A prospective, randomized, open-label, active-controlled study to compare the efficacy and safety of levocetirizine and bepotastine in chronic spontaneous urticaria
Abstract
Background: Management of chronic spontaneous urticaria (CSU) is challenging because of its unpredictable course and negative influence on the quality of life. Second-generation antihistaminics are the first-line treatment. Levocetirizine, a time-tested antihistaminic, has proven efficacy in CSU. Bepotastine, which was previously used for allergic rhinitis and conjunctivitis, has recently been tried in urticaria. It may be a better alternative to levocetirizine because of its long-term safety. Objectives: The aim of this study was to compare the efficacy and safety of levocetirizine and bepotastine in CSU. Materials and Methods: A randomized, active-controlled, open-label, prospective, interventional study was conducted on 70 patients of CSU. After initial clinical assessment and baseline investigations, bepotastine and levocetirizine were prescribed to separate groups of 35 patients for a period of 12 weeks. Urticaria Activity Score (UAS) and Dermatology Life Quality Index (DLQI) were used for assessing the severity of disease. Follow-up visits were planned for evaluating clinical improvement and adverse effects. Results were compared using Mann–Whitney U test and Fisher's exact test. P < 0.05 was considered statistically significant. Results: The reduction in UAS and DLQI score in levocetirizine group was better than bepotastine group, and the results were statistically significant at 12 weeks (P = 0.0001). Incidence of adverse effects such as sedation and weight gain was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 70 participants or records.
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