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- Title
The Efficacy of Flogofilm ® in the Treatment of Chronic Bacterial Prostatitis as an Adjuvant to Antibiotic Therapy: A Randomized Prospective Trial.
- Authors
Barone, Biagio; Mirto, Benito Fabio; Falcone, Alfonso; Del Giudice, Francesco; Aveta, Achille; Napolitano, Luigi; Del Biondo, Dario; Ferro, Matteo; Busetto, Gian Maria; Manfredi, Celeste; Terracciano, Daniela; Gambardella, Raffaele; Pandolfo, Savio Domenico; Trama, Francesco; De Luca, Ciro; Martino, Raffaele; Capone, Federico; Giampaglia, Gaetano; Sicignano, Enrico; Tataru, Octavian Sabin
- Abstract
Introduction: Bacterial prostatitis (BP) is a common prostatic infection characterized by a bimodal distribution in young and older men, with a prevalence between 5–10% among all cases of prostatitis and a high impact on quality of life. Although the management of bacterial prostatitis involves the use of appropriate spectrum antibiotics, which represent the first choice of treatment, a multimodal approach encompassing antibiotics and nutraceutical products in order to improve the efficacy of chosen antimicrobial regimen is often required. Objective: To evaluate the efficacy of Flogofilm® in association with fluoroquinolones in patients with chronic bacterial prostatitis (CBP). Methods: Patients diagnosed with prostatitis (positivity to Meares–Stamey Test and symptoms duration > 3 months) at the University of Naples "Federico II", Italy, from July 2021 to December 2021, were included in this study. All patients underwent bacterial cultures and trans-rectal ultrasounds. Patients were randomized into two groups (A and B) receiving antibiotic alone or an association of antibiotics plus Flogofilm® tablets containing Flogomicina® for one month, respectively. The NIH-CPSI and IPSS questionnaires were administered at baseline, four weeks, twelve and twenty-four weeks. Results: A total of 96 (Group A = 47, Group B = 49) patients concluded the study protocol. The mean age was comparable, with a mean age of 34.62 ± 9.04 years for Group A and 35.29 ± 10.32 years for Group B (p = 0.755), and IPSS at the baseline was 8.28 ± 6.33 and 9.88 ± 6.89 (p = 0.256), respectively, while NIH-CPSI at baseline was 21.70 ± 4.38 and 21.67 ± 6.06 (p = 0.959), respectively. At 1, 3 and 6 months, the IPSS score was 6.45 ± 4.8 versus 4.31 ± 4.35 (p = 0.020), 5.32 ± 4.63 versus 3.20 ± 3.05 (p = 0.042) and 4.91 ± 4.47 versus 2.63 ± 3.28 (p = 0.005) for Groups A and B, respectively. Similarly, the NIH-CPSI total score at 1, 3 and 6 months was 16.15 ± 3.31 versus 13.10 ± 5.03 (p < 0.0001), 13.47 ± 3.07 versus 9.65 ± 4.23 (p < 0.0001) and 9.83 ± 2.53 versus 5.51 ± 2.84 (p < 0.0001), respectively. Conclusions: Flogofilm®, associated with fluoroquinolones, demonstrate a significant improvement in pain, urinary symptoms and quality of life in patients affected by chronic bacterial prostatitis in both IPSS and NIH-CPSI scores compared with fluoroquinolones alone.
- Subjects
NAPLES (Italy); ITALY; PROSTATITIS; FREDERICK II, Holy Roman Emperor, 1194-1250; OLDER men; BACTERIAL cultures; ANTIBIOTICS; FLUOROQUINOLONES; PRODUCT improvement
- Publication
Journal of Clinical Medicine, 2023, Vol 12, Issue 8, p2784
- ISSN
2077-0383
- Publication type
Article
- DOI
10.3390/jcm12082784