| Methods |
Randomised double‐blind controlled clinical trial comparing 2 different doses of intravenous methylprednisolone. Method of randomisation was not described and allocation concealment was unclear. Method of blinding not described. Primary author has been contacted, but has not been able to provide further details as yet.
Study duration: 10 days |
| Participants |
Patients with status asthmaticus admitted to hospital. Patients had to fulfil the American Thoracic Society criteria for the diagnsosis of asthma. Status asthmaticus was defined as an acute exacerbation of airway obstruction requiring hospitalisation and not responding to emergency room treatment with optimal doses of theophylline, oral and aerosolized beta adrenergic therapy.
Exclusions: Patients with an abnormal diffusing capacity or clinical history of bronchitis.
Ages: Not specified in advance but the mean age for the whole group was 54 years.
PFTs: Mean baseline FEV1 for the whole group 0.7L. |
| Interventions |
Group A received 20mg methylprednisolone QID intavenously for 7 days. Group B received 125mg QID methylprednisolone intravenously for 7 days. Both groups were then given the same regimen of 60, 40, 20 mg of prednisone orally on days 8,9, and 10.
Cointerventions both groups received IV aminophylline (adjusted to maintain serum levels between 10 and 20 mcg/ ml), aerosolised isoetharine or isoproterenol every four hours, intravenous fluids and supplemental oxygen. |
| Outcomes |
The primary outcome was pulmonary function. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF) were measured each morning for 10 days. Reported as a percentage of each patients best ventilatory function recorded within 6 months of the study. Not reported whether values were pre or post bronchodilator.
Other outcomes not discussed. |
| Notes |
Statistical methods not described and standard deviations not presented with post treatment values.
Losses to follow up: No clear statement on losses to follow up or withdrawals.
One patient in each group was on regular oral glucocorticoids. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
