K F Klippel1, D M Hiltl, B Schipp. 1. Department of Urology, Allgemeines Krankenhaus Celle, Academic Hospital, Germany.
Abstract
OBJECTIVE: To report the results of a double-blind, placebo-controlled trial to evaluate Azuprostat, a beta-sitosterol, in patients with symptoms of outlet obstruction caused by benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: A randomized, double-blind and placebo-controlled clinical trial was conducted to assess the efficacy and safety of 130 mg free beta-sitosterol (phytosterol) daily, using the international prostate symptom score (IPSS) as the primary outcome variable. In total, 177 patients with BPH were recruited for 6 months of treatment in 13 study centres. In addition to the relative difference in the IPSS, changes in quality of life, peak urinary flow rate (Qmax) and post-void residual urinary volume (PVR) were recorded. The drug used in the trial consisted of a chemically defined extract of phytosterols, derived for example from species of Pinus, Picea or Hypoxis, with beta-sitosterol as the main component. RESULTS: There were significant (P < 0.01) improvements over placebo in those treated with beta-sitosterol; the mean difference in the IPSS between placebo and beta-sitosterol, adjusted for the initial values, was 5.4 and in the quality-of-life index was 0.9. There were also significant improvements in the secondary outcome variables, with an increase in Qmax (4.5 mL/s) and decrease in PVR (33.5 mL) in favour of beta-sitosterol when adjusted for the changes after placebo. CONCLUSION: These results show that beta-sitosterol is an effective option in the treatment of BPH.
RCT Entities:
OBJECTIVE: To report the results of a double-blind, placebo-controlled trial to evaluate Azuprostat, a beta-sitosterol, in patients with symptoms of outlet obstruction caused by benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: A randomized, double-blind and placebo-controlled clinical trial was conducted to assess the efficacy and safety of 130 mg free beta-sitosterol (phytosterol) daily, using the international prostate symptom score (IPSS) as the primary outcome variable. In total, 177 patients with BPH were recruited for 6 months of treatment in 13 study centres. In addition to the relative difference in the IPSS, changes in quality of life, peak urinary flow rate (Qmax) and post-void residual urinary volume (PVR) were recorded. The drug used in the trial consisted of a chemically defined extract of phytosterols, derived for example from species of Pinus, Picea or Hypoxis, with beta-sitosterol as the main component. RESULTS: There were significant (P < 0.01) improvements over placebo in those treated with beta-sitosterol; the mean difference in the IPSS between placebo and beta-sitosterol, adjusted for the initial values, was 5.4 and in the quality-of-life index was 0.9. There were also significant improvements in the secondary outcome variables, with an increase in Qmax (4.5 mL/s) and decrease in PVR (33.5 mL) in favour of beta-sitosterol when adjusted for the changes after placebo. CONCLUSION: These results show that beta-sitosterol is an effective option in the treatment of BPH.
Authors: R Berges; K Dreikorn; K Höfner; U Jonas; K U Laval; S Madersbacher; M C Michel; R Muschter; M Oelke; L Pientka; C Tschuschke; U Tunn; H Palmtag; M Goepel; K Schalhhäuser; B Göckeel-Beining; A Heidenreich; H Rübben; K Schalkerhäuser; W Thon; J Thüroff; W Weidner Journal: Urologe A Date: 2003-03-22 Impact factor: 0.639
Authors: R Berges; K Dreikorn; K Höfner; S Madersbacher; M C Michel; R Muschter; M Oelke; O Reich; W Rulf; C Tschuschke; U Tunn Journal: Urologe A Date: 2009-12 Impact factor: 0.639