Tracy 1998.

Methods	Randomised, placebo‐controlled trial; 3 parallel groups
Participants	61 children aged from 3 to 11 years recruited from a military‐dependent population referred to the Medical Centre‐based paediatric Chronic Ear Clinic Participants had persistent middle ear effusion for at least 3 months and a minimum of 3 episodes of acute OM within past 6 months or 4 in past year Diagnosis: 1B, 2C Not clear how many bilateral
Interventions	Antibiotic (amoxycillin) plus aqueous intra‐nasal beclomethasone 2 sprays BD in each nostril both for 12 weeks (n = 19) versus antibiotic plus placebo (n = 20) (versus antibiotic alone (n = 20))
Outcomes	Tympanic pressures scores, otoscopic examination scores, symptom scores and OME resolution. For patient symptoms both a mean total score (using a visual analogue scale, range 0 to 100) and a mean score for 4 ear‐associated symptoms were reported, but only the former is included in our meta‐analyses. OME resolution was reported separately according to middle ear pressure criteria and otoscopic examination score criteria (the former was used in the meta‐analysis). Antibiotic plus placebo and antibiotic alone groups pooled for the outcomes relating to resolution of OME Follow up at 4, 8 and 12 weeks after entry Other than transient nasal stinging and epistaxis no significant side effects (that required discontinuation of treatment) were reported (numbers not stated)
Notes	Validation of symptom score not described No differences in outcome between atopic and non‐atopic subjects
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of sequence generation not stated
Allocation concealment (selection bias)	Low risk	Quote: "Preparation and dispensing of drugs as well as randomization of patients to each arm of the study was accomplished independently by a clinical pharmacologist"
Blinding (performance bias and detection bias) All outcomes	Low risk	Unclear if outcome assessors were blind, but study reported as double‐blind
Incomplete outcome data (attrition bias) < 1 month	Unclear risk	—
Incomplete outcome data (attrition bias) 1 to 6 months	Low risk	2 participants (3%) were lost to follow up due to families moving away (group allocation not stated) and excluded from analysis
Selective reporting (reporting bias)	Unclear risk	OME resolution data reported as percentages. Mean tympanic membrane pressure and median otoscopic exam score were reported in graphical format only and data were presented separately for left and right ear; number of participants with unilateral and bilateral OME not stated.
Other bias	Unclear risk	More participants in the placebo group (45%) had a smoker present at home than in the intervention group (16%)