Table 137Summary clinical evidence profile: Comparison 1. Fluticasone versus placebo

Comparison 1. Fluticasone versus placebo
OutcomesIllustrative comparative risks* (95% CI)Relative effect (95% CI)No of Participants (studies)Quality of the evidence (GRADE)Comments
Assumed riskCorresponding risk
PlaceboFluticasone
Time to first exacerbation
Follow-up: 6 months
460 per 10001483 per 1000 (342 to 645)1HR 1.07 (0.68 to 1.6838)2171
(Balfour-Lynn 2006)
⊕⊕⊝⊝
low1
Growth (change in height) SDS (standard deviation) score
Follow-up: 12 months
The mean growth (change in height) in the placebo groups was −0.01 SDSThe mean growth (change in height) in the fluticasone groups was 0.37 SDS lower
(0.77 lower to 0.03 higher)
30
(De Boeck 2007)
⊕⊕⊕⊝
moderate3
Growth (change in height) in paediatric participants cm
Follow-up: 8 months
The mean growth (change in height) in paediatric participants in the placebo groups was 3.5 cmThe mean growth (change in height) in paediatric participants in the fluticasone groups was 0.6 cm higher
(0.46 lower to 1.66 higher)
80
(Balfour-Lynn 2006)
⊕⊕⊕⊝
moderate3
*

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).

Abbreviations: CI: confidence interval; HR: hazard ratio; MD: mean difference; SDS: standard deviation score

1

The quality of the evidence was downgraded by 2 as 95%CI crossed the null effect line, and it is very wide.

2

Calculated by the NGA technical team from percentage of participants in group with at least 1 exacerbation.

3

The quality of the evidence was downgraded by 1 because 95%CI crossed 1 default MID.

From: 9, Pulmonary monitoring, assessment and management

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Cystic Fibrosis: Diagnosis and management.
NICE Guideline, No. 78.
National Guideline Alliance (UK).
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