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