Abstract
Hyaluronic acid (HA) is involved in modulating inflammatory airway processes and mucociliary clearance. Some studies have tested the effectiveness of the topical administration of HA in patients with upper airway diseases with positive preliminary results. A prospective, single-blind, 1:1 randomised controlled study was performed to assess the efficacy and safety of the daily topical administration of 9 mg of sodium hyaluronate in 3 mL of a 0.9 % sodium saline solution on the basis of endoscopic and clinical parameters in children with chronic adenoiditis associated with recurrent acute otitis media and otitis media with effusion; age- and gender-matched children receiving normal 0.9 % sodium chloride saline solution were used as controls. Analysis was based on 103 (mean age 63.3 ± 18.2 months; 52 males, 50.5 %) children: 54 in the study group and 49 in the control group. A statistically significant reduction in the mean number of all acute otitis media episodes (AOME) (mean reduction 0.8 ± 0.4 per month; p value 0.05) and AOME without tympanic membrane perforation (mean reduction 0.6 ± 0.3 per month; p value 0.04) after recruitment was documented only in the study group. HA significantly improved all the endoscopic outcomes (p values ranging between 0.05 and <0.01) but one. Nasal washing with saline solution was effective on only three of them (p values ranging between 0.03 and <0.01). No untoward effects were documented. Our results confirm the safety and document the positive effect of topically administered HA solution on children with chronic adenoiditis associated with middle ear disease.
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Acknowledgments
We would like to thank Air Liquide Medical Systems Italy S.p.A. for the supply of the micronised nasal douche (Rhinowash) used in this study and Dr. Carla Pascariello for her role in children assessment.
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This study was sponsored by IBSA Farmaceutici Italia Srl.
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Authors do not have any financial relationship with the organization that sponsored the study.
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Torretta, S., Marchisio, P., Rinaldi, V. et al. Endoscopic and clinical benefits of hyaluronic acid in children with chronic adenoiditis and middle ear disease. Eur Arch Otorhinolaryngol 274, 1423–1429 (2017). https://doi.org/10.1007/s00405-016-4327-4
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DOI: https://doi.org/10.1007/s00405-016-4327-4