Western Regional Blog – BC, YK, AB, NWT and Nunavut
Several important strengths of this study comparing ginseng to placebo make the findings relevant for practice.
Patients from 40 cancer centers, most in community settings, were enrolled; changes in fatigue were consistent with two well-validated measures and were of a magnitude that is considered clinically meaningful. The results reported in the current trial are consistent with those seen in our previously published randomized, placebo-controlled, dose-finding study.1 Therefore, enough information presented here supports ginseng as an option for patients with cancer-related fatigue, with the caveat that more studies would help us understand this treatment better.
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.
J. Natl. Cancer Inst. 2013 Jul 13;[EPub Ahead of Print], DL Barton, H Liu, SR Dakhil, B Linquist, JA Sloan, CR Nichols, TW McGinn, PJ Stella, GR Seeger, A Sood, CL Loprinzi
1. Barton DL, Soori GS, Bauer BA, et al. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010;18(2):179-187.