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

Abstract

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.

Serenoa repensfor benign prostatic hyperplasia

“…The updated search strategy (2008) identified 12 new trials, of which 9 met inclusion criteria (Preuss 2001; Debruyne 2002; Glémain 2002; Willetts 2003; Lopatkin 2005; Engelmann 2006; Bent 2006; Hizli 2007; Shi 2007). Excluded were Pecoraro 2004, Popa 2005, and Vela-Navarrete 2005.…”

<b><i>Serenoa repens</i></b> bei benigner Prostatahyperplasie

“…Tacklind wertete 32 Studien aus, die in Tabelle 1 aufgeführt sind [8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39]. …”

“…In diesem Sinn hätten die Autoren des vorliegenden Reviews die neun Studien von Carbin et al [13], Engelmann et al [20], Gabric und Miskic [21], Lopatkin et al [26], Marks et al [28], Metzker et al [30], Preuss et al [33], Shi et al [36] sowie Sökeland und Albrecht [37] gar nicht in diese Meta-Analyse aufnehmen dürfen, weil die Prüfpräparate dieser Studien neben S. repens noch weitere, unterschiedliche Pflanzenextrakte oder andere Substanzen enthielten.…”

Urtica dioica L., Urtica urens et/ou hybrides (Urticaceae)

“…La racine d'ortie n'inhiberait que faiblement la 5-aréductase et n'influence pas la liaison de la dihydrotestostérone à ses récepteurs. La racine d'ortie a un effet comparable à celui de la tamsulosine [54].…”