Efficacy and Safety of a Natural Supplement Containing Serenoa Repens, Solanum Lycopersicum, Lycopene, and Bromelain in Reducing Symptoms of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Cohort Study in 250 Patients
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Intervention
2.3. Outcome Measures
2.4. Assessments and Follow-Up
2.5. Statistical Analysis
3. Results
3.1. Patient Demographics and Baseline Characteristics
3.2. Treatment Tolerability and Adverse Events
3.3. Primary and Secondary Outcomes
3.4. Subgroup Analysis
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristic | Overall Cohort (n = 245) | Voiding Symptoms (n = 43) | Storage Symptoms (n = 202) |
---|---|---|---|
Number of Patients | 245 | 182 | 63 |
Age (years) | 46.7 ± 11.2 | 47.1 ± 11.5 | 45.5 ± 10.4 |
Prostate Volume (cc) | 34.6 ± 9.4 | 35.1 ± 9.6 | 33.2 ± 8.2 |
Total PSA (ng/mL) | 3.25 ± 1.1 | 3.12 ± 1.0 | 3.72 ± 1.3 |
NIH-CPSI Score (Baseline) | 20.3 ± 5.6 | 22.5 ± 5.2 | 18.5 ± 5.2 |
Pain subscore | 9.1 ± 2.8 | 9.6 ± 3.0 | 8.0 ± 1.8 |
Urinary subscore | 6.7 ± 2.1 | 6.4 ± 2.2 | 7.3 ± 1.7 |
Quality of Life subscore | 4.5 ± 1.4 | 4.4 ± 1.5 | 4.8 ± 1.1 |
IPSS (Baseline) | 19.5 ± 3.8 | 19.6 ± 4.8 | 20.1 ± 5.1 |
Voiding subscore | 11.4 ± 2.5 | 11.5 ± 2.9 | 11.1 ± 1.8 |
Storage subscore | 8.1 ± 2.2 | 8.1 ± 2.1 | 8.2 ± 2.5 |
QoL (Baseline) | 5.6 ± 1.9 | 5.6 ± 1.9 | 5.6 ± 1.9 |
Outcome Measure | Voiding Symptoms (n = 202) | Storage Symptoms (n = 43) | |
---|---|---|---|
NIH-CPSI | Mean baseline score (SD) | 22.5 (5.2) | 18.5 (5.2) |
Mean 1-month score (SD) | 16.7 (4.2) | 16.7 (4.2) | |
Mean 3-month score (SD) | 12.3 (3.8) | 13.3 (3.8) | |
Mean difference from baseline (95% CI) | −10.2 (−11.3 to −9.1) | −5.2 (−11.3 to −9.1) | |
IPSS | Mean baseline score (SD) | 19.6 (4.8) | 20.1 (5.1) |
Mean 1-month score (SD) | 15.7 (4.2) | 16.3 (3.8) | |
Mean 3-month score (SD) | 14.4 (3.4) | 13.4 (4.1) | |
Mean difference from baseline (95% CI) | −5.2 (−6.4 to −3.9) | −5.0 (−6.1 to −3.1) | |
QoL | Mean baseline score (SD) | 5.6 (1.9) | 5.6 (1.9) |
Mean 1-month score (SD) | 3.4 (1.5) | 3.6 (1.5) | |
Mean 3-month score (SD) | 2.4 (1.2) | 2.8 (1.3) | |
Mean difference from baseline (95% CI) | −3.2 (−3.6 to −2.6) | −2.8 (−3.3 to −2.5) |
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Lambertini, L.; Sandulli, A.; Salamone, V.; Bacchiani, M.; Giudici, S.; Massaro, E.; Cadenar, A.; Mariottini, R.; Coco, S.; Bardina, L.; et al. Efficacy and Safety of a Natural Supplement Containing Serenoa Repens, Solanum Lycopersicum, Lycopene, and Bromelain in Reducing Symptoms of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Cohort Study in 250 Patients. Uro 2023, 3, 199-207. https://doi.org/10.3390/uro3030021
Lambertini L, Sandulli A, Salamone V, Bacchiani M, Giudici S, Massaro E, Cadenar A, Mariottini R, Coco S, Bardina L, et al. Efficacy and Safety of a Natural Supplement Containing Serenoa Repens, Solanum Lycopersicum, Lycopene, and Bromelain in Reducing Symptoms of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Cohort Study in 250 Patients. Uro. 2023; 3(3):199-207. https://doi.org/10.3390/uro3030021
Chicago/Turabian StyleLambertini, Luca, Alessandro Sandulli, Vincenzo Salamone, Mara Bacchiani, Sofia Giudici, Eleana Massaro, Anna Cadenar, Riccardo Mariottini, Simone Coco, Laia Bardina, and et al. 2023. "Efficacy and Safety of a Natural Supplement Containing Serenoa Repens, Solanum Lycopersicum, Lycopene, and Bromelain in Reducing Symptoms of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Cohort Study in 250 Patients" Uro 3, no. 3: 199-207. https://doi.org/10.3390/uro3030021
APA StyleLambertini, L., Sandulli, A., Salamone, V., Bacchiani, M., Giudici, S., Massaro, E., Cadenar, A., Mariottini, R., Coco, S., Bardina, L., Ciaralli, E., Saladino, M., Romano, A., Valastro, F., Grosso, A. A., Di Maida, F., Siena, G., Scelzi, S., & Mari, A. (2023). Efficacy and Safety of a Natural Supplement Containing Serenoa Repens, Solanum Lycopersicum, Lycopene, and Bromelain in Reducing Symptoms of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Cohort Study in 250 Patients. Uro, 3(3), 199-207. https://doi.org/10.3390/uro3030021