Efficacy and safety of a combination of sabal and urtica extract in lower urinary tract symptoms. A randomized, double-blind study versus tamsulosin.
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.
Engelmann
Udo
U
Department of Urology, University Clinics of Cologne, Cologne, Germany.
Walther
Carola
C
Bondarenko
Boris
B
Funk
Petra
P
Schläfke
Sandra
S
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use; D011446:Prospective Studies; D028024:Serenoa / Q000737:chemistry*; D012735:Sexual Dysfunction, Physiological / Q000150:complications; D013449:Sulfonamides / Q000627:therapeutic use; D000077409:Tamsulosin; D014563:Urodynamics; D014570:Urologic Diseases / Q000188:drug therapy*; D027003:Urticaceae / Q000737:chemistry*
D000317:Adrenergic alpha-Antagonists; D010936:Plant Extracts; D013449:Sulfonamides; D000077409:Tamsulosin