Clinical efficacy of sublingual-swallow immunotherapy : a double-blind, placebo-controlled trial of a standardized five-grass-pollen extract in rhinitis

• Published in: Allergy (Copenhagen) Vol. 53; no. 5; pp. 493 - 498
• Main Authors: CLAVEL, I. R, BOUSQUET, J, ANDRE, C
• Format: Journal Article
• Language: English
• Published: Oxford Blackwell 01.05.1998
• Subjects: Administration, Sublingual; Adolescent; Adult; Biological and medical sciences; Child; Deglutition; Double-Blind Method; Female; Humans; Immunoglobulins - analysis; Immunopathology; Immunotherapy (general aspects); Immunotherapy - methods; Male; Medical sciences; Middle Aged; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Poaceae - chemistry; Pollen - chemistry; Rhinitis, Allergic, Seasonal - blood; Rhinitis, Allergic, Seasonal - therapy; Human; Allergy; Nose disease; Desensitization; Rhinitis; Respiratory disease; Treatment efficiency; Sublingual administration; Asthma; Treatment; Immunotherapy; Double blind study; ENT disease; Pollen; Obstructive pulmonary disease; Allergen
• ISSN: 0105-4538; 1398-9995
• DOI: 10.1111/j.1398-9995.1998.tb04086.x

Sublingual-swallow immunotherapy (SLIT) using high doses of standardized allergen extracts has been found to be effective in reducing allergic symptoms and medication needs. A double-blind, placebo-controlled study was carried out in a large number of patients to determine whether medication needs can be reduced by SLIT. Some 136 patients with grass-pollen rhinitis with or without mild asthma were studied. Patients received either placebo or SLIT with a standardized grass-pollen extract administered daily with increasing doses up to 300 IR (index of reactivity) from January to the end of July 1994. During the grass-pollen season, patients were instructed to use medications as required and to visit their doctors in case of asthma. Symptom-medications scores were assessed during the pollen season, and serum-specific IgG4 was measured before and at the end of SLIT. In the SLIT group, drug consumption dropped significantly throughout the pollen season (P < 0.02). Moreover, at the peak of the pollen season, betamethasone consumption was significantly reduced in the SLIT group (P < 0.02). Only one patient in the SLIT group had an asthma attack compared to eight patients in the placebo group (P < 0.02). IgG4 levels increased significantly in the SLIT group (P < 0.001) but without correlation with symptoms. Side-effects were comparable in both groups. This study indicates that SLIT in grass-pollen rhinitis is well tolerated, improves overall clinical symptoms, and reduces drug consumption and the need for oral corticosteroids.