Acta Scientific Otolaryngology (ASOL) (ISSN: 2582-5550)

Research Article Volume 4 Issue 11

Post-marketing Surveillance of Long-term Use of Stérimar™ Seawater-based Nasal Irrigation Solutions

Marco Bertini1*, Alejandro Jimenez Chobillon2 and Josip Culig3

1Laboratori Baldacci SpA, Pisa, Italy
2National Institute of Respiratory Diseases Ismael Cosío Villegas, Mexico DF, Mexico
3Department of Medicine and Clinical Pharmacology, University of Applied Health Sciences, Zagreb, Croatia

*Corresponding Author: Marco Bertini, Laboratori Baldacci SpA, Pisa, Italy.

Received: August 22, 2022; Published: October 12, 2022

Abstract

Saline nasal irrigation (SNI) is a simple, easy-to-use and efficient method to keep a healthy nasal mucosa and to be used as an adjuvant treatment in different sinonasal conditions. Although its efficacy has been clinically demonstrated, the long-term safety profile of SNI has only been empirically addressed. The aim of this article is to present the post-marketing surveillance (PMS) data of Stérimar, a pioneer brand of nasal hygiene offering a wide range of seawater-based solutions. The PMS data presented in this article was collected from January 2018 to April 2021 in four countries (France, United Kingdom, Mexico and Australia) and from different sources (social media, email, health authorities, distributors, among others). In that period, more than 23 million units of these seawater-based products were sold in these markets with only 37 reported complaints. The most frequent complaints were considered not serious adverse events, mostly related to getting the product into the eyes, epistaxis and pain/burning sensation. This data, along with the high-quality manufacturing process of these products confirms the long-term safety profile of this range of SNI products in babies, children and adults.

Keywords: Seawater; Nasal; Hygiene; Safety; Adverse Events

References

  1. Shusterman D. “The effects of air pollutants and irritants on the upper airway”. Proceedings of the American Thoracic Society 8 (2011): 101-105.
  2. Vareille M., et al. “The Airway Epithelium: Soldier in the Fight against Respiratory Viruses”. Clinical Microbiology Review 24 (2011): 210-229.
  3. Schraufnagel DE., et al. “Air Pollution and Noncommunicable Diseases: A Review by the Forum of International Respiratory Societies’ Environmental Committee, Part 1: The Damaging Effects of Air Pollution”. Chest 155 (2019): 409-416.
  4. Principi N and Esposito S. “Nasal Irrigation: An Imprecisely Defined Medical Procedure”. International Journal of Environmental Research and Public Health 14 (2017): 516.
  5. Bastier P-L., et al. “Nasal irrigation: From empiricism to evidence-based medicine. A review”. European Annals of Oto-rhino-laryngology, Head and Neck 132 (2015): 281-285.
  6. Huijghebaert S., et al. “Essentials in saline pharmacology for nasal or respiratory hygiene in times of COVID-19”. European Journal of Clinical Pharmacology 77 (2021): 1275-1293.
  7. Jiang M., et al. “Efficacy and Safety of Sea Salt-Derived Physiological Saline Nasal Spray as Add-On Therapy in Patients with Acute Upper Respiratory Infection: A Multicenter Retrospective Cohort Study”. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research 27 (2021): e929714-1-e929714-7.
  8. Rabago D and Zgierska A. “Saline Nasal Irrigation for Upper Respiratory Conditions”. American Family Physician 80 (2009): 1117-1119.
  9. L’eau de mer STÉRIMARTM 100% naturelle pour les sprays nasales. Internet. Cited on 10th August (2022).
  10. De Servi B., et al. “In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene”. Medical Devices (Auckland, N.Z.)13 (2020): 391-398.
  11. Bulletin de la Surveillance de la Qualité du Milieu Marin Littoral 2013. Départements d’ille et Vilaine et des Côtes d’Armor. Résultats acquis jusqu’en 2013 (2013): 150.
  12. Technicité STÉRIMARTM des sprays pour le nez adaptés à toute la famille. Internet. Cited on 10th August (2022).
  13. Huang S., et al. “In vitro safety and performance evaluation of a seawater solution enriched with copper, hyaluronic acid, and eucalyptus for nasal lavage”. Medical Devices (Auckland, N.Z.) 12 (2019): 399-410.
  14. Huang S., et al. “Is a diluted seawater-based solution safe and effective on human nasal epithelium?” European Archives of Oto-Rhino-Laryngology 278 (2021): 2837-2842.
  15. Huang S., et al. “Efficacy of a seawater solution enriched with copper, hyaluronic acid and eucalyptus against nasal pathogens”. Rhinology Online 2 (2019): 119-24.
  16. Constant S., et al. “Efficacy and safety evaluation of a hypertonic seawater solution enriched with manganese and copper salts”. Rhinology Online 4 (2021): 113-119.
  17. Elmiyeh B., et al. “A prospective, single-blind, randomised, crossover study comparing three nasal hygiene systems and corresponding patient preference for such devices”. Journal of Laryngology and Otology 128 (2014): 73-77.
  18. Grasso M., et al. “The effectiveness of long-term course of Sterimar Mn nasal spray for treatment of the recurrence rates of acute allergic rhinitis in patients with chronic allergic rhinitis”. Drug Design, Development and Therapy 12 (2018): 705-709.
  19. Sbrocca F., et al. “Safety and Efficacy Assessment of Stérimar Stop and Protect Cold for Adults and Stérimar Blocked Nose in Common Cold: A Randomized, Double-blind, Controlled Parallel-group, Clinical Study”. Acta Scientific Otolaryngology 3 (2021): 07-17.
  20. Culig J., et al. “Efficiency of hypertonic and isotonic seawater solutions in chronic rhinosinusitis”. Medicinski Glasnik 7 (2010): 116-123.
  21. Kanjanawasee D., et al. “Hypertonic Saline Versus Isotonic Saline Nasal Irrigation: Systematic Review and Meta-analysis”. American Journal of Rhinology and Allergy 32 (2018): 269-79.
  22. Robinson M., et al. “Effect of increasing doses of hypertonic saline on mucociliary clearance in patients with cystic fibrosis”. Thorax 52 (1997): 900-903.
  23. Chong LY., et al. “Saline irrigation for chronic rhinosinusitis”. Cochrane Database System Review 2016 (2016): CD011995.
  24. Tan L and Xu Y. “Application of nasal saline irrigation in nasal inflammatory diseases”. Journal of Otolaryngology-Head and Neck Surgery 33 (2019): 90-96.
  25. Viehweg TL., et al. “Epistaxis: diagnosis and treatment”. Journal of Oral and Maxillofacial Surgery 64 (2006): 511-518.
  26. Cauna N and Hinderer KH. “Fine structure of blood vessels of the human nasal respiratory mucosa”. Annals of Otology, Rhinology and Laryngology 78 (1969): 865-879.
  27. Gilyoma JM and Chalya PL. “Etiological profile and treatment outcome of epistaxis at a tertiary care hospital in Northwestern Tanzania: a prospective review of 104 cases”. BMC Ear Nose and Throat Disorder 11 (2011): 8.
  28. Bergmann C., et al. “Real-World Data on the Use of Hypertonic Saline Nasal Spray in ENT Practice”. SN Comprehensive Clinical Medicine 1 (2019): 354-361.
  29. Sunwoo Y., et al. “Physiological and Subjective Responses to Low Relative Humidity”. Journal of Physiological Anthropology 25 (2006): 7-14.
  30. Marchisio P., et al. “Hypertonic saline is more effective than normal saline in seasonal allergic rhinitis in children”. International Journal of Immunopathology and Pharmacology 25 (2012): 721-730.
  31. Baraniuk J., et al. “Hypertonic Saline Nasal Provocation Stimulates Nociceptive Nerves, Substance P Release, and Glandular Mucous Exocytosis in Normal Humans”. American Journal of Respiratory and Critical Care Medicine 160 (1998).
  32. Piromchai P., et al. “Effectiveness of nasal irrigation devices: a Thai multicentre survey”. Peer Journal 7 (2019): e7000.

Citation

Citation: Marco Bertini., et al. “Post-marketing Surveillance of Long-term Use of Stérimar™ Seawater-based Nasal Irrigation Solutions".Acta Scientific Otolaryngology 4.11 (2022): 03-10.

Copyright

Copyright: © 2022 Marco Bertini., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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