Acta Scientific Medical Sciences (ASMS)(ISSN: 2582-0931)

Research Article Volume 6 Issue 12

Treatment of Laryngopharyngeal Reflux Disease Using an Oral Medical Device: A Clinical Investigation into Signs, Symptoms and Quality of Life of Patients

Enrico Maffezzoni1, Ketty Luciano2, Federico Maffezzoni3, Stefano Agostini4 and Mario Notargiacomo2*

1Rhinocytoallergology Unit, Istituto Figlie di San Camillo, Cremona, Italy
2Otorhinolaryngology Unit, Melzo Hospital, Milan, Italy
3Clinical psychology, Poliambulatorio Oberdan, Brescia, Italy
4Scientific Writer, Lodi, Italy

*Corresponding Author: Mario Notargiacomo, Otorhinolaryngology Unit, Melzo Hospital, Milan, Italy.

Received: November 04, 2022; Published: November 24, 2022

Abstract

In recent years, there has been a trend towards the application of alternative therapeutic approaches for the treatment of Laryngopharyngeal reflux (LPR), motivated by the not always satisfactory efficacy of proton pump inhibitors and the risks associated with their long-term use. Based on these premises, this prospective study assesses the results of treating LPR by taking a medical device (MDL) by mouth, aiming to prevent the reflux of gastric contents, and to protect the oesophageal and laryngopharyngeal mucosa. The study was carried out by enlisting 67 subjects divided into two groups: 40 LPR patients were treated for 30 consecutive days with MDL, whilst the other 27 subjects were recruited from the healthy population and used as a healthy control group. Before the start of treatment (T0), at the end of 30 days of treatment (T1) and 30 days after the discontinuation of treatment (T2), symptoms were assessed using the Reflux Symptom Index (RSI), signs were assessed using video laryngoscopy and the Reflux Finding Score (RFS) and health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). At T1, the total RSI and RFS scores improved significantly (p < 0.0001) and remained significantly better than before treatment, even after 30 days of stopping MDL treatment (p < 0.0001). The thick endolaryngeal mucus sign included in the RFS improved so much that, after 30 days of MDL treatment, the figure was not significantly different from that gathered in healthy subjects (p = 0.0765).

Health-related quality of life, as measured by the SF-12 questionnaire, also improved at the end of 30 days of MDL treatment: Physical Component Summary and Mental Component Summary (MCS) index scores improved significantly at T1 (p < 0.0001), confirming the improvement in patients' physical and mental state. At T1, the difference between the MCS index score of patients treated with MDL and that of healthy subjects was no longer significant (p = 0.2015).

Patients treated with MDL gave a positive assessment of the effectiveness of the medical device at the end of the treatment. The study confirmed the safe use of the product.

Keywords: Laryngopharyngeal Reflux; Thick Endolaryngeal Mucus; Magnesium Alginate; Opuntia ficus-indica Extract; Olea europea Extract; Medical Device

References

  1. Maffezzoni E., et al. “Efficacy of oral intake of a compound medical device in the treatment of laryngopharyngeal reflux disease: a clinical investigation and nasal cytological correlations”. Journal of Biological Regulators and Homeostatic Agents1 (2022): 167-174.
  2. Koufman JA. “The otolaryngologic manifestations of gastroesophageal reflux disease (GERD): a clinical investigation of 225 patients using ambulatory 24-hour pH monitoring and an experimental investigation of the role of acid and pepsin in the development of laryngeal injury”. Laryngoscope53 (1991): 1-78.
  3. Lechien JR., et al. “Evaluation and management of laryngopharyngeal reflux disease: state of the art review”. Otolaryngology–Head and Neck Surgery 160 (2019): 762-782.
  4. Kuo CL. “Laryngopharyngeal Reflux: An Update”. Archives of Otorhinolaryngology-Head and Neck Surgery1 (2019): 1.
  5. Lechien JR., et al. “Review of management of laryngopharyngeal reflux disease”. European Annals of Oto-rhino-laryngology, Head and Neck Diseases 4 (2021): 257-267.
  6. Lechien JR., et al. “Clinical outcomes of laryngopharyngeal reflux treatment: a systematic review and meta-analysis”. Laryngoscope5 (2019): 1174-1187.
  7. Wei C. “A meta-analysis for the role of proton pump inhibitor therapy in patients with laryngopharyngeal reflux”. European Archives of Oto-Rhino-Laryngology 11 (2016): 3795-3801.
  8. Gong EJ., et al. “Quality of life, patient satisfaction, and disease burden in patients with gastroesophageal reflux disease with or without laryngopharyngeal reflux symptoms”. Journal of Gastroenterology and Hepatology 7 (2017): 1336-1340.
  9. Carroll TL., et al. “Rethinking the laryngopharyngeal reflux treatment algorithm: Evaluating an alternate empiric dosing regimen and considering upfront, pH-impedance, and manometry testing to minimize cost in treating suspect laryngopharyngeal reflux disease”. Laryngoscope 127 (2017): S1-S13.
  10. Lanas-Gimeno A., et al. “Proton pump inhibitors, adverse events and increased risk of mortality”. Expert Opinion on Drug Safety 11 (2019): 1043-1053.
  11. Oridate N., et al. “Acidsuppression therapy offers varied laryngopharyngeal and esophageal symptom relief in laryngopharyngeal reflux patients”. Digestive Diseases and Sciences 53 (2008): 2033-2038.
  12. Park W., et al. “Laryngopharyngeal reflux: prospective cohort study evaluating optimal dose of proton-pump inhibitor therapy and pretherapy predictors of response”. Laryngoscope 115 (2005): 1230-1238.
  13. Belafsky PC., et al. “Validity and reliability of the reflux symptom index (RSI)”. Journal of Voice2 (2002): 274-277.
  14. Belafsky PC., et al. “The validity and reliability of the reflux finding score (RFS)”. Laryngoscope8 (2001): 1313-1317.
  15. Torquati A., et al. “Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease”. Surgical Endoscopy 10 (2004): 1475-1479. 
  16. Rodríguez L., et al. “Two-year results of intermittent electrical stimulation of the lower esophageal sphincter treatment of gastroesophageal reflux disease”. Surgery3 (2015): 556-567.
  17. Young GP., et al. “Treatment of reflux oesophagitis with a carbenoxolone/antacid/alginate preparation: a double-blind controlled trial”. Scandinavian Journal of Gastroenterology 9 (1986): 1098-1104.
  18. Manabe N., et al. “Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial”. Diseases of the Esophagus 5 (2012): 373-380.
  19. Greally P., et al. “Gaviscon and Carobel compared with cisapride in gastroesophageal reflux”. Archives of Disease in Childhood 5 (1992): 618-621.
  20. Leiman DA., et al. “Alginate therapy is effective treatment for GERD symptoms: a systematic review and meta-analysis”. Diseases of the Esophagus 5 (2017): 1-9.
  21. Galati EM., et al. “Study on the increment of the production of gastric mucus in rats treated with Opuntia ficus indica (L.) Mill. Cladodes”. Journal of Ethnopharmacology3 (2002): 229-233.
  22. Galati EM., et al. “Chemical characterization and biological effects of sicilian Opuntia ficus indica (L.) Mill. fruit juice: antioxidant and antiulcerogenic activity”. Journal of Agricultural and Food Chemistry 17 (2003): 4903-4908.
  23. Al-Quraishy S., et al. “Olive (Olea europaea) leaf methanolic extract prevents HCl/ethanol-induced gastritis in rats by attenuating inflammation and augmenting antioxidant enzyme activities”. Biomed Pharmacotherapy 91 (2017): 338-349.
  24. Dekanski D., et al. “Attenuation of cold restraint stress-induced gastric lesions by an olive leaf extract”. General Physiology and Biophysics 28 (2009): 135-142.
  25. Musa A., et al. “Antiulcer Potential of Olea europea cv. Arbequina Leaf Extract Supported by Metabolic Profiling and Molecular Docking”. Antioxidants (Basel) 10.5 (2021): 644.
  26. Trachtenberg S., et al. “Biophysical properties of Opuntia ficus-indica mucilage”. Phytochemistry12 (1980): 2835-2843.
  27. El SN and Karakaya S. “Olive tree (Olea europaea) leaves: potential beneficial effects on human health”. Nutrition Review11 (2009): 632-638.
  28. Bitler CM., et al. “Hydrolyzed olive vegetation water in mice has anti-inflammatory activity”. Journal of Nutrition6 (2005): 1475-1479.
  29. Goulas V., et al. “Contribution of flavonoids to the overall radical scavenging activity of olive (Olea europaea) leaf polar extracts”. Journal of Agricultural and Food Chemistry 58.6 (2010): 3303-3308.
  30. Serrilli AM., et al. “Nocellaralactone, a new monoterpenoid with anti-inflammatory activity, from Olea europaea, cultivar Nocellara del Belice”. Natural Product Research 27.24 (2013): 2311-2319.
  31. Venditti A., et al. “Aromadendrine, a new component of the flavonoid pattern of Olea europaea and its anti-inflammatory activity”. Natural Product Research 27.4-5 (2013): 340-349.
  32. Rizza L., et al. “Caco-2 cell line as a model to evaluate mucoprotective proprieties”. International Journal of Pharmaceutics 1-2 (2012): 318-322.
  33. Wilkie MD., et al. “Gaviscon® Advance alone versus co-prescription of Gaviscon® Advance and proton pump inhibitors in the treatment of laryngopharyngeal reflux”. European Archives of Oto-Rhino-Laryngology 10 (2018): 2515-2521.
  34. Alecci U., et al. “Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double-Blinded Randomized-Controlled Study”. Evidence-Based Complementary and Alternative Medicine 2016 (2016): 2581461.

Citation

Citation: Mario Notargiacomo., et al. “Treatment of Laryngopharyngeal Reflux Disease Using an Oral Medical Device: A Clinical Investigation into Signs, Symptoms and Quality of Life of Patients”.Acta Scientific Medical Sciences 6.12 (2022): 89-102.

Copyright

Copyright: © 2022 Mario Notargiacomo., 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.




Metrics

Acceptance rate30%
Acceptance to publication20-30 days
Impact Factor1.403

Indexed In





Contact US