Greally 1994.
Study characteristics | ||
Methods | Randomised. Double‐blinded. | |
Participants | 24 participants aged 5.5 years to 19.5 years recruited. CF diagnosed by raised sweat sodium (>70 mmol/l) and established respiratory disease (FEV1 < 85% predicted). | |
Interventions | Soluble prednisolone 2 mg/kg/ daily for 14 days and then 1 mg/kg/ day on alternate days for 10 weeks (maximum dose 40 mg) or identical inert placebo tablets. | |
Outcomes | The following were measured at baseline, 14 days and 12 weeks: FEV1, FVC, Serum interleukin‐ 1‐ alpha, interleukin‐ 2R, IgG. Specific side effects (raised blood pressure, high blood sodium, low blood potassium, fluid retention and glucose intolerance) were looked for at each visit. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but method not stated. |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as double‐blind and placebo and prednisolone tablets were identical, but true blinding might not have been possible since at the doses used, it would have been obvious which participants were in the treatment group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals. |
CF: cystic fibrosis FEV1: forced expiratory volume at one second FVC: forced vital capacity IgA: immunoglobulin A IgG: immunoglobulin G IgM: immunoglobulin M mmol/l: millimoles per litre PEFR: peak expiratory flow rate P. aeruginosa: Pseudomonas aeruginosa