Otology & Neurotology 36:65Y69 Ó 2014, Otology & Neurotology, Inc.
Can Nasal Decongestants Improve Eustachian Tube Function? *Attila Ovari, *Anne Buhr, †Mareike Warkentin, ‡Gu¨nther Kundt, *Karsten Ehrt, and *Hans-Wilhelm Pau *Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center; ÞFaculty of Mechanical Engineering and Marine Technology, Department of Material Science and Medical Engineering; and þInstitute for Biostatistics and Informatics in Medicine and Ageing Research, University of Rostock, Rostock, Germany
equalization tests (swallowing at negative and positive external ear canal pressures). Results: In most cases, nasal decongestion or intratympanal use of decongestants have no effect on ET opening. Improvement in tube opening is rather an exception and, in a minority of patients, a reduced ET function was evident. Conclusion: Our acute studies revealed no improvement in eustachian ventilatory tube function with the administration of nasal decongestants. Key Words: Eustachian tubeVNasal decongestantsVOtitis mediaVPressure equalization.
Objective: To evaluate the effect of nasal decongestants on eustachian tube (ET) opening. Study design: A prospective nonrandomized study. Setting: A tertiary referral center. Patients: Twenty-four patients (44 ears) with intact eardrums, 39 patients (43 ears) having a noninfected eardrum defect, and six patients with an upper airway infection. Interventions: Nasal or intratympanal (in perforated ears) application of a nasal decongestant (xylometazoline 0.1%). Main outcome measures: Change of tube opening quality (yes or no; better or worse) measuring tube opening parameters (pressure, latency) using the Este`ve method and pressure
Otol Neurotol 36:65Y69, 2015.
Otitis media, either acute (AOM) or secretory (SOM), is closely related to dysfunctions of the eustachian tube (ET) in terms of middle ear ventilation (1). As otitis usually starts associated with upper airway infections causing nasal obstructions, it is commonly believed that nasal decongestants may not only open the nasal passages but also the ET. At least in Germany, such nasal decongestants are commonly given in cases of AOM or SOM. Also on international flights, such nasal drops or sprays are offered by crew if earache occurs during the landing phase. Although, from the literature, there are no indications that nasal decongestants are beneficial in chronic secretory otitis, many physicians give these drops or sprays routinely. In this study, we tried to measure the effects of nasal decongestants on the ventilatory function of the ET. Thus, the opening function of the tube after the application of nasal decongestants was examined using two different methods for tubomanometry: the pressure equalization test
for ears with perforated tympanic membranes and a special test according to Este`ve that can be applied to both closed and perforated ears (2). In a small additional study, using the pressure equalization test, decongestants were applied to the tympanic orifice of the ET via a preexisting perforation of the tympanic membrane. MATERIALS AND METHODS All tests were performed according to the recommendations of the Declaration of Helsinki and the local ethics committee of the University of Rostock in Germany.
Pressure Equalization Test In persons with perforated tympanic membranes, positive pressures were applied to the tympanic orifice of the ET via the plugged external ear canal. First, we tested the equalization of negative (j100 or j300 daPa) and positive (+300 daPa) pressure by swallowing in each patient. Then, with increasing pressures, the forced opening of the ET was recorded, indicated by a sudden descent of the pressure curve. These tests mentioned above were applied to 20 individuals (n = 20) before and 15 minutes after the application of a decongestant nasal spray (xylometazoline; Otrivine).
Address correspondence and reprint requests to Attila Ovari, Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center, Rostock, Germany; E-mail: [email protected] A. O. and A. B. contributed equally to this work. The authors disclose no conflicts of interest.
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66
A. OVARI ET AL.
FIG. 1. Typical pressure/time curves using the Este`ve method (at the bottom with yellow line [see online version]: in the nasopharynx; above with blue line [see online version]: in the outer ear canal) in a perforated ear. C1 indicates time point for pressure increasing in the nasopharynx; C2, beginning of pressure plateau in the nasopharynx; P1, pressure increasing in the outer ear canal; P2, pressure plateau in the outer ear canal. R = 0.47 s/s (see Materials and Methods for discussion on the ratio of tube opening latency). Program version DTF TM ´ tienne, France/Spiggle&TheisMedizintechnik Version 4.2.1a; hardware: Tubomanometer 0459 (La Diffusion Technique Fran0aise, St-E GmbH, Overath, Germany).
In another small study (n = 7), this method was used to detect any effect of decongestants administered directly into the middle ear and thus having much more contact with the ET mucosa because of the tubal clearance function. In seven patients with perforations of the tympanic membrane because of chronic otitis media (COM), decongestant nose drops were applied directly to the tympanic cavity.
The Este`ve Method (Tube Manometry) This method is based on the application of a defined air pressure bolus, which is administered into the nose via a special applicator fitted into the vestibulum nasi and that is triggered by deglutition (2). Because, during swallowing, the nasopharynx is closed against the oropharynx, an almost rectangular pressure stimulus reaches the nasopharyngeal ostium of the ET. Via a pressure probe in the corresponding external ear canal, one can measure whether the nasopharyngeal pressure peak is transmitted to the middle ear, either deforming an intact tympanic membrane or reaching the probe directly in the case of a perforation. The pressure bolus provided by the device can be adjusted to 30, 40, or 50 mbar. The tests were performed in ascending order, starting with a 30-mbar pressure level. The Este`ve method supplies precise and interpersonally comparable data about tube opening. Beyond a yes or no answer concerning tube opening, several parameters of the resulting pressure curves can indicate the resistance of the tube. The latency of tube opening is calculated from the ratio [R = (P1 Y C1)/(C2 Y C1), s/s], using the time point of pressure rise in the nasopharynx (C1), the time point of the pressure plateau in the nasopharynx (C2), and, similarly, the pressure rise (P1) and pressure plateau (P2) in the outer ear canal (Fig. 1). Tube opening before or at the onset time of the pressure plateau in the nasopharynx was designated as early or normal (R e 1); after this time point, it was considered to be late opening (R 9 1) (Fig. 1) (2). The patient group was composed of individuals with and without acute ear problems and with intact or perforated eardrums (COM).
This patient group consisted of 24 patients (n = 44 ears) with intact eardrums, again before and 15 minutes after the application of nasal sprays. In a second patient group (39 patients, n = 43 ears), the same test setup was used. The test persons had a noninfected eardrum defect caused by COM. Another study (n = 6) focused on patients with tube problems during a cold or with signs of secretory otitis. Apart from these inclusion criteria, the procedure was the same as in the other two groups. The results were divided into three categories: improvement, no effect, or deterioration of tube opening by decongestants. Improvement means that, after treatment, the tube opened during pressures that had no effect before treatment. No effect means no opening at all or opening during the same pressures with or without decongestants. Deterioration means a restriction of the opening after treatment.
Statistical Analysis All data were stored and analyzed using the SPSS Statistical Package 22.0 (SPSS Inc., Chicago, IL, USA). Descriptive statistics were computed for continuous and categoric variables. Statistics computed included means and standard deviations of continuous variables and frequencies and percentage frequencies of categoric factors. For categoric variables, comparisons between groups were performed using the W2 test (Fisher’s exact test) for contingency tables. All p values resulted from two-sided statistical tests, and values G0.05 were considered to be statistically significant.
RESULTS Pressure Equalization Test Pressure equalization tests showed no improvement in the opening function of the ET: on increasing pressures
Otology & Neurotology, Vol. 36, No. 1, 2015
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TUBE FUNCTION AND NASAL DECONGESTANTS
FIG. 2. Spontaneous tube opening with increasing pressure in the outer ear canal before and after nasal application of xylometazoline (0.1%) in patients with perforated eardrums (pressure equalization test).
up to 300 daPa, 19 of the 20 patients showed no change (Fig. 2). In one patient, the opening function had deteriorated after the application of xylometazoline spray (W2 test for a 3 2 table, p = 0.362). Concerning the equalization of negative pressures, there was no difference at all. In the seven patients in whom the decongestant drug was applied into the tympanic cavity via a perforation, no difference could be seen in either of the tests (Fig. 3).
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(for details, see Table 1). After the application of nasal drops, we registered an improvement in tube opening in seven ears albeit a deteriorated tube function in five ears (n = 43). Considering the pressures applied, there was only a minor trend toward earlier tube opening by elevated pressure levels before nasal drop application (W2 test for a 3 3 table, p = 0.743). However, after the use of nasal drops, there was a small but significant impact of pressures applied on the overall number of tube openings (W2 test for a 3 3 table, p = 0.040) (Table 2). Analyzing each pressure level, it seems that nasal drop application has no effect on the tube opening rate measured at 30 mbar (Fisher’s exact test for a 2 2 table, p = 0.815). For higher pressure levels (40 and 50 mbar), there was a trend of increasing success rate of tube opening after application of nasal drops, and the 50-mbar pressure shows a greater increase than 40 mbar (40 mbar: Fisher’s exact test for a 2 2 table, p = 0.589; 50 mbar: Fisher’s exact test for a 2 2 table, p = 0.382) (Table 2). On average, before use of nasal drops, 67% of ears examined showed an early/normal tube opening; 22%, a delayed opening; and 11%, no opening. After decongestion of nasal mucosa, the distribution of tube function was 44%, 17%, and 39%, respectively (Table 3).
DISCUSSION The Este`ve Method (Tube Manometry) The Este`ve test provides a more detailed picture of tube opening. The tests were carried out with three pressure levels applied to each patient. For the 30-mbar level, 34 out of 44 ears showed no difference after application of xylometazoline, six improved, but four deteriorated. For the 40-mbar level, 35 showed no effect, four improved, but five deteriorated. For 50 mbar, 33 remained the same, six improved, but five deteriorated (Fig. 4) (W2 test for a 3 3 table, p = 0.951). Altogether, before application of nasal drops, 48.5% of the examined ears showed a delayed ET opening, independent of pressure. In 51.5%, a normal or early tube opening was detected. The use of nasal decongestant drops with an application time of 15 minutes yielded almost the same result (48.6% delayed tube opening, 51.4% normal/ early opening) (Fisher’s exact test for a 2 2 table, p = 1.00)
The idea behind the application of nasal decongestants is simple: if the nasal passages are opened by these drugs, especially during an upper airways infection, why should the ET not react similarly? This idea has made the use of nasal drops or sprays very commonVat least in Germany. There are, however, no authoritative studies showing positive effects, for example, in the treatment of tuberelated middle ear effusions in children or adults. These studies mostly proved whether such effusions cleared after the use of nasal decongestants or whether at least the course of a secretory otitis could be shortened (3Y5). A meta-analysis of the Cochrane database found no benefit but some harm from the use of antihistamines or decongestants alone or in combination in the management of SOM in children (6). Therefore, practitioners did not recommend these therapy regimes. From their study results,
FIG. 3. Spontaneous tube opening before and after intratympanic application of xylometazoline (0.1%) in patients with perforated eardrums (pressure equalization test).
FIG. 4. Tube opening before and after nasal application of xylometazoline (0.1%) in patients with intact eardrums (Este`ve method). Otology & Neurotology, Vol. 36, No. 1, 2015
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TABLE 1.
R values (tube opening latency) in patients with perforated eardrum due to a non-infected eardrum defect (n = 43 ears) Before nasal drops
Tube opening Distribution (%) R (average)
After nasal decongestion
Normal
Late
Normal + late
Normal
Late
Normal + late
17/33 (51.5) 0.69 T 0.25
16/33 (48.5) 2.19 T 0.94
33/33 (100) 1.42 T 1.01
18/35 (51.4) 0.61 T 0.28
17/35 (48.6) 2.31 T 1.59
35/35 (100) 1.48 T 1.43
See text defining normal and late tube opening in Materials and Methods.
van Heerbeek et al. (7) discouraged the prevention or treatment of otitis media with nasal decongestants in children. The same conclusion had been reached by Lildholdt et al. (8) in a study on children having tympanostomy tubes because of severe dysfunction of the ET. However, Griffin and Flynn (6) remarked that decongestants may be helpful for otitis media related to upper respiratory infection or postYacute otitis media, and these special problems are possible future research fields. In addition, Stillwagon et al. (9) assumed a potential for these drugs in the therapy of allergen-induced ET dysfunction. However, we could not find any studies in the PubMed database dealing with ET dysfunction and allergy or postYacute otitis media. Our study focused on the function of the tube itself, which is very difficult to measure because of the lack of physiologic tests. There are two possibilities: 1) tube function can be estimated indirectly by measuring its effects on middle ear pressure, for example, by tympanometry; or 2) under certain test conditions, the opening function of the tube can be recorded, regardless whether it is sufficient for middle ear gas equilibration or not. For the second condition, there are quite a number of tests such as tube manometry (pressure equalization tests, etc.), sonotubometry, impedance measurements in pressure chambers, and others. Our study focused only on the acute effects of nasal decongestants. For nasal ventilation, such short-time effects can be quantified by performing rhinomanometry before and, for example, 15 minutes after application of nose drops, which is long enough to reduce congestion of the turbinate mucosa. We used the same setting to perform tube manometryValways being aware of the fact that other time intervals might have been chosen and none of the tests mentioned above sufficiently reflect tube function. In the study by van Heerbeek et al. (7), a 15-minute period was also chosen after application of nasal drops. Nevertheless, in a study on infants with symptoms of common cold, longer application times (1 h) seemed to be ineffective for normalizing middle ear pressures (10). Indeed, the
TABLE 2.
tube opening function obviously remained unchanged after the use of nasal decongestants. One might argue that the setting of Test Series 1 and 2 did not represent the clinical situation because many of the test persons involved had no acute problems with the ET. For that reason, we included a study that only addressed persons with such problems, upper airway infections, signs of negative middle ear pressure, effusions, and so on. Even in this group, no effects could be verified. There was even a trend toward a deteriorated tube function after nasal decongestion independent of the pressures applied. Because of the limited number of cases, a clear statement cannot be made here. Coming back to the ideas behind the application of nasal decongestants, a closer look reveals that there are no rational facts promoting the assumption of positive effects. The effect of xylometazoline depends on vasoconstriction of the nasal sinusoidal network of vessels, which the ET cannot offer at all. Moreover, it seems very questionable whether the decongestant drug reaches the tube at all (11,12). From rhinologic spray applications, we know how difficult it is to reach the ostia of the sinusesVmost of the ingredients deposit on the surface of the lower turbinate. If however xylometazoline should indeed be deposited on the nasopharyngeal orifice, it is very unlikely that it can enter the ET lumen against the mucosal cilia beating toward the nasopharynx. To exclude the possibility that the missing effect is only related to the latter problem, we applied xylometazoline to the tympanic lumen, assuming that the ciliary beat would carry it all through the tube, allowing a much closer contact between the drug and the mucosa. Also in these cases, we saw no significant effect. Interestingly, we observed a small but significant increase in tube opening after nasal drop application if higher pressures were applied with tube manometry. Jensen et al. (13) applied decongestants directly to the pharyngeal opening of the ET and concluded that tube opening improved but only at nonphysiologically high
Tube opening in ears with a noninfected eardrum defect measured with the Este`ve method (n = 43 ears) Before nasal drops, n (%)
After nasal decongestion, n (%)
Stimulus/TO
Re1
R91
No TO
TO
Re1
R91
No TO
TO
30 mbar 40 mbar 50 mbar Mean T SD Average (%)
9 (20.9) 19 (44.2) 23 (53.5)
22 (51.2) 14 (32.5) 11 (25.6)
12 (27.9) 10 (23.3) 9 (20.9) 10.3 T 1.53 24.0
31 (72.1) 33 (76.7) 34 (79.1) 32.7 T 1.53 76.0
16 (37.2) 22 (51.2) 21 (48.8)
13 (30.2) 14 (32.5) 17 (39.6)
14 (32.6) 7 (16.3) 5 (11.6) 8.67 T 4.73 20.2
29 (67.4) 36 (83.7) 38 (88.4) 34.3 T 4.73 79.8
R indicates TO latency ratio; TO, tube opening. Otology & Neurotology, Vol. 36, No. 1, 2015
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TUBE FUNCTION AND NASAL DECONGESTANTS TABLE 3.
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Tube opening before and after nasal decongestants in patients with an acute infection in the upper airway tract (n = 6) Before nasal drops, n (%)
After nasal decongestion, n (%)
Stimulus/TO
Re1
R91
No TO
TO
Re1
R91
No TO
TO
30 mbar 40 mbar 50 mbar Mean T SD Average (%)
3 (50) 4 (67) 5 (83)
1 (17) 2 (33) 1 (17)
2 (33) 0 (0) 0 (0) 0.67 T 1.15 11
4 (67) 6 (100) 6 (100) 5.33 T 1.15 89
2 (33) 2 (33) 4 (67)
0 (0) 2 (33) 1 (17)
4 (67) 2 (33) 1 (17) 2.33 T 1.53 39
2 (33) 4 (67) 5 (83) 3.67 T 1.53 61
See text defining normal and late TO using the Este`ve method in Materials and Methods. R indicates TO latency ratio; TO, tube opening.
pressures. Similar to our study, they measured tubal patency in both directions, that is, from the middle ear with equalization tests and through the nose/pharynx with the Valsalva maneuver. The Este`ve method represents an automated and calibrated Valsalva maneuver and, with its use, we could precisely measure tube opening pressure and latency. In concordance with the results of Jensen et al. (13), we found that nasal decongestion has a benefit on tube opening if higher pressures are applied in the pharynx. Interestingly, just as in the study by Jensen et al. (13), pressure changes in the outer ear canal (aspiration test and deflation test) did not yield this effect demonstrated with the Valsalva maneuver. Again, it must be emphasized that, according to the setting of our study, these results only refer to measurable short-time effects of nasal decongestants on the tube opening mechanism. However, there are long-term studies in the literature that clinically indicate that any longterm effect of such drops or sprays on tube function is very questionable (6). In conclusion, the application of nasal decongestants will, of course, improve nasal ventilation and perhaps reduce potential nasopharyngeal deposits of mucous but, according to our findings, there are no clinically relevant effects on the ventilatory function of the ET. REFERENCES 1. Swarts JD, Alper CM, Luntz M, et al. Panel 2: Eustachian tube, middle ear, and mastoidVanatomy, physiology, pathophysiology, and pathogenesis. Otolaryngol Head Neck Surg 2013;148:E26Y36.
2. Ars B. Fibrocartilaginous Eustachian TubeYMiddle Ear Cleft. Den Haag, The Netherlands: Kugler, 2003:151Y8. 3. Fraser JG, Mehta M, Fraser PA. The medical treatment of secretory otitis media. A clinical trial of three commonly used regimes. J Laryngol Otol 1977;91:757Y65. 4. Bhambhani K, Foulds DM, Swamy KN, Eldis FE, Fischel JE. Acute otitis media in children: are decongestants or antihistamines necessary? Ann Emerg Med 1983;12:13Y6. 5. Hayden GF, Randall JE, Randall JC, Hendley JO. Topical phenylephrine for the treatment of middle ear effusion. Arch Otolaryngol 1984;110:512Y4. 6. Griffin G, Flynn CA. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database Syst Rev 2011;9:CD003423. 7. van Heerbeek N, Ingels KJ, Zielhus GA. No effect of a nasal decongestant on eustachian tube function in children with ventilation tubes. Laryngoscope 2002;112:1115Y58. 8. Lildholdt T, Cantekin EI, Bluestone CD, Rockette HE. Effect of a topical nasal decongestant on Eustachian tube function in children with tympanostomy tubes. Acta Otolaryngol 1982;94:93Y7. 9. Stillwagon PK, Doyle WJ, Fireman P. Effect of an antihistamine/ decongestant on nasal and Eustachian tube function following intranasal pollen challenge. Ann Allergy 1987;58:442Y6. 10. Turner RB, Darden PM. Effect of topical adrenergic decongestants on middle ear pressure in infants with common colds. Pediatric Infect Dis J 1996;15:621Y4. 11. Karagama YG, Rashid M, Lancaster JL, Karkanevatos A, William RS. Intranasal delivery of drugs to Eustachian tube orifice. J Laryngol Otol 2011;125:934Y9. 12. Rashid M. Rationale and feasibility of intranasal delivery of drugs to the Eustachian tube orifice. Curr Allergy Asthma Rep 2012;12: 541Y6. 13. Jensen JH, Leth N, Bonding P. Topical application of decongestant in dysfunction of the Eustachian tube: a randomized, double-blind, placebo-controlled trial. Clin Otolaryngol Allied Sci 1999;15: 197Y201.
Otology & Neurotology, Vol. 36, No. 1, 2015
Copyright © 2014 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.
Can Nasal Decongestants Improve Eustachian Tube Function? *Attila Ovari, *Anne Buhr, †Mareike Warkentin, ‡Gu¨nther Kundt, *Karsten Ehrt, and *Hans-Wilhelm Pau *Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center; ÞFaculty of Mechanical Engineering and Marine Technology, Department of Material Science and Medical Engineering; and þInstitute for Biostatistics and Informatics in Medicine and Ageing Research, University of Rostock, Rostock, Germany
equalization tests (swallowing at negative and positive external ear canal pressures). Results: In most cases, nasal decongestion or intratympanal use of decongestants have no effect on ET opening. Improvement in tube opening is rather an exception and, in a minority of patients, a reduced ET function was evident. Conclusion: Our acute studies revealed no improvement in eustachian ventilatory tube function with the administration of nasal decongestants. Key Words: Eustachian tubeVNasal decongestantsVOtitis mediaVPressure equalization.
Objective: To evaluate the effect of nasal decongestants on eustachian tube (ET) opening. Study design: A prospective nonrandomized study. Setting: A tertiary referral center. Patients: Twenty-four patients (44 ears) with intact eardrums, 39 patients (43 ears) having a noninfected eardrum defect, and six patients with an upper airway infection. Interventions: Nasal or intratympanal (in perforated ears) application of a nasal decongestant (xylometazoline 0.1%). Main outcome measures: Change of tube opening quality (yes or no; better or worse) measuring tube opening parameters (pressure, latency) using the Este`ve method and pressure
Otol Neurotol 36:65Y69, 2015.
Otitis media, either acute (AOM) or secretory (SOM), is closely related to dysfunctions of the eustachian tube (ET) in terms of middle ear ventilation (1). As otitis usually starts associated with upper airway infections causing nasal obstructions, it is commonly believed that nasal decongestants may not only open the nasal passages but also the ET. At least in Germany, such nasal decongestants are commonly given in cases of AOM or SOM. Also on international flights, such nasal drops or sprays are offered by crew if earache occurs during the landing phase. Although, from the literature, there are no indications that nasal decongestants are beneficial in chronic secretory otitis, many physicians give these drops or sprays routinely. In this study, we tried to measure the effects of nasal decongestants on the ventilatory function of the ET. Thus, the opening function of the tube after the application of nasal decongestants was examined using two different methods for tubomanometry: the pressure equalization test
for ears with perforated tympanic membranes and a special test according to Este`ve that can be applied to both closed and perforated ears (2). In a small additional study, using the pressure equalization test, decongestants were applied to the tympanic orifice of the ET via a preexisting perforation of the tympanic membrane. MATERIALS AND METHODS All tests were performed according to the recommendations of the Declaration of Helsinki and the local ethics committee of the University of Rostock in Germany.
Pressure Equalization Test In persons with perforated tympanic membranes, positive pressures were applied to the tympanic orifice of the ET via the plugged external ear canal. First, we tested the equalization of negative (j100 or j300 daPa) and positive (+300 daPa) pressure by swallowing in each patient. Then, with increasing pressures, the forced opening of the ET was recorded, indicated by a sudden descent of the pressure curve. These tests mentioned above were applied to 20 individuals (n = 20) before and 15 minutes after the application of a decongestant nasal spray (xylometazoline; Otrivine).
Address correspondence and reprint requests to Attila Ovari, Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center, Rostock, Germany; E-mail: [email protected] A. O. and A. B. contributed equally to this work. The authors disclose no conflicts of interest.
65
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66
A. OVARI ET AL.
FIG. 1. Typical pressure/time curves using the Este`ve method (at the bottom with yellow line [see online version]: in the nasopharynx; above with blue line [see online version]: in the outer ear canal) in a perforated ear. C1 indicates time point for pressure increasing in the nasopharynx; C2, beginning of pressure plateau in the nasopharynx; P1, pressure increasing in the outer ear canal; P2, pressure plateau in the outer ear canal. R = 0.47 s/s (see Materials and Methods for discussion on the ratio of tube opening latency). Program version DTF TM ´ tienne, France/Spiggle&TheisMedizintechnik Version 4.2.1a; hardware: Tubomanometer 0459 (La Diffusion Technique Fran0aise, St-E GmbH, Overath, Germany).
In another small study (n = 7), this method was used to detect any effect of decongestants administered directly into the middle ear and thus having much more contact with the ET mucosa because of the tubal clearance function. In seven patients with perforations of the tympanic membrane because of chronic otitis media (COM), decongestant nose drops were applied directly to the tympanic cavity.
The Este`ve Method (Tube Manometry) This method is based on the application of a defined air pressure bolus, which is administered into the nose via a special applicator fitted into the vestibulum nasi and that is triggered by deglutition (2). Because, during swallowing, the nasopharynx is closed against the oropharynx, an almost rectangular pressure stimulus reaches the nasopharyngeal ostium of the ET. Via a pressure probe in the corresponding external ear canal, one can measure whether the nasopharyngeal pressure peak is transmitted to the middle ear, either deforming an intact tympanic membrane or reaching the probe directly in the case of a perforation. The pressure bolus provided by the device can be adjusted to 30, 40, or 50 mbar. The tests were performed in ascending order, starting with a 30-mbar pressure level. The Este`ve method supplies precise and interpersonally comparable data about tube opening. Beyond a yes or no answer concerning tube opening, several parameters of the resulting pressure curves can indicate the resistance of the tube. The latency of tube opening is calculated from the ratio [R = (P1 Y C1)/(C2 Y C1), s/s], using the time point of pressure rise in the nasopharynx (C1), the time point of the pressure plateau in the nasopharynx (C2), and, similarly, the pressure rise (P1) and pressure plateau (P2) in the outer ear canal (Fig. 1). Tube opening before or at the onset time of the pressure plateau in the nasopharynx was designated as early or normal (R e 1); after this time point, it was considered to be late opening (R 9 1) (Fig. 1) (2). The patient group was composed of individuals with and without acute ear problems and with intact or perforated eardrums (COM).
This patient group consisted of 24 patients (n = 44 ears) with intact eardrums, again before and 15 minutes after the application of nasal sprays. In a second patient group (39 patients, n = 43 ears), the same test setup was used. The test persons had a noninfected eardrum defect caused by COM. Another study (n = 6) focused on patients with tube problems during a cold or with signs of secretory otitis. Apart from these inclusion criteria, the procedure was the same as in the other two groups. The results were divided into three categories: improvement, no effect, or deterioration of tube opening by decongestants. Improvement means that, after treatment, the tube opened during pressures that had no effect before treatment. No effect means no opening at all or opening during the same pressures with or without decongestants. Deterioration means a restriction of the opening after treatment.
Statistical Analysis All data were stored and analyzed using the SPSS Statistical Package 22.0 (SPSS Inc., Chicago, IL, USA). Descriptive statistics were computed for continuous and categoric variables. Statistics computed included means and standard deviations of continuous variables and frequencies and percentage frequencies of categoric factors. For categoric variables, comparisons between groups were performed using the W2 test (Fisher’s exact test) for contingency tables. All p values resulted from two-sided statistical tests, and values G0.05 were considered to be statistically significant.
RESULTS Pressure Equalization Test Pressure equalization tests showed no improvement in the opening function of the ET: on increasing pressures
Otology & Neurotology, Vol. 36, No. 1, 2015
Copyright © 2014 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.
TUBE FUNCTION AND NASAL DECONGESTANTS
FIG. 2. Spontaneous tube opening with increasing pressure in the outer ear canal before and after nasal application of xylometazoline (0.1%) in patients with perforated eardrums (pressure equalization test).
up to 300 daPa, 19 of the 20 patients showed no change (Fig. 2). In one patient, the opening function had deteriorated after the application of xylometazoline spray (W2 test for a 3 2 table, p = 0.362). Concerning the equalization of negative pressures, there was no difference at all. In the seven patients in whom the decongestant drug was applied into the tympanic cavity via a perforation, no difference could be seen in either of the tests (Fig. 3).
67
(for details, see Table 1). After the application of nasal drops, we registered an improvement in tube opening in seven ears albeit a deteriorated tube function in five ears (n = 43). Considering the pressures applied, there was only a minor trend toward earlier tube opening by elevated pressure levels before nasal drop application (W2 test for a 3 3 table, p = 0.743). However, after the use of nasal drops, there was a small but significant impact of pressures applied on the overall number of tube openings (W2 test for a 3 3 table, p = 0.040) (Table 2). Analyzing each pressure level, it seems that nasal drop application has no effect on the tube opening rate measured at 30 mbar (Fisher’s exact test for a 2 2 table, p = 0.815). For higher pressure levels (40 and 50 mbar), there was a trend of increasing success rate of tube opening after application of nasal drops, and the 50-mbar pressure shows a greater increase than 40 mbar (40 mbar: Fisher’s exact test for a 2 2 table, p = 0.589; 50 mbar: Fisher’s exact test for a 2 2 table, p = 0.382) (Table 2). On average, before use of nasal drops, 67% of ears examined showed an early/normal tube opening; 22%, a delayed opening; and 11%, no opening. After decongestion of nasal mucosa, the distribution of tube function was 44%, 17%, and 39%, respectively (Table 3).
DISCUSSION The Este`ve Method (Tube Manometry) The Este`ve test provides a more detailed picture of tube opening. The tests were carried out with three pressure levels applied to each patient. For the 30-mbar level, 34 out of 44 ears showed no difference after application of xylometazoline, six improved, but four deteriorated. For the 40-mbar level, 35 showed no effect, four improved, but five deteriorated. For 50 mbar, 33 remained the same, six improved, but five deteriorated (Fig. 4) (W2 test for a 3 3 table, p = 0.951). Altogether, before application of nasal drops, 48.5% of the examined ears showed a delayed ET opening, independent of pressure. In 51.5%, a normal or early tube opening was detected. The use of nasal decongestant drops with an application time of 15 minutes yielded almost the same result (48.6% delayed tube opening, 51.4% normal/ early opening) (Fisher’s exact test for a 2 2 table, p = 1.00)
The idea behind the application of nasal decongestants is simple: if the nasal passages are opened by these drugs, especially during an upper airways infection, why should the ET not react similarly? This idea has made the use of nasal drops or sprays very commonVat least in Germany. There are, however, no authoritative studies showing positive effects, for example, in the treatment of tuberelated middle ear effusions in children or adults. These studies mostly proved whether such effusions cleared after the use of nasal decongestants or whether at least the course of a secretory otitis could be shortened (3Y5). A meta-analysis of the Cochrane database found no benefit but some harm from the use of antihistamines or decongestants alone or in combination in the management of SOM in children (6). Therefore, practitioners did not recommend these therapy regimes. From their study results,
FIG. 3. Spontaneous tube opening before and after intratympanic application of xylometazoline (0.1%) in patients with perforated eardrums (pressure equalization test).
FIG. 4. Tube opening before and after nasal application of xylometazoline (0.1%) in patients with intact eardrums (Este`ve method). Otology & Neurotology, Vol. 36, No. 1, 2015
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A. OVARI ET AL.
TABLE 1.
R values (tube opening latency) in patients with perforated eardrum due to a non-infected eardrum defect (n = 43 ears) Before nasal drops
Tube opening Distribution (%) R (average)
After nasal decongestion
Normal
Late
Normal + late
Normal
Late
Normal + late
17/33 (51.5) 0.69 T 0.25
16/33 (48.5) 2.19 T 0.94
33/33 (100) 1.42 T 1.01
18/35 (51.4) 0.61 T 0.28
17/35 (48.6) 2.31 T 1.59
35/35 (100) 1.48 T 1.43
See text defining normal and late tube opening in Materials and Methods.
van Heerbeek et al. (7) discouraged the prevention or treatment of otitis media with nasal decongestants in children. The same conclusion had been reached by Lildholdt et al. (8) in a study on children having tympanostomy tubes because of severe dysfunction of the ET. However, Griffin and Flynn (6) remarked that decongestants may be helpful for otitis media related to upper respiratory infection or postYacute otitis media, and these special problems are possible future research fields. In addition, Stillwagon et al. (9) assumed a potential for these drugs in the therapy of allergen-induced ET dysfunction. However, we could not find any studies in the PubMed database dealing with ET dysfunction and allergy or postYacute otitis media. Our study focused on the function of the tube itself, which is very difficult to measure because of the lack of physiologic tests. There are two possibilities: 1) tube function can be estimated indirectly by measuring its effects on middle ear pressure, for example, by tympanometry; or 2) under certain test conditions, the opening function of the tube can be recorded, regardless whether it is sufficient for middle ear gas equilibration or not. For the second condition, there are quite a number of tests such as tube manometry (pressure equalization tests, etc.), sonotubometry, impedance measurements in pressure chambers, and others. Our study focused only on the acute effects of nasal decongestants. For nasal ventilation, such short-time effects can be quantified by performing rhinomanometry before and, for example, 15 minutes after application of nose drops, which is long enough to reduce congestion of the turbinate mucosa. We used the same setting to perform tube manometryValways being aware of the fact that other time intervals might have been chosen and none of the tests mentioned above sufficiently reflect tube function. In the study by van Heerbeek et al. (7), a 15-minute period was also chosen after application of nasal drops. Nevertheless, in a study on infants with symptoms of common cold, longer application times (1 h) seemed to be ineffective for normalizing middle ear pressures (10). Indeed, the
TABLE 2.
tube opening function obviously remained unchanged after the use of nasal decongestants. One might argue that the setting of Test Series 1 and 2 did not represent the clinical situation because many of the test persons involved had no acute problems with the ET. For that reason, we included a study that only addressed persons with such problems, upper airway infections, signs of negative middle ear pressure, effusions, and so on. Even in this group, no effects could be verified. There was even a trend toward a deteriorated tube function after nasal decongestion independent of the pressures applied. Because of the limited number of cases, a clear statement cannot be made here. Coming back to the ideas behind the application of nasal decongestants, a closer look reveals that there are no rational facts promoting the assumption of positive effects. The effect of xylometazoline depends on vasoconstriction of the nasal sinusoidal network of vessels, which the ET cannot offer at all. Moreover, it seems very questionable whether the decongestant drug reaches the tube at all (11,12). From rhinologic spray applications, we know how difficult it is to reach the ostia of the sinusesVmost of the ingredients deposit on the surface of the lower turbinate. If however xylometazoline should indeed be deposited on the nasopharyngeal orifice, it is very unlikely that it can enter the ET lumen against the mucosal cilia beating toward the nasopharynx. To exclude the possibility that the missing effect is only related to the latter problem, we applied xylometazoline to the tympanic lumen, assuming that the ciliary beat would carry it all through the tube, allowing a much closer contact between the drug and the mucosa. Also in these cases, we saw no significant effect. Interestingly, we observed a small but significant increase in tube opening after nasal drop application if higher pressures were applied with tube manometry. Jensen et al. (13) applied decongestants directly to the pharyngeal opening of the ET and concluded that tube opening improved but only at nonphysiologically high
Tube opening in ears with a noninfected eardrum defect measured with the Este`ve method (n = 43 ears) Before nasal drops, n (%)
After nasal decongestion, n (%)
Stimulus/TO
Re1
R91
No TO
TO
Re1
R91
No TO
TO
30 mbar 40 mbar 50 mbar Mean T SD Average (%)
9 (20.9) 19 (44.2) 23 (53.5)
22 (51.2) 14 (32.5) 11 (25.6)
12 (27.9) 10 (23.3) 9 (20.9) 10.3 T 1.53 24.0
31 (72.1) 33 (76.7) 34 (79.1) 32.7 T 1.53 76.0
16 (37.2) 22 (51.2) 21 (48.8)
13 (30.2) 14 (32.5) 17 (39.6)
14 (32.6) 7 (16.3) 5 (11.6) 8.67 T 4.73 20.2
29 (67.4) 36 (83.7) 38 (88.4) 34.3 T 4.73 79.8
R indicates TO latency ratio; TO, tube opening. Otology & Neurotology, Vol. 36, No. 1, 2015
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TUBE FUNCTION AND NASAL DECONGESTANTS TABLE 3.
69
Tube opening before and after nasal decongestants in patients with an acute infection in the upper airway tract (n = 6) Before nasal drops, n (%)
After nasal decongestion, n (%)
Stimulus/TO
Re1
R91
No TO
TO
Re1
R91
No TO
TO
30 mbar 40 mbar 50 mbar Mean T SD Average (%)
3 (50) 4 (67) 5 (83)
1 (17) 2 (33) 1 (17)
2 (33) 0 (0) 0 (0) 0.67 T 1.15 11
4 (67) 6 (100) 6 (100) 5.33 T 1.15 89
2 (33) 2 (33) 4 (67)
0 (0) 2 (33) 1 (17)
4 (67) 2 (33) 1 (17) 2.33 T 1.53 39
2 (33) 4 (67) 5 (83) 3.67 T 1.53 61
See text defining normal and late TO using the Este`ve method in Materials and Methods. R indicates TO latency ratio; TO, tube opening.
pressures. Similar to our study, they measured tubal patency in both directions, that is, from the middle ear with equalization tests and through the nose/pharynx with the Valsalva maneuver. The Este`ve method represents an automated and calibrated Valsalva maneuver and, with its use, we could precisely measure tube opening pressure and latency. In concordance with the results of Jensen et al. (13), we found that nasal decongestion has a benefit on tube opening if higher pressures are applied in the pharynx. Interestingly, just as in the study by Jensen et al. (13), pressure changes in the outer ear canal (aspiration test and deflation test) did not yield this effect demonstrated with the Valsalva maneuver. Again, it must be emphasized that, according to the setting of our study, these results only refer to measurable short-time effects of nasal decongestants on the tube opening mechanism. However, there are long-term studies in the literature that clinically indicate that any longterm effect of such drops or sprays on tube function is very questionable (6). In conclusion, the application of nasal decongestants will, of course, improve nasal ventilation and perhaps reduce potential nasopharyngeal deposits of mucous but, according to our findings, there are no clinically relevant effects on the ventilatory function of the ET. REFERENCES 1. Swarts JD, Alper CM, Luntz M, et al. Panel 2: Eustachian tube, middle ear, and mastoidVanatomy, physiology, pathophysiology, and pathogenesis. Otolaryngol Head Neck Surg 2013;148:E26Y36.
2. Ars B. Fibrocartilaginous Eustachian TubeYMiddle Ear Cleft. Den Haag, The Netherlands: Kugler, 2003:151Y8. 3. Fraser JG, Mehta M, Fraser PA. The medical treatment of secretory otitis media. A clinical trial of three commonly used regimes. J Laryngol Otol 1977;91:757Y65. 4. Bhambhani K, Foulds DM, Swamy KN, Eldis FE, Fischel JE. Acute otitis media in children: are decongestants or antihistamines necessary? Ann Emerg Med 1983;12:13Y6. 5. Hayden GF, Randall JE, Randall JC, Hendley JO. Topical phenylephrine for the treatment of middle ear effusion. Arch Otolaryngol 1984;110:512Y4. 6. Griffin G, Flynn CA. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database Syst Rev 2011;9:CD003423. 7. van Heerbeek N, Ingels KJ, Zielhus GA. No effect of a nasal decongestant on eustachian tube function in children with ventilation tubes. Laryngoscope 2002;112:1115Y58. 8. Lildholdt T, Cantekin EI, Bluestone CD, Rockette HE. Effect of a topical nasal decongestant on Eustachian tube function in children with tympanostomy tubes. Acta Otolaryngol 1982;94:93Y7. 9. Stillwagon PK, Doyle WJ, Fireman P. Effect of an antihistamine/ decongestant on nasal and Eustachian tube function following intranasal pollen challenge. Ann Allergy 1987;58:442Y6. 10. Turner RB, Darden PM. Effect of topical adrenergic decongestants on middle ear pressure in infants with common colds. Pediatric Infect Dis J 1996;15:621Y4. 11. Karagama YG, Rashid M, Lancaster JL, Karkanevatos A, William RS. Intranasal delivery of drugs to Eustachian tube orifice. J Laryngol Otol 2011;125:934Y9. 12. Rashid M. Rationale and feasibility of intranasal delivery of drugs to the Eustachian tube orifice. Curr Allergy Asthma Rep 2012;12: 541Y6. 13. Jensen JH, Leth N, Bonding P. Topical application of decongestant in dysfunction of the Eustachian tube: a randomized, double-blind, placebo-controlled trial. Clin Otolaryngol Allied Sci 1999;15: 197Y201.
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