Carroccio 1992.
Methods | Randomised, double‐blind, placebo‐controlled cross‐over trial for 2 successive 6‐month treatment periods. | |
Participants | 10 children with CF (7 males, 5 females), mean age 12.5 years, age range 7 ‐ 18 years, with persistent steatorrhoea on enzymatic supplements (12 children were originally enrolled, but 2 were excluded). | |
Interventions | 2 groups: 1. usual enzyme therapy plus famotidine 1 mg/kg/day; 2. usual enzyme therapy plus placebo. |
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Outcomes | Faecal weight, fat absorption, weight and height changes, serum calcium, triglycerides, cholesterol, phosphate, iron, Hb, albumin, Crispin Norman score, Shwachman score. | |
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 | 12 children were originally enrolled, but 2 were excluded with severe pulmonary infections. |