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Saline Irrigation for Chronic Rhinosinusitis (Review) Cochrane Database of Systematic Reviews Saline irrigation for chronic rhinosinusitis (Review) Chong LY, Head K, Hopkins C, Philpott C, Glew S, Scadding G, Burton MJ, Schilder AGM Chong LY, Head K, Hopkins C, Philpott C, Glew S, Scadding G, Burton MJ, Schilder AGM. Saline irrigation for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD011995. DOI: 10.1002/14651858.CD011995.pub2. www.cochranelibrary.com Saline irrigation for chronic rhinosinusitis (Review) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 7 OBJECTIVES ..................................... 8 METHODS ...................................... 8 RESULTS....................................... 12 Figure1. ..................................... 14 Figure2. ..................................... 17 Figure3. ..................................... 18 ADDITIONALSUMMARYOFFINDINGS . 22 DISCUSSION ..................................... 25 AUTHORS’CONCLUSIONS . 26 ACKNOWLEDGEMENTS . 27 REFERENCES ..................................... 27 CHARACTERISTICSOFSTUDIES . 31 DATAANDANALYSES. 42 Analysis 1.1. Comparison 1 Nasal saline (hypertonic, 2%, large-volume) versus usual treatment, Outcome 1 Disease- specific HRQL - measured using RSDI (range 0 to 100). ........ 43 Analysis 1.2. Comparison 1 Nasal saline (hypertonic, 2%, large-volume) versus usual treatment, Outcome 2 Disease severity - using single-item score (range not known). ...... 44 Analysis 1.3. Comparison 1 Nasal saline (hypertonic, 2%, large-volume) versus usual treatment, Outcome 3 Generic HRQL - measured using SF-12 (range 0 to 100). 45 Analysis 1.4. Comparison 1 Nasal saline (hypertonic, 2%, large-volume) versus usual treatment, Outcome 4 Percentage of 2-weekblocks. ................................. 46 Analysis 2.1. Comparison 2 Intranasal steroids versus nasal saline (nebulised, small-volume), Outcome 1 Disease severity - overallscore(rangenotknown). 47 Analysis 2.2. Comparison 2 Intranasal steroids versus nasal saline (nebulised, small-volume), Outcome 2 Adverse events. 48 Analysis 2.3. Comparison 2 Intranasal steroids versus nasal saline (nebulised, small-volume), Outcome 3 Endoscopy score - measured using modified Lund-Mackay (range unknown). ......... 49 APPENDICES ..................................... 49 CONTRIBUTIONSOFAUTHORS . 58 DECLARATIONSOFINTEREST . 58 SOURCESOFSUPPORT . 58 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 59 INDEXTERMS .................................... 59 Saline irrigation for chronic rhinosinusitis (Review) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Saline irrigation for chronic rhinosinusitis Lee Yee Chong1, Karen Head1, Claire Hopkins2, Carl Philpott3, Simon Glew4, Glenis Scadding5, Martin J Burton1, Anne GM Schilder 6 1UK Cochrane Centre, Oxford, UK. 2ENT Department, Guy’s Hospital, London, UK. 3Department of Medicine, Norwich Medical School, University of East Anglia, Norwich, UK. 4Division of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK. 5Department of Rhinology, Royal National Throat, Nose & Ear Hospital, London, UK. 6evidENT, Ear Institute, Faculty of Brain Sciences, University College London, London, UK Contact address: Lee Yee Chong, UK Cochrane Centre, Oxford, UK. [email protected]. Editorial group: Cochrane ENT Group. Publication status and date: New, published in Issue 4, 2016. Review content assessed as up-to-date: 30 October 2015. Citation: Chong LY, Head K, Hopkins C, Philpott C, Glew S, Scadding G, Burton MJ, Schilder AGM. Saline irrigation for chronic rhinosinusitis. Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD011995. DOI: 10.1002/14651858.CD011995.pub2. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis. Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Nasal saline irrigation is commonly used to improve patient symptoms. Objectives To evaluate the effects of saline irrigation in patients with chronic rhinosinusitis. Search methods The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 9); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 30 October 2015. Selection criteria Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing saline delivered to the nose by any means (douche, irrigation, drops, spray or nebuliser) with (a) placebo, (b) no treatment or (c) other pharmacological interventions. Data collection and analysis We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation and discomfort. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. Saline irrigation for chronic rhinosinusitis (Review) 1 Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results We included two RCTs (116 adult participants). One compared large-volume (150 ml) hypertonic (2%) saline irrigation with usual treatment over a six-month period; the other compared 5 ml nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Large-volume, hypertonic nasal saline versus usual care One trial included 76 adult participants (52 intervention, 24 control) with or without polyps.Disease-specific HRQL was reported using the Rhinosinusitis Disability Index (RSDI; 0 to 100, 100 = best quality of life). At the end of three months of treatment, patients in the saline group were better than those in the placebo group (mean difference (MD) 6.3 points, 95% confidence interval (CI) 0.89 to 11.71) and at six months there was a greater effect (MD 13.5 points, 95% CI 9.63 to 17.37). We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up. Patient-reported disease severity was evaluated using a “single-item sinus symptom severity assessment” but the range of scores is not stated, making it impossible for us to determine the meaning of the data presented. No adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including epistaxis. General HRQL was measured using SF-12 (0 to 100, 100 = best quality of life). No difference was found after three months of treatment (low quality evidence) but at six months there was a small difference favouring the saline group, which may not be of clinical significance and has high uncertainty (MD 10.5 points, 95% CI 0.66 to 20.34) (very low quality evidence). Low-volume, nebulised saline versus intranasal corticosteroids One trial included 40 adult participants with polyps. Our primary outcome of disease-specific HRQL was not reported. At the end of treatment (three months) the patients who had intranasal corticosteroids had less severe symptoms (MD -13.50, 95% CI -14.44 to - 12.56); this corresponds to a large effect size. We assessed the evidence to be of very low quality. Authors’ conclusions The two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there is no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids. There is some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution when compared with placebo, but the quality of the evidence is low for three months and very low for six months of treatment. PLAIN LANGUAGE SUMMARY Saline irrigation for chronic rhinosinusitis Review question We reviewed the evidence for the benefits and harms of nasal saline irrigation in patients with chronic rhinosinusitis. Background Chronic rhinosinusitis is a common condition that is defined as inflammation of the nose and paranasal sinuses (a group of air-filled spaces behind the nose, eyes and cheeks). Patients with chronic rhinosinusitis experience at least two or more of the following symptoms for at least 12 weeks: blocked nose, discharge from their nose or runny nose, pain or pressure in their face and/or a reduced sense of smell (hyposmia). Some people will also have nasal polyps, which are grape-like swellings of the normal nasal lining inside the nasal passage and sinuses. Nasal irrigation (also know as nasal douche, wash or lavage) is a procedure that rinses the nasal cavity with isotonic or hypertonic saline (salt water) solutions. The patient instils
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