Randomised trial on performance, safety and clinical benefit of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms

Thieme, Uta and Mueller, Karolina and Bergmann, Christoph and Bock, Bernward and Wurzer-Materna, Nadine and Shahab, Taufik and Zeman, Florian and Eberhardt, Yvonne and Huppertz, Gunnar and Koller, Michael and Meiser, Peter (2020) Randomised trial on performance, safety and clinical benefit of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms. AURIS NASUS LARYNX, 47 (3). pp. 425-434. ISSN 0385-8146, 1879-1476

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Abstract

Objective: Limited data exist on the clinical benefits of nasal applications for moistening the nasal mucosa. We therefore investigated the effects of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms in an otorhinolaryngological outpatient setting. Methods: 240 patients were randomised into this prospective, three-armed clinical trial with two assessment points (baseline and 4 weeks later). Patients received either hyaluronic acid, hyaluronic acid plus dexpanthenol or isotonic saline nasal spray over a period of four weeks. Rhinitis Sicca Symptom Score (RSSS) was assessed as primary endpoint, and individual symptoms and tolerability of all treatments as secondary endpoints. Patient perceptions after first application of the allocated nasal spray were recorded using the Nasal Spray Sensory Scale. Treatment effects were analysed for each study arm first and subsequently compared against each other. Results: RSSS (hyaluronic acid: mean difference = 8.90 [98.33% CI = 7.34/10.45]; hyaluronic acid plus dexpanthenol: mean difference = 8.42 [98.33% CI = 6.91/9.94]; isotonic saline: mean difference = 8.94 [98.33% CI = 7.33/10.54]), individual symptoms and Endoscopy Score im proved significantly (p < 0.001) in all treatment arms. Tolerability was assessed as "flawless" in more than 85% of all treatments, which is reflected in overall high rankings in the Nasal Spray Sensory Scale. Perception of nasal moisturisation was reported to be significantly higher in patients receiving hyaluronic acid plus dexpanthenol as compared to patients receiving hyaluronic acid or isotonic saline. No further significant differences were observed between the three treatments. Conclusion: All three tested sprays (hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline) proved to be suitable treatments for patients suffering from dry nose symptoms. (DRKS-ID: DRKS00013357) (C) 2020 The Authors. Published by Elsevier B.V. on behalf of Oto-Rhino-Laryngological Society of Japan Inc.

Item Type: Article
Uncontrolled Keywords: SLEEP-APNEA SYNDROME; NONALLERGIC RHINITIS; SJOGRENS-SYNDROME; ANTERIOR; DISEASES; THERAPY; SKIN; Hyaluronic acid; Dexpanthenol; Isotonic saline; Nasal spray; Dry nose; Rhinitis sicca
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Depositing User: Dr. Gernot Deinzer
Date Deposited: 22 Mar 2021 08:32
Last Modified: 22 Mar 2021 08:32
URI: https://pred.uni-regensburg.de/id/eprint/44433

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