1996

    Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia

    Carraro JC, Raynaud JP, Koch G, Chisholm GD, Di Silverio F, Teillac P, Da Silva FC, Cauquil J, Chopin DK, Hamdy FC

    Published in Prostate

    Abstract

    Six-month comparative study showing 320mg saw palmetto extract (Permixon) equivalent efficacy to finasteride 5mg for BPH symptoms and flow rates, with superior tolerability and fewer side effects on sexual function.

    Methodology

    Randomised, double-blind, six-month international equivalence trial comparing Permixon with finasteride in men with moderate BPH.

    Key Findings

    In 1,098 men with benign prostatic hyperplasia, Serenoa repens extract (Permixon 320 mg/day) and finasteride 5 mg/day produced comparable improvements in IPSS symptom score and peak urinary flow over six months. Finasteride reduced prostate volume and PSA more, while Permixon caused markedly fewer sexual adverse effects (loss of libido 6% vs 12%).

    Conclusions

    Over six months, saw palmetto extract matched finasteride for symptom relief with better sexual tolerability, but without the prostate-shrinking or PSA-lowering effect — and later placebo-controlled trials failed to confirm benefit over placebo.

    Limitations

    Active-comparator design with no placebo arm, so a shared placebo response cannot be excluded; six-month duration only; industry-sponsored.

    Outcomes Measured

    Six-month comparative study showing 320mg saw palmetto extract equivalent efficacy to finasteride 5mg for BPH symptoms and flow rates, with superior tolerability and fewer side effects on sexual function.

    Study Details

    Year:1996
    Sample Size:1,098
    Duration:26 weeks
    Quality Score:6/10

    Disclosures

    Funding

    Pierre Fabre Medicament, manufacturer of Permixon

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