology.

[13]  T. Wilt,et al.  Excessive antibiotic use in men with prostatitis. , 2008, The American journal of medicine.

[14]  N. Ohara,et al.  Antiinflammatory effect of topically applied propolis extract in carrageenan‐induced rat hind paw edema , 2007, Phytotherapy research : PTR.

[15]  O. Werz,et al.  Boswellic acids: biological actions and molecular targets. , 2006, Current medicinal chemistry.

[16]  A. Crisci,et al.  The Italian version of the National Institutes of Health Chronic Prostatitis Symptom Index. , 2005, European Urology.

[17]  D. Engeler,et al.  EAU guidelines on chronic pelvic pain. , 2004, European urology.

[18]  M. Pontari,et al.  The National Institutes of Health chronic prostatitis symptom index: Development and validation of a new outcome measure , 1999 .

[19]  M. Pontari,et al.  The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. , 1999, The Journal of urology.

[20]  I. Osterloh,et al.  The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. , 1997, Urology.

[21]  J. Quentin Clemens.  Male chronic pelvic pain syndrome: Prevalence, risk factors, treatment patterns, and socioeconomic impact , 2008 .

[22]  J. Elist.  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. , 2006, Urology.

[23]  X. Badia,et al.  Ten-language translation and harmonization of the International Prostate Symptom Score: developing a methodology for multinational clinical trials. , 1997, European urology.