Heijerman 1993.
Methods | Randomised, double‐blind, placebo‐controlled cross‐over trial for successive 14‐day treatment periods. | |
Participants | 11adults with CF (5 males, 6 females), age range 20 ‐ 42 years. There were no withdrawals. | |
Interventions | 2 groups: 1. pancrealipase plus placebo; 2. pancrealipase plus oral omeprazole 20 mg. |
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Outcomes | Faecal fat, serum trypsin, pancreatic polypeptide, insulin and gastrin, PABA in urine. | |
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 further details given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 11 participants randomised, data for 11 participants presented, therefore there were no withdrawals. |