| ObjectiveBy evaluation and analysis of traditional Chinese medicine treatment of clinical randomized controlled trial documents of diabetic retinopathy,it used to give some suggestions to the future of clinical trials of traditional Chinese medicine treatment of diabetic retinopathy research,to improve the quality and credibility of clinical randomized controlled trials of the diabetic retinopathy,to make it normalization,and to lay the foundation in further large-scale randomized controlled trial of traditional Chinese medicine to treat diabetic retinopathy MethodsBy retrieving the CNKI database,the Wanfang database and the VIP database,the clinical randomized controlled trial literature on traditional Chinese medicine treatment of diabetic retinopathy was downloaded.After reading the full article,the literature was further screened in accordance with the inclusion criteria.The literature was evaluated from the published year,fund support,research object distribution,sample size,time of treatment and follow-up,diagnosis standard of disease,intervention measures and control measures,curative effect standard,frequency statistics of TCM syndrome type,and frequency statistics of traditional Chinese medicine.Results1.Basics Situation statistics:we searched comprehensively of papers published from January 1,2000 to May 31,2017,to screen of 487 relevant articles based on inclusion criteria.Research discoveried that:(1)From the beginning of 2000 to the end of 2010,there were 218 literature,accounting for 56.33% of the total;and from the beginning of 2011 to 2017,with a total of 269 literature,accounting for 43.66% in the total number.487 related literature,only47 of it had research fund support.(2)Among all the subjects that were included in the literature,the number of DR patients was the most,accounting for 86.44%.(3)In the sample size,34090 eye cases were completed in 487 papers.(4)About terms of intervention time,the intervention time ranged from 15 days to 2 years,and 137 papers of the literature took 3 months as intervention time.(5)In the study of follow-up time,385 articles were not followed up,the follow-up time of 34 literature was set as 12 months,and no literature explained the date of follow-up.2.Research statistics:(1)There were various diagnostic criteria for diabetic retinopathy in the literature.In 487 articles,there were 163 standard documents formulated with reference to various conferences,139 references to authoritative academic books and books,38 of various academic organizations,and 7of international standards,and 23 articles were unmarked.117 articles had no diagnostic criteria.(2)In the situation of intervention,only 3 articles in the literature of the selected randomized controlled trials were divided into 3 groups,one group was the observation group and the other two were the control group.The rest of the literatures were divided into 2 groups,one group of observation group and the other one the control group.The control group took various measures.There were 17 articles in the control group using analogue agents.The literature of the western medicine as a control observation was 171.485 articles were observed by pure Chinese medicine intervention,accounting for 85.36% of the total,and 17.86% of the literatures were combined with traditional Chinese medicine and Western medicine.(3)The standard of curative effect used in the literature was also not uniform.Over half of the literatures used self-made standard as the curative effect standard.3.Analysis of experimental design factors:(1)In randomization,the 487 articles were called "random groups",and 231 of them simply mention "random" without specifying a specific random method,accounting for 47.43% of the total number of documents.In the remaining articles,225 were used by the complete random method.(2)In the blind method,in the 487 literature,9.2% articles used of double blind method,and 39 literature referred to the use of single blind method,of which 29 had detailed introduction of specific operation methods.4.Analysis of the use of traditional Chinese medicine:(1)In TCM syndrome differentiation standard,there were 344 articles of TCM syndrome differentiation standard,involving 14 kinds of standards.(2)In the study of TCM syndrome type,344 papers have TCM syndrome types,involving 20 types of syndrome types.(3)On the basis of syndrome differentiation and treatment,42 articles were treated with syndrome differentiation but did not specifically describe the addition and subtraction of drugs;163 were treated with syndrome differentiation,and the addition and subtraction of drugs were described in detail;the other 282 were not treated with syndrome differentiation.(4)The use of traditional Chinese medicine,all literature observation group involving 183 Chinese herbs,9 kinds of traditional Chinese medicine with more than 100 frequency.The most common Chinese medicine category is supplementing deficiency drugs,antipyretic drugs,antipyretic drugs and blood circulation removing stasis drugs.ConclusionAccording to the study of related literature,we found that the quality of the randomized controlled trials of Chinese medicine for the treatment of diabetic retinopathy is inadequate.Although the number of research is increasing,but there are few large projects with funds and in-depth research.The types of medical syndrome differentiation standards are different,lack of authoritative and unified standards,we should standardize relevant standards in the future.Attention to the observation of adverse reactions,follow-up and the quality of life of the patients is not enough.It is suggested that ethical review of clinical trials should be strengthened,safety indexes and the follow-up are included in the observation items.Increasing the safety and comprehensiveness of the experiment,and improving the credibility of the research,these experiment can guide the clinical practice better.In the field of experimental design,there is no clear description of the application of specific random methods and blind methods in the literature in many articles.The blind method and the estimation method of sample size are not clearly described in many articles.In the future,specific experimental design methods need to be pointed out to increase the rigor of the experiment.In the analysis of the application of traditional Chinese medicine,there are various experimental schemes in the control group and lack of unified standard.It is suggested that the treatment method of the control group should be unified in order to make the scientific experiment of different research directions comparable. |
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