Efficacy of COLD-fX in the prevention of respiratory symptoms in community-dwelling adults: a randomized, double-blinded, placebo controlled trial.
BACKGROUND
COLD-fX (CVT-E002), a proprietary extract of the roots of North American ginseng (Panax quinquefolium), rich in poly-furanosyl-pyranosyl-saccharides, has been found efficacious in the prevention of respiratory infections in institutionalized seniors and healthy adults.


OBJECTIVE
We examined the efficacy of COLD-fX in the prevention of acute respiratory illness (ARI) in community dwelling seniors.


METHODS
This was a randomized, double-blind, placebo controlled trial.


METHODS
The participants were asked to take 2 capsules/day of either COLD-fX or placebo (200 mg/ capsule) for a period of 4 months.


METHODS
A total of 43 community-dwelling adults aged 65 years or older were recruited. Following one month of intervention, subjects were immunized with influenza vaccine.


METHODS
Subjects recorded the incidence and duration of respiratory symptoms during the study. They also recorded the incidence of adverse events during the study.


RESULTS
The frequency and duration of ARI during the first two months of the study was found to be similar in the two groups. However, during the last 2 months (November and December) significantly fewer subjects in the COLD-fX group 32% reported ARI compared to the placebo group 62%. The duration of symptoms during the last 2 months was significantly shorter in the COLD-fX group than the placebo group (5.6 days in the COLD-fX group vs 12.6 days in the placebo group). There was no influenza illness circulating in the community during the period of the study.


CONCLUSIONS
Ingestion of COLD-fX by immunocompetent seniors during an early "cold and flu" season reduced the relative risk and duration of respiratory symptoms by 48% and 55%, respectively. Daily COLD-fX administration can thus be a safe, natural therapeutic means for the prevention of ARI in healthy seniors.
Center for Immunotherapy of Cancer and Infectious Diseases, School of Medicine, University of Connecticut, Farmington, CT, USA.
Janet E
JE
McElhaney
Vinti
V
Goel
Benjamin
B
Toane
Johnathan
J
Hooten
Jacqueline J
JJ
Shan
D000368:Aged; D000369:Aged, 80 and over; D003139:Common Cold / Q000188:drug therapy / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage; D007251:Influenza, Human / Q000188:drug therapy / Q000517:prevention & control*; D008297:Male; D005894:Panax; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D018517:Plant Roots; D016896:Treatment Outcome
C511203:COLD-fX; D007252:Influenza Vaccines; D010936:Plant Extracts