Double-blind placebo-controlled evaluation of sublingual-swallow immunotherapy with standardized Parietaria judaica extract in children with allergic.

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Double-blind placebo-controlled evaluation of sublingual-swallow immunotherapy with standardized Parietaria judaica extract in children with allergic rhinoconjunctivitis Mario La Rosa, MDa, Carmen Ranno, MDa, Claude André, MD, PhDb, Florina Carat, MDb, Maria Angela Tosca, MDc, Giorgio Walter Canonica, MDc Journal of Allergy and Clinical Immunology Volume 104, Issue 2, Pages 425-432 (August 1999) DOI: 10.1016/S0091-6749(99)70388-X Copyright © 1999 Mosby, Inc. Terms and Conditions

Fig. 1 Rhinitis symptom scores. Daily means ± SEM of rhinitis symptoms (sneezing, rhinorrhea, and nasal blockage; each symptom scored from 0 = absent to 3 = severe) were plotted against time during first pollen season (1996) (A) and second pollen season (1997) (B). Shaded area, Parietaria pollen counts. Active treatment group was clearly less symptomatic during second year. Journal of Allergy and Clinical Immunology 1999 104, 425-432DOI: (10.1016/S0091-6749(99)70388-X) Copyright © 1999 Mosby, Inc. Terms and Conditions

Fig. 2 Proportion of patients with reduction of at least 30% of rhinitis symptom scores. A total of 87.5% of patients receiving active treatment reduced their symptom scores by at least 30%, which can be considered to be clinically relevant.9 Significant difference was observed between groups (asterisk, P = .02). Error bars indicate exact 0.95 confidence interval (binomial). Journal of Allergy and Clinical Immunology 1999 104, 425-432DOI: (10.1016/S0091-6749(99)70388-X) Copyright © 1999 Mosby, Inc. Terms and Conditions

Fig. 3 Antirhinitis medication scores. Daily means ± SEM of antiallergic drugs (arbitrarily scored: 0.25 point for each dose of topical cromoglycate, 0.5 point for each dose of nasal corticosteroids, 2 points for each dose of antihistamine, and 3 points for each oral corticosteroid tablet) were plotted against time during first pollen season (1996) (A) and during second pollen season (1997) (B). Shaded area, Parietaria pollen counts. Medication scores did not differ significantly between groups throughout study. Asterisk, Patients in active treatment group took significantly fewer antiallergic drugs only during 1 week of first pollen season (P = .05); two pound signs, 1 patient took 3 oral corticosteroid tablets. Journal of Allergy and Clinical Immunology 1999 104, 425-432DOI: (10.1016/S0091-6749(99)70388-X) Copyright © 1999 Mosby, Inc. Terms and Conditions

Fig. 4 Quantitative skin tests. Groups were compared in terms of diameter of wheal obtained with 100-IR concentration on dose-response curve estimated by regression analysis. After 1 year of treatment, increase in skin reactivity was observed in placebo group (asterisk, P = .02) and, after 2 years of treatment, skin reactivity decreased in active treatment group and difference between groups became highly significant (two asterisks, P = .002). Journal of Allergy and Clinical Immunology 1999 104, 425-432DOI: (10.1016/S0091-6749(99)70388-X) Copyright © 1999 Mosby, Inc. Terms and Conditions

Fig. 5 Threshold dose for conjunctival provocation tests (mean ± SEM). After 1 year of treatment threshold dose increased in both groups, but to significantly greater extent in active treatment group (asterisk, P = .02). During second year threshold dose decreased in both groups, but to lesser extent in active treatment group, maintaining significant difference (asterisk, P = .02) between groups. Journal of Allergy and Clinical Immunology 1999 104, 425-432DOI: (10.1016/S0091-6749(99)70388-X) Copyright © 1999 Mosby, Inc. Terms and Conditions

Fig. 6 Anti-Parietaria–specific IgG4 as percent binding (mean ± SEM). There was no change in placebo group throughout the study, whereas specific IgG4 increased during treatment period in active treatment group. Analysis of variation of specific IgG4 in active treatment group and placebo group revealed significant difference (asterisk, P = .02). Journal of Allergy and Clinical Immunology 1999 104, 425-432DOI: (10.1016/S0091-6749(99)70388-X) Copyright © 1999 Mosby, Inc. Terms and Conditions