Abstract
Purpose
Smoking is a self-destructive behavior that is known to induce remodeling of the lower airways, leading to squamous metaplasia, but little is known about its effects on the nose and paranasal sinuses. Nasal irrigations are often mentioned as measures for treating sinonasal inflammations. The purpose of our study was to compare the effects of nasal irrigations with sulfurous-arsenical-ferruginous thermal water or isotonic sodium chloride solution in smokers with nonallergic chronic rhinosinusitis, based on clinical and olfactory evidence.
Materials and methods
The present study was a prospective, randomized, double-blind study performed in a tertiary academic referral center. Seventy smokers with nonallergic chronic rhinitis were enrolled. Nasal endoscopy, rhinomanometry, nasal cytology, and odor threshold measurements were performed in subjects randomized to daily nasal irrigations with either thermal water or isotonic sodium chloride solution for 1 month.
Results
Immediately after the treatment, the thermal water irrigations revealed a positive pharmacologic action, judging from a tendency toward lower nasal resistances ( P = .07) and larger numbers of ciliated cells in the patients treated ( P = .003). Endoscopic findings in the thermal water group were still better than in the control group a further 2 months later ( P = .03).
Conclusions
Our results indicate that nasal irrigations with thermal water had a good effect on endoscopic objective signs, nasal resistances, and epithelial trophism.
1
Introduction
Smoking is a form of self-destructive behavior known to induce remodeling of the lower airways (trachea, bronchi, and lungs), leading to squamous metaplasia . There is a paucity of literature, however, on how smoking affects the nose and paranasal sinuses and the olfactory epithelium in particular .
The normal respiratory mucosa in the adult nose is composed of ciliated cells, striated cells, muciparous goblet cells, and basal cells , whereas the olfactory mucosa consists of an apical layer of olfactory sustentacular cells and layers of olfactory sensory neurons that are constantly being replaced via neurogenesis from a population of resident basal cells lying above the basement membrane .
Davis et al recently demonstrated that exposure to cigarette smoke damaged the nasal mucosa in mice, causing edema, epithelial blebbing, and changes in gross epithelial structure. In 1974, Matullionis had conducted ultrastructural studies on mice exposed to cigarette smoke, finding various, often dose-related anatomical changes in the olfactory mucosa, such as a reduction in the number and size of the olfactory vessels and cilia. In 2004, using immunohistochemistry to study the olfactory epithelium of rats exposed to tobacco smoke, Vent et al found evidence of olfactory sensory neuron caspase 3–mediated apoptosis: the authors concluded that loss of the sense of smell in smokers seems to be triggered by an increased olfactory sensory neuron death. In the clinical setting, Hadar et al compared the histologic changes in the human nasal mucosa of 47 smokers with nonsmoking volunteers in 2009, finding a significantly greater goblet cell hyperplasia and thicker epithelium in the former. In the same year, Yee et al considered the effect of cigarette smoking on histopathologic specimens of olfactory mucosa from patients with chronic rhinosinusitis. There was a predominance of squamous metaplasia in most (66.7%) of the patients enrolled, and when smokers were compared with nonsmokers, the former revealed significantly more squamous metaplasia. The number of cigarettes smoked yearly also correlated with the occurrence of squamous metaplasia. Recent research by Piotrowska et al focused on nasal cytology in smokers: when nasal lavage cells from smokers with chronic obstructive pulmonary disease were compared with those of healthy controls who had never smoked, the smokers revealed a tendency toward significantly larger numbers of lymphocytes.
Katotomichelakis et al investigated the functional effects of smoking with the aid of “Sniffin’ Sticks” and reported that smoking was a strong independent risk factor of olfactory impairment. The authors said that smokers were more likely to develop an olfactory deficit than nonsmokers and that its severity depended on how long they had been smokers and how many cigarettes they smoked a day, confirming a previous report from Frye et al , based on the “UPSIT” (University of Pennsylvania Smell Identification Test). In 2007, Ishimaru and Fujii reported similar results after using another smell test, known as the “Cross-Cultural Smell Identification Test (CC-SIT) scores.”
Nasal irrigations are often mentioned as adjunctive measures in the treatment of several sinonasal conditions. In discussing rational treatment of chronic sinusitis, Hamilos and Subramanian et al advocated the use of nasal irrigations, and Benninger et al recommended including nasal irrigations in the treatment of most patients with rhinosinusitis. Unfortunately, studies conducted on the benefits of nasal irrigations have often been small and poorly controlled, and their conclusions have not always been evidence based. No generally accepted standard recommendations currently exist on the use of nasal irrigations .
Because no studies have been conducted to date to assess the effects of nasal irrigations in smokers, the aim of the present prospective, randomized, double-blind study was to compare the effects of nasal irrigations with sulfurous-arsenical-ferruginous thermal water and isotonic sodium chloride solution in smokers with nonallergic chronic rhinitis, based on endoscopic clinical evidence, nasal resistances, cytology (number of ciliated cells and neutrophils), and olfactory thresholds.
2
Materials and methods
2.1
Ethical considerations
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 at Padova University Hospital (protocol no. 1338P). Written informed consent was obtained from all subjects before undertaking any study-related procedures.
2.2
Study design
Inclusion criteria were as follows: age ranging from 18 to 65 years, diagnosis of nonallergic chronic rhinitis, and cigarette smoking habit for at least 5 years. Exclusion criteria were a diagnosis of autoimmune disease, cystic fibrosis, or diabetes. At enrollment, participants underwent a butanol olfactory threshold test, nasal cytology, active anterior rhinomanometry, and nasal endoscopy (using rigid 0° or 30° endoscopes).
Subjects were randomly assigned to nasal irrigations with sulfurous-arsenical-ferruginous thermal water (20 mL/d for 1 month) or isotonic sodium chloride solution (20 mL/d for 1 month). The thermal water and sodium chloride solution containers were identical and indistinguishable for participants and investigators. The thermal water for the sulfurous-arsenical-ferruginous thermal water irrigations came from Levico Spa (Levico, Italy). The chemical analysis of thermal water is reported in Table 1 . Italian legislation in terms of natural springs used for therapeutic aims stated that chemical and physical properties cannot vary more than 15% from the initial analysis. The chemical analysis on Levico Spa natural thermal water is repeated 4 times per year to rule out significant variability in its composition. Considering the total dissolved solid (TDS) content calculated in sulfurous-arsenical-ferruginous natural thermal water from Levico Spa, the solution pre-diluted to 10% with the distilled water that we used for nasal irrigation had a TDS content of approximately 693 mg/L.
| Parameters | Results | Units of measurement |
|---|---|---|
| Temperature at source | 9.4 | °C |
| Acidity (pH) | 1.9 | – |
| Conductivity (at source) (at 20°C) | 10400 | μ S/cm |
| TDS | 6927 | mg/L |
| Carbon dioxide (CO 2 ) | 22 | mg/L |
| Bicarbonate (HCO 3 − ) | Absent | mg/L |
| Oxidability (as O 2 ) | ND | mg/L |
| Ammonium ion (NH 4 + ) | 0.46 | mg/L |
| Nitrites (NO 2 − ) | <0.01 | mg/L |
| Fluoride (F − ) | 0.9 | mg/L |
| Chloride (Cl − ) | 1.2 | mg/L |
| Bromine (Br − ) | <0.1 | mg/L |
| Nitrate (NO 3 − ) | <0.1 | mg/L |
| Sulfate (SO 4 − ) | 4680 | mg/L |
| Total phosphorous (P) | 0.04 | mg/L |
| Sulfide (H 2 S) | <0.02 | mg/L |
| Iodine (J − ) | <0.010 | mg/L |
| Silica (SiO 2 ) | 26 | mg/L |
| Cyanide (CN − ) | <0.001 | mg/L |
| Anionic surfactants | <0.02 | mg/L |
| Solute or emulsified hydrocarbons (infrared spectrophotometry) | ND (<10) | mg/L |
| Iron (Fe) | 1550 | mg/L |
| Iron (ferric) (Fe 3+ ) | 175 | mg/L |
| Iron (ferrous) (Fe 2+ ) | 1375 | mg/L |
| Sodium (Na) | 2.2 | mg/L |
| Potassium (K) | 2.3 | mg/L |
| Lithium (Li) | 0.093 | mg/L |
| Calcium (Ca) | 128.4 | mg/L |
| Magnesium (Mg) | 87.7 | mg/L |
| Strontium (Sr) | 0.100 | mg/L |
| Barium (Ba) | 0.019 | mg/L |
| Aluminum (Al) | 49.7 | mg/L |
| Antimony (Sb) | 0.294 | mg/L |
| Arsenic (As) | 4.73 | mg/L |
| Boron (B) | ND (<0.005) | mg/L |
| Cadmium (Cd) | 0.221 | mg/L |
| Chromium (Cr) | 0.018 | mg/L |
| Manganese (Mn) | 6.97 | mg/L |
| Nickel (Ni) | 0.054 | mg/L |
| Lead (Pb) | 2.08 | mg/L |
| Copper (Cu) | 16.9 | mg/L |
| Selenium (Se) | ND (<0.05) | mg/L |
| Zinc (Zn) | 144 | mg/L |
| Mercury (Hg) | 0.0001 | mg/L |
All participants were assessed twice during the follow-up (immediately after completing the treatment and 2 months later), when n -butanol olfactory threshold tests, nasal cytology, active anterior rhinomanometry, and nasal endoscopy were performed.
2.3
Study population
Seventy consecutive adult smokers with nonallergic chronic rhinitis were eligible and enrolled in the present study. None of these patients reported previous head trauma. They were all asked not to use topical nasal treatments or systemic steroids or antibiotics during the study period. Patients were randomly assigned, 35 (11 males and 24 females) to have nasal irrigations with sulfurous-arsenical-ferruginous thermal water and 35 (11 males and 24 females) with isotonic sodium chloride solution.
2.4
Endoscopy
Endoscopic findings were classified as follows: 0, no anatomical alterations or acute inflammation; 1, septal deviation; 2, hypertrophic inferior turbinates; and 3, acute rhinosinusitis.
2.5
Nasal cytology
All specimens were fixed in 100% alcohol, and May-Grunwald-Giemsa staining was performed. All specimens were examined under the light microscope by an operator (GO) blinded to the nasal irrigation method used in each case. The cytologic data recorded were total number of ciliated cells, total number of neutrophils, and total number of eosinophils counted in 5 separate high-power fields (original magnification ×100) obtained from each specimen.
2.6
Active anterior rhinomanometry
Nasal patency was examined by active anterior rhinomanometry (AAR) (RhinoLab, Rendsburg, Germany), according to the International Standardisation Rhinomanometric Committee. A minimum of 5 breaths were recorded at a fixed transnasal pressure of 150 Pa during quiet breathing with the mouth closed in a seated position. Airflow values were expressed in milliliters per second. Total nasal resistance was calculated by combining 2 separate nasal resistance values, one for each nostril, using the following equation:
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