Abstract | OBJECTIVES: To determine the long-term effects of phytotherapy with beta-sitosterol (the trade name for beta-sitosterol used in this study is Harzol(R)) for symptomatic benign prostatic hyperplasia (BPH). Patient and methods At 18 months after enrolment in a 6-month multicentre double-blind placebo-controlled clinical trial with beta-sitosterol (reported previously), patients were re-evaluated using the modified Boyarsky score, the International Prostate Symptom Score and quality-of-life index, the maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR). In this open extension of the original trial (after 6 months of treatment or placebo), patients were free to chose their further treatment for BPH. RESULTS: In all, 117 patients (59%) were eligible for analysis during the follow-up. Of the formerbeta- sitosterol group, 38 patients who continued beta-sitosterol treatment had stable values for all outcome variables between the end of the double-blind study and after 18 months of follow-up. The 41 patients choosing no further therapy had slightly worse symptom scores and PVR, but no changes in Qmax. Of the former placebo group, 27 patients who started beta-sitosterol after the double-blind trial improved to the same extent as the treated group for all outcome variables. The 18 patients choosing no further therapy showed no signs of improvement. CONCLUSION: The beneficial effects of beta-sitosterol treatment recorded in the 6-month double-blind trial were maintained for 18 months. Further clinical trials should be conducted to confirm these results before concluding that phytotherapy with beta-sitosterol is effective.
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Authors | R R Berges, A Kassen, T Senge |
Journal | BJU international
(BJU Int)
Vol. 85
Issue 7
Pg. 842-6
(May 2000)
ISSN: 1464-4096 [Print] England |
PMID | 10792163
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Sitosterols
- gamma-sitosterol
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Topics |
- Double-Blind Method
- Follow-Up Studies
- Humans
- Male
- Prostatic Hyperplasia
(blood, drug therapy)
- Quality of Life
- Sitosterols
(therapeutic use)
- Treatment Outcome
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