Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2004; 9: 19
In this prospective, randomised, placebo-controlled, double-blind multicentre trial following current international guidelines, we investigated the efficacy and tolerability of a fixed combination of sabal and urtica extract [PRO 160/120 (Prostagutt forte; manufacturer: Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany); PRO] in patients with lower urinary tract symptoms.
Two hundred and seventy-one patients [benign prostatic hyperplasia (BPH) stage I–II acc. to Alken, I-PSS ≥ 14, quality of life (QoL) ≥ 4, Qmax < 15 ml/s] were included, 257 patients were randomised. The trial measuring efficacy by I-PSS, QoL and uroflow consisted of a 2-week placebo run-in phase, followed by a 24-week double-blind-treatment [2 × 1 capsule PRO vs. placebo (PL)], a 24-week control period and a subsequent 48-week follow-up period (both periods: all patients received PRO). The essential parameter was the I-PSS, which was evaluated in the full analysis set using the U-test stratified by centre.
Two hundred and fifty-three patients (PRO 127, PL 126) were evaluated for efficacy. At baseline, the demographically well-comparable patients showed a median I-PSS of 17 points in both groups. After the double-blind treatment, a statistically significant group difference in the decrease in I-PSS could be shown (PRO –6 points, PL –4 points; P = 0.003, one-sided). After the control period, the I-PSS in the former PL- and now PRO-treated patients was reduced by another 2 points vs. 1 point in the former PRO-treated patients, which was also statistically significant (P = 0.01, one-sided). During the follow-up period, the I-PSS was reduced by another 1 point (median; P = 0.001, one-sided Wilcoxon signed rank test). For the follow-up patients, a median I-PSS reduction of 9 points (P < 0.001; one-sided Wilcoxon signed rank test) was observed compared to baseline at the end of the whole long-term study (96 weeks). The tolerability of PRO was very good.
The combination of sabal and urtica extract was demonstrated to be an effective and safe therapeutic option for relieving the symptoms of BPH as measured by the I-PSS, and also in long-term use.
This study was kindly funded by Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany.
