Dietary Supplements: A Framework for Evaluating Safety

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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

TABLE B Summary of Adverse Effects in Clinical Trials Using Saw Palmetto in Blended Preparations

Study Design	Subjects	Parameters Monitored	Supplement / Placebo / Reference	Adverse Effects and Related Findings
Clinical Trial Using Blended Preparations with Female Subjects
1 trial, 20 subjects ingested blended saw palmetto-containing preparations, 10 subjects in placebo group
Timmermans and Timmermans, 1990 Randomized? Double-blind? Placebo-control	Condition: Hypotonic bladder [incontinence (18 subjects) and other conditions] Age: 25-76 y *All subjects were female.*	Parameters monitored: Unknown	Saw palmetto group: Number of subjects: 20 (25–68 y, mean age of 45y) Type: Extract of saw palmetto fruit plus extract of Echinacea purpurea in drops^a Amount: 78-104 mg/day (90-120 drops/day) Route: Oral Frequency: ~3 times/day (20–25 drops/dose) Duration: ~ 77 days (mean)	Saw palmetto group: Adverse effects: Unknown
			Placebo group: Number of subjects: 10 (29–76 y, mean age of 52 y) Form: Drops Duration: ~52 days (mean)	Placebo group: Adverse effects: Unknown
^a Urgenin® (Madaus GmbH, Wien, Austria) contained an extract/tincture of saw palmetto fruit (78-104 mg/day) and an extract of rhizomes/roots of purple coneflower (Echinacea purpurea) (84-112 mg/day). This product was a liquid intended for use as drops (~25 drops) to be ingested in water before meals (or after meals in subjects with gastric disturbances). Urgenin was used in the one clinical trial with female subjects summarized in this table.