Effectiveness of an Herbal Preparation Containing Echinacea, Propolis, and Vitamin C in Preventing Respiratory Tract Infections in Children: A Randomized, Double-blind, Placebo-Controlled, Multicenter Study

Archives of Pediatrics and Adolescent Medicine

Volumn 158, Issue 3, 2004, Pages 217-221

  Cohen, Herman A ^a,c,d   Varsano, Itzchak ^b   Kahan, Ernesto ^c,d   Sarrell, E Michael ^a,d   Uziel, Yosef ^d,e  

^a General Health Services   (Israel)

^b SCHNEIDER CHILDREN S MEDICAL CENTER OF ISRAEL   (Israel)

^c TEL AVIV UNIVERSITY   (Israel)

^d ISR Ambulatory Pediat Association   (Israel)

^e MEIR MEDICAL CENTER   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

ASCORBIC ACID; ECHINACEA EXTRACT; HERBACEOUS AGENT; PLACEBO; PROPOLIS;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ELIXIR; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HERBAL MEDICINE; HUMAN; MAJOR CLINICAL STUDY; MALE; PALATABILITY; PRESCHOOL CHILD; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; TREATMENT OUTCOME; TREATMENT PLANNING;

ASCORBIC ACID; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; ECHINACEA; HUMANS; INFANT; PHYTOTHERAPY; PLANT PREPARATIONS; PLANTS, MEDICINAL; PROPOLIS; RESPIRATORY TRACT INFECTIONS;

EID: 1442313881     PISSN: 10724710     EISSN: None     Source Type: Journal    
DOI: 10.1001/archpedi.158.3.217     Document Type: Article

References (51)

1. Grunwald J, Buttel K. Der Europaische Markt fur Phytotherapeutika. Pharm Ind. 1996;58:209-214.
2. Vickers A, Zollman C. ABC of complementary medicine: herbal medicine [published correction appears in BMJ. 1999;319: 1422]. BMJ. 1999;319:1050-1053.
3. Vickers A, Zollman C. ABC of complementary medicine: herbal medicine [published correction appears in BMJ. 1999;319: 1422]. BMJ. 1999;319:1050-1053.
4. Percival SS. Use of echinacea in medicine. Biochem Pharmacol. 2000;60:155-158.
5. Echinacea for prevention and treatment of upper respiratory infections. Wed Lett Drugs Ther. 2002;44:29-30.
6. Melchart D, Linde K, Worku F, et al. Results of five randomized studies on the immunomodulatory activity of preparations of echinacea. J Altern Complement Med. 1995;1:145-160.
7. Melchart D, Walther E, Linde K, Brandmaier R, Lersch C. Echinacea root extacts for the prevention of upper respiratory tract infections: a double-blind, placebo-controlled randomized trial. Arch Fam Med. 1998;7:541-545.
8. Stimpel M, Proksch A, Wagner H, Lohmann-Matthies ML. Macrophage activation and induction of macrophage cytotoxicity by purified polysaccharide fractions from the plant Echinacea purpurea. Infect Immun. 1984;46:845-849.
9. Mark JD, Grant KL, Barton LL. The use of dietary supplements in pediatrics: a study of echinacea. Clin Pediatr (Phila). 2001;40:265-269.
10. Bauer R, Wagner H. Echinacea species as potential immunostimulatory drugs. In: Wagner H, ed. Economic and Medicinal Plants Research. London, England: Academic Press Inc; 1991:253-321.
11. Elsasser BU, Willenbacher W, Bartsch HH, Gallati H, Schulte Monting J, Von Kleist S. Cytokine production in leukocyte cultures during therapy with echinacea extract. J Clin Lab Anal. 1996;10:441-445.
12. Tubaro A, Tragni E, Del Negro P, Galli CL, Della Loggia R. Anti-inflammatory activity of a polysaccharidic fraction of Echinacea angustifolia. J Pharm Pharmacol. 1987;39:567-569.
13. Ghisalberti EL. Propolis: a review. Bee World. 1979;60:59-84.
14. Burdock GA. Review of the biological properties and toxicity of bee propolis (propolis). Food Chem Toxicol. 1998;36:347-363.
15. Khayyal MT, el-Ghazaly MA, el-Khatib AS. Mechanisms involved in antiinflammatory effect of propolis extract. Drugs Exp Clin Res. 1993;19:197-203.
16. Grange JM, Davey RW. Antibacterial properties of propolis (bee glue). J R Soc Med. 1990;83:159-160.
17. Guarini L, Su ZZ, Zucker S, Lin J, Grunberger D, Fisher PB. Growth inhibition and modulation of antigenic phenotype in human melanoma and glioblastoma multiforme cells by caffeic acid phenethyl ester (CAPE) [correction published in Cell Mol Biol (Noisy-le-grand). 1992;38:615]. Cell Mol Biol (Noisy-le-grand). 1992; 38:513-527.
18. Guarini L, Su ZZ, Zucker S, Lin J, Grunberger D, Fisher PB. Growth inhibition and modulation of antigenic phenotype in human melanoma and glioblastoma multiforme cells by caffeic acid phenethyl ester (CAPE) [correction published in Cell Mol Biol (Noisy-le-grand). 1992;38:615]. Cell Mol Biol (Noisy-le-grand). 1992; 38:513-527.
19. Amoros M, Simeos CM, Girre L, Sauager F, Cormier M. Synergistic effect of flavones and flavonols against herpes simplex virus type 1 in cell culture: comparison with the antiviral activity of propolis. J Nat Prod. 1992;55:1732-1740.
20. Dumitrescu M, Crisan I, Esanu V. Mechanism of the anti-herpetic activity of aqueous extract of propolis, II: activity of lectins from the aqueous extract of propolis [in French]. Rom J Virol. 1993;441:49-54.
21. Serkedja J, Manolova N, Bankova V. Anti-influenza virus effect of some propolis constituents and their analogue esters of substitute cinnamic acids. J Nat Prod. 1992;55:294-302.
22. Harish Z, Rubinstein A, Golodner M, Elmaliah M, Mizrahi Y. Suppression of HIV-1 replication by propolis and its immunoregulatory effects. Drugs Exp Clin Res. 1997;20:89-96.
23. Manzella JP, Roberts NJ. Human macrophage and lymphocyte response to mitogen stimulation after exposure to influenza virus, ascorbic acid, and hyperthermia. J Immunol. 1979;123:1940-1944.
24. Smit MJ, Anderson R. Inhibition of mitogen-activated proliferation of human lymphocytes by hypochlorous acid in vitro: protection and reversal by ascorbate and cysteine. Agents Actions. 1990;30:338-343.
25. Dahl H, Degre M. The effect of ascorbic acid on production of human interferon and antiviral activity in vitro. Acta Pathol Microbiol Scand B. 1976;84B:280-284.
26. Siegel BV. Enhancement of interferon production by poly(rI)-poly(rC) in mouse cell cultures by ascorbic acid. Nature. 1975;254:531-532.
27. Washko PW, Wang Y, Levine M. Ascorbic acid recycling in human neutrophils. J Biol Chem. 1993;268:5531-5535.
28. Schoenhoefer PS, Schulte-Sasse H. Sind pflanzliche Immunstimulatien wirksam and unbedenklich. Dtsch Med Wochenschr. 1989;114:1804-1806.
29. Melchart D, Linde K, Worku F, Bauer R, Wagner H. Immunomodulation with echinacea: a systematic review of controlled clinical trials. Phytomedicine. 1994;1: 245-254.
30. Kahan E, Giveon SM, Zalevsky S, Imber-Shachar Z, Kitai E. Behavior of patients with flu-like symptoms: consultation with physician versus self-treatment. Isr Med Assoc J. 2000;2:421-425.
31. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-1259.
32. Grimm W, Muller HH. A randomized controlled trial of the effect of fluid extract of Echinacea purpurea on the incidence and severity of colds and respiratory infections. Am J Med. 1999;106:138-143.
33. Barret B, Vohmann M, Calabrese C. Echinacea for upper respiratory infection. J Fam Pract. 1999;48:628-635.
34. Gunning K, Steele P. Echinacea for the prevention of upper respiratory tract infections [letter]. J Fam Pract. 1999;48:93.
35. Schoneberger D. Influence of the immunostimulating effects ofthe pressed juice of Echinacea purpureae on the duration and intensity of the common cold: results of a double blind clinical trial [in German]. Forum Immunol. 1992;2:18-22.
36. Schmidt U, Albrecht M, Schenk N. Plankliches Immunstimulans senkt Haufigkeit grippaler Infekte: Plazebokontrollierte Doppelblindstudie mit einem kombinierten Echinacea-Praparat mit 646 Studenten der Kolner Universitate. Nat Ganzheits Med. 1990;3:227-281.
37. Forth H, Beuscher N. Beeinflussing de Haufigkeit banaler Erkaltungsinfekte durch Esberitox. Z Allgemeinmed. 1981;57:2272-2275.
38. Henneicke-von Zepelin HH, Hentschel C, Schnitker J, Kohnen R, Kohler G, Wustenberg P. Efficacy and safety of a fixed combination phytomedicine in the treatment of common cold (acute viral respiratory tract infection): results of a randomised, double blind, placebo controlled, multicentre study. Curr Med Res Dpin. 1999;15:214-227.
39. Turner RB, Riker DK, Gangemi JD. Ineffectiveness of echinacea for prevention of experimental rhinovirus colds. Antimicrob Agents Chemother. 2000;44:1708-1709.
40. Crisan I, Zaharia CN, Popovici F, et al. Natural propolis extract Nivcrisol in the treatment of acute and chronic rhinopharyngitis in children. Rom J Virol. 1995; 46:115-133.
41. Review of Natural Products. St Louis, Mo: Walters Kluwer Co; 1996.
42. Hoheisel O, Sandberg M, Bertram S, Bulitta M, Schafer M. Echinacea treatment shortens the course of the common cold: a double-blind, placebo-controlled clinical trial. Eur J Clin Res. 1997;9:261-269.
43. Mullins RJ, Heddle R. Adverse reactions associated with echinacea: the Australian experience. Ann Allergy Asthma Immunol. 2002;88:42-51.
44. Parnham MJ. Benefit-risk assessment of the squeezed sap of the purple cone-flower (Echinacea purpurea) for long-term oral immunostimulation. Phytomedicine. 1996;3:95-102.
45. Hoffler D. Fur die Arzneimittelkommision der deutschen Arzteschaft: aus der 59: Sitzung des Ausschusses "unerwunschte Arzneimittelnebenwirkungen." Arzneiverordnung Prax. 1996;3:7-8.
46. Mullins RJ. Echinacea-associated anaphylaxis. Med J Aust. 1998;168:170-171.
47. Valleron AJ, Grimfield A. Evaluation of clinical trials of immunomodulators for prevention of recurrent respiratory infections in children. Dev Biol Stand. 1992; 77:149-158.
48. Berber A, Del-Rio-Navarro B. Compilation and meta-analysis of randomized placebo-controlled clinical trials on the prevention of respiratory tract infections in children using immunostimulants. J Investig Allergol Clin Immunol. 2001;11: 235-246.
49. Blumenthal M. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Boston, Mass: American Botanical Council With Interpretive Medicine Communications; 1998.
50. AltMedDex Database: Echinacea Monograph. Englewood, Colo: Micromedex Inc; 1999.
51. Pepping J. Echinacea. Am J Health Syst Pharm. 1999;56:121-122.