中医药治疗儿童注意力缺陷多动障碍临床随机对照试验结局指标的文献研究OACSTPCD

Objective To analyze the clinical outcome indicators of randomized controlled trials(RCT)involving traditional Chinese medicine for children with ADHD,in order to provide insights for establishing a core outcome set of TCM clinical trials for ADHD.Methods We searched RCTs of traditional Chinese medicine in the treatment of ADHD in the databases of PubMed,EMbase,the Cochrane Library,Web of Science,CNKI,WanFang Data,Sinomed and VIP.The search spanned from January 1900 to December 2022.We collect RCTs of traditional Chinese Medicine therapy for children with ADHD,including TCM herbal decoctions,acupuncture and moxibustion,cupping,Taiji,Baduanjin and other therapies.Outcome indicators and relevant information(including diagnostic criteria,traditional Chinese medicine syndrome types,efficacy indicators,course of treatment,and follow-up)were extracted.The outcome indicators were classified by functional attributes and a descriptive analysis of their frequency was conducted.Results 151 papers were included in the final analysis.The indicator field can be divided into 5 categories:symptoms and signs(38 types),examination and laboratory tests(33 types),traditional Chinese medicine syndromes(48 types),clinical efficacy evaluation(39 types),safety evaluation(17 types)and the development of reference standards for each evaluation.The follow-up report rate is 15.8%,and a total of 21 studies had a follow-up period exceeding three months.Conclusion The selection of outcome indicators in RCTs for the TCM treatment of ADHD in children is relatively diverse,covering symptoms and signs,examinations and laboratory tests,traditional Chinese medicine syndrome scores,clinical efficacy evaluation,and safety evaluation.However,challenges were identified such as unclear description of the scale version,insufficient in-depth data analysis,lack of characteristic indicators for TCM treatment,and insufficient follow-up.