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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 another condition.
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 demonstrated.
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 tympanogram record.
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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This project was supported in part by The Ear Foundation in Santa Barbara.
*Associate Clinical 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
© 1992 by the American Journal of Otology, Inc. All rights reserved.