A new antioxidant nutraceutical compound is able to reduce the level of prostate pro-inflammatory mediators: results from a phase III, placebo controlled trial

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is still a challenging disease for all urologists. Several therapeutic approaches haven been purposed for symptoms relief and quality of life improvement. Here, we aim to evaluate the efficacy of a new nutraceutical compound in patients affected by CP/CPPS and perform a detailed evaluation of pro-inflammatory mediators [interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10)] in order to establish the treatment mechanism of action and evaluate its clinical efficacy. METHODS: All patients with a diagnosis of CP/CPPS attending the same urologic centre between January and December 2024 were enrolled in this randomised controlled phase III study. Participants were randomised to receive oral capsules of a dietary supplement containing solanum lycopersicum (100 mg), brassica oleracea (333 mg), silybum marianum (50 mg), glutathione (50 mg), aesculus hippocastanum (2 mg), tryptophane (25 mg), camellia sinensis (25 mg) (one capsule every 24 h) or placebo (one capsule every 24 h) for three months. At the enrolment time, all patients underwent baseline questionnaires (NIHCPSI, SF-36), urological examination and microbiological evaluation by using the Meares-Stamey test. Moreover, level of IL-6, IL-8 and IL-10 have been evaluated in seminal plasma collected at the enrolment time and at the follow-up time (3 months after the enrolment with a urological and microbiological examination and questionnaire collection). The main outcome measures were: the improvement of quality of life and the decrease of proinflammatory mediators, at the end of the whole study period. RESULTS: In the per-protocol analysis, 77 males (mean age of 31.9 ± 2.5 years) were randomly allocated to the dietary supplement (n = 38) or placebo (n = 39) groups. At the follow-up examination, in the dietary supplement group, 21/38 patients (55.3%) showed a significant reduction of the NIH-CPSI total score (more than 25% from baseline), compared with 12/39 (30.7%) in the control group (p < .0001). In addition, at the 3 months follow-up visit, the mean level of IL-8 was significantly lower in the dietary supplement group compared with control group [IL-8 316 pg/ml vs IL-8 986 pg/ml] (p < .0001). In the dietary supplement group, we found a statistically significant reduction of IL-8 level between the enrolment and follow-up visit [IL-8 856 pg/ml vs IL-8 298 pg/ml] (p < .0001). No statistically significant difference in terms of IL-6 or IL-10 evaluation have been reported. CONCLUSIONS: This new antioxidant dietary supplement treatment is able to improve quality of life in patients affected by CP/CPPS through the reduction pro-inflammatory cytokine levels (IL-8).