Dietary Supplements: A Framework for Evaluating Safety

Questions? Call 800-624-6242

About | Ordering | New

LoginRegister

| Items in cart [0]

HARDBACK
price:$59.95
add to cart

Rights & Permissions

Free PDF Access

Free Resources

Related Titles

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

Citation Manager Export the bibliographic data for this book in your chosen format
Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web.
Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book.
Reference Finder Paste in your own text to find books that relate to your topic.

Citation Manager

. "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.

Please select a format:

Page
420


E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore

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 B Chaparral: Summary of Adverse Effects in a Clinical Trial

Study Design

Subjects

Parameters Monitored

Supplement

Adverse Effects and Related Findings

Smart et al., 1970^a

36 subjects in chaparral tea group; 23 subjects in NDGA group; no control group

Condition: advanced incurable malignancy

Age: unknown

Male/Female: unknown

Concurrent medications: at least one subject continued treatment with 5-fluorouracil

Pre-existing medical conditions: none mentioned beyond malignancy

Parameters monitored: Regression vs. nonregression

Hemoglobin, white blood cell count, BUN, SGOT, and urinalysis (before trial and at 2–4 wk intervals in the majority of subjects)

Subjective improvement

Duration was not stated but most subjects (≥ 45 out of the total 59 subjects) were treated for ≥ 4 wk

Chaparral tea group:

Number of subjects: 36

Dose: chaparral tea, 16–24 oz/d

Route: oral

Frequency: 1×/d

Duration: unknown

NDGA group:

Number of subjects: 23

Dose: NDGA, 250–3,000 mg/d

Route: oral

Frequency: 1×/d

Duration: unknown

Combined groups:

Adverse effects: fever (1 subject) In a significant number of subjects, there appeared to be stimulation of tumor growth

No clinical laboratory abnormalities were observed that could be attributed to chaparral tea or NDGA

Total of 14 subjects (25%) withdrew before 4 wk and were not evaluated

NOTE: NDGA = nordihydroguaiaretic acid, BUN = blood urea nitrogen, SGOT = serum glutamic-oxaloacetic transaminase.

^a This study was evaluated as published with additional information and quotes from one of the authors published by the American Cancer Society (ACS, 1970).