(A) RCTs of inhaled corticosteroids—children | |||||||
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Source | Sequence generation | Allocation concealment | Blinding of participants and personnel | AE monitoring | Adverse events | Discontinued, number (%) | Loss to follow-up, number (%) |
CAMP/Kelly et al15 32 | Permuted blocks, stratified | Adequate | Adequate | Height recorded at every visit; BMD once every year | Fracture rate (adjusted for age, ethnic group, sex, clinic, base line duration, skin-test reactivity and asthma severity): BUD: 5.7 per 100 person-years Placebo: 5.1 per 100 person-years p=0.59 Mean difference in BMD (ICS vs placebo): Females: −0.001 (derived SE 0.0016) Male:−0.003 (derived SE 0.0014) | 11% | 5% |
Ferguson et al 200714 | Not reported | Remote computerised allocation | Adequate | Lumbar-spine BMD assessed at beginning and end of treatment with DEXA scan | Mean difference in lumbar spine BMD for FP vs BUD: 0.0075 (95% CI −0.033 to 0.048) | 90% patients received >40 weeks | 26% did not reach 51 weeks |
Roux et al19 | Central Block randomisation with gender stratification | . | Largely open. Analysis of DEXA scans blinded | Lumber spine and femoral neck BMD (DEXA) during run-in and 6, 12 and 24 months. Adjusted for age, height, weight, baseline BMD, gender and measuring device | Mean difference in lumbar spine BMD for FP vs control: 0.012 (SE 0.0073); values calculated from % change in manuscript | 23% | 4% |
Turpeinen et al20 | Block | Unclear | Blinded for budesonide and placebo arms | BMD of L1–4 measured by radiologist using DEXA at baseline and at 18 months | Mean change in lumbar spine BMD: Budesonide for 12 months 0.023 (SD 0.022) Placebo for 12 months 0.029 (SD 0.022) DSCG: 0.034 (SD 0.022) | 20% | 3% |
BUD, budesonide; DEXA, dual-energy X-ray absorptiometry; DSCG, disodium cromoglicate; FP, fluticasone propionate.