Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind Trial, N07C2
- Study type
- Clinical trial
- Study name
- N07C2
- Phase
- Phase 3
- Design
- Multicentre, randomised, double-blind trial (placebo comparison)
- Sample size
- 364 participants from 40 institutions
- Source
- JNCI Journal of the National Cancer Institute · 2013
In plain words
Fatigue caused by cancer is a common problem and there are few safe treatments for it. In this study, cancer survivors with fatigue were given either American ginseng or a placebo (dummy pill) for 8 weeks. After 8 weeks, fatigue had eased more in the ginseng group, and no notable side effects were seen. Even so, always talk to your treating doctor before taking any herbal supplement.
Key results
Treatment arms and regimens
American ginseng 2000 mg (daily) for 8 weeks. Further details (such as the number and form of capsules) are in the full text.
Placebo for 8 weeks. Details are in the full text.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Cancer survivors with fatigue enrolled in a multicentre trial. Exact eligibility criteria are not given in the abstract and are available in the full text.
Endpoints
Primary endpoint: the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at week 4. Change from baseline at weeks 4 and 8 was compared between groups with a two-sided two-sample t test. Toxicities were assessed by patient self-report and provider grading per the National Cancer Institute CTCAE criteria.
Safety and side effects
Toxicities by patient self-report and CTCAE grading did not differ significantly between the groups. No notable treatment-related toxicity is reported in the abstract.
Clinical significance and place in guidelines
This trial supports a benefit of American ginseng at 2000 mg per day on cancer-related fatigue over 8 weeks with no discernible toxicity, but the authors stress that further studies are needed to define the exact role of ginseng. Guideline recommendation status should be checked separately and is not mentioned in the abstract.
Limitations
The difference at the primary endpoint (week 4) was not statistically significant (P=0.07), and a significant difference was seen at week 8. The abstract indicates that the benefit was greater in patients receiving active treatment; the authors themselves stress the need for further studies. Other limitations should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.