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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

 

Quercitrin – 3,3,4,5,7-pentahydroxyflavone (Hiermann, 1989). In vitro: inhibitor of human prostate type 1 steroid 5--reductase (transfected as cDNA into rat 1A cells in culture; IC50 23 μM) (Hiipakka et al., 2002). Inhibited platelet aggregation and (Kokkalou and Souleles, 1988).

Isoquercitrin – quercetin-3-glucoside (Hiermann, 1989).

Rutin – quercitin-3-O-rutinoside (Hiermann, 1989).

Polyprenoids – No data suggestive of toxicity are available.

 

Farnesol – C15:3; 3 isoprenic units (Jommi et al., 1988). In vitro: farnesol or geraniol (30 ηg/mL) inhibited proliferation of human prostate cells in culture induced by basic fibroblast growth factor (BFGF) or epidermal growth factor (EGF) (Paubert-Braquet et al., 1998; data not shown). Geraniol is a precursor of farnesyl pyrophosphate and geranyl geraniol.

Phytol – C20:1; 4 isoprenic units (Jommi et al., 1988).

Geranyl geraniol – C20:4; 4 isoprenic units (Jommi et al., 1988).

Serenoa polyprenol 2 – C30; 0.0005% of dry weight (Jommi et al., 1988).

Serenoa polyprenol 3 – C35; 0.0035% of dry weight (Jommi et al., 1988).

Octamethyldotriacontaoctaenol – C40:8; 8 isoprenic units; 0.027% of dry weight (Jommi et al., 1988).

Nonamethylhexatriacontanonaenol – C45:9; 9 isoprenic units (Jommi et al., 1988).

Phenolic glycosides – No data suggestive of toxicity are available.

Populin – 2-(hydroxymethyl)phenyl--D-glucopyranoside 6-benzoate (Hiermann, 1989).

Water-soluble components

Saccharides – No data suggestive of toxicity are available.

 

Monosaccharides – Glucose, fructose, galactose, mannose, arabinose, fucose, rhamnose, glucuronic acid, uronic acid, xylose (Harnischfeger and Stolze, 1989; Jommi et al., 1988; Wagner and Flachsbarth, 1981).

Polysaccharides: galactoarabane.

High-molecular-weight polysaccharides: acidic high molecular weight polysaccharides (25–500 kDa with immunostimulating activity) (Wagner et al., 1985).

NOTE: IC50 = concentration at which response has decreased to 50 percent of the original response, cDNA = complementary to mRNA.

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465
Front Matter (R1-R20)
Executive Summary (1-18)
1 Introduction and Background (19-42)
2 Approaches Used by Others and Existing Safety Frameworks (43-84)
3 The Framework (85-125)
4 Categories of Scientific Evidence--Human Information and Data (126-155)
5 Categories of Scientific Evidence--Animal Data (156-174)
6 Categories of Scientific Evidence--Information About Related Substances (175-216)
7 Categories of Scientific Evidence--In Vitro Data (217-234)
8 Interactions (235-246)
9 Vulnerable Groups and Prevalance of Use (247-252)
10 Scientific Principles for Integrating and Evaluating the Available Data (253-268)
11 Applying the Framework: Case Studies Using the Prototype Safety Monographs (269-291)
12 Factors Influencing Use of the Safety Framework (292-296)
13 Findings and Recommendations (297-306)
Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances (307-315)
Appendix B: Scope of Work and Comments to Initial July 2002 Framework (316-321)
Appendix C: Plant Family Information (322-355)
Appendix D: Chaparral: Prototype Monograph Summary (356-362)
Appendix E: Glucosamine: Prototype Monograph Summary (363-366)
Appendix F: Melatonin: Prototype Monograph Summary (367-371)
Appendix G: Chromium Picolinate: Prototype Monograph Summary (372-375)
Appendix H: Saw Palmetto: Prototype Monograph Summary (376-379)
Appendix I: Shark Cartilage: Prototype Monograph Summary (380-384)
Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral (385-449)
Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women (450-477)
Appendix L: Acknowledgements (478-480)
Appendix M: Biographical Sketches of Commitee Members (481-488)
Index (489-506)