Akashi 2017.
Methods | Randomized controlled trial | |
Participants | 36 participants, age 3 years to 15 years, inclusion criteria as defined by authors: (i) complete elimination of egg from the diet; (ii) egg‐specific IgE ≥ 0.7 UA/mL; (iii) positive immediate allergic reaction on double‐blind, placebo‐controlled food challenge (DBPCFC) for egg performed after admission to hospital; and (iv) participant and caregiver desire to join this study. | |
Interventions | Participants in the oral immunotherapy group ingested the dry powder every day, while the control participants followed their usual egg avoidance diet. The starting dose of oral immunotherapy was 0.1 mg dried powdered egg, and this was increased to 0.2, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 10, 15, 30, 50, 70, 100, 150, 200, 300, 500, 700 mg, 1, 1.2, 1.5, 2, 3, and 4 g, at 3 to 4 day intervals. Once a dose of 4 g, equivalent to the total dose in the oral food challenge, was achieved, participants continued on that dose daily until the second oral food challenge. Control group: egg avoidance diet. |
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Outcomes | The primary outcome was the percentage of participants who were able to tolerate 4 g powdered egg without allergic symptoms in the second oral food challenge. Secondary outcomes were comparison of cumulative tolerated dose in the first oral food challenge with that in the second oral food challenge, and the changes in egg white‐specific IgE and IgG4. |
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Vested interest | The authors declared no conflicts of interest. | |
Notes | The study was approved by the institutional ethics committee, and registered with the UMIN Clinical trials registry (Clinical trial registry number, UMIN000001268). The study was partially supported by a grant from the Ministry of Health, Labour and Welfare Japan and funds from a Research Center of Taiho Pharmaceutical Company. | |
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 computerized system. |
Allocation concealment (selection bias) | Low risk | Randomization was performed using a computerized system |
Blinding of participants and personnel (performance bias) All outcomes | High risk | unblinded intervention |
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 groups |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |