Analysis of Differences in the Definition and Evaluation Criteria of Effectiveness in RCT on TCM for the Prevention and Control of Pseudomyopia Based on Data Mining
OBJECTIVE To analyze the differences in the definition and evaluation criteria of effectiveness in randomized controlled trials(RCT)of Traditional Chinese Medicine(TCM)for the prevention and control of pseudomyopia.This analysis aims to provide theoretical support and improved choices for the application of effectiveness in related research.METHODS A systematic search was conducted in seven databases,including China National Knowledge Infrastructure(CNKI),China Biology Medicine(CBM),Wanfang Data,VIP Information,PubMed,Cochrane Library,and Embase,from the inception of the databases to December 31st,2021.The retrieved literature was imported into the reference management software NoteExpress 3.6,and an Excel 2016 spreadsheet was established to document intervention measures,reference standards for effectiveness definition,efficacy grading,and the involved single and combined indicators.Frequency and descriptive analyses were performed.RESULTS(1)Intervention measures classification:A total of 135 studies were included,including 109(80.74%)focused on TCM therapies,and 26(19.26%)investigated integrated TCM and Western Medicine approaches.(2)Reference standards for effectiveness:The top three reference standards for effectiveness were Guiding Principles for Clinical Research of New TCM(Third Edition)in 29 studies(21.48%),Diagnostic and Therapeutic Criteria of Tcm Syndromes in 17 studies(12.59%),and Diagnostic Criteria for Common Diseases and Efficacy Judgment(standards)in 16 studies(11.85%).In 21 studies(16.60%),the definition of effectiveness integrated two to three reference standards,while 37 studies(27.40%)did not specify reference standards.(3)Efficacy evaluation levels:Six studies(4.44%)categorized efficacy into five levels,80 studies(59.26%)into four levels,and 49 studies(36.30%)into three levels.(4)Frequency of single indicators:The top three indicators in terms of frequency of use were distant vision in 68 studies(50.37%),clinical symptoms in 51 studies(37.78%),and visual acuity in 43 studies(31.85%).(5)Frequency of combined indicators:The top three combined indicators in terms of frequency of use were visual acuity and refraction and clinical symptoms in 39 studies(28.89%),visual acuity and refraction in 36 studies(26.67%),and visual acuity and clinical symptoms in 11 studies(8.15%).CONCLUSIONS Due to the lack of standardized criteria,there are numerous issues with the reference standards,grading criteria,level names,composition,and more in the definition of effectiveness in clinical research on TCM for the prevention and control of pseudomyopia.Further standardization is needed.
pseudomyopiapseudo-near-sightednessTraditional Chinese Medicineout-come measuresrandomized controlled trialsliterature review
NETL
NSTL
万方数据
维普
