Wong 1988.
| Methods | Controlled clinical study. Single centre in Canada. Duration 10 ‐ 14 days. |
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| Participants | 22 CF participants admitted for pulmonary infection. | |
| Interventions | Group A: oral fat‐soluble vitamin E 10 mg/kg/day (n = 8). Group B: oral water‐miscible vitamin E (Aquasol E) 10 mg/kg/day (n = 5). Group C: no supplementation (n = 9). |
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| Outcomes | Serum vitamin E levels, alpha‐tocopherol/cholesterol ratio, 3‐day faecal fat excretion. | |
| Notes | All participants also received appropriate intravenous antibiotics, 10% Nutralipid 15 ml/kg/day and usual dosage of enteric‐coated pancreatic enzymes. The study does not clarify whether the participants were pancreatic sufficient or insufficient. Abstract only available. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation not stated, abstract states participants divided into 3 groups. |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not stated, blinding of no treatment compared to either of treatment arms not possible, but not clear if blinded between treatment arms. Objective outcome is measured so absence of blinding unlikely to increase risk of bias. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of no treatment compared to either of treatment arms not possible, but not clear if blinded between treatment arms. Objective outcome is measured so absence of blinding unlikely to increase risk of bias. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of participants recruited and randomized not stated, only numbers of participants for whom results available given. |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available, abstract only so no 'Methods' section available to compare to 'Results' section. |
| Other bias | Unclear risk | None identified. Limited information on the basis for diagnosis of CF and if pancreatic sufficient or insufficient. |
CF: cystic fibrosis DNAse: dornase alfa IU: international units PI: pancreatic insufficient PS: pancreatic sufficient PT: prothrombin PTT: partial thromboplastin time RBC: red blood cell SD: standard deviation S‐GOT: glutamic oxalacetic transaminase