23

We conclude from this pilot trial that saw palmetto extract is safe and well-tolerated; it is somewhat effective in relieving symptoms and increasing flow; it is desirable to most men; it does not alter hormones; and it appears to induce epithelial atrophy in the prostate. Further studies we plan include long-term follow-up of our open label extension group, including re-biopsy, and we also believe a Phase III type of randomized trial using a pure saw palmetto substance would be timely.