Double-blind placebo-controlled evaluation of sublingual-swallow immunotherapy with standardized Parietaria judaica extract in children with allergic rhinoconjunctivitis☆,☆☆,★
Section snippets
Study design
This was a double-blind, placebo-controlled, parallel-group study.
Forty-one patients with a positive history of rhinoconjunctivitis, with or without mild intermittent asthma, caused by Parietaria pollen sensitization documented by positive skin tests (wheal diameter >4mm) and positive radioallergosorbent test results (class II and above) were enrolled between November 1995 and March/April 1996. Patients with uncontrolled asthma, symptomatic polysensitization or who were treated with β-blockers
Patients
The 2 groups did not differ in terms of demographic variables, history of rhinitis, conjunctival provocation tests, skin reactivity, and immunologic parameters.
Of the 41 randomized patients, 3 from the active group and 3 from the placebo group left the study before the first pollen season and another 2 patients (1 active and 1 placebo) dropped out of the trial during the second year. Thirty-three patients (16 in the active treatment group and 17 in the placebo group) were therefore evaluable at
DISCUSSION
This study compared the efficacy of sublingual immunotherapy with standardized P judaica extract versus placebo in children with Parietaria pollinosis. The major outcome, indicating efficacy of treatment, was reduction in rhinitis symptom scores. Because no baseline assessment was performed, the active group was more severely symptomatic at the start of the trial, and this difference persisted during the first pollen season. As classically reported, no effect of immunotherapy was observed
Acknowledgements
We thank Dr Enrique Fernandez-Caldas, LETI, Spain, for Par j 1 dosage assays and ARMIA (Associazione Ricerca Malattie Immunologiche ed Allergiche) for supporting the study. We also thank Dr Giovanni Passalacqua for critically reading the text and Dr Anthony Saul for revising the English.
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Supported by Stallergènes SA, France.
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Reprint requests: Claude André, MD, PhD, Stallergènes, 6, rue de Alexis de Tocqueville, 92183, Antony, France.
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