title: 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.
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.affiliation: Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.
authors.forename: Dörte
authors.initials: D
authors.lastname: Müller
authors.affiliation: Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.
authors.forename: Torben
authors.initials: T
authors.lastname: Lindemann
authors.affiliation: Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany.
authors.forename: Kija
authors.initials: K
authors.lastname: Shah-Hosseini
authors.affiliation: bitop AG, Witten, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Scherner
authors.affiliation: bitop AG, Witten, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Knop
authors.affiliation: bitop AG, Witten, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Bilstein
authors.affiliation: Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany. ralph@moesges.de.
authors.forename: Ralph
authors.initials: R
authors.lastname: Mösges
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000284:Administration, Oral; D000599:Amino Acids, Diamino / Q000627:therapeutic use; D005858:Germany; D007827:Laryngitis / Q000188:drug therapy; D058993:Oral Sprays; D010612:Pharyngitis / Q000188:drug therapy; D011446:Prospective Studies; D012965:Sodium Chloride; D016896:Treatment Outcome
chemical_list: D000599:Amino Acids, Diamino; C045628:ectoine; D058993:Oral Sprays; D012965:Sodium Chloride
keywords: Acute laryngitis; Acute pharyngitis; Ectoine mouth and throat spray; Oral treatment; Pharyngeal treatment; Saline lozenges