Protective Effects Induced by a Novel Food Supplement Based on Epilobium angustifolium, Ptychopetalum olacoides, Ginkgo biloba, and Equisetum arvense Extracts and Citrulline in the Lower Urinary Tract: Preclinical and Clinical Evidence

Oxyfil is a dietary supplement including plant extracts from Epilobium angustifolium, Ptychopetalum olacoides (Muira puama), Ginkgo biloba, and Equisetum arvense and citrulline. The aim of the study was to investigate the protective effects on prostatic muscles of the Oxyfil formulation in an in vitro experimental model consisting of isolated mouse prostate specimens exposed to Escherichia coli lipopolysaccharide (LPS) as a pro-inflammatory stimulus. The study also assessed the tolerability and effectiveness of Oxyfil in alleviating lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH) when used in association with standard care. In the preclinical phase, Oxyfil was analysed via liquid chromatographic in order to identify and quantify phenolic compounds. Thereafter, the formulation was tested on isolated mouse prostate challenged with LPS in order to upregulate the gene expression of different pro-inflammatory and oxidative stress biomarkers, namely COX-2, i-NOS, TNFα, IL-6, VEGFA, HIF1α. The clinical trial was a retrospective, multicentre study. Fifty-nine patients were analyzed: 27 received Oxyfil, 18 Oxyfil + α-blocker, 7 Oxyfil + PDE5i, and 7 Oxyfil + 5-ARI. Key inclusion criteria were age 50–75 years, moderate to severe LUTS (IPSS), mild erectile dysfunction, and baseline Qmax 4–15 mL/s; exclusions were endocrine/hormonal erectile dysfunction, bladder-neck sclerosis, and urethral stricture. Treatment selection was non-randomized and left to the treating physician. The chromatographic analysis identified 25 phenolic compounds in the Oxyfil formulation. The total phenolic content can explain, albeit partially, the Oxyfil efficacy in blunting LPS-induced upregulation of the gene expression of all tested biomarkers in isolated prostate. The protective effects demonstrated in the preclinical phase also support, albeit partially, the clinical efficacy in ameliorating uroflowmetry and symptom outcomes in the patients' cohort. In conclusion, the present study demonstrated anti-inflammatory and antioxidant effects of the Oxyfil formulation in the prostate which corroborated the observed clinical outcomes.