International Journal of Pediatric Otorhinolaryngology 158 (2022) 111183

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International Journal of Pediatric Otorhinolaryngology

journal homepage: www.elsevier.com/locate/ijporl

Effectiveness of pediatric nasal irrigation solution with or without xylitol

Yücel Kurt a, YAVUZ Selim Yildirim b, *
a
KBB Uzmanı, Antalya Finike Devlet hastanesi, Turkey
b
Dogus University, Turkey and Hisar Intercontinental Hospital, Ümraniye, Istanbul, Turkey

A R T I C L E I N F O A B S T R A C T

Keywords: Objectives: /Hypothesis: The aim of this study was to compare the efficacy and outcome of daily hypertonic saline
Xylitol irrigation versus saline/xylitol for treating pediatric chronic rhinosinusitis (CRS).
Nasal irrigation Study design: This was a prospective, randomized, single-blinded study.
Saline irrigation
Methods: One hundred and twenty-five children diagnosed with CRS were enrolled in this study. The patients
Chronic rhinosinusitis
Pediatric
were randomized to twice-daily hypertonic irrigations with saline or saline/xylitol for 6 weeks. The treatment
Quality of life outcomes were measured using: Sinonasal Quality of Life Survey (SN-5) completed at baseline and after 6 weeks
of irrigation.
Results: There were statistically significant improvements in the hypertonic nasal saline group’s (reduction in SN-
5 domain scores) four domains and an increase in the overall QoL score within each group after 6 weeks of
treatment compared to baseline; however, there were no differences in the activity limitation (p = 0.1803). The
xylitol solution groups had no differences between the two groups in the SN-5 scores in any of the domains or the
overall score at baseline, and post irrigation treatment.
Conclusions: Due to low tolerance, compliance, and the side effects, xylitol irrigation is not recommended as a
first-line treatment for pediatric CRS. The use of a large volume of low pressure, twice-daily intranasal hypertonic
irrigation for 6 weeks is safe and effective in the treatment of pediatric CRS; therefore, it can be used as a baseline
treatment for pediatric CRS before considering surgical interventions.

1. Introduction also depend on addressing the underlying comorbidities, such as al­

Pediatric rhinosinusitis is a common problem treated by pediatri­
cians, primary care physicians and otolaryngologists, this problem cause
significant morbidity and health care expenditure. Also, this condition
affects the quality of life (QoL) for pediatric populations. This condition
could lead to long-term symptoms, such as nasal airway obstruction,
mouth opening, snoring is due to a physical obstruction in the nose,
congestion, rhinorrhea, cough, headache, and daytime fatigue. Rhino­
sinusitis can adversely affect the lives of children and their family due to
missed school and workdays, respectively, and increase the need to
utilize the health care system [1].
Children with intermittent episode of acute sinusitis following a
routine upper respiratory tract are treated with short courses of anti­
biotic therapy with good results. Although treatment of chronic and
recurrent sinusitis can be more challenging for physicians and frus­
trating for families. Various treatment choices for pediatric CRS
currently exist, with varying efficacies and risks. Therapy for CRS may
lergies. Treatment for CRS are divided into medical and surgical options.
Medical treatments have traditionally included antibiotics, nasal sprays,
antihistamines, corticosteroids, and nasal irrigation [2].
The Abfen Sinus Rinse Kit (Abfen Farma, Ankara, Turkey) is a hy­
pertonic solution which contains xylitol, purified water, and salt. The
hyperosmolarity of the solution keeps the nasal passages and sinuses
moist and clean for a much longer time than saline alone. The addition of
xylitol to saline nasal kits and positive pressure bottles has been shown
to help cleaning sinus infections in children [3].
Nasal Rinse performed with a large volume and delivered with low
positive pressure are more effective than saline sprays over two-month
periods for the therapy of chronic nasal and sinus symptoms among a
gathering population with self-reported symptoms. There is also a
benefit from saline rinse as adjunctive therapy for chronic nasal and
sinus-related symptoms [4].
The use of nasal rinse for the management of pediatric CRS has been
studied, however not broadly. Based on clinical experience, it remains

* Corresponding author. Dogus University, and Hisar Hospital Intercontinental Istanbul, Saray Mahallesi, site yolu caddesi, no: 7 34768 Ümraniye/İstanbul.
E-mail addresses: yucelkurt00@gmail.com (Y. Kurt), dryavuzselim@yahoo.com (Y.S. Yildirim).

https://doi.org/10.1016/j.ijporl.2022.111183
Received 20 February 2022; Received in revised form 20 April 2022; Accepted 11 May 2022
Available online 17 May 2022
0165-5876/© 2022 Elsevier B.V. All rights reserved.
Y. Kurt and Y.S. Yildirim International Journal of Pediatric Otorhinolaryngology 158 (2022) 111183

not popular in the pediatric population. In this study, the efficacy and
safety of the use of xylitol nasal irrigation was investigated and
compared.
The aim of this study was to compare the efficacy and outcome of
daily hypertonic saline irrigation versus saline/xylitol for managing
chronic rhinosinusitis (CRS).
2. Materials and methods
The study protocol was approved by the Ethics Committee of the
University, and a written consent form was obtained from each family
member. Additionally, the patients and caretakers were provided with
the necessary information on the nature and scope of the clinical study.
All patients and their primary caretakers consented to participate and
were randomized into two treatment groups.
We conducted a prospective, randomized study in patients who had
inflammation of the nose and the paranasal sinuses characterized by two
or more symptoms, one of which was either nasal blockage/obstruction/
congestion or nasal discharge (anterior/posterior nasal drip): ± facial
pain/pressure, ± cough; and either endoscopic signs of disease and/or
relevant changes on the CT scan of the sinus that was refractory to
medical treatment.
Exclusion criteria consisted of the inability of the caregiver to read
and understand the survey; mental retardation, cognitive impairment,
or developmental delay; history of endoscopic sinus surgery; history of
the patient’s inability to tolerate attempted nasal irrigation in the past 6
months; history of the presence of cystic fibrosis; and history of allergic
reactions.
One hundred and twenty-five pediatric chronic rhinosinusitis pa­
tients were enrolled in this study and followed up by the ENT and pe­
diatric ambulatory outpatient clinic. All patients were examined in
detail with a 2.7 rigid and flexible fiberoptic endoscope (KARL STORZ,
78503 Tuttlingen, Germany).
During the 6 week therapy period, fourteen patients discontinued
therapy due to the side effects of xylitol (detailed in Table 1). Ten pa­
tients were excluded for not using their solution regularly, and there
were seven patients drop outs during the therapy period. The final
groups of patients were as follows: forty-eight patients (mean age: 11.02;
27 females, 21 males) having hypertonic nasal wash and forty-six pa­
tients (mean age: 10.02; 26 females, 20 males) having the xylitol nasal
wash.
All patients included in the study carried a clinical diagnosis of CRS
according to EPOS 2012 [5]. After the confirmation of the diagnosis of
CRS by one of the authors (YSY), therapy was given consecutively, either
a large volume low pressure hypertonic nasal irrigation solution or large
volume low pressure xylitol solution (Abfen Sinüs Rinse kit 25 × 120
mL) for 6 weeks. Warm drinking water (120 mL) was poured into the
plastic application bottle, and one pack of the Sinus Rinse kit was added.
After shaking the bottle thoroughly, the solution was applied to both
nasal cavities twice a day. A nurse was assigned to teach the children and
their families how to use the kit. During the teaching session, the
Table 1
Summary Statistics for SN-5 Sinus and Nasal Quality of Life Survey before and
after 6 week nasal xylitol solution treatment.
Table I N Before xylitol treatment/After xylitol P value
Treatment
preparation and application of the kit was explained in detail and
practiced.
2.1. Evaluation of treatment
The EPOS 2012 guidelines [5] were used, which recommended
evaluation of the response to treatment with a SN-5 questionnaire for the
treatment of chronic pediatric rhinosinusitis. The evaluation of the
postnasal drip in chronic rhinosinusitis was recorded as “Differences in
postnasal drip scoring”: none = 0, mild = 1, mild-intermediate = 2,
intermediate = 3, intermediate-upper intermediate = 4, and advanced
= 5.
The efficacy of the treatment and quality of life were evaluated
(Postnasal Drip Evaluation and SN-5) before and after the application of
the nasal solutions.
2.2. Statistics
The statistical analysis was carried out using the Statistical Package
for the Social Sciences version 13.0 software for Windows (SPSS Inc.,
Chicago, Illinois, USA). All quantitative variables were estimated using
measures of the central location (i.e. mean and median) and measures of
the dispersion (i.e. standard deviation; SD). The data normality was
checked using the Kolmogorov–Smirnov test of normality, and the stu­
dent t independent test was used for comparing variable data between
the groups. Repeated Anova testing was used for the within group
variability analysis. The Pearson correlation analysis was used for
comparing the correlation of the evaluation methods of the groups, and
a value of p < 0.05 was accepted as being statistically significant.
3. Results
A total of 125 patients were enrolled, and the mean age of the pa­
tients was 10.9 years old (range 4–17; 69 females, 56 males). There were
no significant differences in the demographics, including age and sex.
During the 6-week therapy period, fourteen patients discontinued the
therapy due to the side effects (Otalgia [3], Nose burning [3], Dizziness
[2], Headache [2], Eye pain [2], Epiphora and conjunctivitis [2]) of the
xylitol. Ten patients were excluded for not using their solution regularly
and seven patients dropped out during the therapy period. The patients
were grouped as follows: forty-eight patients (mean age: 11.02; 27 fe­
males, 21 males) were grouped as receiving hypertonic nasal irrigation
and forty-six patients (mean age: 10.02; 26 females, 20 males) as
receiving xylitol nasal irrigation. Initial symptoms (nasal obstruction,
purulent rhinorrhea, postnasal drip, or cough) were not different be­
tween the groups.
The SN-5 survey scores at baseline and post-treatment (6 weeks) are
presented in Tables 2–3. The five domains surveyed plus the overall QoL
scores are listed in the left column.
The xylitol solution group had no differences for the SN-5 scores in
any of the domains or the overall score at baseline, and post irrigation
treatment (Table 1).
Table 2
The result of SN-5 Sinus and Nasal Quality of Life Survey before and after nasal
hypertonic saline treatment.

Mean SD Min Max Table II N Before nasal hypertonic/after nasal P value

hypertonic
Sinus infection 48 6.75/6.26 0.75/1.87 4/4 7/7 0.095
Nasal obstruction 48 6.08/5.78 1.38/1.42 2/2 7/7 0.296 Mean SD Min Max
Allergy symptoms 48 4.97/4.36 1.57/1.52 2/2 7/7 0.056 Sinus infection 46 6.95/4.02 0.20/1.70 6/6 7/7 P < 0.0001
Emotional distress 48 4.47/3.94 1.52/1.48 2/2 7/6 0.086 Nasal obstruction 46 5.93/4.00 1.56/1.80 2/2 7/7 P < 0.0001
Activity limitation 48 2.56/2.24 0.94/0.82 1/1 4/4 0.078 Allergy symptoms 46 4.65/3.85 1.43/1.22 2/2 7/7 P = 0.005
Overall QoL 48 3.52/3.50 1.01/3.50 2/2 6/6 0.922 Emotional distress 46 4.65/2.95 1.58/1.18 2/2 7/7 P < 0.0001
Activity limitation 46 2.76/2.45 1.09/1.01 1/2 6/6 P = 0.1803
For the top five domains, 0 equals the score for answer of ‘‘none of the time,’’
Overell QoL 46 3.23/4.57 0.76/0.72 2/1 6/6 P < 0.001
and 7 equals the score for answer of ‘‘all of the time’’.

2
Y. Kurt and Y.S. Yildirim
Table 3
Postnasal drip evaluation.
Table III Before (mean ± SD) After (mean ± SD) P value
Xylitol nasal 3.17 ± 1.3 2.8 ± 1.2 P = 0.1356
Hypertonic nasal 2.9 ± 1.2 1.7 ± 1.1 P < 0.001
Postnasal Drip Evaluation: No = 0, mild = 1, Mild-Moderate = 2, Moderate =
3, Moderate-Advance = 4, Advance = 5.
There were statistically significant improvements in the hypertonic
nasal saline group’s (reduction in SN-5 domain scores) four domains and
an increase in the overall QoL score within each group after 6 weeks of
treatment, compared to baseline, but no differences in activity limitation
(p = 0.1803) (Table 2).
4. Discussion
Nose blockage is an important quality of life condition which is
observed very commonly in the population. Many systemic factors are
reported to be the reasons for nasal obstruction, however, in these pa­
tients, the main etiological factors causing nose obstruction are the local
factors. Rhinosinusitis, Allergic rhinitis, deviation of the nasal septum,
nasal polyps, and inferior nasal concha hypertrophy are the main local
etiological factors which can cause nasal blocking and sinusitis [6].
Chronic rhinosinusitis has its own diagnostic criteria, as determined
in August 1996 by the multidisciplinary rhinosinusitis task force, on
behalf of the American Academy of Otolaryngology–Head and Neck
Surgery. The resulting article, “Adult Rhinosinusitis Defined,” was
published in 1997 and endorsed by the American Academy of Otolar­
yngology–Head and Neck Surgery, the American Academy of Otolar­
yngic Allergy and the American Rhinologic Society [7]. The main
defining marker is the presence of symptoms for at least 12 weeks.
Additionally, the patient should have at least two major factors present,
or one major factor and at least two minor factors, or nasal purulence
upon examination.
A few studies have investigated the efficacy of nasal irrigation to
relieve sinus symptoms in pediatric patients [8]. One randomized
controlled trial comparing saline to saline with gentamycin indicated
that nasal irrigation was well tolerated, with >95% compliance during a
6-week treatment course, and remarkably improved the QoL as
measured by the Sinonasal 5 (SN-5) survey [9]. Other studies have also
shown the safety of irrigation without any serious adverse effects; most
commonly reported minor adverse events included post-irrigation nasal
drainage and initial discomfort [10,11]. A meta-analysis on the use of
nasal irrigation for the treatment of CRS concluded that its benefits
predominate its adverse effects [12].
Xylitol is a five-carbon sugar alcohol that has obtained relative in­
fluence in the past decade as an intrinsically consist of antibacterial
agent. It is not generally believed to possess its own antibacterial
properties; rather, it appears to improve the body’s own innate bacte­
ricidal mechanisms [13,14]. However most of the basic literature on
xylitol has built up in the past 10–15 years, the clinical usage of xylitol
long precedes it, with studies being published as early as the 1970s
reporting its inhibitory effects on dental caries when chewed in gum
[14]. It is generally thought that this result is secondary to the effects on
the biofilms of many dental pathogens.
Xylitol relief the detrimental bacteria that cause upper respiratory
tract infections from adherent to the tissue by creating a humid unin­
habitable perimeter [3] Furthermore, xylitol may be of value in
decreasing airway surface liquid salt concentrations and improve the
innate antimicrobial protection at the airway surface [13]. Assouline
et al. [15] reported that hyperosmotic solutions of sodium chloride or of
xylitol keeping strong anti-ulcer activity and reduce gastric acidity in
rats. Souques et al. [16] showed that hyperosmolar solutions can stim­
ulate the activation of nasal cells, but there is no information based on
nasal rinse and the side effects of xylitol in the literature.
3
International Journal of Pediatric Otorhinolaryngology 158 (2022) 111183
Although there were many beneficial studies about xylitol, our study
did not find any statistically significant improvement on the SN-5 sur­
vey, in postnasal drip, or the Lund-Mackay Score before and after using
xylitol nasal solution on pediatric CRS. Xylitol also has numerous side
effects on pediatric CRS patients.
Descriptive statistics of the postnasal drip results are presented in
Table 3 (Mean ± SD). The pre-treatment values were similar in the two
groups, but a statistically significant postnasal drip score was only
observed in the hypertonic group. Additionally, the reduction in the
Lund-Mackay score after the hypertonic solution was better than the
xylitol, and this difference was statistically significant. In Table 2 and
the SN-5 Sinus and Nasal Quality of Life Survey results are presented,
and the pre-treatment values were similar in all groups. A statistically
significant improvement in the Sinus and Nasal Quality of Life Survey
score was only observed in the hypertonic group.
No life threatening or serious adverse events were reported during
the study in any of the treatment groups. However, during the 6 week
therapy period, fourteen patients discontinued the therapy due to the
side effects of xylitol (detailed in Table 1).
Lin L et al. [17] reported that xylitol nasal irrigation results in greater
improvement of symptoms of CRS in adult patients, nasal irrigation with
Xylitol provided a great improvement in the symptoms of chronic
sinusitis, but in our study, we applied it to pediatric patients, but we find
that less symptoms score with Xylitol compared to saline irrigation.
Contrary to the studies [3,17] in the literature, in our study, it can be
said that there is no extra benefit of rinsing the nose with Xylitol solu­
tion, especially in children, and saline rinsing gives us a better result
nowadays.
We reviewed the characteristics and treatment outcomes after 6
weeks of twice daily nasal rinse in pediatric CRS based on family reports
of the following use of nasal irrigation for recurring symptoms. How­
ever, the present study does have some limitations. For example,
although we worked hard to spot rhinosinusitis or similar mucosal dis­
eases before the patients were included in the study, it is always possible
that some cases will go unobserved, particularly if the symptoms were
not clear at the time of recruiting. In these cases, the doctors must not
only treat with an appropriately but must also address the associated
conditions contributing to the problem.
Our findings suggest that if hypertonic saline nasal rinse is used as a
treatment modality for pediatric CRS, parents and caretakers are likely
to utilize it again for recurrent symptoms. This is beneficial and sup­
portive knowledge that motivate patients and families to manage their
symptoms without the overutilization of the health care system, and use
of multiple medications.
5. Conclusions
Low tolerance, compliance, and the side effects of xylitol irrigation
suggest that it not recommended as a first-line treatment for pediatric
CRS. The use of large volume low pressure, twice-daily intranasal hy­
pertonic irrigation for 6 weeks is safe and effective in the treatment of
pediatric CRS, and it can be used as a baseline treatment for pediatric
CRS before considering surgical interventions.
Funding source
None.
Financial disclosures
None.
Declaration of competing interest
The authors do not have a financial relationship with any organi­
zation or any company. Nobody sponsored the research.
Y. Kurt and Y.S. Yildirim
Acknowledgement
Financial Disclosure: I have no commercial associations (Non-
financial relationship)
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