EFFICACY OF A CO₂-ENRICHED EFFERVESCENT NASAL SPRAY FOR IRRIGATING-ELIMINATIVE THERAPY IN ACUTE BACTERIAL RHINOSINUSITIS

Abstract

Background: Acute rhinosinusitis (ARS) is one of the most prevalent diseases of the upper respiratory tract. Bacterial rhinosinusitis (ABRS), as a distinct form of ARS, remains considerably common, accounting for approximately 0.5-2% of all ARS cases. Saline-based irrigating-eliminative therapy is currently recognised by a number of guidelines, including EPOS 2020, as a highly evidence-based component of rhinosinusitis management - both acute and chronic. A substantial body of publications exists addressing the optimal composition of aqueous saline solutions for nasal cavity irrigation, with investigations exploring the use of xylitol, menthol, various electrolytes, hyaluronic acid, and numerous other adjuvant agents. Nevertheless, no optimal combination has yet been established. The majority of studies remain focused exclusively on standard normal saline for nasal rinsing, while data concerning supplementary substances and their potential impact on the course of acute rhinosinusitis remain limited.

Objective: To evaluate the efficacy of the nasal solution "Sparklin" (a solution supplemented with 0.4% CO₂) compared to standard isotonic saline as part of complex treatment for acute bacterial rhinosinusitis.

Materials and methods: A prospective controlled study was conducted at the Svyato-Mykhailivska Clinical Hospital, Kyiv. Fifty-four adult patients (aged 18-60 years) with a verified diagnosis of ABRS were enrolled and allocated into two groups: a control group (n=28, irrigation with 0.9% sodium chloride solution) and a study group (n=26, irrigation with "Sparklin"). All patients received identical standard therapy: amoxicillin/clavulanate, phytotherapy, and xylometazoline. Severity of four cardinal symptoms (headache, facial pain/discomfort, nasal congestion, and nasal discharge) was assessed using a visual analogue scale (VAS, 0-10 points) at four time points: baseline, after the first irrigation, at day 7, and at day 14. Mucosal pH of the inferior nasal meatus was measured with Combur indicator test strips (Roche Diagnostics) at the same time points. All data obtained were subjected to statistical analysis.

Results: Both groups demonstrated a statistically significant reduction in the severity of all symptoms by day 14 (p<0.001); however, effect sizes in the "Sparklin" group were substantially greater across all parameters (Cohen's d 7.51-8.26 vs. 5.43-6.83 in the control group). Already after the first irrigation, mucosal pH in the "Sparklin" group decreased from 7.52 to 6.63, whereas in the control group it remained at 7.52 (p<0.001). By day 14, the mean pH in the "Sparklin" group was 6.33±0.24 compared to 7.05±0.42 in the control group (p<0.001). At the end of the observation period, a statistically significant positive correlation was identified between residual mucosal pH and the severity of all four symptoms (r=0.468–0.591, p<0.001).

Conclusions: The addition of the CO₂-enriched isotonic solution "Sparklin" to complex treatment of ABRS provides significantly greater reduction of clinical symptoms and more effective normalisation of nasal mucosal pH compared to standard isotonic nasal irrigation; accordingly, "Sparklin" may be recommended as an adjuvant irrigating agent in the management of ABRS in adult patients.