Abstract | OBJECTIVE: PATIENTS AND METHODS: 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 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 (Qmax) 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 beta-sitosterol as the main component. RESULTS: 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 Qmax (4.5 mL/s) and decrease in PVR (33.5 mL) in favour of beta-sitosterol when adjusted for the changes after placebo. CONCLUSION: These results show that beta-sitosterol is an effective option in the treatment of BPH.
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Authors | K F Klippel, D M Hiltl, B Schipp |
Journal | British journal of urology
(Br J Urol)
Vol. 80
Issue 3
Pg. 427-32
(Sep 1997)
ISSN: 0007-1331 [Print] England |
PMID | 9313662
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Phytosterols
- Plant Extracts
- Sitosterols
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Topics |
- Aged
- Double-Blind Method
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Phytosterols
(adverse effects, therapeutic use)
- Plant Extracts
(adverse effects, therapeutic use)
- Prostatic Hyperplasia
(drug therapy)
- Sitosterols
(adverse effects, therapeutic use)
- Treatment Outcome
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