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FPIN Journal Club
RANDOMIZED CONTROLLED TRIAL
SPEAKER NOTES
Title: Finally, a way to relieve cancer-related fatigue
PURL Citation: J Fam Pract. 2014 May;63(5):270-272.
Original Article: Barton DL, Liu H, Dakhil SR et al. Wisconsin Ginseng (Panax quinquefolius) to
Improve Cancer-Related Fatigue: A Randomized, Double-Blind Trial, N07C2. J Natl Cancer Inst.
2013 Aug 21;105(16):1230-8.
Journal Club Author: Sarah-Anne Schumann, MD, University of Oklahoma Tulsa
Journal Club Editor: Corey Lyon, DO University of Colorado
1. What question did the study attempt to answer?
Patients - cancer patients within 2 years of diagnosis either currently in treatment or posttreatment with fatigue
Intervention – 1000 mg American ginseng twice daily
Comparison - placebo
Outcome – change in score on Multidimensional Fatigue Symptom Inventory at 4 and 8 weeks
Did the study address an appropriate and clearly focused question
Yes
No
2. Determining Relevance:
a. Did the authors study a clinically meaningful
Yes
No
and/or a patient oriented outcome?
b. The patients covered by the review similar to your population
Yes
No
It depends on whether the physician manage patients currently receiving treatment
for cancer
3. Determining Validity:
Study design;
a. Was it a controlled trial?
Yes
No
b. Were patients randomly allocated to
comparison groups?
Yes
No
Unclear
c. Were groups similar at the start of a trial?
Yes
No
Unclear
Yes
No
Unclear
No
Unclear
d. Were patients and study personnel “blind” to treatment?
e. Aside from allocated treatment, were groups treated equally?
Yes
f. Were all patients who entered the trial properly accounted for at it’s conclusion
Yes
No
Unclear
4. What are the results?
a. What are the overall results of the study?
Changes from baseline in the general subscale of the MFSI-SF (100 point scale,
higher score indicate less fatigue) were 14.4 in the ginseng arm vs 8.2 in the placebo
arm at 4 weeks, which was not statistically different (primary outcome) (P = .07).
However, a statistically significant difference was seen at 8 weeks with a change score of
20 for the ginseng group and 10.3 for the placebo group (P = .003). Greater benefit was
reported in patients receiving active cancer treatment at both 4 weeks (P=.02) and 8
weeks (P=.01) whereas patients not receiving treatment did not show a significant
difference at either time point. Toxicities per self-report and CTCAE grading did not
differ statistically significantly between arms.
b. Are the results statistically significant?
c. Are the results clinically significant?
d. Were there other factors that might have
affected the outcome?
Yes
Yes
No
No
Yes
No
5. Applying the evidence:
a. If the findings are valid and relevant, will this change
your current practice?
Yes
No
There is currently no other treatment for cancer related fatigue
b. Is the change in practice something that can be done in
a medical care setting of a family physician?
Yes
No
Yes, be sure to use American ginseng root, as was used in this study
c. Can the results be implemented?
Yes
No
d. Are there any barrier to immediate implementation?
Yes
No
However, should be cautions with pts on Coumadin and follow INR
e. How was this study funded? NCI and Breast Cancer Research Foundation
6. Teaching Points
Statistical vs clinical significance:
This article provides a good opportunity to discuss the difference of statistical significance and
clinical significance. Statistical significance tell us if the difference between the 2 interventions
is due to chance, or the difference is the intervention under investigation. Here, the difference
at 8 weeks in the fatigue score of 20 for the ginseng group vs 10.3 for the placebo group, with a
p value of 0.003, is statistically significant; we are confident that this difference is due to the
ginseng. We know this is statistically significant based on the p value; the readers need to
decide whether a difference of 10 points on a 100 point scale is clinically significant or not.
In this trial, they attempt to help with that; they define “strong clinical response” as >30%
improvement, which most patients obtained (figure 3).