Lederle 1987.
Methods |
Design: randomised, double‐blind trial Duration: corticosteroid treatment continued for 7 weeks post discharge; follow‐up continued until 12 weeks after initial admission Setting: treatment initiated while inpatient and completed at home |
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Participants |
Population: 43 adults with an acute exacerbation of asthma were randomised to a long taper course (n = 22) or a short taper course (n = 21) of prednisolone Age: 30‐78 years; mean age in long taper group 62.6 years and in short taper group 63 years Inclusion criteria: men admitted to medicine services with exacerbation of asthma requiring systemic steroids; exacerbation defined as worsening dyspnoea due to airways obstruction with no other cause identified, and evidence of a reversible component to obstruction Exclusion criteria: already receiving oral corticosteroids; evidence of pneumonia, pulmonary oedema or cardiomegaly on chest x‐ray; other significant lung disease such as bronchiectasis, fibrosis, cancer; renal failure, hepatic failure and inability to comply with study protocol Percentage withdrawn: withdrawal 0% in both treatment arms Allowed medication: beta‐agonists and theophylline allowed at treating physician's discretion. Inhaled beclomethasone given throughout study period Disallowed medication: antibiotics not allowed once tapering period had begun |
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Interventions |
Prednisolone long taper group: 45 mg prednisolone once daily reducing by 5 mg weekly to 0 mg daily over 7 weeks (total dose 1575 mg prednisolone equivalent) Prednisolone short taper group: 45 mg prednisolone once daily reducing by 5 mg daily to 0 mg daily over 7 days (total dose 225 mg prednisolone equivalent) |
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Outcomes | Failure of tapering regimen (defined as re‐exacerbation of asthma requiring further corticosteroid administration during 12‐week follow‐up period); symptom diary with 10‐point VAS to evaluate breathing each day from 'best' to 'worst'; physical examination, spirometry, symptoms, adverse events and compliance assessed at 4, 8 and 12 weeks post admission | |
Notes |
Type of publication: peer‐reviewed Funding: placebo tablets provided by Rowell Laboratories Inc., Baudette, Minn Other: mean age in both groups over 60, all but 5 included participants with > 10 pack‐year smoking history, mean of 49 years of age in long‐taper group and 56 in short‐taper group. Baseline spirometry results also suggest that many participants may have had a diagnosis of COPD (mean FEV1/FVC in both groups < 0.7). Study authors acknowledge that many participants may have had COPD with a reversible component |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned.."; no further details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All participants received identical calender blister packs that contained the tapering regimen |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary outcome of failure of tapering regimen (i.e. re‐exacerbation requiring additional oral steroids) decision made by physician blinded to participant allocation, as was decision to admit. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 43 enrolled and randomised participants followed up to 12 weeks as planned (2 withdrew before starting taper; results not included) |
Selective reporting (reporting bias) | High risk | Not all outcomes reported in a way allowing for meta‐analysis. FEV1 outcome reported as percentage of baseline value without variance. Diary measures narratively reported in text with minimal supporting data |
Other bias | Low risk | None noted |