Chalmers 1985.
Methods | Randomised, double‐blind, placebo‐controlled cross‐over trial for 2 successive 6‐month periods. | |
Participants | 17 people with CF (7 males, 10 females) age range 5 ‐ 19 years. Results reported from the 13 who gave adequate faecal samples. | |
Interventions | 2 groups: 1. usual enzyme therapy plus cimetidine 25 mg/kg/day; 2. usual enzyme therapy plus placebo. |
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Outcomes | Faecal fat, weight, nitrogen, bile acids, anthropometric measurements, bone age, peak flow, Crispin Norman score, Shwachman score, haemoglobin, albumin, calcium, creatinine and plasma vitamin A levels. | |
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 in text but no further details given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 10 months 1 participant withdrew from group originally assigned to cimetidine (withdrew whilst taking placebo) due to deterioration in respiratory function. This left 8 participants in each group. |