National Academy of Sciences | 150 Year Anniversary

Questions? Call 800-624-6242

| Items in cart [0]

The National Academies Press

HARDBACK
price:$59.95
add to cart

Rights & Permissions

topleft topright

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

Citation Manager

. "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.

Please select a format:

BibTeX EndNote RefMan


Page
471
bottomleft bottomright

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.


Dietary Supplements: A Framework for Evaluating Safety

TABLE F Saw Palmetto: Summary of In Vitro Studies

Substance

Study Design

Results and Conclusions

Alteration of cells

Saw palmetto, extract of fruit (Permixon)

Cells in culture: PC3 cells cotransfected with androgen receptor (wild-type) and CAT reporter genes (under control of androgen response element)

Addition of extract (25–50 μg/mL) inhibited CAT transcription induced by androgen (methyltrienolone) stimulation. No effect was observed in the absence of androgen-stimulation or in mock-transfected cells (Ravenna et al., 1996).

Saw palmetto, extract of fruit (Permixon), 10 μg/mL for 24 hours

In situ studies in human prostate biopsy samples:

Normal tissue donors: 10 donors; 9 were ages 20–29 y, 1 was age 51 y

BPH biopsy tissue samples: 10 from subjects without medical treatment, ages 62–83 y; 10 from subjects ingesting extract of saw palmetto fruit for previous 3 mo, 320 mg/d, BID

Model of proliferation/ apoptotic balance in prostate tissue samples: in epithelial tissue from subjects with BPH who had ingested extract, apoptotic index was increased (as assessed by TUNEL) compared with samples from subjects with untreated BPH. A small increase in the apoptotic index was observed in stromal tissue.

In epithelial and stromal tissue from subjects with BPH who had ingested extract, proliferative index was decreased (as assessed by a MIB-1 immunohisto-chemical stain for Ki-67 proliferation antigen) compared to samples from subjects with untreated BPH (Vacherot et al., 2000). (The proliferative index is increased in untreated BPH tissues as compared with normal tissues. Ingestion of extract returned the proliferative index to the level found in normal tissue.)

Page
471
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)