Original Article
Improvement in Health-Related Quality of Life in Food-Allergic Patients: A Meta-Analysis

https://doi.org/10.1016/j.jaip.2021.05.020Get rights and content

Background

Food allergy (FA) is a growing global problem that can affect patients' health-related quality of life (HRQoL) owing to increased anxiety as well as social and economic restrictions. Interventions such as oral food challenges (OFCs) and oral immunotherapy (OIT) have been shown to improve HRQoL. However, meta-analyses and systematic synthesis of these data are lacking.

Objective

To review and quantitatively synthesize potential benefits of interventions (OIT and OFC) systematically to address FA to a variety of foods.

Methods

We conducted a systematic search through PubMed and Cochrane Medical Library databases and performed a meta-analysis focusing on studies assessing changes in HRQoL after OIT and/or OFCs in FA participants and caregivers from 2010 to July 2020. Random effects model and I2 statistics were used to assess overall intervention effects and heterogeneity across studies.

Results

We included 13 publications in this meta-analysis (OIT = 7; OFCs = 6). Mean change in HRQoL scores after OIT and OFCs was –1.25 (P < .001) and –0.78 (P = .052), with a significant I2 of 87% (P < .001) and 90% (P < .001), respectively. Five OIT studies found significant improvements in HRQoL in the OIT group compared with the placebo group, with an overall standardized mean difference of –0.56 (P = .007; I2 = 42%, P = .099).

Conclusions

This meta-analysis showed that in FA patients, both OIT and OFCs are associated with an improvement in HRQoL. Well-designed and long-term HRQoL studies are necessary to ascertain sustained benefits of OIT and OFCs.

Introduction

Food allergy (FA) is a public health burden affecting personal, social, nutritional, and economic aspects of one’s life. Its prevalence is growing in the Western world,1 currently affecting about 6% of children and 10% of adults in the United States.2 Currently, the only approved FA treatment is Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp]3 for children aged 4 to 17 years with peanut allergy. The standard of care for patients with other FAs remains dietary avoidance of the implicated food allergen and administration of rescue medicine in case of accidental allergen exposure.4,5 Dietary avoidance can be challenging. Approximately 40% of patients with FAs present with reactions ranging from mild allergic reactions to fatal anaphylaxis, in rare cases, upon accidental exposure, even upon minimal exposures each year.6,7 Studies suggest that higher levels of anxiety and stress are often found in FA patients and their caretakers, with resultant negative effects on health-related quality of life (HRQoL).8,9

Although HRQoL and quality of life (QoL) are commonly used interchangeably in the literature, they represent two distinct constructs.10 Quality of life is a broad, multidimensional concept that covers all aspect of one’s life: physical, material, social, and emotional well-being, and development and activity. Health-related QoL measures disease-specific QoL (eg, burden of treatment, symptoms). It is a patient- and caregiver-perspective multidimensional questionnaire that evaluates physical, psychological, and social aspects that may be affected by a disease or medical condition.11 Awareness of risk for severe allergic reactions (including rare cases of fatal anaphylaxis) leads to anxiety and stress among FA patients and their caretakers.12 Strategies for avoiding ingestion of allergens can prove burdensome to families (eg, buying special foods, limiting social encounters, work and school absenteeism, changing careers, and frequent emergency room visits) and can lead to psychological distress (eg, depression, anxiety, and social stress).13 The Food Allergen Labelling and Consumer Protection Act requires every US Food and Drug Administration–regulated packaged food labeled on or after January 1, 2006 to list the major allergens it contains (eg, milk, eggs, fish, shellfish, peanuts, tree nuts, wheat, and soy). However, the Food Allergen Labelling and Consumer Protection Act does not apply to restaurant foods, which do not require precautionary “may contain” statements.14 The overall HRQoL for FA patients and their caretakers has been found to be significantly impaired, even more than in other chronic childhood diseases such as type 1 diabetes mellitus.15

Longitudinal HRQoL changes in FA were evaluated by numerous studies after allergen-specific oral immunotherapy (OIT) or after oral food challenge (OFC), and many of these studies found substantial improvements in participants' HRQoL after either of these interventions. Carraro et al16 found a significant improvement of HRQoL after OIT in milk-allergic children. A randomized controlled study by Reier-Nilsen et al17 reported that both children’s self-reported and parental proxy-reported HRQoL scores significantly improved in the OIT group at 2 years compared with baseline. In addition, DunnGalvin et al18 assessed the longitudinal effect of OFC in caregivers of FA children. The results showed a rapid improvement in caregivers' HRQoL irrespective of the outcome of the challenge.

Although a substantial number of published studies reported improvements in HRQoL after OIT and OFC, in the field of FA immunotherapy there is a lack of rigorous HRQoL data and quantitative synthesis.19,20 Therefore, the primary objective of our study was to provide a systematic review and quantitative synthesis of published studies to identify potential HRQoL benefits of OFCs for diagnosing and OIT as a therapeutic option for food-allergic individuals.

Section snippets

Searching strategy

We performed a systematic search using several online publication databases, including PubMed, Cochrane Medical Library, and Stanford Lane Medical Library. We limited our search to articles in English and did not restrict studies based on age or study type. Key words such as “food allergies” and “quality of life questionnaires” were used. We focused on clinical studies conducted in children, adolescents, adults, and caregivers of patients with FA to milk, eggs, peanuts, tree nuts, or other

Study overview

The online database searches resulted in 979 publications. After duplicate publications were removed, we screened 946 publications through titles and/or abstracts, reviewed 32 in full text, and included 13 publications in the meta-analysis (Figure 1). Tables I and II list the characteristics of each study. Seven studies focused on HRQoL changes before and after OIT (Table I) and six focused on the food challenge (Table II).

Instruments used for Food Allergy Quality of Life Questionnaire

The HRQoL questionnaires varied widely among studies. Questionnaires

Discussion

This study provides solid evidence evaluating the effect of clinical interventions such as OIT and OFC on participants' and caregiver’s HRQoL assessed with age-specific iterations of the FAQoL questionnaires. Over 1000 participants with FA enrolled in 13 studies were included in this systematic review and meta-analysis.

All OIT studies showed a significant improvement in HRQoL scores after OIT compared with baseline (P < .0001). In addition, after evaluating placebo-controlled studies, we found

References (45)

  • B.L. Cohen et al.

    Development of a questionnaire to measure quality of life in families with a child with food allergy

    J Allergy Clin Immunol

    (2004)
  • FDA approves first drug for treatment of peanut allergy for children
    (2020)
  • J.A. Boyce et al.

    Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel

    J Allergy Clin Immunol

    (2010)
  • A. Muraro et al.

    EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy

    Allergy

    (2014)
  • M. Greenhawt

    Food allergy quality of life and living with food allergy

    Curr Opin Allergy Clin Immunol

    (2016)
  • D. Antolín-Amérigo et al.

    Quality of life in patients with food allergy

    Clin Molecular Allergy

    (2016)
  • A. DunnGalvin et al.

    The effects of food allergy on quality of life

    Chem Immunol Allergy

    (2015)
  • A. Dunn Galvin et al.

    The longitudinal impact of probiotic and peanut oral immunotherapy on health-related quality of life

    Allergy

    (2018)
  • T. Umasunthar et al.

    Incidence of fatal food anaphylaxis in people with food allergy: a systematic review and meta-analysis

    Clin Exp Allergy

    (2013)
  • R. Gupta et al.

    The economic impact of childhood food allergy in the United States

    JAMA Pediatr

    (2013)
  • M.S. Shaker et al.

    An update on the impact of food allergy on anxiety and quality of life

    Curr Opin Pediatr

    (2017)
  • A.J. Cummings et al.

    The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review

    Allergy

    (2010)
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    This study was supported by National Institute of Allergy and Infectious Diseases (NIAID) grants 5U19AI104209, 5UM1AI130839, and 5UM2AI130836, the Parker Foundation, the Sunshine Foundation, and the Crown Foundation.

    Conflicts of interest: S. Sindher reports that she has received grants from National Institutes of Health, DBV Technologies, Aimmune Therapeutics, Regeneron, Novartis, CoFAR National Institute of Allergy and Infectious Diseases, and FARE; Advisory committee of Astra Zeneca and DBV Technologies. K. Nadeau reports grants from the National Institute of Allergy and Infectious Diseases, National Heart, Lung, and Blood Institute, and National Institute of Environmental Health Sciences; Food Allergy Research and Education, Director of World Allergy Organization Center of Excellence at Stanford; is an advisor at Pharmaceutical Development Company, Inc.; is a cofounder of Before Brands, Alladapt Immunotherapeutics, Inc., Latitude, and IgGenix; is a National Scientific Committee member at Immune Tolerance Network and National Institutes of Health clinical research centers; is a Data and Safety Monitoring Board member for the National Heart, Lung, and Blood Institute; and holds US patents for basophil testing, multifood immunotherapy and prevention, monoclonal antibody from plasmoblasts, and a device for diagnostics. R. S. Chinthrajah receives grant support from CoFAR National Institute of Allergy and Infectious Diseases, Aimmune, DBV Technologies, Astellas, AnaptysBio, Novartis, and Regeneron; and is an advisory board member for Alladapt Immunotherapeutics, Inc., Novartis, and Genentech. The rest of the authors declare that they have no relevant conflicts of interest.

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