Abstract
Objectives
Nasal irrigations are mentioned among the adjunctive measures for treating several sinonasal conditions. Hyperchromatic supranuclear stria (HSS) in the ciliated cells (CCs) has recently been suggested as a potential cytological marker of the anatomofunctional integrity of nasal mucosa. The aim of this study was to compare the effects of nasal irrigations with sulfurous, salty, bromic, iodic (SSBI) thermal water or isotonic sodium chloride solution (ISCS) in patients with nonallergic chronic rhinosinusitis, considering the endoscopic, functional, microbiological, and cytological evidence (including the ratio of HSS-positive CCs to total CCs [the HSS+ rate]).
Methods
In a prospective, randomized, double-blind setting, 80 patients were recruited for nasal irrigations with SSBI water or ISCS for 1 month.
Results
An endoscopically assessed significant clinical improvement was seen after both SSBI thermal water and ISCS irrigations. Before treatment, Staphylococcus aureus was isolated in 5 patients in the SSBI thermal water group and 4 in the ISCS group. After the nasal irrigations, there was no sign of the bacteria in either group. Only the SSBI water irrigations significantly reduced total nasal resistance, as determined by rhinomanometry. Mild nasal irritation (6 cases) and episodes of extremely limited epistaxis (5 cases) were only reported after SSBI thermal water irrigations. Neither type of nasal irrigation significantly increased the mean HSS+ rate at cytological control after 1 month.
Conclusions
Both types of nasal irrigation improved the endoscopic and microbiological features of patients with nonallergic chronic rhinosinusitis, whereas only SSBI irrigations significantly reduced total nasal resistance. Further investigations are needed based on longer treatments and follow-up periods to establish whether the HSS+ rate is useful for monitoring clinical improvements in chronic rhinosinusitis treated with nasal irrigations.
1
Introduction
Rhinosinusitis is a common disease that affects more than 31 million people in the United States every year . Nasal irrigations are often recommended among the adjunctive measures for treating several sinonasal conditions. In 2000, Hamilos discussed the rational treatment of chronic sinusitis and advocated the use of nasal irrigations; Benninger et al also suggested including nasal irrigations in the treatment of most patients with rhinosinusitis. There is some controversy over the efficacy of nasal irrigation solutions of different tonicities and the use of additives in the solution . In 2002, Rabago and coworkers found that hypertonic nasal irrigations improved quality of life and overall symptom severity in patients with rhinosinusitis. Further investigations confirmed that hypertonic nasal irrigations were superior to isotonic solutions . When Staffieri and Abramo measured the mucociliary transport time before and after inhalatory treatment with sulfurous, arsenical, ferruginous thermal water in 37 consecutive patients with chronic rhinosinusitis, they found a significant reduction in the transport time after the treatment. However, most of the available studies on nasal irrigations are based on limited, inadequately controlled series; and the exact mechanism behind the effects of nasal irrigations remains highly controversial. Some believe that nasal irrigations take effect mainly by clearing the mucus; others are convinced that they remove nasal inflammatory mediators . Staffieri et al found a direct correlation between sulfurous, salty, bromic, iodic (SSBI) thermal water irrigations and nasal secretory immunoglobulin A and albumin concentrations, concluding that this might be one of the mechanisms by which such irrigations may be effective in treating nasal inflammation.
Interest in cytological studies on the nasal mucosa is due to the relative simplicity of sample collection and to their utility in the clinical follow-up, especially to monitor the efficacy of medical and surgical treatments . Normal nasal mucosa contains 4 types of cell: ciliated cells ( Fig. 1 ), mucus-secreting cells, basal cells, and striated cells. In 2003, Gelardi and coworkers found a hyperchromatic area in the cytoplasm of ciliated cells ( Fig. 2 ) of healthy individuals, termed the hyperchromatic supranuclear stria (HSS) because of its position above the nucleus; the authors hypothesized that the HSS might express a high protein content because of a good metabolic activity of the cells and that it might consequently be a valid marker of the anatomical and functional integrity of the ciliated cells in the nasal mucosa .
Our prospective, double-blind, randomized study investigated the effects of nasal irrigations with SSBI thermal water vs isotonic sodium chloride solution (ISCS) in patients with nonallergic chronic rhinosinusitis, considering the clinical and microbiological evidence, and the cytological picture (the numbers of the HSS-positive and total ciliated cells).
2
Methods
2.1
Study design
The present investigation was a prospective, randomized, double-blind study conducted in accordance with the 1996 Helsinki Declaration. The study protocol was approved by the Ethics Committee of Padova University Hospital in Italy (protocol no. 7302).
The inclusion criteria were age ranging from 18 to 65 years and nonallergic chronic rhinosinusitis; the exclusion criteria were autoimmune diseases, cystic fibrosis, and diabetes. At enrolment, patients provided microbiological nasal swabs and underwent anterior active rhinomanometry and nasal endoscopy (using the rigid, 0°, or 30° endoscope). Written informed consent was obtained from all patients before starting any study-related procedures.
Each patient was randomly assigned to nasal irrigations with SSBI thermal water (5 mL, 4 times a day for a month) or ISCS (5 mL, 4 times a day for a month). The thermal water and ISCS containers were identical and indistinguishable for patients and investigators. For the SSBI thermal water irrigations, we used the thermal water from Sirmione Spa (Sirmione, Brescia, Italy). All patients were reassessed after 1 month of treatment, obtaining a microbiological nasal swab and performing nasal cytology, anterior active rhinomanometry, and nasal endoscopy.
2.2
Study population
Eighty consecutive adult patients with chronic rhinosinusitis were eligible and were enrolled in the study. They were all asked not to use topical nasal treatments or systemic steroids or antibiotics during the study. They were randomly assigned, regardless of disease severity, to have nasal irrigations: 40 with SSBI thermal water and 40 with ISCS.
2.3
Endoscopy
Endoscopic findings were classified as follows: 0, no anatomical changes or acute inflammation; 1, septal deviation; 2, hypertrophic inferior turbinates; or 3, acute rhinosinusitis.
2.4
Anterior active rhinomanometry
Nasal patency was evaluated by active anterior rhinomanometry (Rhinolab, Rendsburg, Germany), according to the International Committee on the Standardization of Rhinomanometry. At least 5 breaths were recorded at a fixed transnasal pressure of 150 Pa during quiet breathing with the mouth closed in the seated position. Airflow values were expressed in milliliters per second. Total nasal resistance was calculated by combining the nasal resistance values for the 2 nasal passages using the following formula:
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