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\begin{document}

\title{Xylitol-Gum Chewing for the Management of Otitis Media with Effusion}



\author[1]{kanokrat suvarnsit}%
\author[1]{Jutamas  Techapanuwat}%
\author[1]{Sarun  Prakairungthong}%
\author[1]{Kanthong Thongyai}%
\author[1]{Siriporn  Limviriyakul }%
\author[1]{Kitirat  Ungkanont}%
\author[1]{Suvajana Atipas}%
\affil[1]{Mahidol University Faculty of Medicine Siriraj Hospital}%


\vspace{-1em}



  
  \date{June 08, 2024}


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\selectlanguage{english}
\begin{abstract}
Introduction: Otitis media with effusion (OME) is the collection of
fluid in the middle ear without signs or symptoms of an acute infection.
It is cured by treating the cause and restoring normal eustachian tube
function. By activating jaw movement and inducing frequent swallowing,
chewing gum could be effective in the conservative management of OME.
Objectives: To determine the recovery rate after chewing xylitol gum for
the treatment of OME, and the factors associated with OME cures in
adults. Materials and methods: A non-randomized, controlled trial was
conducted on 30 OME patients May 2018--December 2019. The subjects
chewed 2 tabs of gum for 5--10 minutes, 3 times daily, for up to 3
months. Physical and audiometric examinations were performed at 2, 6 and
12 weeks. Results: Thirty patients were enrolled. Their mean age was
55.0 \selectlanguage{ngerman}± 20.19 years. OME resolution was found in 23/43 ears (53.49\%).
Myringotomy was performed in 13/43 ears (30.23\%). Two factors were
associated with shorter resolution times. Firstly, a patient age of
40--60 years, compared with other ages (p-value = 0.030). Secondly, an
initial average air-bone gap of \selectlanguage{english}[?] 20 dB, compared with larger gaps
(p-value = 0.027). Conclusions: Xylitol-gum chewing did not increase the
overall OME resolution rate. Nonetheless, it is still a choice for OME
management as it tends to shorten the resolution time, with only minor
side effects being experienced by some patients. Keywords: Otitis media
with effusion, otitis media, OME, xylitol chewing gum, gum chewing,
xylitol gum, gum%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{Introduction}

Otitis media with effusion (OME) is a condition in which the middle ear
contains fluid but without any signs or symptoms of an acute infection.
It may occur following an upper respiratory tract infection or
spontaneously due to poor eustachian-tube function.\textsuperscript{1}

Finkelstein et al.\textsuperscript{2} found that the incidence of
adult-onset OME is far less than in children, and that it commonly
follows rhinosinusitis, nasopharyngeal lymphatic tissue hypertrophy, and
smoking, resulting in an inflammation of the eustachian tube
lumen.\textsuperscript{3} According to our electronic database, an
average of 100 patients per year were diagnosed with OME at our clinic
during 2011--2016. Of those, 50\%--60\% were aged 12 years or older.

OME and eustachian tube dysfunction lead to hearing impairments ranging
from normal hearing to a moderate hearing loss (0--55 dB HL), with an
average hearing threshold of 28 dB.\textsuperscript{1} In addition,
chronic OME without treatment may result in retraction of the tympanic
membrane, atelectatic ear, ossicular erosion, tympanic membrane
perforation, or even cholesteatoma
formation.\textsuperscript{1,4}Therefore, patients with OME should
receive proper management in order to prevent such complications.

Regarding the results from previous literature, conservative treatment
by medical therapies (such as antihistamines, decongestants, antireflux
therapy, and topical nasal steroids) is ineffective in both the short
and long term.\textsuperscript{5}

As for adult OME, the aim of treatment is to eliminate the cause of
eustachian tube dysfunction and to restore eustachian tube function.
Swallowing and chewing are two possibilities that can help to recover
normal tube function. Nevertheless, no previous studies have
investigated the relationship between the applicable use of gum-chewing
and OME in adults.

Gum-chewing activates jaw movement and induces frequent swallowing. In
the resting position, the eustachian tube is collapsed due to the
passive effect of the cartilage, the elastic fibers, and the pressure of
the surrounding tissues.\textsuperscript{6,7} In contrast, the
activation of 2 peritubal muscles---the levator veli palatini and the
tensor veli palatini---stimulates the swallowing mechanism, thereby
opening the eustachian tube.\textsuperscript{8}

Gum is easily obtained in the marketplace and is low-priced. It is made
from the resin of a tree, to which a variety of ingredients, including
xylitol, are added to sweeten its flavor. Xylitol has long been used in
food, pharmaceutical, and oral-health products.\textsuperscript{9} It
has minimal effect on blood sugar and insulin levels, with 40\% fewer
calories than regular gum and a low glycemic index. Xylitol is safe for
consumption by diabetic patients.\textsuperscript{9}

\textbf{Objectives}

The primary purpose of this study was to establish the resolution rate
of OME after xylitol-gum chewing was used for the conservative treatment
of adult patients diagnosed with OME. The secondary aim was to identify
the factors affecting the improvement of OME after xylitol-gum chewing.

\textbf{Materials and methods}

Thirty patients were enrolled. They were aged 12 years or older, and
they had presented with aural fullness, hearing loss, ear popping,
and/or ear discomfort. Ear microscopy was used by an otologist to
establish a diagnosis of OME. Once OME was confirmed, the patients were
sent for pure tone audiometry, given 84 tabs of xylitol gum, and
requested to chew 2 gums for 5--10 minutes or until they were tasteless,
3 times a day. The patients were also provided with a logbook to record
how many gums they used and how frequently they were chewed.

Excluded from the study were patients with craniofacial anomalies,
nasopharyngeal lesions, diabetes mellitus, previous ear and/or nasal
cavity surgery, prior head and neck radiation, or an inability to chew
gum due to a limitation (such as osteoarthritis of the temporomandibular
joint).

The follow-up sessions were at 2, 6, and 12 weeks. At each visit, the
patients were examined by microscopy by an otologist, and they underwent
an audiometric assessment. A package of gum was given along with a new
logbook if middle-ear fluid was still confirmed. However, if the fluid
was found to have resolved at the subsequent follow-up appointment, the
patients were told to cease using the gum. On the other hand, if the
middle-ear fluid persisted until the final follow-up at 12 weeks, a
myringotomy was performed.

\emph{Data analysis}

The statistical analyses were performed using PASW Statistics for
Windows, version 18.0 (SPSS Inc., Chicago, IL, USA) and Stata, version
15 (StataCorp LLC., College Station, TX, USA). The demographic data were
analyzed with descriptive statistics.; the categorical data were
expressed as number (\%), whereas the continuous data were presented as
mean (\selectlanguage{ngerman}±~standard deviation). The Kaplan--Meier method was used to
examine the time to improvement during follow-up, while Cox regression
was employed to analyze the correlated time-to-event data. After a
univariable analysis was performed, the selection of variables for a
multivariable analysis was based on a univariable p-value of
\textless{}~0.1. Results were shown as adjusted hazard ratio (HR),
95\%~CI, and p-value. P-values of \textless{}~0.05 were considered
statistically significant.

\textbf{Results}

\emph{Demographic data and patients' characteristics}

The 30 patients were comprised of 22 females (73.33\%) and 8 males
(26.67\%). Their mean age was 55.0~±~20.19 years, ranging between 12--77
years. The average duration of the symptoms to the first treatment was
30 days. Seventeen patients had unilateral OME (56.67\%) while the
remaining thirteen had bilateral OME (43.33\%). The physical
examinations revealed a normal nasal cavity and nasopharynx in 18
patients (60\%), nasal congestion in another 4 (13.33\%), and nasal
discharge in 8 (26.67\%). The contour of the tympanic membrane was
normal in 22 ears (51.16\%), but 21 ears (48.84\%) had tympanic membrane
retraction. Right-sided OME was identified in 24 ears (55.81\%) and
left-sided OME in 19 ears (44.19\%). There were 26 ears (60.47\%) full
of fluid and 17 (39.53\%) with air in the middle ear. Twenty-two ears
(51.16\%) contained clear fluid whereas 21 ears (48.84\%) had
amber-colored fluid. The demographic data are presented in \textbf{Table
1} .

\emph{Time to improvement of OME}

At the 2-week follow-up, 11 ears were free of OME. At the 6-week
follow-up, 9 more ears were found to be OME-free. At the 12-week
follow-up, a further 3 ears were free of OME, giving a total of 23 ears
(53.49\%) OME-free over the 12-week period. Myringotomy was performed
after xylitol gum chewing in 13 ears (30.23\%) or 10 patients (33.33\%)
The data are presented in \textbf{Table 2} .

\emph{Audiometry}

Three out of the 30 patients had missing data, and all three had
unilateral OME. Consequently, the statistical evaluation was based on 40
audiometric results.

The mean difference between the pure tone average at the first and last
visits was 10.30~±~13.20 (p-value \textless{}~0.001).

When we performed a statistical analysis of the average air-bone gap, 3
audiometric results had zero air-bone gap at the beginning. The
remaining 37 audiometry results were therefore used for the evaluation,
which revealed a significant statistical difference (p-value
=~0.042;\textbf{Table 3} ).

\emph{Factors associated with time to improvement}

Factors known to affect OME in adults were statistically analyzed. They
were patient age; the duration of symptoms; a history of OME; a history
of myringotomy; the characteristics of the middle-ear fluid, such as its
color; air in the middle ear; and the average air-bone gap. Three
factors were found to be related to time to improvement: a patient age
between 40 and 60 years, a duration of symptoms of \textless{}~2 weeks,
and a history of OME (Table 4).

\emph{Age}

We classified age into 3 groups. One out of the six (16.67\%) patients
who were aged \textless{}~40 years recovered from OME. A further six out
of the seven (85.71\%) patients aged 40--60 years recovered, while
another nine out of the seventeen (52.94\%) aged \textgreater{}~60 years
recovered (Table 5).

\emph{Duration of symptoms}

We classified the duration of onset into 2 groups. Eight out of the
eleven patients (72.73\%) who had OME for \selectlanguage{english}[?]~2 weeks recovered from OME,
while another 8 out of the nineteen (42.11\%) who had OME for
\textgreater{}~2 weeks recovered (Table 5).

\emph{History of OME}

Only 9 patients had previously had OME. Three out of those nine
(33.33\%) recovered from OME, whereas thirteen out of the twenty-one
(61.90\%) without a history of OME did so (Table 5).

\emph{History of myringotomy}

There were 25 patients without a history of myringotomy. Of those,
fifteen (60\%) recovered from OME (Table 5).

\emph{Air in middle ear}

Patients with air in the middle ear (for example, air-fluid level or air
bubbles) had a 1.42-times greater OME resolution (95\% CI 0.62, 3.24)
than those with a middle ear fully filled with fluid, but without
statistical significance (p-value =~0.833).

\emph{Color of middle-ear fluid}

Patients with a clear middle-ear fluid had a 1.07-times greater OME
resolution (95\% CI 0.42, 2.75) than those with an amber-colored fluid;
however, this was without statistical significance (p-value =~0.883).

\emph{Average air-bone gap}

We divided the initial, average, air-bone gaps into 2 groups: gaps of
\selectlanguage{english}[?]~20 dB, and gaps of \textgreater{}~20 dB. Those patients with an
initial, average, air-bone gap of \selectlanguage{english}[?]~20 dB had a 2.25-times greater OME
resolution (95\% CI 0.94, 5.53) than those with an average air-bone gap
of \textgreater{}~20 dB. Nevertheless, the difference was not
statistically significant (p-value =~0.068).

The multivariable analysis (Table 6) found that only 2 variables
affected OME resolution: age group, and average air-bone gap. Patients
aged 40--60 years had an 11.19-times (95\% CI 1.26, 99.39) better OME
resolution than those aged \textless{}~40 years, with statistical
significance (p-value =~0.030). Similarly, patients with an average
air-bone gap of \selectlanguage{english}[?]~20 dB had a 3.80-times (95\% CI 1.16, 12.41) higher
OME resolution than those with an average air-bone gap of
\textgreater{}~20 dB, again with statistical significance (p-value
=~0.027). In contrast, neither the duration of the symptoms nor a
history of OME were found to be associated with the cure rate (p-value
\textgreater{}~0.05).

\emph{Complications}

No major complications were detected. However, some patients reported
minor side effects: an irritating and burning sensation in the oral
cavity, the xylitol gum being too sticky, and the gum sticking to
dentures.

\textbf{Discussion}

OME usually occurs following eustachian tube dysfunction. Rather than
solely relying on natural resolution, hastening the process of restoring
normal tube function will lead to a better quality of life for OME
patients. Several techniques have been proposed to improve the function
of the eustachian tube; for example, the Toynbee and Valsalva maneuvers
aim to force open the eustachian tubes.\textsuperscript{3,8,10} In this
study, we investigated the use of gum-chewing as a way of opening the
tubes.

Gum-chewing creates jaw movement and induces more frequent swallowing.
Gum-chewing is particularly beneficial for senile patients, who tend to
have less eustachian tube activity due to dental problems, a poor or
lost appetite, being less talkative, and a reduced swallowing
frequency.\textsuperscript{11,12} In an earlier experimental study
measuring tensor veli palatini muscle activity before and after
eustachian tube rehabilitation by using electromyography monitoring, it
was found that swallowing increases the strength of the tensor veli
palatini muscle.\textsuperscript{13} Given that chewing gum increases
the frequency of swallowing, the eustachian tube function should
therefore improve.

Regarding the results, only 23 out of 43 ears (53.49\%) became free of
OME during the 12-week study period. Even though there is no definite,
documented, resolution rate for OME in adults, this proportion is lower
than the usual resolution rates in children reported in the literature
(75\%--90\%)\textsuperscript{1} In other words, the gum-chewing did not
enhance the cure rate. The reason why the resolution rates for adults
are lower than those for children is possibly due to the cause of the
eustachian tube dysfunction. OME in children often follows an acute
upper-respiratory infection, such as the common cold or acute sinusitis.
The OME is temporary and easy to cure. In contrast, the causes of OME in
adults tend to be more chronic, for example, allergic rhinitis, exposure
to smoking, and hormonal changes, all of which affect mucociliary
activity.\textsuperscript{14,15} The other explanation is that there are
age-related, morphological changes to the eustachian tubes. With
advancing age, there are alterations in the size and shape of the
eustachian tube cartilage, as well as in the positions of the levator
veli palatini and tensor veli palatini muscles. Consequently, chewing
gum may not always be sufficient to solve these problems in adult or
senile patients, even though the method is intended to promote the
swallowing activity.\textsuperscript{16}

Taking a closer look at the data, only 2 parameters---patient age and
the initial average air-bone gap---affected the resolution rate and time
to improvement. The patients who were 40--60 years of age demonstrated a
higher OME resolution and a shorter time to improvement than the other
age groups. The effect of the muscular opening function could be the
reason. In another study that measured middle-ear pressure after
chewing, mouth opening, and jaw movement, the muscular opening function
was found to be stronger in adults than in children or senile
patients.\textsuperscript{17}

Initial, average, air-bone gaps of \selectlanguage{english}[?]~20 dB yielded a better OME
resolution rate than gaps of \textgreater{}~20 dB. This could be
explained by middle-ear fluid viscosity. Previous research has suggested
that there is a correlation between middle-ear fluid viscosity and
audiometry. Highly viscous or thick middle-ear fluid was found to result
in a poorer air-conduction threshold and a larger air-bone gap (p-value
\textless{}~0.001) than thin middle-ear
effusion.\textsuperscript{18}Thus, lighter viscosities tend to lead to
faster resolutions of OME.

There were some limitations of this study. Firstly, only a small number
of patients was investigated. Moreover, confounding factors (such as
intranasal corticosteroid use, oral antibiotic use, and underlying
conditions) might have affected the eustachian tube function.
Furthermore, we lacked an exact protocol for the gum-chewing (the number
of gums, frequency, and duration of gum-chewing). As a result, the
conclusion that chewing gum is ineffective for the management of OME is
still inconclusive. A further study with a randomized controlled trial
utilizing a larger population is suggested.

Overall, given its minor side effects and low cost, xylitol-gum chewing
could prove to be an adjunctive treatment to complement watchful waiting
for the management of OME in selected patients. Its primary benefit is
that it may help to hasten the natural resolution of OME.

\textbf{Conclusions}

Xylitol-gum chewing did not increase the overall OME resolution rate.
Nevertheless, it is still a choice for the management of OME in that it
may help to accelerate the resolution time, with only minor side effects
being experienced by some patients. Two factors that would need to be
considered before suggesting gum-chewing are the patient's age and the
size of the initial air-bone gap.

\textbf{References}

1. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical Practice
Guideline: Otitis Media with Effusion (Update). Otolaryngol Head Neck
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2. Finkelstein Y, Ophir D, Talmi YP, Shabtai A, Strauss M, Zohar Y.
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3. Schilder AG, Bhutta MF, Butler CC, et al. Eustachian tube
dysfunction: consensus statement on definition, types, clinical
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12. Kapila YV, Dodds WJ, Helm JF, Hogan WJ. Relationship between swallow
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13. Picciotti PM, Della Marca G, D'Alatri L, Lucidi D, Rigante M,
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Shelton: People's Medical Publishing House, 2009:201-208.

16. Sadler-Kimes D, Siegel MI, Todhunter JS. Age-related morphologic
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Ann Otol Rhinol Laryngol 1989; 98:854-858.

17. Bylander A. Comparison of eustachian tube function in children and
adults with normal ears. Ann Otol Rhinol Laryngol Suppl 1980; 89:20-24.

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Arch Otolaryngol 1983; 109:360-363.

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