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 5α‐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. © 1996 Wiley‐Liss, Inc.

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 5a-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 d s e c 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. KEY WORDS: 0 1996 Wiley-Liss, Inc.benign prostatic hyperplasia, phytotherapy, lipidsterol extract of Semoa repens, Permixon", 5a-reductase inhibitor, finasteride

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The study confirms that the most prominent phenomenon is that of an age-related decrease in the index of free testosterone, which is indicated in particular by an increase in the level of SHBG, and by a decrease in dehydroepiandrosterone and its derivatives. No significant correlation was found between levels of hormones and single items on the questionnaire, nor with the overall score arrived at by studying the patients' data.

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