Soybean Extracts (Glycine Max) with Curcuma, Boswellia, Pinus and Urtica Are Able to Improve Quality of Life in Patients Affected by CP/CPPS: Is the Pro-Inflammatory Cytokine IL-8 Level Decreasing the Physiopathological Link?

Abstract

The present study evaluates the efficacy of a combination of soyabean extracts associated with Curcuma Longa, Boswellia, Pinus pinaster and Urtica dioica (PROSTAFLOG®) in patients affected by CP/CPPS, through the evaluation of interleukin-8 (IL-8) plasma seminal levels. All patients diagnosed with CP/CPPS, attending the same urologic center, were enrolled in this randomized, controlled phase III study. Participants were randomized to receive oral capsules of PROSTAFLOG® (two capsules at bedtime every 24 h) or Ibuprofen 600 mg (1 tablet daily), lasting for a period of four weeks. NIH-CPSI and SF-36 questionnaires, as urological evaluations with a transrectal ultrasound (TRUS), the Meares–Stamey test, and IL-8 dosage in seminal plasma were performed at baseline and at 3 months follow-up. A total of 77 patients (mean age of 34.5 ± 6.1) were enrolled (PROSTAFLOG® (n = 39); ibuprofen (n = 38)) in the study. At 3 months, in the PROSTAFLOG® series, 69.2% of patients showed a significant reduction in the NIH-CPSI score, compared with 34.2% in the ibuprofen group (p < 0001). The mean IL-8 levels were significantly lower in the PROSTAFLOG® cohort compared with the ibuprofen series (p < 0.0001), while a significant reduction in the IL-8 level between the enrolment and last follow-up evaluation was also observed in this group (p < 0.0001). Additionally, a significant reduction in the volume of the seminal vesicles assessed by TRUS was also found in the PROSTAFLOG® series during the observational timeframe (18.3 ± 7.1 mL vs. 11.2 ± 2.4 mL (p < 0.0001). In conclusion, PROSTAFLOG® significantly improves the QoL in patients affected by CP/CPPS and it provides a significant reduction in IL-8 seminal levels as the overall seminal vesicles volume.