Efficacy and Safety of a Combination of Sabal and Urtica Extract in Lower Urinary Tract Symptoms

• DOI: 10.1055/s-0031-1296714
• Publication Date: 2012-07-31T12:51:29Z
• Authors: Udo Engelmann; Carola Walther; Boris Bondarenko; Petra Funk; Sandra Schläfke
• Keywords: Male; Tamsulosin; Urologic Diseases; Sulfonamides; 0303 health sciences; Plant Extracts; Middle Aged; 3. Good health; Sexual Dysfunction, Physiological; Urodynamics; 03 medical and health sciences; Double-Blind Method; Serenoa; Humans; Female; Prospective Studies; Urticaceae; Adrenergic alpha-Antagonists; Aged

The aim of this prospective, randomized, double-blind, double-dummy, multicenter clinical trial was to investigate the efficacy and safety of PRO 160/120 (Prostagutt forte), a fixed combination preparation of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule, in comparison to the alpha1-adrenoceptor antagonist tamsulosin (CAS 106463-17-6) in lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). 140 elderly out-patients suffering from LUTS caused by BPH, with an initial score > or = 13 points in the International Prostate Symptom Score (I-PSS), received 2 x 1 capsule/d PRO 160/120 or 1 x 0.4 mg/d tamsulosin and were treated for 60 weeks with interim visits at weeks 8, 16, 24, 36, and 48. The primary outcome measure for efficacy was the change in I-PSS total score, the percentage of patients with an I-PSS score < or = 7 points at endpoint ('responders') was analyzed as well. During 60 weeks of randomized treatment the I-PSS total score was reduced by a median of 9 points in both groups. In total, 32.4 % of the patients in the PRO 160/120 group and 27.9% in the tamsulosin group were responders (test for non-inferiority of PRO 160/120: p = 0.034; non-inferiority margin 10%). Both drugs were well tolerated, with one adverse event in 1514 treatment days for PRO 160/120 and one event in 1164 days for tamsulosin. The study supports non-inferiority of PRO 160/120 in comparison to tamsulosin in the treatment of LUTS caused by BPH.