Efficacy of a Non-addictive Nasal Irrigation Based on Sea Salt Enriched with Natural Enzymes among Patients with Sinusitis: An In Vivo, Randomized, Controlled Trial

Riccardo  Nocini; Michele Di Cosola; Angela Pia Cazzolla; Stefania Cantore; Francesca Castellaneta; Michele Covelli

doi:10.3889/oamjms.2022.8164

Authors

Riccardo Nocini Department of Surgical Sciences, Dentistry, Gynecology and Pediatric, University of Verona, Verona, Italy
Michele Di Cosola Department of Clinical and Experimental Medicine, Università degli Studi di Foggia, Foggia, Italy
Angela Pia Cazzolla Department of Clinical and Experimental Medicine, Università degli Studi di Foggia, Foggia, Italy https://orcid.org/0000-0003-0842-7351
Stefania Cantore Faculty of Dentistry, University of Medicine, Tirana, Tirana, Albania; Department of Interdisciplinary of Medicine, University of Bari Aldo Moro, Bari, Italy
Francesca Castellaneta School of Medicine, University of Bari Aldo Moro, Bari, Italy
Michele Covelli Interuniversity Research Center “Population, Environment and Health - CIRPAS, University of Bari Aldo Moro, Bari, Italy

DOI:

https://doi.org/10.3889/oamjms.2022.8164

Keywords:

Chronic rhinosinusitis, Nasal irrigation, Sea salt, Natural enzymes and lysozyme

Abstract

BACKGROUND: Chronic rhinosinusitis (CRS) is a common condition that is defined as inflammation of the nose and paranasal sinuses. Nasal irrigation plays an important role in the treatment of CRS. Evidence from basic research favors hypertonic saline over isotonic saline for mucociliary clearance, but evidence from clinical studies is controversial.

AIM: This study aims to investigate the hypothesis that the use of daily nasal irrigation based on sea salt, enriched with natural enzymes and lysozyme, may be useful in patients with CRS.

PATIENT AND METHODS: Patients (30 men and 30 women) 18–55 years old (mean age 41 ± 3 y.o.), with two episodes of acute sinusitis or one episode of chronic sinusitis per year for 2 consecutive years, were enrolled stratified by sex and age and randomly divided into two groups supplementation: Group A (test) and Group B (control/placebo). Moreover, an exit questionnaire was asked to Group A subjects to report whether their sinus-related quality of life has gotten worse, stayed the same, or improved (scale from 0 to ±100%).

RESULTS: The result showed that in the test group (A) from T0 to T1, a reduction of 17.65% for the symptoms related headache and/or facial pressure and a reduction of the 18.18%, for the symptoms relates to congestion and/or nasal discharge. On the other hand, the control group (B) shown less difference between T0 and T1.

CONCLUSIONS: This study strengthens the argument that the tested formulation is a safe, well-tolerated, long-term therapy that patients with chronic sinonasal complaints can and will use at home with minimal training and follow-up.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Plum Analytics Artifact Widget Block

References

Santacroce L, Charitos IA, Ballini A, Inchingolo F, Luperto P, De Nitto E, et al. The human respiratory system and its microbiome at a glimpse. Biology (Basel). 2020;9(10):E318. https://doi.org/10.3390/biology9100318 PMid:33019595 DOI: https://doi.org/10.3390/biology9100318

Passali D, Damiani V, Passali GC, Cassano P, Piemonte M, Ciprandi G. The impact of rhinosinusitis in clinical practice: An Italian survey. Acta Biomed. 2020;91(1-S):28-35. https://doi.org/10.23750/abm.v91i1-S.9247 PMid:32073558

Tan NC, Psaltis AJ. Latest developments on topical therapies in chronic rhinosinusitis. Curr Opin Otolaryngol Head Neck Surg. 2020;28(1):25-30. https://doi.org/10.1097/MOO.0000000000000598 PMid:31789928 DOI: https://doi.org/10.1097/MOO.0000000000000598

Woods CM, Lee VS, Hussey DJ, Irandoust S, Ooi EH, Tan LW, et al. Lysozyme expression is increased in the sinus mucosa of patients with chronic rhinosinusitis. Rhinology. 2012;50(2):147-56. DOI: https://doi.org/10.4193/Rhin11.229

Giudice G, Cutrignelli DA, Sportelli P, Limongelli L, Tempesta A, Di Gioia G, et al. Rhinocerebral mucormycosis with orosinusal involvement: Diagnostic and surgical treatment guidelines. Endocr Metab Immune Disord Drug Targets. 2016;16(4):264-9. https://doi.org/10.2174/1871530316666161223145055 PMid:28017141 DOI: https://doi.org/10.2174/1871530316666161223145055

Cazzolla AP, Cosola MD, Ballini A, Santacroce L, Lovero R, Testa NF, et al. The association between nutritional alterations and oral lesions in a pediatric population: An epidemiological study. Biomed Res Int. 2021;2021:9992451. https://doi.org/10.1155/2021/9992451 PMid:34746317 DOI: https://doi.org/10.1155/2021/9992451

Di Cosola M, Ballini A, Zhurakivska K, Ceccarello A, Nocini R, Malcangi A, et al. Retrospective analysis of clinical and radiologic data regarding zygomatic implant rehabilitation with a long-term follow-up. Int J Environ Res Public Health. 2021;18(24):12963. https://doi.org/10.3390/ijerph182412963 PMid:34948572 DOI: https://doi.org/10.3390/ijerph182412963

Charitos IA, Castellaneta F, Santacroce L, Bottalico L. Historical anecdotes and breakthroughs of histamine: From discovery to date. Endocr Metab Immune Disord Drug Targets. 2021;21(5):801-14. https://doi.org/10.2174/1871530320666200729150124 PMid:32727338 DOI: https://doi.org/10.2174/1871530320666200729150124

Lin SY, Baugher KM, Brown DJ, Ishman SL. Effects of nasal saline lavage on pediatric sinusitis symptoms and disease-specific quality of life: A case series of 10 patients. Ear Nose Throat J. 2015;94(2):E13-8. https://doi.org/10.1177/014556131509400212 PMid:25651352 DOI: https://doi.org/10.1177/014556131509400212

Santacroce L, Sardaro N, Topi S, Pettini F, Bottalico L, Cantore S, et al. The pivotal role of oral microbiota in health and disease. J Biol Regul Homeost Agents. 2020;34(2):733-7. https://doi.org/10.23812/20-127-L-45 PMid:32492992

Kanjanawasee D, Seresirikachorn K, Chitsuthipakorn W, Snidvongs K. Hypertonic saline versus isotonic saline nasal irrigation: Systematic review and meta-analysis. Am J Rhinol Allergy. 2018;32(4):269-79. https://doi.org/10.1177/1945892418773566 PMid:29774747 DOI: https://doi.org/10.1177/1945892418773566

Zahedi FD, Asmi NH, Husain S, Gendeh BS. Identification of nasal irrigation bottle contamination in post sinonasal surgery. Indian J Otolaryngol Head Neck Surg. 2019;71(Suppl 3):1837-42. https://doi.org/10.1007/s12070-017-1219-x PMid:31763256 DOI: https://doi.org/10.1007/s12070-017-1219-x

Ballini A, Dipalma G, Isacco CG, Boccellino M, Di Domenico M, Santacroce L, et al. Oral microbiota and immune system crosstalk: A translational research. Biology (Basel). 2020;9(6):E131. https://doi.org/10.3390/biology9060131 PMid:32560235 DOI: https://doi.org/10.3390/biology9060131

Ballini A, Scacco S, Boccellino M, Santacroce L, Arrigoni R. Microbiota and obesity: Where are we now? Biology (Basel). 2020;9(12):E415. https://doi.org/10.3390/biology9120415 PMid:33255588 DOI: https://doi.org/10.3390/biology9120415

Signorini L, Ballini A, Arrigoni R, De Leonardis F, Saini R, Cantore S, et al. Evaluation of a nutraceutical product with probiotics, vitamin d, plus banaba leaf extracts (Lagerstroemia speciosa) in glycemic control. Endocr Metab Immune Disord Drug Targets. 2020;21(7):1356-65. https://doi.org/10.2174/1871530320666201109115415 PMid:33167849 DOI: https://doi.org/10.2174/1871530320666201109115415

Muzio LL, Ballini A, Cantore S, Bottalico L, Charitos IA, Ambrosino M, et al. Overview of Candida albicans and human papillomavirus (HPV) infection agents and their biomolecular mechanisms in promoting oral cancer in pediatric patients. Biomed Res Int. 2021;2021:7312611. https://doi.org/10.1155/2021/7312611 PMid:34765678 DOI: https://doi.org/10.1155/2021/7312611

Crincoli V, Cazzolla AP, Di Comite M, Lo Muzio L, Ciavarella D, Dioguardi M, et al. Evaluation of Vitamin D (25OHD), bone alkaline phosphatase (BALP), serum calcium, serum phosphorus, ionized calcium in patients with mandibular third molar impaction. An observational study. Nutrients. 2021;13(6):1938. https://doi.org/10.3390/nu13061938 PMid:34200107 DOI: https://doi.org/10.3390/nu13061938

Charitos IA, Ballini A, Cantore S, Boccellino M, Di Domenico M, Borsani E, et al. Stem cells: A historical review about biological, religious, and ethical issues. Stem Cells Int. 2021;2021:9978837. https://doi.org/10.1155/2021/9978837 DOI: https://doi.org/10.1155/2021/9978837

Santacroce L, Di Cosola M, Bottalico L, Topi S, Charitos IA, Ballini A, et al. Focus on HPV infection and the molecular mechanisms of oral carcinogenesis. Viruses. 2021;13(4):559. https://doi.org/10.3390/v13040559 PMid:33810374 DOI: https://doi.org/10.3390/v13040559

Di Cosola M, Cazzolla AP, Charitos IA, Ballini A, Inchingolo F, Santacroce L. Candida albicans and oral carcinogenesis. A brief review. J Fungi (Basel). 2021;7(6):476. https://doi.org/10.3390/jof7060476 PMid:34204731 DOI: https://doi.org/10.3390/jof7060476

Man A, Ciurea CN, Pasaroiu D, Savin AI, Toma F, Sular F, et al. New perspectives on the nutritional factors influencing growth rate of Candida albicans in diabetics. An in vitro study. Mem Inst Oswaldo Cruz. 2017;112(9):587-92. https://doi.org/10.1590/0074-02760170098 PMid:28902283 DOI: https://doi.org/10.1590/0074-02760170098

Di Cosola M, Ambrosino M, Limongelli L, Favia G, Santarelli A, Cortelazzi, R, et al. Cocaine-induced midline destructive lesions (CIMDL): A real challenge in diagnosis. Int J Environ Res Public Health. 2021;18(15):7831. https://doi.org/10.3390/ijerph18157831 PMid:34360121 DOI: https://doi.org/10.3390/ijerph18157831

Grassi FR, Pappalettere C, Di Comite M, Corsalini M, Mori G, Ballini A, et al. Effect of different irrigating solutions and endodontic sealers on bond strength of the dentin-post interface with and without defects. Int J Med Sci. 2012;9(8):642-54. https://doi.org/10.7150/ijms.4998 PMid:23055816 DOI: https://doi.org/10.7150/ijms.4998

Campanella V, Syed J, Santacroce L, Saini R, Ballini A, Inchingolo F. Oral probiotics influence oral and respiratory tract infections in pediatric population: A randomized double-blinded placebo-controlled pilot study. Eur Rev Med Pharmacol Sci. 2018;22(22):8034-41. https://doi.org/10.26355/eurrev_201811_16433 PMid:30536353

Santacroce L, Inchingolo F, Topi S, Del Prete R, Di Cosola M, Charitos IA, et al. Potential beneficial role of probiotics on the outcome of COVID-19 patients: An evolving perspective. Diabetes Metab Syndr. 2021;15(1):295-301. https://doi.org/10.1016/j.dsx.2020.12.040 PMid:33484986 DOI: https://doi.org/10.1016/j.dsx.2020.12.040

Ballini A, Di Cosola M, Saini R, Benincasa C, Aiello E, Marrelli B, et al. Comparison of manual nylon bristled versus thermoplastic elastomer toothbrushes in terms of cleaning efficacy and biological potential role on gingival health. Appl Sci. 2021;11:7180. DOI: https://doi.org/10.3390/app11167180

Di Cosola M, Cantore S, Balzanelli MG, Isacco CG, Nguyen KC, Saini R, et al. Dental-derived stem cells and biowaste biomaterials: What’s next in bone regenerative medicine applications. Biocell. 2022;46(4):923-9. DOI: https://doi.org/10.32604/biocell.2022.018409

Posa F, Colaianni G, Di Cosola M, Dicarlo M, Gaccione F, Colucci S, et al. the myokine irisin promotes osteogenic differentiation of dental bud-derived MSCs. Biology (Basel). 2021;10(4):295. https://doi.org/10.3390/biology10040295 PMid:33916859 DOI: https://doi.org/10.3390/biology10040295