Summary of findings 3. Dornase alfa versus hypertonic saline.
| Dornase alfa compared with hypertonic saline for cystic fibrosis | ||||||
|
Patient or population: Children with cystic fibrosis Settings: Outpatients Intervention: Dornase alfa (once daily) Comparison: Hypertonic saline | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Hypertonic Saline | Dornase alfa | |||||
|
Mean relative percentage in FEV1 (L) at 3 months |
See comment | See comment | MD 8.00 (2.00 to 14.00) | up to 431,2 (1 cross‐over study) (see comment) |
⊕⊕⊝⊝ low3,4 | Positive MD indicates an advantage for dornase alfa. Participants received both interventions in cross‐over design. |
|
Mean relative percentage in FVC (L) at 3 months |
See comment | See comment | MD 0.08, (‐0.02 to 0.18) | up to 431,2 (1 cross‐over study) |
⊕⊕⊝⊝ low3,4 | Positive MD indicates an advantage for dornase alfa. Participants received both interventions in cross‐over design. |
|
Mean relative percentage in quality of life score at 3 months |
See comment | See comment | MD 0.03, (‐0.01 to 0.07) | up to 431,2 (1 cross‐over study) |
⊕⊕⊝⊝ low3,4 | Positive MD indicates an advantage for dornase alfa. Participants received both interventions in cross‐over design. |
|
Number of pulmonary exacerbations at 3 months |
15 exacerbations | 17 exacerbations | NA (see comment) | up to 431,2 (1 cross‐over study) |
⊕⊕⊝⊝ low3,4 | No difference was found in the number of pulmonary exacerbations (no statistical comparison made) |
| *Assumed and corresponding risk not calculated lung function and quality of life. Relative effect and 95% CI presented is adjusted for the cross‐over design of the study. CI: confidence interval; MD: mean difference | ||||||
| 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. In the cross‐over trial, 43 participants completed the dornase alfa arm and 40 completed the hypertonic saline arm (Suri 2001).
2. Two additional cross‐over trials compared dornase alfa and hypertonic saline, no significant differences were found between the treatments for % change in FEV1 and other primary outcomes of the review were not recorded in these trials (Adde 2004; Ballmann 2002).
3. Downgraded once for lack of applicability: Suri included children only so results are not applicable to adults (Suri 2001).
4. Downgraded once for high risk of bias due to lack of blinding.