Francisco 2002.
| Methods | Randomised double‐blind placebo‐controlled cross‐over trial of 4 different 3‐day treatment periods. | |
| Participants | 22 participants: 10 adults with CF, aged 18 ‐ 36 years; 12 children with CF aged 6 ‐ 17 years. One adult dropped out of the study after completing 2 of the 4 treatment arms. | |
| Interventions | 4 treatment arms compared to placebo 2x daily: 1. children < 40 kg ‐ ranitidine 5 mg/kg; 2. children < 40 kg ‐ ranitidine 10 mg/kg;2. 3. children > 40 kg and adults ‐ ranitidine 150 mg 4. children > 40 kg and adults ‐ ranitidine 300 mg twice daily. Adults also received omeprazole 20 mg daily as adjuvant therapy to pancreatic enzymes compared with placebo. |
|
| Outcomes | Faecal fat absorption. | |
| 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‐blind, but no further details given. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One adult dropped out of the study after completing 2 of the 4 treatment arms. For 12 of the 96 admissions (12.5%) recognisable errors were made in the protocol. Analyses were performed including and excluding these admissions. |