| Obectives: Carry on qualitative and the quantitative analysis on randomized Controlled trials (RCT) of Traditional Chinese Medicine(TCM) therapies for chronic hepatitis B since 1995 to 2006 with Evidence-based medicine method, providing the best proof for the clinical treatment, and lay foundation for carrying on further study.Method: (1) With the searching terms including Chronic Hepatitis B, 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 chronic hepatitis B which including the words"rando~'.Search the Chinese science and technology periodical full text from the VIP consultation limited company the database for full text, search again from the Chinese science and technology the full text database of Chin Hua tong fang for full text. 6 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) Randomised or quasi-randomised clinical trials of TCM therapies for chronic hepatitis B were selected for this study. (3) The evidence-based medicine's methodwill 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 r-eaction, 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 results 306 articles were found from 635 pieces of title records concerning this kind of literature, 48.2% (306/635) of which took the design of randomized trial control, and last got 269 full texts. 269 randomized clinical trials (RCrs) and pseudo-randomized clinical trials involving 27726 chronic hepatitis B patients were identified that tested Traditional Chinese medical therapeutic effect. They were published in 131 Chinese journals. Only 3.34% (9/269) of the studies reported the method by which they randomized patients. Only two 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 CHB from 1995 to 2006 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 stillnot enough perfect with careful. Both the total efficient rate and the anti-virus effect of the kurorinone is better than the contrast obviously. The appraisal content mainly includes carrying on the ordinary circumstances and the qualitative analysis on selected clinical trials. Carry on Meta analysis on selected randomized controlled trials (RCT) about the treatment of CHB with kurorinone.Conclusion: At present, the quantity of RCT on Traditional Chinese Nedicine(TCN) therapies for chronic hepatitis B has raised sharply year by year, and the quality of the studies has enhanced increasingly, 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. Both the total efficient rate and the anti-virus effect of the kurorinone are better than the contrast obviously. |
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