Table 7 Summary of RCTs with hen egg
Study (Author, year, country) | Design | Active group vs comparator | Sample size (AG/CG) | Age (yrs) [mean (range)] | Duration desensitization protocol/maintenance dose | Outcomes: desensitization/sustained unresponsiveness | Discontinued due to AEs | SAEs |
|---|---|---|---|---|---|---|---|---|
Burks, 2012, USA [130] | RCT | OIT vs placebo | 40/15 | 7 (5–11) | 22 months/1.6 g DEW | After 22 months, 30 (75%) pts in AG passed 10-g- OFC/at 6–8 weeks later only 11 (28%) | 5 | No reports of severe or life-threatening symptoms or death |
Caminiti, 2015, Italy [131] | DBPCRT | OIT vs placebo | 17/14 | 6 (4–11) | 4 months/4 g DEW | AG: 16/17 pts (1 dropout) complete OD/AG: After 3-months-HE-avoidance, 31% of these 16 pts remained tolerant. CG: only 1 pt passed the final OFC. | 1 | 3 SAEs: during OD, 1 pt [withdrawal (U, throat pruritus, R, A, vomiting); during HE-containing diet: 1 pt presented U, abdominal pain after exercise (1 cooked HE) and another wheezing and cough during upper respiratory infection (1 cooked HE). [Both tolerant after 3 months of HE containing diet discontinuation] |