| Methods |
Randomised, double‐blind. placebo‐controlled cross‐over trial with 4 successive 14‐day treatment periods. |
| Participants |
9 adults with CF, mean age 29 years, age range 23 ‐ 42 years. There were no withdrawals. |
| Interventions |
4 consecutive 14‐day treatment periods:
1. a high dose pancreatic enzyme, pancrelipase (Pancrease®) (4 capsules, 3 times daily) in conjunction with an oral proton pump inhibitor omeprazole 20 mg daily;
2. a high dose pancreatic enzyme, pancrelipase (Pancrease®) (4 capsules, 3 times daily) in conjunction with placebo;
3. a low dose pancreatic enzyme, pancrelipase (Pancrease®) (2 capsules, 3 times daily) in conjunction with an oral proton pump inhibitor omeprazole 20 mg daily;
4. a low dose pancreatic enzyme, pancrelipase (Pancrease®) (2 capsules, 3 times daily) in conjunction with placebo. |
| Outcomes |
Faecal fat. |
| Notes |
|
| 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‐blinded in text but no details given. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
9 participants randomised, data for all 9 presented, therefore there were no withdrawals. |
