Elliott 1992.
Study characteristics | ||
Methods | Randomised, double‐blind, cross‐over trial. Duration: 4 weeks for each treatment arm with a 2‐week run‐in period. Single‐centre trial in New Zealand. Home setting. |
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Participants | 30 children previously diagnosed with CF using clinical and laboratory data. Age: median 10.1 years. Gender split: 17 girls, 13 boys. |
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Interventions | Group 1: Creon® (lipase 8000 BP, amylase 9000 BP, protease 210 BP). Group 2: Pancrease® (lipase 5000 BP, amylase 3000 BP, protease 350 BP). Participants were started on doses of lipase slightly lower or equivalent to pretrial period. Later they were allowed to adjust according to their requirement. |
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Outcomes | Mean weight gain, adequate daily intake of energy, fat and nitrogen, stool weight, FFE and nitrogen excretion. | |
Notes | For the outcomes of interest to the review, the results were given in a descriptive method; means and SDs not given. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information not given. |
Allocation concealment (selection bias) | Unclear risk | Information not given. |
Blinding of participants and personnel (performance bias) Participants | Low risk | Both formulations were prepared in identical opaque capsules from commercial stock. |
Blinding of participants and personnel (performance bias) Clinicians | Unclear risk | Information not given. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information not given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants withdrew consent and 1 participant was hospitalised due to respiratory exacerbations during the run‐in period. |
Selective reporting (reporting bias) | High risk | Results were reported in a narrative method and could not be included in analysis |
Other bias | High risk | Boehringer Ingelheim (NZ) Limited Kali Chemie provided funding and trial materials. |