Analysis of outcome indicators of randomized controlled trials of traditional Chinese medicine in the treatment of autism spectrum disorder
[Objective]To sort out the outcome indicators of randomized controlled trials(RCTs)in the treatment of autism spectrum disorder(ASD)with traditional Chinese medicine(TCM),and analyze the existing problems,so as to provide a basis for the design of clinical trials and the construction of core outcome indicators set.[Methods]From January 1,2018 to December 31,2023,CNKI,WanFang Database,SinoMed,VIP,PubMed,Web of Science,Embase,and the Cochrane Library databases were searched for RCTs of TCM treatment of ASD.Through literature screening and data extraction,the outcome indicators and measurement tools were summarized and analyzed.[Results]A total of 72 studies were included,with a total sample size of 5 207 cases and a single study sample size of 18 to 169 cases.The treatment period was 30 days to10 months.The 12 studies reported the TCM syndrome differentiation and classification of ASD,64 studies reported the Western medical diagnostic criteria for ASD,and 17 studies reported the TCM diagnostic criteria.A total of 41 studies were evaluated the efficacy,and 13 effective measurement tools were used.A total of 54 outcome indicators were included in all studies,which were classified into 8 index domains:one clinical effective rate,one TCM syndrome,35 symptoms/signs in total,13 physical and chemical tests,3 items of quality of life,and one item of safety event.And the long-term prognosis and economic assessment were not assessed.A single RCT reported a minimum of one and a maximum of 8 indicators,and all 54 outcomes were used 259 times.The most frequently applied outcome indicator is the children's autism rating scale score(CARS),a total of 50 times,followed by the autism behavior scale score(ABC),which has been reported 45 times,and the clinical efficiency index has been reported 41 times.[Conclusion]The application status of RCTs outcome indicators in the treatment of ASD with traditional Chinese medicine has some problems in clinical research,such as the lack of trial design methodology,large differences in the number and selection of outcome indicators,many elements in the design of efficacy indicators,the neglect of adverse outcome indicators,and insufficient characteristic indicators of TCM.When selecting outcome indicators,researchers should reasonably evaluate the quality and applicability of various scales and clinical efficacy reference standards,pay attention to the characteristics of TCM disease syndromes,and select authoritative and reliable tools to help construct the core index set of TCM in the treatment of ASD.
autism spectrum disordertraditional Chinese medicinerandomized controlled trialcore indicator set of traditional Chinese medicineoutcome indicator
万方数据
维普
