Patchell 1999.
| Study characteristics | ||
| Methods | Prospective, randomized, open‐label, cross‐over trial. Duration: treatment was for a period of 10 weeks; 2‐week run‐in, followed by randomization to 1 of the 2 arms for 4 weeks, and then cross over to alternative treatment for the next 4 weeks. Multicentre trial at 3 hospitals in the UK. |
|
| Participants | 59 children with CF, diagnosed by 2 sweat tests or genotype, had proven pancreatic insufficiency. Age: mean (SD) age of 10 (3.5) years. Gender split: not given. |
|
| Interventions | Group 1: ECM (Creon 8000 MS®). Group 2: ECMM (Creon 10000 MMS ®). Dose was lipase for lipase. The median intake of lipase/kg body weight/day was 6689 for Creon 8000® and 8527 for Creon 10000 ®. |
|
| Outcomes | FFE, CFA, stool frequency, abdominal pain, participant preference. | |
| Notes | The stool collection for CFA was done only in 1 centre, with 22 participants. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomized, further information not given. |
| Allocation concealment (selection bias) | Unclear risk | Information not given. |
| Blinding of participants and personnel (performance bias) Participants | High risk | No blinding. |
| Blinding of participants and personnel (performance bias) Clinicians | High risk | No blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Stool collection data were from 1 hospital only with 22 participants in an intent‐to‐treat analysis. 54 participants completed the trial, 2 dropped out in run‐in period due to abdominal pain and loose stools; a further 2 dropped out during the ECMM phase (1 due to abdominal pain and loose stools and 1 due to meconium ileus equivalent). The 5th participant dropped out during the ECMM phase due to an appendix abscess considered to be unrelated to treatment. |
| Selective reporting (reporting bias) | High risk | Data on stool frequency and abdominal pain reported in a way that could not be included in the analysis. |
| Other bias | Low risk | Study appears to be free of other sources of bias. |