Caminiti 2015.
| Methods | Double‐blinded randomized controlled trial | |
| Participants | 31 children, age 4 to11 years, clinical history of egg allergy, positive skin prick test (SPT), specific IgE positive assay for egg, and positive double‐blind placebo‐controlled food challenge (DBPCFC) at a starting dose of 0.12 g egg white. According to clinical history, none of the children had previously consumed baked eggs. | |
| Interventions | The oral immunotherapy procedure consisted of weekly administration, at the hospital clinic, of increasing dosages of dehydrated egg white, diluted in sterile saline, starting with 0.1 mg. The dose was doubled every week until week 16, to achieve a cumulative dose of 4 g in approximately 4 months. The placebo (corn flour, indistinguishable from active) was administered following the same protocol. The doses were prepared separately by a trained nurse according to the randomization list, so that the physicians remained blinded to the treatment. All doses were administered at the hospital. Control group: placebo |
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| Outcomes | The primary endpoint was the achievement of desensitization after the 4‐month randomized period of oral immunotherapy with dehydrated egg white. Secondary endpoints were the maintenance of tolerance to hen's egg after the 3‐month period of withdrawal, together with selected immunological parameters (IgE, IgG4, wheal diameter). | |
| Vested interest | The authors declare that they have no relevant conflicts. | |
| Notes | No funding was received for this work. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The participants were randomly assigned by means of a computer‐generated list. |
| Allocation concealment (selection bias) | Low risk | Randomization by means of a computer‐generated list |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The doses were prepared separately by a trained nurse according to the randomization list, so that the physicians remained blinded to the treatment. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | All outcomes accounted for but imbalance in numbers for missing data across intervention group |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available and therefore selective outcome reporting could not be assessed |