February 2006

Saw palmetto found no better than placebo

The New England Journal of Medicine published results of a year-long, double-blind study of 225 men that revealed saw palmetto, an herbal extract commonly taken to improve urinary symptoms in men with enlargement of the prostate gland, or benign prostate hyperplasia (BPH), was no more effective than a placebo for an enlarged prostate. But industry experts dispute the results of the study.

A primary criticism of experts is that this study was conducted on men with moderate-to-severe symptoms, whereas other studies found saw palmetto most effective in those with mild to moderate BPH.

Andrew Halpner at Douglas Labs commented, “It is interesting that in the light of this data, the National Institutes of Health (NIH) is moving forward with a follow-up study that will involve more subjects. Hopefully, the other positive data that exists will not be disregarded based on one negative finding.”

The National Nutritional Foods Association (NNFA) siad that the study had a number of flaws, including a lack of proper controls and the authors failing to provide effective chemical and biological standardization of the test materials.

Michael McGuffin, president of the American Herbal Products Association (AHPA), stated, “This new study needs to be considered in the totality of what we know from clinical research on saw palmetto. Numerous other well-designed studies have shown significant benefits with the same dosage range and similar, or in many cases, more representative populations. It is important to evaluate the results of this new data in the context of these earlier results.”

Andrew Shao, PhD, vice president of the Council for Responsible Nutrition (CRN), noted that the trial’s disappointing conclusions may have resulted from an inappropriate study population. “Future trials need to explore in more detail the response of those with both mild and moderate symptoms.”

The American Botanical Council (ABC) is concerned with an anomaly of the trial — the significantly higher adverse effect profile in the placebo group. The minor adverse effects were nearly equal in the saw palmetto group and the placebo group, but the serious adverse effects were almost twice as many in the placebo group (11) as in the saw palmetto group (6), suggesting that the patient population may have had other serious illnesses, possibly interfering in the attempt to treat the moderate-to-severe BPH symptoms.

Sources: EurekAlert, www.eurekalert.org; Douglas Laboratories, www.douglaslabs.com; National Nutritional Foods Association, www.nnfa.org; American Herbal Products Association, www.ahpa.org; Council for Responsible Nutrition, www.crnusa.org; American Botanical Council, www.herbalgram.org

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