Literature Quality Evaluation Of Randomized Clinial Trial Of Chinese Medicine For Hyperlipidemia

ObjectiveTo evaluate the basic information of clinical trial of Chinese medicine for hyperlipidemia. Summarizes TCM therapy for hyperlipidemia randomized controlled clinical trial literature's current situation and existing problems; Evaluate the literature's quality of TCM therapy for hyperlipidemia in order to find the reason and resolvement of the problem above. Explore the method of literature evaluation of clinical trial of Chinese medicine for hyperlipidemia and provide certain form of research design and thesis writing. So as to guide the the launch of the research of TCM randomized controlled clinical trial of hyperlipidemia including decoction and proprietary Chinese medicine. Improve the literature quality, standardization and credibility. Lay the foundation for further large-scale randomized controlled trials in hyperlipidemia of TCM.MethodWe used the Evidence-based medicine search strategy, collected the articles about the Chinese medicine for hyperlipidemia for 10 years. After evaluated those articles, we had statistics on account of the numerical data from that articles.Results1. General situation analysis:After evaluated, we collected 243articles.23.3% of them published in central journal,28.6% of them published in local journal, 48.1% of them published in professional journal. Only 24 researches gained scientific fund support,2 researches gained central scientific research fund,22 researches gained local scientific research fund, fund of others researches unclear, these demonstrated that the investment of relevant researches were not enough. 90.1% of the involved literatures used "hypelipidemia" as disease relevant keywords. However, keywords about intervene measures were seldom.89% of intervene measures were pure TCM,10.3%of them were integrative medicine.41 of these literatures described basic research of interventive measures. Most of the purposes of researches were observing the curative and safety of lipid low drugs, which takes up 93.4%.9 researches had other complement purposes. Only 3 articles had the record of clinic stages. Only 3 articles had described ethic problem.5.7% of the researches use international diagnosis standard as their diagnosis standard,62.1% of the researches use nation standard as their diagnosis standard,9.4% of the researches use domestic professional standard. The literature included lack of attention of inclusion criteria, exclusion standard, exit criteria.Especially exit criteria. Only seven articles mentioned exit criteria.2. Experimental design factor analysis:None of the literature described the method of sample estimate; 17 articles described the randomized methods in details; Only 5 articles described the blind method; 61 articles described the consistent of baseline, the rest of them didn't describe baseline consistency problem. Only 11 articles described the rate of fall off proportion,15 literature describes elution period. There are 9 literatures described its installation period.200 of the literatures described effect assessment standard in detail. There is also effect assessment of common standard. Evaluation of health economics and statistical method only briefly descriped in a few words. The intervention measures for treatment group are various. They could be divided into 2 kinds. They are 47 reseach used method of TCM decoction and 199 reseach use proprietary Chinese medicine. The control group intervention measures positive contrasts:192 article, placebo-controlled:7 article, blank control:22 article; The control group used about 26 kinds of medicine, ZHIBIUO,XUEZHIGANG,AND Statins are representatives.3. TCM syndrome type:the contribution of TCM syndrome type and the symptoms of attention is not enough. Description of TCM symptoms improve should be further standardize. There are 31 kinds of hyperlipidemia TCM syndrome type in 243 articles. The descriptions for symptoms were very deficient.4. Safety index, adverse reactions, diet control:176 articles dscribed adverse reactions,121 articles of them described as no obvious adverse reactions.134 references described safety evaluation.30 references described the diet control in experimental process.We should pay more attention to diet control.ConclusionsConsult to principles and methods of evidence based medicine, There were many problems in the clinical trail of hyperlipidemia, the quality urged to be improved. Diagnostic criteria, the inclusion criteria for the application is not standard, the attention in TCM syndrome type and Contributions of symptoms of hyperlipemia is not enough. So they should be described more clearly in the future. The attention to ethics is not enough,we should pay more attention to it. There are many problems in the description of design factors of included literatures, and should be further improved. Only in this way can we better improve clinical randomized controlled trials of hyperlipemia using TCM therapy, and promote the healthy development of TCM course.