Evaluation of the efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis-caused cough(syndrome of phlegm-heat obstructing the lung)in children
Objective To evaluate the efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of cough caused by acute bronchitis in children,which is defined in TCM terms as a syndrome of phlegm-heat obstructing the lung.Methods This was a block-randomized,double-blind,placebo-controlled,multicenter clinical trial.From January 2022 to September 2023,359 children aged 3 to 7 years old diagnosed as acute bronchitis(lung-obstructing phlegm-heat syndrome)were enrolled from 21 participating hospitals and randomly assigned to the experimental group and placebo group in a 3∶1 ratio,and respectively treated with Xiao'er Huangjin Zhike Granules and its matching placebo.Cough resolution/general resolution rate after 7 days of treatment was used as the primary efficacy outcome for both groups.Results(1)On the seventh day of treatment,the rate of cough disappearance/basically disappearance in the experimental group and placebo group were 73.95％and 57.61％retrospectively,which had statistically significance(P=0.001).(2)After 7 days of treatment,the median duration of cough disappearance/basic disappearance were 5 days and 6 days in the two groups,with a statistically significant difference(P=0.006).The area under the curve of cough symptom severity time was 7.20±3.79 in the experimental group and 8.20±4.42 in the placebo group.The difference between the two groups was statistically significant(P=0.039).(3)After 7 days of treatment,the difference between TCM syndrome score and baseline was-16.0(-20.0,-15.0)points in the experimental group and-15.0(-18.0,-12.0)points in the placebo group,with significant difference between the two groups(P=0.004).In the experimental group,the clinical control rate,the markedly effective rate,the effective rate and the ineffective rate were 49.04％,28.35％,16.48％and 6.13％severally;and in the placebo group,the clinical control rate,the markedly effective rate,the effective rate and the ineffective rate were 38.04％,26.09％,29.35％,and 6.52％separately,which had statistically significant(P=0.014).(4)There was no significant difference in the incidence of adverse events or adverse reactions during the trial between both groups.Moreover,while adverse reactions in the form of vomiting and diarrhea were occasionally reported,no serious drug-related adverse event or adverse reaction was reported.(5)The tested drug provided good treatment compliance,showing no statistically significant difference from the placebo in terms of compliance rate.Conclusions Based on the above findings,it can be concluded that Xiao'er Huangjin Zhike Granules provides good safety,efficacy,and treatment compliance in the treatment of cough caused by acute bronchitis,and lung-obstructing phlegm-heat syndrome,in children.
ChildXiao'er Huangjin Zhike GranulesAcute bronchitisSyndrome of phlegm-heat obstructing the lungBlock-randomized,double-blind
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