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document
Pilot study of Panax quinquefolius ( American ginseng ) to improve cancer-related fatigue : a randomized , double-blind , dose-finding evaluation : NCCTG trial N03CA . PURPOSE This pilot trial sought to investigate whether any of three doses of American ginseng ( Panax quinquefolius ) might help cancer-related fatigue . A secondary aim was to evaluate toxicity . METHODS Eligible adults with cancer were randomized in a double-blind manner , to receive American ginseng in doses of 750 , 1,000 , or 2,000 mg/day or placebo given in twice daily dosing over 8 weeks . Outcome measures included the Brief Fatigue Inventory , vitality subscale of the Medical Outcome Scale Short Form-36 ( SF-36 ) , and the Global Impression of Benefit Scale at 4 and 8 weeks . RESULTS Two hundred ninety patients were accrued to this trial . Nonsignificant trends for all outcomes were seen in favor of the 1,000- and 2,000-mg/day doses of American ginseng . Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460-467 in the placebo group and 750 mg/day group versus 480-551 in the 1,000- and 2,000-mg/day arms , respectively . Change from baseline in the vitality subscale of the SF-36 was 7.3-7.8 in the placebo and the 750-mg/day arm , versus 10.5-14.6 in the 1,000- and 2,000-mg/day arms . Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo . There were no significant differences in any measured toxicities between any of the arms . CONCLUSION There appears to be some activity and tolerable toxicity at 1,000-2,000 mg/day doses of American ginseng with regard to cancer-related fatigue . Thus , further study of American ginseng is warranted .
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Intervention_Pharmacological
Panax quinquefolius ( American ginseng )
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Intervention_Pharmacological
American ginseng ( Panax quinquefolius )
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Intervention_Pharmacological
American ginseng
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Intervention_Control
placebo
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Intervention_Pharmacological
American ginseng
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Intervention_Control
placebo
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Intervention_Control
placebo
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Intervention_Pharmacological
ginseng
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Intervention_Control
placebo
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Intervention_Pharmacological
American ginseng
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Intervention_Pharmacological
American ginseng
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Outcome_Physical
Brief Fatigue Inventory
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Outcome_Physical
vitality subscale of the Medical Outcome Scale Short Form-36 ( SF-36 )
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Outcome_Physical
Global Impression of Benefit Scale
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Outcome_Physical
activity interference from the Brief Fatigue Inventory
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Outcome_Physical
vitality subscale
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Outcome_Other
satisfied
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Outcome_Adverse-effects
toxicities
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Participant_Condition
cancer-related fatigue
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Participant_Condition
cancer-related fatigue
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Participant_Age
adults
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Participant_Condition
cancer
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Participant_Sample-size
Two hundred ninety
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Participant_Condition
cancer-related fatigue