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| Boswellia resin extract and propolis derived polyphenols in patients with type III chronic prostatitis/chronic pelvic pain syndrome: An Italian prospective multicenter study |
Fabrizio Presiccea,*( ),Francesco Barresea,Andrea Cantianib,Alessio Filianotia,Domenico Tuzzoloc,Paolo Di Palmad,Stefano Laurettie,Stefano Brunorif,Marco Martinia
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a San Filippo Neri Hospital, Department of Urology, Rome, Italy
b Sant’Eugenio Hospital, Department of Urology, Rome, Italy
c Casa del Sole Clinic, Department of Urology, Formia, Italy
d Fabrizio Spaziani Hospital, Department of Urology, Frosinone, Italy
e Santa Caterina della Rosa Clinic, Department of Urology, Rome, Italy
f Villa Stuart Clinic, Department of Urology, Rome, Italy |
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Abstract Objective: To assess the efficacy and safety of a treatment regimen based on rectal administration of Boswellia resin extract and propolis derived polyphenols in patients with type IIIa and type IIIb chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). Methods: Patients with type IIIa and type IIIb CP/CPPS received one rectal suppository a day for 15 days per month for 3 consecutive months. Participants were evaluated with National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Scores (IPSS), International Index of Erectile Function (IIEF), four-glass test, uroflowmetry, and prostate-specific antigen assessments at baseline and at Week 4, and Week 12. Primary endpoints were improvement in pain domain of NIH-CPSI and improvement of NIH-CPSI total score. Secondary outcomes included improvement of micturition and quality of life (QoL) domains of NIH-CPSI questionnaire. Results: A total of 61 males were enrolled. No adverse events were reported. Significant improvements from baseline to Day 30 were reported for NIH-CPSI total score (mean difference: -9.2; p<0.01), NIH-CPSI pain domain (mean difference: -5.5; p<0.01), NIH-CPSI micturition domain, NIH-CPSI QoL domain, and IPSS total score (mean difference: -5.6; p<0.01). No significant changes from baseline in terms of IIEF score or maximum flow rate were observed. At final follow-up (Day 90), further significant improvements in terms of NIH-CPSI total score (mean difference: -12.2; p<0.01), NIH-CPSI pain domain (mean difference: -6.6; p<0.01), NIH-CPSI micturition domain, NIH-CPSI QoL domain, and IPSS total score were reported. Conclusion: Rectal administration of Boswellia resin extract and propolis derived polyphenols is well tolerated and delivers a significant symptomatic improvement in most patients with type IIIa and type IIIb CP/CPPS.
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Received: 11 December 2020
Available online: 20 April 2022
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Corresponding Authors:
Fabrizio Presicce
E-mail: fabriziopresicce@libero.it
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| Variable | Overall (n=61) | IIIaa (n=31) | IIIbb (n=30) | | Agec, year | 61.0 (52.5-64.0) | 59.0 (45.0-63.0) | 61.0 (53.7-66.5) | | PSAc, ng/mL | 2.9 (1.6-3.5) | 2.9 (1.1-3.9) | 2.5 (1.6-3.2) | | IPSS totalc, year | 18.0 (12.0-23.5) | 22.0 (18.0-25.0) | 15.5 (11.7-20.0) | | Voiding | 5.0 (3.0-6.0) | 5.0 (4.0-6.0) | 4.0 (3.0-7.0) | | Storage | 12.0 (8.0-16.5) | 15.0 (12.0-20.0) | 11.0 (8.0-14.0) | | IIEF scorec | 18.0 (15.0-21.0) | 19.0 (17.0-22.0) | 15.5 (12.0-20.0) | | NIH-CPSI total scorec | 21.0 (18.0-24.0) | 23.0 (21.0-29.0) | 19.5 (18.0-21.0) | | Pain | 9.0 (8.0-10.0) | 10.0 (8.0-12.0) | 9.0 (8.0-10.0) | | Micturition | 5.0 (4.0-6.0) | 6.0 (5.0-7.0) | 4.0 (2.7-6.0) | | Quality of life | 7.0 (5.0-9.0) | 9.0 (6.0-10.0) | 6.0 (5.0-7.0) | | Prostate volumec, mL | 44.0 (33.0-48.5) | 40.0 (33.0-47.0) | 45.0 (33.0-56.2) | | Leukocytes in VB3cd | 20.0 (8.0-25.0) | 33.0 (12.0-45.0) | 8.0 (7.0-8.0) | | Residual urine volumec, mL | 30.0 (5.0-50.0) | 30.0 (20.0-45.0) | 25.0 (0-50.0) | | Maximum flow ratec, mL/s | 14.0 (11.2-18.0) | 12.0 (10.0-14.2) | 16.0 (14.0-19.0) | | Mean flow ratec, mL/s | 8.8 (7.0-10.0) | 8.9 (7.0-9.6) | 8.5 (7.0-10.0) |
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Characteristics of the enrolled population at baseline.
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| Variable | Mean value at Day 30 (percentage of change from baseline) | Mean change±SE at Day 30 | Mean value at Day 90 (percentage of change from baseline) | Mean change±SE at Day 90 | | PSA, ng/mL | Not evaluated | Not evaluated | 2.3 (-20.7) | -0.6±0.9 | | IPSS total score | 12.4 (-31.1) | -5.6±5.9 | 10.1 (-43.9) | -7.9±6.5 | | IIEF score | 18.5 (2.8) | 0.5±1.5 | 18.9 (5.0) | 0.9±2.1 | | NIH-CPSI total score | 11.8 (-43.8) | -9.2±5.1 | 8.8 (58.1) | -12.2±6.3 | | Pain | 3.5 (-61.1) | -5.5±2.3 | 2.4 (-73.3) | -6.6±2.6 | | Micturition | 3.5 (-30.0) | -1.5±1.7 | 2.8 (-44.0) | -2.2±2.3 | | Quality of life | 5 (-28.6) | -2.0±2.2 | 3.8 (-45.7) | -3.2±2.7 | | Leukocytes in VB3a | Not evaluated | Not evaluated | 4.1 (-79.5) | -15.9±4.5 | | Maximum flow rate, mL/s | 15 (7.1) | 1.0±2.2 | 15.3 (9.2) | 1.3±2.3 |
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Clinical evolution after treatment in the enrolled population.
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Mean change ±SE from baseline in NIH-CPSI total score at Day 30 and Day 90 of treatment, respectively. NIH-CPSI, National Institutes of Health-Chronic Prostatitis Symptom Index; SE, standard error.
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Mean change ±SE from baseline in NIH-CPSI pain domain at Day 30 and Day 90 of treatment, respectively. NIH-CPSI, National Institutes of Health-Chronic Prostatitis Symptom Index; SE, standard error.
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Patients with important clinical improvement (decrease of 25% or 6 points in National Institutes of Health-Chronic Prostatitis Symptom Index total score) at Day 30 and Day 90 of treatment, respectively.
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| Variable | Mean value at Day 30 (percentage of change from baseline) | Mean change±SE at Day 30 | Mean value at Day 90 (percentage of change from baseline) | Mean change±SE at Day 90 | | IIIa | IIIb | IIIa | IIIb | IIIa | IIIb | IIIa | IIIb | | PSA, ng/mL | Not evaluated | Not evaluated | Not evaluated | Not evaluated | 2.2 (-24.1) | 2.1 (-16.0) | -0.7±0.9 | -0.4±1.0 | | IPSS total score | 12.1 (-45.1) | 13.6 (-12.2) | -9.9±6.0 | -1.9±2.3 | 10.2 (-53.6) | 11.3 (-27.1) | -11.8±7.1 | -4.2±2.4 | | IIEF | 20.2 (6.3) | 15.6 (0.6) | 1.2±1.2 | 0.1±1.6 | 20.6 (8.4) | 15.6 (0.6) | 1.6±1.8 | 0.1±2.1 | | NIH-CPSI total score | 10.2 (-55.6) | 13.5 (-30.8) | -12.8±4.6 | -6.0±3.0 | 7.9 (-65,6) | 10.3 (-47.2) | -15.1±7.0 | -9.2±3.7 | | Pain | 4.5 (-55.0) | 5.7 (-36.7) | -5.5±2.3 | -3.3±2.0 | 3.4 (-66.0) | 4.6 (-48.9) | -6.6±2.1 | -4.4±2.2 | | Micturition | 3.4 (-43.3) | 3.4 (-15.1) | -2.6±1.7 | -0.6±1.0 | 2.5 (-58.3) | 3.1 (-22.5) | -3.5±2.5 | -0.9±1.1 | | Quality of life | 5.5 (-38.9) | 5.2 (-13.3) | -3.5±2.0 | -0.8±1.4 | 4.5 (-50.0) | 4.0 (-33.3) | -4.5±2.9 | -2.0±1.6 | | Leukocytes in VB3a | Not evaluated | Not evaluated | Not evaluated | Not evaluated | 6.8 (-79.4) | 3.0 (-62.5) | -26.2±5.2 | -5.0±2.3 | | Maximum flow rate, mL/s | 13.5 (12.5) | 16.5 (3.1) | 1.5±3.0 | 0.5±0.9 | 14.1 (17.5) | 16.6 (3.8) | 2.1±2.9 | 0.6±1.1 |
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Clinical evolution after treatment in the enrolled population according the category of type III CP/CPPS.
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Mean change±SE from baseline in NIH-CPSI total score at Day 30 and Day 90 of treatment in patients with type IIIa and type IIIb chronic prostatitis/chronic pelvic pain syndrome, respectively. NIH-CPSI, National Institutes of Health-Chronic Prostatitis Symptom Index; SE, standard error.
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Mean change±SE from baseline in NIH-CPSI pain domain at Day 30 and Day 90 of treatment in patients with type IIIa and type IIIb chronic prostatitis/chronic pelvic pain syndrome. NIH-CPSI, National Institutes of Health-Chronic Prostatitis Symptom Index; SE, standard error.
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