Bowler 1993.
Methods | Randomised, double‐blind, placebo‐controlled cross‐over trial. 3‐arm trial for successive 2‐week treatment periods. |
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Participants | 14 children with CF, mean age 11.9 years, age range 5.5 ‐ 16.3 years. Inclusion criteria: all receiving > 30 pancreatic enzyme capsules a day and faecal fat output > 15 g/day or fat absorption < 85%. | |
Interventions | 3 groups: 1. high‐dose pancreatic enzyme (Creon®) and H2 receptor antagonist ranitidine; 2. high‐dose pancreatic enzyme (Creon®) and placebo; 3. low‐dose pancreatic enzyme and placebo. | |
Outcomes | Faecal fat output, stool weight. | |
Notes | We were unable to include the results from the Bowler trial in the meta‐analysis due to insufficient data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details of method given. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as double‐blind in text but no further details given. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Discrepancy between the number of participants entering and completing the trial which was not addressed. |