Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women
Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women
Pages 450-477
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From page 450... ...
The dried ripe fruit is typically the part of the plant used for dietary supplements. 1This is a focused monograph, prepared for the purpose of illustrating how a safety review of a dietary supplement ingredient might be prepared following the format for focused monographs described in this report.
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In numerous clinical trials, the typical dose of saw palmetto for a subject with symptomatic benign prostatic hyperplasia (BPH) 2 was 320 mg 2BPH is a nonmalignant enlargement of the prostate from excessive proliferation, which causes nodules of the prostate gland to enlarge around the urethra, eventually limiting urinary flow from the bladder.
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From page 452... ...
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)
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Information about substances that are functionally related because they inhibit steroid 5 -- reductase is included. In summary, several of the substances functionally related to saw palmetto extract are contraindicated for use in women because of potential deleterious effects on the external genitalia and internal reproductive organs of the male fetus.
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From page 454... ...
It is indigenous to undeveloped areas of the southern costal regions of the United States, especially Florida and Georgia, and is also abundant in Cuba and the Bahamas. Most saw palmetto fruit used in dietary supplements is harvested in Florida.
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urology clinic, 20 percent were combining conventional and botanical therapies, and 15 percent were using botanical dietary supplements alone (Bales et al., 1999)
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status for use in various urinary problems associated with BPH in Switzerland, Sweden, and Denmark. In Spain, standardized lipid/sterol extracts are approved as a drug with prescription status, and nonstandardized extracts are approved as dietary supplements.
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Animal data indicate that orally consumed saw palmetto preparations are antiandrogenic in vivo. Several animal studies were completed with oral administration of saw palmetto extracts following androgen stimulation of prostate hyperplasia.
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in patients with benign prostatic hyperplasia who had ingested extract of saw palmetto fruit for 3 months. The historical use of saw palmetto does not mitigate any concern about safety for pregnant women for several reasons.
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1996. Supercritical fluid chromatography of free fatty acids and ethyl esters in ethanolic extracts of Sabal serrulata.
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1969. Activity and isolated phytoestrogen of shrub palmetto fruits (Serenoa repens Small)
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1984. Inhibition of androgen metabolism and binding by a lipidosterolic extract of "Serenoa repens B" in human foreskin fibroblasts.
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1996. Effects of the Sabal serrulata extract IDS 89 and its subfractions on 5-reductase activity in human benign prostatic hyperplasia.
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Most fatty acids are also present as ethyl esters. Some reviewers reported relatively small proportions as ethyl esters 1 (Nemecz, 1998)
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. In vitro: inhibitor of human prostate type 2 steroid 5 -- reductase (transfected as cDNA into rat 1A cells in culture; IC50 12 µM)
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inhibited proliferation of human prostate cells in culture induced by basic fibroblast growth factor (BFGF) or epidermal growth factor (EGF)
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group: of y, fruit Extract a Oral one palmetto 68 Echinacea 25 76 Drops intended the Palmetto subjects (25 palmetto of drops (90-120 (20 Duration: (29 in Supplement Placebo Saw Number Type: Amount: Route: Frequency: Placebo Number Form: Duration: palmetto 10 liquid Saw saw a used of was was Using monitored: preparations, product Urgenin Trials extract/tincture This Subjects Unknown an Parameters Monitored Parameters Clinical Female mg/day)
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From page 467... ...
No relevant adverse event reports
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From page 468... ...
(Paubert Braquet et al., 1998) Males Rat model of prostate hyperplasia due to Extract of saw palmetto fruit androgen stimulation: in castrated rats, administration of testosterone stimulated prostate hyperplasia Oral administration of an extract of saw palmetto fruit (200 mg/d, for 6 d)
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Studies with dogs (oral administration) 20 males with moderate-severe prostate Benign prostatic hypertrophy model in dogs enlargement, but without clinical signs (the only domestic animal that commonly of prostatic hyperplasia, > 4 yr, develops prostatic hyperplasia in aging)
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. Other animal toxicity studies in rats, mice, and dogs have been reported in a review article (Bombardelli and Morazzoni, 1997)
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From page 471... ...
, prostate biopsy samples: apoptotic balance in 10 µg/mL for 24 hours Normal tissue donors: prostate tissue samples: in 10 donors; 9 were ages epithelial tissue from 2029 y, 1 was age 51 y subjects with BPH who BPH biopsy tissue samples: had ingested extract, 10 from subjects apoptotic index was without medical increased (as assessed by treatment, ages 6283 y; TUNEL) compared with 10 from subjects samples from subjects ingesting extract of saw with untreated BPH.
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Addition of extract inhibited binding of [3H] -DHT to androgen receptor(s)
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. Extract of fruit Cells in coculture: human Addition of extract inhibited (Permixon)
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. Petroleum ether extract of Cells in culture: human Addition of pet ether extract fruit genital skin fibroblasts inhibited steroid 5- reductase of fibroblasts.
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CAT = chloramphenicol acetyltransferase, BPH = benign prostatic hypertrophy, TUNEL = terminal deoxynucleotidyl transferase dUTP nick end labeling, BID = twice a day, MIB-1 = a monoclonal antibody used to detect Ki-67 antigen, Ki-67, a proliferation antigen, a cellular protein which is not present during G0 phase of cell cycle, IC50 = concentration at which response has decreased 50 percent of the original response, DHT = dihydrotestosterone, PBH = prostate benign hyperplasia, PSA = prostate-specific antigen.
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, male offspring were observed to have smaller prostate, smaller seminal vesicles, delayed preputial/foreskin separation, and transient nipple development as compared to control animals. In pregnant rats treated with finasteride ( 3 µg/kg/d)
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"Functionally related" substances may exhibit an activity that saw palmetto exhibits, based on in vitro or other data; they are not listed here because they have a similar chemical composition b Botanical ingredients in dietary supplements with uses similar to extracts of saw palmetto fruit were considered. No data suggestive of toxicity are available and thus these substances were omitted from this table.
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