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      Carrageenan nasal spray in virus confirmed common cold: individual patient data analysis of two randomized controlled trials

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          Abstract

          Background

          Clinical trials applying iota-carrageenan nasal spray have previously shown to reduce duration of virus-confirmed common cold. The present study pooled data of two similar clinical trials to provide further evidence for the antiviral effectiveness of carrageenan.

          Methods

          Individual patient data were analyzed from two randomized double blind placebo controlled trials assessing the therapeutic effectiveness of carrageenan nasal spray in acute common cold. Patients with virus-confirmed common cold (n = 254, verum 126, placebo 128) were included and the following parameters were appraised: duration of disease, number of patients with relapses, number of respiratory viruses and viral titers at inclusion (visit 1) compared to days 3–5 (visit 2).

          Results

          Carrageenan treated patients showed a significant reduction in duration of disease of almost 2 days (p < 0.05) as well as significantly fewer relapses during 21 days of observation period (p < 0.05). The virus clearance between visit 1 and visit 2 was significantly more pronounced in the carrageenan group (p < 0.05). In both studies, virus-confirmed common cold was caused by three main virus subtypes: human rhinovirus (46%), human coronavirus (25%) and influenza A (14%) virus. Carrageenan nasal spray showed significant antiviral efficacy in all three virus subgroups, the highest effectiveness was observed in human corona virus-infected patients. The reduced duration of disease was 3 days (p < 0.01) and the number of relapses was three times less (p < 0.01) in carrageenan treated corona-virus-infected patients compared to control patients.

          Conclusions

          Administration of carrageenan nasal spray in children as well as in adults suffering from virus-confirmed common cold reduced duration of disease, increased viral clearance and reduced relapses of symptoms. Carrageenan nasal spray appeared as an effective treatment of common cold in children and adults.

          Trial registration

          Pooled data from ISRCTN52519535 and ISRCTN80148028

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          Most cited references15

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          The economic burden of non-influenza-related viral respiratory tract infection in the United States.

          Viral respiratory tract infection (VRTI) is the most common illness in humans. Despite the high incidence, the economic impact of non-influenza-related VRTI has not been rigorously explored. Our objectives were to obtain an updated incidence of non-influenza-related VRTI in the United States and to quantify the health care resource use (direct costs) and productivity losses (indirect costs) associated with these infections. A nationwide telephone survey of US households (N = 4051) was conducted between November 3, 2000, and February 12, 2001 to obtain a representative estimate of the self-reported incidence of non-influenza-related VRTI and related treatment patterns. Direct treatment costs measured included outpatient clinician encounters, use of over-the-counter and prescription drugs, and associated infectious complications of non-influenza-related VRTI. Absenteeism estimates for infected individuals and parents of infected children were extrapolated from National Health Interview Survey data. Of survey respondents, 72% reported a non-influenza-related VRTI within the past year. Respondents who experienced a self-reported non-influenza-related VRTI averaged 2.5 episodes annually. When these rates are extrapolated to the entire US population, approximately 500 million non-influenza-related VRTI episodes occur per year. Similarly, if the treatment patterns reported by the respondents are extended to the population, the total economic impact of non-influenza-related VRTI approaches $40 billion annually (direct costs, $17 billion per year; and indirect costs, $22.5 billion per year). Largely because of the high attack rate, non-influenza-related VRTI imposes a greater economic burden than many other clinical conditions. The pending availability of effective antiviral therapies warrants increased attention be paid to this common and expensive illness.
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            Viruses and bacteria in the etiology of the common cold.

            Two hundred young adults with common colds were studied during a 10-month period. Virus culture, antigen detection, PCR, and serology with paired samples were used to identify the infection. Viral etiology was established for 138 of the 200 patients (69%). Rhinoviruses were detected in 105 patients, coronavirus OC43 or 229E infection was detected in 17, influenza A or B virus was detected in 12, and single infections with parainfluenza virus, respiratory syncytial virus, adenovirus, and enterovirus were found in 14 patients. Evidence for bacterial infection was found in seven patients. Four patients had a rise in antibodies against Chlamydia pneumoniae, one had a rise in antibodies against Haemophilus influenzae, one had a rise in antibodies against Streptococcus pneumoniae, and one had immunoglobulin M antibodies against Mycoplasma pneumoniae. The results show that although approximately 50% of episodes of the common cold were caused by rhinoviruses, the etiology can vary depending on the epidemiological situation with regard to circulating viruses. Bacterial infections were rare, supporting the concept that the common cold is almost exclusively a viral disease.
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              Acute respiratory illness in the community. Frequency of illness and the agents involved.

              Investigations of respiratory illnesses and infections in Tecumseh, Michigan, USA, were carried out in two phases, together covering 11 years. During the second phase, there were 5363 person-years of observation. Respiratory illness rates in both males and females peaked in the 1-2 year age group and fell thereafter. Adult females had more frequent illnesses than adult males; illnesses were less common in working women than in women not working outside the home. Isolation of viruses fell with increasing age; rhinoviruses were the most common isolate. Influenza infection rates, determined serologically, suggested relative sparing of young children from infection with type A (H1N1) and type B. Infection rates were highest in adult age groups for type A (H3N2). The isolation and serological infection rates were used to estimate the extent to which laboratory procedures underestimated the proportion of respiratory illnesses caused by each infectious agent; data from other studies were also used in this estimation. Severity of respiratory illnesses was assessed by the proportion of such illnesses that resulted in consultation of a physician. Rhinoviruses produced the greatest number of consultations. Overall, physician consultations were associated with 25.4% of respiratory illnesses.
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                Author and article information

                Contributors
                martin.koenighofer@meduniwien.ac.at
                thomas.lion@ccri.at
                abodenteich@marinomed.com
                eva.prieschl@marinomed.com
                andreas.grassauer@marinomed.com
                Hermann.Unger@vetmeduni.ac.at
                christian.a.mueller@meduniwien.ac.at
                tamas.fazekas@aon.at
                Journal
                Multidiscip Respir Med
                Multidiscip Respir Med
                Multidisciplinary Respiratory Medicine
                BioMed Central (London )
                1828-695X
                2049-6958
                12 November 2014
                12 November 2014
                2014
                : 9
                : 1
                : 57
                Affiliations
                [ ]St. Anna Children’s Hospital, Kinderspitalgasse 6, 1090 Vienna, Austria
                [ ]Department of Otorhinolaryngology, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria
                [ ]Children’s Cancer Research Institute and Lab DiaLabordiagnostik, Zimmermannplatz 8, 1090 Vienna, Austria
                [ ]Marinomed Biotechnologie GmbH, Veterinaerplatz 1, 1210 Vienna, Austria
                [ ]Laboratory of Tropical Veterinary Medicine, Veterinary University Vienna, Veterinaerplatz 1, 1210 Vienna, Austria
                Article
                183
                10.1186/2049-6958-9-57
                4236476
                25411637
                51e6b211-6280-472c-b14e-bd5d8bfec495
                © Koenighofer et al.; licensee BioMed Central Ltd. 2014

                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/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 13 August 2014
                : 17 October 2014
                Categories
                Original Research Article
                Custom metadata
                © The Author(s) 2014

                Respiratory medicine
                carrageenan,common cold,coronavirus,respiratory disease,rhinovirus,influenza,virus
                Respiratory medicine
                carrageenan, common cold, coronavirus, respiratory disease, rhinovirus, influenza, virus

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