A Randomized, Double-Blind Trial
J. Natl. Cancer Inst. 2013 Aug 21;105(16)1230-1238, DL Barton, H Liu, SR Dakhil, B Linquist, JA Sloan, CR Nichols, TW McGinn, PJ Stella, GR Seeger, A Sood, CL Loprinzi
ABSTRACT
Background: Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF.
Methods: A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) provider grading.
Results: Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms.
Conclusions: Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.
TAKE-HOME MESSAGE
- Is American ginseng effective in improving cancer-related fatigue?
- Patients with cancer-related fatigue from multiple sites were randomized to ginseng vs placebo.
- Results showed that 2000 mg of American ginseng improved fatigue at 8 weeks of follow-up without toxicity.
Story Source: http://www.practiceupdate.com/journalscan/5990
Link to Abstract: http://dx.doi.org/10.1093/jnci/djt181