Safety and tolerability of north american ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules

Pediatrics

Volumn 122, Issue 2, 2008, Pages

  Vohra, Sunita ^a   Johnston, Bradley C ^a   Laycock, Keri L ^a   Midodzi, William K ^b   Dhunnoo, Indra ^a   Harris, Evan ^a   Baydala, Lola ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

^b UNIVERSITY OF ALBERTA   (Canada)

Author keywords

Children; Ginseng; Safety; Upper respiratory tract infection

Indexed keywords

ANTIASTHMATIC AGENT; ANTIBIOTIC AGENT; ANTIPYRETIC AGENT; COLD FX; GINSENG EXTRACT; PLACEBO; UNCLASSIFIED DRUG; PLANT EXTRACT;

ANOREXIA; ARALIACEAE; ARTICLE; CANADA; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG USE; EPISTAXIS; FATIGUE; FEMALE; FEVER; GINSENG; HEADACHE; HUMAN; IRRITABILITY; LEG PAIN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; OTALGIA; PANAX QUINQUEFOLIUS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZATION; RASH; SAMPLE SIZE; SCORING SYSTEM; SIDE EFFECT; SINUSITIS; SLEEP DISORDER; SORE THROAT; STOMACH PAIN; UPPER RESPIRATORY TRACT INFECTION; VOMITING; COMMON COLD; DOSE RESPONSE; DRUG ADMINISTRATION; FOLLOW UP; MAXIMUM TOLERATED DOSE; METHODOLOGY; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PHYTOTHERAPY; PRESCHOOL CHILD; PROBABILITY; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; RESPIRATORY TRACT INFECTION; RISK ASSESSMENT; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ALBERTA; CHILD; CHILD, PRESCHOOL; COMMON COLD; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MAXIMUM TOLERATED DOSE; PANAX; PHYTOTHERAPY; PLANT EXTRACTS; PROBABILITY; REFERENCE VALUES; RESPIRATORY TRACT INFECTIONS; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 49849092416     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2007-2186     Document Type: Article

References (38)

1. Jacobs B, Young NL, Dick PT, et al. Canadian Acute Respiratory Illness and Flu Scale (CARIFS): development of a valid measure for childhood respiratory infections. J Clin Epi. 2000;53(8): 793-799
2. Mossad SB. Fortnightly review: treatment of the common cold. BMJ. 1998;317(7150):33-36
3. Arroll B, Kenealy T. Antibiotics for the common cold [Cochrane Review]. In: The Cochrane Library. Issue 3. Oxford, United Kingdom: Update Software; 2004
4. Nordlie, AL, Anderson BM. Children in day-care centers; infections and antibiotic treatment [in Norwegian]. Tidsskr Nor Laegeforen. 2002;122(28):2702-2710
5. Crowe S, Lyons, B. Herbal medicine use by children presenting for ambulatory anesthesia and surgery. Pediatr Anesth. 2004; 14(11):916-919
6. Noonan K, Arensman R, Hoover J. Herbal medication use in the pediatric surgical patient. J Pediatr Surgery. 2004;39(3):500-503
7. Simpson N, Pearce A, Finlay F, Lenton S. The use of complementary medicine in pediatric outpatient clinics. Ambul Child Health. 1998;3(4):351-356
8. Ottolini M, Hamburger E, Loprieto J, et al. Alternative Medicine Use Among Children in the Washington DC Area. San Francisco, CA: Paediatric Academic Societies; 1999
9. Lanski SL, Greenwald M, Perkins A, Simon HK. Herbal therapy use in a pediatric emergency department population: expect the unexpected. Pediatrics. 2003;111(5 pt 1):981-985
10. Cincotta DR, Crawford NW, Lim A, et al. Comparison of complementary and alternative medicine use: reasons and motivations between two tertiary children's hospitals. Arch Dis Child. 2006;91(2):153-158
11. Goldman RD, Vohra S. Complementary and alternative medicine use by children visiting a pediatric emergency department. Can J Clin Pharm. 2004;11(2):e247
12. Scaglione F, Cattaneo G, Alessandria M, Cogo R. Efficacy and safety of the standardized ginseng extract G 115 for the potentiating vaccination against common cold and/or influenza syndrome. Drugs Exptl Clin Res. 1996;22(2):65-72
13. McElhaney JE, Gravenstein S, Cole SK, et al. A placebo- controlled trial of a proprietary extract of North American Ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults. J Am Geriatr Soc. 2004;52(1):13-19
14. Predy GN, Goel V, Lovlin R, et al. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl- saccharides for preventing upper respiratory tract infections: a randomized controlled trial. CMAJ. 2005;173(9):1043-1048
15. McElhaney JE, Goel V, Toane B, et al. Efficacy of COLD-fX in the prevention of respiratory symptoms in community- dwelling adults: a randomized, double-blind, placebo controlled trial. J Alternat Comple Med. 2006;12(2):153-157
16. Thommessen B, Laake K. No identifiable effect of ginseng (Gericomplex) as an adjuvant in the treatment of geriatric patients. Aging (Milano). 1996;8(6):417-420
17. Srisurapanon S, Rungroeng K, Apibal S, et al. The effect of standardized ginseng extract on peripheral blood leukocytes and lymphocyte subsets: a preliminary study in young healthy adults. J Med Assoc Thai. 1997;80(suppl 1):S81-S85
18. Jie YH, Cammisuli S, Baggiolini M. Immunomodulatory effects of panax ginseng C.A. Meyer in mouse. Agents Actions. 1984; 15(3-4):386-391
19. Wang B, Cui J, Liu A. The effect of ginseng on immune responses. In: Advances Chinese Medical Materials Research: Proceedings of an International Symposium. Beijing, China: World Scientific Publication; 1985:519-527.
20. Scaglione F, Ferrara F, Dugnani S, Falchi M, Santoro G, Fra- schini F. Immunomodulatory effects of two extracts of panax ginseng C.A. Meyer. Drugs Exptl Clin Res. 1990;16(10):537-542
21. Wang M, Guilbert LJ, Ling L, et al. Immunomodulating activity of CVT-E002, a proprietary extract from North American ginseng (Panax quinquefolium). J Pharm Pharmacol. 2001;53(11): 1515-1523
22. Wang M, Guilbert LJ, Li J, et al. A proprietary extract from North American ginseng (Panax quinquefolium) enhances IL-2 and IFN-r productions in murine spleen cells induced by Con-A. Int Immunopharmacol. 2004;4(2):311-315
23. Market Track Drug Service for all categories of cough and cold remedies, natural supplements and vitamin category for the 52 week periods ending November 30, 2005 and September 2, 2006. Markham, ON, Canada: AC Nielsen, 2006
24. Coon JT, Ernst E. Panax ginseng: a systematic review of adverse events and drug interactions. Drug Saf. 2002;25(5):323-344
25. Jones BD, Runikis AM. Interaction of ginseng with phenelzine. J Clin Psychopharmacol. 1987;7(3):201-202
26. McRae S. Elevated serum digoxin levels in a patient taking digoxin and Siberian ginseng. CMAJ. 1996;155(3):293-295
27. Sotaniemi EA, Haapakoski E, Rautio A. Ginseng therapy in non-insulin-dependent diabetic patients. Diabetic Care. 1995;18(10):1373-1375
28. Yuan CS, Wei G, Dey L, et al. Brief communication: American ginseng reduces warfarin's effect in healthy patients: a randomized, controlled trial. Ann Intern Med.. 2004;141(1):23-27
29. Lamberts H, Wood M, eds. International Classification of Primary Care. New York, NY: Oxford University Press; 1987
30. NIH (CTCAE) Common Terminology Criteria for Adverse Events. General characteristics of the CTCAE grading (severity) scale. Available at: https://webapps.ctep.nci.nih.gov/webobjs/ ctc/webhelp/Grading-General- Characteristics.htm. Accessed December 10, 2007
31. World Health Organization. WHO causality algorithm. Available at: www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ guide/guide-ldir-indust-e. html#a2. Accessed December 10,2007
32. Taylor JA, Weber W, Standish L, et al. Efficacy and safety of Echinacea in treating upper respiratory tract infections in children; a randomized controlled trial. JAMA. 2003;290(21):2824-2830
33. Ritschel WA. Drug dosage in children. In: Ritschel WA. Handbook of Basic Pharmacokinetics. 2nd ed. Hamilton, IL: Drug Intelligence; 1980:296-310
34. Kearns GL, Abdel-Rahmna SM, Alander SW, Blowey DL,Leeder JS, Kaufman RE. Developmental pharmacology: drug disposition, action, and therapy in infants and children. NEngl J Med. 2003;349(12):1157-1167
35. Ben Arfa A, Combes S, Preziosi-Belloy L, Gontard N, Chalier P. Antimicrobial activity of carvacrol related to its chemical structure. Lett Appl Microbiol. 2006;43(2):149-154
36. Canadian Paediatric Society, Drug Therapy and Hazardous Substances Committee. Toxicological risk for herbal remedies. Peadiatr Child Health. 1999;4(8):536-538
37. Jonas WB. Alternative medicine-learning from the past, examining the present, advancing for the future. Pediatrics. 1998;280(18):1616 -1617
38. Ernst E. Herbal medicines: where is the evidence? BMJ. 2000; 321(7258):395-396