Barton, D.L., Liu, H., Dakhil, S.R., Linquist, B., Sloan, J.A., Nichols, C.R., . . . Loprinzi, C.L. (2013). Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2. Journal of the National Cancer Institute, 105, 1230–1238.
DOI Link
Study Purpose
To evaluate the efficacy of Wisconsin ginseng on cancer-related fatigue (CRF).
Intervention Characteristics/Basic Study Process
2,000 mg of Wisconsin ginseng or placebo BID (breakfast and lunch) over eight weeks. The assessment conducted at baseline and at four and eight weeks.
Sample Characteristics
- N = 364
- MEAN AGE = 55.3 years for the ginseng group, 55.9 for the placebo group
- MALES: 19% in ginseng group and 25% in placebo group, FEMALES: 81% in ginseng group and 75% in placebo group
- KEY DISEASE CHARACTERISTICS: Primarily breast (64% in ginseng and 57% in placebo groups) but included colon, prostate, hematologic, gynecologic, and combination/unknown/other cancers having completed or receiving curative intent therapy within past two years and who scored a minimum of 4 on 11-point scale that was present at least a month prior to study entry.
- OTHER KEY SAMPLE CHARACTERISTICS: Some were on active treatment during the study and some were post-cancer treatment.
Setting
- SITE: Multi-site
- SETTING TYPE: Not specified
- LOCATION: Mostly community cancer centers; location not specified
Phase of Care and Clinical Applications
- PHASE OF CARE: Multiple phases of care
Study Design
- Randomized, double-blind trial
Measurement Instruments/Methods
- Multidimensional Fatigue Symptom Inventory–Short Form (general subscale)
- Profile of Mood States (fatigue-inertia and vigor-activity subscales)
- Brief Fatigue Inventory
- CTCAE (version not specified)
Results
Statistically significant changes in scores for MFSI-SF between ginseng and placebo groups at four and eight weeks was in favor of ginseng, but only among those in active treatment. No differences in BFI scores were noted. Greater benefit reported among patients receiving active cancer treatment versus those who had completed treatment.
Conclusions
The ginseng group had improvements in fatigue scores over four- and eight-week periods without significant toxicities. However, data lacking on selected drug-ginseng interactions.
Limitations
- Selective outcomes reporting
- Subject withdrawals ≥ 10%
Nursing Implications
Supports use of (controlled, manufactured) Wisconsin ginseng to modify CRF; however, more research is needed to determine how to maximize positive effects. It appears that ginseng effects may only be seen during active treatment.