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. 2016 Aug 22;2016(8):CD003424. doi: 10.1002/14651858.CD003424.pub4

Bowler 1993.

Methods Randomised, double‐blind, placebo‐controlled cross‐over trial.
3‐arm trial for successive 2‐week treatment periods.
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.