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Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc Containing only Food Ingredients

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The aim of this double-blinded, randomized, controlled study was to determine if OraCoat XyliMelts, an over the counter, dissolvable, adhering disc used to reduce excessive day time or night time dry mouth by increasing salivation, would also reduce reflux and heartburn symptoms occurring during sleep among subjects suffering from both GERD and xerostomia. Subjects submitted 14 days of baseline data by answering questions and were then randomized into one of two groups: one receiving a dry mouth gel (control) and a second receiving a disc (product of interest). Neither the identities of the two products nor the manufacturers of the products was revealed to subjects. Answers to the same set of questions were then collected for an additional 14 days as the supplied products were used. The accumulated data were evaluated for pre-post treatment changes within and between groups. Variables included reported heartburn, reflux, reflux taste, hoarseness, dry mouth, and antacid use. The results showed a significant decrease in the severity of the above symptoms of GERD with both disc and gel use, although improvement was greatest for those using the discs. Comparison between the gel and disc groups for most symptoms did not reveal significant differences. For heartburn, subjects using the discs perceived significantly less pain than subjects using the gel. We conclude that the use of certain products intended to reduce dry mouth during sleep, including OraCoat XyliMelts, may be an effective adjunctive remedy for reducing reflux and heartburn symptoms in patients with GERD and xerostomia.
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Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral
Adhering Disc Containing only Food Ingredients
Peter Van Der Ven, Jeffrey Alan Burgess* and Michael D Karcher
Department of Oral Medicine, University of Washington, Seattle, USA
*Corresponding author: Burgess JA, Department of Oral Medicine, University of Washington, Seattle, USA, Tel: 2064502640; E-mail:
oral.care.research.assoc@gmail.com
Receiving date: August 10, 2017; Accepted date: August 30, 2017; Published date: August 31, 2017
Copyright: ©
use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
The aim of this double-blinded, randomized, controlled study was to determine if OraCoat XyliMelts, an over the
counter, dissolvable, adhering disc used to reduce excessive day time or night time dry mouth by increasing
salivation, would also reduce reflux and heartburn symptoms occurring during sleep among subjects suffering from
both GERD and xerostomia. Subjects submitted 14 days of baseline data by answering questions and were then
randomized into one of two groups: one receiving a dry mouth gel (control) and a second receiving a disc (product of
interest). Neither the identities of the two products nor the manufacturers of the products was revealed to subjects.
Answers to the same set of questions were then collected for an additional 14 days as the supplied products were
used. The accumulated data were evaluated for pre-post treatment changes within and between groups. Variables
included reported heartburn, reflux, reflux taste, hoarseness, dry mouth, and antacid use. The results showed a
significant decrease in the severity of the above symptoms of GERD with both disc and gel use, although
improvement was greatest for those using the discs. Comparison between the gel and disc groups for most
symptoms did not reveal significant differences. For heartburn, subjects using the discs perceived significantly less
pain than subjects using the gel. We conclude that the use of certain products intended to reduce dry mouth during
sleep, including OraCoat XyliMelts, may be an effective adjunctive remedy for reducing reflux and heartburn
symptoms in patients with GERD and xerostomia.
Keywords: Esophageal reux; Heartburn; Xerostomia; Mouth
dryness
Introduction
Background
Gastro-esophageal reux disease, commonly referred to as GERD, is
estimated to occur in ten to 30% of the population in developed
countries, with its frequency increasing [1]. Nocturnal GERD involves
reux of acid into the esophagus during sleep. e condition is
estimated to occur once a month in up to 43% of individuals and once
a week in 20% of the population [2,3]. GERD and its variants, is
associated with multiple symptoms including heartburn, sleep
disturbance, impaired salivation and swallowing, reduced esophageal
motility, and erosion of teeth [4-6]. e two classic’ symptoms that are
typically associated with GERD are heartburn (epigastric pain) and
acid reux (an acidic taste at the back of the throat) [7,8]. As a natural
antidote to GERD, salivary ow serves to neutralize, dilute, and wash
down acid that escapes the stomach [9,10].
Hence, we hypothesized that stimulation of salivation during sleep
by a slowly dissolving avored disc that adheres to the oral mucosa
could improve reux and heartburn symptoms associated with GERD.
ere is no denitive test to diagnose GERD. Upper endoscopy and
pH (acid) monitoring have demonstrated low predictive values and are
not considered to be stand-alone criteria for identifying GERD [11].
Consequently, in selecting subjects for this on-line study, we relied on
Guidelines for diagnosing GERD published by the American College
of Gastroenterology and the American Gastroenterological Association
[12,13]. ese guidelines state that “a presumptive diagnosis of GERD
can be established” in the clinical setting “by the typical symptoms of
heartburn and acid regurgitation and response to empiric trials of
proton pump inhibitors (PPIs).
A signicant problem associated with GERD is sleep disturbance.
e research supporting the connection between GERD and sleep
disturbance includes epidemiologic as well as clinical studies [14,15].
GERD-associated sleep disturbance may contribute to greater health
care utilization, work loss, and decreased quality of life [16-21]. An
epidemiological study by Mody et al. using data from the US National
Health and Wellness Survey, notes that 19% of their over 60,000
surveyed respondents experienced heartburn at least two times a
month [22].
Of those with night-time GERD, 68% also reported sleep diculties,
with 49% indicating diculty getting to sleep and 58% indicating
diculty maintaining sleep. Of potential signicance, subjects
reporting night-time GERD had 1.5 times more overall sleep problems
compared to those reporting daytime GERD. In addition, sleep
diculty was reported to be associated with increased health care
utilization, impairment of daily activity, and loss of work productivity.
Similar results have been published elsewhere [23]. Evidence suggests
that reducing nocturnal GERD could provide a signicant
improvement in sleep, health care costs, and quality of life [24].
Other problems associated with nighttime GERD include oral
disease, epigastric pain, and hoarseness. Oral problems arising as a
direct result of GERD include tooth erosion and halitosis [5,25-27].
Tooth erosion is thought to result from the acidity of the gastric
Journal of Gastrointestinal &
Digestive System der Ven et al., J Gastrointest Dig Syst 2017, 7:4
DOI: 10.4172/2161-069X.1000524
Research Article OMICS International
J Gastrointest Dig Syst, an open access journal
ISSN:2161-069X
Volume 7 • Issue 4 • 1000524
2017 der Ven PV,, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted
contents that reach the mouth during repeated GERD episodes,
especially if they are inadequately buered by saliva [28,29].
Saliva, or a lack thereof, may also have an eect on the esophageal
mucosa exposed to reuxed acid, with this resulting in subsequent
thoracic symptoms including chest pain (heartburn) and voice changes
(hoarseness) [30]. A reduction in GERD could be expected to reduce
the risk of acidic taste, dental pathology, bad breath, chest pain, and
morning hoarseness.
Saliva is thought to play an important role in protecting the
esophageal lining, by diluting, washing down, and buering stomach
acid that enters the esophagus through reux [31-35]. Salivary ow has
been shown to fall signicantly during the night, according to an
individual’s circadian rhythm [36]. is is signicant because a
number of studies report that stimulated night time production of
saliva and its associated constituents can mitigate the symptoms of
heartburn and reux [32,37,38]. It has been proposed that increased
salivation resulting from esophageal acidication may be mediated
through an 'esophago-salivary' reex [39]. Reex salivation with
associated increased bicarbonate content appears to be greatest when
acid accumulates in the upper region of the esophagus [40].
e eect of acid infusion into the lower part of the esophagus does
not appear to have the same eect on salivary ow. It has been
reported that a signicant increase in heartburn occurs when acid
reaches the upper area of the esophagus [32,41]. Hence, in patients
with reux where the acid does not reach the upper area of the
esophagus, a reexive increase in saliva production may not be
initiated. us, there may be benet from stimulating the release of
additional saliva whose buering capacity could help protect the lower
esophageal lining from reuxed acid.
Current Medication Management of GERD
GERD is managed by various medications including drugs that
inhibit acid secretion, such as proton pump inhibitors (PPI’s) and
histamine receptor antagonists (H2 blockers), and prokinetic drugs
which increase tone in the lower esophageal sphincter [42,43]. Other
remedies include OTC alkaline agents such as calcium carbonate,
which simply neutralize acid. While the above drugs may help some
patients, they may not be helpful in all cases. For example, it is
reported that one-third of patients taking the PPI drugs do not
respond to these drugs and side eects can be problematic [44].
PPI use has also been associated with an increased risk of bone
fracture and Vitamin B12 deciency [45]. PPI’s44 inhibit the liver P450
enzyme system and may interact with other drugs [46]. Further, the
literature suggests that women planning on becoming pregnant or who
are pregnant should consult their physician prior to taking PPI’s, and
patients with kidney or liver problems or certain lung diseases such as
COPD, diabetes, or a history of porphyria should also be cautious with
the use of these drugs [47,48].
Prokinetic medications are only recommended for short term use
and their potential side eect such as depression and severe muscle
twitching, dizziness or lightheadedness, and potentially fatal heart
arrhythmias limit their general usefulness [49]. Antacids are eective
in managing acute GERD but are not considered reasonable for long
term use due to potential side eects [50].
Another problem with antacid use is that for GERD occurring at
night, it is not until sleep is disturbed that this class of medication is
taken, which reduces the benet in terms of sleep quality. Given the
facts that many people do not gain relief from PPIs, that histamine-2
receptor antagonists are associated with multiple side eects and
interactions with other drugs, and that the benet of antacid use is
limited by associated sleep disturbance and side eects can be an issue
with chronic use, additional approaches to the treatment of GERD
occurring during sleep need to be considered [15].
Study Rationale
e aim of this study was to determine if an orally dissolvable,
adhering disc, previously shown to reduce excessive day time or night
time dry mouth, would also reduce reux and heartburn occurring
during sleep. e discs are made from food ingredients and stimulate
saliva via slowly released avor when used as directed. Ho et al. report
that among people with xerostomia, their use more than doubled saliva
production when applied during the day [51].
Reux symptoms are sometimes more prominent at night because
acid can more readily enter the esophagus while patients are lying
down. Anecdotal reports and research show that salivary stimulants
can reduce the sensation of dry mouth. Research also suggests that
salivation can ameliorate reux and heartburn [24,31,32]. We
hypothesized that the stimulation of salivation by a slowly dissolving
intraoral disc could signicantly reduce nocturnal reux and
heartburn symptoms associated with GERD in subjects who self-report
xerostomia.
Subjects and Methods
Study design
is study was approved by the Western Institutional Review Board
on September 16, 2014 (WIRB; 1019 39th Ave S, Ste 120, Puyallup, WA
98374). It was designed as a randomized, double-blinded, controlled
trial involving two over the counter products currently on the market
for use in the management of dry mouth symptoms. e product of
interest was cleared by the FDA for investigation in the context of
GERD on September 4, 2014 (Investigational New Drug Application
number 123574 US FDA). Study information and results can be found
on ClinicalTrials.gov (project identier NCT02274636)
Both the participants and the research coordinator conducting the
study were blinded as to which of the two products was the one of
interest and delivery was independently randomized. e product of
interest, OraCoat XyliMelts, was produced by OraHealth Corporation
in Bellevue, Washington.
e ingredients are all-natural and commonly used in foods: xylitol
for sweetness, mild mint for additional avor, cellulose gum to slow
dissolution and lubricate the mouth, an acacia gum adhesive layer, and
a small amount of calcium carbonate to neutralize the acidity of acacia
gum and render the product slightly basic. When a single disc is
dissolved in 5 parts water, the resulting pH is 8.1 [52]. When used
during the day by subjects with dry mouth having a mean salivary pH
of 7.25, the use of two discs did not make saliva more basic [51].
Product users also report that discs slowly dissolve over six hours
during sleep and that the avor can still be sensed upon awakening
aer 8 hours of sleep [51,53]. e product used as a control was a water
based gel containing cellulose hydrocolloid gums with sorbitol and
xylitol sweeteners marketed by GlaxoSmithKline as a remedy for dry
mouth. As it is a soluble gel introduced prior to sleep, it was presumed
Citation: Burgess JA, Der Ven PV, Karcher MK (2017) Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc
Containing only Food Ingredients. J Gastrointest Dig Syst 7: 524. doi:10.4172/2161-069X.1000524
Page 2 of 7
J Gastrointest Dig Syst, an open access journal
ISSN:2161-069X
Volume 7 • Issue 4 • 1000524
to be eliminated from the oral cavity fairly quickly via salivary
stimulation.
Study population/subjects
Subjects were drawn from 372 individuals living in the United States
who responded to an ad soliciting paid volunteers for an internet
administered study involving substances recognized as safe for possible
management of reux symptoms. When individuals expressed interest
in the study, a 21 item questionnaire was sent to them via email. For
inclusion in the study, subjects had to have internet email access and be
computer literate, be 18 years of age or older, have had a medical
evaluation in the prior year, and have self-reported frequent symptoms
of reux or heartburn and dry mouth while sleeping.
Study exclusion criteria included a history of thoracic, esophageal or
gastric surgery, current or past coronary artery disease, gallbladder
disease, gastric or esophageal cancer, peptic ulcer disease, esophagitis,
and eosinophilic, infectious, or esophageal motility disorders. Subjects
were also excluded if another member of their household was already
participating in the study. It was not necessary to have received a
medical diagnosis of reux, but 91% of nal subjects reported this
diagnosis. Subjects satisfying the inclusion criteria and qualifying for
the study based on medical criteria were sent a comprehensive, WIRB
approved consent form detailing the study intent, design, procedures,
risks and discomforts, benets, alternatives, condentiality, legal
rights, and other information.
Variables of interest
Study subjects were emailed a questionnaire every day during an
initial two week baseline collection period and then a two week
product intervention trial, for a total of four weeks participation.
Questionnaire variables (listed below) were chosen because previous
research suggests that reux, characterized by a perception of a sour
taste at the back of the mouth, is also associated with symptoms of
heartburn, morning hoarseness, use of water during the night, and
antacid use [8,54].
Procedures
Phase 1: Baseline
Upon receiving written consent via email response, subjects were
entered into the 14 day baseline data collection phase of the study
(Phase 1). During this period, they were instructed to continue with
their normal daily activities including their usual diet and the use of
ongoing OTC and/or prescribed medication for reux, heartburn, and
any other non-excluded medical conditions. Each subject was asked to
answer the same nine questions delivered by email each morning by
the research coordinator, relating to what occurred during their prior
night’s sleep.
e specic questions were:
Did you taste reuxed stomach acid during your sleep last night
(yes/no);
How severe was the reux (mild, moderate, severe, very severe);
Did you have heartburn when you slept (yes/no);
How severe was the heartburn (mild, moderate, severe, very
severe);
Did you keep water by your bedside because of dry mouth
occurring during sleep (yes/no);
Did you have uncomfortable dry mouth when you slept or upon
awakening (yes/no);
Did you experience hoarseness of your voice in the morning (yes/
no);
Did you need to take antacids during sleep (yes/no); and
If so, how many did you take (number).
Subjects were asked not to view their prior email responses when
replying in the morning and to maintain the same email thread for
subsequent review, should it be necessary. When a subject replied with
the exact same answers each day without variation during the baseline
data-collection period he/she was disqualied from the study as this
was considered to be statistically improbable.
Phase 2: Product trials
Upon completion of Phase 1, each subject’s data were quantied to
see if he/she qualied for the second product phase of the study. To be
accepted into Phase 2, subjects had to have reported reux taste on
eight of the fourteen mornings following their night’s sleep during
baseline assessment and dry mouth on seven of the same mornings.
ose qualifying were then randomized into one of two groups:
treatment or control. Each subject then received by mail either the
adhering discs disguised in unmarked packaging (treatment), or the
sweetened water based gel in an unmarked white tube (control), with
printed instructions copied from the manufacturer’s instructions for
their method of use at bedtime.
e dispensed product was then used by each subject every night
for two weeks. During this second phase of the study, subjects
answered the same nine questions as in Phase one delivered to them by
email each morning. As in Phase one, subjects were asked not to view
their prior email responses when replying.
In both study arms, subjects were allowed to miss one night’s
responses but were disqualied if they failed to respond more than
once. Some questions posed by subjects during the study relating to
how the questionnaire should be completed indicated that there were
instances of confusion regarding interpretation and intent. When
subjects asked for clarication regarding completion of the
questionnaire, consistent advice was provided by the research
coordinator.
Statistics
As noted, variables of interest included reux taste, reux severity,
heartburn sensation, heartburn severity, morning voice hoarseness,
and antacid use each night. Baseline data for the above variables was
collected from a total of 119 subjects who qualied for and consented
to be in the study.
Based on the above qualifying criteria 53 subjects were selected to
enter the two week intervention phase of the study, randomized to
receive the disc or the gel. Comparisons were made within and
between groups for all outcome variables. e severity data take the
form of two clinical phases (baseline and treatment), each representing
14 nights of ordinal categorical data (no heartburn, mild heartburn,
moderate heartburn, severe heartburn, and very severe heartburn).
e ordinal data suggest using a Mann-Whitney U test to compare
the results from the treatment phase to the baseline phase for disc and
gel groups, the results from the baseline phase of the disc group to the
baseline phase of the gel group, and the treatment phase of the disc
group to the treatment phase of the gel group [55]. e U test
Citation: Burgess JA, Der Ven PV, Karcher MK (2017) Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc
Containing only Food Ingredients. J Gastrointest Dig Syst 7: 524. doi:10.4172/2161-069X.1000524
Page 3 of 7
J Gastrointest Dig Syst, an open access journal
ISSN:2161-069X
Volume 7 • Issue 4 • 1000524
compares two groups of ordinal data by tabulating the pairwise
comparisons (greater than, equal, or less than) between the data in
each group and then comparing that tabulation to the known null
distribution under the null hypothesis that a random member of either
group is equally likely to be greater than a random member of the
other group.
As with T-tests, U test alternative hypotheses can be one-sided or
two-sided, depending on which outcomes are clinically relevant. e
reux taste and hoarseness data take the form of two clinical phases
(baseline and treatment), each representing 14 nights of yes/no data
stating whether each of the 26 subjects using the disc experienced the
taste of acid during the night. e yes/no data suggest use of logistic
regression with a random eect of subject. e nightly antacid use data
take the form of two clinical phases (baseline and treatment), each
representing 14 nights with computation of the mean number of
antacids used. is suggests the use of a matched-pair T-test.
Results
ree hundred seventy-one individuals responded to the solicitation
for participation in the study. Baseline data for the above variables was
collected from a total of 119 subjects who qualied for and consented
to be in the study. Based on the above described inclusion criteria post
baseline, 53 subjects were selected to enter the two week intervention
phase of the study, with 26 randomized to receive the disc and 27 to
receive the gel. Forty-two qualifying subjects did not complete the rst
phase of the study.
Eight subjects did not qualify for the second phase of the study,
while sixteen subjects were terminated from the study either because
they did not comply with daily reporting or because someone in the
household had already been in the study. Subjects in the two nal
intervention groups were not signicantly dierent when compared on
the basis of gender, age, or prior medical diagnosis of reux. Mean age
for the disc group was 46.1 (SD 12.1) and for the gel group was 41.3
(SD 13.4).
Heartburn
Subjects using the discs demonstrated a signicant reduction in
reported pain of heartburn when compared with baseline (one sided
U-test p-value <0.001). Subjects using the gel also experienced a
signicant reduction in pain when compared to baseline (U-test p-
intervention demonstrates signicantly greater improvement in
heartburn pain than gel intervention (U-test p-value <0.01) (Figure 1).
Reux severity
Subjects using the disc intervention reported a signicant reduction
in reux severity when compared with baseline (one sided U-test p-
value <0.001) (Figure 2).
Subjects using the gel also experienced a signicant reduction in
reux severity when compared to baseline values (U-test p-value
<0.001). When the performance between the disc and gel treatments is
compared, a statistically signicant dierence is not observed (U-test
p>0.13).
Figure 1: Comparison of the Disc and Gel under the conditions No
Treatment and Treatment for Heartburn. e Y axis is the number
of nights reported; the X axis is the reported severity level.
Figure 2: Comparison of subjects for severity of reux taste; the Y
axis is the mean number of nights with the reported severity level
without disc treatment and with disc treatment.
Using logistic regression with a random eect of subject, the disc
treatment had a statistically signicant (p <0.001) eect on taste of
acid, with an 81% reduction in the odds of reporting taste of acid.
For the gel treatment, we also observed a statistically signicant (p
<0.001) eect on acid taste, with an 82% reduction in the odds of
reporting taste of acid. When we test for a dierence between the two
treatments, the dierence is not statistically signicant (p=0.71)
(Figure 3).
Hoarseness
Using logistic regression with a random eect of subject, the disc
treatment had a statistically signicant (p<0.001) eect on reduced
hoarseness, with an 87% reduction in the odds of reporting hoarseness.
Citation: Burgess JA, Der Ven PV, Karcher MK (2017) Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc
Containing only Food Ingredients. J Gastrointest Dig Syst 7: 524. doi:10.4172/2161-069X.1000524
Page 4 of 7
J Gastrointest Dig Syst, an open access journal
ISSN:2161-069X
Volume 7 • Issue 4 • 1000524
value <0.001). When these two remedies are compared via U-test, disc
For the gel treatment, there was a statistically signicant (p <0.001)
eect with a 92% reduction in the odds of reporting hoarseness. e
dierence between the two treatments was not statistically signicant
(p=0.41) (Figure 3).
Antacid use
Using a matched-pairs T-test, for the disc treatment, a mean of 60%
fewer antacids were used compared to baseline (average 11 fewer used
in 14 days, with standard deviation 9.8), with a p-value <0.001.
For the gel treatment, an average of 45% fewer antacids were used
(average 11.5 fewer used in 14 days, with standard deviation 17.9),
with p-value <0.001. A T-test comparing the two treatments did not
show a signicant dierence (p=0.89) (Figure 3).
Figure 3: Comparison of antacid usage, nights with the taste of acid,
and mornings with hoarseness in subjects during 14 nights without
treatment and during 14 nights of disc use. Gel data is not presented
here as the results were statistically indistinguishable.
Discussion
e data indicate that nightly use of both discs and gel signicantly
reduces symptoms associated with GERD, including morning
hoarseness, reux acid taste, night time heartburn, and perceived
reux. Subjects who used the discs and gel for two weeks also
demonstrated a signicant reduction in antacid use during the night in
comparison to two weeks of baseline use. e discs were found to be
generally more eective in reducing symptoms than the gel, although
most of the dierences were not statistically signicant. e exception
was heartburn, where improvement was found to be signicantly
better for subjects using the discs than the gel. Signicant side eects
were not reported in either group during product use.
Subjects in the ‘control’ gel group were asked to use what was
assumed would be an ineective remedy. It was thought that the
applied gel would wash out or be swallowed relatively quickly during
the initial hours of sleep, thus providing only a narrow window of
possible eectiveness. e unexpected result demonstrating signicant
reduction in symptoms for both disc and gel users, however, suggests
that both of these products may have the eect of increasing salivation
during sleep. Or alternatively, one or more constituents of the disc or
gel, when swallowed, may have helped to protect the esophageal lining
from acid irritation. Hence, rather than being an inert control, the gel,
like the disc, appeared to function as an active agent.
As with any type of questionnaire methodology, reliance on subject
memory of events can be problematic and the reliability of daily
responses, in the absence of corroboration by direct measurement may
be questioned. However, studies assessing questionnaire methodology
suggest that memory issues may be lessened by regularly providing
questions that are repeated in the exact same order and wording which
was the approach used in this study [56]. Further, the specic
questions used to assess the presence of symptoms were based on other
previously validated self-reported questionnaires assessing potential
GERD [57-60].
Subjects accepted into the study were not asked to discontinue any
previously prescribed medication for reux or heartburn during their
participation. ey were instructed that the disc or the gel were to be
taken in conjunction with any other prescribed treatment. Our study
protocol did not include a detailing by each subject of additional
prescribed treatments (including the use of medication) during gel or
disc use, hence it remains unknown if these additional prescribed
interventions may have confounded or altered the ndings. However,
the use of any additional prescribed treatments by any subject was the
same during the baseline and treatment phases, and the tested
treatment showed a signicant eect beyond any eect of the
additional prescribed treatments.
Conclusions
is study suggests that two available OTC products used to
manage dry mouth during sleep may provide an eective adjunctive
remedy for reducing reux and heartburn symptoms in patients with
concomitant xerostomia. e discs and the gel were well tolerated and
not associated with adverse reactions during use. Further, the data
appear to support the hypothesis that an increase in salivation during
sleep may be the reason for symptom reduction. However, more
research is needed to conrm the mechanisms responsible for the
therapeutic eects identied in the study.
e ndings of this study are novel and potentially medically
relevant for physicians treating GERD. And they are encouraging with
respect to future research. Individuals who have dry mouth and
experience symptoms of GERD during sleep may nd benet in using
an OTC dry mouth product such as OraCoat XyliMelts.
Acknowledgements
e authors wish to thank OraHealth Corporation for providing the
OraCoat XyliMelts discs and for coordinating the blinded distribution
of the gel and disc products to subjects.
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Citation: Burgess JA, Der Ven PV, Karcher MK (2017) Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc
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Citation: Burgess JA, Der Ven PV, Karcher MK (2017) Effect on Acid Reflux Symptoms Occurring during Sleep of an Oral Adhering Disc
Containing only Food Ingredients. J Gastrointest Dig Syst 7: 524. doi:10.4172/2161-069X.1000524
Page 7 of 7
J Gastrointest Dig Syst, an open access journal
ISSN:2161-069X
Volume 7 • Issue 4 • 1000524
... The study was designed as a randomized, double-blinded, controlled trial involving two over the counter products currently on the market for use in the management of dry mouth symptoms. The product of interest was cleared by the FDA for investigation in the context of GERD on September 4, 2014 [43]. ...
... The discs more than doubled saliva production while awake [45]. The discs slowly dissolved over six hours during sleep and the flavor was still sensed upon awakening after 8 hours of sleep [43,46]. ...
... As a natural antidote to GERD, saliva flow serves to neutralize, dilute, and wash down acid that escapes the stomach [3,4]. Stomach acid infusion into the upper esophagus is thought to stimulate salivation through what has been termed an 'esophago-salivary' reflex, but when saliva flow is significantly reduced during sleep in patients who have excessive dry mouth, the normal reflex may not be initiated when acid escapes into the lower esophagus. ...
... The study was conducted by Peter Van der Ven, Michael Karcher, and myself and published in August 2017. 38 The aim of this study was to see if OraCoat XyliMelts, an OTC dissolvable, adhering disc used to reduce excessive day time or night time dry mouth, would also reduce reflux and heartburn occurring during sleep. OraCoat XyliMelts are made from food grade ingredients and stimulate saliva via slowly released flavor when used as directed. ...
Article
Full-text available
The aim of this double-blinded, randomized, controlled study was to determine if OraCoat XyliMelts, an over the counter, dissolvable, adhering disc used to reduce excessive day time or night time dry mouth by increasing salivation, would also reduce reflux and heartburn symptoms occurring during sleep among subjects suffering from both GERD and xerostomia. Subjects submitted 14 days of baseline data by answering questions and were then randomized into one of two groups: one receiving a dry mouth gel (control) and a second receiving a disc (product of interest). Neither the identities of the two products nor the manufacturers of the products was revealed to subjects. Answers to the same set of questions were then collected for an additional 14 days as the supplied products were used. The accumulated data were evaluated for pre-post treatment changes within and between groups. Variables included reported heartburn, reflux, reflux taste, hoarseness, dry mouth, and antacid use. The results showed a significant decrease in the severity of the above symptoms of GERD with both disc and gel use, although improvement was greatest for those using the discs. Comparison between the gel and disc groups for most symptoms did not reveal significant differences. For heartburn, subjects using the discs perceived significantly less pain than subjects using the gel. We conclude that the use of certain products intended to reduce dry mouth during sleep, including OraCoat XyliMelts, may be an effective adjunctive remedy for reducing reflux and heartburn symptoms in patients with GERD and xerostomia.
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Background: The goal of this study was to identify the in vivo effects in patients with hyposalivation of a novel slowly dissolving adhering test disc upon on enamel remineralization, oral biofilm, salivary production, pH and buffering, gingival health, and on self-evaluation of oral well-being. Methods: Five subjects with xerostomia wore custom made retainers carrying 5 demineralized enamel chips for periods of 1 week each. In 1 study arm, subjects used the test agent plus oral hygiene self-care; in the other they used oral hygiene self-care only, with a 1 week washout in between arms. The treatment sequence was randomized. Before and after each study arm Plaque Index (PI), Gingival Index (GI) and Sulcus Bleeding Index (mSBI) were recorded. Clinical plaque staining was quantified using digital image analysis. Saliva production, pH and buffering capacity were recorded. Subjects completed a self-evaluation questionnaire for oral comfort. Enamel samples underwent standardized Knoop microhardness testing to quantify mineralization status. Results: Plaque presence and clinical Plaque Indices decreased significantly with test agent use (p<0.05). Five-minute saliva production almost doubled 10 and 40 minutes after oral test disc insertion (significant, p<0.05). Salivary pH buffering improved in 4/5 subjects with disc use. All demineralized tooth samples re-hardened intraorally (p>0.05). The discs favorably impacted eating problems and dental sensitivity. Subjects were positive about disc flavor and mouth feel. Conclusion: Using established in vivo techniques, the effects of a novel product in xerostomic patients were evaluated and quantified. The adhering disc facilitated eating, reduced dental sensitivity, improved saliva production and buffering capacity, reduced plaque, and alleviated xerostomia symptoms. Clinical relevance: Xerostomia management is challenging. A novel dry mouth disc was effective in alleviating dry mouth symptoms.
Article
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Background: It has been previously demonstrated that patients with reflux esophagitis exhibit a significant impairment in the secretion of salivary protective components versus controls. However, the secretion of salivary protective factors in patients with nonerosive reflux disease (NERD) is not explored. The authors therefore studied the secretion of salivary volume, pH, bicarbonate, nonbicarbonate glycoconjugate, protein, epidermal growth factor (EGF), transforming growth factor alpha (TGF-α) and prostaglandin E2 in patients with NERD and compared with the corresponding values in controls (CTRL). Methods: Salivary secretion was collected during basal condition, mastication and intraesophageal mechanical (tubing, balloon) and chemical (initial saline, acid, acid/pepsin, final saline) stimulations, respectively, mimicking the natural gastroesophageal reflux. Results: Salivary volume, protein and TGF-α outputs in patients with NERD were significantly higher than CTRL during intraesophageal mechanical (P < 0.05) and chemical stimulations (P < 0.05). Salivary bicarbonate was significantly higher in NERD than CTRL group during intraesophageal stimulation with both acid/pepsin (P < 0.05) and saline (P < 0.01). Salivary glycoconjugate secretion was significantly higher in the NERD group than the CTRL group during chewing (P < 0.05), mechanical (P < 0.05) and chemical stimulation (P < 0.01). Salivary EGF secretion was higher in patients with NERD during mechanical stimulation (P < 0.05). Conclusions: Patients with NERD demonstrated a significantly stronger salivary secretory response in terms of volume, bicarbonate, glycoconjugate, protein, EGF and TGF-α than asymptomatic controls. This enhanced salivary esophagoprotection is potentially mediating resistance to the development of endoscopic mucosal changes by gastroesophageal reflux.
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Numerous questionnaires with a wide variety of characteristics have been developed for the assessment of gastroesophageal reflux disease (GERD). Four well-defined dimensions are noticeable in these GERD questionnaires, which are symptoms, response to treatment, diagnosis, and burden on the quality of life of GERD patients. The aim of this review is to develop a complete overview of all available questionnaires, categorized per dimension of the assessment of GERD. A systematic search of the literature up to January 2013 using the Pubmed database and the Embase database, and search of references and conference abstract books were conducted. A total number of 65 questionnaires were extracted and evaluated. Thirty-nine questionnaires were found applicable for the assessment of GERD symptoms, three of which are generic gastrointestinal questionnaires. For the assessment of response to treatment, 14 questionnaires were considered applicable. Seven questionnaires with diagnostic purposes were found. In the assessment of quality of life in GERD patients, 18 questionnaires were found and evaluated. Twenty questionnaires were found to be used for more than one assessment dimension, and eight questionnaires were found for GERD assessment in infants and/or children. A wide variety of GERD questionnaires is available, of which the majority is used for assessment of GERD symptoms. Questionnaires differ in aspects such as design, validation and translations. Also, numerous multidimensional questionnaires are available, of which the Reflux Disease Questionnaire is widely applicable. We provided an overview of GERD questionnaires to aid investigators and clinicians in their search for the most appropriate questionnaire for their specific purposes.
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Objectives: Gastroesophageal reflux disease (GERD) in primary care practice presents symptomatically, and resources to distinguish promptly between erosive esophagitis and endoscopy-negative reflux disease (ENRD) are limited. It is therefore important to determine the roles of proton pump inhibitors and histamine-2-receptor antagonists for first-line symptom-based therapy in patients with erosive esophagitis and ENRD. The aim of this study was to compare pantoprazole 40 mg once daily versus nizatidine 150 mg b.i.d. in a mixed GERD patient population with ENRD or erosive esophagitis (Savary-Miller grades 1-3). Methods: A 4-wk randomized, double-blind, parallel-group, multicenter study conducted in Canada. Eligible patients had experienced GERD symptoms > or = 4 times weekly for > 6 months. Patients were randomized to pantoprazole 40 mg once daily or nizatidine 150 mg b.i.d.. Endoscopy was performed before randomization and after 4 wk of therapy. Results: Of 220 patients randomized to therapy, 208 were available for a modified intent-to-treat analysis. Erosive esophagitis was present in 125 patients; 35 patients were Helicobacter pylori positive. There was complete symptom relief after 7 days of therapy in 14% of patients on nizatidine and in 40% of those on pantoprazole (p < 0.0001), and after 28 days of treatment in 36% and 63% of patients, respectively (p < 0.0001). After 28 days of treatment, adequate heartburn control was reported by 58% of the nizatidine group and in 88% of the pantoprazole (p < 0.0001); erosive esophagitis healing rates were 44% for nizatidine and 79% for pantoprazole (p < 0.001). Rescue antacid was needed by a greater number of patients using nizatidine than of those using pantoprazole (p < 0.001). H. pylori infection was associated with an increased probability of erosive esophagitis healing. Conclusions: Pantoprazole once daily was superior to nizatidine b.i.d. in producing complete heartburn relief in a mixed population of GERD patients and in achieving erosion healing. The proportions of patients with complete symptom relief were greater with pantoprazole after 7 days of therapy than with nizatidine after 28 days. The present study data suggest that pantoprazole is a highly effective first-line therapy for the management of gastroesophageal reflux disease in a primary care practice setting.
Article
Objective: To assess the influence of self-reported intrinsic factors [gastroesophageal reflux disease (GERD), long-term alcoholism, long-term heavy use of alcohol and multiple pregnancies] on erosive tooth wear in a middle-aged cohort sample. Materials and methods: Of the total Northern Finland Birth Cohort (NFBC 1966), a convenience sample (n = 3,181) was invited for an oral health examination in 2012-2013, of which 1,962 participated, comprising the final study group. Erosive tooth wear was assessed by sextants using the Basic Erosive Wear Examination Index (BEWE, 0-18). Clinical data were supplemented by questionnaires conducted in 1997/1998 and 2012/2013. The participants were divided into severe (BEWE sum ≥9) and no-to-moderate (BEWE sum 0-8) erosive wear groups, and the logistic regression model was applied. Results: Selected intrinsic factors were quite rare in this cohort sample and explained only 5.9% of the difference in the prevalence and severity of erosive wear. Daily symptoms of GERD [odds ratio (OR) 3.8, confidence interval (CI) 1.2-12.0] and hyposalivation (OR 3.8, CI 1.2-11.8) were the strongest risk indicators for severe erosive wear. Additionally, variables associated with an elevated risk for severe erosive wear were diagnosed alcoholism at any point (OR 2.5, CI 0.7-9.7) and self-reported heavy use of alcohol in both questionnaires (OR 2.0, CI 0.6-6.2). Even low-dose long-term consumption of alcohol was associated with erosive wear. Conclusions: In this cohort sample, intrinsic factors such as GERD or alcoholism alone are relatively uncommon causes of erosive tooth wear. The role of long-term use of alcohol in the erosion process may be bigger than presumed.
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Taste perception is an important criterion for the state of the oral mucous membrane in patients with gastroesophageal reflux disease. The tongue, as an organ of taste, is characterized by serious changes in the functional state after injury with acid-containing substrates due to reflux. The specific features of taste perception and possibility for their correction were studied in 75 patients with this disorder. The type of changes in activity of tongue taste receptors and taste thresholds in patients before and after therapy were estimated by means of advanced gustometry and functional mobility technique. Specific changes in sensory function of the oral cavity were shown to be associated with acid aggression. Our results illustrate the possibility of taste correction in patients with gastroesophageal reflux disease. Taking into account some features of the general disease, it can be concluded that the introduction of Parodontax-F toothpaste and Emalan into combined therapy is accompanied by the improvement of taste perception. Correction of dysgeusia is an important criterion for the improvement of the quality of life of patients.
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It has been previously demonstrated that the exposure of the lower esophageal mucosa to acid and pepsin results in significant increase in salivary protective factors secretion, mediated by the esophago-salivary reflex. The impact of the upper esophageal mucosal exposure to acid and pepsin on salivary secretory response remains unknown. To investigate the rate of salivary protective factors secretion during the upper esophageal mucosal exposure to acid and pepsin and to compare with the corresponding results recorded during the lower esophageal mucosal exposure, in the same group of asymptomatic volunteers. The study was conducted in 10 asymptomatic volunteers. Salivary samples were collected during the esophageal mucosal exposure to saline, followed by acid/pepsin and the final saline, using the esophageal perfusion catheter. Salivary bicarbonate and non-bicarbonate buffers were analyzed using TitraLab. Salivary mucin and protein were quantified through PAS and Lowry methodologies, respectively, whereas PE2 using radioimmunoassay. Statistical analysis was performed using Σ-Stat software. The rate of salivary bicarbonate secretion was significantly higher (3.1-fold) during the upper versus the lower esophageal mucosal exposure to acid and pepsin (87.5 ± 14.4 vs. 28.0 ± 7.70 μEq/min, p < 0.05). The volumes of saliva, pH, salivary protein, mucin and PE2 were similar in both esophageal perfusions. Threefold stronger secretion of salivary bicarbonate could be a major factor protecting the upper esophageal mucosa. This phenomenon may represent an ultimate defense mechanism potentially preventing further complications within the upper esophageal mucosa; however, it needs to be confirmed in patients of gastroesophageal reflux disease.
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The mainstay of pharmacological therapy for GERD is gastric acid suppression with proton pump inhibitors (PPIs), which are superior to histamine-2 receptor antagonists for healing erosive esophagitis and achieving symptomatic relief. However, up to one-third of patients may not respond to PPI therapy, creating the need for alternative treatments. Potential approaches include transient lower esophageal sphincter relaxation inhibitors, augmentation esophageal defense mechanisms by improving esophageal clearance or enhancing epithelial repair, and modulation of sensory pathways responsible for GERD symptoms. This review discusses the effectiveness of acid suppression and the data on alternative pharmacological approaches for the treatment of GERD.
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Proton pump inhibitors (PPIs) and histamine 2 receptor antagonists (H2RAs) suppress the production of gastric acid and thus may lead to malabsorption of vitamin B12. However, few data exist regarding the associations between long-term exposure to these medications and vitamin B12 deficiency in large population-based studies. To study the association between use of PPIs and H2RAs and vitamin B12 deficiency in a community-based setting in the United States. We evaluated the association between vitamin B12 deficiency and prior use of acid-suppressing medication using a case-control study within the Kaiser Permanente Northern California population. We compared 25,956 patients having incident diagnoses of vitamin B12 deficiency between January 1997 and June 2011 with 184,199 patients without B12 deficiency. Exposures and outcomes were ascertained via electronic pharmacy, laboratory, and diagnostic databases. Risk of vitamin B12 deficiency was estimated using odds ratios (ORs) from conditional logistic regression. Among patients with incident diagnoses of vitamin B12 deficiency, 3120 (12.0%) were dispensed a 2 or more years' supply of PPIs, 1087 (4.2%) were dispensed a 2 or more years' supply of H2RAs (without any PPI use), and 21,749 (83.8%) had not received prescriptions for either PPIs or H2RAs. Among patients without vitamin B12 deficiency, 13,210 (7.2%) were dispensed a 2 or more years' supply of PPIs, 5897 (3.2%) were dispensed a 2 or more years' supply of H2RAs (without any PPI use), and 165,092 (89.6%) had not received prescriptions for either PPIs or H2RAs. Both a 2 or more years' supply of PPIs (OR, 1.65 [95% CI, 1.58-1.73]) and a 2 or more years' supply of H2RAs (OR, 1.25 [95% CI, 1.17-1.34]) were associated with an increased risk for vitamin B12 deficiency. Doses more than 1.5 PPI pills/d were more strongly associated with vitamin B12 deficiency (OR, 1.95 [95% CI, 1.77-2.15]) than were doses less than 0.75 pills/d (OR, 1.63 [95% CI, 1.48-1.78]; P = .007 for interaction). Previous and current gastric acid inhibitor use was significantly associated with the presence of vitamin B12 deficiency. These findings should be considered when balancing the risks and benefits of using these medications.