A double-arm, randomized, and controlled trial to compare the efficacy and safety of bepotastine with levocetirizine in patients of chronic spontaneous urticaria
Abstract
Background: Second generation antihistamines are first line therapy for chronic spontaneous urticaria (CSU). Sedation has been always a concern as a side effect of antihistamine for both patients and treating dermatologist. It is always better to prefer non-sedative antihistamine for CSU. Bepotastine is such promising non-sedative agent.
Aim and Objectives: The objective of the study was to compare the efficacy and safety of bepotastine and levocetirizine in patients of CSU.
Materials and Methods: This is a double arm, open label, randomized, and controlled study. Out of 99 patients, 50 patients belonged to Group A while 49 belonged to Group B. Subjects in Group A received bepotastine 10 mg twice daily while subjects in Group B received levocetirizine 5 mg once daily for 8 weeks. Patients were evaluated at baseline, day 14, day 28, and day 56 using Urticaria Activity Score (UAS) and Urticaria Control Test (UCT) for efficacy; and visual analog scale (VAS) for safety, that is, sedation.
Results: The fall in mean UAS scores was statistically significant at day 14, day 28, and day 56 for both Groups A and B (P 0.05). At day 56, there was significant difference in mean VAS of Group A and B. Only one patient in Group B developed headache.
Conclusion: Thus, both levocetirizine and bepotastine are equally effective for the treatment of CSU. Bepotastine has less sedative potential than levocetirizine.
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: 99 participants or records.
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