Lee 1993.
Methods | A prospective, randomised, double blinded, placebo‐controlled clinical trial Comparison of single dose of IM dexamethasone versus oral dexamethasone Randomization was accomplished using computer‐generated random set of numbers (9 blocks). Allocation concealment was reported but method was not described. |
|
Participants | Patients diagnosed with asthma (based on the American Thoracic Society criteria, 1962), presented to ED with acute asthma and did not require hospital admission Exacerbation severity not discussed. Exacerbation severity estimated as mild/moderate based on baseline PEF Ages: enrolled patients 16 to 60 years. Mean age of IM corticosteroid group: 37 years (SD: 4). Mean age of oral corticosteroid group: 40 years (SD: 4) Patients who received systemic corticosteroids prior to enrolment in the study were excluded. Set in Taiwan Sex: 20 men, 16 women |
|
Interventions | Patients were divided into 3 groups (A, B, and C)
Tapering of dexamethasone was as follows: 3.0 mg day 1 and 2, 2.0 mg day 3, 1.5 mg day 4, 1.0 mg day 5, 0.75 mg day 6 and 0.5 mg day 7)
|
|
Outcomes | Primary and secondary outcomes were not defined.
|
|
Notes | Attempts to contact the authors failed No registered protocol was identified |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients randomised via block randomised computer generated numbers. Quote (p. 26): "The subjects were randomly assigned into one of three groups using a double blind model. Randomisation was by means of a set of computer‐generated set of random‐numbers in blocks of nine." |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blinded study. Oral corticosteroids and oral placebo were indistinguishable from each other but no information provided as to whether IM corticosteroids were indistinguishable from IM placebo. Quote (p. 26): "The subjects were randomly assigned into one of three groups using a double blind model." "The oral dexamethasone and oral placebo were indistinguishable." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided on outcome assessment blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study did not report attrition/exclusions. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | Source of funded not provided. |