Durie 1980.
Methods | Randomised cross‐over trial of 4 periods of 7 days treatment. | |
Participants | 21 people with CF, age range 10 ‐ 17 years. 6 withdrawals: 2 voluntarily after 3 days; 3 on evidence of poor drug and diet compliance and inadequate stool collection; and 1 with a possible complication with cimetidine. | |
Interventions | 4 groups: 1. pancreatic supplement (Pancrelipase, 27 capsules per day); 2. pancreatic supplement plus cimetidine (20 mg/kg body weight/24h); 3. pancreatic supplement plus sodium bicarbonate (15g/m2/24h); 4. pancreatic supplement plus cimetidine (20 mg/kg body weight/24h) and sodium bicarbonate (15g/m2/24h). |
|
Outcomes | Faecal fat (gm/24 h and %) | |
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 | Level of blinding not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 withdrawals: 2 voluntarily after 3 days; 3 on evidence of poor drug and diet compliance and inadequate stool collection; and 1 with a possible complication with cimetidine. |