Changing Patient Mindsets About Non-Life-Threatening Symptoms During Oral Immunotherapy: A Randomized Clinical Trial

Publication date: Available online 23 January 2019

Source: The Journal of Allergy and Clinical Immunology: In Practice

Author(s): Lauren C. Howe, Kari A. Leibowitz, Margaret A. Perry, Julie M. Bitler, Whitney Block, Ted J. Kaptchuk, Kari C. Nadeau, Alia J. Crum

Abstract

Background

Oral immunotherapy (OIT) can lead to desensitization to food allergens, but patients can experience treatment-related symptoms of allergic reactions that cause anxiety and treatment dropout. Interventions to improve OIT for patients are needed.

Objective

To determine whether fostering the mindset that non-life-threatening symptoms during OIT can signal desensitization improves treatment experience and outcomes.

Methods

In a randomized, blinded, controlled phase II study, 50 children/adolescents (28% girls, aged 7-17, M=10.82, SD=3.01) completed six-month OIT for peanut allergies. Patients and their parent(s) had monthly clinic visits at the Sean N. Parker Center for Allergy & Asthma Research between 1/5/2017-8/3/2017. All families received identical symptom management training. In a 1:1 approach, 24 patients and their families were informed that non-life-threatening symptoms during OIT were unfortunate side effects of treatment, and 26 patients and their families were informed that non-life-threatening symptoms could signal desensitization. Families participated in activities to reinforce these symptom mindsets.

Results

Compared to families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B=-0.46, 95% CI (-0.76 to -0.16), p=0.003), less likely to contact staff about symptoms (5/24[9.4%] vs. 27/154[17.5%] instances, p=0.036), experienced fewer non-life-threatening symptoms as doses increased (B_Interaction=-0.54(-0.83 to -0.27), p<0.001), less likely to skip/reduce doses (1/26[4%] vs. 5/24[21%] patients, p=0.065), and showed greater increase in patient peanut-specific blood IgG4 levels (B_Interaction=0.76(0.36 to 1.17), p<0.001).

Conclusion

Fostering the mindset that symptoms can signal desensitization improves OIT experience and outcomes. Changing how providers inform patients about non-life-threatening symptoms is a promising avenue for improving treatment.

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