O’Driscoll 1993.
Methods |
Design: randomised, double‐blind trial Duration: corticosteroid treatment continued for 10‐17 days depending on allocation; follow‐up continued until 4‐6 weeks after discharge Setting: treatment initiated on inpatient basis and completed at home; trial carried out in the UK |
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Participants |
Population: 39 adults with an acute exacerbation of asthma were randomised to a tapering (n = 18 completed) or non‐tapering (n = 17 completed) course of prednisolone Age: 16‐55 years; mean age (range) in tapering group was 28 (18‐55) years and in non‐tapering group 37 (20‐53) years Inclusion criteria: 16‐55 years of age presenting with an acute asthma attack with PEFR < 65% predicted, admission under care of designated chest physician, ability to give informed consent and maintain PEFR diary for 28 days, use of inhaled corticosteroid (400‐2000 mcg daily) on discharge Exclusion criteria: major medical illnesses (especially pneumonia, heart failure, bronchiectasis and lung cancer), COPD, long‐term use of oral steroids, nebulisation at home, unable to comply with trial protocol, receiving IV hydrocortisone for > 2 days, requiring mechanical ventilation, had taken part in the trial during preceding 2 months Percentage withdrawn: 4 participants (10.3%) withdrawn overall but number from each group not reported Allowed medication: all other asthma treatments allowed at the discretion of the participant's personal physician, provided they were allowed under trial criteria. All participants received short‐acting beta‐2‐agonists and inhaled corticosteroids Disallowed medication: not reported |
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Interventions |
Prednisolone taper group: 40 mg prednisolone once daily for 10 days, then tapering by 5 mg/d for 7 days (total dose 540 mg prednisolone equivalent) Prednisolone non‐taper group: 40 mg prednisolone once daily for 10 days, followed by placebo taper (total dose 400 mg prednisolone equivalent) |
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Outcomes | PEFR, asthma symptoms on a numerical scale (1‐5) | |
Notes |
Type of publication: peer‐reviewed Funding: placebo tablets provided by Pfizer UK Ltd |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Prescriptions were sealed in a plain brown envelope and shuffled into a random order |
Allocation concealment (selection bias) | Low risk | Prescriptions were sealed in a plain brown envelope and shuffled into a random order.. whenever an eligible patient entered the trial, one of the investigators would open the next envelope and dispatch the enclosed coded prescription to the pharmacy |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants received oral prednisolone for the active tapering arm or identical placebo tablets |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Only the pharmacist was unblinded to allocation and prepared study medications according to the coded prescription; however, it is not clear whether outcome assessments were performed blinded throughout the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 4 of 39 participants were enrolled and randomised but did not complete the trial. Two were lost to follow‐up and 2 were withdrawn for protocol violation and incorrect enrolment (PEFR did not meet inclusion criteria) |
Selective reporting (reporting bias) | High risk | Many diary outcomes are not reported numerically so cannot be included in the meta‐analysis. Data displayed graphically in many cases with no variance. Not clear whether study was prospectively registered |
Other bias | Low risk | None noted |