Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children
Abstract
Objective To evaluate the potential of nasal isotonic saline application to prevent reappearance of cold and flu in children during the winter. Design Prospective, multicenter, parallel-group, open, and randomized comparison. Setting Eight pediatric outpatient clinics. Patients A total of 401 children (aged 6-10 years) with uncomplicated cold or flu. Interventions We randomly assigned patients to 2 treatment groups, one with just standard medication, the other with nasal wash with a modified seawater solution (Physiomer) plus standard medication, and observed them for 12 weeks. Main outcome measures The primary efficacy end points were nasal symptoms resolution during acute illness (visits 1 and 2). We also looked for reappearance of cold or flu, consumption of medication, complications, days off school, and reported days of illness during the following weeks when preventive potential was evaluated (visits 3 and 4). Results At visit 2, patients in the saline group achieved primary end points (measured on a 4-point numeric scale on which 1 indicated no symptoms and 4, severe symptoms) in the parameters nasal secretion and obstruction (mean scores vs nonsaline group, 1.79 vs 2.10 and 1.25 vs 1.58, respectively) (P Conclusion Children in the saline group showed faster resolution of some nasal symptoms during acute illness and less frequent reappearance of rhinitis subsequently.
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For nasal patency (breathing score) at the second visit, the mean difference between saline wash and control groups was -0.33 (95% CI -0.47 to -0.19).
“The difference for the saline wash group compared with the control group at the second visit was MD ‐0.33 (95% CI ‐0.47 to ‐0.19).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 reported a significant reduction in nasal secretion score at visit two (up to three weeks) for all nasal saline groups compared to control, with a mean difference of -0.31 (95% CI -0.48 to -0.14) on a four-point scale.
“Slapak 2008 reported a significant reduction nasal secretion score at visit two (up to three weeks after enrolment) for all nasal saline groups compared to control as a mean difference (MD) of ‐0.31 (95% confidence interval (CI) ‐0.48 to ‐0.14) on a four‐point scale.”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 adequately discussed drop-outs and losses to follow-up, which numbered only 11 out of the initial 401 participants enrolled (low risk of bias).
“Slapak 2008 adequately discussed drop‐outs and losses to follow‐up, which numbered only 11 out of the initial 401 participants enrolled in the trial (low risk of bias).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
In Slapak 2008, patient blinding was largely impossible, and outcome assessors were blinded only to the type of saline spray delivery, not to whether participants were using saline treatment (unclear risk of bias).
“In particular, the design of Slapak 2008 made patient blinding largely impossible as each participant either used the saline spray or did not. The outcome assessors were blinded only to the type of saline spray delivery used and not blinded as to whether or not participants were using the saline treatment (unclear risk of bias).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 reported statistically significant reductions in nasal decongestant and mucolytic medication used for symptomatic relief in the saline groups (P < 0.5) (Table 4).
“Slapak 2008 did report statistically significant reductions in nasal decongestant and mucolytic medication used for symptomatic relief in the saline groups (P value < 0.5) (Table 4).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
In Slapak 2008, the mean health status score at follow-up for the control group was 2.6 (SD 1.02) for cold and 2.00 (SD 0.91) for flu, compared with 1.87 (SD 0.84) for cold and 1.59 (SD 0.74) for flu in the saline wash group, with P < 0.05 for both.
“The mean health status score at the follow‐up examination for the subgroups 'entry during cold' and 'entry during flu' respectively was 2.6 (standard deviation (SD) 1.02) and 2.00 (SD 0.91) for the control group, compared with 1.87 (SD 0.84) and 1.59 (SD 0.74) for the saline wash group, with a P value of < 0.05 reported for both groups.”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
King 2012 and Slapak 2008 found a trend to reduced antibiotic use in the nasal saline group, though this did not reach statistical significance (Analysis 2.1).
“King 2012 and Slapak 2008 compared the use of antibiotics in saline groups versus controls and found a trend to reduced antibiotic use in the nasal saline group, though this did not reach statistical significance (Analysis 2.1).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 found an overall rate of adverse events of 8.7%, most of which were reported by participants in the medium jet group and associated with the higher flow rate.
“The third study, using children, found an overall rate of adverse events of 8.7%, most of which were reported by participants in the medium jet group and associated with the higher flow rate (Slapak 2008).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
For nasal secretion type at the second visit, the mean difference between saline wash and control groups was -0.34 (95% CI -0.50 to -0.18) on a four-point scale, indicating a small improvement with nasal saline irrigation.
“For this comparison of the saline wash and control groups at the second visit on a four‐point scale the MD was ‐0.34 (95% CI ‐0.50 to ‐0.18), indicating a small improvement with nasal saline irrigation.”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
The largest trial (Slapak 2008), which had a high risk of bias, reported statistically significant outcomes for the nasal saline group at follow-up, including reduction of sore throat, nasal secretion and secretion type, nasal breathing score, and improvement in health status score.
“The largest trial, which also had a high risk of bias, reported a number of statistically significant outcomes for the nasal saline group at follow‐up, including reduction of sore throat, nasal secretion and secretion type and nasal breathing score (Slapak 2008). It also reported a significant improvement in the health status score.”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
There was a trend towards reduced antibiotic use in one study with saline nasal irrigation, and this study also demonstrated a statistically significant reduction in the use of adjunct nasal decongestant treatment with nasal saline irrigation compared to control (Slapak 2008).
“There was a trend towards reduced antibiotic use in one study with saline nasal irrigation and this study also demonstrated a statistically significant reduction in the use of adjunct nasal decongestant treatment with nasal saline irrigation compared to control (Slapak 2008).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Only one of the included papers (Slapak 2008) examined the effect of saline irrigation on other symptoms, such as anosmia and cough associated with acute URTIs.
“Only one of the included papers examined the effect of saline irrigation on other symptoms, such as anosmia (loss of the sense of smell) and cough associated with acute URTIs (Slapak 2008).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Discomfort in one study was associated with higher application pressures rather than the nasal saline solution itself (Slapak 2008).
“Discomfort in one study was associated with higher application pressures rather than the nasal saline solution itself (Slapak 2008).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
No serious adverse effects occurred in the included trials, although three children in one study experienced nosebleeds (Slapak 2008).
“No serious adverse effects occurred in the included trials, although three children in one study experienced nosebleeds (Slapak 2008).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 used a commercial isotonic seawater product containing zinc and other elements that may be a factor in the effects of the product.
“In particular, Slapak 2008 used a commercial isotonic seawater product containing zinc and other elements that may be a factor in the effects of the product.”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
In Slapak 2008, drop-out and losses to follow-up were small and adequately discussed, with 390 of 401 completing the study, judged low risk of attrition bias.
“Drop‐out and losses to follow‐up small and adequately discussed. 390 of 401 completed the study (11 lost to follow‐up)”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
In Slapak 2008, no patient blinding was possible due to study design, and outcome assessors were blinded to saline delivery method but not to intervention versus control, judged unclear risk of performance and detection bias.
“No patient blinding possible due to study design; outcome assessors blinded to saline delivery method but not to intervention versus control”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
In Slapak 2008, intention-to-treat analysis was not performed and the original study protocol was not available, judged unclear risk of reporting bias.
“Intention‐to‐treat analysis not performed; original study protocol not available”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 used sequence of clinic arrival for allocation, judged high risk of selection bias.
“Sequence of clinic arrival used for allocation”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
No other potential sources of bias were identified in Slapak 2008, judged low risk of other bias.
“No other potential sources of bias identified”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
The review omitted the outcome 'time off work or school' from Slapak 2008 because it was based on follow-up periods outside the specifications for acute URTIs as specified in the protocol.
“Also, we noted the inclusion of the outcome 'time off work or school' from Slapak 2008 in the original review to be based on follow‐up periods outside of the specifications for acute URTIs as specified in the protocol, so we omitted this from inclusion in this 2014 update.”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Slapak 2008 did not mention allocation concealment, judged unclear risk of selection bias.
“Not mentioned in paper”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Slapak 2008
Cites
A Clinical Trial of Hypertonic Saline Nasal Spray in Subjects With the Common Cold or Rhinosinusitis
Adam, P. (1998) · Archives of Family Medicine · doi:10.1001/archfami.7.1.39 · Cited by 118 · see citing works
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Saline nasal irrigation for acute upper respiratory tract infections
King, D., Mitchell, B., Williams, C. P., & Spurling, G. K. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006821.pub3 · Cited by 226 · see citing works
Rhinitis in children less than 6 years of age: current knowledge and challenges
Hardjojo, A., Shek, L. P., van Bever, H. P., & Lee, B. W. (2011) · Asia Pacific Allergy · doi:10.5415/apallergy.2011.1.3.115 · Cited by 28 · see citing works
- Authors
- Šlapak, I., Skoupá, J., Strnad, P., & Horník, P.
- ORCID
- Strnad, Petr
- Venue
- Archives of Otolaryngology–Head & Neck Surgery
- Publisher
- American Medical Association (AMA)
- Published
- 2008-01-01
- Volume
- 134
- Issue
- 1
- Pages
- 67
- ISSN
- 0886-4470 (ISSN-L)
- OpenAlex
- W2140070827
- Cited by
- 134
- References
- 1
- Citations by year
- 2026: 6 · 2025: 8 · 2024: 8 · 2023: 9 · 2022: 9 · 2021: 12 · 2020: 12 · 2019: 9 · 2018: 5 · 2017: 7 · 2016: 7 · 2015: 8 · 2014: 4 · 2013: 3 · 2012: 8
- FWCI
- 9.99
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Otolaryngology - Head and Neck Surgery (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
- Keywords
- common cold, influenza, children, nasal congestion, nasal secretions, school absenteeism, medication use
- MeSH terms
- Administration, Intranasal, Analysis of Variance, Child, Female, Humans, Isotonic Solutions, Male, Prospective Studies, Rhinitis, Sodium Chloride, Chi-Square Distribution, Treatment Outcome, Statistics, Nonparametric
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