Received: 21 January 2021 Revised: 29 March 2021
DOI: 10.1002/alr.22807
ORIGINAL ARTICLE
Effects of large volume, isotonic nasal saline irrigation for
acute rhinosinusitis: a randomized controlled study
Wirach Chitsuthipakorn MD1,2 Angsuthorn Thanaphiphatsatja MD1
Peeravuit Doungbuppha2 Saranath Lawpoolsri MD, PhD3
Kachorn Seresirikachorn MD, PhD4,5
1 Center of Excellence in Otolaryngology,
Head and Neck Surgery, Rajavithi
Hospital, Bangkok, Thailand
2College of Medicine, Rangsit University,
Bangkok, Thailand
3
Department of Tropical Hygiene, Faculty
of Tropical Medicine, Mahidol University,
Bangkok, Thailand
4Department of Otolaryngology, Faculty
of Medicine, Chulalongkorn University,
Bangkok, Thailand
5Endoscopic Nasal and Sinus Surgery
Excellence Center, King Chulalongkorn
Memorial Hospital, Bangkok, Thailand
Correspondence
Kornkiat Snidvongs, MD, PhD, Faculty
of Medicine, Chulalongkorn University,
Pathumwan, Bangkok 10330, Thailand.
Email: drkornkiat@yahoo.com
Funding information
This study was supported by the propri-
etary research fund of Rajavithi Hospital.
INTRODUCTION
Acute rhinosinusitis (ARS) is an inflammatory disease
associated with viral or bacterial infection. The infil-
Int Forum Allergy Rhinol. 2021;1–12.
Accepted: 6 April 2021
Kornkiat Snidvongs MD, PhD4,5
Abstract
Background: The purpose of this study was to compare the effects of nasal saline
irrigation (large volume, positive pressure isotonic saline) in addition to standard
treatment in patients with acute rhinosinusitis (ARS).
Methods: This parallel, randomized controlled trial was conducted at a tertiary
hospital. The adult patients with ARS (age ≥18 years) were randomly assigned to
two groups. The irrigation group received 0.9% saline irrigation twice daily, using
a 250-ml squeeze bottle, in addition to standard treatment. The no-irrigation
group received standard treatment only. Patients were evaluated at baseline,
1 week, and 2 weeks. The quality of life, rhinologic subscore, symptom score,
endoscopy score, and cure rate were compared.
Results: Sixty-one patients (30: irrigation, 31: no-irrigation) were enrolled. There
were 17 males and 44 females. The mean age was 41.06 years. Although both
groups showed improvements, the improvement of each outcome was not dif-
ferent between the groups. Subgroup analysis by ARS subtype showed benefits
of irrigation in the common cold subgroup; the improvements that were greater
than control included: rhinologic subscore, intergroup mean difference −4.15
[95% confidence interval (CI), −7.49, −0.80] at 1 week and −5.23 [95% CI, −9.69,
−0.78] at 2 weeks; combined symptom score −5.35 [95% CI, −10.55, −0.14] at
1 week and −8.02 [95%CI, −14.36, −1.70] at 2 weeks.
Conclusion: The add-on isotonic nasal saline irrigation using a large volume,
positive pressure device did not add benefits equally for all ARS patients. The
benefits of irrigation on quality of life and nasal symptoms were only observed
in the common cold patient subgroup.
KEYWORDS
endoscopy, nasal lavage, saline solution, sino-nasal outcome test, sinusitis
tration of the inflammatory cells into nasal epithelial
cells causes fluid extravasation, engorgement, nasal
congestion, and sinus obstruction.1 Mucociliary clear-
ance is impaired, and the discharge from the nasal
wileyonlinelibrary.com/journal/alr © 2021 ARS-AAOA, LLC 1
2 ISOTONIC NASAL SALINE IRRIGATION FOR ACUTE RHINOSINUSITIS
cavity and the paranasal sinuses is tenacious and
discolored.
Nasal saline irrigation is utilized for mechanical lavage
of mucus, debris, and inflammatory cytokines and enhanc-
ing mucociliary function.2 It has been recommended as
an adjunctive treatment for ARS.1,3–5 However, evidence
shows that the benefits of nasal saline irrigation for treat-
ing ARS are limited. The International Consensus State-
ment on Rhinology and Allergy: Rhinosinusitis (2021)3 rec-
ommended nasal saline irrigation as an “option” for ARS
treatment, whereas the European Position Paper on Rhi-
nosinusitis and Nasal Polyps 2020 (EPOS 2020)1 stated that
“no advice can be given”. However, low-volume devices
were used to deliver the nasal isotonic saline in all the ran-
domized controlled trials (RCTs) that assessed the effects
of nasal saline treatment versus no saline treatment.6–9
For example, Adam et al.6 used nasal saline spray and
evaluated nasal symptoms and time to resolution. Inanli
et al.7 used a 10-ml syringe and assessed the effect of
saline on saccharin transit time. Chanaseeyotin et al.8
used a 20-ml syringe and assessed the effects on nasal
symptoms reduction. These studies found few additional
effects of nasal saline irrigation over no-saline treatment.
Likewise, the data from an unpublished study by King
et al. 2012, from the Cochrane Database of Systematic
Reviews,9 showed that saline spray into the nose did not
improve nasal symptom score any better than no-saline
control. The pooled data of two studies showed no bene-
ficial effects of nasal saline irrigation over no-irrigation.9
Whether nasal saline treatment brought no benefit to ARS
or low-volume devices could not deliver saline effectively is
unknown.
Several factors, such as the volume and pressure of the
saline delivered by the devices during irrigation, may influ-
ence the effect of nasal saline irrigation.10,11 Large volume
and positive pressure are required to maximize the effec-
tiveness of mechanical flushing. A large amount of saline
creates an overflow from one nasal cavity to the other side
and effectively clears out the pus. A study by Gelardi et al.12
compared two delivery devices and showed the benefits
of a 250-ml saline bag over a 10-ml syringe on symptom
improvement. The nasal resistance was decreased in the
large-volume irrigation group but not in the syringe group.
For these reasons, we hypothesized that large-volume,
positive-pressure nasal saline irrigation should improve
nasal symptoms and endoscopic findings. To the best of
our knowledge, the effects of nasal saline irrigation, using
a large-volume, positive-pressure device, for treating ARS
has not yet been assessed. The objective of this study was to
evaluate the add-on effect of nasal saline irrigation deliv-
ered by a large-volume, positive-pressure device in adult
patients with ARS.
PATIENTS AND METHODS
Study design and ethical considerations
The present study was an open label, parallel, randomized
controlled trial. The patients were recruited from October
2019 to October 2020, at the Center of Excellence in Oto-
laryngology, Head and Neck Surgery, Rajavithi Hospital (a
tertiary hospital), Bangkok, Thailand. The study was con-
ducted in accordance with The Principles of the Declara-
tion of Helsinki. It was approved by the Ethics Committee
of Rajavithi Hospital (IRB Trial No.62142; October 17, 2019)
and was registered with the Thai Clinical Trials Registry
(TCTR, Trial No. 20200616001). This study was supported
by the proprietary research fund of Rajavithi Hospital. The
reporting flowchart of patients in this study followed the
Consolidated Standards of Reporting Trials (CONSORT)
statement 2010.13
Study population
The study population included adult patients with ARS,
aged ≥18 years. The diagnosis of ARS was made accord-
ing to the European Position Paper on Rhinosinusitis and
Nasal Polyps 2012 (EPOS-2012) guideline.14 The diagnos-
tic criteria consisted of at least two of the four following
symptoms: nasal obstruction, nasal discharge, pain, and
smell impairment, in which nasal obstruction or nasal dis-
charge must be included. ARS was classified to three sub-
groups: common cold (symptoms <10 days), acute postvi-
ral rhinosinusitis (symptoms >10 days or worsen after 5
days), and acute bacterial rhinosinusitis (ABRS). The clini-
cal diagnosis of ABRS must include three of the five follow-
ing criteria: discolored discharge, severe local pain, fever
(>38◦ C), elevated erythrocyte sedimentation rate (ESR) or
C-reactive protein (CRP), and signs of acute rhinosinusi-
tis that worsen within 10 days after initial improvement
(double worsening). Exclusion criteria were previous sinus
surgery, sinonasal neoplasm, previous radiation in head
and neck regions, sinusitis with complication, currently
pregnant, or breastfeeding, mental disorder, and currently
taking anti-allergy medication or corticosteroid.
Study process
Eligible patients were approached and informed about
the study protocol. An informed consent document was
obtained from every participant before participating in
the study. The study duration was 2 weeks. At visit 0
(V0), additional history taking, and nasal endoscopy were
CHITSUTHIPAKORN et al.
performed. The nasal endoscopy was recorded by an
outpatient video recorder for further analysis. A blood
sample was taken for ESR and CRP levels. An ESR
value >10 mm/h and a CRP value > 10 mg/l were consid-
ered elevated. The middle meatal swab for nasal discharge
was taken and sent for bacterial culture. All participants
were scheduled for the follow-up visits at 1 week (V1) and
2 weeks (V2).
Randomization and blinding
The sample size was calculated using a power of 0.80 and
95% confidence interval (CI) to detect nine points differ-
ence in the 22-item Sino-Nasal Outcome Test (SNOT-22)
score. The mean ± standard deviation (SD) score of 20-item
Sino-Nasal Outcome Test (SNOT-20) in patients with no-
irrigation after 14 days of treatment was 14.1 ± 12.5.8 The
calculation yielded a sample size of 72 participants, with
an allowance for a potential dropout rate of 20%.
A computer-generated block randomization was per-
formed. A total of 12 blocks with a block size of six were
generated. The patients were allocated (allocation ratio 1:1)
into: irrigation group (group A) and no-irrigation group
(group B). Allocation codes were concealed in 72 sequen-
tially numbered, opaque, sealed envelopes before the study
commenced. The envelope was opened after the patient
was enrolled. Physicians and patients were unblinded;
however, the outcome assessor who assessed the nasal
endoscopy video clip was blinded to the treatment
protocols.
Intervention
At the first visit (V0), patients in group A received a
squeeze bottle and packs of non-iodinated salt sachets
for nasal saline irrigation. The squeeze bottle volume was
250 ml, and the salt (NaCl) sachet was 2.265 g in weight
(Cleanoze; Farmaline, Bangkok, Thailand). The solution,
after mixing with 250 ml room temperature, boiled tap
water, was isotonic buffered saline. The instructions on
saline preparation and irrigation technique were provided
verbally with a recorded video clip demonstration. The
nasal saline irrigation was required twice a day. The
patients were advised to decongest their noses if they had
nasal stuffiness before the irrigation.
Both groups received standard treatments according to
the EPOS-2012 guideline.14 Analgesics and decongestant
(0.05% oxymetazoline, one puff/nostril when necessary
[PRN] for nasal stuffiness) were given to patients with
the common cold. Intranasal corticosteroid (fluticasone
furoate, two puffs/nostril once daily [OD]) was added to
decongestant for patients with postviral ARS. Amoxicillin-
3
clavulanate (1000 mg) twice daily (BID) was added for
patients with clinically diagnosed ABRS, or clindamycin
(300 mg) three times daily (TID) was given to the ABRS
patients with penicillin allergy. Antibiotics were tailored
to bacterial culture and sensitivity results at V1 for nonre-
sponsive patients.
Outcomes
Primary outcomes were the disease-specific quality of life
questionnaire (SNOT-22),15 the SNOT-22’s rhinologic sub-
score, and the combined nasal symptom visual analogue
scale (VAS) score. Secondary outcomes were the modified
Lund-Kennedy endoscopic score (MLKES),16 cure rate,
individual nasal symptom VAS score, device compliance,
and adverse events. The outcomes were compared with the
baseline within group and compared between the groups at
all time points.
Patient-reported outcome measures
The Thai version of the SNOT-22 was used to measure the
overall quality of life of rhinosinusitis patients.15 The ques-
tionnaire was a 5-point rating scale. A score of 0 in each
item indicated that the symptom was not at all bothering,
whereas a score of 5 meant the most bothersome. The total
score ranged from 0 to 110. The questionnaire consisted
of rhinologic subscore (0–30) and four other subscores.17
The minimal clinically important difference (MCID) was
9 points for the total SNOT-22 score and 3.8 points for the
rhinologic subscore.18
The self-reported nasal symptoms consisted of four indi-
vidual nasal symptom VAS scores: nasal obstruction, dis-
charge, facial pain, and smell impairment. Each nasal
symptom was reported in a 10-point rating scale, where 0
represented no symptom, and 10 was the most severe. The
four individual nasal symptom VAS scores were summed
into the combined nasal symptom VAS score ranging from
0 to 40.
Nasal endoscopy
The MLKES of each visit was assessed from a nasal endo-
scopic record by a physician who was blinded to the
patient’s group, time point, and diagnosis. The MLKES
consisted of three findings (polyp, edema, and discharge)
of each side. Each finding was scored as 0, 1, or 2. The
total score ranged from 0 to 12. An MLKES of 0 to 2 was
acknowledged as “perfect” or “near-perfect” based on a
study by Schlosser et al.19
4 ISOTONIC NASAL SALINE IRRIGATION FOR ACUTE RHINOSINUSITIS
Cure rate
A cure was defined when the combined nasal symptom
VAS score was ≤12 (30% of the total score) and the MLKES
score returned to perfect or near-perfect (score of 0–2).
Adverse events and compliances
At every follow-up visit, an open question was asked for
any adverse events or any discomfort. Closed questions
(yes/no) were asked for potential adverse events such as
ear fullness, otalgia, nasal saline irritation, discomfort, and
epistaxis.20 Tolerability and compliance of nasal saline irri-
gation were also evaluated.
Statistical analysis
The mean ± SD score of SNOT-20 in patients with no-
irrigation after 14 days of treatment, was 14.1 ± 12.5.8 The
sample size was calculated based on a power of 0.80 and
95% CI to detect nine points difference in SNOT-22 score.
The calculation yielded a total sample size of 72 partici-
pants, with an allowance for a potential dropout rate of
20%. Student t test or Mann-Whitney U test was used for
continuous variables. Chi-square or Fisher’s exact test was
used for categorical variables. Means and SDs were calcu-
lated for the outcomes, such as the SNOT-22, the combined
nasal symptom VAS score, the MLKES, and the individ-
ual nasal symptom VAS score. The Generalized Estimating
Equation (GEE) method was used to compare the scores of
each visit with the baseline within the group and between
the groups. Mean differences and 95% CIs were calculated.
Change of scores from baseline in each group was calcu-
lated to assess an improvement after treatment at 1 week
and 2 weeks. Intergroup mean difference was calculated
from the mean change of scores of each group to compare
the effects of treatment between the groups. Cure rates
were compared between the two groups at week 1 and week
2, using chi-square or Fisher’s exact test as appropriate. A
p value < 0.05 was considered statistically significant. Data
were analyzed using SAS/STAT software version 9.4 (SAS
Institute Inc., Cary, NC, USA).
RESULTS
In total, 66 patients were eligible. Five patients declined to
participate. The remaining 61 patients were enrolled (30 in
the irrigation group and 31 in the no-irrigation group). The
Consolidated Standards of Reporting Trials (CONSORT)
flow diagram of participants is displayed in Figure 1. There
were 17 males and 44 females. The mean ± SD age was
41.06 ± 14.32 years. The median duration of symptoms
was 7 days (interquartile range, 3–10). The demographic
and clinical characteristics of the patients are displayed in
Table 1.
At the end of the study, none were lost to follow-up. All
61 patients were included in the final analysis. The over-
all SNOT-22 mean score at baseline was 42.73 ± 20.89 and
decreased to 9.80 ± 15.22 at the end of the study. The mean
rhinologic subscore at baseline was 11.89 ± 5.13 and 2.29 ±
3.98 at the end. The combined nasal symptom VAS score
at baseline was 17.29 ± 7.88 and 2.68 ± 4.99 at the end. The
cure rate was 44.3% at 1 week and 91.8% at 2 weeks.
The effects of nasal saline irrigation were not statistically
different from control in any outcomes. The intergroup dif-
ferences of the SNOT-22 improvement from baseline were
−0.92 (95% CI, −10.73 to 8.89) at 1 week, and −5.70 (95%
CI, −15.70 to 4.29) at 2 weeks. The intergroup differences of
the SNOT-22 rhinologic subscore improvement were −1.72
(95% CI, −4.21 to 0.78) at 1 week and −2.09 (95% CI, −4.73
to 0.56) at 2 weeks. The intergroup differences of the com-
bined nasal symptom VAS score improvement were −2.24
(95% CI, −6.09 to 1.61) at 1 week and −3.36 (95% CI, −7.38
to 0.65) at 2 weeks.
The intergroup differences of MLKES improvement
from the baseline were 0.15 (95% CI, −1.05 to 1.35) at 1 week,
and 0.12 (95% CI, −0.84 to 1.08) at 2 weeks. The cure rate
in the irrigation group was 36.7% at 1 week and 90% at
2 weeks. In the no-irrigation group, it was 51.6% at 1 week
and 93.5% at 2 weeks. The intergroup difference at 1 week
was −14.9 (95% CI, −39.6 to 9.7) and at 2 weeks was −3.5
(95% CI, −17.3 to 10.2). The summarized comparison data
of the baseline and two follow-up visits are displayed in
Table 2 and are graphically displayed in Figure 2. The
effects of saline irrigation on individual nasal symptom
VAS score were not different from no-irrigation. The sum-
marized data are separately displayed in Table S1.
Subgroup analysis was performed to assess the adjunct
effects of nasal saline irrigation in subgroups of patients,
including common cold, postviral rhinosinusitis, and clin-
ically diagnosed ABRS. The common cold patients bene-
fited from saline irrigation, compared with no-irrigation.
The intergroup difference in the SNOT-22 rhinologic sub-
score improvement was −4.15 (95% CI, −7.49 to −0.80) at
1 week and −5.23 (95% CI, −9.69 to −0.78) at 2 weeks. The
intergroup difference in the combined nasal symptom VAS
score improvement was −5.35 (95% CI, −10.55 to −0.14) at
1 week and −8.02 (95% CI, −14.36 to −1.07) at 2 weeks.
The summarized data on the SNOT-22, the combined nasal
and individual nasal symptom VAS scores of the common
cold patient subgroup are displayed in Table 3. The effects
of saline irrigation on the ABRS patient subgroup are dis-
played separately in Table S2. The number of patients with
CHITSUTHIPAKORN et al.
FIGURE 1 The 2010 CONSORT flowchart of patient recruitment. Abbreviation: CONSORT, Consolidated Standards of Reporting Trials
postviral rhinosinusitis in this study was small. When post
hoc analysis was performed by collapsing two groups into
a “viral rhinosinusitis” group, we found nasal saline irriga-
tion benefited the “viral rhinosinusitis” group.
Intragroup analyses were also performed. Compared
with the baseline, both groups showed significant
improvements in the SNOT-22 score, rhinologic subscore,
the combined nasal symptom VAS score, and the MLKES
score (all, p < 0.01) at 1 week and 2 weeks. These results
are displayed with the 95% CI in Table 2.
Adverse event of nasal saline irrigation was not reported
in any patients. Nasal saline irrigation was well tolerated.
All participants in the irrigation group reported high com-
pliance, >90%. No participants violated the protocol.
DISCUSSION
The findings of this study showed that the addition of
nasal saline irrigation to standard treatment did not add
clinical benefits for treating patients with ARS. This is in
5
contrast to our hypothesis that a large volume of saline
irrigation delivered via a high positive pressure device
should improve nasal symptoms and quality of life. The
aim of large volume, positive pressure saline irrigation
is to mechanically wash nasal discharge out of the nasal
cavity.21 In a recent survey of 129 acute rhinosinusitis
patients, the patients reported that large-volume, positive-
pressure devices help clear secretion more effectively than
low-volume devices.5 The present study was designed to
assess patients with ARS which included all ARS subtypes
(common cold, postviral rhinosinusitis, and ABRS). These
subtypes are different in pathogenesis, clinical symptoms,
disease onset, and duration. This may be the reason why
the beneficial effects of nasal saline irrigation were not
revealed. Subgroup analyses by ARS subtype were con-
ducted to explore this question. In the common cold sub-
group, the rhinologic subscore reduction in the saline
irrigation group was significantly greater than the no-
irrigation group at both 1 week and 2 weeks (above the
MCID of 3.8). The combined nasal symptom VAS score
reduction was also significantly greater in the irrigation
6 ISOTONIC NASAL SALINE IRRIGATION FOR ACUTE RHINOSINUSITIS

TA B L E 1 Summary of demographic data and clinical characteristics of patients

Clinical data Irrigation (n = 30) No irrigation (n = 31)
Sex, male, n (%) 9 (30) 8 (26)
Age (years), mean ± SD 38.73 ± 14.27 43.32 ± 14.24
Duration in days, median (IQR) 6.5 (3–14) 7.0 (3–10)
Symptoms, n (%)
Nasal blockage 22 (73) 23 (74)
Nasal discharge 21 (70) 22 (71)
Facial pain or pressure 14 (47) 20 (65)
Reduction or loss of smell 11 (37) 15 (48)
Temperature >38◦ C, n (%) 1 (3) 3 (10)
Double worsening, n (%) 10 (33) 8 (26)
Elevated ESR (value > 10), n (%) 26 (87) 29 (94)
Elevated CRP (value > 10), n (%) 16 (53) 17 (55)
Common cold, n (%) 13 (43) 12 (39)
Post-viral rhinosinusitis, n (%) 2 (7) 2 (6)
ABRS by clinical diagnosis, n (%) 15 (50) 17 (55)
ABRS with positive bacterial culture, n (%) 6 (20) 7 (23)
Notes: The pathogens consisted of: Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, or
Pseudomonas aeruginosa. No significant difference between the two groups.
Abbreviations: ABRS, acute bacterial rhinosinusitis; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; IQR, interquartile range; n, number of patients
in the group; SD, standard deviation.

F I G U R E 2 The effect of saline irrigation group compared to no-irrigation in each outcome. Abbreviations: SNOT-22, 22-item Sino-Nasal
Outcome Test; VAS: visual analogue scale
TA B L E 2 Effects of nasal saline irrigation on disease-specific quality of life, symptoms score, endoscopy score, and cure rate
Actual scores after treatment Mean change from baseline, after treatment
Parameter Actual scores at baseline 1 week 2 weeks 1 week 2 weeks
CHITSUTHIPAKORN et al.

SNOT-22, mean total score, range 0–110

Irrigation 44.20 (18.93) 26.63 (22.34) 8.37 (11.81) −17.57 [−25.79, −9.34] −35.83 [−43.25, −28.42]
No irrigation 41.32 (22.85) 24.68 (18.44) 11.19 (18.01) −16.65 [−21.99, −11.30] −30.13 [−36.83, −23.42]
Intergroup mean difference 2.88 [−7.47, 13.22] 1.96 [−8.17, 12.08] −2.83 [−10.32, 4.67] −0.92 [−10.73, 8.89] −5.70 [−15.70, 4.29]
p value 0.58 0.85 0.26
SNOT-22, mean rhinologic subscore, range 0–30
Irrigation 12.83 (5.03) 7.63 (5.52) 2.17 (3.30) −5.20 [−12.74, −8.59] −10.67 [−12.74, −8.59]
No irrigation 10.97 (5.13) 7.48 (4.22) 2.39 (4.59) −3.48 [−4.89, −2.07] −8.58 [−10.22, −6.94]
Intergroup mean difference 1.87 [−0.64, 4.37] 0.15 [−2.28, 2.58] −0.22 [−2.19, 1.75] −1.72 [−4.21, 0.78] −2.09 [−4.73, 0.56]
p value 0.14 0.18 0.12
Combined nasal symptom VAS, mean score, range 0–40
Irrigation 18.73 (7.53) 11.27 (7.10) 2.47 (3.88) −7.47 [−10.68, −4.25] −16.27 [−19.02, −13.52]
No irrigation 15.81 (8.06) 10.58 (6.59) 2.90 (5.93) −5.23 [−7.34, −3.11] −12.90 [−15.83, −9.98]
Intergroup mean difference 2.93 [−0.92, 6.77] 0.69 [−2.70, 4.07] −0.44 [−2.90, 2.03] −2.24 [−6.09, 1.61] −3.36 [−7.38, 0.65]
p value 0.14 0.25 0.10
MLKES, mean score, range 0–12
Irrigation 5.03 (1.47) 2.73 (1.53) 0.70 (1.29) −2.30 [−3.04, −1.56] −4.33 [−5.01, −3.65]
No irrigation 4.87 (1.62) 2.42 (1.88) 0.42 (0.81) −2.45 [−3.39, −1.51] −4.45 [−5.13, −3.77]
Intergroup mean difference 0.16 [−0.60, 0.93] 0.31 [−0.53, 1.16] 0.28 [−0.25, 0.81] 0.15 [−1.05, 1.35] 0.12 [−0.84, 1.08]
p value 0.68 0.80 0.81
Cure (%)
Irrigation N/A 36.7 90.0 N/A N/A
No irrigation 51.6 93.5
Intergroup difference −14.9 [−39.6, 9.7] −3.5 [−17.3, 10.2]
p value 0.24 0.67
Notes: Standard deviation of the samples are shown in parentheses, 95% confidence intervals are shown in square brackets. The p values and 95% confidence interval were calculated based on the GEE method.
Abbreviations: GEE, Generalized Estimating Equation; MLKES, modified Lund-Kennedy endoscopic score; N/A, not applicable; SNOT-22, 22-item Sino-Nasal Outcome Test; VAS, visual analogue scale.
7
 8

TA B L E 3 Effects of nasal saline irrigation on the common cold patient subgroup

Actual scores after treatment Mean change from baseline, after treatment
Parameter Actual scores at baseline 1 week 2 weeks 1 week 2 weeks
SNOT-22, mean total score, range 0–110
Irrigation 45.77 (7.13) 16.38 (4.82) 2.38 (1.32) −29.38 [−39.88, −18.88] −43.38 [−56.52, −30.25]
No irrigation 38.75 (7.37) 17.33 (3.90) 11.58 (6.98) −21.41 [−31.05, −11.78] −27.17 [−39.06, −15.27]
Intergroup mean difference 7.02 [−12.25, 26.29] −0.95 [−12.60, 10.70] −9.20 [−22.53, 4.14] −7.97 [−22.22, 6.28] −16.22 [−33.94, 1.50]
p value 0.48 0.27 0.07
SNOT-22, mean rhinologic subscore, range 0–30
Irrigation 13.77 (1.80) 5.54 (1.41) 0.54 (0.37) −8.23 [−10.39, −6.08] −13.23 [−16.56, −9.90]
No irrigation 10.33 (1.78) 6.25 (1.05) 2.33 (1.75) −4.08 [−6.64, −1.52] −8.00 [−10.96, −5.04]
Intergroup mean difference 3.44 [−1.32, 8.19] −0.71 [−4.02, 2.60] −1.79 [−5.15, 1.56] −4.15 [−7.49, −0.80] −5.23 [−9.69, −0.78]
p value 0.16 0.02 0.02
Combined nasal symptom VAS, mean score, range 0–40
Irrigation 20.46 (7.08) 8.61 (1.83) 0.77 (0.62) −11.85 [−15.45, −8.22] −19.69 [−23.53, −15.86]
No irrigation 14.83 (2.34) 8.33 (1.59) 3.17 (2.35) −6.50 [−10.23, −2.77] −11.67 [−16.70, −6.63]
Intergroup mean difference 5.63 [−0.11, 11.37] 0.28 [−4.28, 4.84] −2.40 [−6.97. 2.17] −5.35 [−10.55, −0.14] −8.02 [−14.36, −1.70]
p value 0.06 0.04 0.01
Nasal obstruction
Irrigation 6.92 (2.10) 3.08 (2.40) 0 (0) −3.85 [−5.16, −2.53] −6.92 [−8.02, −5.83]
No irrigation 5.67 (2.81) 3.00 (2.34) 0.67 (1.78) −2.67 [−3.73, −1.60] −5.00 [−6.82, −3.18]
Intergroup mean difference 1.25 [−0.62, 3.13] 0.08 [−1.70, 1.86] −0.67 [−1.62, 0.30] −1.18 [−2.87, 0.51] −1.92 [−4.05, 0.20]
p value 0.19 0.17 0.08
Nasal discharge
Irrigation 5.85 (2.08) 2.46 (1.85) 0.15 (0.55) −3.39 [−3.28, −2.49] −5.69 [−6.72, −4.67]
No irrigation 4.50 (3.21) 2.83 (2.48) 0.83 (1.80) −1.67 [−3.62, 0.28] −3.67 [−5.32, −2.01]
Intergroup mean difference 1.35 [−0.70, 3.39] −0.37 [−2.03, 1.28] −0.68 [−1.70, 0.34] −1.72 [−3.86, 0.43] −2.03 [−3.98, −0.08]
p value 0.20 0.11 0.04
Facial pain
Irrigation 4.15 (3.41) 1.54 (2.33) 0.46 (1.66) −2.62 [−4.34, −0.89] −3.69 [−5.69, −1.70]
No irrigation 1.83 (2.89) 1.67 (2.17) 1.00 (2.49) −0.67 [−2.42, 1.08] −0.83 [−2.65, 0.98]
Intergroup mean difference 2.32 [−0.05, 4.69] 0.37 [−1.32, 2.06] −0.54 [−2.14, 1.06] −1.95 [−4.41, 0.51] −2.86 [−5.56, −0.16]
p value 0.06 0.12 0.04
Smell impairment
Irrigation 3.54 (3.28) 1.54 (1.85) 0.15 (0.55) −2.00 [−3.81, −0.19] −3.39 [−5.06, −1.71]
No irrigation 2.83 (2.62) 1.33 (2.15) 0.67 (2.31) −1.50 [−2.55, −0.45] −2.17 [−3.66, −0.67]
Intergroup mean difference 0.71 [−1.53, 2.93] 0.21 [−1.31, 1.72] −0.51 [−1.80, 0.77] −0.50 [−2.59, 1.59] −1.22 [−3.46,1.02]
p value 0.53 0.64 0.29

Notes: Standard deviation of the samples are shown in parentheses, 95% confidence intervals are shown in square brackets. The p values and 95% confidence interval were calculated based on the GEE method.
Abbreviations: GEE, Generalized Estimating Equation; MLKES, modified Lund-Kennedy endoscopic score; N/A, not applicable; SNOT-22, 22-item Sino-Nasal Outcome Test; VAS, visual analogue scale.
ISOTONIC NASAL SALINE IRRIGATION FOR ACUTE RHINOSINUSITIS
CHITSUTHIPAKORN et al.
group at both 1 week and 2 weeks. The adjunct therapy
of nasal saline irrigation brought benefits to the patients
with common cold who had nasal discharge. Although the
adverse effects of first-generation antihistamines outweigh
the benefits and second-generation antihistamines have a
limited role for treating common cold,22,23 nasal saline irri-
gation should be a better option. Post hoc analyses did not
show clinical effectiveness of saline irrigation for patients
with ABRS subgroup. In contrast to common cold, patients
with ABRS had greater severity and tenacious nasal dis-
charge from the paranasal sinuses. A study by Snidvongs
et al.24 showed that without sinus surgery, nasal saline irri-
gation did not effectively enter the paranasal sinus cavi-
ties. Thus, we do not recommend nasal saline irrigation for
patients with ABRS.
In addition to mechanical lavage, large-volume nasal
saline irrigation has potential benefits for improving nasal
obstruction and decreasing nasal resistance.12 However,
the results of this study did not reveal any benefit on nasal
obstruction improvement. The patients in this trial were
instructed to decongest their nose with a potent decon-
gestant (oxymetazoline)25 prior to the saline irrigation,
to avoid possible adverse effects of saline irrigation to
the middle ear. In the no-irrigation group, oxymetazoline
was allowed periodically for stuffiness. This co-treatment
might have relieved the patients from nasal congestion,
which could overshadow the effects of nasal saline irriga-
tion.
There were four published RCTs,6–8,26 one meta-
analysis,9 and one unpublished RCT by King et al. (2012),
which assessed the effects of saline nasal treatment in adult
patients with ARS or common cold. In agreement with our
study, two RCTs and one meta-analysis reported no differ-
ence on symptoms score,6,8,9 and one RCT showed no dif-
ference in saccharin transit time between the saline treat-
ment and no-saline group.7 It was noted that the devices
used in these studies ranged from simple spray (< 5 ml) to
20 ml syringe. To the best of our knowledge, our study was
the first RCT that assessed the effects of nasal saline irriga-
tion using a large volume and positive pressure device. The
summarized data of studies with comparisons of saline
treatment and no-saline are displayed in Table 4.
About half of the patients were cured at the first week
and almost all patients were cured at the second week. The
cure rate was not different between the irrigation group
and no-irrigation group. This is consistent with previous
studies. Adam et al.6 reported the symptom resolution was
at 8.0 to 9.2 days. An unpublished study by King et al.
reported the same resolution period at 7.7 to 10.5 days. One
recent study demonstrated that saline treatments (nasal
saline irrigation with mouth gargling) reduced the dura-
tion of common cold by 1.9 days and decreased the use of
over the counter medication by 36%, compared with the
9
no-saline group.26 However, the saline administration and
tonicity used in that study were different from our study.
Potential adverse events from large-volume, high-
pressure devices were ear pain/hearing loss, aspiration,
pain, and epistaxis.5 Dry nose and burning sensation were
also reported by previously published studies which often
found in high tonicity or high saline flow.6,9,27 Neverthe-
less, all patients in our study reported excellent tolera-
bility and compliance (>90%). In general, ear pain may
occur when the patients with nasal congestion squeeze the
saline bottle with an increased pressure during the irriga-
tion to overcome the blockage. Our patients were advised
to decongest their noses before the irrigation and whenever
they feel stuffiness. This might be the reason that there was
no major adverse event in the irrigation group in this study.
ARS has a short duration of illness of around 6 to 9
days.6,26 Stjarne et al.28 assessed 150 patients with ARS and
found that by day 15, all but 1.4% returned to their pre-
morbid health status. The authors decided on 2 weeks of
follow-up in this regard. Although SNOT-22 is a tool orig-
inally developed for chronic rhinosinusitis to consider the
following symptoms over the past 2 weeks, the 16-item
Sino-Nasal Outcome Test (SNOT-16) has been validated
for use in ARS. Garbutt et al.29 assessed 166 adult patients
with ARS using SNOT-16 at days 3, 7, and 10, and found
high sensitivity to clinical change, validity, and high inter-
nal consistency. In addition, it has been commonly used
and recommended for ARS.1,3,8,30–34 In this study, overall
baseline SNOT-22 score of 42.7 was consistent with other
ARS studies.8,30 At the end of the study, it decreased to 9.8,
where 92% of patients had been cured. This was in line
with the study by Hopkins et al.35 that reported the healthy
subjects’ mean score of 9.3 (95% CI, 7.5–11.1). The endo-
scopic score was used to measure disease severity in this
study. The modified version of the Lund-Kennedy score
removes the scarring and crusting component from the
original version. It was chosen because of its independence
to the surgical status and better correlation with patient-
reported outcome measures (PROMs).16 Particularly, all
eligible patients in this study did not undergo an opera-
tion. Cured patients in this study must have both “mini-
mal severity of nasal symptoms” (combined nasal symp-
toms VAS score 0–12) and “near-perfect nasal endoscopy”
to reflect normal health status. The combined nasal symp-
toms VAS score for four nasal symptoms of 0 to 12 was
acknowledged mild severity. This is based on EPOS-2012,
suggesting that each nasal symptom VAS score 0 to 3 is
mild.14 However, this criteria had a limitation for evaluat-
ing mild patients who had a baseline score below 12.
This study has several limitations. The patients and the
attending doctors who prescribed the treatment and irri-
gation bottle were unblinded. We minimized the bias by
blinding the assessor for nasal endoscopy and cure rate.
 10

TA B L E 4 Summarized of previously published studies with a comparison of saline treatment versus no saline treatment
Total number of Saline types (number per Devices, Method, duration
Study Year Study type patients, disease group) volume of treatment Outcomes Results
Chitsuthipakorn et al. 2021 RCT 61, ARS I. Isotonic saline (30) Squeeze bottle, 1 bottle/time SNOT-22, rhinologic No difference between groups
(this study) II. No saline (31) 250 ml 2 times/day subscore, symptom VAS, in any outcomes. Post hoc
2 weeks MLKES, %Cure rate analysis showed the
benefits of saline irrigation
to the common cold
subgroup.
Ramalingam et al.26 2019 RCT 61, Common cold I. Hypertonic seawater 2%–3% Not stated, Nasal saline Duration of illness, OTC Duration of illness reduced by
(30) 100 ml irrigation and medication used 1.9 days in the irrigation and
II. No irrigation and gargling mouth gargling gargling group, p = 0.01.
(31) 100 ml/time Less medication used by 36%,
2–3 times/day p = 0.004
2–14 days
Chanaseeyotin et al.8 2016 RCT 54, ABRS I. Isotonic saline (28) Syringe, 20 ml 5 times/nostril Symptom VAS, SNOT-20 No difference between groups
II. No saline (26) 2 times/day in any outcomes
4 weeks
King et al.9 2015 SRMA 152, URI I. Isotonic saline Spray 2–3 sprays/nostril Days to resolution No difference between groups
2 studies in the II. No saline 3–6 times/day
meta-analysis 1–3 weeks
King et al. 2012 RCT 33, URI I. Isotonic saline Spray 2–3 sprays/nostril Symptom score, days to No difference between groups
(unpublished study) II. No saline 4 times/day resolution in symptoms score.
Day to resolution reduced by
2.81 days, p = 0.046
Inanli et al.7 2002 RCT 60, ABRS I. Hypertonic saline 3.0% (12) Not stated, 10 ml/time STT No difference between groups
II. Isotonic saline (13) 10 ml 3 times/day 3 weeks
III. Nasal steroid spray (14)
IV. Oxymetazoline 0.05% (9)
V. No saline (12)
Adam et al.6 1998 RCT 119, ARS, I. Hypertonic saline 1.6% (41) Spray 2 sprays/nostril Nasal symptom on third No difference between groups
common cold II. Isotonic saline (35) 3 times/day 1 week day, days to resolution, in any outcomes
III. No saline (43) OTC medication used

Abbreviations: ABRS, acute bacterial rhinosinusitis; ARS, acute rhinosinusitis; MLKES, modified Lund-Kennedy endoscopic score; N/A, not applicable; OTC, over the counter; RCT, randomized controlled trial; SNOT-20, 20-item
Sino-Nasal Outcome Test; SNOT-22, 22-item Sino-Nasal Outcome Test; SRMA, systematic review and meta-analysis; STT, saccharin transit time; URI, upper respiratory tract infection; VAS, visual analogue scale; Roman number I–V:
patient group 1–5.
ISOTONIC NASAL SALINE IRRIGATION FOR ACUTE RHINOSINUSITIS
CHITSUTHIPAKORN et al.
Placebo effects of saline irrigation should be considered
when a study is unblinded. However, this should happen to
all subgroups because patients were not aware of the sub-
group they were put into. Second, daily nasal symptoms
were not recorded. Thus, the beneficial effects, if any, may
not be shown if the patients were cured prior to the first
follow-up visit (1 week) evaluation. We could not rule out
the possibility that some patients could get the beneficial
effects at the very early period after the treatment.
This study found routine nasal saline irrigation may not
be of benefit for all subtypes of ARS. Preliminary data of
this study showed that nasal saline irrigation brought ben-
efits to patients with the common cold. Further studies are
required. Specific subgroups may be selected for patient
homogeneity.
CONCLUSION
Although the results from this study did not find signif-
icant improvements with saline irrigation, except for in
the viral ARS group; however, with the lack of significant
adverse side effects and the fact that most ARS patients are
viral ARS, routine use of saline irrigation may be of some
benefit.
CONFLICTS OF INTEREST
Kornkiat Snidvongs has served on speaker’s bureau for
Merck Sharp Dolme and Menarini. None of the authors
has anything to disclose related to this study. Wirach Chit-
suthipakorn, Angsuthorn Thanaphiphatsatja, Peeravuit
Doungbuppha, Saranath Lawpoolsri, and Kachorn Sere-
sirikachorn have no conflicts of interest.
AUTHOR CONTRIBUTIONS
Wirach Chitsuthipakorn: study concept and design,
material preparation, data collection, data analysis,
manuscript drafting. Angsuthorn Thanaphiphatsatja,
Peeravuit Doungbuppha: material preparation, data col-
lection. Saranath Lawpoolsri: material preparation, data
analysis. Kachorn Seresirikachorn, Kornkiat Snidvongs:
study concept and design, manuscript review. All authors
approved the final manuscript.
ORCID
Wirach Chitsuthipakorn MD https://orcid.org/0000-
0002-9787-6767
Peeravuit Doungbuppha https://orcid.org/0000-0003-
0053-1226
Saranath Lawpoolsri MD, PhD https://orcid.org/0000-
0003-4841-7924
11
Kachorn Seresirikachorn MD, PhD https://orcid.org/
0000-0002-0158-7638
Kornkiat Snidvongs MD, PhD https://orcid.org/0000-
0001-7537-4718
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S U P P O RT I N G I N F O R M AT I O N
Additional supporting information may be found online
in the Supporting Information section at the end of the
article.
How to cite this article: Chitsuthipakorn W,
Thanaphiphatsatja A, Doungbuppha P, Lawpoolsri
S, Seresirikachorn K, Snidvongs K. Effects of large
volume, isotonic nasal saline irrigation for acute
rhinosinusitis: a randomized controlled study. Int
Forum Allergy Rhinol. 2021;1-12.
https://doi.org/10.1002/alr.22807