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

Autor: Ibekwe TS; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Division of Otorhinolaryngology, Garki Hospital, Abuja, Nigeria., Dahilo EA; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria., Folorunso D; 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., Uzochukwu T; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria., Egbe BI; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria., Quadri OR; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria., Fred D; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria., Etukumana I; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria., Nwankwo BC; Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Awka, Anambra State, Nigeria., Gbujie IO; Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Abuja Clinic, ENT Unit, Abuja, Nigeria.
Jazyk: angličtina
Zdroj: Annals of African medicine [Ann Afr Med] 2022 Jan-Mar; Vol. 21 (1), pp. 65-70.
DOI: 10.4103/aam.aam_17_21
Abstrakt: 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.
Competing Interests: None
Databáze: MEDLINE
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