| Objectives It provides reference and guidance for the methodological design of standardized clinical trials of traditional Chinese medicine for children,increases the feasibility of comparing the results of different clinical trials,and provides a reliable literature basis for the formulation of Technical Guidelines for the Design and Evaluation of Clinical Trials of Traditional Chinese Medicine for Children with Cough Variable Asthma.Methods According to the proposed retrieval strategy,computer retrieval China journal full-text database,a database of ten thousand,Chinese biomedical literature database,Chinese clinical trial registry,Embase,Pub Med,the Cochrane Library1991-2020 of children cough variant asthma randomized controlled trial of relevant literature,at the same time professional manual retrieval data,related magazines and the Internet.The searched literatures were imported into the Note Express document management software for re-screening,and the remaining literatures were screened and re-screened according to the inclusion and exclusion criteria.The included population was children under 18 years old,the intervention measures were Chinese and western medicine treatment,the modified Jadad scale score was ≥4 points,and the language was limited to English or Chinese.Results A total of 3746 literatures were retrieved,and 23 literatures were included,including19 randomized controlled trial reports and 4 protocols.Summarize and refine 10 basic elements :(1)Clinical positioning: Among the 23 studies,14(60.87%)were mainly focused on relieving cough symptoms,7(30.43%)were mainly focused on controlling disease,1(4.35%)was mainly focused on preventing typical asthma,and 1(60.87%)was mainly focused on relieving cough symptoms.(2)Trial design: 22 studies used positive control(95.65%),1 study used placebo control(4.35%),and 3 studies included placebo(13.04%).There were 3 double-blind designs(13.04%),2 single-blind designs(8.70%),2open designs(8.70%),and 16 blind designs(69.56%)without reference to blind methods.There were 7 cases of multi-center(30.43%)and 16 cases of single-center(69.57%).The sample size of 1 study was estimated(4.35%);22 studies(91.30%)were tested for difference,and 2 studies(8.70%)were tested for superior efficacy.(3)Diagnostic criteria: 23 study of the diagnostic criteria of western medicine,with a clear source of 20(86.96%),in three(13.04%),including the 2007,2008,2009 and 2013)in the diagnosis and treatment of chronic cough in children’s guide to eight(40.00%),1998,2008,2016)the children bronchial asthma diagnosis and prevention guide 13(65.00%),"2006 the American college of chest physicians clinical practice guidelines for chronic cough" item 1(5.00%).Among the 15 domestic TCM studies,4 had clear TCM diagnostic criteria(26.67%),including "Pediatrics of TCM","Diagnosis and Differential Diagnosis of TCM","Guidelines for Clinical Diagnosis and Treatment of Pediatrics of TCM · Children with Cough Variable Asthma(Formulation)",and "Criteria for Diagnosis and Efficacy of TCM Diseases and Synmes"(6.67%)each.Of traditional Chinese medicine has a clear standard of 11(84.62%),the Chinese medicine new medicine clinical research guiding principles(try out)"5(33.33%),the TCM pediatrics clinical guidelines,infantile cough variant asthma(for)two(13.33%)," standard of ophthalmic diagnostic efficacy of traditional Chinese medicine ",journal of pediatrics of traditional Chinese medicine(20.00%),each 3 internal medicine of TCM,the study of syndromes of cough variant asthma,the diagnosis and differential diagnosis of traditional Chinese medicine(6.67%)each one;(4)Subjects’ selection and withdrawal: Inclusion criteria were designed for23 studies,which were in line with Western medicine diagnostic criteria(100%),TCM diagnostic criteria or TCM syndrome differentiation criteria(52.17%)for 12 studies,and age of the included subjects was clearly defined for 20 studies(86.96%).2 of them further limited the course of disease(8.70%),5 of them required prediagnostic medication(21.74%),12 of them explicitly required informed consent(52.17%),and 2 of them limited the degree of cough at baseline(8.70%).18 items(78.26%)were related to diseases,14 items(73.68%)were related to experimental drugs,and 19 items(82.60%)were general exclusion criteria.17 studies mentioned the number of cases of shedding and loss of follow-up(73.91%),and 15 studies described shedding criteria(65.22%).(5)Intervention measures: 8 items of Chinese medicine(34.78%)were tested,including 4 items of proprietary Chinese medicine(17.39%),4 items of self-prepared Chinese medicine decoction(17.39%),7 items of Chinese medicine combined with chemical drugs(30.44%),and 8 items of chemical drugs(34.78%).The treatment cycle included 1 item at 7 days(4.35%),2 items at 2 weeks(8.70%),4 items at 4weeks(17.39%),5 items at 8 weeks(21.74%),6 items at 12 weeks(26.09%),and 1 item at 16 weeks,20 weeks and 24 weeks(4.35%).5 items mentioned combination drugs(21.74%).(6)Induction period and follow-up: 1 study set up the induction period(4.35%),12 study set up the follow-up period(52.17%),2 study set up the follow-up period(4.35%),4 and 12 weeks(8.70%),20 weeks,24 weeks and 12 months(4.35%),18 months(8.70%).(7)Efficacy evaluation: cough severity was the main index of 14(60.87%),disease control was the main index of 7(30.44%),cough severity and disease control was the main index of 1(4.35%),typical asthma was the main index of 1(4.35%).(8)Safety evaluation: adverse reactions/events were selected as the main outcome index in all 17 studies(73.91%),and routine laboratory indicators were described in all 4 studies(17.39%).(9)Quality control.Quality control was described in detail in 4 studies(17.39%),including case report form,training of relevant personnel,and daily registration form.(10)Attensitive ethics requirements: 12 signed informed consent,13 research descriptions were approved by the ethics committee,but the batch number of ethics documents was not provided.Conclusion This study include literature quality is higher,but the basic is given priority to with domestic research,the foreign literature,rare basic covers children cough variant asthma clinical trial design and evaluation of the basic elements,Chinese medicine clinical trial design and evaluation for children,has a certain reference value to improve the feasibility of the comparison of different test result,for children CVA guide clinical trial design and evaluation of traditional Chinese medicine to provide literature basis. |
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