COMPARISON OF PHYTOTHERAPY (PERMIXON(R)) WITH FINASTERIDE IN THE TREATMENT OF BENIGN PROSTATE HYPERPLASIA - A RANDOMIZED INTERNATIONAL STUDY OF 1,098 PATIENTS

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(R)) with those of a 5 alpha-reductase inhibitor (5 mg finasteride) in 1,098 me n with moderate BPH using the International Prostate Symptom Score (IP SS) as the primary end-point. RESULTS. Both Permixon(R) and finasterid e decreased the IPSS (-37% and -39%, respectively), improved quality o f 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 re sponders with a 3 ml/sec improvement. Finasteride markedly decreased p rostate volume (-18%) and serum PSA levels (-41%); Permixon(R) improve d symptoms with little effect on volume (-6%) and no change in PSA lev els. Permixon(R) fared better than finasteride in a sexual function qu estionnaire and gave rise to less complaints of decreased libido and i mpotence. CONCLUSIONS. Both treatments relieve the symptoms of BPH in about two-thirds of patients but, unlike finasteride, Permixon(R) has little effect on so-called androgen-dependent parameters. This suggest s that other pathways might also be involved in the symptomatology of BPH. (C) 1996 Wiley-Liss, Inc.