Analysis of outcome indicators in randomized controlled trials of traditional Chinese medicine treatment for AIDS
Objective To analyze the application of outcome indicators in randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)treatment for AIDS,and discuss existing issues,so as to provide a basis for establishing a clinical efficacy evaluation criteria of TCM for AIDS based on a core indicator set.Methods RCTs of TCM treatment for AIDS were retrieved from seven databases including China National Knowledge Internet(CNKI),VIP Chinese Journal Service Platform,Wanfang Data Knowledge Service Platform,China Biomedical Literature Service System,PubMed,Cochrane Library,and EMbase,from the inception of each database to September 14,2023.After literature screening and data extraction,statistical analysis was carried out on the included outcome indicators,and indicator domains were classified according to the functional attributes of the outcome indicators.Results A total of 99 studies were included,with a sample size of 9 203 cases and an observation period ranging from 1 to 60 months.A total of 70 outcome indicators were obtained,with a total frequency of 787 times.The outcome indicators could be divided into 6 categories,with the highest to lowest frequency of use being physiological and biochemical tests(90.91％),TCM syndrome differentiation(76.77％),safety events(66.67％),quality of life(43.43％),symptoms and signs(30.30％),and long-term prognosis(14.14％).The top 10 outcome indicators in terms of frequency of use were CD4 cells,total score of TCM syndromes and signs,viral load,liver function,blood routine,kidney function,CD8 cells,urine routine,total efficacy of TCM symptoms,and Karnovsky score.Conclusions There are issues with the selection of outcome indicators in RCTs of TCM treatment for AIDS,including unclear primary and secondary outcome indicators,lack of health economic evaluation indicators,limited use of long-term prognostic indicators,and significant differences in the use of outcome indicators.In the future,it is necessary to further establish a core indicator set for TCM treatment of AIDS,providing more reliable evidence of the clinical efficacy for TCM treatment of AIDS.
AIDStraditional Chinese medicine(TCM)randomized controlled trials(RCTs)outcome indicatorscore indicator set
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