| Methods |
Randomised double‐blind controlled clinical trial comparing intravenous methylprednisolone pulse therapy with oral corticosteroids. Allocation concealment and method of randomisation not described. Method of blinding well described and appropriate. Primary author has responded to initial correspondence but has not been able to provide further details yet.
Study duration: 12 weeks. |
| Participants |
Patients presenting to an allergy clinic with acute severe asthma. Patients were given nebulised salbutamol 2.5mg followed by standard treatment including beta‐agonists and intravenous theophylline, if after 1 hour of treatment, the FEV1 was less than 60% predicted and corticosteroids were indicated, patients were offered participation in the study following hospitalisation. All patients fulfilled the American Thoracic Society criteria for asthma.
Exclusions: pregnancy or patients with diabetes mellitus, cardiac failure or hypertension.
Ages: Criteria not specified, mean age for whole group was 47 years.
PFTs: the mean % predicted FEV1 & PEFR for the whole group at baseline was 38% & 45% respectively. |
| Interventions |
MP group: received 1g of intravenous methylprednisolone (single dose) followed by placebo daily tablets.
OP group: received daily oral prednisolone tablets starting at a dose of 50mg and reducing to zero within 18 days.
Cointerventions: beta‐agonists and intravenous theophylline were administered in a standardised fashion for at least the first 24 hours. |
| Outcomes |
Outcomes considered included pulmonary function (FEV1 and PEF), need for subsequent prednisolone treatment, medication use and side effects.
Peak expiratory flow was measured hourly (while awake) for the first 24 hours. FEV1was measured at 24 hours, then 1,2,4,8 and 12 weeks. |
| Notes |
Losses to follow up: There was no clear statement on withdrawals or losses to follow up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
