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. 2015 Jul 22;2015(7):CD011032. doi: 10.1002/14651858.CD011032.pub2

Summary of findings 2. Intermittent ICS versus placebo for preschool children with wheeze.

Intermittent ICS versus placebo for preschool children with wheeze
Patient or population: Preschool children
 Settings: Community
 Intervention: Intermittent ICS
Control: Placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Exacerbations requiring oral corticosteroids 
 Follow‐up: 12‐52 weeks 434 per 1000 269 per 1000 
 (192 to 359) OR 0.48 
 (0.31 to 0.73) 490
 (4 studies) ⊕⊕⊕⊝
 moderate1  
Serious adverse events 
 Follow‐up: 3 to 12 months 82 per 1000 36 per 1000 
 (15 to 83) OR 0.42 
 (0.17 to 1.02) 439
 (3 studies) ⊕⊕⊝⊝
 low1,2  
Hospitalisations 
 Follow‐up: 6 to 12 months 149 per 1000 113 per 1000 
 (39 to 286) OR 0.73 
 (0.23 to 2.29) 327
 (3 studies) ⊕⊝⊝⊝
 very low1,2,3  
Quality of Life 
 PedsQL total score
 Follow‐up: mean 12 months   The mean quality of life in the intervention groups was
 3.28 higher 
 (‐2.13 to 8.69 higher)   143
 (1 study) ⊕⊕⊝⊝
 low3,4  
Day time asthma score 
 Standardised mean difference
 Follow‐up: 12‐52 weeks   The mean daytime asthma score in the intervention groups was
 0.35 standard deviations lower 
 (0.57 to 0.13 lower)   364
 (3 studies) ⊕⊕⊕⊝
 moderate1 SMD ‐0.35 (‐0.57 to ‐0.13); where higher symptom scores indicate worse symptoms
Night time asthma score 
 Standardised mean difference
 Follow‐up: 12‐52 weeks   The mean nighttime asthma score in the intervention groups was
 0.28 standard deviations lower 
 (0.50 to 0.06 lower)   364
 (3 studies) ⊕⊕⊕⊝
 moderate1 SMD ‐0.28 (‐0.50 to ‐0.06); where higher symptom scores indicate worse symptoms
Adverse events 
 Follow‐up: 6 months 304 per 1000 273 per 1000 
 (155 to 433) OR 0.86 
 (0.42 to 1.75) 166
 (1 studies) ⊕⊕⊝⊝
 low2,4  
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

1 The included studies vary significantly in their inclusion criteria and risk factors for developing asthma.
 2 There were very few events leading to wide confidence intervals.

3 The confidence interval crosses no difference and does not rule out a small increase.

4 This is based on the results of only one study.