Otology & Neurotology 36:1593–1600 ß 2015, Otology & Neurotology, Inc.
Treatment Effectiveness for Symptoms of Patulous Eustachian Tube: A Systematic Review Kimberly Luu, Andrew Remillard, yMarcela Fandino, zAlexander Saxby, and Brian D. Westerberg Division of Otolaryngology–Head and Neck Surgery, B.C. Rotary Hearing and Balance Clinic, University of British Columbia, Vancouver, British Columbia, Canada; yCardiovascular Foundation of Colombia, Bucaramanga, Santander, Colombia; and zRoyal Prince Alfred Hospital, Sydney, New South Wales, Australia
Objectives: To determine the effectiveness of currently available medical and surgical interventions for treating symptoms of Patulous Eustachian Tube (PET). Data Sources: A comprehensive search of MEDLINE (January 1948 to July 8, 2015), EMBASE (January 1974 to July 8, 2015), gray literature, hand searches, and cross-reference checking. Study Selection: Original published reports evaluating an intervention to treat the symptoms of patulous eustachian tube in patients 18 years and older. Data Extraction: Quality-of-case reviews were assessed with the National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Data Synthesis: The search strategy identified 1,104 unique titles; 39 articles with 533 patients are included. The available
evidence consists of small case series and case reports. The most common medical treatment was nasal instillation of normal saline. Surgical treatments were categorized as mass loading of the tympanic membrane, eustachian tube plugging, and manipulation of eustachian tube musculature. Conclusions: The available evidence for management of patients with PET is poor in quality and consists predominantly of small case series. Further research is needed to determine the comparative efficacy of the current treatments. Key Words: Auditory perceptual disorders— Auditory tube—Auditory tube dysfunction—Autophony— Eustachian tube—Medical treatment—Patulous Eustachian tube—Surgical treatment.
The Eustachian tube (ET) allows pressure equalization between the mesotympanum and nasopharynx, maintaining the health of the middle ear space. The cartilaginous ET mucosal surfaces are normally in contact during the resting state, closing the orifice (1). Patulous eustachian tube (PET) is an abnormal patency of the ET that affects 0.3% to 6.6% of people (2). Patients usually report symptoms such as autophony (perception of one’s own voice), hearing physiologic sounds at an increased level, and aural fullness (3). This autophony is often intermittent and relieved in the supine position. Physical examination often reveals synchronous movement of the tympanic membrane with respiration. A number of additional tests have been used to try to strengthen the ability to diagnose PET (CT scan, tympanometry, sonotubonometry, or direct nasopharyngoscopy) (4). However, the diagnosis of PET remains a clinical diagnosis based on symptoms
and/or visualization of movement of the tympanic membrane with respiration. Several theories have been proposed for the etiology of PET, including loss of tissue within the cartilaginous portion of ET (weight loss, pregnancy, use of high-dose oral contraceptives, and estrogen therapy) and atrophy or scarring within the nasopharynx or involving the musculature associated with ET function (adenoidectomy, radiation therapy, poliomyelitis, and other iatrogenic trauma) (3,5,6). Treatments include conservative measures such as weight gain, to medical treatment with nasal topical application of various solutions, to surgical procedures that generally increase the bulk around the eustachian tube orifice. Literature reviews have been included in articles that discuss PET management options, but none systematically or comprehensively covers all the treatment options. Hussein et al. (7) recently published a review of surgical treatment options, but did not look at medical treatments. The number of different treatment options highlights that there is no single effective treatment for symptoms of PET. The results of the studies have been variable and thus, no general consensus on management exists.
Otol Neurotol 36:1593–1600, 2015.
Address correspondence and reprint requests to Dr. Brian D. Westerberg, M.D., B. C. Rotary Hearing and Balance Centre at St Paul’s Hospital, Providence 2, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; E-mail: [email protected] No financial support was received in producing this article. The authors disclose no conflicts of interest.
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The primary objective of this systematic review was to determine the effectiveness of interventions for symptoms of patulous eustachian tube described in the literature of all reported medical and surgical modalities reported in case series, cohort studies, and randomized control trials. The secondary objective was to evaluate the safety of the above interventions through summarizing the number of reported adverse events. Given the lack of a standard definition of the condition based on characteristic findings on investigations, we chose to use a symptom-based definition of PET when selecting studies for inclusion reporting patients with PET. MATERIALS AND METHODS Research methods were documented in the research protocol a priori. The PRISMA guidelines were followed (8). The study protocol was peer reviewed by the University of British Columbia Division of Otolaryngology–Head and Neck Surgery Research Committee. For inclusion in this review, studies had to be original published reports evaluating any intervention to treat the symptoms of PET in patients 18 years and older. All levels of study types of any surgical or medical treatment were included. No minimum follow-up was required, however follow-up time was recorded. Studies explicitly stated a diagnosis of patulous eustachian tube based on clinical assessment in their test subjects. Symptoms of autophony, aural fullness, and hearing bodily sounds and/or documentation of synchronous tympanic membrane movement were attributed to this etiology. The primary outcome extracted for each intervention was the proportion of patients who experienced subjective improvement or resolution of their constellation of symptoms of PET based on the study authors’ opinion. The secondary outcome was the rate and type of complications attributed to the therapy. Adverse events included intraoperative or postoperative complications and were included if noted in the studies. Studies including pregnant patients or patients with significant weight loss that did not include a specific intervention other than weight gain or birth were excluded. Nonhuman and non-English studies were excluded; exclusion of non-English articles has been shown to have minimal impact on review conclusions (9). Two authors (K.L./A.R.) independently reviewed titles and abstracts, read full text articles, extracted data, and assessed study quality. Disagreements were resolved by consensus. A third author (M.F.) resolved disagreements between reviewers when consensus was not possible. We searched MEDLINE (January 1948 to July 8, 2015) and EMBASE databases (January 1974 to July 8, 2015) (Table 1). A hand search of PubMed and Google scholar was done to verify search results and to identify articles supporting historical TABLE 1. EMBASE
MEDLINE
treatments. Cross-reference checking and related article search, gray literature search of Google scholar, National Institute of Health, and Worldcat was also performed. Data extracted included: study type, criteria for diagnosis of PET, demographic characteristics of patients, treatment type, treatment effect, and adverse events. Other diagnostic criteria such as electroacoustic impedence tests, nasal audiometry, transnasal endoscopic examination, and radiologic imaging were recorded when documented. Meta analysis of the results was not attempted given the heterogeneity in design and reporting of data in each study. The Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence (OCEBM) table was used to determine the level of evidence of each article (10). As there were no randomized studies, quality of articles with more than seven subjects was assessed using the National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies (11). This scale assesses the quality of a article on the basis of selection, comparability, and exposure giving studies a score out of nine. Series of less than seven subjects were considered low quality but included to give a comprehensive overview of the treatment options being reported.
RESULTS The search strategy identified 1,513 titles (1,086 EMBASE, 295 MEDLINE). After removing 409 duplicates, a total of 1,104 titles and abstracts were reviewed by two independent reviewers (K.L./A.R.) (Fig. 1). Sixty-two articles underwent full text review. Thirty-six articles were eventually included with very good agreement between reviewers (k ¼ 0.91, 95% CI 0.878–0.958). A third reviewer resolved discrepancies in three studies. Three additional articles from cross-reference checking and gray literature were found. A total of 39 articles were included. There was no randomized control or cohort studies found on the treatment of patients with symptoms related to PET. The 39 studies included in this article did not rise above the case series or fourth OCEBM level of evidence (see Tables 2–5). Effect of Medical Interventions Five articles described various topical intranasal and intratubal/intratympanic administrations for the treatment of patients with symptoms of PET (Table 2). Saline was the most commonly used topical treatment, but historical formulas such as salicylic and boric acid powder (in a 1:4 proportion), diluted hydrochloric acid, Search strategy
(exp Eustachian tube/ OR pharyngotympanic tube.mp. OR eustachian.mp. OR auditory tube.mp. OR tympanic membrane/ OR eardrum.mp. OR exp ear, middle/ OR hearing disorders/ OR auditory perceptual disorders/ OR auditory tube dysfunction.mp.) AND (patulous.mp. OR patent.mp. OR autophon.mp. OR dilatation, pathologic/ OR dilatation/ OR eustachian tube.mp. OR patent eustachian tube.mp.) Limits: English language and humans and (‘‘young adult and adult (19–24 and 19–44)’’ or ‘‘middle aged (45 plus years)’’ or ‘‘all aged (65 and over)’’) (exp auditory tube/ OR pharyngotympanic tube.mp. OR eustachian tube.mp. OR eustachian.mp. OR patulous eustachian disorder.mp. OR exp eardrum/ OR tympanic membrane.mp. OR exp middle ear/ OR tympanic cavity.mp. OR tympanum.mp. OR exp ear disease/ OR exp perception deafness) AND (autophon.mp. OR patulous.mp. OR patent.mp. OR pathologic dilatation.mp. OR dilatation.mp. OR exp auditory tube dysfunction) Limits: human and English language and (adult or aged )
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Irritation from solution
None reported
100% (n ¼ 27)
100% (n ¼ 12) Reported symptoms
Reported symptoms
12 RCS Moore (8) 1951
4
27 RCS Miller (7) 1961
2
6 (8 ears) 1 PCS Case report
N/A N/A
10 6 PCS
DiBartolomea (4) 1992 Morita (5) 1988 Bhide (6) 1976
PCS indicates prospective case series; RCS, retrospective case series. Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
None reported None reported Reported symptoms Reported symptoms
Reported symptoms
80% (n ¼ 8)
20% (n ¼ 2) 100% (n ¼ 6) 100% (n ¼ 1)
None reported Acute cochlearvestibular deficit (vertigo and SNHL) when drops instilled into ear 2 rhinorrhea and nasal irritation 17.3% (n ¼ 9) 46.2% (n ¼ 24) Reported symptoms Reported symptoms RCS Case report Oshima (2) 2010 Boudewyn (3) 2001
7 N/A
52 1
Sniffing resolution
Instruction to stop sniffing þ nasal saline instillation Nasal saline instillation Saturated potassium iodide solution (60 g potassium iodide in 42 g water), 20 drops daily through tympanostomy tubes Diluted hydrochloric acid þ chlorobutanol, benzyl alcohol nasal drops Intratubal atropine 1:4 salicylic: boric acid powder through tympanostomy tubes Boric and salicylic acid powder insufflated directly into the torus tubarius Insufflation of salicylic acid powder and boric acid powder 1:4 proportions 3
35 (63 ears)
Outcome Quality
Subjects
Treatment
RCS
Mass Loading of Tympanic Membrane The symptoms of PET are postulated to arise from tympanic membrane movement, thus techniques to
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Ikeda (1) 2011
Effect of Surgical Interventions Surgical intervention is grouped by the procedure type including mass loading of tympanic membrane; ET occlusion through plugging the ET, cautery of the ET orifice, or material injection; muscle ligation or transposition; and combination approaches.
Study Type
chlorobutanol, and benzyl alcohol and saturated potassium iodide solution have been studied (2,12–17). All articles, but one, used resolution of all symptoms to assess the treatment. Results ranged from 63.5% to 100% partial or full resolution of symptoms. Ikeda evaluated patients with PET who had developed habitual sniffing to relieve their symptoms (1). Outcome was measured as resolution of sniffing, although patients were also specifically instructed to stop sniffing. The true effect of the saline is questioned, as despite improvement in symptoms, studies reported patients who continued to show tympanic membrane movement with respiration (1). Furthermore, results are confounded by the placement of tympanostomy tubes to instill the drops. There were no reported adverse events with saline drops but one patient developed a cochleovestibular deficit from topical instillation of Boudewyn’s potassium iodine solution (3). Although nasal estrogen cream was a referenced treatment (18), neither our search strategy nor a subsequent hand search could identify an original publication despite it being a common historical treatment for PET. Evidence to support the effectiveness of this treatment modality is anecdotal.
Author Year
FIG. 1. Study flow diagram.
TABLE 2. Medical treatment techniques
% Complete Resolution
% Partial Resolution
Adverse Events
None reported 65.7% (n ¼ 23)
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K. LUU ET AL. TABLE 3. Tympanic membrane mass loading treatment techniques
Author Year
Study Type Quality
Brace (9) 2014
RCS
8
Ikeda (1) 2011 Boedts (10) 2014 Bartlett (11) 2010 Chen (12) 1990
RCS RCS
4 7
PCS
7
RCS
5
Thaler (13) 1966
RCS
N/A
Subjects
Treatment
10(15)
Resurface TM with KTP laser 10(11) Cartilage tuboplasty 8 ears Ventilation tubes 21 (33 ears) Paper patch on TM 14
Mass loading of TM with blue tack 46 (60 ears) Ventilation tubes
4
Outcome Reported symptoms, tympanometry Reported symptoms Reported symptoms Reported symptoms Reported symptoms
Short, double flanged, Reported symptoms polyethylene tube
% Complete Resolution
% Partial Resolution
46.7 % (n ¼ 7)
Adverse Events Not mentioned
72.7 % (n ¼ 8) 75% (n ¼ 6) 25% (n ¼ 2) 76.2 % (n ¼ 16) Discomfort with drying patch 78.6% (n ¼ 11) 1 dislodged tac 53.3% (n ¼ 32) 75% (n ¼ 3)
2 otorrhoea 2 persistent perforation 25% (n ¼ 1) 1 AOM
PCS indicates prospective case series; RCS, retrospective case series. Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
weigh down the TM have been attempted (Table 3). Tympanostomy tube insertion was the most frequently described method, with three case series identified (12,19,20). Results ranged from 53% to 100% of patients achieving partial or full resolution of symptoms. Adverse events in these series included temporary otorrhea, persistent perforation, and acute otitis media. Mass loading the tympanic membrane with blue tack was reported in a prospective case series of 14 patients (21). The duration of the relief ranged from 2 weeks to 4 months with some patients receiving repeated procedures. There were no adverse events; however hearing thresholds were not reported. Most recently, a study using tympanic membrane paper patches reported complete relief in 76.2% of patients (n ¼ 16) (22). Patches dislodged in 1 to 2 months. Interestingly, once dislodged, only 50% of patients experienced a return of symptoms treated with reapplications. An unspecified number of patients complained of discomfort when the paper patches dried, relieved by moistening or removal of the patch. Patients responding to the blue tack were enrolled in a subsequent study to more permanently augment the TM with laser resurfacing or cartilage tuboplasty with variable results (see Table 3) (23). Eustachian Tube Occlusion To prevent the movement of air through an abnormally open ET, transtympanic or transoral occlusion of the ET opening has been attempted (Table 4). This is accomplished with ET plugging, suture ligation or cautery of the ET orifice, or injection of bulking substance at the ET orifice. A variable number of patients additionally underwent tympanostomy tube insertion in the treated ears, again confounding results. Eustachian Tube Plugging Eight studies looked at plugging the ET. The devices used included: intravenous angiocatheter, silicone plug, fat grafting, and ligation of the ET orifice (12,24–30). Access to the ET was through a tympanomeatal flap or
nasal endoscopy. Each study used patient symptoms as the outcome of interest. Again, to prevent middle ear complications, many studies placed a tympanostomy tube at the time of the procedure, confounding the results. Eustachian Tube Cautery Three studies investigated cautery of the ET orifice to promote inflammation and scarring. Cautery was done with either silver nitrate or diathermy (3,31). Patients in the two studies done in the 1980s received multiple treatments during an unclear timeframe. In a novel technique, Yanez described 11 patients who were endoscopically treated with KTP laser assisted curvature inversion of the medial and lateral lamina of the Eustachian tube to alter the shape of the posterior cushion, reporting moderate success over a 24-month follow-up (32). Serous otitis media was reported as a complication in three patients. Eustachian Tube Injection Eleven studies looked at injection of the ET orifice as a method of occlusion. Injection material included: Teflon, silicone, cartilage, gelatin sponge, calcium hydroxylapatite, and a polytef paste (33–42). The manufacturer of polytef paste has since advised against these injections because of a report of cerebral thrombosis and death resulting from injection into the internal carotid artery. Poe proposed a PET reconstruction technique with the placement of cartilage graft and subsequently alloderm around the ET orifice (39). Bleeding from the septal graft harvest site and other technical challenges prompted the authors to switch to alloderm. Injection of Radiesse by Wolraich was confounded by patient comorbid conditions such as recent weight loss, previous surgeries, and botulinum toxin injection for palatal myoclonus (38). Muscular Transposition/Ligation/Inactivation Alterations to the tensor veli palatini muscle may potentially decrease the patency of the ET orifice. Methods to alter the musculature of the eustachian tube
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TABLE 4. Author Year
Study Type
Eustachian tube occlusion: Plugging Rotenberg PCS (14) 2014
Adverse Events
Reported symptoms and Autophony score (1–5)
85.7 (n ¼ 6)
14.3 (n ¼ 1)
None
Reported symptoms and Autophony score (1–5)
92.8% (n ¼ 13)
1 Epistaxis
Reported symptoms
100% (n ¼ 13)
1 Middle ear effusion
Reported symptoms; Synchronous TM movement Reported symptoms; Sonotubometry
52.4% (n ¼ 22)
Complete closure of ET at nasopharyngeal orifice (cautery of the internal circumference of the ET orifice, fat graft, further electrocautery) and tympanostomy tubes Transcanal insertion of an angio-catheter into the ET via tympanomeatal flap and tympanostomy tube Transtympanic insertion of IV indwelling catheter through a tympanotomy and tympanostomy tube
Reported symptoms
100% (n ¼ 2)
1 temporary OME 1 infection 1 odynophagia 3 revision operations None reported
Reported symptoms
100% (n ¼ 1)
None reported
Reported symptoms
100% (n ¼ 4)
None reported
Unilateral or bilateral curvature inversion tubuloplasty Eustachian tube diathermy 20% silver nitrate cautery
Reported symptoms
72.7% (n ¼ 8)
9% (n ¼ 1)
None reported
Reported autophony Reported symptoms
66.7% (n ¼ 4) 83.3% (n ¼ 5)
16.7% (n ¼ 1) 16.7% (n ¼ 1)
2 Secretory otitis media 1 Serous OM
35% (n ¼ 7)
30% (n ¼ 6)
Transient epistaxis
1
Reported symptoms, tympanometry in some pts Reported symptoms
1
Reported symptoms; endoscopic examination Reported symptoms
5
7
Endoscopic insertion of a 3.5 cm shim (trimmed irrigation catheter with bone wax) sutured into the eustachian tube in patients who failed ET suture ligation 11 (14 ears) Endoscopic closure of ET (cautery, fat placed in ET, ET orifice sutured, tissue glue injected into the torus orifice) and tympanostomy tube 13 ears Transtympanic ET plugging with a Kobayashi PEP through a myringotomy 35 (42 ears) Transtympanic insertion of silicone plug through a myringotomy
8
Ikeda (1) 2011 Sato (15) 2005
RCS
3
RCS
6
Takano (16) 2007
PCS
6
Doherty (17) 2003
RCS
N/A
2
Case report
N/A
1
RCS
N/A
4
7
11
N/A N/A
5 (6 ears) 6
Eustachian tube occlusion: Cautery Yanez (20) 2011 RCS Robinson 1989 O’connor (21) 1981
RCS RCS
Eustachian tube occlusion: Injection Schroder (22) 2015 RCS
5
Oh (23) 2014
Case report
N/A
Vaezeafshar (24) 2014
RCS
7
Rodrigues (25) 2014 Case report
N/A
Treatment
10 (15 ears) Endoscopic transnasal/transoral ligation of pharyngeal orifice of ET
20 (26 ears) Endoscopic injection of soft tissue bulking agent into torus tuburius (Vox-Implants) Transnasal endoscopic injection of calcium hydroxyapatite to ET orifice 14 (23 ears) Transnasal endoscopic injection of calcium hydroxyapatite to ET orifice
13.3% (n ¼ 2)
19% (n ¼ 8) 11 exchanged for larger plug 46.7% (n ¼ 7)
100% (n ¼ 1)
Foreign body sensation
None reported
57–63% (n ¼ 12) None reported
100% (n ¼ 1)
None reported
continued on next page
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Transcutaneous CT guided silicone elastomer suspension implant
Outcome
REVIEW OF TREATMENT OF PATULOUS EUSTACHIAN TUBE
% Partial Resolution
Subjects
PCS
Bluestone (19) 1981
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% Complete Resolution
Quality
Rotenberg (2) 2013
Dyer (18) 1991
Eustachian tube occlusion treatment techniques
Study Type
Quality
Subjects
RCS
N/A
2
Case report
N/A
Poe (28) 2007
PCS
4
Crary (29) 1979
PCS
5
Ogawa (30) 1976
PCS
5
Pulec (31) 1970 Pulec (3) 1967
RCS RCS
5 4
Author Year Kong (26) 2011 Wolraich (27) 2010
% Complete Resolution
% Partial Resolution
Reported symptoms
100% (n ¼ 2)
None reported
Resolution of otorrhea
100% (n ¼ 1)
Treatment
Autologous cartilage injection to anterior/ posterior nasopharyngeal ET orifice (0.8 mL of tragal cartilage) 1 Transoral injection of calcium hydroxylapatite to lateral pharyngeal wall and torus tubarius 11 (14 ears) Endoscopic patulous ET reconstruction: Cartilage graft 2 Pts; Alloderm 12 Pts: placed around ET orifice 10 Polytef paste injection
16 (22 ears) Infusion of absorbable gelatin sponge solution into ET (1 g gelfoam þ 10 mL glycerin þ 10 mL saline þ/ 1 g carbomethylcellulose sodium) 50 Teflon to anterior ET 26 Teflon to anterior ET
Outcome
Reported symptoms
7% (n ¼ 1)
Reported symptoms and psychologic impact scales Reported symptoms
100% (n¼22)
Reported symptoms Reported symptoms
54% (n¼27) 73.1% (n¼19)
Adverse Events
None reported
86% (n ¼ 12)
1 temporary OME
90% (n ¼ 9)
None reported
2 Temporary tinnitus
30% (n¼15) 23.1% (n¼6)
Localized discomfort Ear or TMJ discomfort for 1 week
K. LUU ET AL.
PCS indicates prospective case series; RCS, retrospective case series. Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
TABLE 5. Muscular transposition/ligation/inactivation treatment techniques Author Year
Study Type
Quality
Subjects
Olthoff (32) 2007
Case report
N/A
1
Virtanen (33) 1982
PCS
6
13 (16 ears)
Misurya (34) 1974 Stroud (35) 1974
RCS RCS
N/A N/A
2 3
Treatment Injection of 2.5 mouse units of botox type A into the paratubal muscles Tensor veli palatini transection or transposition with pterygoid hamulotomy Tensor veli palati tendon rerouting Tensor veli palatini release
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TABLE 4 (Continued)
Outcome
% Complete Resolution
Reported symptom; Otomicroscopy; Tympanometry Reported symptoms; TM movement on forced respiration tympanometry; Sonotubometry Reported symptoms Reported symptoms
56.2 (n ¼ 9)
100% (n ¼ 2) 100% (n ¼ 3)
% Partial Resolution
Adverse Events
100% (n ¼ 1)
None reported
43.8% (n ¼ 7)
None reported
None reported None reported
RCS indicates retrospective case series, PCS, prospective case series Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
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REVIEW OF TREATMENT OF PATULOUS EUSTACHIAN TUBE orifice included: transoral tensor veli palatini tendon rerouting, tensor veli palatini transposition and pterygoid hamulotomy, and botulinum toxin injection into the paratubal muscles to paralyze the muscles (Table 5) (43–46). These procedures are published in case reports or small case series only and are to be considered experimental. Virtanen had the largest series but inclusion criteria were unclear and success was not well defined with patients showing improvement on sonometry, synchronous TM movement, or symptoms, making it difficult to discern actual treatment effectiveness. DISCUSSION Patulous Eustachian tube is a benign disorder that can be symptomatically troubling. Many treatments have been proposed; however none have shown consistent effectiveness. Medical management consists predominantly of instillation of various formulas into the nasal cavity or middle ear space. This seems to be moderately successful, but requires continued treatment for symptom relief. Surgical treatment is extremely varied ranging from simple tympanostomy tubes to manipulation of the Eustachian tube orifice. Tympanostomy tubes treatments do show some success, but again many require repeated treatments or leave patients with milder, but still persistent symptoms. Although the described surgical interventions targeted common anatomical areas, details of the more invasive procedures were so varied it was difficult to draw any conclusions. This review is the first to comprehensively collate the existing literature on medical and surgical management options for the treatment of symptoms of patulous eustachian tube. During manuscript preparation, a systematic review of the surgical management of patients with PET was published (7). This review was comprehensive for surgical management without consideration of options for medical management. Smaller case series were left out of the review that are included in this article for a comprehensive overview of what exists in the literature. There are no published controlled studies, randomized or otherwise, evaluating the treatment of patients with symptoms of PET. The studies uniformly suffer from limitations in sample size, selection bias, the lack of a control group, and failure to control for confounding factors such as weight gain or insertion of a tympanostomy tube. Although a few had well defined follow-up on the scale of years, most studies followed patients for days to months or had undefined followup periods. The diagnosis of PET is made clinically on the basis of subjective characteristic symptoms and signs. In the studies reviewed, patient inclusion criteria were generally consistent, including autophony and often a physical examination measure of a patulous eustachian tube (i.e., tympanic membrane movement on respiration). The study populations were predominantly patients with severe, refractory symptomatology, a distinct subpopulation of all patients with the disorder but a population
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likely representative of those patients observed in an Otolaryngologist’s clinic seeking treatment. There are a few significant confounders to be considered including the propensity for many patients to improve naturally over time with or without treatment, the bias of a largely subjective outcome, few objective measures of PET that were poorly reported, and a poor correlation between symptom severity and objective signs such as TM movement with respiration. The placebo effect of many interventions is suggested by the fact that many studies reported a prolonged symptom relief despite reversal or cessation of the intervention. The high variability in technique of intervention and reporting of outcomes does not allow for comparison of results. Properly randomized, comparative studies are needed to determine the best course of management for patients with PET. CONCLUSION This review systematically identifies and summarizes the existing evidence for the medical and surgical treatment of the symptoms of patulous Eustachian tube. There is no consensus on the optimal management of patients with PET. The available evidence is poor in quality and consists predominantly of small case series. Nasal instillation of saline or simple mass loading of the tympanic membrane has shown moderate effectiveness and a good safety profile making them initial options for the practicing otolaryngologist to consider. Most surgical options are presented in low-quality studies and should be considered experimental. Future procedures in symptomatic patients with PET should be performed as part of an ethically approved clinical trial. REFERENCES 1. Grimmer JF, Poe DS. Update on eustachian tube dysfunction and the patulous eustachian tube. Curr Opin Otolaryngol Head Neck Surg 2005;13:277–82. 2. DiBartolomeo JR, Henry DF. A new medication to control patulous eustachian tube disorders. Am J Otol 1992;13:323–7. 3. O’Connor AF, Shea JJ. Autophony and the patulous eustachian tube. Laryngoscope 1981;91:1427–35. 4. Yoshida H, Kobayashi T, Takasaki K, et al. Imaging of the patulous eustachian tube: High-resolution CT evaluation with multiplanar reconstruction technique. Acta Otolaryngol (Stockh) 2004;124: 918–23. 5. Plate S, Johnsen NJ, Nodskov Pedersen S, et al. The frequency of patulous eustachian tubes in pregnancy. Clin Otolaryngol Allied Sci 1979;4:393–400. 6. Pulec JL. Abnormally patent eustachian tubes: Treatment with injection of polytetrafluoroethylene (teflon) paste. Laryngoscope 1967;77:1543–54. 7. Hussein AA, Adams AS, Turner JH. Surgical management of patulous eustachian tube: A systematic review. Laryngoscope 2015;125:2193–8. 8. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. J Clin Epidemiol 2009;62:1–34. 9. Moher D, Pham Klassen TP, Schulz KF, et al. What contributions do languages other than English make on the results of metaanalyses? J Clin Epidemiol 2000;53:964–72. Otology & Neurotology, Vol. 36, No. 10, 2015
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10. Howick J, Chalmers I, Glasziou P, et al. The 2011 oxford CEBM levels of evidence (introductory document). Oxford Centre for Evidence-Based Medicine. 11. NIH. Quality assessment tool for case series studies. National Institutes of Health Web site. http://www.nhlbi.nih.gov/healthpro/guidelines/in-develop/cardiovascular-risk-reduction/tools/ case_series. Updated 2014. Accessed July 22, 2015. 12. Ikeda R, Oshima T, Oshima H, et al. Management of patulous eustachian tube with habitual sniffing. Otol Neurotol 2011;32:790–3. 13. Oshima T, Kikuchi T, Kawase T, et al. Nasal instillation of physiological saline for patulous eustachian tube. Acta Otolaryngol 2010;130:550–3. 14. Boudewyns A, Claes J. Acute cochleovestibular toxicity due to topical application of potassium iodide. Eur Arch Otorhinolaryngol 2001;258:109–11. 15. Bhide AR. Dizziness due to patulous eustachian tube. Indian J Otolaryngol 1976;28:148. 16. Miller J. Patulous eustachian tube. Arch Otolaryngol 1961;73:80. 17. Moore PM, Miller JB. Patulous eustachian tube. AMA Arch Otolaryngol 1951;54:643–50. 18. Dyer JRK, McElveen JJT. The patulous eustachian tube: Management options. Otolaryngol Head Neck Surg 1991;105:832–5. 19. Thaler S, Yanagisawa E. The abnormally patent eustachian tube. Arch Otolaryngol 1966;84:418–21. 20. Chen DA, Luxford WM. Myringotomy and tube for relief of patulous eustachian tube symptoms. Am J Otol 1990;11:272–3. 21. Bartlett C, Pennings R, Ho A, et al. Simple mass loading of the tympanic membrane to alleviate symptoms of patulous eustachian tube. J Otolaryngol Head Neck Surg 2010;39:259–68. 22. Boedts M. Paper patching of the tympanic membrane as a symptomatic treatment for patulous eustachian tube syndrome. J Laryngol Otol 2014;128:228–35. 23. Brace MD, Horwich P, Kirkpatrick D, et al. Tympanic membrane manipulation to treat symptoms of patulous eustachian tube. Otol Neurotol 2014;35:1201–6. 24. Rotenberg BW, Busato GM, Agrawal SK. Endoscopic ligation of the patulous eustachian tube as treatment for autophony. Laryngoscope 2013;123:239–43. 25. Rotenberg B, Davidson B. Endoscopic transnasal shim technique for treatment of patulous eustachian tube. Laryngoscope 2014;124:2466–9. 26. Sato T, Kawase T, Yano H, et al. Trans-tympanic silicone plug insertion for chronic patulous eustachian tube. Acta Otolaryngol 2005;125:1158–63. 27. Takano A, Takahashi H, Hatachi K, et al. Ligation of eustachian tube for intractable patulous eustachian tube: A preliminary report. Eur Arch Otorhinolaryngol 2007;264:353–7. 28. Doherty JK, Slattery III WH. Autologous fat grafting for the refractory patulous eustachian tube. Otolaryngol Head Neck Surg 2003;128:88–91.
29. Dyer RK Jr, McElveen JT Jr. The patulous eustachian tube: Management options. Otolaryngol Head Neck Surg 1991;105: 832–5. 30. Bluestone CD, Cantekin EI. ‘‘How I do it’’–otology and neurotology. A specific issue and its solution. management of the patulous eustachian tube. Laryngoscope 1981;91:149–52. 31. Robinson PJ, Hazell JWP. Patulous eustachian tube syndrome: The relationship with sensorineural hearing loss. treatment by eustachian tube diathermy. J Laryngol Otol 1989;103:739–42. 32. Yanez C, Pirron JA, Mora N. Curvature inversion technique: A novel tuboplastic technique for patulous eustachian tube—A preliminary report. Otolaryngol Head Neck Surg 2011;145:446–51. 33. Schroder S, Lehmann M, Sudhoff HH, et al. Treatment of the patulous eustachian tube with soft-tissue bulking agent injections. Otol Neurotol 2015;36:448–52. 34. Vaezeafshar R, Turner JH, Li G, et al. Endoscopic hydroxyapatite augmentation for patulous eustachian tube. Laryngoscope 2014; 124:62–6. 35. Oh SJ, Kang DW, Goh EK, et al. Calcium hydroxylapatite injection for the patulous eustachian tube. Am J Otolaryngol 2014;35:443–4. 36. Rodrigues JC, Waddell A, Cook JL. A novel, computed tomography guided, trans-cutaneous approach to treat refractory autophony in a patient with a patulous eustachian tube. J Laryngol Otol 2014;128:182–4. 37. Kong SK, Lee IW, Goh EK, et al. Autologous cartilage injection for the patulous eustachian tube. Am J Otolaryngol 2011;32:346–8. 38. Wolraich D, Zur KB. Use of calcium hydroxylapatite for management of recalcitrant otorrhea due to a patulous eustachian tube. Int J Pediatr Otorhinolaryngol 2010;74:1455–7. 39. Zhou G, Gopen Q, Poe DS. Clinical and diagnostic characterization of canal dehiscence syndrome: A great otologic mimicker. Otol Neurotol 2007;28:920–6. 40. Crary WG, Wexler M, Berliner K. The abnormally patent eustachian tube. Alterations in psychological status resulting from polytef paste injections. Arch Otolaryngol 1979;105:21–3. 41. Ogawa S, Satoh I, Tanaka H. Patulous eustachian tube. A new treatment with infusion of absorbable gelatin sponge solution. Arch Otolaryngol 1976;102:276–80. 42. Pulec JL, Hahn FW Jr. The abnormally patulous eustachian tube. Otolaryngol Clin North Am 1970;3:131–40. 43. Olthoff A, Laskawi R, Kruse E. Successful treatment of autophonia with botulinum toxin: Case report. Ann Otol Rhinol Laryngol 2007;116:594–8. 44. Virtanen H, Palva T. Surgical treatment of patulous eustachian tube. Arch Otolaryngol 1982;108:735–9. 45. Misurya VK. Surgical treatment of the abnormally patulous eustachian tube. J Laryngol Otol 1974;88:877–83. 46. Stroud MH, Spector GJ, Maisel RH. Patulous eustachian tube syndrome. Preliminary report of the use of the tensor veli palatini transposition procedure. Arch Otolaryngol 1974;99:419–21.
Otology & Neurotology, Vol. 36, No. 10, 2015
Copyright © 2015 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.
Treatment Effectiveness for Symptoms of Patulous Eustachian Tube: A Systematic Review Kimberly Luu, Andrew Remillard, yMarcela Fandino, zAlexander Saxby, and Brian D. Westerberg Division of Otolaryngology–Head and Neck Surgery, B.C. Rotary Hearing and Balance Clinic, University of British Columbia, Vancouver, British Columbia, Canada; yCardiovascular Foundation of Colombia, Bucaramanga, Santander, Colombia; and zRoyal Prince Alfred Hospital, Sydney, New South Wales, Australia
Objectives: To determine the effectiveness of currently available medical and surgical interventions for treating symptoms of Patulous Eustachian Tube (PET). Data Sources: A comprehensive search of MEDLINE (January 1948 to July 8, 2015), EMBASE (January 1974 to July 8, 2015), gray literature, hand searches, and cross-reference checking. Study Selection: Original published reports evaluating an intervention to treat the symptoms of patulous eustachian tube in patients 18 years and older. Data Extraction: Quality-of-case reviews were assessed with the National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Data Synthesis: The search strategy identified 1,104 unique titles; 39 articles with 533 patients are included. The available
evidence consists of small case series and case reports. The most common medical treatment was nasal instillation of normal saline. Surgical treatments were categorized as mass loading of the tympanic membrane, eustachian tube plugging, and manipulation of eustachian tube musculature. Conclusions: The available evidence for management of patients with PET is poor in quality and consists predominantly of small case series. Further research is needed to determine the comparative efficacy of the current treatments. Key Words: Auditory perceptual disorders— Auditory tube—Auditory tube dysfunction—Autophony— Eustachian tube—Medical treatment—Patulous Eustachian tube—Surgical treatment.
The Eustachian tube (ET) allows pressure equalization between the mesotympanum and nasopharynx, maintaining the health of the middle ear space. The cartilaginous ET mucosal surfaces are normally in contact during the resting state, closing the orifice (1). Patulous eustachian tube (PET) is an abnormal patency of the ET that affects 0.3% to 6.6% of people (2). Patients usually report symptoms such as autophony (perception of one’s own voice), hearing physiologic sounds at an increased level, and aural fullness (3). This autophony is often intermittent and relieved in the supine position. Physical examination often reveals synchronous movement of the tympanic membrane with respiration. A number of additional tests have been used to try to strengthen the ability to diagnose PET (CT scan, tympanometry, sonotubonometry, or direct nasopharyngoscopy) (4). However, the diagnosis of PET remains a clinical diagnosis based on symptoms
and/or visualization of movement of the tympanic membrane with respiration. Several theories have been proposed for the etiology of PET, including loss of tissue within the cartilaginous portion of ET (weight loss, pregnancy, use of high-dose oral contraceptives, and estrogen therapy) and atrophy or scarring within the nasopharynx or involving the musculature associated with ET function (adenoidectomy, radiation therapy, poliomyelitis, and other iatrogenic trauma) (3,5,6). Treatments include conservative measures such as weight gain, to medical treatment with nasal topical application of various solutions, to surgical procedures that generally increase the bulk around the eustachian tube orifice. Literature reviews have been included in articles that discuss PET management options, but none systematically or comprehensively covers all the treatment options. Hussein et al. (7) recently published a review of surgical treatment options, but did not look at medical treatments. The number of different treatment options highlights that there is no single effective treatment for symptoms of PET. The results of the studies have been variable and thus, no general consensus on management exists.
Otol Neurotol 36:1593–1600, 2015.
Address correspondence and reprint requests to Dr. Brian D. Westerberg, M.D., B. C. Rotary Hearing and Balance Centre at St Paul’s Hospital, Providence 2, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; E-mail: [email protected] No financial support was received in producing this article. The authors disclose no conflicts of interest.
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The primary objective of this systematic review was to determine the effectiveness of interventions for symptoms of patulous eustachian tube described in the literature of all reported medical and surgical modalities reported in case series, cohort studies, and randomized control trials. The secondary objective was to evaluate the safety of the above interventions through summarizing the number of reported adverse events. Given the lack of a standard definition of the condition based on characteristic findings on investigations, we chose to use a symptom-based definition of PET when selecting studies for inclusion reporting patients with PET. MATERIALS AND METHODS Research methods were documented in the research protocol a priori. The PRISMA guidelines were followed (8). The study protocol was peer reviewed by the University of British Columbia Division of Otolaryngology–Head and Neck Surgery Research Committee. For inclusion in this review, studies had to be original published reports evaluating any intervention to treat the symptoms of PET in patients 18 years and older. All levels of study types of any surgical or medical treatment were included. No minimum follow-up was required, however follow-up time was recorded. Studies explicitly stated a diagnosis of patulous eustachian tube based on clinical assessment in their test subjects. Symptoms of autophony, aural fullness, and hearing bodily sounds and/or documentation of synchronous tympanic membrane movement were attributed to this etiology. The primary outcome extracted for each intervention was the proportion of patients who experienced subjective improvement or resolution of their constellation of symptoms of PET based on the study authors’ opinion. The secondary outcome was the rate and type of complications attributed to the therapy. Adverse events included intraoperative or postoperative complications and were included if noted in the studies. Studies including pregnant patients or patients with significant weight loss that did not include a specific intervention other than weight gain or birth were excluded. Nonhuman and non-English studies were excluded; exclusion of non-English articles has been shown to have minimal impact on review conclusions (9). Two authors (K.L./A.R.) independently reviewed titles and abstracts, read full text articles, extracted data, and assessed study quality. Disagreements were resolved by consensus. A third author (M.F.) resolved disagreements between reviewers when consensus was not possible. We searched MEDLINE (January 1948 to July 8, 2015) and EMBASE databases (January 1974 to July 8, 2015) (Table 1). A hand search of PubMed and Google scholar was done to verify search results and to identify articles supporting historical TABLE 1. EMBASE
MEDLINE
treatments. Cross-reference checking and related article search, gray literature search of Google scholar, National Institute of Health, and Worldcat was also performed. Data extracted included: study type, criteria for diagnosis of PET, demographic characteristics of patients, treatment type, treatment effect, and adverse events. Other diagnostic criteria such as electroacoustic impedence tests, nasal audiometry, transnasal endoscopic examination, and radiologic imaging were recorded when documented. Meta analysis of the results was not attempted given the heterogeneity in design and reporting of data in each study. The Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence (OCEBM) table was used to determine the level of evidence of each article (10). As there were no randomized studies, quality of articles with more than seven subjects was assessed using the National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies (11). This scale assesses the quality of a article on the basis of selection, comparability, and exposure giving studies a score out of nine. Series of less than seven subjects were considered low quality but included to give a comprehensive overview of the treatment options being reported.
RESULTS The search strategy identified 1,513 titles (1,086 EMBASE, 295 MEDLINE). After removing 409 duplicates, a total of 1,104 titles and abstracts were reviewed by two independent reviewers (K.L./A.R.) (Fig. 1). Sixty-two articles underwent full text review. Thirty-six articles were eventually included with very good agreement between reviewers (k ¼ 0.91, 95% CI 0.878–0.958). A third reviewer resolved discrepancies in three studies. Three additional articles from cross-reference checking and gray literature were found. A total of 39 articles were included. There was no randomized control or cohort studies found on the treatment of patients with symptoms related to PET. The 39 studies included in this article did not rise above the case series or fourth OCEBM level of evidence (see Tables 2–5). Effect of Medical Interventions Five articles described various topical intranasal and intratubal/intratympanic administrations for the treatment of patients with symptoms of PET (Table 2). Saline was the most commonly used topical treatment, but historical formulas such as salicylic and boric acid powder (in a 1:4 proportion), diluted hydrochloric acid, Search strategy
(exp Eustachian tube/ OR pharyngotympanic tube.mp. OR eustachian.mp. OR auditory tube.mp. OR tympanic membrane/ OR eardrum.mp. OR exp ear, middle/ OR hearing disorders/ OR auditory perceptual disorders/ OR auditory tube dysfunction.mp.) AND (patulous.mp. OR patent.mp. OR autophon.mp. OR dilatation, pathologic/ OR dilatation/ OR eustachian tube.mp. OR patent eustachian tube.mp.) Limits: English language and humans and (‘‘young adult and adult (19–24 and 19–44)’’ or ‘‘middle aged (45 plus years)’’ or ‘‘all aged (65 and over)’’) (exp auditory tube/ OR pharyngotympanic tube.mp. OR eustachian tube.mp. OR eustachian.mp. OR patulous eustachian disorder.mp. OR exp eardrum/ OR tympanic membrane.mp. OR exp middle ear/ OR tympanic cavity.mp. OR tympanum.mp. OR exp ear disease/ OR exp perception deafness) AND (autophon.mp. OR patulous.mp. OR patent.mp. OR pathologic dilatation.mp. OR dilatation.mp. OR exp auditory tube dysfunction) Limits: human and English language and (adult or aged )
Otology & Neurotology, Vol. 36, No. 10, 2015
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Irritation from solution
None reported
100% (n ¼ 27)
100% (n ¼ 12) Reported symptoms
Reported symptoms
12 RCS Moore (8) 1951
4
27 RCS Miller (7) 1961
2
6 (8 ears) 1 PCS Case report
N/A N/A
10 6 PCS
DiBartolomea (4) 1992 Morita (5) 1988 Bhide (6) 1976
PCS indicates prospective case series; RCS, retrospective case series. Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
None reported None reported Reported symptoms Reported symptoms
Reported symptoms
80% (n ¼ 8)
20% (n ¼ 2) 100% (n ¼ 6) 100% (n ¼ 1)
None reported Acute cochlearvestibular deficit (vertigo and SNHL) when drops instilled into ear 2 rhinorrhea and nasal irritation 17.3% (n ¼ 9) 46.2% (n ¼ 24) Reported symptoms Reported symptoms RCS Case report Oshima (2) 2010 Boudewyn (3) 2001
7 N/A
52 1
Sniffing resolution
Instruction to stop sniffing þ nasal saline instillation Nasal saline instillation Saturated potassium iodide solution (60 g potassium iodide in 42 g water), 20 drops daily through tympanostomy tubes Diluted hydrochloric acid þ chlorobutanol, benzyl alcohol nasal drops Intratubal atropine 1:4 salicylic: boric acid powder through tympanostomy tubes Boric and salicylic acid powder insufflated directly into the torus tubarius Insufflation of salicylic acid powder and boric acid powder 1:4 proportions 3
35 (63 ears)
Outcome Quality
Subjects
Treatment
RCS
Mass Loading of Tympanic Membrane The symptoms of PET are postulated to arise from tympanic membrane movement, thus techniques to
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Ikeda (1) 2011
Effect of Surgical Interventions Surgical intervention is grouped by the procedure type including mass loading of tympanic membrane; ET occlusion through plugging the ET, cautery of the ET orifice, or material injection; muscle ligation or transposition; and combination approaches.
Study Type
chlorobutanol, and benzyl alcohol and saturated potassium iodide solution have been studied (2,12–17). All articles, but one, used resolution of all symptoms to assess the treatment. Results ranged from 63.5% to 100% partial or full resolution of symptoms. Ikeda evaluated patients with PET who had developed habitual sniffing to relieve their symptoms (1). Outcome was measured as resolution of sniffing, although patients were also specifically instructed to stop sniffing. The true effect of the saline is questioned, as despite improvement in symptoms, studies reported patients who continued to show tympanic membrane movement with respiration (1). Furthermore, results are confounded by the placement of tympanostomy tubes to instill the drops. There were no reported adverse events with saline drops but one patient developed a cochleovestibular deficit from topical instillation of Boudewyn’s potassium iodine solution (3). Although nasal estrogen cream was a referenced treatment (18), neither our search strategy nor a subsequent hand search could identify an original publication despite it being a common historical treatment for PET. Evidence to support the effectiveness of this treatment modality is anecdotal.
Author Year
FIG. 1. Study flow diagram.
TABLE 2. Medical treatment techniques
% Complete Resolution
% Partial Resolution
Adverse Events
None reported 65.7% (n ¼ 23)
REVIEW OF TREATMENT OF PATULOUS EUSTACHIAN TUBE
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K. LUU ET AL. TABLE 3. Tympanic membrane mass loading treatment techniques
Author Year
Study Type Quality
Brace (9) 2014
RCS
8
Ikeda (1) 2011 Boedts (10) 2014 Bartlett (11) 2010 Chen (12) 1990
RCS RCS
4 7
PCS
7
RCS
5
Thaler (13) 1966
RCS
N/A
Subjects
Treatment
10(15)
Resurface TM with KTP laser 10(11) Cartilage tuboplasty 8 ears Ventilation tubes 21 (33 ears) Paper patch on TM 14
Mass loading of TM with blue tack 46 (60 ears) Ventilation tubes
4
Outcome Reported symptoms, tympanometry Reported symptoms Reported symptoms Reported symptoms Reported symptoms
Short, double flanged, Reported symptoms polyethylene tube
% Complete Resolution
% Partial Resolution
46.7 % (n ¼ 7)
Adverse Events Not mentioned
72.7 % (n ¼ 8) 75% (n ¼ 6) 25% (n ¼ 2) 76.2 % (n ¼ 16) Discomfort with drying patch 78.6% (n ¼ 11) 1 dislodged tac 53.3% (n ¼ 32) 75% (n ¼ 3)
2 otorrhoea 2 persistent perforation 25% (n ¼ 1) 1 AOM
PCS indicates prospective case series; RCS, retrospective case series. Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
weigh down the TM have been attempted (Table 3). Tympanostomy tube insertion was the most frequently described method, with three case series identified (12,19,20). Results ranged from 53% to 100% of patients achieving partial or full resolution of symptoms. Adverse events in these series included temporary otorrhea, persistent perforation, and acute otitis media. Mass loading the tympanic membrane with blue tack was reported in a prospective case series of 14 patients (21). The duration of the relief ranged from 2 weeks to 4 months with some patients receiving repeated procedures. There were no adverse events; however hearing thresholds were not reported. Most recently, a study using tympanic membrane paper patches reported complete relief in 76.2% of patients (n ¼ 16) (22). Patches dislodged in 1 to 2 months. Interestingly, once dislodged, only 50% of patients experienced a return of symptoms treated with reapplications. An unspecified number of patients complained of discomfort when the paper patches dried, relieved by moistening or removal of the patch. Patients responding to the blue tack were enrolled in a subsequent study to more permanently augment the TM with laser resurfacing or cartilage tuboplasty with variable results (see Table 3) (23). Eustachian Tube Occlusion To prevent the movement of air through an abnormally open ET, transtympanic or transoral occlusion of the ET opening has been attempted (Table 4). This is accomplished with ET plugging, suture ligation or cautery of the ET orifice, or injection of bulking substance at the ET orifice. A variable number of patients additionally underwent tympanostomy tube insertion in the treated ears, again confounding results. Eustachian Tube Plugging Eight studies looked at plugging the ET. The devices used included: intravenous angiocatheter, silicone plug, fat grafting, and ligation of the ET orifice (12,24–30). Access to the ET was through a tympanomeatal flap or
nasal endoscopy. Each study used patient symptoms as the outcome of interest. Again, to prevent middle ear complications, many studies placed a tympanostomy tube at the time of the procedure, confounding the results. Eustachian Tube Cautery Three studies investigated cautery of the ET orifice to promote inflammation and scarring. Cautery was done with either silver nitrate or diathermy (3,31). Patients in the two studies done in the 1980s received multiple treatments during an unclear timeframe. In a novel technique, Yanez described 11 patients who were endoscopically treated with KTP laser assisted curvature inversion of the medial and lateral lamina of the Eustachian tube to alter the shape of the posterior cushion, reporting moderate success over a 24-month follow-up (32). Serous otitis media was reported as a complication in three patients. Eustachian Tube Injection Eleven studies looked at injection of the ET orifice as a method of occlusion. Injection material included: Teflon, silicone, cartilage, gelatin sponge, calcium hydroxylapatite, and a polytef paste (33–42). The manufacturer of polytef paste has since advised against these injections because of a report of cerebral thrombosis and death resulting from injection into the internal carotid artery. Poe proposed a PET reconstruction technique with the placement of cartilage graft and subsequently alloderm around the ET orifice (39). Bleeding from the septal graft harvest site and other technical challenges prompted the authors to switch to alloderm. Injection of Radiesse by Wolraich was confounded by patient comorbid conditions such as recent weight loss, previous surgeries, and botulinum toxin injection for palatal myoclonus (38). Muscular Transposition/Ligation/Inactivation Alterations to the tensor veli palatini muscle may potentially decrease the patency of the ET orifice. Methods to alter the musculature of the eustachian tube
Otology & Neurotology, Vol. 36, No. 10, 2015
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TABLE 4. Author Year
Study Type
Eustachian tube occlusion: Plugging Rotenberg PCS (14) 2014
Adverse Events
Reported symptoms and Autophony score (1–5)
85.7 (n ¼ 6)
14.3 (n ¼ 1)
None
Reported symptoms and Autophony score (1–5)
92.8% (n ¼ 13)
1 Epistaxis
Reported symptoms
100% (n ¼ 13)
1 Middle ear effusion
Reported symptoms; Synchronous TM movement Reported symptoms; Sonotubometry
52.4% (n ¼ 22)
Complete closure of ET at nasopharyngeal orifice (cautery of the internal circumference of the ET orifice, fat graft, further electrocautery) and tympanostomy tubes Transcanal insertion of an angio-catheter into the ET via tympanomeatal flap and tympanostomy tube Transtympanic insertion of IV indwelling catheter through a tympanotomy and tympanostomy tube
Reported symptoms
100% (n ¼ 2)
1 temporary OME 1 infection 1 odynophagia 3 revision operations None reported
Reported symptoms
100% (n ¼ 1)
None reported
Reported symptoms
100% (n ¼ 4)
None reported
Unilateral or bilateral curvature inversion tubuloplasty Eustachian tube diathermy 20% silver nitrate cautery
Reported symptoms
72.7% (n ¼ 8)
9% (n ¼ 1)
None reported
Reported autophony Reported symptoms
66.7% (n ¼ 4) 83.3% (n ¼ 5)
16.7% (n ¼ 1) 16.7% (n ¼ 1)
2 Secretory otitis media 1 Serous OM
35% (n ¼ 7)
30% (n ¼ 6)
Transient epistaxis
1
Reported symptoms, tympanometry in some pts Reported symptoms
1
Reported symptoms; endoscopic examination Reported symptoms
5
7
Endoscopic insertion of a 3.5 cm shim (trimmed irrigation catheter with bone wax) sutured into the eustachian tube in patients who failed ET suture ligation 11 (14 ears) Endoscopic closure of ET (cautery, fat placed in ET, ET orifice sutured, tissue glue injected into the torus orifice) and tympanostomy tube 13 ears Transtympanic ET plugging with a Kobayashi PEP through a myringotomy 35 (42 ears) Transtympanic insertion of silicone plug through a myringotomy
8
Ikeda (1) 2011 Sato (15) 2005
RCS
3
RCS
6
Takano (16) 2007
PCS
6
Doherty (17) 2003
RCS
N/A
2
Case report
N/A
1
RCS
N/A
4
7
11
N/A N/A
5 (6 ears) 6
Eustachian tube occlusion: Cautery Yanez (20) 2011 RCS Robinson 1989 O’connor (21) 1981
RCS RCS
Eustachian tube occlusion: Injection Schroder (22) 2015 RCS
5
Oh (23) 2014
Case report
N/A
Vaezeafshar (24) 2014
RCS
7
Rodrigues (25) 2014 Case report
N/A
Treatment
10 (15 ears) Endoscopic transnasal/transoral ligation of pharyngeal orifice of ET
20 (26 ears) Endoscopic injection of soft tissue bulking agent into torus tuburius (Vox-Implants) Transnasal endoscopic injection of calcium hydroxyapatite to ET orifice 14 (23 ears) Transnasal endoscopic injection of calcium hydroxyapatite to ET orifice
13.3% (n ¼ 2)
19% (n ¼ 8) 11 exchanged for larger plug 46.7% (n ¼ 7)
100% (n ¼ 1)
Foreign body sensation
None reported
57–63% (n ¼ 12) None reported
100% (n ¼ 1)
None reported
continued on next page
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Transcutaneous CT guided silicone elastomer suspension implant
Outcome
REVIEW OF TREATMENT OF PATULOUS EUSTACHIAN TUBE
% Partial Resolution
Subjects
PCS
Bluestone (19) 1981
Otology & Neurotology, Vol. 36, No. 10, 2015
% Complete Resolution
Quality
Rotenberg (2) 2013
Dyer (18) 1991
Eustachian tube occlusion treatment techniques
Study Type
Quality
Subjects
RCS
N/A
2
Case report
N/A
Poe (28) 2007
PCS
4
Crary (29) 1979
PCS
5
Ogawa (30) 1976
PCS
5
Pulec (31) 1970 Pulec (3) 1967
RCS RCS
5 4
Author Year Kong (26) 2011 Wolraich (27) 2010
% Complete Resolution
% Partial Resolution
Reported symptoms
100% (n ¼ 2)
None reported
Resolution of otorrhea
100% (n ¼ 1)
Treatment
Autologous cartilage injection to anterior/ posterior nasopharyngeal ET orifice (0.8 mL of tragal cartilage) 1 Transoral injection of calcium hydroxylapatite to lateral pharyngeal wall and torus tubarius 11 (14 ears) Endoscopic patulous ET reconstruction: Cartilage graft 2 Pts; Alloderm 12 Pts: placed around ET orifice 10 Polytef paste injection
16 (22 ears) Infusion of absorbable gelatin sponge solution into ET (1 g gelfoam þ 10 mL glycerin þ 10 mL saline þ/ 1 g carbomethylcellulose sodium) 50 Teflon to anterior ET 26 Teflon to anterior ET
Outcome
Reported symptoms
7% (n ¼ 1)
Reported symptoms and psychologic impact scales Reported symptoms
100% (n¼22)
Reported symptoms Reported symptoms
54% (n¼27) 73.1% (n¼19)
Adverse Events
None reported
86% (n ¼ 12)
1 temporary OME
90% (n ¼ 9)
None reported
2 Temporary tinnitus
30% (n¼15) 23.1% (n¼6)
Localized discomfort Ear or TMJ discomfort for 1 week
K. LUU ET AL.
PCS indicates prospective case series; RCS, retrospective case series. Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
TABLE 5. Muscular transposition/ligation/inactivation treatment techniques Author Year
Study Type
Quality
Subjects
Olthoff (32) 2007
Case report
N/A
1
Virtanen (33) 1982
PCS
6
13 (16 ears)
Misurya (34) 1974 Stroud (35) 1974
RCS RCS
N/A N/A
2 3
Treatment Injection of 2.5 mouse units of botox type A into the paratubal muscles Tensor veli palatini transection or transposition with pterygoid hamulotomy Tensor veli palati tendon rerouting Tensor veli palatini release
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TABLE 4 (Continued)
Outcome
% Complete Resolution
Reported symptom; Otomicroscopy; Tympanometry Reported symptoms; TM movement on forced respiration tympanometry; Sonotubometry Reported symptoms Reported symptoms
56.2 (n ¼ 9)
100% (n ¼ 2) 100% (n ¼ 3)
% Partial Resolution
Adverse Events
100% (n ¼ 1)
None reported
43.8% (n ¼ 7)
None reported
None reported None reported
RCS indicates retrospective case series, PCS, prospective case series Quality assessed with National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. Italics indicate case studies or low number case series.
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REVIEW OF TREATMENT OF PATULOUS EUSTACHIAN TUBE orifice included: transoral tensor veli palatini tendon rerouting, tensor veli palatini transposition and pterygoid hamulotomy, and botulinum toxin injection into the paratubal muscles to paralyze the muscles (Table 5) (43–46). These procedures are published in case reports or small case series only and are to be considered experimental. Virtanen had the largest series but inclusion criteria were unclear and success was not well defined with patients showing improvement on sonometry, synchronous TM movement, or symptoms, making it difficult to discern actual treatment effectiveness. DISCUSSION Patulous Eustachian tube is a benign disorder that can be symptomatically troubling. Many treatments have been proposed; however none have shown consistent effectiveness. Medical management consists predominantly of instillation of various formulas into the nasal cavity or middle ear space. This seems to be moderately successful, but requires continued treatment for symptom relief. Surgical treatment is extremely varied ranging from simple tympanostomy tubes to manipulation of the Eustachian tube orifice. Tympanostomy tubes treatments do show some success, but again many require repeated treatments or leave patients with milder, but still persistent symptoms. Although the described surgical interventions targeted common anatomical areas, details of the more invasive procedures were so varied it was difficult to draw any conclusions. This review is the first to comprehensively collate the existing literature on medical and surgical management options for the treatment of symptoms of patulous eustachian tube. During manuscript preparation, a systematic review of the surgical management of patients with PET was published (7). This review was comprehensive for surgical management without consideration of options for medical management. Smaller case series were left out of the review that are included in this article for a comprehensive overview of what exists in the literature. There are no published controlled studies, randomized or otherwise, evaluating the treatment of patients with symptoms of PET. The studies uniformly suffer from limitations in sample size, selection bias, the lack of a control group, and failure to control for confounding factors such as weight gain or insertion of a tympanostomy tube. Although a few had well defined follow-up on the scale of years, most studies followed patients for days to months or had undefined followup periods. The diagnosis of PET is made clinically on the basis of subjective characteristic symptoms and signs. In the studies reviewed, patient inclusion criteria were generally consistent, including autophony and often a physical examination measure of a patulous eustachian tube (i.e., tympanic membrane movement on respiration). The study populations were predominantly patients with severe, refractory symptomatology, a distinct subpopulation of all patients with the disorder but a population
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likely representative of those patients observed in an Otolaryngologist’s clinic seeking treatment. There are a few significant confounders to be considered including the propensity for many patients to improve naturally over time with or without treatment, the bias of a largely subjective outcome, few objective measures of PET that were poorly reported, and a poor correlation between symptom severity and objective signs such as TM movement with respiration. The placebo effect of many interventions is suggested by the fact that many studies reported a prolonged symptom relief despite reversal or cessation of the intervention. The high variability in technique of intervention and reporting of outcomes does not allow for comparison of results. Properly randomized, comparative studies are needed to determine the best course of management for patients with PET. CONCLUSION This review systematically identifies and summarizes the existing evidence for the medical and surgical treatment of the symptoms of patulous Eustachian tube. There is no consensus on the optimal management of patients with PET. The available evidence is poor in quality and consists predominantly of small case series. Nasal instillation of saline or simple mass loading of the tympanic membrane has shown moderate effectiveness and a good safety profile making them initial options for the practicing otolaryngologist to consider. Most surgical options are presented in low-quality studies and should be considered experimental. Future procedures in symptomatic patients with PET should be performed as part of an ethically approved clinical trial. REFERENCES 1. Grimmer JF, Poe DS. Update on eustachian tube dysfunction and the patulous eustachian tube. Curr Opin Otolaryngol Head Neck Surg 2005;13:277–82. 2. DiBartolomeo JR, Henry DF. A new medication to control patulous eustachian tube disorders. Am J Otol 1992;13:323–7. 3. O’Connor AF, Shea JJ. Autophony and the patulous eustachian tube. Laryngoscope 1981;91:1427–35. 4. Yoshida H, Kobayashi T, Takasaki K, et al. Imaging of the patulous eustachian tube: High-resolution CT evaluation with multiplanar reconstruction technique. Acta Otolaryngol (Stockh) 2004;124: 918–23. 5. Plate S, Johnsen NJ, Nodskov Pedersen S, et al. The frequency of patulous eustachian tubes in pregnancy. Clin Otolaryngol Allied Sci 1979;4:393–400. 6. Pulec JL. Abnormally patent eustachian tubes: Treatment with injection of polytetrafluoroethylene (teflon) paste. Laryngoscope 1967;77:1543–54. 7. Hussein AA, Adams AS, Turner JH. Surgical management of patulous eustachian tube: A systematic review. Laryngoscope 2015;125:2193–8. 8. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. J Clin Epidemiol 2009;62:1–34. 9. Moher D, Pham Klassen TP, Schulz KF, et al. What contributions do languages other than English make on the results of metaanalyses? J Clin Epidemiol 2000;53:964–72. Otology & Neurotology, Vol. 36, No. 10, 2015
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