Probiotic as an adjuvant therapy in chronic urticaria: a blinded randomized controlled clinical trial.

Summary: Background. Chronic spontaneous urticaria (CSU) is a common and treatment challenging disorder which may involve about 2% of normal population and in 50% do not respond properly even to the second line therapies. We aimed to evaluate the efficacy and safety of a synbiotic (prebiotic + probiotic) named as LactoCare in treatment of CSU in the RCT for the first time. Methods. This blinded RCT conducted on 42 patients (21 patients in control antihistamine group and 21 in intervention antihistamine + probiotic group) with CSU during 8 weeks. The efficacy assessed by Urticaria Activity Score (UAS7) and quality of life measured by Persian validated Dermatology Life Quality Index (DLQI). Results. Before and after UAS7 score in control group was 35.33 ± 7.81 and 16.86 ± 13.54, respectively. There was 53% score reduction in control group. Before and after UAS7 score in intervention group was 32 ± 7.84 and 11 ± 11.41, respectively. There was 66% score reduction in intervention group. Improvement of DLQI in control and intervention group was 44% and 66%, respectively. At the end, UAS7 score reduction and DLQI improvement in both groups was statistically significant. Conclusions. Probiotics are effective, safe and satisfactory adjuvant therapy for CSU. Combination of probiotic and antihistamines had no statistically significant different efficacy than the antihistamine alone, based on UAS7 score. But Patients with combination therapy may experience higher reduction rate of itch, number of urticaria and total UAS7 score that is clinically of great value and is really practical by itself. Patients with combination therapy experienced more improvement of quality of life (DLQI).