Summary of findings 6. Hypertonic saline compared with mannitol for cystic fibrosis.
| Hypertonic saline compared with mannitol for cystic fibrosis | ||||||
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Patient or population: adults and children with cystic fibrosis Settings: outpatients Intervention: hypertonic saline Comparison: mannitol | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Mannitol | Hypertonic saline | |||||
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FEV1: short term Follow‐up: up to 95 minutes |
See comment. | NA | 12 (1 trial) | ⊕⊝⊝⊝ very low1,2,3 | Trial had cross‐over design. FEV1 was assessed in the included trial at 5 minutes and 95 minutes post‐intervention. These very short‐term time‐points are not of clinical relevance to this review. Change from baseline within‐groups was reported but no between‐group data. |
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| FEV1: long term | Outcome not reported. | NA | NA | NA | ||
| LCI | Outcome not reported. | NA | NA | NA | ||
| Mortality | Outcome not reported. | NA | NA | NA | ||
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Measures of sputum clearance Follow‐up: up to 95 minutes |
There was no significant difference between treatment groups for matched voluntary cough. | NA | 12 (1 trial) | ⊕⊝⊝⊝ very low1,2,4 | Trial had cross‐over design. | |
| Pulmonary exacerbations | Outcome not reported. | NA | NA | NA | ||
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Adverse events Follow up: up to 95 minutes |
See comment. | NA | 12 (1 trial) | ⊕⊝⊝⊝ very low1,2,4 | Trial had cross‐over design. Mannitol was considered to be a more 'irritating' treatment than other treatments (4‐armed trial); no specific data given. |
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| *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; LCI: lung clearance index; 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 detection bias as participants could discern the taste of the intervention and no washout period was used. 2. Downgraded once due to applicability: results apply only to those who can tolerate hypertonic saline and the trial included only participants over the age of 16 so results may not apply to younger children. 3. Downgraded once due to applicability: the outcome measured only at very short‐term time‐points (minutes after intervention), which are not of clinical relevance to this review. 4. Downgraded once due to imprecision: no numerical data provided and small sample size.