Effectiveness, safety, and tolerability of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic spontaneous urticaria: A double-blind, parallel group, randomized controlled trial
Abstract
Chronic spontaneous urticaria (CSU) is a debilitating condition, adversely affecting the patient's quality of life. Bilastine is a recently introduced, non‐sedative H1‐antihistamine for its treatment. We wanted to compare the effectiveness, safety, and tolerability of bilastine 20 mg vs levocetirizine 5 mg in moderate‐to‐severe CSU. We conducted a double‐blind, randomized controlled trial with two groups: bilastine 20 mg (n = 31) and levocetirizine 5 mg (n = 27), once daily for 42 days. We included patients (18‐65 years), with moderate‐to‐severe CSU. UAS7, VAS, and DLQI were used to assess severity of urticaria, global urticaria‐induced discomfort and quality of life, respectively. DLQI was assessed at baseline (D0) and end‐of‐treatment (D42), while UAS7 and VAS were noted at baseline and all follow‐up visits. Assessment of UAS7 alteration was our primary objective, while changes in DLQI and VAS were the secondary outcomes. Safety was assessed by recording drug‐related adverse events, biochemical investigations, and electrocardiogram, along with tolerability and compliance. Both drugs significantly improved UAS7, DLQI, and VAS at end‐of‐treatment (D42) compared with baseline (intra‐group). At the end‐of‐treatment, all parameters showed greater improvement with bilastine, but only UAS7 reduction was significant (bilastine > levocetirizine, P = .03). In both the groups, UAS7 and VAS improved significantly D14 onwards, and was maintained throughout the study. Sedation was…
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: 31 participants or records.
Read the paper
Related studies
- Artificial Intelligence in Medicine: Cross-Sectional Study Among Medical Students on Application, Education, and Ethical Aspects
- Information quality of videos related to esophageal cancer on tiktok, kwai, and bilibili: a cross-sectional study
- The quality and reliability of short videos about hypertension on TikTok: a cross-sectional study
- Quality and reliability evaluation of pancreatic cancer-related video content on social short video platforms: a cross-sectional study
- Quality and reliability of pediatric pneumonia related short videos on mainstream platforms: cross-sectional study
- Association between metabolic score for insulin resistance (METS-IR) and hypertension: a cross-sectional study based on NHANES 2007–2018
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.