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

Research Article Volume 7 Issue 4

Effectiveness of a Medical Device Based on Ectoine, Propolis, Grapefruit Extract with Glycerol for the Treatment of Uncomplicated Acute Pharyngitis

Enrico Maffezzoni1, Federico Maffezzoni2 and Stefano Agostini3*

1Rhinocytoallergology Unit, Istituto Figlie di San Camillo, Cremona, Italy
2Clinical Psychology, Poliambulatorio Oberdan, Brescia, Italy
3Scientific Writer, Lodi, Italy

*Corresponding Author: Stefano Agostini, Scientific Writer, Lodi, Italy.

Received: February 21, 2023; Published: March 07, 2023

Abstract

The pharynx is often exposed to infectious and non-infectious factors that can lead to an inflammatory reaction referred to as pharyngitis or sore throat. Even if viral pharyngitis is a self-limiting disease, the related acute sore throat can be very annoying; therefore, rapid pain relief, obtained effectively and safely, must be the primary therapeutic goal. Moreover, an effective pain alleviation can result in the reduction of drug abuse. A medical device based on a compound made up of ectoine, propolis, grapefruit extract and glycerol (VG), to be sprayed directly into the oral cavity by means of a special nozzle, was compared with an oral spray based on isotonic saline solution (IS). The study is a prospective, controlled, monocentric, single-blind clinical trial. 49 patients were enrolled in the VG group and 52 patients were enrolled in the IS group. The investigators measured the patients’ pharyngeal redness, their pharyngeal edema and their mucous secretion on an 11-point numerical rating scale (NRS) and compiled the relevant 3 questionnaires. Patients graded their sore throat, difficulty swallowing and swelling of the throat with the same 11-point NRS and compiled the relevant 3 questionnaires. The first application of VG or IS was made by patients with 4 sprays directly onto the pharynx and they compiled the relevant NRSs questionnaires within 3 hours from the first application, at predefined intervals. The patients then left the clinic and applied VG or IS 4 times throughout the first day and 5 times per day in the following 2 days, each time with 4 sprays directly onto the pharynx. Patients compiled the 3 NRS questionnaires at the end of the first, of the second and of the third day of therapy. At the end of the third day of application of the oral sprays, the patients evaluated the effectiveness of the spray based on a 5-point Likert scale. In the morning of the fourth day, the patients were visited again in the clinic by the investigators. The reduction of the characteristic signs and symptoms of uncomplicated acute pharyngitis resulted significantly more pronounced on patients treated with VG versus those treated with IS. Both investigators and patients evaluated VG significantly more effective than IS. Both the tolerability and the safety of VG have proven to be equivalent to those of IS. In conclusion, the oral spray containing ectoine, propolis, grapefruit extract and glycerol can be considered a valid alternative for the treatment of signs and symptoms of uncomplicated acute pharyngitis.

Keywords: Acute Pharyngitis; Sore Throat; Difficulty Swallowing; Swelling of the Throat; Medical Device; Ectoine; Propolis; Grapefruit Extract; Citrus paradisi; Glycerol

References

  1. Addey D., et al. “Incidence, causes, severity and treatment of throat discomfort: a four-region online questionnaire survey”. BMC Ear Nose Throat Disorder 12 (2012): 9.
  2. Ebell MH., et al. “The rational clinical examination. Does this patient have strep throat?”. JAMA22 (2000): 2912-2918.
  3. Spinks A., et al. “Antibiotics for sore throat.” Cochrane Database System Review 11 (2013): CD000023.
  4. Van Driel ML., et al. “Are sore throat patients who hope for antibiotics actually asking for pain relief?”. Annals of Family Medicine6 (2006): 494-499.
  5. Van der Velden AW., et al. “Sore throat: effective communication delivers improved diagnosis, enhanced self-care and more rational use of antibiotics”. International Journal of Clinical Practice180 (2013): 10-16.
  6. de Mey C., et al. “Efficacy and Safety of an Oral Ambroxol Spray in the Treatment of Acute Uncomplicated Sore Throat”. Drug Research (Stuttg) 12 (2015): 658-667.
  7. de Looze F., et al. “Locally Delivered Flurbiprofen 8.75 mg for Treatment and Prevention of Sore Throat: A Narrative Review of Clinical Studies”. Journal of Pain Research 12 (2019): 3477-3509.
  8. Rachelefsky G.S., et al. “Impact of inhaled corticosteroid-induced oropharyngeal adverse events: results from a meta-analysis”. Annals of Allergy, Asthma and Immunology 3 (2007): 225-238.
  9. Rousse M., et al. “A randomized, double-blind, controlled study to evaluate clinical efficacy and safety of novel filmogen osmotic treatment for pharyngitis”. Clinical Investigation3 (2017).
  10. Farrar J. “Advances in clinical research methodology for pain clinical trials”. Nature Medicine16 (2010): 1284-1293.
  11. Farrar JT., et al. “Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale”. Pain 94 (2001): 149-158.
  12. Galinski EA., et al. “1,4,5,6-Tetrahydro-2-methyl-4-pyrimidinecarboxylic acid. A novel cyclic amino acid from halophilic phototrophic bacteria of the genus Ectothiorhodospira”. European Journal of Biochemistry1 (1985): 135-139.
  13. Yancey PH. “Organic osmolytes as compatible, metabolic and counteracting cytoprotectants in high osmolarity and other stresses”. The Journal of Experimental Biology 208 (2005): 2819-2830.
  14. Bownik A., et al. “Ectoine as a promising protective agent in humans and animals”. Arhiv za Higijenu Rada i Toksikologiju 4 (2016): 260-265.
  15. Sydlik U., et al. “Recovery of neutrophil apoptosis by ectoine: a new strategy against lung inflammation”. European Respiratory Journal 41 (2013): 433-442.
  16. Abdel-Aziz H., et al. “Bacteria-derived compatible solutes ectoine and 5a-hydroxyectoine act as intestinal barrier stabilizers to ameliorate experimental inflammatory bowel disease”. Journal of Natural Production 78 (2015): 1309-1315.
  17. Peuschel H., et al. “c-Src-mediated activation of Erk1/2 is a reaction of epithelial cells to carbon nanoparticle treatment and may be a target for a molecular preventive strategy”. Biological Chemistry 391 (2010): 1327-1332.
  18. Harishchandra R.K., et al. “The effect of compatible solute ectoines on the structural organization of lipid monolayer and bilayer membranes”. Biophysics Chemistry 150 (2010): 37-46.
  19. Dwivedi M., et al. “Biophysical investigations of the structure and function of the tear fluid lipid layer and the effect of ectoine. Part A: natural meibomian lipid films”. Biochimica et Biophysica Acta 1838 (2014): 2708-2715.
  20. Dwivedi M., et al. “Biophysical investigations of the structure and function of the tear fluid lipid layers and the effect of ectoine. Part B: artificial lipid films”. Biochimica et Biophysica Acta 1838 (2014): 2716-2727.
  21. Widderich N., et al. “Biochemical properties of ectoine hydroxylases from extremophiles and their wider taxonomic distribution among microorganisms”. PLoS ONE 9 (2014): e93809.
  22. Marini A., et al. “Ectoine containing cream in the treatment of mild to moderate atopic dermatitis: a randomised, comparator-controlled, intra-individual double-blind, multi-center trial”. Skin Pharmacology and Physiology 27 (2014): 57-65.
  23. Eichel A., et al. “A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragées) in patients with acute rhinosinusitis”. Current Medical Research and Opinion 29 (2013): 739-746.
  24. Werkhauser N., et al. “Treatment of allergic rhinitis with ectoine containing nasal spray and eye drops in comparison with azelastine containing nasal spray and eye drops or with cromoglycic acid containing nasal spray”. Journal of Allergy (Cairo) (2014): 176597.
  25. Sonnemann U., et al. “Treatment of rhinitis sicca anterior with ectoine containing nasal spray”. Journal of Allergy (Cairo) (2014): 273219.
  26. Müller D., et al. “Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial”. European Archives of Oto-Rhino-Laryngology 9 (2016): 2591-2597.
  27. Zaccaria V., et al. “Multi Dynamic Extraction: an Innovative Method to Obtain a Standardized Chemically and Biologically Reproducible Polyphenol Extract from Poplar-Type Propolis to Be Used for Its Anti-Infective Properties”. Materials (Basel) 12 (2019): 3746.
  28. Zaccaria V., et al. “Effect of Green and Brown Propolis Extracts on the Expression Levels of microRNAs, mRNAs and Proteins, Related to Oxidative Stress and Inflammation”. Nutrients 9 (2017): 1090.
  29. Curti V., et al. “Bioavailability and In Vivo Antioxidant Activity of a Standardized Polyphenol Mixture Extracted from Brown Propolis”. International Journal of Molecular Sciences 20 (2019): 1250.
  30. Esposito, et al. “A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial”. Phytomedicine 80 (2021): 153368.
  31. Cristóbal-Luna JM., et al. “Grapefruit and its biomedical, antigenotoxic and chemopreventive properties”. Food and Chemical Toxicology 112 (2018): 224-234.
  32. Eccles R., et al. “Soothing Properties of Glycerol in Cough Syrups for Acute Cough Due to Common Cold”. Pharmacy (Basel) 1 (2017): 4.

Citation

Citation: Enrico Maffezzoni., et al. “Effectiveness of a Medical Device Based on Ectoine, Propolis, Grapefruit Extract with Glycerol for the Treatment of Uncomplicated Acute Pharyngitis”.Acta Scientific Medical Sciences 7.4 (2023): 51-60.

Copyright

Copyright: © 2023 Enrico Maffezzoni., 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