CHICAGO — American ginseng showed promise for reducing fatigue among patients with several types of cancer in a placebo-controlled, randomized pilot trial presented at the annual meeting of the American Society of Clinical Oncology.
Patients on higher doses of ginseng—1,000 mg and 2,000 mg/day—had a better mean change on the vitality subscale of the SF-36 than did those on placebo or on the 750-mg/day dose during 8 weeks of treatment.
“We believe that ginseng doses of 1,000–2,000 mg should be evaluated [further] for the treatment of cancer-related fatigue,” said Debra Barton, Ph.D., an associate professor of oncology at the Mayo Clinic in Rochester, Minn.
Up to 90% of cancer survivors experience fatigue. So far, exercise is the only treatment with a well-established evidence base.
Evidence from animal studies has suggested that American ginseng could be useful for treating fatigue in these patients, but there have been no well-designed clinical trials.
Results from a randomized, controlled trial are welcome news for many physicians who struggle with what to tell their patients about herbal supplements, said Dr. Bruce D. Cheson, director of hematology services at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital in Washington, and moderator of a press briefing on alternative therapies.
“One of the most common questions my patients ask me is about these things they have snookered away in their purses and pocketbooks. They pull out a whole big bag of [supplements] and say, 'Can I take this?' or 'Is this going to help me?' … Most of the time we can't answer that,” Dr. Cheson said.
For this study, 282 patients were randomized to placebo or to 750 mg, 1,000 mg, or 2,000 mg/day of American ginseng for 8 weeks. Patients assigned to the intervention received powdered extract of 4-year-old Wisconsin ginseng root in capsules. The placebo group received matching placebo capsules. The ginseng capsules were standardized to a 5% ginsenoside content. Ginsenosides, found exclusively in ginseng, are phytoestrogens with a common steroidlike chemical structure; they are thought to be the active compounds responsible for reducing fatigue.
Patients were included if they had cancer-related fatigue rated as at least 4 on a 0- to 10-point scale. They also had to have fatigue for at least a month but no other reasons for fatigue. They could not be on any treatments for fatigue.
Patients were assessed using the vitality subscale of the SF-36 health survey (0–100 points), a linear analog self-assessment scale, and the Global Impression of Change tool.
A total of 175 patients completed the trial. Those who dropped out were fairly evenly distributed among the groups. Patient were more likely to drop out during the first 4 weeks. Patients who dropped out were also twice as likely to have stage III or IV disease. Patients on 1,000-mg and 2,000-mg doses had mean improvements of 14.6 and 10.5, respectively, on the vitality subscale of the SF-36. Those on placebo or 750 mg had improvements of 7.3 and 7.8, respectively.
Patients on 1,000 mg had the greatest mean change in overall physical well-being, improving 12 points on the 100-point scale.
Those on placebo, 750 mg, and 2,000 mg improved by 5.6, 5.3, and 6.5 points, respectively. Only 10% of patients in the placebo and 750-mg groups perceived that their fatigue improved moderately or very much, compared with 25% of those in the 1,000-mg group and 27% of those in the 2,000-mg group.
“[Roughly] three times as many patients in the higher-dose arms were more likely to be satisfied with treatment” than those on placebo, Dr. Barton said. A third of patients in the 1,000-mg and 2,000-mg groups were satisfied, compared with 13% in the placebo group and 24% in the 750-mg group.
Side effects were assessed using a questionnaire that asked patients to rate various symptoms, such as nausea, on a scale of 0–10. There was no suggestion of gastrointestinal symptoms, neurologic symptoms, or sleep trouble.
Despite the positive findings, patients shouldn't rush right out and start taking ginseng, Dr. Barton indicated.
“As a physician or nurse, what I would recommend patients do is the evidence-based, proven treatment for fatigue, which right now is exercise,” she said. “If a patient really insisted that they wanted to take something now and they wanted to take ginseng, it's their right to do so. I would guide them to a product that I knew had ginseng in it.”
Supplement purity is often a stumbling block in trial design and something that patients often don't consider.
When patients buy supplements, “they may not be getting pure anything,” Dr. Cheson pointed out.