Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial)

• Published in: The Prostate 2014-11, Vol.74 (15), p.1471-1480
• Main Authors: Morgia, Giuseppe, Russo, Giorgio I., Voce, Salvatore, Palmieri, Fabiano, Gentile, Marcello, Giannantoni, Antonella, Blefari, Franco, Carini, Marco, Minervini, Andrea, Ginepri, Andrea, Salvia, Giuseppe, Vespasiani, Giuseppe, Santelli, Giorgio, Cimino, Sebastiano, Allegro, Rosalinda, Collura, Zaira, Fragalà, Eugenia, Arnone, Salvatore, Pareo, Rosaria M.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antioxidants - therapeutic use; BPH; Carotenoids - therapeutic use; Double-Blind Method; Drug Therapy, Combination; Humans; Italy; Lower Urinary Tract Symptoms - drug therapy; LUTS; lycopene; Male; Medical research; Men; Middle Aged; Older people; phytotherapy; Phytotherapy - methods; Prostatic Hyperplasia - drug therapy; Quality of Life; Selenium; Selenium - therapeutic use; Serenoa - chemistry; serenoa repens; Sulfonamides - therapeutic use; tamsulosin; Treatment Outcome; Urodynamics - drug effects; Urological Agents - therapeutic use
• ISSN: 0270-4137; 1097-0045
• DOI: 10.1002/pros.22866

BACKGROUND Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies. METHODS PROCOMB trial (ISRCTN78639965) was a randomized double‐blinded, double‐dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR)