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Keywords:

  • Benign prostatic hyperplasia;
  • phytotherapy;
  • β-sitosterol;
  • long-term outcome;
  • symptom score

Objectives  To determine the long-term effects of phytotherapy with β-sitosterol (the trade name for β-sitosterol used in this study is Harzol®) 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 β-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 formerβ-sitosterol group, 38 patients who continued β-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 β-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 β-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 β-sitosterol is effective.