What is saw palmetto?

Saw palmetto is an herbal supplement that has gained increasing interest in the United States for alleviating urinary symptoms resulting from benign (not cancerous) enlargement of the prostate gland, referred to as benign prostatic hypertrophy (BPH). Currently, such plant-derived treatment (phytotherapy) is more commonly used in European countries such as Germany and Austria. There, saw palmetto is the initial treatment of choice for mild-to-moderate urinary tract symptoms of benign prostatic hyperplasia (a term used synonymously with hypertrophy). Although still not widely used in the United States, plant-derived, herbal agents claiming to maintain prostate health (as the manufacturers say) now are readily available as nonprescription dietary supplements. On the basis of the favorable European experience, the accessibility of saw palmetto without a prescription, the desire for personal control without "medication" or surgery, and possible dissatisfaction with conventional treatments, herbal treatment for benign prostatic hyperplasia is likely to gain greater popularity in the United States.

Where does saw palmetto come from?

The saw palmetto extract is derived from the dried, ripe berry of the American dwarf palm tree, Serenoa repens (scientific name); Sabal Serrulata (botanical name). The main source of saw palmetto is the southeastern United States. With the enlarging reputation of saw palmetto, this plant now is grown commercially. Harvesting of saw palmetto berries is becoming a big industry with nearly 2000 tons of these berries being shipped to Europe for the herbal supplement market.

What are the conventional medical options for the treatment of BPH?

Currently, few doctors in the United States at this time recommend plant extracts for treatment of urinary tract symptoms secondary to BPH. Instead, conventional drug therapies such as finasteride (Proscar) and several a-adrenergic blockers are favored in the U.S. Finasteride blocks the conversion of the male hormone testosterone to its more potent active state. Since the growth of the prostate is dependent on this potent form of testosterone, finasteride reduces prostatic growth by preventing this hormone's production. The other drugs used for BPH symptoms are called a-adrenergic blocking agents. The action of these drugs is based on the fact that the flow of urine depends not only on the size of the opening of the urinary passage (which may be reduced by an enlarged prostate) but also on the muscle tone of the prostate and the urinary bladder neck. By relaxing the muscle tone in these areas with a-adrenergic blocker drugs (such as prazosin, terazosin, and doxazosin), a better urine flow can be achieved, even without mechanically or surgically enlarging the urinary passage.

What is the evidence supporting the use of saw palmetto as a treatment for the prostate?

Of the approximately thirty plant-derived compounds that exist for alleviating the symptoms of BPH, the saw palmetto extract is the most widely used and studied. Most of the saw palmetto studies have been conducted in Europe. Recently, a systematic review of 18 randomized controlled trials involving a total of 2,939 men was published. The trials used either saw palmetto by itself or in combination with other herbal treatments. The effectiveness of these agents was compared to a placebo (an inactive or inert substance) or one of the conventional drug therapies for benign prostatic hyperplasia. The researchers looked at the following: (1) urinary symptoms such as hesitancy; (2) the number of times a night that a patient arose to urinate; (3) the average urine rate of flow; and (4) the amount of urine remaining in the bladder after voiding (urinating). Changes resulting from the use of this herbal agent in these four areas were compared to placebo results to determine if an improvement occurred in the patients' urinary symptoms or urinary flow. These researchers reported that there was 28% greater reduction in urinary symptoms in the group treated with saw palmetto than the group taking the placebo. Secondly, there was a 25% greater reduction in nighttime urination; for example, a treated patient might urinate three times nightly instead of four. Thirdly, the average improvement in urine flow rate was 28% with saw palmetto as compared with the placebo. Finally, there was 43% less urine remaining in the bladder after voiding with saw palmetto than with the placebo.

The systematic review of the clinical trials also showed that saw palmetto provided similar response as finasteride (Proscar) in terms of urine flow measures and urinary symptoms. A large, double-blind study (neither the patient nor the doctor knew which drug was used) involving 1,069 participants with moderate BPH was recently conducted with subjects treated with either saw palmetto or finasteride for six months. Similar efficacy was found between the two treatments in terms of self-rated quality-of-life scores and urinary symptom scores. The symptom score improved by 37% with saw palmetto and by 39% with finasteride; and the quality-of-life score improved by 69% with saw palmetto and by 73% with finasteride. Thus, it appears that the saw palmetto extract is more effective than placebo, and the extract is similar in effectiveness to finasteride for symptoms of BPH.

Not many studies have been performed comparing saw palmetto and a- adrenergic blocking agents, the other conventional drugs used in the treatment of BPH symptoms. In a small, double-blind study comparing saw palmetto with prazosin in 41 patients for three months, prazosin was found to have slightly greater effect on urine flow rate, nighttime urination, and amount of urine remaining in the bladder after voiding than saw palmetto. Studies comparing the effect of saw palmetto to that of surgery for symptoms of BPH have not been performed.

How does saw palmetto work?

The way in which saw palmetto works to relieve the urinary symptoms of BPH is unclear. Laboratory studies suggest that the extract of saw palmetto blocks the conversion of testosterone to its more active potent form, in the same way that the conventional drug finasteride does. However, studies in humans have not been able to confirm a significant reduction in activated testosterone. Other proposed mechanisms of action of saw palmetto include interference with the action of activated testosterone on prostate cells, as well as an anti-inflammatory effect.

What are the adverse effects of saw palmetto?

Adverse effects of saw palmetto are rare. They include headache, nausea, and upset stomach and are comparable in frequency to the symptoms experienced by the group taking the placebo. Erectile dysfunction has not been commonly reported among patients taking saw palmetto. It has been reported in 1.1% of men taking saw palmetto, 0.7% of men taking placebo, and 4.9% of men taking finasteride. The percent of men with erectile dysfunction after surgery for BPH is not clear. In one study, approximately 28% of men subjectively reported a decrease in the quality of erection after surgery; however, no worsening of objective parameters of erectile function were found. Although no drug interactions with saw palmetto have been systematically sought, no such interactions have been documented to date.

Is saw palmetto officially approved for use in BPH?

While saw palmetto is not officially approved in the United States for the treatment of urinary symptoms from BPH, it has been approved for this use in Germany. The German government assigned a commission in 1978 to oversee the efficacy and safety of herbal agents. The commission (German Commission E) reviews data from clinical trials and case reports, and considers opinions that they determine have merit.

What other concerns relate to using saw palmetto?

While the results of the trials are encouraging, the response from a product purchased from your local nutritional supplement store is not always predictable. This is because saw palmetto products are not standardized in terms of dosages or preparations. Even the available clinical studies used different doses and preparations of saw palmetto. The most common dose used in these studies was 160 mg twice per day. Since long term studies are not available, the incidence of adverse effects from the chronic use of saw palmetto extract has yet to be determined. Knowing adverse effects of the chronic use of saw palmetto is important because BPH is a chronic condition that requires continuous treatment indefinitely.

General information about saw palmetto

As a dietary supplement, saw palmetto cannot be claimed by its manufacturers to treat or prevent disease. Dietary supplements are regulated under the 1994 Dietary Supplement Health and Education Act, which does not demand particular testing procedures for the safety or effectiveness of these products before they are brought to market. Since they are not considered drugs under regulation by the Food and Drug Administration, prescriptions are not needed to obtain them in the United States.

What about the future of saw palmetto?

To establish the use of saw palmetto in the management of BPH, additional well designed studies are needed. Clinical trials must compare the efficacy and adverse effects of saw palmetto directly with those of the conventional medical and surgical treatments for BPH. We especially need data on the safety of ingesting this herb for the long term. Meanwhile, information should be obtained on what the active ingredient is in saw palmetto, and how it works in treating BPH.

Saw Palmetto At A Glance

• Saw palmetto is an herbal treatment for symptoms of benign prostatic hypertrophy (BPH) such as hesitancy, urgency, dribbling, increased frequency in urinating, and increased nighttime urination.
• Saw palmetto is comparable in effectiveness to conventional medication in the treatment of urinary symptoms associated with BPH.
• Short term use of saw palmetto has fewer adverse effects than conventional medications for BPH.
• The incidence of adverse effects from long term use of saw palmetto is unknown, and long term treatment is needed for BPH.

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