| Objectives:Carry on qualitative and the quantitative analysis on randomized controlled trials (RCT) of Traditional Chinese Medicine (TCM) control liver regeneration therapies for fulminant hepatitis, liver fibrosis, liver cancer, alcoholic liver disease , sub-acute chronic severe hepatitis and chronic severe hepatitis since 1999to 2009with Evidence-based medicine method , in order to have a comprehensive and accurately grasp of the present situation of the research field and inherit valuable theoretical knowledge and clinical experience , to provide the best proof for the clinical treatment, and to lay foundation for carrying on further study.Method:(1) With the searching terms including fulminant hepatitis, liver fibrosis, liver cancer, alcoholic liver disease , sub-acute chronic severe hepatitis and chronic severe hepatitis, Traditional Chinese Medicine literature, Quality evaluation, Evidence-based medicine and so on, the Chinese Biomedical CD database were searched from its data of inception onward. And then, pick out the title records of Traditional Chinese Medical (TCM) therapyies for fulminant hepatitis, liver fibrosis, liver cancer, alcoholic liver disease , sub-acute chronic severe hepatitis and chronic severe hepatitis which including the words "random" . Searching the Chinese science and technology periodical full text from the VIP consultation limited company the database for full text, Searching again from the Chinese science and technology the full text database of Qin Hua tong fang for full text. 8 Chinese medical journals and relevant academic conference proceedings have been searched by hand. The references lists of identified documents were checked as the complementary search.(2) Selecte randomised or quasi-randomised clinical trials of TCM therapies for fulminant hepatitis, liver fibrosis, liver cancer, alcoholic liver disease , sub-acute chronic severe hepatitis and chronic severe hepatitis whose observing indexes including hepatocyte growth factor (HGF) , the epidermal growth factor (EGF) , tumor necrosis factorα(TNF-α), transforming growth factorβTGF-βinterleukin (IL)and so on for this study.(3) The evidence-based medicine's method will be abided by for the study. Data were extracted independently by two reviewers according to the selection criteria. Any rift will be solved by discussion or third party's arbitrament .Withdraw following data from each randomized or quasi-randomised clinical trials: author's name, author's unit Class, publishing year, article topic and announce magazine name, Chinese medicine dialectical or the dialectical cent type standard, modern medicine diagnosis standard, selected standard, expel standard, the curative effect judge standard, observation norm, allotment method of randomization, concealment of allocation sequence, contrastive circumstance, sample quantity and estimation of sample , whether described a sample content, intervention measure and treatment measure, time of therapy, comparison of inter-class's balance, blind method, adverse reaction, termination measurement (including termination event or momentous event, such as case-fatality rate, incidence rate of hepatic cirrhosis and liver cancer and so on) the appraisal of quality of life, with visit, withdraw and lose to visit a circumstance and statistics method and analysis checkout. The evaluation of methodological quality of clinical trials will be carried on according to the request of Cochrane manual, including allotment method of randomization, concealment of allocation sequence, blind method, withdraw or lose to visit case number and reason, intention-to-treat analysis and so on.Main results563 articles were found from 1055 pieces of title records concerning this kind of literature, 53.4% (563/1055) of which took the design of randomized trial control, 15.8%(89/563)of RTC articles adopt cell factors related to liver regeneration such as "hepatocyte growth factor (HGF)" , "the epidermal growth factor (EGF) " , "tumor necrosis factor (TNF)-α" , " transforming growth factorβ(TGF-β)", "interleukin (IL)and so on , as observing indexes,and last we got 42 full texts. 42 randomized clinical trials (RCTs) and pseudo-randomized clinical trials involving 3108 patients were identified that tested Traditional Chinese medical therapeutic effect. Only 4.76% (2/42) of the studies reported the method by which they randomized patients. None of them reported allocation concealment and were considered as adequate. In an overall view, the methodological quality of trials designed for these literatures regarding TCM therapies for Liver disease mentioned above from 1998 to 2009 were very poor: the criteria of inclusion and exclusion was absent or not standardized in most of the reports; blinded method was adopted scarcely; drop-out and missed cases were rarely mentioned while adverse effects were reported usually. Data on long-term clinical outcomes and quality of life were lacking. The credibility of data processing is bad, and the design of a project is still not enough perfect with careful. 196 animal experiment research literatures were found concerning TCM regulation liver regeneration, the number of which has raised sharply since 2003 while more and more literatures have been published in core periodicals year by year.Conclusion:At present, most of RCT on Traditional Chinese Medicine (TCM) therapies for regulating liver regeneration are evaluate by the improvement of liver function, bilirubin, fibrosis , virus and so on . No RCT research is found consciously designed at TCM regulation liver regeneration except 42 unconsciously designed researches on this purpose. However, its methodological quality was poor in total. The overall trial design level of clinical studies in this aspect need enhance urgently due to the demands of clinical practice. The quantity of animal experiments on TCM regulation liver regeneration has raised sharply year by year while the quality of the studies has improved . And those animal experiments providing the best proof for the clinical decision-making, and lay foundation for carrying on further study.
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