|Year : 2020 | Volume
| Issue : 4 | Page : 221-226
Assessing the efficiency of intranasal steroid treatment in cases with Eustachian dysfunction via the Turkish version of Eustachian tube Dysfunction Questionnaire-7
Adem Bora1, Kasim Durmus1, Berat Baturay Demirkiran1, Yasin Aslan1, Emine Elif Altuntas2
1 Department of Otolaryngology, Faculty of Medicine, Sivas Cumhuriyet University, Sivas, Turkey
2 Department of Otolaryngology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey
|Date of Submission||24-Jul-2020|
|Date of Decision||02-Aug-2020|
|Date of Acceptance||25-Sep-2020|
|Date of Web Publication||23-Apr-2021|
Dr. Adem Bora
Assistant Professor MD. Adem Bora, Department of Otolaryngology, Faculty of Medicine Sivas Cumhuriyet University 58140, Sivas
Source of Support: None, Conflict of Interest: None
Aim: The aim of this study was to evaluate the efficiency of the treatment in the cases, who were diagnosed with Eustachian tube dysfunction (ETD) via history, physical examination, and tympanometry and for whom intranasal steroid treatment was planned to be used before surgical treatment options, by using Eustachian Tube Dysfunction Questionnaire (ETDQ)-7. Materials and Methods: Fifty-five cases, who applied to the otorhinolaryngology outpatient clinic due to the complaints suggesting Eustachian dysfunction such as aural fullness and pressure sensation and for whom the diagnosis of Eustachian dysfunction was considered due to the results of the examination, history, and physical examination, were included in the study. The 3rd and 6th weeks of intranasal steroid treatment ETDQ-7 scores were recorded. Results: ETDQ-7 mean scores of the cases were 2.72 ± 0.97 at the time of initial diagnosis (minimum–maximum: 1–4.71), 2.31 ± 0.85 in the 3rd week of the treatment (minimum–maximum: 1–5), and 2.12 ± 0.78 (minimum–maximum: 1–4, 14) in the 6th week. A statistically significant difference was observed when statistically assessing the ETDQ-7 scores determined at the time of diagnosis and in the 3rd and 6th weeks of the treatment (P < 0.001). When ETDQ-7 scores were assessed based on gender in assessment time, there was a statistically significant difference in the assessment conducted in the 3rd week (P < 0.05; P = 0.039). Conclusion: It is believed that the current study is the first study that evaluates the efficiency of intranasal corticosteroid treatment, which is frequently used by the doctors in daily practice in pharmacotherapy in the cases with ETD from young adult and adult age groups, on the symptoms via ETDQ-7. In addition, the results of the present study indicated that intranasal steroid treatment in early periods caused a significant recovery in the symptoms, however this recovery also reached a plateau after the treatment.
Keywords: Dysfunction, Eustachian Tube Dysfunction Questionnaire-7, Eustachian tube, intranasal steroid, treatment
|How to cite this article:|
Bora A, Durmus K, Demirkiran BB, Aslan Y, Altuntas EE. Assessing the efficiency of intranasal steroid treatment in cases with Eustachian dysfunction via the Turkish version of Eustachian tube Dysfunction Questionnaire-7. Indian J Otol 2020;26:221-6
|How to cite this URL:|
Bora A, Durmus K, Demirkiran BB, Aslan Y, Altuntas EE. Assessing the efficiency of intranasal steroid treatment in cases with Eustachian dysfunction via the Turkish version of Eustachian tube Dysfunction Questionnaire-7. Indian J Otol [serial online] 2020 [cited 2021 Jun 16];26:221-6. Available from: https://www.indianjotol.org/text.asp?2020/26/4/221/314341
| Introduction|| |
Being a complex organ, the Eustachian tube (ET) is composed of a dynamic, mucosal lined canal, cartilage, surrounding soft tissue, peritubal muscles, superior bony support, and the sphenoid sulcus. The ET is normally closed only except for being open to facilitate gaseous pressure regulation of the middle ear. The ET has important functions for the middle ear cavity such as ventilation, pressure regulation, and protection. Eustachian tube dysfunction (ETD) develops when there is a failure in the opening and closing mechanism of the ET or disruption in its functions. IN addition, the term ETD describes various signs, symptoms, and physical findings associated with the disrupted ET functions. Aural fullness, tinnitus, a sensation of being “underwater,” and an inability to rapidly equilibrate middle ear pressure are among the symptoms of ETD. However, its symptoms are frequently unspecific. The ETD can be seen as acute or chronic. Acute ETD can develop during nasal congestion. Therefore, acute ETD is caused mostly by mucosal inflammation within the cartilaginous ET. For this reason, inflammatory procedures including allergic rhinitis, chronic rhinosinusitis, laryngo-pharyngeal reflux, and smoke exposure should be examined for patients. When ETD becomes chronic, it may cause recurrent otitis media with effusion, tympanic membrane retractions, adhesions, chronic otitis media, and hearing loss, depending on the presence of continuous negative pressure in the middle ear cavity.,,,
Majority of the ETD cases are diagnosed based on the reported clinical history; examination; and routine tests such as tympanometry, reflex decay tympanometry, nine-step inflation deflation test, modified inflation deflation test, forced response test, tubomanometry Politzer test, Valsalva and Toynbee maneuver, observation of tympanic membrane movement, computed tomography, tubo-tympano-aerodynamic-graphy, and ET score. Any gold standard method used to diagnose ETD is not present, and the clinical diagnosis established by an experienced clinician has been used as the default reference standard for many years.,,,, The aim of traditional medical treatment including nasal steroid, decongestants, and antihistamines is to enhance the mucosal conditions of the ET. However, their efficiency has not been proven because there is no high-quality studies. In 2011, Gluth et al., investigated the effect of the use of intranasal steroid in the treatment of Eustachian dysfunction both on adult and pediatric patient population and showed that the results obtained had no negative effect on ET functions of intranasal steroid application. However, they pointed out that the most significant weak point of their study was that the questionnaire used in their assessment was not a survey having validity in the assessment of ETD. In 2012, McCoul et al. developed the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) as the first disease-specific instrument for ETD symptoms. The questionnaire was validated and translated into a number of languages. The Turkish validity and reliability study of ETDQ 7 was conducted by Özgür et al., in 2018.
Certainly, ET functions should also be evaluated using objective methods in order to assess objectively the results of the studies in the treatment of ETD. In their study, Gluth et al. pointed out that a nonvalidated questionnaire was used in the interpretation of the results regarding the efficiency of nasal steroids in the treatment of ETD. Due to these reasons, it was aimed to evaluate the efficiency of the treatment in the cases, who were diagnosed with ETD via history, physical examination, and tympanometry and for whom intranasal steroid treatment was planned to be used before surgical treatment options, by using ETDQ-7.
| Materials and Methods|| |
The researchers informed all the participants, who were voluntary to participate in the study, about the study and then their verbal and written consents were obtained and they signed the consent form. Ethics approval of this study was obtained from Sivas Cumhuriyet University Clinical Trials Ethics Committee (dated June 26, 2018, with decision no. 2018-06/02).
Fifty-five cases, who applied to the otorhinolaryngology outpatient clinic due to the complaints suggesting Eustachian dysfunction such as aural fullness and pressure sensation and for whom the diagnosis of Eustachian dysfunction was considered due to the results of the examination, history, and physical examination, were included in the study. No control group was used in the study because the results will be compared with the results obtained before and after treatment.
The inclusion and exclusion criteria specified in accordance with the results of the study by Smith et al., in the literature were taken as a basis in determining the cases to be included in and excluded from the study. Accordingly, the presence of one of the following symptoms in cases was accepted as the inclusion or exclusion criterion of the study.
- The presence of at least two of the symptoms suggesting Eustachian dysfunction
- AND/OR tympanic membrane retraction
- AND/OR negative pressure tympanogram (≤−100 daPa).
- The presence of otoscopic findings likely preventing the use of the full range of index tests (otitis media with effusion, tympanic membrane perforation, cholesteatoma, and discharging or infected ear)
- The use of cardiac pacemaker (incompatible with the sonotubometry speaker)
- The presence of cleft palate or craniofacial abnormality (due to concerns about their ability to perform the full range of tests or to obtain interpretable results)
- Failing to consent or understand written English (Turkish for our study).
In addition, all the cases, who did not agree to sign in the informed consent form or did not agree to participate in the study, and, those, who did not participate in the clinical follow-ups in the 3rd and 6th weeks, were excluded from the study.
Nasal steroid regimen included two sprays of budesonide to each nostril once per day (a total daily dose of 256μg).
The demographic data of all of the cases, who were included in the study, had compliance to treatment, and came for their follow-ups regularly, their examination findings, their application symptoms, their otoscopic examination findings in the 3rd and 6th weeks of intranasal steroid treatment, tympanometric assessment results, and ETDQ-7 scores were recorded. Tympanometric assessment was conducted by using the Tympanometry MAICO MI 44 Analyzer (MAICO Diagnostic GmbH Salzufer 13/14; D-10587 Berlin) device.
Evaluation of Eustachian Tube Dysfunction Questionnaire-7
The cases were assessed by using ETDQ-7, which was revealed to be a valid and reliable method for the clinical practices by McCoul et al., and for which the Turkish validity and reliability were conducted by Özgür et al., ETDQ-7 consists of seven questions and is rated with a 7-point Likert scale. The patient scores the questions in ETDQ-7 between 1 and 7 points. While 1 point signifies no problem, 7 points mean a serious problem. The results are interpreted by dividing the total score into the number of questions.
SPSS 23.0 (SPSS Inc., Chicago, IL) packaged software was used for the assessment of the data. Frequency tables of categoric data were eliminated. Cross-tables of the clinical symptoms, examination findings, and tympanogram shapes were calculated by gender. In the normality test applied for the mean scores of ETDQ-7, it was found out that the variables were normally distributed (P > 0.05). Analysis of variance was used to assess the change of the mean scores of ETDQ-7 depending on the assessment time and dependent samples t-test was used for the change by gender. Results were assessed at confidence level of 95%. In all the analyses, P < 0.05 was accepted as statistically significant.
| Results|| |
Demographic characteristics of the cases
Of the cases included in the study, 72.7% (n = 40) were female (age average of 24.25 ± 7.58 years [minimum–maximum: 15–46 years]) and 27.3% (n = 15) (age average of 24.25 ± 7.58 years [minimum–maximum: 15–46 years]) were male, and the age average of 55 cases was 26.87 ± 11.93 years (minimum–maximum: 15–74 years).
When the cases were assessed in terms of their educational backgrounds, it was found that 78.2% (n = 43) received undergraduate or postgraduate education and 21.8% (n = 12) graduated from high school, secondary school, or primary school. Because all of the cases were literate, they answered all of the questionnaire questions by themselves.
When the cases were assessed in terms of smoking habits, it was found that while 18.2% (n = 10) were smoking 20 and more cigarettes per day, 78.2% (n = 43) never smoked and 3.6% (n = 2) quitted smoking. There was no case that showed a change in smoking habits during the treatment process. For this reason, the effect of smoking habits on ETD has not been evaluated.
When examined in terms of the symptoms before the treatment, it was found that 21.8% (n = 12) had hearing loss, 47.3% (n = 26) had tinnitus, 18.2% (n = 10) had dizziness, 70.9% (n = 39) had the sensation of pressure in the ear, 38.2% (n = 21) had pain, 67.3% (n = 37) had aural fullness, 32.7% (n = 18) had autophonia, and 56.4% (n = 31) had the complaint of hearing sounds from the ear during swallowing. When the cases were examined in terms of the ear suffering from the symptoms, it was found that 3.6% (n = 2) had the complaint in the right ear, 9.1% (n = 5) had the complaint in the left ear, and 87.3% (n = 48) had bilateral complaint. [Table 1] shows distribution of the symptoms before the treatment in terms of gender. When examined in terms of the symptoms after the 6-week treatment, it was found that 21.8% (n = 12) had hearing loss, 40.0% (n = 22) had tinnitus, 14.5% (n = 8) had dizziness, 52.7% (n = 29) had the sensation of pressure in the ear, 38.2% (n = 21) had pain, 54.5% (n = 30) had aural fullness, 23.6% (n = 13) had autophonia, and 56.4% (n = 31) had the complaint of hearing sounds from the ear during swallowing. The changes observed in symptoms after treatment were not statistically significant.
|Table 1: Distribution of the symptoms in the cases in terms of gender before the treatment|
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When the cases were examined in terms of the ear suffering from the symptoms, it was found that 3.6% (n = 2) had the complaint in the right ear, 9.1% (n = 5) had the complaint in the left ear, and 87.3% (n = 48) had bilateral complaint.
[Table 2] shows the shape of the tympanometry determined in the tympanometric assessments conducted in the 3rd and 6th weeks of the treatment and in the initial applications of the cases and its gender distribution.
|Table 2: Distribution of the tympanogram shapes of the cases monitored during their clinical follow-ups, in terms of gender|
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Eustachian Tube Dysfunction Questionnaire-7 assessment
ETDQ-7 mean scores of the cases were 2.72 ± 0.97 at the time of initial diagnosis (minimum–maximum: 1–4.71), 2.31 ± 0.85 in the 3rd week of the treatment (minimum–maximum: 1–5), and 2.12 ± 0.78 (minimum–maximum: 1–4, 14) in the 6th week. In all the 55 cases included in the study, a statistically significant difference was observed when statistically assessing the ETDQ-7 scores determined at the time of diagnosis and in the 3rd and 6th weeks of the treatment (P < 0.001). When ETDQ-7 scores were assessed based on gender in assessment time, it was determined that no statistically difference was found at the time of initial diagnosis and in the 6th week, there was a statistically significant difference in the assessment conducted in the 3rd week (P < 0.05; P = 0.039). This difference was caused by a statistically significant decrease in the ETDQ-7 scores in the 3rd week of intranasal steroid treatment in the male cases when compared to the female cases. In addition, it was observed that ETDQ-7 scores were statistically similar in the 6th week in both genders (P > 0.05; P = 0.129). [Table 3] shows the results of the distribution of ETDQ-7 mean scores according to the time of application and gender.
|Table 3: Distribution of the Eustachian Tube Dysfunction Questionnaire-7 mean scores in terms of the time of application and gender|
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| Discussion|| |
As there is no accepted objective standard diagnostic method for the diagnosis of ETD, it is often conventionally diagnosed by the doctors by assessing their current medical history and current symptoms. However, this method of assessment is a subjective process. Therefore, it is of prime importance to use a reliable and standard measurement method in the assessment of the symptoms as well as the clinical history of patients in the diagnosis of ETD.,, The first questionnaire shown to be specifically used for ETD is EDTQ-7. The fact that EDTQ-7 is used routinely in daily clinical practices similar to questionnaires used for assessing the quality of life surely allows doctors to assess symptoms of patients objectively, establish diagnosis easier, document symptoms in a standardized way, and monitor treatment results reliably. Apart from this, it will play an important role in motivating the treatment compliances of the patients, thereby allowing to monitor the results of the treatment objectively.
Although there is still no exact consensus regarding the treatment of ETD today, the accepted main opinion is to apply a treatment oriented to the underlying reason if the etiological reason can be revealed. As is known, various recommendations and exercises and clinical follow-ups for the patients, pharmacological treatments, and different surgical options such as the insertion of a ventilation tube and balloon tuboplasty take place among the treatment options of ETD. The pharmacological interventions include nasal steroids, antihistamines, and inhale and systemic decongestants.,
In the literature, the number of publications investigating the efficiency of various pharmacological agents in the treatment of ETD with prospective studies is very limited. As a result of the literature review conducted by Norman et al., in 2014, they pointed out that there was no sufficient evidence regarding the primary care medical approaches including the pharmacotherapies and active observation in the treatment of ETD; the published studies were conducted mostly on limited number of patients and had high bias risk, and they had limited level of evidence. As a result, they reported that the evidence level of these studies investigating the efficacy of nasal steroids, antihistamine-ephedrine combinations and decongestants in the treatment of ETD was low.
Gluth et al. pointed out that pathophysiology of ETD is not exactly known, and inflammatory processes in nasal cavity and/or nasopharynx may have a potential in playing a role in acute ETD development. From this point of view, they suggested the hypothesis that “topical nasal corticosteroids may contribute to treatment of ETD” in their study. In their study published in 2011, they assessed the efficiency of intranasal corticosteroid treatment on adult cases and those older than 6 years who completed Eustachian development. The results obtained showed that the use of nasal steroids or placebo did not cause a statistically significant change in the results of tympanometry in the 6th week in pediatric age group and did not make any contribution to treatment. They pointed out that the data obtained from infants should not be applied for adult patients because the ET did not complete its anatomical development exactly in pediatric cases. They found that the success rate in the adult age group with ETD was 6% via the intranasal corticosteroid treatment and specified that this rate was low for the doctors to prefer intranasal corticosteroids in the treatment. Gluth et al. specified that another weak point in their study was the use of a nonvalidated questionnaire for assessing the symptoms.
Apart from the study of Gluth et al., there are other studies investigating the efficiency of nasal corticosteroids in the treatment of ETD in pediatric age group.,,,, In the literature review, conducted by Thomas et al., in 2006 to review systematically the current prospective data regarding the oral or nasal steroid use in otitis media treatment in pediatric age group in the Cochrane Database, they observed that only one prospective study concluded that that nasal steroid treatment combined with antibiotics was more effective than the antibiotic therapy alone in the treatment of chronic otitis media effusion. Of course, the results of a single prospective study are not sufficient to make a consensus decision in the treatments to be applied in the specified patient group. In another study conducted on children with persistent ETD, it was shown that intranasal corticosteroid administration for 3 weeks could have a positive effect on the treatment. In the present study, it was emphasized that the highest recovery in the symptoms of patients was observed in the first 2 weeks of intranasal corticosteroid treatment, thus, it was important to limit the treatment with 2 weeks in pediatric cases in order to prevent the changes in serum cortisol levels. The results obtained from the study showed similarity with the results of the study by Shapiro et al., and it was seen that there was a statistically significant decrease in the ETDQ-7 scores as from the 3rd week of the treatment in all of the cases. When the change in the ETDQ-7 mean scores was assessed according to the application time and gender, it was seen that even though there was a significant decrease in the ETDQ-7 mean scores of male cases in the 3rd week of treatment process, the difference between two genders was eliminated as from the 6th week. Apart from this, although it was not statistically significant in female cases, there was a tendency to decrease in the ETDQ-7 mean scores evaluated throughout the treatment period; however, a slight increase was found in male cases between the 3rd and 6th weeks. It was thought that the difference in the change in the ETDQ-7 scores between both genders may have caused by the anatomical and physiological differences. However, because there is no similar study in the literature in order to compare the results, it is thought that it will not be correct to make a judgment about this matter.
| Conclusion|| |
As a result, Özgür et al. previously showed that ETDQ-7, whose Turkish validity and reliability was conducted, can be used in the diagnosis of ETD and in the assessment of the severity of the disease. However, upon the literature reviews, no study assessing the efficiency of intranasal corticosteroid treatment in patients with ETD by using ETDQ-7 was not found. Therefore, it is believed that the current study is the first study that evaluates the efficiency of intranasal corticosteroid treatment, which is frequently used by the doctors in daily practice in pharmacotherapy in the cases with ETD from young adult and adult age groups, on the symptoms via ETDQ-7. In addition, the results of the present study indicated that intranasal steroid treatment in early periods caused a significant recovery in the symptoms, however this recovery also reached a plateau after the treatment.
When all the results are taken into account, this has suggested that the clinical results of the treatment options applied in the cases with ETD can be monitored by ETDQ-7 in future. However, we believe that it would be a more correct approach to make definite interpretations on a larger patient population and after a long-term follow-up in terms of assessing efficiency intranasal corticosteroid treatment in cases with ETD. Moreover, it is thought that it is required to conduct further studies in order to evaluate whether or not ETDQ-7 is a suitable scale to assess the treatment response.
We would like to thank Selim Çam for his contribution to statistical evaluation.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]