| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described; placebo tablets contained lactose |
| Participants |
N = 40 (randomised and completed)
WITHDRAWAL/DROPOUT: exclusion of patients never going to follow‐up visits, these cases were replaced
AGE: 6‐12 years (mean 9,4 years)
SEVERITY: minimum of 2 years of evolution of sickness, showing low to moderate crisis, non corticosteroid‐dependent with equal intervals or less than 15 days; inclusion of patients with allergic asthma defined by coexistence of other allergic sickness (rhinitis, conjunctivitis, eczema), by the child's family history of allergic problems and because they had positive results in skin tests; exclusion of patients requiring frequent hospitalization, being in danger, with intrinsic asthma |
| Interventions |
DOSE: 1 mg twice daily
RUN‐IN: 0 weeks
TREATMENT: 16 weeks
ADDITIONAL MEDICATION: "bronchodilators" |
| Outcomes |
reduction on crisis frequency, crisis intensity, time crisis lasted, reduction on bronchodilator consumption, treatment results (evaluated by parents) and global treatment results |
| Notes |
three arm trial comparing nifedipine, ketotifen and placebo; only data of ketotifen and placebo group extracted |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; other information not available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Unclear risk |
Placebo tablets contained lactose |
