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, Nina Werkhäuser, Andreas Bilstein, Kathrin Mahlstedt, Uwe Sonnemann

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).

Keywords: Acute rhinosinusitis; Ectoine; Ectoin® Rhinitis nasal spray; Nasal spray; Xylometazoline.

Conflict of interest statement

NW is an employee of bitop AG, a company where medical devices, including Ectoin® containing nasal spray and eye drops, are developed and registered. At the time of the study conduction, AB was also an employee of bitop AG. US and KM received payment from bitop AG to conduct the study.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Development of rhinosinusitis sum scores in patients treated with Ectoin® Rhinitis Spray (ectoine), Ectoin® Rhinitis Spray and Xylometazoline spray (ectoine + Xylo) or Xylometazoline spray (Xylo). a Total sum scores (mean ± SD) assessed at visit 1 (V1) and at visit 2 (V2). *p < 0.0001. b Percentual decrease of sum scores (mean ± SD) from visit 1 (V1) to visit 2 (V2)
Fig. 2
Fig. 2
Change in nasal dryness from V1 to V2 (mean ± SD). Ectoine = Ectoin® Rhinitis Nasal Spray, Xylo = Xylometazoline nasal spray. Dryness was assessed on a scale from 0 = none to 3 = very strong
Fig. 3
Fig. 3
Distribution (% of patients) of endonasal oedema severity scores (0 = no symptoms, 4 = very strong symptoms) at V1 and V2: patients were either treated with Ectoin® Rhinitis Nasal Spray (SNS01), Ectoin® Rhinitis Nasal Spray + Xylometazoline nasal spray (Xylo/SNS01) or Xylometazoline nasal spray (Xylomet)
Fig. 4
Fig. 4
Development of the most bothersome symptoms nasal congestion (a), the need to blow the nose (b), and runny nose (c) depicted as total values on day 0 (d0) and day 7 (mean ± SD). Respective percentual decrease (mean ± SD) from day 0 to day 7 is shown in d–f. Patients evaluated symptoms on a scale ranging from 0 = no problem to 5 = as bad as possible. *p < 0.0001

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