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. 2023 Jun 14;2023(6):CD001506. doi: 10.1002/14651858.CD001506.pub5

Summary of findings 6. Hypertonic saline compared with mannitol for cystic fibrosis.

Hypertonic saline compared with mannitol for cystic fibrosis
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) Certainty of the evidence
(GRADE) Comments
Assumed risk Corresponding risk
Mannitol Hypertonic saline
FEV1: short‐term
 
Follow‐up: up to 95 minutes
See comment. NA 12
(1 trial) ⊕⊝⊝⊝
very lowa,b,c
 
Trial had cross‐over design.
FEV1 was assessed in the included trial at 5 minutes and 95 minutes postintervention. 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.
FEV1: long‐term Outcome not reported.  
LCI Outcome not reported.  
Mortality Outcome not reported.  
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 lowa,b,d Trial had cross‐over design.
Pulmonary exacerbations Outcome not reported.  
Adverse events
 
Follow‐up: up to 95 minutes
See comment. NA 12
(1 trial) ⊕⊝⊝⊝
very lowa,b,d Trial had cross‐over design.
Mannitol was considered to be a more 'irritating' treatment than other treatments (4‐armed trial); no specific data given.
*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 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 detection bias as participants could discern the taste of the intervention and no washout period was used.
bDowngraded 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.
cDowngraded 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.
dDowngraded once due to imprecision: no numerical data provided and small sample size.