I read the study by Barton and colleagues in Journal of the National Cancer Institute with great interest. Ginseng seems potentially to be one treatment for cancer-related fatigue, a poorly understood but debilitating symptom that patients experience during and after treatment.1
I am impressed that the authors have not only built on phase II trial data to power a full trial, but have also published the study in one of the major cancer journals. It is rightfully in the spotlight, as nearly all patients undergoing cancer treatment feel the major effects of fatigue. We also know that experiencing higher-than-average fatigue on treatment puts a patient at higher risk of long-term fatigue after completion of successful treatment—for up to years afterwards.2
We must be able to offer patients potential interventions and guidance upon completion of treatment. This need not be limited to drugs and could include exercise, especially in cancer survivors. However, as patient groups have pointed out, in the maelstrom of treatment, this is not always practical. A pill to be taken offers an easier solution to reduce fatigue—ginseng may be the pill we reach for.
I would not want to overplay the results of this trial—it is one isolated finding. In comparison, although there have been negative trials of psychostimulants, psychostimulant treatment maintains a moderate positive effect on meta-analysis.3 It is too early based on one trial—which, as the authors state, has a low effect size—to dismiss all pharmacologic alternatives.
My ongoing query (shared with the authors) concerns what ginseng is doing to ameliorate fatigue—especially given that there was not a significant difference between groups in the primary endpoint of fatigue at 4 weeks. Also, while toxicities experienced may have been minimal, this does not preclude longer-term harm from prolonged use, however unlikely it may be.
In addition, as ginseng is not a drug per se and is not regulated to the same degree, preparations will differ. This is an important practical aspect, as even the authors struggled to obtain the same preparation as that used in the preceding phase II study. There is a clear suggestion of a dose-response effect, which will need to be explored in conjunction with our understanding of the mechanisms of fatigue.4
I would feel able to recommend ginseng to my patients, knowing its limitations. However, I would be clear that the exact formulation needs to be carefully examined. Herbal remedies are not without potential harm, and it will be vital to exclude other “natural” ingredients in a mixture. I also don’t know how American ginseng availability would affect wider use. I would want to be reassured that this is a class effect of ginseng going forward.
I would make the following recommendations for future research: (1) Use different formulations of ginseng and measure inflammatory markers to correlate to clinical outcomes; and (2) Separate out the on-treatment and long-term survivor populations to identify the distinct roles of acute and chronic fatigue. ■
Dr. Minton is Consultant and Honorary Senior Lecturer in Palliative Medicine, St. George’s, University of London, UK.
Disclosure: Dr. Minton reported no potential conflicts of interest.
1. Minton O, Berger A, Barsevick A, et al: Cancer-related fatigue and its impact on functioning. Cancer 119:2124-2130, 2013.
2. Minton O, Stone P: How common is fatigue in disease-free breast cancer survivors? A systematic review of the literature. Breast Cancer Res Treat 112:5-13, 2008.
3. Minton O, Richardson A, Sharpe M, et al: Psychostimulants for the management of cancer-related fatigue: A systematic review and meta-analysis. J Pain Symptom Manage 41:761-767, 2011.
4. Minton O, Stone PC: Review: The use of proteomics as a research methodology for studying cancer-related fatigue: A review. Palliat Med 24:310-316, 2010.
In a collaborative phase III trial of the North Central Cancer Treatment Group and Mayo Clinic (N07C2) reported in Journal of the National Cancer Institute by Debra L. Barton, RN, PhD, AOCN, FAAN, of the Mayo Clinic and colleagues, patients with cancer-related fatigue were treated with Wisconsin...