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) | Certainty 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 | 130 (1 trial) |
⊕⊕⊝⊝ lowa,b | |
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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) |
⊕⊕⊝⊝ lowb,c | 1 trial had a cross‐over design. | |
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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) |
⊕⊕⊝⊝
lowa,b |
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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 lowb,c,d | 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 certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded once due to risk of bias: high risk of selection bias due to sequential allocation. bDowngraded 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. cDowngraded 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. dDowngraded once due to imprecision: no numerical data provided and small sample size.