ARIA guidelines for allergic rhinitis in specialist practices. A randomized controlled trial with ebastine

Abstract

Rationale Guidelines are more effective than free-treatment choice in the treatment of allergic rhinitis. The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines were validated in the treatment of intermittent and persistent allergic rhinitis induced by pollens. Methods A multicenter, open label, parallel, randomized study comparing two therapeutic strategies in allergic rhinitis was carried out in specialist practices. In the first strategy, 417 patients received a step treatment using ARIA guidelines with ebastine as oral anti-histamine at 10 or 20 mg/day according to severity of symptoms. In the second strategy (422 patients), investigators had a free choice of treatment. Co-primary outcome measures were quality-of-life (RQLQ) and daily symptom-medication scores. Results Of the 839 randomized patients, 94.2% returned the baseline-visit questionnaires and 88.6% returned the post-treatment period questionnaires. Overall and individual domain scores in the RQLQ were similar in the two treatment groups at baseline. During the treatment period, there were significant improvements in overall and individual domain scores in both groups. However, the improvements in overall scores in the Guidelines Group (−1.70 ± 1.20) were significantly greater than in the Free choice treatment Group (−1.52 ± 1.22, p<0.02). For all domains the improvement in RQLQ scores were greater than 0.5. Conclusions The use of a simple therapeutic scheme based on ARIA Guidelines with ebastine offers patients a significant improvement in comparison to the use of a non-standardized treatment regimen.