Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients

Prostate. 1996 Oct;29(4):231-40; discussion 241-2. doi: 10.1002/(SICI)1097-0045(199610)29:4<231::AID-PROS4>3.0.CO;2-E.


Background: Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia (BPH).

Methods: This was a 6-month double-blind randomized equivalence study that compared the effects of a plant extract (320 mg Permixon) with those of a 5 alpha-reductase inhibitor (5 mg finasteride) in 1,098 men with moderate BPH using the International Prostate Symptom Score (IPSS) as the primary end-point.

Results: Both Permixon and finasteride decreased the IPSS (-37% and -39%, respectively), improved quality of life (by 38 and 41%), and increased peak urinary flow rate (+25% and +30%, P = 0.035), with no statistical difference in the percent of responders with a 3 ml/sec improvement. Finasteride markedly decreased prostate volume (-18%) and serum PSA levels (-41%); Permixon improved symptoms with little effect on volume (-6%) and no change in PSA levels. Permixon fared better than finasteride in a sexual function questionnaire and gave rise to less complaints of decreased libido and impotence.

Conclusions: Both treatments relieve the symptoms of BPH in about two-thirds of patients but, unlike finasteride, Permixon has little effect on so-called androgen-dependent parameters. This suggests that other pathways might also be involved in the symptomatology of BPH.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Androgen Antagonists / adverse effects
  • Androgen Antagonists / therapeutic use*
  • Cholestenone 5 alpha-Reductase
  • Double-Blind Method
  • Enzyme Inhibitors / therapeutic use
  • Finasteride / therapeutic use
  • Humans
  • International Cooperation
  • Male
  • Middle Aged
  • Oxidoreductases / antagonists & inhibitors
  • Phytotherapy*
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Prostate / drug effects
  • Prostate / pathology
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / pathology
  • Prostatic Hyperplasia / physiopathology
  • Serenoa
  • Sexual Behavior / drug effects
  • Treatment Outcome


  • Androgen Antagonists
  • Enzyme Inhibitors
  • Plant Extracts
  • Finasteride
  • Oxidoreductases
  • Cholestenone 5 alpha-Reductase
  • saw palmetto extract