A MULTICENTRIC, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL-TRIAL OF BETA-SITOSTEROL (PHYTOSTEROL) FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

Objective To report the results of a double-blind, placebo-controlled trial to evaluate Azuprostat(R), a beta-sitosterol, in patients with s ymptoms of outlet obstruction caused by benign prostatic hyperplasia ( BPH). Patients and methods A randomized, double-blind and placebo-cont rolled clinical trial was conducted to assess the efficacy and safety of 130 mg free beta-sitosterol (phytosterol) daily, using the internat ional prostate symptom score (IPSS) as the primary outcome variable. I n total, 177 patients with BPH were recruited for 6 months of treatmen t in 13 study centres. In addition to the relative difference in the I PSS, changes in quality of life, peak urinary now rate (Q(max)) and po st-void residual urinary volume (PVR) were recorded, The drug used in the trial consisted of a chemically defined extract of phytosterols, d erived 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; t he mean difference in the IPSS between placebo and beta-sitosterol, ad justed for the initial values, was 5.4 and in the quality-of-life inde x was 0.9. There were also significant improvements in the secondary o utcome variables, with an increase in Q(max) (4.5 mL/s) and decrease i n PVR (33.5 mL) in favour of beta-sitosterol when adjusted for the cha nges after placebo. Conclusion These results show that beta-sitosterol is an effective option in the treatment of BPH.