Observational study investigating Ectoin Rhinitis Nasal Spray as natural treatment option of acute rhinosinusitis compared to treatment with Xylometazoline.

Nina Werkhäuser, Andreas Bilstein, Kathrin Mahlstedt, Uwe Sonnemann

Journal: 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 2022;279(3):1371-1381

PMID: 34089097

Abstract

INTRODUCTION

Symptomatic relief of acute rhinosinusitis is commonly achieved with nasal decongestants. The current observational study investigated the efficacy and safety of treatment of acute rhinosinusitis with Ectoin Rhinitis Spray compared to or in combination with Xylometazoline-containing decongesting nasal spray.

METHODS

Patients with acute rhinosinusitis applied either Ectoin Rhinitis Spray, Xylometazoline nasal spray or a combination of both products. Rhinosinusitis symptoms were assessed, and nasal oedema and endonasal redness were determined by rhinoscopy. Patient diaries based on the validated SNOT (Sino Nasal Outcome Test) questionnaire evaluated rhinosinusitis parameters over time and influences of the disease on quality of life. Following treatment, investigators and patients judged the efficacy and tolerability.

RESULTS

Ectoin Rhinitis Spray diminished common rhinosinusitis symptoms such as nasal obstruction, nasal secretion, facial pain/headache, and smell/taste impairment. Upon treatment over 7 days, rhinosinusitis sum scores decreased statistically significantly (p < 0.001) by - 64.25%, which was comparable to that achieved with Xylometazoline-containing decongesting nasal spray (- 67.60%). No side effects were observed during treatment with Ectoin Rhinitis Spray, whereas treatment with Xylometazoline-containing nasal spray resulted in nasal mucosa dryness. Concomitant treatment with both products diminished the development of nasal dryness and required fewer applications of Xylometazoline-containing nasal spray.

CONCLUSION

Ectoin Rhinitis Spray is an effective, natural treatment option for acute rhinosinusitis, which may be used as monotherapy or as add-on treatment with a Xylometazoline-containing nasal spray. The concomitant use of Ectoin Rhinitis Spray might reduce the needed dose of decongestant nasal spray and counteract bothersome side effects such as dry nasal mucosa.

TRIAL REGISTRATION

The current study was registered in the ClinicalTrials.gov database under the identifier: NCT03693976 (date of registration: Oct 3, 2018).

© 2021. The Author(s).

Address: Bitop AG, Carlo-Schmid-Allee 5, 44263, Dortmund, Germany. [email protected].; AB-MSC, Am Platz 2, 50129, Bergheim, Germany.; , Reichsstr. 108, 14052, Berlin, Germany.; , Hermann-Ehlers-Weg 4, 25337, Elmshorn, Germany.
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