81097
document
Randomised , placebo-controlled , double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia . Beta-sitosterol Study Group . Medical treatments have become available for benign hypertrophy of the prostate , including alpha-receptor blocking agents and 5-alpha-reductase inhibitors . Drugs derived from plants , for which no precise mechanism 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 symptomatic 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 Boyarsky score between treatment groups after 6 months ; secondary end-points were changes in International Prostate Symptom Score ( IPSS ) , urine flow , and prostate volume . Modified Boyarsky score decreased significantly with a mean of -6.7 ( SD 4.0 ) points in the beta-sitosterol-treated 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-treated group vs -2.1 [ 3.8 ] points in the placebo group ) and changes in urine flow parameters : beta-sitosterol treatment resulted in increasing peak flow ( 15.2 [ 5.7 ] mL/s from 9.9 [ 2.5 ] mL/s ) , and decrease of mean residual urinary volume ( 30.4 [ 39.9 ] mL from 65.8 [ 20.8 ] mL ) . These parameters did not change in the placebo group ( p < 0.01 ) . No relevant reduction of prostatic volume was observed in either group . Significant improvement in symptoms and urinary flow parameters show the effectiveness of beta-sitosterol in the treatment of benign prostatic hyperplasia .
81098
Intervention_Control
placebo-controlled
81099
Intervention_Pharmacological
beta-sitosterol
81100
Intervention_Control
placebo-controlled
81101
Intervention_Pharmacological
20 mg beta-sitosterol
81102
Intervention_Pharmacological
phytosterols )
81103
Intervention_Control
placebo .
81104
Outcome_Physical
Boyarsky score
81105
Outcome_Physical
International Prostate Symptom Score ( IPSS )
81106
Outcome_Physical
urine flow
81107
Outcome_Physical
prostate volume
81108
Outcome_Physical
Modified Boyarsky score
81109
Outcome_Physical
IPSS
81110
Outcome_Physical
urine flow parameters
81111
Outcome_Physical
peak flow
81112
Outcome_Physical
mean residual urinary volume
81113
Outcome_Physical
prostatic volume
81114
Outcome_Physical
symptoms and urinary flow parameters
81115
Participant_Condition
Beta-sitosterol Study Group .