Efficacy of bilastine up-dosing (40 mg) versus combination of bilastine 20 mg with levocetirizine 5 mg in the treatment of chronic spontaneous urticaria:a prospective randomized controlled study
Abstract
Objective: To compare the efficacy of bilastine up-dosing (40 mg/day) with combination therapy consisting of bilastine 20 mg and levocetirizine 5 mg in patients with chronic spontaneous urticaria (CSU). Study Design: Randomized controlled trial. Place and Duration of Study: Department of Dermatology, Combined Military Hospital, Okara, Pakistan, from September 2025 to January 2026. Methodology: The research enrolled 60 adult patients (aged 18 to 70 years) who had experienced CSU symptoms for more than six weeks and showed Urticaria Assessment Score (UAS7) scores above 3 after taking bilastine 20 mg. The study assigned patients to two equal groups through random distribution. Group A received bilastine 20 mg twice daily (40 mg/day) while Group B received bilastine 20 mg in the morning plus levocetirizine 5 mg at night for six weeks. The researchers used UAS7 to measure patient progress during their treatment period. Results: The six-week assessment shows Group A achieved better results than Group B through its UAS7 score, which reached 11.0 (IQR 4) compared to Group B, which reached 25.0 (IQR 5). Group A achieved mild or well-controlled disease status in 96.7% of patients, while Group B achieved this status in no patients (p<0.001). Conclusion: The study found that bilastine up-dosing (40 mg/day) produced better results than the combination therapy of bilastine and levocetirizine for managing chronic spontaneous urticaria.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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