RESUMEN
INTRODUCTION: Benign prostatic hyperplasia (BPH) mainly leads to lower urinary tract symptoms (LUTS) in aging men. The present study investigates the role of cholecalciferol, Silymarin, and their combined administration in patients with BPH suffering from LUTS. METHODS: This double-blind, randomized, controlled trial enrolled 80 participants (50-80 years) diagnosed with BPH, from March 2019 to March 2020. Based on serum 25-(OH) vitamin D levels we formed subgroups, each receiving specific interventions. Measurements of International Prostate Symptom Score (IPSS), Maximal Urinary Flow Rate (Q-max), Prostate Volume (PV), Post-Void Residual (PVR), and Prostate-Specific Antigen (PSA) were recorded at baseline and following 3 months of follow-up. RESULTS: Participants with serum concentration of 25-(OH) vitamin D below 20 ng/ml simultaneously received cholecalciferol and Silymarin that significantly improved IPSS, irritation, obstruction, PV, and PVR. In those with concentrations ⩾20 ng/ml, a single use of Silymarin significantly reduced IPSS, irritation, obstruction, and PVR. Adjustment of confounding variables revealed independent and significant effects of both cholecalciferol and Silymarin on PVR, IPSS, and obstruction. Cholecalciferol also improved irritation, while Silymarin reduced prostate volume. These findings highlight potential therapeutic benefits for BPH-associated LUTS, encouraging further exploration and clinical consideration. CONCLUSIONS: In this investigation, combination therapy with cholecalciferol at 50,000 IU/w for 8 weeks and Silymarin at a dosage of 480 mg for 3 months resulted in a notable improvement in the IPSS score, PV, and PVR, as well as both irritative and obstructive symptoms. However, the total PSA and free PSA amounts did not reach a significant difference.