Pre-seasonal Specific Immunotherapy in rhino-conjunctivitis versus Placebo

Abstract

RATIONALE: Evaluate the efficacy and safety of specific immunotherapy with grass pollens (SIT) in a blind controlled study with a pre-seasonal treatment during 5 years in patients with seasonal rhino-conjunctivitis. METHODS: We selected 36 patients with rhino-conjunctivitis, who were sensitised to grass pollens, 18 male and 18 female with moderate or severe grade of rhino-conjunctivitis according ARIA. The patients received during 5 years immunotherapy in pre-seasonal period of an extract of 7 grass pollens by sub cutaneous route. All patients received information about forecasts and total pollens count in their residential area. The placebo group had received physiological serum daily in sublingual drops during 7 weeks before spring. The ANOVA test and T test was used for analyse differences between groups and for analyse the correlations the Spearman method was used. RESULTS: A significant improvement was observed regarding symptoms in all patients as in throughout the treatment period in those who specific immunotherapy was performed. The severity of symptoms was smaller in SIT group that in the placebo group. Rescue medication was reduced either in anti-histamine and/or nasal steroids in SIT group with a mean of 23.5 days of medication when compared with the placebo with 61.9 days of medication during the season (p<0.01). The tolerance and safety of immunotherapy was excellent and just in 0.8%. CONCLUSIONS: The short-term and pre-seasonal immunotherapy, subcutaneous for patients sensitised to grass pollens is effective and safety. A considerable reduction of symptoms and reduction in the medication was found. The use of oral anti-histamine drugs and topical steroids was significantly reduced by immunotherapy.