Summary of findings 5. Hypertonic saline compared with sodium‐2‐mercaptoethane sulphonate (Mistabron®) for cystic fibrosis.
| Hypertonic saline compared with sodium‐2‐mercaptoethane sulphonate (Mistabron®) for cystic fibrosis | ||||||
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Patient or population: adults and children with cystic fibrosis Settings: outpatients Intervention: hypertonic saline Comparison: sodium‐2‐mercaptoethane sulphonate | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Sodium‐2‐mercaptoethane sulphonate | Hypertonic saline | |||||
| FEV1: short term | Outcome not reported. | NA | NA | NA | ||
| 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: 2 months |
No significant difference in sputum volume, colour or cough frequency between the groups. | NA | 29 (1 trial) | ⊕⊝⊝⊝ very low1,2,3 | Trial had cross‐over design. | |
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Pulmonary exacerbations Follow‐up: 2 months |
See comment. | NA | 29 (1 trial) | ⊕⊝⊝⊝ very low1,2,3 | Trial had cross‐over design. The only information provided relevant to this outcome was that there was no change in the number of courses of antibiotics prescribed. |
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Adverse events Follow‐up: 2 months |
See comment. | NA | 29 (1 trial) | ⊕⊝⊝⊝ very low1,2,3 | Trial had cross‐over design. Participants in both treatment groups described coughing at the beginning of their inhalations. No serious adverse events occurred during the trial. |
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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 limited information was provided about the trial design. 2 Downgraded once due to applicability: results apply only to those who can tolerate hypertonic saline and the trial included only children aged 6 to 15 years so results may not apply to other age groups. 3 Downgraded once due to imprecision: no numerical data provided and small sample size.