Lessons learned from a double-blind randomised placebo-controlled study with a iota-carrageenan nasal spray as medical device in children with acute symptoms of common cold

BMC Complementary and Alternative Medicine

Thomas Lion²  Helmut Gadner²  Andreas Zoubek¹  Maria Verdianz²  Margit Rauch²  Christopher Diakos¹  Gustav Fischmeister¹  Georg Vollnhofer¹  Nathalie Pruckner¹  Philipp Eickhoff¹  Tamas Fazekas¹ 

[1] St. Anna Children’s Hospital, Vienna, Austria;Children’s Cancer Research Institute and LabDia Labordiagnostik, Vienna, Austria

关键词: Pediatric pulmonology;    Upper respiratory tract infections;    Viral infection;    Common cold;    Carrageenan;   

Others  :  1232021
DOI  :  10.1186/1472-6882-12-147

 received in 2012-05-16, accepted in 2012-08-31,  发布年份 2012

【 摘 要 】

Background

Common cold is caused by a variety of respiratory viruses. The prevalence in children is high, and it potentially contributes to significant morbidity. Iota-carragenan, a polymer derived from red seaweed, has reduced viral load in nasal secretions and alleviated symptoms in adults with common cold.

Methods

We have assessed the antiviral and therapeutic activity of a nasal spray containing iota-carrageenan in children with acute symptoms of common cold. A cohort of 153 children between 1–18 years (mean age 5 years), displaying acute symptoms of common cold were randomly assigned to treatment with a nasal spray containing iota-carrageenan (0.12%) as verum or 0.9% sodium chloride solution as placebo for seven days. Symptoms of common cold were recorded and the viral load of respiratory viruses in nasal secretions was determined at two consecutive visits.

Results

The results of the present study showed no significant difference between the iota carrageenan and the placebo group on the mean of TSS between study days 2–7. Secondary endpoints, such as reduced time to clearance of disease (7.6 vs 9.4 days; p = 0.038), reduction of viral load (p = 0.026), and lower incidence of secondary infections with other respiratory viruses (p = 0.046) indicated beneficial effects of iota-carrageenan in this population. The treatment was safe and well tolerated, with less side effects observed in the verum group compared to placebo.

Conclusion

In this study iota-carrageenan did not alleviate symptoms in children with acute symptoms of common cold, but significantly reduced viral load in nasal secretions that may have important implications for future studies.

Trial registration

ISRCTN52519535, http://www.controlled-trials.com/ISRCTN52519535/ webcite

【 授权许可】

   
2012 Fazekas et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Henrickson KJ, Hoover S, Kehl KS, et al.: National disease burden of respiratory viruses detected in children by polymerase chain reaction. Pediatr Infect Dis J 2004, 23:11-18.
• [2]Tregoning JS, Schwarze J: Respiratory Viral Infections in Infants: causes, clinical symptoms, virology, and immunology. Clin Microbiol Rev 2010, 23:74-98.
• [3]Nichols WG, Peck Campbell AJ, Boeckh M: Respiratory viruses other than influenza virus: impact and therapeutic advances. Clin Microbiol Rev 2008, 21:274-90.
• [4]Jackson DJ, Johnston SL: The role of viruses in acute exacerbations of asthma. J Allergy Clin Immunol 2010, 125:1178-1187.
• [5]Busse WW, Lemanske RF Jr, Gern JE: Role of viral respiratory infections in asthma and asthma exacerbations. Lancet 2010, 376:826-834.
• [6]Eccles R: Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu. J Clin Pharm Ther 2010, 31:309-319.
• [7]Vassilev ZP, Kabadi S, Villa R: Safety and efficacy of over-the-counter cough and cold medicines for use in children. Expert Opin Drug Saf 2010, 9:233-242.
• [8]Isbister GK, Prior F: Kilham HA. Paediatr Child Health: Restricting cough and cold medicines in children; 2010. [Epub ahead of print]
• [9]Leibbrandt A, Meier C, Konig-Schuster M, et al.: Iota-carrageenan is a potent inhibitor of influenza A virus infection. PLoS One 2010, 5:e14320.
• [10]Grassauer A, Weinmuellner R, Meier C, et al.: Iota-Carrageenan is a potent inhibitor of rhinovirus infection. Virol J 2008, 5:107. BioMed Central Full Text
• [11]Gonzalez ME, Alarcon B, Carrasco L: Polysaccharides as antiviral agents: antiviral activity of carrageenan. Antimicrob Agents Chemother 1987, 31:1388-1393.
• [12]Kilmarx PH, Blanchard K, Chaikummao S, et al.: A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand. Sex Transm Dis 2008, 35:226-232.
• [13]Skoler-Karpoff S, Ramjee G, Ahmed K, et al.: Efficacy of carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet 2008, 372:1977-1987.
• [14]Buck CB, Thompson CD, Roberts JN, et al.: Carrageenan is a potent inhibitor of papillomavirus infection. PLoS Pathog 2006, 2:e69.
• [15]Eccles R, Meier C, Jawad M, et al.: Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold. Respir Res 2010, 11:108. BioMed Central Full Text
• [16]Jackson GG, Dowling HF, Spiesman IG, et al.: Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med 1958, 101:267-278.
• [17]Watzinger F, Suda M, Preuner S, et al.: Real-time quantitative PCR assays for detection and monitoring of pathogenic human viruses in immunosuppressed pediatric patients. J Clin Microbiol 2004, 42:5189-5198.
• [18]van Elden LJ, Sachs AP, van Loon AM, et al.: Enhanced severity of virus associated lower respiratory tract disease in asthma patients may not be associated with delayed viral clearance and increased viral load in the upper respiratory tract. J Clin Virol 2008, 41:116-121.
• [19]Sharfstein JM, North M, Serwint JR: Over the counter but no longer under the radar–pediatric cough and cold medications. N Engl J Med 2007, 357:2321-2324.
• [20]Taverner D, Latte J: Nasal decongestants for the common cold. C ochrane Database Syst Rev. 2007, 24:CD001953.
• [21]Taylor JA, Weber WJ, Martin ET, et al.: Development of a symptom score for clinical studies to identify children with a documented viral upper respiratory tract infection. Pediatr Res 2010, 68:252-257.
• [22]Burch J, Corbett M, Stock C, et al.: Prescription of anti-influenza drugs for healthy adults: a systematic review and meta-analysis. Lancet Infect Dis 2009, 9:537-545.
• [23]Franz A, Adams O, Willems R, et al.: Correlation of viral load of respiratory pathogens and co-infections with disease severity in children hospitalized for lower respiratory tract infection. J Clin Virol 2010, 48:239-245.
• [24]Jansen RR, Schinkel J, Dek I, et al.: Quantitation of respiratory viruses in relation to clinical course in children with acute respiratory tract infections. Pediatr Infect Dis J 2010, 29:82-84.
• [25]Utokaparch S, Marchant D, Gosselink JV, et al.: The relationship between respiratory viral loads and diagnosis in children presenting to a pediatric hospital emergency department. Pediatr Infect Dis J 2011, 30(2):e18-23.