Abstract
BACKGROUND: Chronic idiopathic urticaria (CIU) is a debilitating condition characterized by recurrent hives, itching and angioedema lasting for more than 6 weeks without an identifiable cause. It significantly impacts quality of life, causing physical discomfort and emotional distress. CIU's complex pathophysiology involves immune interactions, mast cells and histamine release, with aeroallergens potentially exacerbating symptoms in sensitized patients. Current treatments primarily involve antihistamines, but many patients experience inadequate relief, prompting the exploration of alternative therapies. Intranasal corticosteroids, typically used for allergic rhinitis, may offer potential benefits for CIU, although evidence of their efficacy is limited. OBJECTIVES: To investigate the effect of intranasal corticosteroids in adults with CIU who had a positive skin prick test for aeroallergens. METHODS: In this double-blind placebo-controlled trial, 69 adults with CIU sensitized to aeroallergens received budesonide 32 µg per actuation, 2 sprays per nostril twice daily or identical placebo for 6 months while maintained on a stable single-agent nonsedating H1 antihistamine. Participants were randomly assigned to receive either budesonide or placebo. Outcomes included changes in urticaria symptoms and Urticaria Severity Score and quality of life. The study was registered with the Iranian Registry of Clinical Trials (IRCT 20231229060563N1). RESULTS: At baseline, both groups were comparable. Post-treatment, participants in the corticosteroid group showed a greater reduction in Urticaria Activity Score (mean difference = 4.25, P = 0.02). No significant difference was found in chronic urticaria quality of life questionnaire scores (mean difference = 4.74, P = 0.35). CONCLUSIONS: Intranasal corticosteroids were effective in reducing urticaria symptoms but did not offer significant benefits over placebo with regard to overall quality of life. The results highlight the complexity of CIU management and suggest a potential placebo effect.