Summary of findings 5. Summary of findings: ECM compared with TPE.
| ECM compared with TPE for cystic fibrosis | ||||||
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Patient or population: children with cystic fibrosis Settings: home setting Intervention: ECM (Creon®) (1.2 ‐ 2.4 g/day) Comparison: lyophilized TPE (4 ‐ 8 g/day) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (trials) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| TPE | ECM | |||||
| Change in weight (kg) Follow‐up: 1 month |
One trial comparing ECM to TPE did not report any significant difference in change in body weight. | N/A | 17 (1) | ⊕⊝⊝⊝ very lowa,b,c | No data available for analysis (Vidailhet 1987). | |
| Change in height | This outcome was not measured. | |||||
| Change in BMI | This outcome was not measured. | |||||
| Frequency of bowel symptoms | This outcome was not measured | |||||
| CFA: change in FFE (g/day) Follow‐up: 1 month |
The mean FFA ranged in the control group was 6.6 g/day. | The mean FFe in the intervention groups was 1.6 g/day lower (3.3 g/day lower to 0.1 g/day higher). | MD ‐1.60 (‐3.31 to 0.11) | 17 (1) | ⊕⊝⊝⊝ very lowa,b,c | P = 0.07 (Vidailhet 1987) |
| Adverse events | This outcome was not measured | |||||
| Pulmonary exacerbations | This outcome was not measured. | |||||
| *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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMI: body mass index; CFA: co‐efficient of fat absorption; CI: confidence interval; ECM: enteric‐coated microspheres; FFE: fecal fat excretion; MD: mean difference; TPE: total pancreatic extracts. | ||||||
| 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. | ||||||
a. Downgraded twice due to unclear or high risk of bias across all domains and lack of information. There was also incomplete reporting of some outcomes.
b. Downgraded once due to imprecision as the trial included a very small number of participants (n = 17).
c. Downgraded once due to indirectness as the trial included only children and therefore may not be applicable to an adult population.