PURLs: Finally, a way to relieve cancer-related fatigue

Posted by Michael Burmeister on

Gayle B. Thomas, MD, Gary N. Asher, MD, MPH, and Anne Mounsey, MD
Bernard Ewigman, MD, MSPH, PURLs EDITOR
Bernard Ewigman, Department of Family Medicine, The University of Chicago

A 4-week course of American ginseng, taken while patients are undergoing radiation or chemotherapy, can reduce cancer-related fatigue.

PRACTICE CHANGER

Recommend American ginseng 1000 mg twice daily for 4 weeks to improve cancer-related fatigue for patients who are undergoing radiation or chemotherapy; no other treatment has been shown to be effective.

STRENGTH OF RECOMMENDATION

B: Based on a single well-done randomized controlled trial (RCT).

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;105:1230-1238.

ILLUSTRATIVE CASE

A 54-year-old woman is receiving chemotherapy for adenocarcinoma of the right breast (T2N1M0) and has persistent, disabling fatigue. She has been unable to work or care for her family since starting chemotherapy. She says she gets enough sleep and denies being depressed or in pain. Lab testing for anemia and thyroid dysfunction is negative.

Is there a safe and effective intervention that can reduce her fatigue?

Cancer-related fatigue is a common, distressing symptom that occurs in more than half of all patients undergoing chemotherapy and over two-thirds of those receiving radiation therapy. For many cancer survivors, fatigue can persist for 5 to 10 years after treatment. Because no treatments have been effective, many clinicians and patients accept it as inevitable. In RCTs, psychostimulants such as methylphenidate and antidepressants such as donepezil and paroxetine have not been found effective. Dietary supplements such as coenzyme Q10 and L-Carnitine also have not been found effective in placebo-controlled trials. The double-blind RCT reported on here looked at whether American ginseng might be effective in relieving cancer-related fatigue.

STUDY SUMMARY: Ginseng reduced fatigue after 8 weeks of treatment

There are 2 major species of ginseng—Asian and American—and they have varying amounts, strengths, and varieties of ginsenosides, which are the active ingredients. In this 8-week, double-blind RCT, Barton et al randomized more than 300 patients from 40 US cancer facilities to receive either 1000 mg of American ginseng twice daily (in the morning and at noon) or matched placebo capsules. Patients were either currently receiving treatment for cancer or were posttreatment, but within 2 years of receiving a cancer diagnosis. All participants had experienced fatigue for at least a month that they rated as ≥4 or higher on a scale of 0 to 10. Patients with other causes of fatigue were excluded, as were those who had pain or insomnia rated ≥4 on a scale of 0 to 10, those with brain cancer or central nervous system (CNS) lymphoma, those taking systemic steroids or opioids, and those who were using, or had used, ginseng or other agents for fatigue.

Of the 364 randomized participants, 300 (147 ginseng patients, 153 placebo patients) remained in the study through the primary endpoint at 4 weeks, and 261 completed the entire 8-week study. There were no baseline differences between groups in demographic characteristics, time since cancer diagnosis, cancer type, current or prior treatment, and fatigue at baseline.

The primary outcome was a change in score on the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Secondary outcomes included a change in MFSI-SF score at 8 weeks. The authors also conducted a subset analysis comparing ginseng vs placebo in just those patients currently undergoing cancer treatment vs those who had completed treatment. To make it easier to compare results, all scores were converted to a 100-point scale; higher scores indicated less fatigue. Adverse events were documented by patient self-report questionnaires and also by researchers who called or visited patients every other week.

While ginseng did not appear to significantly increase the change in fatigue scores over placebo at 4 weeks (14.4 vs 8.2; P=.07), fatigue scores at 8 weeks were significantly improved (20 vs 10.3; P=.003). Interestingly, though, there was a significant improvement in fatigue scores with ginseng at both 4 weeks (P=.02) and 8 weeks (P=.01) when researchers looked at only those patients who were currently receiving cancer treatment. On the other hand, those patients who were not currently undergoing treatment did not show a significant improvement at either time cutoff.

There was no statistically significant difference in adverse events between the ginseng and placebo groups over the 8-week study.

 

Read full article here.


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