Comparison of the efficacy and tolerability of an oral dosage form made from Fumaria vaillantii versus cetirizinein management of chronic urticaria: A single-blind, randomized, clinical trial

Abstract

BACKGROUND: Chronic urticaria (CU) is one of the common allergic diseases whose conventional treatments have failed to desirably manage it. Fumariavaillantii is used in Persian medicine to treat CU. The anti-inflammatory and anti-histaminic effects of chemical components of Fumaria such as fumaric acid and caffeic acid were confirmed. Dimethyl fumarate reduces the pro- inflammatory contribution and monomethyl fumarate can increase IL-4, an antiinflammatory interleukin, or can decrease IFN- , an inflammatory factor. The current study assesses the efficacy and tolerability of Fumaria vaillantii versus cetirizine in the management of CU. METHODS: The formulation and standardization of Fumaria syrup were done in Tehran University of Medical Sciences. Patients were randomized to twice- daily treatment with Fumaria syrup or cetirizine syrup (n=39 in each group) for four weeks. The efficacy assessment included Urticaria Activity Score (UAS) and Chronic Urticaria Quality of Life Questionnaire (CUQ2oL) and the safety evaluations included Common Terminology Criteria for Adverse Events Questionnaire. RESULTS: The fumaric acid content in 5 ml of Fumaria syrup was calculated to be 0.12 mg. The results of clinical trial showed that UAS was significantly higher in the Fumaria group than in the cetirizine group, after the first week of follow-up (p<0.001), but no significant difference was demonstrated between the two groups on week 4 (p=0.57). One month after the research was finished, the UAS score of the cetirizine group was significantly higher than that of the Fumaria group (p<0.001). After finishing the interventions, difference of CU-Q2oL was not significant between the two groups; however, the QOL score was significantly lower in the Fumaria group (p<0.001) at 8th week. About adverse events, the incidence of somnolence in the Fumaria group was significantly lower than in the cetirizine group (p<0.001). CONCLUSIONS: Fumaria vaillantii demonstrated its effects on CU later than cetirizine, but led to more permanent effects, better quality of life, and lower incidence of adverse events as compared to cetirizine. More clinical trials with higher populations are needed to achieve more conclusive results.