North Central Cancer Treatment Group (NCCTG) researchers, based at Mayo Clinic in Rochester, Minn., have generated preliminary data suggesting that a form of American ginseng provides greater improvements in fatigue and vitality in patients who receive the highest doses tested, compared to lower doses or no treatment.
The results of their scientifically rigorous pilot study, the first to evaluate the Wisconsin species of American ginseng as a possible therapy for cancer-related fatigue, were presented June 3 at the annual meeting of the American Society of Clinical Oncology.
Many cancer patients face extreme fatigue after diagnosis and during treatment. Getting more sleep or rest often does not relieve the fatigue, nor is it related to activity levels. Other than exercise, there isn't a good solution available for these patients.
"We hope that Wisconsin ginseng may offer us a much-needed treatment to improve our patients' quality of life, and we look forward to further evaluation," says Debra Barton, Ph.D. a registered nurse, Mayo Clinic cancer researcher and the study's primary investigator.
"Cancer-related fatigue is one of the most profound and distressing issues patients face," she says. This unique type of fatigue can have dozens of causes, and for patients who have completed cancer therapy, fatigue is among their foremost concerns, second only to fear of disease recurrence."
Traditional Chinese medicine and current understanding of ginseng's function both point to its characteristics as an adaptogen -- a substance that helps the body overcome the effects of environmental stress. Since cancer patients have stressors ranging from the psychological stress of diagnosis to the physiological stresses of chemotherapy and radiation, if ginseng helps, the researchers think it would be a valuable addition to currently available therapies.
"With animal data indicating the possibilities of ginseng with respect to increased swimming endurance, and the availability and verified product quality of Wisconsin ginseng, we decided to move forward with a pilot study," says Dr. Barton.
The investigators enrolled 282 patients in a randomized, placebo-controlled trial, averaging 71 patients per each of four arms, with between 39 and 48 patients in each arm completing the eight weeks of treatment. Treatment arms consisted of placebo, and three different daily doses of Wisconsin ginseng -- 750, 1,000 and 2,000 milligrams.
Of the four treatment arms, patients receiving the placebo and the lowest dose of ginseng reported very little improvement in fatigue or other areas of physical or psychological well-being. The patients receiving the larger doses showed improvements in overall energy levels, reporting higher vitality levels and less interference with activity from fatigue. They also reported an improvement in overall mental, physical, spiritual and emotional well-being.
Because this was a pilot trial designed to pinpoint which aspects of fatigue ginseng might help alleviate, determine likely dosage options, and identify possible side effects, Dr. Barton cautions against immediate addition of ginseng supplements to any patient's therapeutic regimen. "While results were promising, we have more research to conduct," she says. "And besides, it's just not a good idea to grab the nearest bottle on the supermarket shelf -- consumers need to research the company and the product. Because there is less federal regulation of dietary supplements, there is no consistency in currently available products. In fact, some research has shown various supplements to contain little or no amount of the ingredient on the label, and sometimes even harmful contaminants."
Dr. Barton's research team hopes to open a new clinical trial in 2008 looking at a specific dose of Wisconsin ginseng versus placebo and trying to better refine the results, in hopes of a confirming a new treatment option for cancer-related fatigue.
According to the National Center for Health Statistics Americans spend between $36 billion and $47 billion per year on complementary and alternative therapies, including herbal supplements. A recent study authored by Mayo Clinic resident Aditya Bardia, M.D., reports that two-thirds of people who use herbs do not use any scientific evidence-based information to guide their purchases. To aid consumers in their decision-making process, Mayo Clinic recently published a book addressing current knowledge regarding a number of complementary and alternative therapies. The Mayo Clinic Book of Alternative Medicine dispels myths and sheds light on therapies that have been scientifically studied for safety and effectiveness.
The ginseng study was a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported by a number of Public Health Service grants. The ginseng used in the study was provided by members of the Ginseng Research Institute of America. Other Mayo Clinic researchers included Brent Bauer, M.D.; Jeff Sloan, Ph.D.; Heshan Liu; and Charles Loprinzi, M.D. Collaborating researchers from other NCCTG member or affiliate institutions included Gamini Soori, M.D., Missouri Valley Cancer Consortium, Omaha, Neb.; Patricia Johnson, M.D., Carle Cancer Center Community Clinical Oncology Program (CCOP), Urbana, Ill.; Cesar Figueras, R.N., B.S.N., Michigan Cancer Research Consortium, Ann Arbor, Mich.; Steven Duane, M.D., Metro-Minnesota CCOP, St. Louis Park, Minn.; and Shaker Dakhil, M.D., Wichita CCOP, Wichita, Kan. A number of other institutions also participated within their relationship to the NCCTG.
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