RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL-TRIAL OF BETA-SITOSTEROL IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA

Medical treatments have become available for benign hypertrophy of the prostate, including alpha-receptor blocking agents and 5-alpha-reduct ase inhibitors. Drugs derived from plants, for which no precise mechan ism of action has been described, are widely used for this purpose in Europe. In a randomised, double-blind, placebo-controlled multicentre study, 200 patients (recruited between April and October 1993) with sy mptomatic benign prostatic hyperplasia were treated with either 20 mg beta-sitosterol (which contains a mixture of phytosterols) three times per day or placebo. Primary end-point was a difference of modified Bo yarsky score between treatment groups after 6 months; secondary end-po ints were changes in International Prostate Symptom Score (IPSS), urin e flow, and prostate volume. Modified Boyarsky score decreased signifi cantly with a mean of -6.7 (SD 4.0) points in the beta-sitosterol-trea ted group versus -2.1 (3.2) points in the placebo group p<0.01. There was a decrease in IPSS (-7.4 [3.8] points in the beta-sitosterol-treat ed group vs -2.1 [3.8] points in the placebo group) and changes in uri ne flow parameters: beta-sitosterol treatment resulted in increasing p eak flow (15.2 [5.7] mL/s from 9.9 [2.5] mL/s), and decrease of mean r esidual urinary volume (30.4 [39.9] mL from 65.8 [20.8] mL). These par ameters did not change in the placebo group (p<0.01). No relevant redu ction of prostatic volume was observed in either group. Significant im provement in symptoms and urinary flow parameters show the effectivene ss of beta-sitosterol in the treatment of benign prostatic hyperplasia .