This decision aid is designed to assist people with IgE-mediated cow’s milk allergy and their families and caregivers to decide whether to undergo oral immunotherapy for cow’s milk allergy
Research results
Below you will find the results of a group of patients who received OIT with cow’s milk compared to those undergoing elimination diet alone.
The balance between health benefits and harms is a major consideration to decide whether or not to recommend OIT for treatment of CMA. To decide whether to do OIT, we selected outcomes critical to making the decision: anaphylaxis, need for intramuscular injection of epinephrine, adverse effects leading to the discontinuation of OIT, severe gastrointestinal symptoms, severe asthma/wheezing, generalized hives or redness of skin, ability to drink cow's milk and eat dairy products without limitation, ability to accidentally consume a small amount of cow's milk without a reaction, and emergency department visits.
Events per 100 patients
Outcomes
OIT with cow's milk
Happens to 100 patients
Elimination diet only
Happens to 100 patients
Certainty of the evidence
Anaphylaxis
Only one study (De Schryver 2019) used current definition of anaphylaxis. The rate of anaphylaxis in this study was 1 per 100 persons per year without OIT and 550 per 100 persons per year with OIT (rate ratio: 60.0; 95% CI: 15 to 244; rate difference: 5 more per 1 person per year (95% CI: 4 to 6)). One study (Skripak 2008) defined anaphylaxis as "some combination of respiratory, gastrointestinal, and/or skin reaction" and reported similar results. Four additional studies reported no anaphylactic reactions, however, they either did not provide the definition that they used or equated it with epinephrine use.
moderate
certainty
certainty
Need to use epinephrine injection
49
per 100
47 fewer
2
per 100
high
certainty
certainty
Adverse effect for which OIT was stopped
12
per 100
5 fewer
7
per 100
moderate
certainty
certainty
Severe nausea, vomiting, stomach pain, or diarrhea
33
per 100
28 fewer
5
per 100
low
certainty
certainty
Severe difficulty breathing or wheezing
0
per 100
0
per 100
moderate
certainty
certainty
Widespread redness of the skin or hives
24
per 100
15 fewer
9
per 100
moderate
certainty
certainty
Ability to drink cow's milk and eat dairy products without a reaction
28 more
30
per 100
2
per 100
moderate
certainty
certainty
Ability to accidentally consume a small amount of cow's milk without a reaction
35 more
39
per 100
4
per 100
moderate
certainty
certainty
Emergency department visit
There were 2 events among 48 children in OIT group and no events in control groups. Only 2 of the 11 studies reported this outcome.
very low
certainty
certainty
Hospital admission
No studies identified.
-
Lip or mouth pruritus, perioral rash
19
per 100
18 fewer
1
per 100
low
certainty
certainty
Any adverse effect
74
per 100
57 fewer
17
per 100
moderate
certainty
certainty
Death
No one died in the studies; death from food allergy in general is very rare and is estimated to be between 2 and 6 per million children with food allergy per year.
high
certainty
certainty
Comparison
OIT with cow's milk
Benefits
There is moderate certainty about the benefits of undergoing OIT. OIT is likely to result in an increase in the probability not to have a reaction after accidental and/or intentional ingestion of the allergen. The probability to tolerate ingestion of cow's milk and/or dairy products without developing an allergic reaction is increased by 12 times in patients treated with OIT. This corresponds to an increase of 28 patients not developing reactions per 100 individuals receiving OIT. The probability to tolerate accidental ingestion of a small amount of cow's milk is increased by 10 times in patients treated with OIT. This corresponds to an increase of 35 patients tolerating accidental exposure per 100 individuals receiving OIT. There is also great uncertainty whether, after OIT discontinuation, you might retain the state of tolerance acquired during the therapeutic regimen. There is also great uncertainty about milk OIT’s impact on quality of life because a limited number of people have almost equally reported improvement, deterioration, and no change.
Harms
Unfortunately, OIT, compared to avoidance alone, provides additional risks to develop a set of adverse effects. OIT probably increases the rate of anaphylactic episodes. It is likely associated with an increase in severe respiratory and cutaneous manifestations, with an increment in adverse effects that might lead to therapy discontinuation. It may be linked to an increase in gastrointestinal manifestation of CMA. OIT also results in a marked increase in uses of IM epinephrine (29 times more, or an increase of 268 injections per 100 OIT patients per year). It is uncertain whether OIT provides an additional risk for emergency department visits.