OBJECTIVE: To systematically evaluate the efficacy and safety of Runzao Zhiyang capsules combined with antihistamine in the treatment of chronic urticaria（CU）. METHODS: PubMed

the Cochrane Library

Embase

Web of Science

CNKI

CBM

Wanfang Data and VIP database were retrieved to collect the randomized controlled trial of Runzao Zhiyang capsules combined with antihistamine versus antihistamine alone in the treatment of CU

and the included references were manually searched for supplementary retrieval. The retrieval time was from the establishment of the database to Jun. 2021. Two researchers independently screened the literature

extracted data and evaluated the quality of the included studies. Meta-analysis was performed by using RevMan 5.3 software

and publication bias was tested by Stata 15.1 software. RESULTS: A total of 32 studies were enrolled

including 3 061 patients with CU. Meta-analysis showed that the total effective rate of Runzao Zhiyang capsules combined with antihistamine was better than that of antihistamine alone（RR=1.16

95%CI=1.13-1.19

P<0.000 01）

and the incidence of adverse drug reactions was lower than that of antihistamine alone（RR=0.49

95%CI=0.40-0.61

P<0.000 01）

the recurrence rate was lower than that of antihistamine alone（RR=0.42

95%CI=0.31-0.57

P<0.000 01）

the differences were statistically significant

yet the evidence quality remained to be improved. Results of publication bias test and non-parametric shear and supplement method showed that the outcome index of total effective rate was biased

but the possible publication bias did not affect the results. CONCLUSIONS: Based on the existing evidence

compared with antihistamine alone

Runzao Zhiyang capsules combined with antihistamine has significant effect in the treatment of CU

with a lower incidence of adverse drug reactions and recurrence. However

due to the low quality of the included studies and the high risk of bias

the above results need to be viewed with caution.