| Background With the development of research and evidence-based medicine in the prevention and treatment of type 2 diabetes mellitus(T2DM),traditional Chinese medicine(TCM)plays an increasingly important role in the treatment of T2 DM.More and more randomized controlled trials and related systematic evaluations/meta of TCM in the prevention and treatment of T2 DM are conducted,but the quality of methodology and reporting criteria are still unclear.In addition,as a tool to standardize clinical diagnosis and treatment and guide clinical decision-making,the quality of clinical practice guidelines directly affects the level of clinical treatment and therapeutic effect.Evaluating the quality of clinical practice guidelines for type 2diabetes can help guideline-makers and users to determine whether the methods used in the process of making guidelines are scientific and rigorous,and whether the recommendations of guidelines are based on them.Whether the reporting quality of the guideline is standardized or not.meanwhile,it is not clear whether there are differences in methodological quality between the clinical practice guideline of TCM for T2 DM and the clinical practice guideline of Western medicine for T2 DM.Objective Through analyzing the research status of TCM in the treatment of T2 DM,the reporting quality of randomized controlled trials of Chinese medicine in the treatment of T2 DM,the quality of systematic reviews/meta-analysis of TCM in the treatment of TT2 DM based on AMSTAR and PRISMA and the methodological quality and reporting standard quality of clinical practice guidelines for T2 DM with AGREE II and RIGHT standards to improve the quality of clinical research of TCM and the production of high-quality evidence for the treatment of T2 DM.Besides,to promote the application of clinical transformation and standardize the formulation of clinical practice guidelines for diabetes mellitus in China.Methods 1)Bibliometric analysis methods: BICOMS-2,gCLUTO,Ucinet 6.0and Netdraw software were used to analyze the research status of TCM in thetreatment of T2DM;2)Systematic reviews: To include randomized controlled trials of TCM in the treatment of T2 DM,using CONSORT-TCM tools to evaluate the reporting quality of included studies;3)Overview: to evaluate the methodological quality and reporting quality of systematic reviews/meta-analysis of TCM in the treatment of T2DM;4)We also assessed the quality of clinical practice guidelines for type 2 diabetes based on AGREE II and RIGHT.Results 1)Current status of TCM in the treatment of T2DM: 6523 articles related to the treatment of T2 DM were finally included.At present,675 Chinese journals and 79 English journals have published relevant studies on the treatment of type 2 diabetes with TCM.The Chinese and English research authors have a wide range of contacts,with two major social network groups respectively.The most frequently used Chinese keywords are diabetes mellitus,diabetic patients,TCM syndromes,TCM,syndrome differentiation and treatment,and complications of diabetes mellitus.The English keywords are humans,metabolism,drug therapy,Animals and Chinese medicine traditionality.2)Results of quality evaluation of randomized controlled trials of TCM in the treatment of T2DM: 117 studies were included.The results showed that only six studies(5.1%)reported the title and abstract adequately,20 studies(17.1%)did not report the background knowledge related to the studies according to the theory of TCM,ten studies(8.5%)did not report the specific purpose of the research In the methodological part,only eight papers(6.8%)fully described the method of sample size calculation in randomized controlled trials(item 7);only 35 papers(29.9%)fully described the method of random sequence generation(item 8),ten papers(8.5%)fully reported the method of group hiding and allocation sequence hiding in randomization(item 9),and three papers(2.6%)respectively fully stated the relevant information of implementation(item 10),22 articles(18.8%)fully reported the blind method(item 11).Meanwhile,in the results section,only three papers(2.6%)fully reported the number of subjects in each group and whether "intention analysis" was used(item 16),no supplementary analysis including subgroup analysis and correction analysis was reported in the included studies(item 18).In the discussion section,only 16 papers(13.7%)fully reported the conflict of interest between researchers and experiments(item 18).3)Quality evaluation results of systematic evaluation/meta-analysis of TCM for T2DM:A total of 92 studies were included.The results of AMSTAR showed that the average score was 6.5,of which 5(3.3%)scored 9-11,75(81.5%)scored 5-8,12(13%)scored less than 5,and the overall methodology quality was medium.The results of PRISMA showed that 18(19.6%)of them were less than 15 points with the report had relatively serious information deficiencies,50(54.3%)of them scored 15-21 points with the report had certain deficiencies,24(26.1%)of them scored 21-27 points with the report was relatively complete.4)Results of quality evaluation of clinical practice guidelines for T2DM: A total of 31 guidelines were included and published in 26 journals from 2008 to 2018.The results of AGREE II showed that only one guide(3.2%)scored less than 40% in domain one(scope and purpose);eight guidelines(25.8%)scored less than 20% in domain two(participants);nine guidelines(29.0%)scored less than 20% in domain three(formulation rigor);one guideline(3.2%)scored less than 20% in domain four(expression clarity);and eleven guidelines(35.5%)scored less than 20% in domain five.(applicability)score was less than 20%;24guidelines(77.4%)scored less than 20% in domain 6(editorial independence).The overall evaluation score of the guideline was 59%.The quality score of the guideline of TCM for T2 DM in six areas was lower than that of the guideline of Western medicine for T2 DM.The quality evaluation results based on RIGHT show that 12guidelines(38.7%)did not present the recommended opinions of the guideline,and that the contents of terminology and abbreviations(item 3)and the contents of all contributors and their roles and responsibilities(item 9a)were fully reported in the guideline.Only ten Guidelines(32.3%)reported evidence and recommendations.Only two guidelines(6.5%)adequately reported the contents of fairness,feasibility and acceptability(item 14c),In addition,only three guidelines(9.7%)fully reported the quality assurance procedures(item 17)and conflict of interest assessment and management methods(item 19b)of the guidelines respectively.Conclusion At present,the research hotspot of traditional Chinese medicine in the treatment of T2 DM lies in the clinical observation of syndrome differentiation and treatment of complications of diabetes mellitus by TCM,the research trend has evolved to experimental research and biomolecular research.However,there are also some problems,such as less publication of English literature,single publication of journals,low impact factors and so on.The quality of research evidence for the treatment of T2 DM by TCM is generally low,there are methodological and reporting quality problems in different degrees,whether in randomized controlled trials,systematic evaluation/meta-analysis or clinical practice guidelines. |
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