Allergists are talking informally about reports of success in clinical trials employing specific oral tolerance induction (SOTI), also know as "oral immunotherapy," as treatment for food allergy. But where are the published reports?
Fisher et al. (Arch Dis Child 2010, doi:10.1136/adc.2009.172460) looked for those clinical trials reports and ran a meta-analysis to see if SOTI is more effective than avoidance for inducing tolerance. The authors’ pivotal criteria for inclusion in the analysis are double-blind oral food challenge before and after treatment.
Fisher and colleagues found only 3 studies that met all inclusion criteria. All three studies found SOTI significantly better than avoidance/placebo for inducing tolerance. However, one study used the endpoint “any tolerance” rather than food challenge-demonstrated tolerance; reanalysis of the published raw data by Fisher et al did not distinguish SOTI from avoidance for that study.
Editors’ note: 2 of the 3 studies were published in the JACI and can be accessed free of charge from http://www.jacionline.org/article/PIIS0091674907020003/fulltext and http://www.jacionline.org/article/PIIS0091674908017259/fulltext.
The three studies comprised only 127 children, which led the authors to comment that a type II error may account for the overall lack of significance to the results. Two studies that reported significance for SOTI did not measure persistence of tolerance over time, which was measured in the 3rd study for which the authors’ reanalysis found no significant difference.
Fisher et al conclude that SOTI cannot be recommended for routine clinical practice for IgE-mediated food allergy treatment yet. They suggest that future, larger trials need to assess persistence of tolerance over time as well as cost-effectiveness and safety.
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