Bukowskyj 1987.
Methods | Randomised controlled trial Cross‐over design ‐ double‐blinded, rule = time (1 week) |
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Participants | Ten patients admitted, 8 (4 male) completed the study Mean age 64.8 (SD = 8) years Severity of asthma: Inclusion criteria: reversible obstructive airway disease, clinically stable, FEV1 < 75% predicted value Exclusion criteria: congestive heart failure, hepatic disease, ingestion of cimetidine, ingestion of oral contraceptives Prescribed medication: 7 patients took oral theophylline and salbutamol; 3 patients took inhaled beclomethasone dipropionate; 1 patient took inhaled beclomethasone dipropionate and prednisolone Control measure: refrained from caffeine, other methylxanthine‐containing substances and orally‐administered beta‐agonists for 12 h prior to and throughout 8 h study. Refrained from inhaling beta‐agonists for 6 h prior to and throughout the 8 h study period. |
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Interventions | 5 mg/kg caffeine versus placebo as a solution in a juice drink | |
Outcomes | % change FEV1, % change FVC, % change FEF25‐75, % change Vmax50, % change Vmax25, FEV1 % predicted, pulse, blood pressure | |
Notes | Administration of corticosteroids was continued unchanged in those patients receiving long‐term therapy with these drugs | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details |
Allocation concealment (selection bias) | Low risk | Allocated by pharmacist |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Double‐blinded" Quote: "The medication code was known only to the hospital pharmacists." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The two patients who withdrew did so because they found the repeated spirometric tests unacceptably tiring. There was one patient who completed the study except for the last four h of the placebo day when she developed dyspnoea." No data used from these patients |