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A multicentric, placebo‐controlled, double‐blind clinical trial of β‐sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia
Author(s) -
KLIPPEL K.F.,
HILTL D.M.,
SCHIPP B.
Publication year - 1997
Publication title -
british journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 0007-1331
DOI - 10.1046/j.1464-410x.1997.t01-1-00362.x
Subject(s) - placebo , medicine , urology , international prostate symptom score , hyperplasia , clinical trial , prostate , lower urinary tract symptoms , alternative medicine , pathology , cancer
Objective To report the results of a double‐blind, placebo‐controlled trial to evaluate Azuprostat ® , a β‐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 β‐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 (Q max ) 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 β‐sitosterol as the main component. Results There were significant ( P <0.01) improvements over placebo in those treated with β‐sitosterol; the mean difference in the IPSS between placebo and β‐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 Q max (4.5 mL/s) and decrease in PVR (33.5 mL) in favour of β‐sitosterol when adjusted for the changes after placebo. Conclusion These results show that β‐sitosterol is an effective option in the treatment of BPH.