| Disease | 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 BHP WERE RECRUITED FOR 6 MONTHS OF TREATMENT IN 13 STUDY CENTERS. 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 B-SITOSTEROL AS THE MAIN COMPONENT. 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 Q MAX (4.5 ML/S) AND DECREASE IN PVR(33.5 ML) IN FAVOR OF BETA-SITOSTEROL WHEN ADJUSTED FOR THE CHANGES AFTER PLACEBO. THESE RESULTS SHOW THAT BETA-SITOSTEROL IS AN
EFFECTIVE OPTION IN THE TREATMENT OF BPH.
A COMMERCIAL PRODUCT, AZUPROSTAT, WAS USED. |