EXTRACT of SAW PALMETTO for TREATMENT of SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
Carraro JC., Raynaud JP., Koch G., Chisholm GD., Di Silverio F., Teiucic P., Da Suva FC., Caucjuil J., Chopin DK., Hamdy FC., Haiius M., Hauri D., Kalinteris A., Marencak J., Pener A., Perrin P.
OBJECTIVE To assess the clinical efficacy of Permixon as compared with finasteride for treatment of symptomatic benign prostatic hyperplasia (BPH). DESIGN Double-blind, randomized, equivalency trial. SETTING Eighty-seven urology centers in 9 European countries. PATIENTS One thousand and ninety-eight men more than 50 years old with symptomatic BPH seen at these centers. INTERVENTION Permixon (a lipid/sterol extract of saw palmetto) 320 mg per day or finasteride (a 5 alpha-reductase inhibitor) 5 mg per day for 6 months. OUTCOME MEASURES International Prostate Symptom Score (1PSS) was the primary endpoint. Secondary endpoints were peak and mean urinary flow rates, and scores on quality of life and sexual function questionnaires. These end points were assessed at 6, 13, and 26 weeks. RESULTS Both Permixon and finasteride decreased the IPSS (-37% and -39%, respectively, p = NS), and improved quality of life (by 38% and 41%, p = NS). Peak urinary flow rate increased in both, but more so in the finasteride group (+25% and +30%, p = .035). The sexual function score declined significantly in the finasteride group compared to the Permixon group (+9% and -6%, p < .001). CONCLUSIONS Permixon and finasteride relieved the symptoms of BPH to the same degree. Finasteride patients had higher peak urinary flow rates but more sexual dysfunction. © 1998 Elsevier Science Inc.