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. 2013 May 31;2013(5):CD006285. doi: 10.1002/14651858.CD006285.pub2

1. Side effects and compliance.

Trial Side effects Compliance
Arick 2005 As part of 1‐year follow‐up 
 2 children with MEE (hearing restored) 
 3 children had either grommets inserted and/or enlarged adenoid Compliance of 97.9% (46/47)
Blanshard 1993 Stratified by compliance level: 
 Attacks of OM: 44% control, 36% HC, 30% LC 
 URTI: 61% LC, 32% HC, 23% control 
 Tonsillitis: 22% LC, 5% HC, 13% control 
 Antibiotics: 43% LC, 21% HC, 33% control 
 "No complications arose from using the treatment" 45% high compliance (HC), 43% low compliance (LC), 12% unable to use device 
 
 Some children with OME found doing the Valsalva manoeuvre painful
Brooker 1992 None reported Parents reported good compliance
De Nobili 2008 None reported Not reported
Ercan 2005 None reported "satisfactory"
Fraser 1977 Some children developed further symptoms and abnormal signs while receiving treatments (do not mention which group) Not reported
Lesinskas 2003 Treatment (middle ear inflation) stopped for 1 adult patient due to painfulness of procedure 100% follow‐up and compliance (done by physician)
Stangerup 1992 "We have not observed an increase incidence in middle ear infection or eardrum perforation in connection with autoinflation" 
 No comment given on baseline incidence level Compliance at 2 weeks: 
 33/51 (65%) high compliance 
 10/51 (20%) low compliance 
 3/51 (6%) no compliance 
 No data given on the other 5 children

HC: high compliance 
 LC: low compliance 
 MEE: middle ear effusion 
 OM: otitis media 
 OME: otitis media with effusion 
 URTI: upper respiratory tract infection