Traditional Chinese Medicine Treatment Of Diabetic Retinopathy Clinical Randomized Controlled Trials Literature Quality Evaluation And Analysis

ObjectiveTo evaluate and analysis literature of clinical randomized control led trial (RCT) on TCM for diabetic rctinopathy (DR); put forward suggestion on clinical research of DR treated by TCM in future, improve the quality, standardization and reliability of RCT on DR and lay the foundation for large-scale development.MethodsThe literature of clinical RCT related to DR treated by TCM were downloaded through retrieving CNKI, Wanfang and VIP database and further screened by full reading. Four aspects were mainly analyzed:literature quality evaluation with Jadad scale; statistical analysis of general situation; analysis of trial design factors; TCM analysis.Results1Literature quality evaluation:354cases were selected, and the ones in high quality were only4.8%.2Statistical analysis of general situation:The years distribution was from1992to2012; the provinces with most literatures was Guangdong;83.1%of literatures were from periodicals, the most of core journals was Journal of Traditional Chinese Ophthalmology while non-core journal was China Practical Medical; only12.4%of all had national financial support; non proliferative stage of DR was studied mostly among objects in all selected cases-, the average sample size was78cases,131eyes, and38.7%of all were treated for three months while84.5%of all did not represent follow-up time; the standards of diagnosis, period division and grading for DR applied in the literatures and treatments used by the control groups were variety, Western medicine treatment as the control methods was58.7%, and placebo applied in the trials was1.9%; in the observation groups, the ones using TCM treatment were69.8%while combination treatment of TCM and Western medicine were30.2%; efficacy standards used in literatures were also not uniform; there were safety indexes accounting for23.2%.3Analysis of trail design factors:The items, of which literatures out of the condition and greater than90%were including, changes of result indexes and reasons for them; estimation of sample size; condition of interim analysis; reasons for terminate research; generated method, allocation concealment and application process of random sequence;et al.4TCM condition:The literatures without standards of TCM syndrome differentiation were84.5%; syndrome classification involved20kinds, according to the frequency the first was qi-yin deficiency syndrome; the most common Chinese herbs were Astragalusmemeranaceus, Salvia miltiorrhiza, Rehmannia glutinosa, Panaxnoto ginseng and Lycium barbrum; the most common categorization was deficiency tonifying medicinal; the most common prescription was Shengmaisan decoction; the most common injection was Yinxindamo injection.ConclusionBased on the evidence-based medicine (EBM) standards, at present the quality of literatures of RCT on DR treated by TCM was poor, which should be further improved. In conclusion, although there is a large amount of clinical RCTs on DR by TCM at present, most of them remain stable in the low level. We should perfect the quality of those from all aspects step by step and enhance the ability to write the reports, et al. With the widespread application of EBM, the regulation receives an opportunity of innovation. The opportunity and challenge should be seized to promote healthy development of TCM career, in which way it could be integrated in the world and go up a higher level.