Clinical Effects of Saw palmetto Extract in Men with Symptomatic BPH. Leonard S. Marks, Frederick J. Dorey, Maria L. Macairan, Paul Bryan C. Santos, Joel B. Garris, Debra K. Jahner, Kerry A. Stonebrook, Los Angeles, CA; Alan W. Partin, Baltimore, MD; Varro E. Tyler, West Lafayette, IN. (Presented by Dr. Marks) INTRODUCTION: Saw palmetto extract (SPE) is used by many men to self-treat symptomatic BPH, but the mechanism of action is not known, and safety - efficacy data from the U.S. are lacking. Thus, we performed a randomized trial of a SPE/herbal blend, using a pharmaceutical-study model. METHODS: 44 men (age = 64 years; symptom score, IPSS = 18; maximum flow, Qmax = 10.8 cc/sec; post-void residual, PVR = 72 cc; prostate volume, PV = 55 cc; PSA = 3.4 ng/ml) were randomized to a placebo or SPE arm of a 6-month double-blind study. Rigid inclusion / exclusion criteria were followed. A one-month, single-blind, placebo lead-in (between baseline and randomization) preceded the double-blind period. One lot of standardized SPE extract was used throughout; dosage was 320 mg/day. Prostate MRI and ultrasound-guided biopsy for tissue study were performed at baseline and after 6 months of randomization. RESULTS: 43 men completed the study, 41 with a follow-up biopsy. No adverse events related to treatment were seen. Compliance by pill count was 95%. A panel of 26 blood tests showed no significant changes. A placebo effect (~15% improvement, p=NS) was seen during the lead-in period for SS and Qmax. At 6 months, the SPE group showed a further decrease in SS of 2.9 points and the placebo group a further decrease of 2.6 points (p=NS); Qmax increased a further 1.1 cc/sec in the SPE group but decreased 0.8 cc/sec in the placebo group (p=NS). No significant changes were seen in PVR, PV (whole or transition zone), or serum levels of PSA (total or free), testosterone, dihydrotestosterone, or estradiol. After the blind was broken at 6 months, 19 of 21 SPE patients elected to continue this treatment. CONCLUSIONS: The SPE/herbal blend appeared to be a safe, somewhat effective treatment, which was desirable to most patients. No hormonal changes were observed. The modest SS and Qmax improvements over placebo in this small group of SPE-treated men followed for 6 months might become more pronounced with more patients and/or longer follow-up. This belief is supported by the clear-cut SPE-induced change in prostate histology of these men (p<0.01), which is described in the companion abstract.