A Hypertonic Seawater Nasal Irrigation Solution Containing Algal and Herbal Natural Ingredients Reduces Viral Load and SARS-CoV-2 Detection Time in the Nasal Cavity.

Nasal irrigation is thought to decrease the viral load present in the nasal cavity. Our aim was to assess the effect of a hypertonic seawater solution [with algal and herbal natural ingredients (Sinomarin®)] on the viral load of nasopharynx in patients hospitalized with severe COVID-19 pneumonia. We conducted a prospective, randomized, controlled trial from June 2022 to December 2022. We allocated 56 patients with COVID-19 pneumonia into two groups (28 in each group)-the hypertonic seawater group [nasal irrigations with a hypertonic seawater solution (Sinomarin®) every 4 h for 16 h per day, for two consecutive days] and the control group (no nasal irrigations). A second nasopharyngeal swab was collected 48 h after the baseline nasopharyngeal swab (8 h after the last wash in the hypertonic seawater group) to estimate the SARS-CoV-2 viral load as determined by cycle threshold (Ct) values. In the hypertonic seawater group, the mean Ct values significantly increased two days after the initial measurement [ΔCt 48-0 h = 3.86 ± 3.03 cycles, p < 0.001 (95%CI: 2.69 to 5.04)]. No significant differences in the Ct values were observed in the control group [ΔCt 48-0 h = -0.14 ± 4.29, p = 0.866 (95%CI: -1.80 to -1.52)]. At follow-up, 17 patients from the hypertonic seawater group had negative test results compared to only 9 patients from the control group (p = 0.03). Nasal irrigations with a hypertonic seawater solution containing algal and herbal natural ingredients significantly decreased nasopharyngeal viral load and the detection time of SARS-CoV-2 in the nasal cavity.

Multicenter, randomized, open-label, comparative study of the effectiveness of nasal spray Aqua Maris Extra Strong as a symptomatic therapy in the technology of delayed antibiotic prescription in the treatment of acute rhinosinusitis in children aged 6-11 years.

Antibacterial therapy in acute rhinosinusitis (ARS) is prescribed 4-9 times more often than recommended, while no >5 % of patients require such treatment. The main motive for the irrational antibiotic prescription is the presence of mucopurulent discharge and nasal congestion in combination with hyperthermia. The study objective was to determine the efficacy of hypertonic seawater solution in the technology of delayed antibiotic prescription in patients with ARS. METHODS: In a multicenter, randomized, open-label, comparative study, 100 children were randomized. 100 children with ARS aged 6-11 years, who received Aqua Maris Extra Strong irrigation therapy in addition to standard therapy or received standard therapy, completed the study. EVALUATION CRITERIA: decreased intensity of nasal congestion, rhinorrhea, postnasal drip, headache and facial pain, assessed by the physician using a 4-point scale at each visit compared to Visit 1, dynamics of self-scored symptoms using a 10-point visual analogue scale, frequency of antipyretic and antibiotic prescription. RESULTS: The use of hypertonic seawater solution in patients with ARS provides a clinically significant reduction in the severity of core or key symptoms: rhinorrhea, nasal congestion, postnasal drip and headache, assessed by the physician at V2 (p < 0.05). There are significant differences in the dynamics of these symptoms according to the patient's self-assessment from treatment Day 2 (p < 0.05). The use of irrigation therapy with Aqua Maris Extra Strong in the technology of delayed antibiotic prescription in patients with ARS allows to reduce the prescription of antibacterial drugs. No on-treatment side effects were observed in any patient. CONCLUSION: Hypertonic seawater solution Aqua Maris Extra Strong is a safe and effective medicinal product for the symptomatic treatment of acute rhinosinusitis in children aged 6-11 years/ It provides a significant therapeutic effect when prescribed in addition to standard therapy and helps to reduce the need for antibiotics.

Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.

PURPOSE: Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS. METHODS: Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events. RESULTS: All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups. CONCLUSIONS: BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.

In vitro safety and performance evaluation of a seawater solution enriched with copper, hyaluronic acid, and eucalyptus for nasal lavage.

BACKGROUND: The common cold is a viral infectious disease with symptoms such as runny nose, sore throat, and mainly, nasal congestion. State-of-the-art therapeutic approaches focus on alleviating the symptoms of this disease by non-invasive and simple-to-use methods. Nasal irrigation is one of the most accepted approaches to ease nasal congestion which, if left untreated, has a negative impact on the quality of life of patients. PURPOSE: In this study, the safety and efficacy of a novel hypertonic seawater solution for nasal lavage enriched with hyaluronic acids, eucalyptus oil, copper, and manganese salts (Stérimar Stop & Protect Cold and Flu; SSPCF) have been investigated in vitro. METHODS: An in vitro 3D reconstituted human nasal epithelium tissue model, MucilAir™, has been used in this study to investigate the safety of SSPCF on nasal epithelium by measuring transepithelial electrical resistance (TEER), lactate dehydrogenase (LDH), and interleukin-8 (IL-8) secretion. The efficacy of SSPCF was measured by mucociliary clearance (MCC), ATP release, Alcian blue and aquaporin (AQP3) stainings. RESULTS: SSPCF treatment respected nasal epithelium tissue integrity and enhanced barrier function without inducing a cytotoxic response. Secreted LDH and IL-8 levels were similar to untreated controls. MCC rate was increased 2.5-fold and ATP release decreased 87% upon SSPCF treatment, indicating improved decongestion activity. SSPCF treatment after hypotonic stress helped recover cellular organization, as shown by Alcian blue and AQP3 staining assays. CONCLUSION: SSPCF appears as a safe and effective nasal irrigation formula that may alleviate the symptoms associated with common cold such as nasal congestion.

Effect of Hypertonic Seawater (Sinomarin(R)) on Mucociliary Clearance in Normal Subjects

BACKGROUND AND OBJECTIVES: The effect of the hypertonic nasal douching solutions on mucociliary clearance was studied to ascertain the effect of hypertonic seawater. MATERIALS AND METHODS: Twenty-eight normal subjects were included in a randomized double -blind crossover trial. Hypertonic seawater (3%, Sinomarin(R)) was used as a hypertonic nasal douching solution. In order to determine the effect of hypertonic seawater on nasal mucosa, the mucociliary clearance was measured by the saccharin clearance time (SCT). RESULTS: The resultant SCT after administration of hypertonic seawater was significantly reduced compared with normal saline (0.9%)(p<0.05). CONCLUSION: This results showed that the hypertonic seawater improved mucociliary clearance time in the nasal cavity. The mechanism of this effect is probably brought about by changes in mucus viscoelastic properties.