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DRY MOUTH - A New Treatment Choice |
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DRY MOUTH—
A New Treatment Choice
by Michel A. Boileau, M.D. and Dorothy B. Smith, R.N., M.S., FAAN
Treatment with a new formulation of
a simple carbohydrate provides significant
relief for dry mouth sufferers.
The symptom of oral dryness, termed
xerostomia, is a troublesome complaint and
growing more common as our population
ages. It has been estimated that 20 percent or
more of older adults report frequent dry
mouth. An increasing prevalence of xerostomia
is correlated with use of an increasing number
of medications and medical conditions. While
everyone has dry mouth occasionally, as many
as 25 million Americans may suffer from
persistent feelings of oral dryness.
Although this is a distressing symptom, it
takes on greater significance since xerostomia is
most often a result of salivary gland dysfunction.
This condition entails more than just
unpleasant symptoms. Salivary gland
dysfunction can lead to significant alterations
of oral health and functions. Patients may
experience such problems as rapid and severe
dental decay, an increase in oral infections,
pain and sensitivity of the oral mucosal and
decreased taste. In addition, there may be significant
difficulties with critical oral functions
which are supported by saliva, such as
chewing and swallowing. This in turn can
compromise nutrition.
Dryness of the mouth can also interfere
with speaking. Many dry mouth patients avoid
social interactions because of difficulties speaking
or eating. Consequently, oral dryness can
have a marked effect on quality of life, as well
as health.
There are numerous causes of occasional
and chronic dry mouth. Dehydration and oral
sensory disturbances can lead to sensations of
oral mucosal dryness even in the presence
adequate saliva. Hundreds of drugs are known
to cause dry mouth. Antidepressants, antihistamines
and certain antihypertensives are
prominent examples. The severity of oral
dryness complicates drug therapy and may
lead patients to stop necessary medications.
Dry mouth is also caused by medical treatments
which affect the salivary glands, such as
radiation therapy to the head and neck area
and bone marrow transplantation. Almost all
of the more than 35,000 persons who receive
head and neck radiation yearly experience persistent
dry mouth.
Other major causes of dry mouth symptoms
are numerous systemic diseases. These
include viral infections, thyroid disease,
hepatic disease and autoimmune disorders.
Prominent among the latter as a cause of often
severe xerostomia is Sjögren’s syndrome, an
autoimmune disease of fluid-secreting glands
which may affect as many as four million persons
in the United States. It is characterized by
salivary and lacrimal gland dysfunction that
leads to complaints of dry mouth and dry eyes.
This disorder primarily affects women, with
nearly 90 percent of all subjects being female.
The diagnosis is usually made in the peri- or
post-menopausal period, although the onset of
disease typically occurs many years earlier. The
condition may present in conjunction with
another connective tissue disease such as
rheumatoid arthritis, systemic lupus erythematosus
or primary biliary cirrhosis, in which
case it is called secondary Sjögren’s syndrome.
When it is the sole autoimmune condition, it
is termed primary Sjögren’s syndrome. Patients
with both primary and secondary Sjögren’s
syndrome have persistent and significant dry
mouth. This is a defining symptom of the disorder
and it is often the most troubling aspect
of the condition for patients. Dysfunction
generally is more severe in patients with the
primary form of the disorder.
Management of dry mouth is often unsatisfactory.
Preventive measures such as use of
supplemental fluoride, avoidance of sucrose
and medications known to cause a dry mouth
and frequent dental checkups are recommended.
Artificial saliva, topical stimulation of
salivation (for example with chewing gum) or
frequent ingestion of liquids may provide
symptomatic benefit of short duration for
some subjects. Pharmacologic agents designed
to increase salivary flow (secretogogues),
including pilocarpine and cevimeline, have
been tested in dry mouth patients. Although
they have been shown to reduce dryness symptoms
and to increase salivary output transiently,
none has demonstrated sustained benefit in
controlled clinical trials. Side effects associated
with these agents limit their use also. With so
many potential causes of dry mouth, effective,
easily administered therapies for dry mouth
with minimal side effects are clearly needed.
Over the past five years two research
studies have been conducted on the potential
of Salive™ a nutritional substance derived
from anhydrous crystalline maltose. Salive
lozenges administered 12 or 24 weeks
improved salivary function and improved dryness
symptoms in patients with primary
Sjögren’s syndrome. Recently a third study was
conducted regarding the safety and efficacy of
Salive™ lozenges in improving salivary function
and reducing dry mouth complaints in
Sjögren’s syndrome patients. This study evaluated
the effects of Salive™ on objectively
measured salivary function, subjective measures
of oral and ocular comfort and safety. This
report confirms the benefits found in the earlier
studies.
Salive™ was administered orally as a small
lozenge (about the size of a baby aspirin) given
three times daily over a 24-week period to a
total of 100 subjects. The lozenge was allowed
to dissolve in the mouth, which took three to
five minutes. All participants had prominent
complaints of persistent dry mouth associated
with a confirmed diagnosis of primary
Sjögren’s syndrome. The patients were seen in
outpatient clinics at a total of 27 sites within
the United States.
Patients were examined at the initiation of
the study and every six weeks during
treatment. Unstimulated whole saliva (UWS)
output, a measure of the resting salivary gland
capability, was determined at each visit. UWS is
an important measure because it represents the
function of the salivary glands for about 90
percent of the day. Unstimulated saliva provides
protection for the oral cavity and is most
responsible for feelings of oral comfort
throughout the day. Symptoms associated with
oral and ocular dryness were assessed at the
same time with the use of standardized questionnaires
and visual analogue scales (VAS).
VAS are a means to measure accurately subjective
impressions. These are constructed by
having the patient put a mark on a line of a
specific length denoting the intensity of the
symptom. At either end of the line are descriptors
which define the worst (on the left) or the
best (on the right) possibility for this symptom.
Later the position of the mark on the line
is measured from the left end. Therefore an
increase in the score correlates with an
improvement in the symptom. Side effects were recorded and safety was assessed by
physical examination and laboratory studies. The
results were tabulated and analyzed
statistically.
During this clinical trial a majority of evaluable
subjects demonstrated an increase in
unstimulated whole saliva output. The group
also showed significant improvements in a number
of dryness symptoms. Mean scores for oral
dryness, oral comfort, eye dryness, eye burning,
throat dryness and ability to swallow dry food
were significantly improved.
The Salive™ treatment exhibited an excellent
safety profile. Mean values for 32 laboratory
variables started and remained within normal
ranges throughout treatment. There were no
serious adverse events. Patients tolerated the
Salive™ lozenges very well, most describing the
flavor as pleasant and slightly sweet.
What distinguishes this treatment from other
reported dry mouth therapies is the
finding of actual increases in salivary function
accompanying the symptomatic improvement.
Over half of the patients experienced an increase
in UWS output after 24 weeks of Salive™ three
times a day. UWS is a measure of basal secretory
function. The saliva collection was not made in
conjunction with administration of the lozenge,
which would reflect function in response to gustatory
or masticatory stimuli. Patients ingested
nothing by mouth for at least 60 minutes before
UWS collections.
The mechanism by which small amounts of
orally administered Salive™ exert biologic
actions remains unclear. It is possible that
Salive™ may interact with the immune system
in a number of ways. It is known that many bacteria
have receptors for maltose. While direct evidence
is not available, we speculate that orally
administered Salive™ may bind to maltose
receptor-bearing bacteria in the oropharynx
before being swallowed; this could presumably
act as the initiator of a cascade of events resulting
in increased immunologic activity. It is also possible
that Salive™ may bind to other immunologically
active cells within the oropharyngeal
region, such as neutrophils, T cells, and dendritic
cells, leading to enhanced immuno-reactivity.
In conclusion, lozenges containing 200 mg of
Salive™ given three times daily for 24 weeks to
subjects with dry mouth related to primary
Sjögren’s syndrome led to a significant reduction
in dry mouth symptoms. The Salive™ dose
administered in this study was well tolerated and
was not associated with significant side effects.
These results were quite consistent with observations
from two previous studies. This safe and
simple therapy appears to provide
significant benefit to patients with symptoms of
dry mouth, whether occasional or chronic.
What is dry mouth?
Dry mouth is the condition of not having enough saliva, or spit, to keep the mouth wet.
What do I need to know about dry mouth?
Everyone has dry mouth once in a while, especially if they are nervous, upset or under stress.
But if you have a dry mouth all or most of the time, it can be uncomfortable and can lead
to serious health problems.
Dry mouth is not a normal part of aging so if you think you have dry mouth, see your
dentist or physician. There are things you can do to get relief.
Dry mouth can cause difficulties in tasting, chewing, swallowing and speaking. It can
increase your chance of developing dental decay and other infections in the mouth. It can be
a sign of certain diseases and conditions and can be caused by certain medications or medical
treatments.
What are the symptoms of dry mouth?
Symptoms may include a sticky dry feeling in the mouth, trouble chewing, swallowing, tasting,
speaking or a burning feeling in the mouth. May also be a dry feeling in the throat,
cracked lips, a dry, tough tongue, mouth sores or an infection in the mouth.
Why is saliva so important?
Saliva does more than keep the mouth wet. It helps digest food. It protects teeth from decay.
It prevents infection by controlling bacteria and fungi in the mouth. It makes it possible for
you to chew and swallow.
Without enough saliva you can develop tooth decay or other infections in the mouth.
You also might not get the nutrients you need if you cannot chew and swallow certain foods.
What causes dry mouth?
People get dry mouth when the glands that make saliva in the mouth are not working properly.
Because of this there might not be enough saliva to keep your mouth wet. There are
several reasons why the glands (called salivary glands) might not work right.
- Side effects of some medicine. More than 400 medicines can cause the salivary glands to make less saliva. Medicines for high blood pressure and depression often cause dry mouth.
- Disease. Some diseases affect the salivary glands Sjögren’s syndrome, HIV/AIDS, diabetes and Parkinson’s disease can all cause dry mouth.
- Radiation therapy. The salivary glands can be damaged if they are exposed to radiation during cancer treatment.
- Chemotherapy. Drugs used to treat cancer can make saliva thicker, causing the mouth to feel dry.
- Nerve damage. Injury to the head or neck can damage the nerves that tell salivary glands to make saliva.
What can be done about dry mouth?
Dry mouth treatment will depend on what is causing the problem. If you think you have dry
mouth, see your dentist or physician. He or she can try to determine what is causing it.
If your dry mouth is caused by your medicine, your physician might change it or adjust
the dosage.
If your salivary glands are not working right but can still produce some saliva, your
physician or dentist might give you a medicine (called pilocarpine) that helps the glands
work better.
Your physician or dentist might suggest that you use artificial saliva to keep your
mouth wet.
What can I do?
- Sip water or sugarless drinks often.
- Avoid drinks with caffeine such as coffee, tea and some sodas.
- Sip water or a sugarless drink during meals. This will make chewing and swallowing easier.
- It may also improve the taste of food.
- Chew on sugarless gum or suck on sugarless hard candy to stimulate saliva flow; citrus, cinnamon or mint-flavored candies are good choices.
- Don’t use tobacco or alcohol.
- Be aware that spicy or salty foods may cause pain in a dry mouth.
- Use a humidifier at night.
Source: NIH Pub. No. 99-3174.
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