Leonard S. Marks, Frederick J. Dorey, Maria
L. Macairan, Paul Bryan C. Santos,
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.