Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA.

2 juli 2012: Hier het meest recente abstract van onderstaand artikel en studie uit 2007 over gebruik van Ginseng - Panax quinquefolius door kankerpatiënten tegen chronische vermoeidheid veroorzaakt door hun kanker.

Support Care Cancer. 2010 Feb;18(2):179-87. Epub 2009 May 6.

Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA.

Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL.

Source

Mayo Clinic and Mayo Foundation, 200 First Street, SW, Rochester, MN 55905, USA. barton.debra@mayo.edu

Abstract

PURPOSE:

This pilot trial sought to investigate whether any of three doses of American ginseng (Panax quinquefolius) might help cancer-related fatigue. A secondary aim was to evaluate toxicity.

METHODS:

Eligible adults with cancer were randomized in a double-blind manner, to receive American ginseng in doses of 750, 1,000, or 2,000 mg/day or placebo given in twice daily dosing over 8 weeks. Outcome measures included the Brief Fatigue Inventory, vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36), and the Global Impression of Benefit Scale at 4 and 8 weeks.

RESULTS:

Two hundred ninety patients were accrued to this trial. Nonsignificant trends for all outcomes were seen in favor of the 1,000- and 2,000-mg/day doses of American ginseng. Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460-467 in the placebo group and 750 mg/day group versus 480-551 in the 1,000- and 2,000-mg/day arms, respectively. Change from baseline in the vitality subscale of the SF-36 was 7.3-7.8 in the placebo and the 750-mg/day arm, versus 10.5-14.6 in the 1,000- and 2,000-mg/day arms. Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo. There were no significant differences in any measured toxicities between any of the arms.

CONCLUSION:

There appears to be some activity and tolerable toxicity at 1,000-2,000 mg/day doses of American ginseng with regard to cancer-related fatigue. Thus, further study of American ginseng is warranted.

PMID:: 19415341; [PubMed - indexed for MEDLINE]

10 juni 2007: Bron: Nutraingredients.com

Ginseng helpt tegen vermoeidheid welke is gerelateerd aan kanker. Dit blijkt uit een gerandomiseerde placebo gecontroleerde studie bij 282 kankerpatienten aan de Mayo Clinic. Afhankelijk van de dosis, er werden drie verschillen doses uitgeprobeerd voelden de kankerpatienten die Ginseng namen zich bij de hogste dosis significant beter en energieker dan de patienten in de controlegroep. Zo ook bleek het algemeen welbwevinden significant beter. Hier eeerst het bericht over deze studie zoals Nutraingredients dat publiceerde, nadat eerder de studie was gepresenteerd op ASCO 2007. Daaronder een studieverslag van de Mayo Clinic waar het onderzoek plaatsvond br>

05/06/2007 - Ginseng may help patients suffering from cancer-related fatigue, according to researchers based at Mayo Clinic, Rochester, US.

Researchers with the North Central Cancer Treatment Group (NCCTG) have suggested that patients who take high doses of a form of American ginseng suffer less from fatigue that their peers. 

Many cancer patients face extreme fatigue after diagnosis and during treatment and getting more sleep or rest often does not relieve the problem. 
"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," said Debra Barton, the study's lead researcher. 

The scientists enrolled 282 patients in a randomized, placebo-controlled trial, whereby different groups received daily doses of Wisconsin ginseng of 750, 1,000 and 2,000 milligrams respectively.

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, said the researchers.

But those receiving the larger doses showed improvements in overall energy levels and reported higher vitality levels and less fatigue. They also reported an improvement in overall mental, physical, spiritual and emotional well-being.

NutraIngredients.com has not seen the full data.

Despite the positive results, Barton said she would like to carry out further research before advising patients to supplement their diet with ginseng.

"While results were promising, we have more research to conduct," she affirmed. "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."

Her team hopes to begin a clinical trial in 2008 looking at a specific dose of Wisconsin ginseng versus placebo, with the aim of a confirming a new treatment option for cancer-related fatigue.

Ginseng is typically taken to enhance stamina and reduce feelings of fatigue and physical stress. It is also believed to have an anti-cancer function and has been reported to normalise blood glucose levels, improve insulin sensitivity and reduce the risk of obesity.

The herb has been gaining popularity in Western societies, finding its way into, for example, energy drinks. In the US it is estimated to be the second top-selling herbal supplement, with $62m (€48.2m) in annual sales.

Source: The results were presented on June 3 at the annual meeting of the American Society of Clinical Oncology 

CHICAGO -- 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, are being 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.<br. 

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. 

Based at Mayo Clinic in Rochester, Minn., NCCTG is a national clinical research group sponsored by the National Cancer Institute. NCCTG is a network of more than 400 community-based cancer treatment clinics in the United States, Canada and Mexico that work with Mayo Clinic to conduct clinical studies for advancing cancer treatment. 

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