Safety and efficacy of cetirizine versus cetirizine plus ranitidine in chronic urticaria: Double-blind randomized placebo-controlled study

Abstract

Background: First-line treatment for chronic urticaria is H1 non-sedating antihistamines. When these fail, guidelines recommend combination with H2 antihistamines. Aim: We conducted a randomized, double-blind, placebo-controlled trial. Methods: Thirty-two patients with chronic urticaria were included. Group A (16 subjects) treated with cetirizine plus ranitidine and Group B (16 subjects) with cetirizine plus placebo, both for 30 days. Efficacy measures were Urticaria Activity Score (UAS), Chronic Urticaria Quality of Life Questionnaire (CU-Q₂oL) and time of symptom remission, safety measures were clinical and laboratory effects. Results: Complete remission was obtained in ten patients (62.5%) from Group A and seven patients (44%) from Group B (p = 0.28). The UAS in Group A was 1.53 ± 2.09 versus Group B 2.06 ± 1.34 (p = 0.20). The CU-Q₂oL in Group A was 12.93 ± 19.20 versus Group B 12.68 ± 10.30 (p = 0.20). At the end of treatment, 13 patients (81%) from Group A and 14 patients (87.5%) from Group B had some type of adverse effect (p = 1.0). Conclusions: Combination of cetirizine with ranitidine was not more effective than cetirizine alone in chronic urticaria. Both treatments resulted equally safe; however, our main limitation is the small sample size.

• Antihistamines
• chronic urticaria
• clinical trial
• efficacy
• safety
• treatment

Acknowledgements

To Drs Canonica and Valero, for the Italian and Spanish version of CU-Q₂oL, they kindly authorize the employment of questioner in a free manner.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.

Cetirizine tablets 10 mg and placebo tablets were funded by the investigators. Ranitidina tablets 300 mg were kindly donated by Laboratorio Senosian (Ranisen®). The laboratory tests were supported by Instituto Dermatológico de Jalisco “Dr. José Barba Rubio”, Secretaria Salud Jalisco.