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

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. "Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral." 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

Subject/Supplement

Adverse Effectsc and Related Findings

49-year-old female (Heron’s patient no. 1)

Multiherb tincture containing 8% chaparral,d ≤ 32 mL taken over 3.5 mo; proposed as a treatment for allergies

Concurrent drug use: estrogens, progesterone, fluticasone nasal spray

Concurrent herbals use: numerous

Subject reported dizziness when 10 mL was taken at one time

General clinical history and physical examination findings were unremarkable; clinical lab tests were virtually unchanged, including serum liver enzymes, BUN, creatinine, glucose, electrolytes, bilirubin, iron ferritin, lipoproteins, and CBC; no elevations in liver function tests that would have indicated liver damage (Heron and Yarnell, 2001)

52-year-old female (Heron’s patient no. 2)

Multiherb tincture containing 8% chaparral, ≤ 240 mL taken over 5 mo; proposed as a treatment for respiratory symptoms of allergies

Concurrent medications: loratidine, clonazepam, zolpidem, valproic acid, thyroid hormone

Concomitant botanicals use: numerous

No elevations in liver function tests that would have indicated liver damage; changes in clinical laboratory values were likely related to concurrent medications; subject had chronic low WBC and platelet counts and low HDL cholesterol; TSH was high necessitating change in medication dose (Heron and Yarnell, 2001)

53-year-old male (Heron’s patient no. 3)

Multiherb tincture containing 7% chaparral, ≤ 34 mL taken over 40 d; proposed as treatment for painful axillary lymphadenopathy, which was later diagnosed as malignant melanoma, 5 mL, 1×/d

Recurrence: 5 combined mL tincture, 3×/d plus topical chaparral in castor oil

Clinical lab tests included serum liver enzymes, BUN, creatinine, glucose, electrolytes, bilirubin, iron ferritin, lipoproteins, and CBC

No elevations in blood levels of hepatic enzymes that would indicate liver damage

Subject’s clinical laboratory values did change in a manner consistent with the eventual diagnosis of malignant melanoma; the disease had metastasized (Heron and Yarnell, 2001)

51-year-old female (Heron’s patient no. 4)

Multiherb tinctures containing 10% chaparral, 5 mL, 3×/d, ≤ 138 mL taken over 3–4 mo; proposed as aid in weight-loss program

General clinical history and physical examination findings were unremarkable; clinical lab tests were virtually unchanged, including serum liver enzymes, BUN, creatinine, glucose, electrolytes, bilirubin, iron ferritin, lipoproteins, and CBC

Page
433
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)