Ginseng Improves Cancer-Related Fatigue in Phase III Trial

Debra Barton, PhD, RN

A multisite, randomized, double-blind trial evaluating the fatigue-ameliorating properties of American ginseng in cancer patients and recent survivors has found the herb to be helpful in reducing some aspects of cancer-related fatigue (CRF), with the benefit strongest among patients currently in treatment.

Encouraging results from two earlier pilot studies of Asian and American ginseng, respectively, suggested that the herb has the potential to help alleviate CRF, which is one of the most prevalent and activity-restricting symptoms patients and survivors face. Preclinical studies also have shown both a link between CRF and inflammation, as well as anti-inflammatory properties associated with ginseng.

Researchers, led by Debra Barton, PhD, RN, from the Mayo Clinic Cancer Center, tested the efficacy of 2000 mg daily of American ginseng in alleviating CRF. Both the Asian (Panax ginseng) and American (Panax quinquefolius) species have a similar mix of active ingredients, but amounts and strengths do vary among the species.

A total of 364 patients at 40 different sites received ginseng twice daily or placebo over an 8-week period. All tumor types were eligible, with the exception of brain cancer and central nervous system lymphoma; to be eligible for the study, patients needed to be in curative treatment or have been treated within the past 2 years, with a baseline CRF score ≥4 (on an 11-point scale where 0 is “no fatigue” and 10 equal to “as bad as it can be”). Those who had previously used ginseng or other agents for fatigue were not eligible, and for patients currently in treatment, there could be no changes planned in their regimens over the course of the 8-week study period.

The study’s primary endpoint was patient ratings on the Multidimensional Fatigue Symptom Inventory—Short Form (MFSI-SF), with assessments carried out at baseline and at weeks 4 and 8. Other outcomes examined included the Profile of Mood States (POMS) and the Brief Fatigue Inventory (BFI). To make outcome comparisons more straightforward across the different instruments, researchers converted scores to a 100-point scale, with higher numbers meaning less fatigue.

At 4 weeks, patients in the ginseng cohort showed a change from baseline on the MFSI-SF of 14.4 versus 8.2 in the placebo group, and a statistically significant fatigue improvement of 20 versus 10.3, respectively, at 8 weeks. The researchers noted that this finding suggests that clinically meaningful results from ginseng (defined as a difference of ≥10 points on the 100-point scale) may not appear until 2 months after starting it.

Looking at the other measures, patients in the ginseng arm showed statistically significant improvements on the fatigue-inertia subscale of the MFSI-SF and the vigor-activity subscale of the POMS, but not on the BFI total score or activity interference measures.

A planned subset analysis compared the effect of the ginseng intervention in patients currently in treatment with those who had completed it. This analysis demonstrated that patients who were currently receiving chemotherapy and/or radiation had better fatigue scores in the ginseng group than did those in the placebo arm, and this was true at both the 4- and 8-week intervals.

Investigators also wanted to determine toxicities related to ginseng, so side-effect data were collected from patients using weekly self-report questionnaires, and from providers using the Common Terminology Criteria for Adverse Events (CTCAE). No significant differences in patient-reported toxicities or provider CTCAE grading were seen between the two arms of the study.

Overall, the researchers reported that more patients responded positively to the ginseng intervention and demonstrated a strong clinical benefit equivalent to a ≥30% improvement compared with those on placebo, a finding that suggests a need for additional research on the herb’s efficacy in ameliorating CRF, as well as work toward a safe, standardized, accessible ginseng product, which is currently not subject to FDA regulation.

Barton DL, Liu H, Dakhil SR, et al. Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2 [published online ahead of print July 13, 2013]. J Natl Cancer Inst. doi:10.1093/jnci/djt181.