A Clinical Trial of Hypertonic Saline Nasal Spray in Subjects With the Common Cold or Rhinosinusitis
Abstract
Objective To determine whether hypertonic saline nasal spray relieves nasal symptoms and shortens illness duration in patients with the common cold or acute rhinosinusitis. Design Randomized trial with 2 control groups. Setting Two family practice clinics. Participants One hundred forty-three adult patients with a cold or sinus infection. Patients with allergic rhinitis, symptoms for more than 3 weeks, or other respiratory diagnoses were excluded, as were those who had used topical decongestants. Intervention Hypertonic saline or normal saline spray 3 times a day or observation. Subjects completed a 7-day symptom checklist that included a well-being question ("Do you feel back to normal?"). Main outcome measures Nasal symptom score (sum of scores for nasal congestion, rhinorrhea, and headache) on day 3 and day of well-being (day of symptom resolution). Results Data were collected for 119 subjects. No difference was found in either primary outcome when hypertonic saline was compared with either normal saline or observation. Mean day of well-being was 8.3 (95% confidence interval [CI], 6.9-9.7), 9.2 (95% CI, 6.9-11.43), and 8.0 (95% CI, 6.7-9.3) days in the hypertonic saline, normal saline, and observation groups, respectively. Day 3 mean nasal symptom score was 3.8 (95% CI, 3.0-4.5) for hypertonic saline, 3.7 (95% CI, 2.9-4.5) for normal saline, and 4.1 (95% CI, 3.5-4.7) for observation. Only 44% of the patients would use the hypertonic saline spray again. Thirty-two percent n…
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Three studies reported nasal symptoms at day three, and all showed no difference between the saline nasal irrigation group and the observation only group (Adam 1998; Bollag 1984; King 2012).
“Three studies reported nasal symptoms at day three. All showed no difference between the saline nasal irrigation group and the observation only group (Adam 1998; Bollag 1984; King 2012).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
Two studies reported nasal symptom scores at day seven, and neither reported statistical differences between the treatment groups (Adam 1998; King 2012).
“Two studies also reported nasal symptom scores at day seven, again neither reporting statistical differences between the treatment groups (Adam 1998; King 2012).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
In Adam 1998, participants and clinicians were blinded, but blinding of outcome assessors was not discussed (low risk of bias).
“Participants and clinicians were blinded in Adam 1998, but blinding of outcome assessors was not discussed (low risk of bias).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
Adam 1998 reported 24 of 143 participants lost to follow-up, and a further 35 of the completers failed to submit a complete symptom checklist; intention-to-treat analysis was performed (unclear risk of bias).
“Adam 1998 reported 24 of 143 participants lost to follow‐up, although a further 35 of the completers failed to submit a complete symptom checklist. Intention‐to‐treat analysis was performed (unclear risk of bias).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
The pooled data for King 2012 and Adam 1998 showed no significant difference between normal saline and the control group (Analysis 1.1).
“The pooled data for King 2012 and Adam 1998 showed no significant difference between normal saline and the control group (Analysis 1.1)”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
Two trials used random number tables for allocation (Adam 1998; Bollag 1984).
“Two trials used random number tables (Adam 1998; Bollag 1984).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
In Adam 1998, among the hypertonic saline irrigation group, 7/33 (21.2%) complained of dry nose and 11/33 (33.3%) reported pain or irritation; among the normal saline irrigation group, 11/36 (30.5%) complained of dry nose and 4/31 (12.9%) reported pain or irritation (P = 0.05 for nasal irritation).
“in the group using hypertonic saline irrigation seven out of 33 participants (21.2%) complained of dry nose and 11 out of 33 (33.3%) reported pain or irritation (Adam 1998). Among the group treated with normal saline irrigation, 11 out of 36 (30.5%) complained of dry nose and four out of 31 (12.9%) reported pain or irritation from the treatment (P value = 0.05 for nasal irritation).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
Adam 1998 found no statistically significant difference in mean day of well-being between any of the groups (hypertonic saline, normal saline, observation only).
“Adam 1998 reported the mean day of well‐being for the three study groups and found no statistically significant difference in mean day of well‐being between any of the groups (Table 3).”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
In Adam 1998, patients and clinicians were blinded, judged low risk of performance and detection bias.
“Patients and clinicians blinded; outcome assessors not discussed”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
In Adam 1998, drop-out and losses to follow-up were not discussed, with 24 participants (16%) lost to follow-up, judged unclear risk of attrition bias.
“Drop‐out and losses to follow‐up not discussed. 24 participants (16%) were lost to follow‐up”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
In Adam 1998, intention-to-treat analysis was performed but the original study protocol was not available, judged unclear risk of reporting bias.
“Intention‐to‐treat analysis performed; original study protocol not available”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
Adam 1998 used a random numbers table for random sequence generation, judged low risk of selection bias.
“Random numbers table used”
From Saline nasal irrigation for acute upper respiratory tract infections (2015) · cites this paper as Adam 1998
Adam 1998 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 Adam 1998
No other potential sources of bias were identified in Adam 1998, 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 Adam 1998
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- Authors
- Adam, P.
- Affiliations
- University of Minnesota (US)
- Corresponding author
- Adam, P.
- Venue
- Archives of Family Medicine
- Publisher
- CLOCKSS Archive
- Published
- 1998-01-01
- Volume
- 7
- Issue
- 1
- Pages
- 39-43
- ISSN
- 1063-3987 (ISSN-L)
- OpenAlex
- W2044588295
- Cited by
- 118
- References
- 15
- Citations by year
- 2023: 1 · 2022: 2 · 2021: 8 · 2020: 10 · 2019: 3 · 2018: 2 · 2017: 7 · 2016: 6 · 2015: 10 · 2014: 5 · 2013: 4 · 2012: 10
- FWCI
- 1.59
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Family Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
- Health Sciences › Medicine › Surgery › Nasal Surgery and Airway Studies
- Keywords
- common cold, acute sinusitis, nasal congestion, rhinorrhea, headache, disease duration, symptom resolution, normal saline, patient acceptability, adverse effects
- MeSH terms
- Administration, Intranasal, Adult, Common Cold, Female, Humans, Male, Rhinitis, Saline Solution, Hypertonic, Sinusitis, Time Factors, Treatment Failure
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