| Objectives:To conduct a meta-analysis of the curative effect of Traditional Chinese Medicine(TCM)in the treatment of pediatric allergic rhinitis based on the syndrome of lung and spleen Qi deficiency.The objective of this study is to clarify the current clinical evidence pertaining to the treatment of allergic rhinitis,present potential problems,and critically appraise current clinical trials conducted on pediatric allergic rhinitis.Besides,this study aims to provide reasonable suggestions on the design of future relevant clinical trials.Methods:Randomized clinical trials(RCTs)that involved the treatment of children with allergic rhinitis based on the syndrome of lung and spleen Qi deficiency using TCM were collected.The searched literature databases include:China National Knowledge Infrastructure(CNKI),Wanfang Database,VIP Database,Chinese Biomedical Literature Database,PubMed,and Cochrane Library,and the retrieval date is from the establishment of the database to December 2020.The study subjects were children with allergic rhinitis diagnosed with lung and spleen Qi deficiency.The experimental group was treated with the method of invigorating the spleen and nourishing the lung(the treatment route is not limited)or received an integrated TCM and pharmaceutical treatment approach.The control group was treated with either conventional pharmaceutical treatment or placebo.The Cochrane systematic review method was adopted to formulate a set of reasonable study inclusion and exclusion criteria,and appropriate search strategies were used to search the Chinese and English databases.Two researchers independently screened the eligible studies and extracted data.The relevant studies were imported into the Endnote X9 software and duplicated studies were excluded.Studies that were irrelevant based on their title and abstract were excluded.The full-text publication of studies that possibly fulfilled the inclusion criteria were subsequently obtained and read.The included studies were evaluated for their risk of bias using the Cochrane Collaboration’s bias risk assessment tool.A defined Excel 2010 table was used to extract relevant data,including the basic characteristics and the experimental methodological characteristics of the included studies.Statistical analysis of the data in the included studies were performed using the RevMan5.3 software.The overall effective rate in the TCM treatment group and the pharmaceutical treatment control group,the changes in the main nasal symptoms and signs,the changes in serum Immunoglobulin E(IgE)levels,the changes in TCM syndrome scores,effective rate after follow-up,and recurrence rate after follow-up were analyzed,and the efficacy and safety issues were compared.Statistical heterogeneity of the included studies was judged based on the magnitude of the I2 value.If the calculated result I2≤50%and P>0.05,it indicated that there was no statistical heterogeneity between the studies,and the fixed effects model could be used for combined analysis.If the calculated result I2>50%and P<0.05,it indicated that there was significant statistical heterogeneity between the studies,and the random-effects model was used and the source of heterogeneity was examined.The relative risk(RR)was used to analyze the effect size of binary variable data results,and the mean difference(MD)was used to analyze continuous variable data according to the outcome-scoring standards utilized by the included studies,and the interval estimation was analyzed using 95%CI.When the outcome index unit or measurement method used was inconsistent,the standard mean difference(SMD)value was used for effect size analysis.Results:A total of 25 RCTs with 2184 participants were eventually included,all of which were Chinese literature.The interventions in the control group were all pharmaceutical treatment,and the intervention measures in the experimental group included TCM herbal medicine treatment,TCM external therapy,a combination of TCM herbal medicine and TCM external therapy,as well as integrated TCM and pharmaceutical treatment approach.There were 1148 children in the experimental group and 1036 children in the control group.The metaanalysis revealed that the overall effective rate of TCM treatment based on lung and spleen Qi deficiency was greater than the overall effective rate of pharmaceutical treatment(RR:1.14,95%CI=[1.09,1.19],Z=5.59,P<0.00001).Since the intervention measures in the included studies were not uniform,and considering that different interventions may produce different effects,subgroup analysis was carried out according to the different interventions of the experimental groups to resolve any possible heterogeneity between the studies.9 studies evaluated based on the improvement of nasal congestion.TCM treatment was superior to pharmaceutical treatment in improving nasal congestion,and the difference was statistically significant(SMD=-0.54,95%CI=[-0.96,-0.13],Z=2.56,P=0.01);9 studies evaluated based on the improvement of sneezing.TCM treatment was better than pharmaceutical treatment in improving sneezing,and the difference was statistically significant(SMD=-0.86,95%CI=[1.34,-0.39],Z=3.57,P=0.0004);9 studies evaluated based on the improvement of nasal itching.TCM treatment was superior to pharmaceutical treatment in improving nasal itching symptoms,and the difference was statistically significant(SMD=-0.54,95%CI=[-0.95,0.13],Z=2.57,P=0.01);9 studies evaluated based on the improvement of rhinorrhoea.TCM treatment was better than pharmaceutical treatment in improving rhinorrhoea,and the difference was statistically significant(SMD=-0.54,95%CI=[-0.98,-0.09],Z=2.37,P=0.02).7 studies evaluated based on the improvement of nasal signs,but the difference between the two groups was not statistically significant(SMD=-0.51,95%CI=[-1.30,0.27]);4 studies evaluated based on the total score of main nasal symptoms.TCM treatment was superior to pharmaceutical treatment in improving nasal symptoms,and the difference was statistically significant(SMD=-1.64,95%CI=[-1.96,-1.33],Z=10.21,P<0.00001).4 studies evaluated based on serum IgE levels.TCM treatment was more advantageous than pharmaceutical treatment in reducing IgE levels,and the difference was statistically significant(MD=-86.98,95%CI=[-135.46,-38.50],Z=3.52,P=0.0004);2 studies evaluated based on the TCM syndrome total score effective rate.The total effective rate of the TCM treatment group was higher than that of the pharmaceutical treatment group,and the difference was statistically significant(RR=1.16,95%CI=[1.01,1.33],Z=2.14,P = 0.03);2 studies evaluated based on changes in the TCM syndrome total scores,but the difference between the two groups was not statistically significant(RR=-2.74;95%CI=[-6.50,1.01]);9 studies reported the total effective rate during follow-up after treatment.The effective rate during follow-up of the TCM treatment group was higher than that of the pharmaceutical treatment group,and the difference was statistically significant(RR=1.44,95%CI=[1.28,1.61],Z=6.16,P<0.00001);5 studies reported the recurrence rate during follow-up after treatment.The recurrence rate during follow-up in the TCM treatment group was lower than that of the pharmaceutical treatment group,and the difference was statistically significant(RR=0.52,95%CI=[0.37,0.72],Z=3.89,P=0.0001).The methodological quality of the included studies was generally low,with high heterogeneity,and a relatively higher risk of selection bias,implementation bias,measurement bias,and reporting bias.Conclusion:TCM treatment of children with allergic rhinitis is more effective in improving nasal symptoms and reducing serum IgE levels than pharmaceutical treatment alone.However,there are no significant differences seen in the improvement of nasal signs and TCM syndrome scores.TCM treatment is more advantageous than pharmaceutical treatment especially in the aspect of long-term efficacy.TCM treatment is superior to pharmaceutical treatment in the improvement of rhinorrhoea and nasal itching symptoms.However,there are no significant differences seen in the improvement of nasal congestion and sneezing symptoms,and nasal signs.Pharmaceutical treatment is better than TCM external therapy in improving nasal signs,but there is no significant difference in the improvement of nasal symptoms.An integrated TCM and pharmaceutical treatment approach is better than pharmaceutical treatment solely in improving nasal symptoms,but there is no significant difference in the improvement of nasal signs.The results from this meta-analysis suggest that treatment of pediatric allergic rhinitis based on lung and spleen Qi deficiency has a certain treatment efficacy.Nevertheless,the conclusions drawn from this study still need to be verified with more large-sample,multicentre,double-blind standardized RCTs in the future. |
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