Wutrich 2003.
Methods | Randomised DBPC trial | |
Participants | Children
Age range 4 to 11 years Active 14 (7 m); losses to f/u 2 Placebo 14 (9 m); losses to f/u 0 |
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Interventions | 24 months SLIT Sublingual drops Mixed grasses (Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis) Build‐up phase 30 days ‐ cumulative dose of major allergen was 1.88 mcg Maintenance phase ‐ cumulative dose of major allergen 6 mcg The first year the cumulative dose was 67.88 mcg and 139.88 mcg of major allergen in total | |
Outcomes | Conjunctival provocation test Skin prick test Symptom scores ‐ diary cards Medication scores ‐ diary cards | |
Notes | Jadad scale 5/5 4 children were not included in data analysis because of their incomplete diary cards | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Patients were randomised |
Allocation concealment? | Unclear risk | No details were provided |
Blinding? All outcomes | Low risk | Investigators and participants were blinded to treatment assignment for the duration of the study |
Incomplete outcome data addressed? All outcomes | Low risk | Participants lost to follow up or excluded were accounted for along with patients followed to designated follow‐up periods |
Free of selective reporting? | Low risk | The specified outcomes in the methodology were reported in the results section |
Free of other bias? | Unclear risk | Small number of patients across each trial group |
DBPC = double‐blind, placebo‐controlled; f/u= follow up; mcg = microgram; ITT = intention‐to‐treat; m = male; n/s = not specified; SCIT = subcutaneous (injection); immunotherapy; SL = sublingual; SLIT = sublingual immunotherapy; SPT = skin prick test