Abstract
BackgroundsChronic urticaria is a common disorder of the skin, characterised by recurrent skin wheals and angioedema. Recent reports have shown that altered diversity and composition of the gut microbiota may lead to imbalances in immune regulation, a causal factor in the occurrence of chronic urticaria.ObjectiveThis study aimed to evaluate the efficacy of the Yimingjia® probiotic formula in the adjuvant treatment of chronic urticaria in children.MethodsWe enrolled 206 children with confirmed diagnoses of chronic urticaria and randomly assigned them to the treatment (n = 104) or placebo group (n = 102). The children in each group were treated with desloratadine dry suspension, and those in the treatment group also received Yimingjia®. Clinical efficacy was evaluated at 1, 2 and 4 weeks.ResultsClinical symptom scores did not differ significantly at weeks 1 and 2 (p > 0.05), but at 4 weeks, wheal size and attack frequency were significantly reduced in the treatment group (p = 0.049 and 0.03, respectively). The overall response rate (significant improvement + complete response) significantly differed between the treatment (80.8%) and placebo groups (62.5%) (χ2 = 4.20, p = 0.04).ConclusionAdjunct therapy with Yimingjia® was safe and effective at 4 weeks in the treatment of chronic urticaria in children. The study was registered under trial number NCT03328897.
Highlights
Urticaria, characterised by wheals, angioedema, or both, is one of the most common diagnoses in dermatologic practice
A total of 213 patients with chronic urticaria were enrolled, 108 of whom were assigned to the treatment group, and the total average symptom score before treatment was 9.1 ± 1.9
The clinical response evaluation in terms of the symptom score reduction index (SSRI) at W1, W2 and W4 (D7, D14, D28) of treatment in the experimental group was 0.62 ± 0.38, 0.72 ± 0.33 and 0.82 ± 0.29, respectively, and 0.53 ± 0.41, 0.66 ± 0.34 and 0.69 ± 0.31 in the placebo group. Both groups experienced relief in subjective and objective symptoms of chronic urticaria over the observation period, while the rank-sum test indicated a significant difference between groups at week 4 (p = 0.04) (Fig. 2)
Summary
Urticaria, characterised by wheals (hives), angioedema (in 10%), or both (in 40%), is one of the most common diagnoses in dermatologic practice. Several studies suggest the microbiota mediate allergic diseases such as asthma [5], food allergy [6], and atopic eczema [7]. Changes in the composition of Akkermansia muciniphila, Faecalibacterium prausnitzii, Clostridium leptum and Enterobacteriaceae have been reported in patients with chronic urticarial [11]. Pathogenic strains such as Escherichia coli are significantly more prevalent in chronic urticaria, while Faecalibacterium prausnitzii, Prevotella copri and Bacteroides sp. Were significantly less prevalent in disease versus healthy controls [12] These findings of altered gut microbiota in chronic urticaria patients may provide the rationale to correct gut dysbiosis using probiotics supplementation
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