Benign prostatic hyperplasia (BPH) is a common condition in adult men. Especially in Europe, increasing attention has been focused on E. angustifolium extracts (EAEs), which are widely used for their positive effects on the symptoms of BPH, although human clinical trials are limited. The aim of this monocentric, randomized, double-blind, placebo-controlled clinical trial is to evaluate if a daily intake of hard, gastric-resistant capsules containing a chemically characterized EAE (500 mg) for 6 months may allow a significant improvement in symptoms in subjects with BPH. This study was conducted in 128 adult men, randomly assigned to receive either EAE food supplement (N = 70) or placebo (N = 58), who underwent four visits (baseline = t0, after 15 days = t1, after 2 months = t2 and after 6 months = t3) in an outpatient setting to evaluate post-void residual (PVR) and prostate volume (PV) by means of prostate ultrasound, prostate-specific antigen (PSA) and neutrofile/lymphocyte ratio (N/L), nocturia before the clinical visits and International Prostate Specific Score (IPSS) registered by the physicians. EAE food supplement induced a significant decrease in the PVR and consequently nocturia improving the quality of life as suggested by the decrease of IPSS. No subjects reported adverse effects related to oral intake of EAE food supplement. Moreover, EAE food supplement did not show hepatic or renal toxicity. In conclusion, EAE food supplements can be used in subjects with BPH, to improve their quality of life and general renal function.
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021 Mar 23 [Epub ahead of print]
Cristina Esposito, Cristina Santarcangelo, Raffaello Masselli, Giuseppe Buonomo, Giovanna Nicotra, Violetta Insolia, Maria D'Avino, Giuseppe Caruso, Antonio Riccardo Buonomo, Roberto Sacchi, Eduardo Sommella, Pietro Campiglia, Gian Carlo Tenore, Maria Daglia
Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy., Samnium Medical Soc. Cooperative, viale Cristoforo Colombo 18, 82100 Benevento, Italy., EPO S.r.l., Via Stadera 19, 20141 Milan, Italy., Department of Internal Medicine, Hospital Cardarelli, via Antonio Cardarelli, 80131 Naples, Italy., Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy., Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy., Department of Pharmacy, University of Salerno, 84084 Fisciano, SA, Italy., Department of Pharmacy, University of Salerno, 84084 Fisciano, SA, Italy; European Biomedical Research Institute of Salerno, via De Renzi 50, I-84125 Salerno, Italy., Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, 212013 Zhenjiang, China. Electronic address: .