| The incidence of diabetes has been increasing on a fast pace around the world. According to World Health Organization (WHO), the global number of patients diagnosed with diabetes will reach300million by2030. Microalbuminuria appears among lots of patients soon after the diagnosis of type2diabetes mellitus (T2DM), and some patients even suffer from overt nephropathy.80%of patients with type1diabetes mellitus (T1DM), if were not intervened effectively, will suffer from persistent microalbuminuria and develop into clinical nephropathy in the following10to15years, with hypertension probably. Once clinical nephropathy occured, if not effectively intervened, glomerular filtration rate will decrease within years, by50%after10years, and20years later more than75%of patients will develop into End-Stage Renal Disease (ESRD). Due to the large number of patients with T2DM, more than half of patients on dialysis in Western countries with kidney disease are diabetics.The literature regarding Chinese medicine treatment of DN are not rare, but the quality of evaluation of the evidence is not high enough, especially when it comes to famous experts’expertise and case reports, which usually belong to the lower level. Considering the properties of Traditional Chinese Medicine (TCM), how to evaluate clinical evidence of TCM scientifically and objectively has been the research focus. High quality evidence is the inherent support of clinical decision, and improving the ability of decision support means to improve the evidence itself.Purpose1. To collect, collate, evaluate all the literature regarding to the treatment of diabetic nephropathy, and to summarize the quality of evidence and its clinical guiding significance and value;2. To obtain the evidence of the curative effects and safety of treatment of diabetic nephropathy in TCM, and to evaluate the defects of the current randomized controlled trials (RCTs) in traditional Chinese medicine. To provide perspective and theoretical basis for the future work of constructing TCM diagnosis and treatment of decision knowledge base and the realization of automatic knowledge extraction. MethodThis study is based on the National Natural Science Foundation of "Chinese medicine clinics cognitive model based on automatic question answering system (No.81072897)"; the Ministry of Education Doctoral Program "Diabetic Nephropathy Diagnosis and Treatment programs Based on a Comprehensive Integrated System Modeling to Achieve (No.20110013110001)"; National Science and Technology Support Program "’Combination of disease and symptoms’Real World Clinical Research in Pharmaceutical Research Methodology (No.2013BAI02B10)".1. We search for relevant literatures regarding the TCM for diabetic nephropathy(DN) in database CNKI, CBM, VIP and Wanfang (Date:each database construction-2014.4), and we classify, summarize and conclude the literature quality by the improved levels of evidence grading proposed by Evidence-Based Medicine Center of Oxford University;2. We search for literatures of randomized controlled trials regarding Zhenwu decoction for DN and Wuling Powder for DN respectively. The retrieval strategy was as follows:PubMed, CNKI, CBM, VIP, Wanfang, were retrieved(Date:1980.1-2014.4).The quality of included studies was evaluated by Cochrane review’s manual version5.2of the evaluation criteria and GRADE evaluation, and meta-analysis was conducted with Rev Man5.2software.Result1. In this study, we have retrieved4573references in total. The results according to the classification standard are as follows:including95system reviews,1521RCTs,376observation researches and so on,869theoretical discussion,468case reports and expert experience,853basic experiments,391other articles. The general characteristics of literature are as follows:the types and quantities of evidence are large, but lack of high-quality researches. Significant increasing in number of research literatures involving multi-disciplinary researches shows great meaning in the guidance of clinical practice. The variety of the formulas’add and substraction and clinical dosage forms reflects the pace of modernization of TCM. The high positive rate of literature means the publication bias is large. Some clinical symptoms terminology and indicators chosen are not standardized. Some clinical symptoms terminology and indicators chosen are not standardized. 2. A total number of728articles were retrieved regarding Zhenwu decoction, and10RCTs were finally included in our study, with703patients mentioned in these RCTs. The study sample size is30-136. Meta analysis has shown that Zhenwu decoction, compared with western medicine, played the same role in improving total effective rate, reducing the24h urine protein and serum creatinine (Scr), and improving quantitative symptom of TCM; and some indicators, such as total effective rate and the24h urine protein quantitative, which have shown that TCM is better than that of control group. No reference is evaluated as high or medium quality;2references are of low quality;8articles are of very low quality. There is only one study reported adverse reaction about the treatment group, but not mentioned the controlled one. No articales explained why the adverse reaction appeared. Consequently, we cannot get the definite conclusion about the safety of Zhenwu decoction for DN.3. A total number of325articles were retrieved regarding Wuling Powder, and5RCTs were finally included in our study, with526patients mentioned in these RCTs. The study sample sizes are21-160. Meta analysis have shown that Wulingsan Powder, compared with western medicine treatment, played comparable role in improving total effective rate for patients with diabetic nephropathy and decreasing cholesterol and triglycerides, and some indexes, such as24h urine protein quantity, have shown that Wuling Powder was better than western medicine treatment; And Wuling Powder can resolve clinical symptoms, and improve the quality of survival, relieve edema, etc. Quality evaluation results are of very low quality with no literatures of high quality, medium quality and low quality. No adverse reactions have been reported. Because the short of treatment trials and follow-up data, we cannot get the exact conclusion about the safety of TCM treatment for DN.Conclusion1. The amount of literatures regarding TCM treatment of DN has been greatly increasing. Overall, the most common3types are RCTs, theoretical researches and experimental researches. The meta-analysis and/or systematic review that are regarded high in evidence grade, even also increases fast, but the quality themselves are not high. The recommendation strength and reference value are also not high.2. The evidences for the effectiveness of Zhenwu Decoction and/or Wuling Powder in treating diabetic nephropathy are very limited, and their quality has not yet to be satisfying. Enough attention should be given to the random sequential generation, random hidden, blind, the estimation of sample size, fell off and lost aspects.3. Great potentials of Zhenwu Decoction and Wuling Powder may respectively have in treating diabetic nephropathy with respect to improving the total effectiveness and reducing the24h urine protein. This is especially true when the two prescriptions respectively used in combination with western medicines in comparison with single administration of western medicine. But this is not a definite conclusion due to the insufficient number of relative RCTs. Therefore, better quality researches (multi-center, large size and strictly designed RCTs) are still expected for enhancing evidence strength and guiding clinical practice.4. No adverse reactions were recorded as for the two prescriptions we studied considering the literatures included in our systematic review. Our recommendation is to supplement this part in future researches, so evidence on prescription safety can be accumulated.5. In conclusion, the research quality of TCM treatment on diabetic nephropathy has to be improved to some extent. The improvement can be realized in aspects such as using correct method in gaining random sequence method, giving enough focus on safety evaluation, and making registration of clinical trial before it is performed. |
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