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Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial.
Eur Arch Otorhinolaryngol 2016; 273(9):2591-7EA

Abstract

The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p < 0.05). Treatment with the spray resulted in significantly greater reduction of cervical lymph node swelling (p < 0.05), ∆ spray = 0.44 ± 0.62, ∆ lozenges = 0.21 ± 0.62. The lozenges showed some advantage in relieving cough, ∆ lozenges = 0.62 ± 0.94 versus ∆ spray = 0.44 ± 0.85. Both patients and investigators rated the tolerability of both medical devices as "good" to "very good". Adverse events of mild to moderate severity were either possibly related or not related to the medical devices used. No serious adverse events occurred. Taken together, while the tolerability was consistent in both treatment groups, the ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis.

Authors+Show Affiliations

Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.bitop AG, Witten, Germany.bitop AG, Witten, Germany.bitop AG, Witten, Germany.Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany. ralph@moesges.de.

Pub Type(s)

Comparative Study
Controlled Clinical Trial
Journal Article
Observational Study

Language

eng

PubMed ID

27126336

Citation

Müller, Dörte, et al. "Efficacy and Tolerability of an Ectoine Mouth and Throat Spray Compared With Those of Saline Lozenges in the Treatment of Acute Pharyngitis And/or Laryngitis: a Prospective, Controlled, Observational Clinical Trial." European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated With the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, vol. 273, no. 9, 2016, pp. 2591-7.
Müller D, Lindemann T, Shah-Hosseini K, et al. Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial. Eur Arch Otorhinolaryngol. 2016;273(9):2591-7.
Müller, D., Lindemann, T., Shah-Hosseini, K., Scherner, O., Knop, M., Bilstein, A., & Mösges, R. (2016). Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial. European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated With the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 273(9), pp. 2591-7. doi:10.1007/s00405-016-4060-z.
Müller D, et al. Efficacy and Tolerability of an Ectoine Mouth and Throat Spray Compared With Those of Saline Lozenges in the Treatment of Acute Pharyngitis And/or Laryngitis: a Prospective, Controlled, Observational Clinical Trial. Eur Arch Otorhinolaryngol. 2016;273(9):2591-7. PubMed PMID: 27126336.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial. AU - Müller,Dörte, AU - Lindemann,Torben, AU - Shah-Hosseini,Kija, AU - Scherner,Olaf, AU - Knop,Markus, AU - Bilstein,Andreas, AU - Mösges,Ralph, Y1 - 2016/04/28/ PY - 2015/09/29/received PY - 2016/04/18/accepted PY - 2016/4/30/entrez PY - 2016/4/30/pubmed PY - 2017/3/3/medline KW - Acute laryngitis KW - Acute pharyngitis KW - Ectoine mouth and throat spray KW - Oral treatment KW - Pharyngeal treatment KW - Saline lozenges SP - 2591 EP - 7 JF - European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery JO - Eur Arch Otorhinolaryngol VL - 273 IS - 9 N2 - The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p < 0.05). Treatment with the spray resulted in significantly greater reduction of cervical lymph node swelling (p < 0.05), ∆ spray = 0.44 ± 0.62, ∆ lozenges = 0.21 ± 0.62. The lozenges showed some advantage in relieving cough, ∆ lozenges = 0.62 ± 0.94 versus ∆ spray = 0.44 ± 0.85. Both patients and investigators rated the tolerability of both medical devices as "good" to "very good". Adverse events of mild to moderate severity were either possibly related or not related to the medical devices used. No serious adverse events occurred. Taken together, while the tolerability was consistent in both treatment groups, the ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis. SN - 1434-4726 UR - https://www.unboundmedicine.com/medline/citation/27126336/Efficacy_and_tolerability_of_an_ectoine_mouth_and_throat_spray_compared_with_those_of_saline_lozenges_in_the_treatment_of_acute_pharyngitis_and/or_laryngitis:_a_prospective_controlled_observational_clinical_trial_ L2 - https://dx.doi.org/10.1007/s00405-016-4060-z DB - PRIME DP - Unbound Medicine ER -