Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia

Purpose: We tested the effects of a saw palmetto herbal blend in men with s ymptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo con trolled trial. Materials and Methods: We randomized 44 men 45 to 80 years old with symptom atic BPH into a trial of a saw palmetto herbal blend versus placebo. End po ints included routine clinical measures (symptom score, uroflowmetry and po st-void residual urine volume), blood chemistry studies (prostate specific antigen, sex hormones and multiphasic analysis), prostate volumetrics by ma gnetic resonance imaging, and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies. Results: Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group (not statisti cally significant). Neither prostate specific antigen nor prostate volume c hanged from baseline. Prostate epithelial contraction was noted, especially in the transition zone, where percent epithelium decreased from 17.8% at b aseline to 10.7% after 6 months of saw palmetto herbal blend (p <0.01). His tological studies showed that the percent of atrophic glands increased from 25.2% to 40.9% after treatment with saw palmetto herbal blend (p <0.01). T he mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis, cellular proliferation, angiogenesis, grow th factors or androgen receptor expression. We noted no adverse effects of saw palmetto herbal blend. When the study was no longer blinded, 41 men ele cted to continue therapy in an open label extension. Conclusions: Saw palmetto herbal blend appears to be a safe, highly desirab le option for men with moderately symptomatic BPH. The secondary outcome me asures of clinical effect in our study were only slightly better for saw pa lmetto herbal blend than placebo (not statistically significant). However, saw palmetto herbal blend therapy was associated with epithelial contractio n, especially in the transition zone (p <0.01), indicating a possible mecha nism of action underlying the clinical significance detected in other studi es.