| Methods |
Randomised double‐blind controlled clinical trial comparing different doses (3 arms) of intravenous methylprednisolone. Patients were randomised using a table of random numbers, however the authors did not describe whether allocation was concealed. Method of double blinding was not well described. Authors have not responded to correspondence as yet.
Study duration: 72 hours. |
| Participants |
Patients with status asthmaticus. Asthma defined according to American Thoracic Society criteria. Status asthmaticus defined as severe asthma that did not respond adequately (FEV1 less than 50% predicted) to conventional treatment with subcutaneous beta‐agonists, IV aminophylline and inhaled bronchodilators.
Exclusions: chronic bronchitis, emphysema, pneumonia, heart failure, pulmonary embolism, upper airway obstruction, pneumothorax, pleural effusion, lung cancer, previous long term mechanical ventilation, any other cause of an abnormal FEV1. Those with relative or absolute contraindication to corticosteroids & patients treated in the previous 7 days with corticosteroids or barbiturates.
Ages: Criteria not described, mean age for whole group was 39 years.
PFTs: the mean baseline FEV1 for the whole group was 26% predicted. |
| Interventions |
Group 1: 15 mg intravenous methylprednisolone 6 hourly.
Group 2: 40 mg intravenous methylprednisolone 6 hourly.
Group 3: 125 mg intravenous methylprednisolone 6 hourly.
Cointerventions: (1) IV aminophylline, loading dose; 3 to 6 mg/kg and infusion 0.6 to 0.9 mg/kg/hr adjusted to daily levels (10 to 20 mg/L) (2) Inhaled beta‐agonist every 4 hours. (3) intravenous or oral fluids. (4) Supplemental oxygen if oxygen saturation less than 90%. |
| Outcomes |
The primary outcome was pulmonary function (FEV1 % predicted).
Blood glucose levels measured. |
| Notes |
Losses to follow up: 25 subjects were randomised & 24 included in the final analysis. One patient was removed after less than 1 day due to refusal to perform spirometry. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
