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ORIGINAL ARTICLE
Year : 2022  |  Volume : 21  |  Issue : 1  |  Page : 65-70  

Update on first African clinical trial on earpopper for the treatment of otitis media with effusion [FCT/UATH/HREC/PR/330]


1 Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Division of Otorhinolaryngology, Garki Hospital, Abuja, Nigeria
2 Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria
3 Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Division of Otorhinolaryngology, Garki Hospital; Department of Surgery, ENT Unit Kubwa General Hospital, Abuja, Nigeria
4 Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Awka, Anambra State, Nigeria
5 Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Abuja Clinic, ENT Unit, Abuja, Nigeria

Date of Submission21-Jan-2021
Date of Acceptance28-Sep-2021
Date of Web Publication18-Mar-2022

Correspondence Address:
Titus Sunday Ibekwe
Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, and Division of Otorhinolaryngology, Garki Hospital
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/aam.aam_17_21

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   Abstract 


Background: Otitis media with effusion (OME) is a middle ear condition characterized by the accumulation of serous fluid. It is common, though not exclusive; among children with its attendant developmental consequence if missed or untreated in early life. OME could be managed surgically, pharmacologically, or physiologically. EarPopper is a medical device developed for physiologic management of OME, Eustachian tube dysfunction, and related problems. We aim to ascertain the suitability/efficiency of EarPopper® device for the treatment of OME in our setting. Methodology: This is a prospective interventional study of volunteers diagnosed with OME from four (4) medical centers in Abuja. Pneumatic otoscopy, video-otoscopy, tympanometry, and pure-tone audiometry were done to confirm the diagnosis. Serial EarPopper sessions were performed twice weekly for 2–12 weeks, and outcome was assessed using patients' reports. The reports include the EarPopper scoring system (ESS) and audiometric parameters (before and after therapy). Results: Forty-five patients (17 males and 28 females) aged between 3–56 years were enrolled. Thirty-five were diagnosed with bilateral OME and 10 unilateral. All patients had Type-B tympanometry tracing with mild-to-moderate conductive hearing losses and ESS of between 2.45% and 84%. Out of the 45 participants, 32 (71.1%) completed the treatment, whereas 13 (28.9%) were lost to follow-up. Duration of EarPopper treatment ranged from 2 to 12 weeks. The outcome revealed improvement in 26/32 (81.3%) with significant reduction in ESS (1% to 9.8%). Six patients 6/32 (18.9%) had persistence symptoms. These 18.9% had the propensity to progress to chronic OME. Conclusion: This study highly suggests good prospect in using EarPopper for the management of OME among Africans.

   Abstract in French 

Résumé
Contexte: L'otite séreuse est une affection de l'oreille moyenne caractérisée par l'accumulation de liquide séreux. Cette condition est courante chez les enfants (mais pas exclusivement) avec des conséquences développementales qui s'élabore si la diagnostique est manquées ou non traitées pendant les premières années de vie. L'otite séreuse peut être prise en charge chirurgicalement, pharmacologiquement ou physiologiquement. “ EarPopper “ est un appareil médical développé pour la gestion physiologique de l'otite séreuse, du dysfonctionnement de la trompe d'Eustache et des problèmes associés. Nous visons à déterminer la convenance/l'efficacité de l'appareil EarPopper® pour le traitement de l'otite séreuse dans notre environnement. Méthodologie: Il s'agit d'une étude interventionnelle prospective sur des volontaires ayant reçu un diagnostic de l'otite séreuse dans quatre (4) centres médicaux à Abuja. Une otoscopie pneumatique, une vidéo-otoscopie, une tympanométrie et une audiométrie tonale ont été réalisées pour confirmer le diagnostic. Des sessions EarPopper® en série ont été effectuées deux fois par semaine pendant 2 à 12 semaines, et les résultats ont été évalués à l'aide des rapports des patients. Les rapports incluent le système de notation EarPopper® (ESS) et les paramètres audiométriques (avant et après la thérapie). Résultats: Quarante-cinq patients (17 hommes et 28 femmes) âgés de 3 à 56 ans ont été inclus. Trente-cinq ont reçu un diagnostic de l'otite séreuse bilatérale et 10 unilatérales. Tous les patients avaient un tracé tympanométrique de type B avec des pertes auditives de transmission légères à modérées et une ESS comprise entre 2,45 % et 84 %. Sur les 45 participants, 32 (71,1 %) ont terminé le traitement, tandis que 13 (28,9 %) ont été perdus de vue. La durée du traitement EarPopper® variait de 2 à 12 semaines. Les résultats ont révélé une amélioration dans 26/32 patients (81,3%) avec une réduction significative de l'ESS (1% à 9,8%). Six patients (6/32 ; 18,9 %) on présentaient avec des symptômes persistants. Ces 18,9% avaient une propension à évoluer vers une otite séreuse chronique. Conclusion: Cette étude suggère fortement de bonnes perspectives d'utilisation d'EarPopper® pour la gestion de l'otite séreuse chez les Africains.
Mots-clés: EarPopper®, l'otite séreuse, tympanométrie

Keywords: EarPopper, otitis media with effusion, tympanometry


How to cite this article:
Ibekwe TS, Dahilo EA, Folorunso D, Uzochukwu T, Egbe BI, Quadri OR, Fred D, Etukumana I, Nwankwo BC, Gbujie IO. Update on first African clinical trial on earpopper for the treatment of otitis media with effusion [FCT/UATH/HREC/PR/330]. Ann Afr Med 2022;21:65-70

How to cite this URL:
Ibekwe TS, Dahilo EA, Folorunso D, Uzochukwu T, Egbe BI, Quadri OR, Fred D, Etukumana I, Nwankwo BC, Gbujie IO. Update on first African clinical trial on earpopper for the treatment of otitis media with effusion [FCT/UATH/HREC/PR/330]. Ann Afr Med [serial online] 2022 [cited 2022 Nov 29];21:65-70. Available from: https://www.annalsafrmed.org/text.asp?2022/21/1/65/339923




   Introduction Top


Otitis media with effusion (OME) is a pathological condition associated with the accumulation of nonpurulent mucoid or serous fluid in the middle ear cleft in an intact tympanic membrane. OME, also called mucoid otitis media, glue ear, secretory otitis media, or serous otitis media depending on the consistency of the fluid, results from either Eustachian tube disorder or hyperactivity of the middle ear glands.[1] Every child aged 2 months to 12 years is prone to developing OME.[2] According to the American Academy of Otorhinolaryngology Head and Neck Surgery's Committee on OME, more than 50% of children will suffer from OME within their 1st year of life and over 60% by their second birthday.[2] Downs syndrome, craniofacial abnormalities, or congenital anatomical defects of the nasopharynx are associated with 93% OME prevalence rate, before surgical repairs.[3] It is mainly a childhood disease (85% of cases) and rarely seen in adults.[4] Adenoid enlargement, eustachian tubes (ET) dysfunctions, and atopy are mainly the etiological factors in children,[4] whereas nasopharyngeal tumors, rhinosinusitis, and barotrauma are in adults.[5]

The management of OME could be medical, surgical, or physiological. Medical measures include the administration of decongestants, antihistamines, corticosteroids, and sometimes antibiotics. The benefits of antihistamines and antibiotics have been questioned and/or not recommended for treatment.[2]

Surgical measures may include myringotomy, with or without tympanostomy tube placement, adenoidectomy with or without tonsillectomy. Critics of the surgical method have cited middle ear infections, retraction of tympanic membrane™, recurrence, among others as some of the setbacks associated with the method. The physiological methods are noninvasive procedures hinging on the natural-physiology of maintaining pressure equilibrium and dry middle ear in man, for example, Valsalva maneuver, functional Eustachian tube, and the Politzer principles. The above enumerated methods could serve as adjunct to the management of the OME or definitive on its own. It is necessary to ensure the early resolution of OME to avoid adverse consequences and complications.[6] To this end, there is a need for an inexpensive, efficient, nontraumatic, and least complication-prone method for the management of OME. This led to the development of the EarPopper® which is based on the Politzer physiology principles.[7],[8] It is a medical device that brings about the decongestion of the middle ear cavity through insufflations of the ET. Similarly, a related problem to OME, where the EarPopper therapy could be indicated is the eustachian tube dysfunction.[8],[9] The ascent or descent of the heights can cause serious discomfort which sometimes threaten career prospects. The Valsalva maneuvers and Politzer have been deployed in managing such patients, and sometimes decompression may be necessary. The EarPopper® was also reported to be effective in two other ways (a) resolution of suppurative otitis media by aeration and oxygenation of the anaerobic milieu in the middle ear[8],[10] and (b) serving as an improvised hand-held respirator in respiratory insufficiency-related illnesses.[11]

It has passed through all necessary stages of scrutiny including clinical trials in the USA and finally got the approval of the FDA in 2007.[8],[9] The method appears safe and efficient among users in the USA and Europe but yet to be tested among Africans. Therefore, this study is aimed at assessing the efficiency of EarPopper® device for the treatment of OME in our setting.


   Methodology Top


A prospective interventional study of volunteers diagnosed with OME from four medical centers in Abuja (registration approval FCT/UATH/HREC/PR/330);

  1. University of Abuja Teaching Hospital, Abuja
  2. Garki Hospital, Abuja
  3. Abuja Clinic, Abuja
  4. Kubwa General Hospital.


A successful pilot study to assess the suitability of the methods and also validate the EarPopper Scoring System (ESS) was conducted in three of the four study centers.[11] Pneumatic otoscopy, video otoscopy, tympanometry, and pure tone audiometry were done to confirm OME on the volunteers before enrollment into the study proper. The criteria for inclusion were (a) clinical evidence of OME, namely, symptoms and otoscopic features; (b) confirmation of OME through Type B tympanogram obtained using Amplaid-tymp model A756; (c) evidence of Conductive Hearing Loss (CHL) with tuning fork and pure tone audiometry using Amplivox 270 model audiometer/ISO calibrated.

The enrollment of patients was through convenient sampling method, and the ethical considerations in line with the Helsinki Declaration were followed. They had serial Ear-Ppopper (model EP-3000) therapies [Figure 5], twice weekly for 2–12 weeks. The outcome was evaluated using patients' reports, ESS, and the Audiometric Assessment Parameters. Resolution of OME: this refers to a total clearance of effusion within the middle ear which was assessed using a dichotomous variable of “absence” or “presence” of effusion posttreatment and clinical reports. Nonresolution for OME – this refers to a persistence or presence of middle ear effusion after 12 weeks of treatment with ear popper.
Figure 1: EarPoppers and the components

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Figure 2: EarPopper scoring system

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Figure 3: Tympanometry tracing 1

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Figure 4: Tympanometry tracing 2

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Figure 5: Performing the EarPopper procedure

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   Results Top


Forty-five patients (17 males and 28 females) aged between 3 and 56 years were enrolled in the study [Table 1]. Thirty-five were diagnosed of bilateral OME and ten were unilateral (80 ears). All the patients had Type B-tympanometry tracing curves with mild-to-moderate CHLs. The pretherapy ESS was between 2.45% and 84% [Table 1]. The duration of the EarPopper therapies ranged from 2 to 12 weeks. Out of the 45 patients that participated, 32 (71.1%) completed the treatment, whereas 13 (28.9%) were lost to follow-up [Table 1] and [Table 2]. PostEarPopper therapy outcome revealed resolution in seven unilateral cases and twenty bilateral cases (comprising a successful resolution in 47 Ears) out of the 29 bilateral and three unilateral cases (61 ears). One bilateral case had unilateral resolution [Table 2]. The overall percentage OME resolution was 47/60 ears (78.3% success) and 27/32 patients (84.4%).
Table 1: Pre - and post - therapy EarPopper scoring system

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Table 2: Values and outcome of the EarPopper scoring system

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The posttherapy ESS dropped significantly; from 2.45%–84% to 1%–9.8%. This is about 240% to 840% significant improvement. Six patients 6/32 (18.9%) had persistence symptoms. These 18.9% had the propensity to progress to chronic OME.


   Discussion Top


The EarPopper [Figure 1] has been successfully tested in young children. Arick and Silman[7] in 2005 carried out a randomized control study on children between 4 and 11 years in the United States of America. The study reported significant improvements with the remarkable recovery of hearing sensitivity. They noted that further studies of safety and effectiveness were required in children younger than 4 years, adolescents, and adults. Our study was aimed at filling in the gap by including both children and adults. Many episodes of OME resolve spontaneously within 3 months, but about 30% to 40% of children have recurrent OME and 5% to 10% of episodes past 1 year or longer.[2] Forty-seven (47-out of the 61 ears involved) in this study, so far, have achieved complete resolution and no harm/injury was noticed in any of the patients [Table 1] and [Table 2]. Their ESS [Table 1] also improved significantly from 2.45%–84% to 1%–9.8% (Over 200% to 800%) improvement. [Figure 2] is the graphic representation of the ESS, whereas [Table 2] depicts the values recorded pre- and post-therapy. [Figure 3] and [Figure 4] are essential graphic representation of values recorded during the course of the EarPopper Therapy including tympanometry and audiometric tracings. Only about 18.9% had the propensity to progress to chronic OME. This clinical trial highly suggests good prospect in the management of OME among Nigerians. There is a need for an expanded multicenter randomized control study.

Recommendations

EarPopper therapy should be considered as first-line treatment option for OME before the contemplation on ear tube insertion to avoid unnecessary surgeries.


   Conclusion Top


This clinical trial highly suggests good prospect in the management of OME among Africans. There is a need for an expanded multicenter randomized control study.

Acknowledgment

Dr. Perpetua Ibekwe for revising the manuscript, Prof. Silman et al. for donating the Ear-poppers used for the research work and the management of the hospitals where the research was conducted.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Ibekwe TS, Nwaorgu OG. Classification and management challenges of otitis media in a resource-poor country. Niger J Clin Pract 2011;14:262-9.  Back to cited text no. 1
[PUBMED]  [Full text]  
2.
Rosenfeld RM, Shin JJ, Schwartz SR, Coggins R, Gagnon L, Hackell JM, et al. Clinical practice guideline: Otitis media with effusion (Update). Otolaryngol Head Neck Surg 2016;154:S1-41.  Back to cited text no. 2
    
3.
Barr E, Dungworth J, Hunter K, McFarlane M, Kubba H. The prevalence of ear, nose and throat disorders in preschool children with Down's syndrome in Glasgow. Scott Med J 2011;56:98-103.  Back to cited text no. 3
    
4.
Songu M, Islek A, Imre A, Aslan H, Aladag I, Pinar E, et al. Risk factors for otitis media with effusion in children with adenoid hypertrophy. Acta Otorhinolaryngol Ital 2020;40:133-7.  Back to cited text no. 4
    
5.
Somefun AO, Adefuye SA, Danfulani MA, Afolabi S, Okeowo PA. Adult onset otitis media with effusion in Lagos. Niger Postgrad Med J 2005;12:73-6.  Back to cited text no. 5
    
6.
Schilder AG. Assessment of complications of the condition and of the treatment of otitis media with effusion. Int J Pediatr Otorhinolaryngol 1999;49 Suppl 1:S247-51.  Back to cited text no. 6
    
7.
Arick DS, Silman S. Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part I: Clinical trial. Ear Nose Throat J 2005;84:567-8, 570-4, 576.  Back to cited text no. 7
    
8.
Silman S, Arick DS, Emmer MB. Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: Validation study. Ear Nose Throat J 2005;84:646, 648, 650.  Back to cited text no. 8
    
9.
Silman S, Arick D. Efficacy of a modified politzer apparatus in management of eustachian tube dysfunction in adults. J Am Acad Audiol 1999;10:496-501.  Back to cited text no. 9
    
10.
Ibekwe TS. Improvised hand-held respirator: Life-saving in the management of moderate to severe COVID-1. Orient J Med 2021;33:67-70.  Back to cited text no. 10
    
11.
Ibekwe TS, Dahilo EA, Folorunsho DO, Uzochukwu T, Egbe B, Quadri OR, et al. Use of EarPopper® for the treatment of otitis media with effusion: A first pilot study in Africa. Orient J Med 2021;33:52-6.  Back to cited text no. 11
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1], [Table 2]



 

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