Table 6.
Summary of the RCTs with cow’s milk
| 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 |
|---|---|---|---|---|---|---|---|---|
| Caminiti, 2009, Italy [125] | RCT [DBPCRT (6 pts); open fashion (7 pts)] | OIT vs placebo | 10/3 | 8 (5–10) | 18 weeks/200 ml | AG: 7 pts complete OD (200 ml of CM); 1 pt partial OD (64 ml of CM)./CG: none spontaneously tolerant, [OFC (+)] | 2 | In AG, 3 SAEs: two withdrawals (both severe anaphylaxis:one including shock, the other laryngeal edema); 1 pt with partial tolerance (generalized urticaria-angioedema, cough) |
| Longo, 2008, Italy [126] | RCT | OIT vs routine care (food avoidance) | 30/30 | 8 (5–17) | 1 year [rush build-up phase (10 days) + maintenance phase]/150 ml | AG: 11 pts (36%) complete OD (≥150 ml CM); 16 (54%) partial OD (5–150 ml)/CG: none spontaneously tolerant [OFC (+)] | 3 | Rush phase: i.m. E four times in 4 pts; nebulized E in 18 pts and more than once in 7 pts. Slow (home) dosing: 2 pts treated in the emergency department (CS, AH), and i.m. E (1 case). |
| Martorell, 2011, Spain [127] | parallel-group, multicentre RCT | OIT vs routine care (food avoidance) | 30/30 | 2.2 (2–3) | 1 year [build-up phase (16 weeks) + maintenance phase]/200 ml | AG: 90% complete OD. Two withdrawals; one partial OD (35 ml of CM)/CG: 23% pts natural tolerance [OFC (+) in 3/23 pts] | 1 | None |
| Pajno, 2010, Italy [128] | Random single-blind controlled study | OIT vs placebo | 15/15 | 9 (4–10) | 18 weeks/200 ml | AG: 10 pts complete OD (200 ml of CM) and in 1 pt partial tolerance (100 ml)/CG: none spontaneously tolerant, [OFC (+)] | 2 | 2 SAEs requiring i.m. E in 2 pts (withdrawals) |
| Skripak, 2008, USA [129] | DBPCRT | OIT vs placebo | 13/7 | 9.3 (6–21) | 23 weeks/500 mg | Median OFC threshold increased from 40 to 5140 mg after OIT in AG/all pts in the PG reacted at 40 mg | 1 | Median frequency of SAEs (E use): 1% (0.2%) of active doses vs none in the placebo group |
AG active group, AH antihistamines, CG control group, CM cow’s milk, CS corticosteroids, E epinephrine, Pt participants, SAE severe adverse event