Methods |
Randomised double‐blind controlled clinical trial comparing methylprednisolone pulse therapy with low dose daily corticosteroids. Method of randomisation or blinding not described. Study duration: 3 months.
Pilot study (total 6 subjects). |
Participants |
Patients with acute asthma, all patients met the asthma criteria of the American Thoracic Society. Those who failed to respond to 1 hour of intensive bronchodilator therapy were eligible for entry. (Failure not defined).
Exclusions: Patients were described as being free from other complicating cardiopulmonary diseases, hypertension, or insulin‐dependent diabetes mellitus.
Ages: Adults, age criteria not specified.
PFTs: mean FEV1 for whole group; 0.6L, mean FVC for the whole group; 1.12L. |
Interventions |
Group A were treated with intravenous methylprednisolone initially 1000 mg on 3 consecutive days followed by placebo tablets. Group B received 50 mg of intravenous methylprednisolone on 3 consecutive days followed by a reducing dose of methylprednisolone tablets over 2 weeks.
Cointerventions: The initial bronchodilator treatment consisted of terbutaline inhalations, intravenous infusions of terbutaline & intravenous injection of aminophylline. Ongoing treatment consisted of terbutaline inhaled (5 mg every 4 h) during the first 3 days and thereafter as needed. Budesonide aerosol 800 mcg BD, Theodur 300 mcg BD & Bricanyl Retard 7.5 mg BD were given throughout the study period. |
Outcomes |
Outcomes included pulmonary function, symptom scores and medication use with follow up to 3 months. |
Notes |
Pulmonary function or symptom scores for the first 3 days not presented in the paper. Authors contacted, but as yet have not been able to provide further data.
Recorded day at which PEF or FEV1 was at least 80% of maximum & day when patients fulfilled no criteria for asthma.
Losses to follow up: Drop outs occured after the first month of treatment but not the first few days. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
Information not available |