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Meta-Analysis
. 2016 Apr 26;4(4):CD011995.
doi: 10.1002/14651858.CD011995.pub2.

Saline irrigation for chronic rhinosinusitis

Lee Yee Chong  1 , Karen Head, Claire Hopkins, Carl Philpott, Simon Glew, Glenis Scadding, Martin J Burton, Anne G M Schilder
Affiliations
Meta-Analysis

Saline irrigation for chronic rhinosinusitis

Lee Yee Chong et al. Cochrane Database Syst Rev. .

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Trials (CENTRAL 2015, Issue 9); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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.

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.

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Conflict of interest statement

Lee Yee Chong: none known.

Karen Head: none known.

Claire Hopkins: I have received financial support from several companies involved in producing instruments for sinus surgery: Acclarent, Sinusys, Cryolife and Medtronic.

Carl Philpott: I have previously received consultancy fees from the companies Acclarent, Navigant, Aerin Medical and Entellus.

Simon Glew: none known.

Glenis Scadding: research grants from GSK and ALK. Honoraria for articles, lectures/chairing, advisory boards and consultancy: Astra Zeneca, Brittania Pharmaceuticals, Capnia, Church & Dwight, Circassia, GSK, Groupo Uriach, Meda, Merck, MSD, Ono Pharmaceuticals, Oxford Therapeutics, Sanofi‐Aventis, Shionogi and UCB. Travel funding from ALK, Bayer, GSK and Meda.

Martin Burton: Professor Martin Burton is joint Co‐ordinating Editor of Cochrane ENT, but had no role in the editorial process for this review.

Anne GM Schilder: Professor Anne Schilder is joint Co‐ordinating Editor of Cochrane ENT, but had no role in the editorial process for this review. Her evidENT team at UCL is supported by her NIHR Research Professorship award with the remit to develop a UK infrastructure and programme of clinical research in ENT, Hearing and Balance. Her institution has received a grant from GSK for a study on the microbiology of acute tympanostomy tube otorrhoea.

Figures

1
1
Process for sifting search results and selecting studies for inclusion.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Nasal saline (hypertonic, 2%, large‐volume) versus usual treatment, Outcome 1 Disease‐specific HRQL ‐ measured using RSDI (range 0 to 100).
1.2
1.2. Analysis
Comparison 1 Nasal saline (hypertonic, 2%, large‐volume) versus usual treatment, Outcome 2 Disease severity ‐ using single‐item score (range not known).
1.3
1.3. Analysis
Comparison 1 Nasal saline (hypertonic, 2%, large‐volume) versus usual treatment, Outcome 3 Generic HRQL ‐ measured using SF‐12 (range 0 to 100).
1.4
1.4. Analysis
Comparison 1 Nasal saline (hypertonic, 2%, large‐volume) versus usual treatment, Outcome 4 Percentage of 2‐week blocks.
2.1
2.1. Analysis
Comparison 2 Intranasal steroids versus nasal saline (nebulised, small‐volume), Outcome 1 Disease severity ‐ overall score (range not known).
2.2
2.2. Analysis
Comparison 2 Intranasal steroids versus nasal saline (nebulised, small‐volume), Outcome 2 Adverse events.
2.3
2.3. Analysis
Comparison 2 Intranasal steroids versus nasal saline (nebulised, small‐volume), Outcome 3 Endoscopy score ‐ measured using modified Lund‐Mackay (range unknown).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Cassandro 2015 {published data only}
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ACTRN12615000154505 {published data only}
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NCT00924404 {published data only}
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NCT01700725 {published data only}
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NCT02097576 {published data only}
    1. NCT02097576. Effectiveness of manuka honey/saline nasal rinses as an adjunct to standard medical therapy for chronic rhinosinusitis: a prospective clinical trial. clinicaltrials.gov/show/NCT02097576 (accessed 17 February 2016).
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Pynnonen 2007 {published data only}
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Rogkakou 2005 {published data only}
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References to ongoing studies

ISRCTN88204146 {published data only}
    1. ISRCTN88204146. A primary care randomised controlled trial of nasal irrigation and steam inhalation for recurrent sinusitis. www.isrctn.com/ISRCTN88204146 (accessed 17 February 2016).
NCT00335309 {published data only}
    1. NCT00335309. Maxillary sinus irrigation in the management of chronic rhinosinusitis. clinicaltrials.gov/show/NCT00335309 (accessed 3 March 2016).
NCT02582099 {published data only}
    1. NCT02582099. Comparison of the efficacy and complication of gentamicin and normal saline nasal irrigation in chronic rhinosinusitis and recurrent sinusitis: a double blind randomized control trial. clinicaltrials.gov/show/NCT02582099 (accessed 7 February 2016).
TCTR20140323002 {published data only}
    1. TCTR20140323002. The effect of warm saline irrigation on mucociliary function in patients with chronic rhinosinusitis. www.clinicaltrials.in.th (accessed 17 February 2016).

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References to other published versions of this review

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Publication types