Hye Ah Joo, Sung-Min Park, Yehree Kim, Dong Kyu Lee, Yun Ji Lee, Yeonjoo Choi, Woo Seok Kang, Joong Ho Ahn, Jong Woo Chung, Won-Ho Chung, Ja-Won Koo, Hong Ju Park
{"title":"球囊咽鼓管成形术治疗慢性化脓性中耳炎和扩张性咽鼓管功能障碍：一项随机对照试验。","authors":"Hye Ah Joo, Sung-Min Park, Yehree Kim, Dong Kyu Lee, Yun Ji Lee, Yeonjoo Choi, Woo Seok Kang, Joong Ho Ahn, Jong Woo Chung, Won-Ho Chung, Ja-Won Koo, Hong Ju Park","doi":"10.21053/ceo.2024.00281","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction. However, its efficacy in patients with both chronic suppurative otitis media (COM) and ET dysfunction remains unclear. The objective of the trial was to assess the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, which was defined by a failed Valsalva maneuver.</p><p><strong>Methods: </strong>In this prospective, multicenter, randomized controlled trial, a total of 116 participants (121 ears) treated between January 2021 and June 2023 were randomly assigned (1:1) to receive either BET with MM or MM alone (fluticasone furoate nasal steroid spray). The short-term primary outcome was the normalization of the Valsalva maneuver at the 8-week follow-up. Secondary outcomes were improved Eustachian Tube Dysfunction Questionnaire- 7 (ETDQ-7) scores and decreased air-bone gap (ABG) analyzed at 8 weeks. Adverse events were monitored in both groups during the follow-up period.</p><p><strong>Results: </strong>Among the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. Demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, and ABG did not differ significantly between the groups. In the BET group, 46.8% (29/62, ears) achieved a successful Valsalva maneuver compared with 15.3% (9/59, ears) in the MM-only group (p<0.001). BET group (-6.2±9.4) showed greater subjective symptom improvement than the MM-only group (-2.6±8.6) regarding ETDQ-7 scores (p=0.028). ABG decreased more in the BET group (-5.8±11.4 dB) compared with the MM-only group (-1.2±10.5 dB) (p=0.023). No serious procedure-related or device-related adverse events occurred in either group during the 8-week follow-up.</p><p><strong>Conclusion: </strong>Our trial suggests that BET, combined with MM, demonstrated superiority over MM alone, along with its safety, in treating dilatory ET dysfunction in patients with COM.</p>","PeriodicalId":10318,"journal":{"name":"Clinical and Experimental Otorhinolaryngology","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Balloon eustachian tuboplasty in chronic suppurative otitis media and dilatory eustachian tube dysfunction: a randomized controlled trial.\",\"authors\":\"Hye Ah Joo, Sung-Min Park, Yehree Kim, Dong Kyu Lee, Yun Ji Lee, Yeonjoo Choi, Woo Seok Kang, Joong Ho Ahn, Jong Woo Chung, Won-Ho Chung, Ja-Won Koo, Hong Ju Park\",\"doi\":\"10.21053/ceo.2024.00281\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction. However, its efficacy in patients with both chronic suppurative otitis media (COM) and ET dysfunction remains unclear. The objective of the trial was to assess the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, which was defined by a failed Valsalva maneuver.</p><p><strong>Methods: </strong>In this prospective, multicenter, randomized controlled trial, a total of 116 participants (121 ears) treated between January 2021 and June 2023 were randomly assigned (1:1) to receive either BET with MM or MM alone (fluticasone furoate nasal steroid spray). The short-term primary outcome was the normalization of the Valsalva maneuver at the 8-week follow-up. Secondary outcomes were improved Eustachian Tube Dysfunction Questionnaire- 7 (ETDQ-7) scores and decreased air-bone gap (ABG) analyzed at 8 weeks. Adverse events were monitored in both groups during the follow-up period.</p><p><strong>Results: </strong>Among the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. Demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, and ABG did not differ significantly between the groups. In the BET group, 46.8% (29/62, ears) achieved a successful Valsalva maneuver compared with 15.3% (9/59, ears) in the MM-only group (p<0.001). BET group (-6.2±9.4) showed greater subjective symptom improvement than the MM-only group (-2.6±8.6) regarding ETDQ-7 scores (p=0.028). ABG decreased more in the BET group (-5.8±11.4 dB) compared with the MM-only group (-1.2±10.5 dB) (p=0.023). No serious procedure-related or device-related adverse events occurred in either group during the 8-week follow-up.</p><p><strong>Conclusion: </strong>Our trial suggests that BET, combined with MM, demonstrated superiority over MM alone, along with its safety, in treating dilatory ET dysfunction in patients with COM.</p>\",\"PeriodicalId\":10318,\"journal\":{\"name\":\"Clinical and Experimental Otorhinolaryngology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-02-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Experimental Otorhinolaryngology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.21053/ceo.2024.00281\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OTORHINOLARYNGOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Otorhinolaryngology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21053/ceo.2024.00281","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OTORHINOLARYNGOLOGY","Score":null,"Total":0}
Balloon eustachian tuboplasty in chronic suppurative otitis media and dilatory eustachian tube dysfunction: a randomized controlled trial.
Objectives: Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction. However, its efficacy in patients with both chronic suppurative otitis media (COM) and ET dysfunction remains unclear. The objective of the trial was to assess the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, which was defined by a failed Valsalva maneuver.
Methods: In this prospective, multicenter, randomized controlled trial, a total of 116 participants (121 ears) treated between January 2021 and June 2023 were randomly assigned (1:1) to receive either BET with MM or MM alone (fluticasone furoate nasal steroid spray). The short-term primary outcome was the normalization of the Valsalva maneuver at the 8-week follow-up. Secondary outcomes were improved Eustachian Tube Dysfunction Questionnaire- 7 (ETDQ-7) scores and decreased air-bone gap (ABG) analyzed at 8 weeks. Adverse events were monitored in both groups during the follow-up period.
Results: Among the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. Demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, and ABG did not differ significantly between the groups. In the BET group, 46.8% (29/62, ears) achieved a successful Valsalva maneuver compared with 15.3% (9/59, ears) in the MM-only group (p<0.001). BET group (-6.2±9.4) showed greater subjective symptom improvement than the MM-only group (-2.6±8.6) regarding ETDQ-7 scores (p=0.028). ABG decreased more in the BET group (-5.8±11.4 dB) compared with the MM-only group (-1.2±10.5 dB) (p=0.023). No serious procedure-related or device-related adverse events occurred in either group during the 8-week follow-up.
Conclusion: Our trial suggests that BET, combined with MM, demonstrated superiority over MM alone, along with its safety, in treating dilatory ET dysfunction in patients with COM.
期刊介绍：
Clinical and Experimental Otorhinolaryngology (Clin Exp Otorhinolaryngol, CEO) is an international peer-reviewed journal on recent developments in diagnosis and treatment of otorhinolaryngology-head and neck surgery and dedicated to the advancement of patient care in ear, nose, throat, head, and neck disorders. This journal publishes original articles relating to both clinical and basic researches, reviews, and clinical trials, encompassing the whole topics of otorhinolaryngology-head and neck surgery.
CEO was first issued in 2008 and this journal is published in English four times (the last day of February, May, August, and November) per year by the Korean Society of Otorhinolaryngology-Head and Neck Surgery. The Journal aims at publishing evidence-based, scientifically written articles from different disciplines of otorhinolaryngology field.
The readership contains clinical/basic research into current practice in otorhinolaryngology, audiology, speech pathology, head and neck oncology, plastic and reconstructive surgery. The readers are otolaryngologists, head and neck surgeons and oncologists, audiologists, and speech pathologists.
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