Armin Bidarian-Moniri1, Maria-João Ramos2, Hasse Ejnell3. 1. Department of Otorhinolaryngology, Institute of Clinical Sciences, Sahlgrenska Academy at the University Of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Otorhinolaryngology, Centro Hospitalar do Algarve, Department of Biomedical Sciences and Medicine, University of Algarve, Algarve, Portugal. Electronic address: armin.bidarian@vgregion.se. 2. Department of Otorhinolaryngology, Centro Hospitalar do Algarve, Department of Biomedical Sciences and Medicine, University of Algarve, Algarve, Portugal. 3. Department of Otorhinolaryngology, Institute of Clinical Sciences, Sahlgrenska Academy at the University Of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
Abstract
OBJECTIVES: The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion (OME) in young children. METHODS:Forty-five children with persistent OME with a bilateral type B or C2 tympanogram for at least three months and history of subjective hearing loss, waiting for grommet surgery, were randomised to a treatment and a control group. Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation. Another 22 children, aged between two and eight years were included as controls. After a period of four weeks, a cross-over was performed. Both groups underwent otomicroscopy, tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency. The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks. Both groups were then followed up for another 10 months. RESULTS: In the treatment group, the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by 166 daPa (p<0.0001) and 6 dB (p<0.0001), respectively after four weeks, while in the control group, non-significant alterations were observed. After the cross-over of the control group to treatment, equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of 187 daPa (p<0.0001) and 7 dB (p<0.01), respectively were achieved also in this group. After treatment in both groups at eight weeks, four of 45 children were submitted to grommet surgery. During the long-term follow-up another five children were submitted to surgery due to recurrence of disease. All the children managed to perform the manoeuvre and no side-effects were detected. CONCLUSION: The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period.
RCT Entities:
OBJECTIVES: The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion (OME) in young children. METHODS: Forty-five children with persistent OME with a bilateral type B or C2 tympanogram for at least three months and history of subjective hearing loss, waiting for grommet surgery, were randomised to a treatment and a control group. Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation. Another 22 children, aged between two and eight years were included as controls. After a period of four weeks, a cross-over was performed. Both groups underwent otomicroscopy, tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency. The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks. Both groups were then followed up for another 10 months. RESULTS: In the treatment group, the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by 166 daPa (p<0.0001) and 6 dB (p<0.0001), respectively after four weeks, while in the control group, non-significant alterations were observed. After the cross-over of the control group to treatment, equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of 187 daPa (p<0.0001) and 7 dB (p<0.01), respectively were achieved also in this group. After treatment in both groups at eight weeks, four of 45 children were submitted to grommet surgery. During the long-term follow-up another five children were submitted to surgery due to recurrence of disease. All the children managed to perform the manoeuvre and no side-effects were detected. CONCLUSION: The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period.
Authors: Henrik Szőke; Márta Maródi; Jan Vagedes; Balázs Székely; István Magyarosi; Adél Bedő; Veronika Fellegi; Krisztina Somogyvári; Péter Móricz Journal: Antibiotics (Basel) Date: 2021-01-30