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of LESP per day in 1 to 3 divided doses taken orally (or rectally in a few trials). The duration of ingestion of LESP varied from several weeks to several years.

II. SAFETY INFORMATION

A. Human Safety Data

1. Historical use

Historical use of saw palmetto for symptoms of BPH has been common in Asia and in native cultures in North America for centuries (Lowe, 2001; Wilt et al., 1998). Of the 30 plants known to have been used historically in phytotherapy for symptoms of BPH, saw palmetto has been the most widely used (Wilt et al., 1998). Historical uses were limited to saw palmetto in the form of the whole fruit, teas, aqueous extracts, and tinctures. They did not include lipid/sterol extracts of saw palmetto fruit such as those available in the current market.

In American Indian cultures, specifically in Florida, saw palmetto fruit was considered useful as a diuretic, sedative, aphrodisiac, nutritional tonic (due to the high oil content of the fruit), and to create a soothing vapor used as an expectorant. As American and European cultures learned about American Indian phytotherapy, the saw palmetto fruit came to be used to improve sexual vigor; to increase sperm production; as a mild diuretic; to relieve urinary difficulty, such as urgency-to-urinate and nocturnal enuresis in both men and women; and to improve urogenital disorders in women, such as ovarian enlargement and dysmenorrhea (Gennaro, 2000; Wilt et al., 1998).

Typically, the dried, ripe fruit is used for medicinal purposes. At times, the fresh fruit may be used; the safety of this practice has not been evaluated.

2. Adverse effects

Clinical trials: The clinical data for saw palmetto is primarily generated on male subjects. The one trial in women is in Table B, but there is no indication that pregnant women were included in this trial.

Spontaneous adverse event reports: Spontaneous reports related to possible effects in utero did not exist.



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