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      Prospective, randomized, controlled, open-label study to compare efficacy of a mineral-rich solution vs normal saline after complete ethmoidectomy

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          Abstract

          Purposes

          The purpose of this study was to compare the efficacy of a mineral-rich solution vs normal saline solution (0.9% NaCl) following endoscopic complete bilateral ethmoidectomy.

          Methods

          This was a prospective, multicenter, randomized, controlled, open-label trial in subjects suffering from steroid-resistant sinonasal polyposis. Adults performed 4 nasal irrigations of mineral or saline solutions daily for 28 days. Evaluations included subject-reported RHINO quality of life (QoL) and NOSE scores, tolerability, and satisfaction, the Lund–Kennedy endoscopic score and assessments of crusting, secretions and mucociliary clearance (rhinoscintigraphy).

          Results

          A total of 189 subjects were randomized. Clinically relevant improvements (> 20 points) in RhinoQOL and NOSE scores were measured in both groups without any significant inter-group difference. Among the subjects with impaired RhinoQOL at pre-inclusion, the change in Impact-RhinoQOL score was significantly superior in mineral-rich vs saline solution at day 21 ( p = 0.028) and day 28 ( p = 0.027). The Lund–Kennedy score continuously improved in both groups earlier with the mineral-rich solution. Crusts were significantly fewer in number and less severe/obstructive in patients receiving mineral-rich vs saline solution at day 7 ( p = 0.026) and day 14 ( p = 0.016). Furthermore, secretions disappeared significantly more quickly and were less thick/purulent with mineral-rich solution at day 14 ( p = 0.002) and day 21 ( p = 0.043). Less epistaxis was reported in the mineral vs saline solution ( p = 0.008 at day 21).

          Conclusions

          Our findings indicate that the composition of a nasal irrigation solution influences endoscopic scores and QoL after sinus surgery for patients over 60, those with an initially poor QoL and higher symptom score, and smokers.

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          Most cited references36

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          European Position Paper on Rhinosinusitis and Nasal Polyps 2012.

          The European Position Paper on Rhinosinusitis and Nasal Polyps 2012 is the update of similar evidence based position papers published in 2005 and 2007.The document contains chapters on definitions and classification, we now also proposed definitions for difficult to treat rhinosinusitis, control of disease and better definitions for rhinosinusitis in children. More emphasis is placed on the diagnosis and treatment of acute rhinosinusitis. Throughout the document the terms chronic rhinosinusitis without nasal polyps and chronic rhinosinusitis with nasal polyps are used to further point out differences in pathophysiology and treatment of these two entities. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. Last but not least all available evidence for management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is analyzed and presented and management schemes based on the evidence are proposed.
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            Clinical practice guideline: adult sinusitis.

            This guideline provides evidence-based recommendations on managing sinusitis, defined as symptomatic inflammation of the paranasal sinuses. Sinusitis affects 1 in 7 adults in the United States, resulting in about 31 million individuals diagnosed each year. Since sinusitis almost always involves the nasal cavity, the term rhinosinusitis is preferred. The guideline target patient is aged 18 years or older with uncomplicated rhinosinusitis, evaluated in any setting in which an adult with rhinosinusitis would be identified, monitored, or managed. This guideline is intended for all clinicians who are likely to diagnose and manage adults with sinusitis. The primary purpose of this guideline is to improve diagnostic accuracy for adult rhinosinusitis, reduce inappropriate antibiotic use, reduce inappropriate use of radiographic imaging, and promote appropriate use of ancillary tests that include nasal endoscopy, computed tomography, and testing for allergy and immune function. In creating this guideline the American Academy of Otolaryngology-Head and Neck Surgery Foundation selected a panel representing the fields of allergy, emergency medicine, family medicine, health insurance, immunology, infectious disease, internal medicine, medical informatics, nursing, otolaryngology-head and neck surgery, pulmonology, and radiology. The panel made strong recommendations that 1) clinicians should distinguish presumed acute bacterial rhinosinusitis (ABRS) from acute rhinosinusitis caused by viral upper respiratory infections and noninfectious conditions, and a clinician should diagnose ABRS when (a) symptoms or signs of acute rhinosinusitis are present 10 days or more beyond the onset of upper respiratory symptoms, or (b) symptoms or signs of acute rhinosinusitis worsen within 10 days after an initial improvement (double worsening), and 2) the management of ABRS should include an assessment of pain, with analgesic treatment based on the severity of pain. The panel made a recommendation against radiographic imaging for patients who meet diagnostic criteria for acute rhinosinusitis, unless a complication or alternative diagnosis is suspected. The panel made recommendations that 1) if a decision is made to treat ABRS with an antibiotic agent, the clinician should prescribe amoxicillin as first-line therapy for most adults, 2) if the patient worsens or fails to improve with the initial management option by 7 days, the clinician should reassess the patient to confirm ABRS, exclude other causes of illness, and detect complications, 3) clinicians should distinguish chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis from isolated episodes of ABRS and other causes of sinonasal symptoms, 4) clinicians should assess the patient with CRS or recurrent acute rhinosinusitis for factors that modify management, such as allergic rhinitis, cystic fibrosis, immunocompromised state, ciliary dyskinesia, and anatomic variation, 5) the clinician should corroborate a diagnosis and/or investigate for underlying causes of CRS and recurrent acute rhinosinusitis, 6) the clinician should obtain computed tomography of the paranasal sinuses in diagnosing or evaluating a patient with CRS or recurrent acute rhinosinusitis, and 7) clinicians should educate/counsel patients with CRS or recurrent acute rhinosinusitis regarding control measures. The panel offered as options that 1) clinicians may prescribe symptomatic relief in managing viral rhinosinusitis, 2) clinicians may prescribe symptomatic relief in managing ABRS, 3) observation without use of antibiotics is an option for selected adults with uncomplicated ABRS who have mild illness (mild pain and temperature <38.3 degrees C or 101 degrees F) and assurance of follow-up, 4) the clinician may obtain nasal endoscopy in diagnosing or evaluating a patient with CRS or recurrent acute rhinosinusitis, and 5) the clinician may obtain testing for allergy and immune function in evaluating a patient with CRS or recurrent acute rhinosinusitis. This clinical practice guideline is not intended as a sole source of guidance for managing adults with rhinosinusitis. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and may not provide the only appropriate approach to diagnosing and managing this problem.
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              EAACI position paper on rhinosinusitis and nasal polyps executive summary.

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                Author and article information

                Contributors
                +33(0)556798788-+33(0)683707206 , ludovic.de-gabory@chu-bordeaux.fr
                Journal
                Eur Arch Otorhinolaryngol
                Eur Arch Otorhinolaryngol
                European Archives of Oto-Rhino-Laryngology
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0937-4477
                1434-4726
                8 December 2018
                8 December 2018
                2019
                : 276
                : 2
                : 447-457
                Affiliations
                [1 ]ISNI 0000 0004 0593 7118, GRID grid.42399.35, ENT Department, , CHU Bordeaux, ; 33000 Bordeaux, France
                [2 ]ISNI 0000 0004 0593 7118, GRID grid.42399.35, CHU Bordeaux, ; CIC 14-01 IT, 33000 Bordeaux, France
                [3 ]ISNI 0000 0001 2106 639X, GRID grid.412041.2, Univ. Bordeaux, ; 33000 Bordeaux, France
                [4 ]ENT Department, Intercommunal Hospital of Créteil, Paris, France
                [5 ]ENT Department, Saint-Augustin Private Hospital, Bordeaux, France
                [6 ]ISNI 0000 0001 1457 2980, GRID grid.411175.7, ENT Department, , University Hospital of Toulouse, ; Toulouse, France
                [7 ]ISNI 0000 0004 1765 1301, GRID grid.410527.5, ENT Department, , University Hospital of Nancy, ; Nancy, France
                [8 ]ISNI 0000 0001 2177 138X, GRID grid.412220.7, ENT Department, , University Hospital of Strasbourg, ; Strasbourg, France
                [9 ]ISNI 0000 0004 1765 1600, GRID grid.411167.4, ENT Department, , University Hospital of Tours, ; Tours, France
                [10 ]Nuclear Medicine Department, Saint-Augustin Private Hospital, Bordeaux, France
                [11 ]ISNI 0000 0004 0471 8845, GRID grid.410463.4, ENT Department, , University Hospital of Lille, ; Lille, France
                [12 ]ISNI 0000 0004 0472 0371, GRID grid.277151.7, ENT Department, , University Hospital of Nantes, ; Nantes, France
                [13 ]ISNI 0000 0004 0593 7118, GRID grid.42399.35, Nuclear Medicine Department, , CHU Bordeaux, ; 33000 Bordeaux, France
                [14 ]GRID grid.414263.6, ENT Department, , University Hospital of Bordeaux, Hôpital Pellegrin, ; Centre F-X Michelet, Place A. Raba-Léon, 33076 Bordeaux Cedex, France
                Author information
                http://orcid.org/0000-0003-0113-6121
                Article
                5232
                10.1007/s00405-018-5232-9
                6394433
                30536161
                947d6504-d0af-4e96-b589-e5c57cc0ed29
                © The Author(s) 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 24 September 2018
                : 28 November 2018
                Funding
                Funded by: Laboratoire de la Mer
                Categories
                Rhinology
                Custom metadata
                © Springer-Verlag GmbH Germany, part of Springer Nature 2019

                Otolaryngology
                nasal irrigation,chronic rhinosinusitis,nasal polyposis,mucociliary clearance,lund–kennedy endoscopic score

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