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

Research Article

Margit Rauch¹  Maria Verdianz¹  Thomas Lion¹  Gustav Fischmeister²  Tamas Fazekas²  Andreas Zoubek²  Nathalie Pruckner²  Georg Vollnhofer²  Philipp Eickhoff²  Christopher Diakos²  Helmut Gadner³ 

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

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

DOI  :  10.1186/1472-6882-12-147

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

来源: Springer

【 摘 要 】

BackgroundCommon 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.MethodsWe 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.ResultsThe 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.ConclusionIn 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 registrationISRCTN52519535, http://www.controlled-trials.com/ISRCTN52519535/

【 授权许可】

Unknown   
© Fazekas et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.