Universität zu Köln

Mueller, Dorte, Lindemann, Torben, Shah-Hosseini, Kija ORCID: 0000-0001-9616-6942, Scherner, Olaf, Knop, Markus, Bilstein, Andreas and Moesges, Ralph (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. Eur. Arch. Oto-Rhino-Laryn., 273 (9). S. 2591 - 2598. NEW YORK: SPRINGER. ISSN 1434-4726

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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), a dagger spray = 0.44 +/- 0.62, a dagger lozenges = 0.21 +/- 0.62. The lozenges showed some advantage in relieving cough, a dagger lozenges = 0.62 +/- 0.94 versus a dagger 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mueller, Dorte UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindemann, Torben UNSPECIFIED UNSPECIFIED UNSPECIFIED Shah-Hosseini, Kija UNSPECIFIED orcid.org/0000-0001-9616-6942 UNSPECIFIED Scherner, Olaf UNSPECIFIED UNSPECIFIED UNSPECIFIED Knop, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Bilstein, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Moesges, Ralph UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-265141
DOI:	10.1007/s00405-016-4060-z
Journal or Publication Title:	Eur. Arch. Oto-Rhino-Laryn.
Volume:	273
Number:	9
Page Range:	S. 2591 - 2598
Date:	2016
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1434-4726
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DOUBLE-BLIND; BIOPHYSICAL INVESTIGATIONS; SORE THROATS; COMMON COLD; LIPID FILMS; ADULTS; INFLAMMATION; STRATEGY; PART Multiple languages Otorhinolaryngology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/26514