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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., 1970a

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).



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