To throw the baby out with the bathwater: double blinding for specific oral tolerance induction

We appreciate the review article by Niggeman et al. (1) about specific oral tolerance induction (SOTI) in children with food allergy but we firmly disagree with their statement about the desirability of doubleblind placebo-controlled trials to validate the procedure. We have performed SOTI for many years (2, 3) with strikingly similar results to those published in the literature (4, 5) and it is clear from clinical practice that blinding is unfeasible, as almost all patients experience symptoms or reactions (mouth tingling, transient stomach pain, transient decrease in voice tone, cough, runny nose, asthma) as a consequence of minimal contact with the food in question. Furthermore, we believe that it would be totally unethical to leave parents uncertain as to whether tolerance has been achieved or not. One should never forget that we are dealing with children with clear-cut symptoms, strong laboratory evidence of sensitization, diagnosis made after repeated positive challenges in the previous years and age beyond the opportunity of naturally acquired tolerance. Regular intake of allergen during SOTI can take months (if not years), and this is a further impairment to the development of placebo-controlled studies. We believe that SOTI is a major opportunity of changing the quality of life of our patients and that large studies with a longterm follow-up are needed to confirm its long-term safety and efficacy. The desirability of double-blind placebo-controlled trials may be a taboo which could contribute to leave SOTI in a grey area of poorly standardized practice, and this would lose a major opportunity for allergic patients and for good quality research.