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From THE AMERICAN JOURNAL OF OTOLOGY/VOLUME 13,
NUMBER 4 July 1992
A NEW MEDICATION TO
CONTROL PATULOUS EUSTACHIAN TUBE DISORDERS
by Joseph R. DiBartolomeo,
M.D., *and David F. Henry, Ph.D.**
The disorder of
hyperpatent Eustachian tube is often unrecognized or misdiagnosed
because of the ambiguous symptom of a “plugged ear.”
But when the patient also complains of autophony and/or hearing
amphoric sounds, a patulous tube should be suspected. Persistent
symptoms are distressing to most patients. This preliminary
report evaluates a new nasal medication that produces closure
of the tube and controls or eliminates these symptoms. It
is demonstrated to be safe, predictable, and effective with
little or no side effects.
Prior to the 19th century, the syndrome of hyperpatent Eustachian tube
was considered a rare disorder. The symptom of a “plugged ear”
was frequently misinterpreted to represent the more common entity, Eustachian
tube obstruction. Over 50 years ago, when it was recognized that if
autophony and/or the awareness of amphoric sounds accompanied by the
sensation of a plugged ear, the tube probably open, the incidence of
diagnosing this condition increased dramatically. Unfortunately, the
success of treatment has yet to be consistent.
The first complete description of the tube connecting the tympanic cavity
with the nasopharynx was reported in 1563 by the anatomist Bartolomeo
Eustachio (1) (1523-1574), in his Epistola de Auditus Organis. Eustachio
believed the tube was normally open and so began a controversy that
persisted for the next two centuries. In 1704 when Valsalva (2) completed
his book, De Aura Humana, he named the tube after Bartolomeo Eustachio.
The theoretic debate over
whether the tube was normally open or closed continued until 1853, when
Toynbee (3) declared that the pharyngeal orifice was normally closed,
but opened during deglutition to permit the inflow of air. In 1861 Politzer
(4) verified this theory by fitting a manometer into the external ear
canal during Toynbee’s maneuver and recording the displacement
of the tympanic membrane resulting from pressure changes within the
Eustachian tube while swallowing.
In 1864, Schwartze (5) published
the first clinical description of the tympanic membrane moving in harmony
with respiration. He observed a scarred atrophic eardrum moving synchronously
with respirations. Within three years Jago (6), who himself had a patulous
Eustachian tube, was first to describe the syndrome complex including
autophony. By also refuting Politzer’s manometer as being unreliable,
Jago supported the anatomists who believed the normal state of the Eustachian
tube lumen to be open and revived the conflict. Finally in 1912 Dionisio
(7) resolved the issue using an endoscope and photoelectric plates to
prove that the tube is normally closed, but opens during swallowing.
In 1953 Metz (8) was the
first to employ and impedance bridge to identify a patulous Eustachian
tube. In 1990, Tolley (9) demonstrated the radiologic findings in the
disorder using computed tomographic imaging.
The incidence of patulous
Eustachian tube has been reported as low as 0.3 percent by Zollner (10)
who studied the general population, and as high as 6.6 percent by Munker
(11), who diagnosed the condition in 100 women with normal ears. In
1960 Suehs (12) reviewed the literature and added 31 of his own patients
seen with this entity during a 7-year period. In 1964, Pulec (13) reported
on 41 cases identified at the Mayo Clinic in 19 years. Once alerted
to suspect the patulous Eustachian tube syndrome when a patient complains
of autophony or amphoric sounds in addition to a plugged ear, clinicians
have been identifying this disorder with greater frequency.
Hyperpatent disorders of
the Eustachian tube may occur in two forms: the patulous Eustachian
tube variant, in which the lumen remains anatomically open, even at
rest; and the semipatulous Eustachian tube, a less severe form, in which
the tube lumen is anatomically closed at rest. Because of low tubal
resistance to airflow, it may open during exercise or in association
with a decrease in peritubal extracellular fluid volume attributable
to disease, exercise, weight loss, or concurrent medical treatment for
PATIENT HISTORY AND SYMPTOMS
It is unfortunate that the sensation of a plugged ear is only an indication
of Eustachian tube disfunction, whether open or closed. Most patients
with an open Eustachian tube complain of autophony. They may also describe
a blowing sound synchronous with each breath or a humming tinnitus,
but they have no “clicks.” It may be aggravated by the sounds
of mastication being transmitted to the ear.
Unfortunately the symptom
of a “blocked ear” is identical to the feeling used to describe
Eustachian tube obstruction, but the patulous patient appears more distressed
by the symptoms described. Patients may also note that their symptoms
are usually absent when they are in the supine position or relieved
when the patient bends forward with the head between the knees.
Predisposing factors include
weight loss, pregnancy, fatigue, or stress. Some symptoms may also be
brought about by exercise or the inappropriate use of nasal decongestants
because of misdiagnosis. When their symptoms are made worse by the medication,
some patients unfortunately are told that they cannot tolerate decongestants
and advised to avoid them in the future.
The diagnosis is visually
confirmed by observing respiratory movements of the eardrum during forced
breathing through one nostril. The syndrome can also be detected when
the physician hears an amphoric sound when listening with a diagnostic
tube in the patient’s ear. This sound is similar to that produced
by blowing across the mouth of an empty bottle.
Patulous Eustachian tube
syndrome should be suspected when a patient complains of a “stopped-up”
ear but, under physical examination, the eardrum is normal in appearance
and demonstrates good mobility, and there is no conductive hearing loss
The otologist should examine
the ear with an operating microscope to detect subtle movements of the
eardrum inward with inspiration and outward with expiration. The excursions
are enhanced by having the patient breather in and out through the nose
with one nostril occluded. Care should be made not to examine the patient
in the supine position, since the extracellular fluid volume around
the Eustachian tube increases in the supine position and may cause the
lumen of the tube to close.
EUSTACHIAN TUBE ANATOMY AND PHYSIOLOGY
In man, the Eustachian tube extends from the anterior wall of the middle
ear into the lateral wall of the nasopharynx. One third of its lateral
(tympanic) length is surrounded by bone, and two thirds of its medial
(pharyngeal) length, by cartilage. The middle ear opening is 2.0 to
2.5 cm higher than the pharyngeal opening. The anatomic disturbance
in hyperpatent disorders and the intended site of medication: tissue
interaction in the pharyngeal end.
The essential function of
the Eustachian tube is to equalize air pressure on the two sided of
the eardrum. It is reported that the normal adult swallows once a minute,
on average, when awake and once every 5 minutes when asleep (14). The
hydrogen ion concentration in normal secretions of the nose and in sinusitis
have been studied. Hilding (15) studied the hydrogen ion concentration
in nasal mucus. The pH readings varied between 7.2 and 8.3 and had a
tendency to change soon after they were collected. In cases of acute
inflammation, the pH of the secretions was acidic whereas in catarrhal
conditions the pH was alkaline (16). Tweedie (17) noted that bacteria
were usually not found in secretions that had a pH of 6.5 or lower.
When in the erect posture,
the minimum pressure change to open the Eustachian tube is approximately
20 mm Hg. The resistance of the tube is further decreased by exercise.
PREVIOUS MEDICAL AND SURGICAL THERAPY
Most of the early forms of medical therapy were poorly tolerated, produced
inconsistent results, or required surgical intervention. Generally,
they fall into five categories:
1. Attempts to narrow the
lumen by an inflammatory response or scar tissue—Bezold’s
(18) salicylic acid/boric acid powder (1:4 ratio), nitric acid and
phenol (19), 20 percent silver nitrate (20), diathermy.
2. Attempts to narrow the lumen by compression—paraffin (21),
Teflon (22), or gelatin sponge injections.
3. Myringotomy and insertion of tube (23).
4. Attempts to alter function of the palatal muscles (24) with or
without pterygoid hamulotomy, tensor palatini tendon rerouting (25).
5. Extracellular fluid—increase or regain lost weight, avoid
diuretics, recline or lower head when symptoms occur.
IMPETUS AND RATIONALE FOR NASAL MEDICATION FORMULA
Since beginning practice in 1968, I was unable to find a medical treatment
for the patulous Eustachian tube syndrome that would yield consistent
results. In 1989 I examined several patients within the same week complaining
of a plugged ear attributed to Eustachian tube congestion precipitated
by swimming in a public pool. Such a history is not uncommon. On the
following day I happened to read a paper by Spencer (26) in which he
reported on the linear relationship between Eustachian tube congestion
and the frequency of swimming in a public pool, in several of his patients.
He suspected that the pool water contained an irritant and the “obvious
candidate was chlorine.”
The following day another
patient complained of a plugged ear, but was more disturbed by autophony.
Examination revealed a patulous Eustachian tube. Because of the experience
earlier in the week, I wondered if one treatment for patulous tube syndrome
might be to swim in public pools.
Instead, the components of
chlorinated water and pool chemicals were analyzed in an attempt to
identify a single safe factor that could produce localized and predictable
congestion of the Eustachian tube mucosa. Sodium hypochlorite, a disinfectant,
was found to be a mucosal irritant and was not tolerated well by volunteer
subjects. There were also problems with the chlorine gas gradually being
released and blowing off the cap of the medicine bottle. The second
chemical studied for its effect on mucous membrane was hydrochloric
acid. Several changes in composition, concentration, and dilution were
tested and evaluated by the first author, who himself has a patulous
Eustachian tube. Finally, a formula was discovered that was well tolerated
and could dependably cause mucous membrane congestion with little or
no side effects. A mild antiseptic was added to eliminate the possibility
of contamination, and a topical anesthetic, to reduce or eliminate the
secretory response associated with topical medications.
After numerous changes in
the composition of the nasal medication, a formula (patent pending,
developed by J. DiBartolomeo, M.D.) containing diluted hydrochloric
acid, chlorobutanol, and benzyl alcohol was determined to produce the
most predictable, favorable results with little or no side effects and
was used in this study.
To assess the effectiveness of the new formula for treating the symptoms
of patulous Eustachian tube, 41 patients with the diagnosis of hyperpatent
Eustachian tube syndrome were evaluated. Patients selected had to be
free of other diseases that could affect Eustachian function, have symptoms
continuous for at least three months, and not be subject to frequent
weight fluctuations. Thirteen patients were excluded because of other
disease (i.e. Wegener’s granulomatosis, cleft palate, stroke,
Hodgkin’s disease of the head and neck area, nasal polyps, or
significant nasal septum deviation). Another fifteen patients were excluded
from the study because their symptoms were quite intermittent, they
already had peritubal injections, or their symptoms correlated with
temporomandibular joint positioning.
METHODS AND MATERIALS
Ten patients were documented to have a continuous history of a plugged
or stopped-up ear and autophony for at least three months. Six had bilateral
patulous tube symptoms. Otologic examination confirmed that the tympanic
membrane movement occurred medially and laterally in synchrony with
breathing with one nostril occluded. The movement of the tympanic membrane
in synchrony with respirations was observed through the surgical microscope
and recorded on videotape.
To provide a quantitative
measurement and graphic record of the movement of the eardrum with respirations,
a Virtual Model 310 digital impedance system connected to a Macintosh
SE/30 admittance tympanometer was used. Testing of the patulous Eustachian
tube was conducted in the acoustic reflex adaptation mode with the tone
being at 60 dB HL, which is the lowest possible, to minimize the possibility
of acoustic reflexes being generated. Testing in this mode allowed measurement
of admittance changes over a 20-second period with the unit set in its
most sensitive mode. For the baseline measurement, the patient was asked
to sit quietly and breathe quietly through the mouth. Then the subject
was asked to breathe deeply several times, first through both nostrils
and, on subsequent trials, through one nostril. Breathing vigorously
and deeply increases intraoral pressure; even more so if one nostril
is occluded. A positive test was obtained when large changes in admittance
are observed in conjunction with either inspiration or expiration of
air through the nostrils. Progress of treatment was monitored by the
Each patient was given the
same protocol to follow. This included a flow chart to record the daily
responses, tolerance, and side effects. On the day that the medication
was to be taken, it was administered between 10:00 a.m. and noon, when
symptoms usually occurred. The nose drops were taken in the Proetz position.
The patient inhaled two drops of the nasal medication into the nostril
closest to the ear being treated. If necessary, a second dose was administered
approximately six hours later. The medication was taken consecutively
for four days, but not on days five and six. This six-day cycle was
repeated five times, a total of thirty days for each course, then the
patient returned to the office for an examination of the ear and nasopharynx.
The effectiveness of the medication in relieving the patient’s
symptoms, any side effects, and the duration of the relief were recorded.
Eight of the ten patients reported excellent results (complete elimination
of symptoms) with no side effects. Their symptoms are no longer continuous
and the medication is now taken as needed. Two patients reported satisfactory
results (control of symptoms), but both complained of slight irritation
of the nose and mild rhinorrhea. One of the eight patients also noted
an increased tolerance to noise, and his audiogram demonstrated an improvement
of the auditory thresholds at 250 Hz.
Follow-up inspection of the
Eustachian tube orifice in each patient confirmed the mucous membrane
to be normal in appearance and color, and covered by clear mucous.
Hyperpatent Eustachian tube disorders are more common than has previously
been recognized. The patient complaining of a “plugged ear”
should be questioned about autophony and amphoric sounds that are relieved
by lying down.
When the tympanic membrane
is observed to move inward and outward with inspiration and expiration
through one nostril, the diagnosis is irrefutable.
When conventional tympanometry
is performed, the equipment may not be designed to indicate the respiratory
excursions or they may be minimal. Admittance tympanometry, capable
of recording real-time changes and generating a graph, is helpful when
symptoms are vague and tympanic membrane movement questionable.
This project evaluated a
new medication developed to produce closure of the tube orifice and
thereby eliminate the symptoms. The results of the study demonstrated
that the medication is effective for treating patulous Eustachian tube
disorders. It is safe, effective, predictable, well tolerated, and titratable,
with little or no side effects.
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(24) Vertanen H, Plava T: Surgical treatment
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This project was supported
in part by The Ear Foundation in Santa Barbara.
Professor, Dept. of Head and Neck Surgery, UCLA; Medical Director, The
Ear Foundation of Santa Barbara
**Director of Hearing and Vestibular Laboratory, The Ear Foundation
of Santa Barbara
Presented at the 26th Annual Meeting of the
American Neurotology Society, Waikoloa, Hawaii, May 4-5, 1991
Reprint requests: Joseph
DiBartolomeo, M.D., 2420 Castillo Street, Santa Barbara, CA 93105-4346
by the American Journal of Otology, Inc. All rights reserved.