Herb Expert Critiques Negative NEJM Study of Saw Palmetto.

A study funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Complementary and Alternative Medicine (NCCAM) found saw palmetto (Serenoa repens) had no more effect than placebo in men with moderate to severe symptoms of benign prostatic hyperplasia (BPH). The study was published in the Feb. 9th issue of the New England Journal of Medicine (354, 6:557-66, 2006). The trial also found that while mild adverse effects were relatively equal between the two groups, there were significantly more serious adverse effects reported by those taking placebo.

Researchers from the University of California, San Francisco, randomly assigned 225 men aged 49 or older with moderate to severe BPH to two groups. Subjects were randomly assigned to either a treatment group, receiving 160 mg twice daily of a leading saw palmetto extract, or a placebo group. Over the course a year, subjects were assessed eight times using the AUASI (American Urological Association symptom index) including maximal urine flow, post-void residual urine volume, prostate size and other health-related indicators. Statistically, improvement was found in both groups, but no significant differences in improvement in BPH symptoms were found between the two groups.

Herbal and nutritional products industry experts challenged the results of the study. Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), explained that saw palmetto is widely recognized for its safety and efficacy in treating “mild to moderate” symptoms associated with BPH, a non-cancerous swelling of the prostate gland in older men that can result in symptoms associated with the interruption of normal urinary flow. “Our primary concern with this trial is the relatively advanced condition of the prostate problems in many of the men who were tested,” he said, noting the men in this latest study had “advanced to severe” BPH. In contrast, at least 21 previous controlled trials of saw palmetto involving more than 30,000 men with “mild to moderate” symptoms showed positive results and confirmed its efficacy. “Most of the official international monographs that recognize the benefits of saw palmetto do so for stage 1 and 2 of BPH, i.e., the mild to moderate range of BPH symptoms,” Blumenthal said. “These include monographs from the German government and the World Health Organization (WHO).”

It is intuitive, based on the known action of Saw Palmetto, to expect it to be of limited benefit to patients with severe BPH. The benefit of Saw Palmetto extract is in reducing the overgrowth of prostate cells by inhibiting the formation of dihydrotestosterone from residual testosterone in the prostate. Severe BPH patients by definition already have advanced prostate cellular overgrowth, which Saw Palmetto would not be expected to reverse.

Take two Bio-Design Saw Palmetto 160 capsule daily.