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Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2591-7. doi: 10.1007/s00405-016-4060-z. Epub 2016 Apr 28.

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.

Author information

1
Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.
2
bitop AG, Witten, Germany.
3
Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany. ralph@moesges.de.

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.

KEYWORDS:

Acute laryngitis; Acute pharyngitis; Ectoine mouth and throat spray; Oral treatment; Pharyngeal treatment; Saline lozenges

PMID:
27126336
PMCID:
PMC4974281
DOI:
10.1007/s00405-016-4060-z
[Indexed for MEDLINE]
Free PMC Article

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