Summary of findings 2. Hypertonic saline 3% to 7% versus isotonic saline for cystic fibrosis (during acute exacerbations of lung disease).
| Hypertonic saline 3% to 7% versus isotonic saline for cystic fibrosis (during acute exacerbations of lung disease) | ||||||
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Patient or population: adults and children with cystic fibrosis (during acute exacerbations of lung disease) Settings: hospitalised patients and outpatients Intervention: hypertonic saline 3% to 7% Comparison: isotonic saline | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Isotonic saline | Hypertonic saline 3% to 7% | |||||
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FEV1 (% predicted) change from baseline, short term Follow‐up: approximately 14 days (at time of hospital discharge) |
The mean % change in FEV1 (% predicted) was 32.3% in the isotonic saline group. | The mean % change in FEV1 (% predicted) was 5.10% higher (14.67% lower to 24.87% higher) in the hypertonic saline 3% to 7% group. | NA | 132 (1 trial) |
⊕⊕⊝⊝ low1,2 | |
|
FEV1 (% predicted) change from baseline, long term Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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LCI Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Mortality Follow‐up: NA |
No deaths were reported in either trial. | NA | 142 (2 trials) |
⊕⊕⊝⊝ low2,3 | 1 trial had a cross‐over design. | |
|
Measures of sputum clearance Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Pulmonary exacerbations Follow‐up: up to 1 year |
There was no significant difference between the groups in time until the next pulmonary exacerbation requiring hospitalisation. | HR 0.86 (95% CI 0.57 to 1.30) | 132 (1 trial) |
⊕⊕⊝⊝ low1,2 | ||
|
Adverse events Follow up: up to 1 year |
Adverse events reported were cough and wheeze. No serious adverse events were reported. |
NA | 142 (2 trials) |
⊕⊝⊝⊝ very low2,3,4, | 1 trial had a cross‐over design. | |
| *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; FEV1: forced expiratory volume in 1 second; HR: hazard ratio;LCI: lung clearance index; MD: mean difference; NA: not applicable. | ||||||
| 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. Downgraded once due to risk of bias: high risk of selection bias due to sequential allocation. 2. Downgraded once due to applicability: results apply only to those who can tolerate hypertonic saline and the trial included only adults so results may not apply to children. 3. Downgraded once due to risk of bias: first trial was at high risk of detection bias as participants could discern the taste of the intervention, second trial was at high risk of selection bias due to sequential allocation. 4. Downgraded once due to imprecision: no numerical data provided and small sample size.