The System Evaluation On Literature Of Chinese Medicine Periodic Therapy For Irregular Menstruation

ObjectiveThrough researching on literature of Chinese medicine periodic therapy for irregular menstruation with system evaluation and Meta analysis, and evaluating significance objectively, Evaluate furtherly the clinical curative effection on TCM periodic therapy for irregular menstruation, and propose deficiencies of clinical research design, to guide clinical and research work better.MethodsResearch objects: the clinical research literature of Chinese medicine periodic therapy for irregular menstruation which published on various medical journal between 1990-2010. Data base:The medical authoritative domestic data base:Chinese BioMedical Literature Database (CBM),China Journal Full-text Database (CNKI),WANFANG Data,VIP Date. Analyze descriptively the specificity design of clinical research, such as general information about thesis, inclusion and exclusion criteria, Criteria of curative effects, randomized methods, sample size, the comparative of balance between groups, blinded use, treatment, statistics method, follow-up, exit and lost to follow-up, records and analysis about adverse reactions. According to assessment form, calculate the percentage of various situations and analyze descriptively.On that basis choice good quality thesis and then do the Meta analysis of Random-effects models with Revman. And analyze publication bias with the funnel diagram.Results1,132 papers were detected which cure irregular menstruation with TCM periodic therapy. And get 19 RCT papers which meet inclusion criteria. According to the Jadad scores of the Cochrance center about literature, quality evaluation of 14 articles is 1 point,1 article is two points, all belong to a low quality research literature. And 4 articles is 0 point.2,In this 19 RCTs,17 articles have specific inclusion criteria,15 articles have specific exclusion standard, all documents have definite outcome standards; For random allocation,1 article adopted random number method,1 article adopted pseudo random method,14 articles just mentioned random, not describing in detail the random distribution and conceal method, so can not judge the randomized methods is right or not. There are 10 articles including Statistical analytical comparison on the baseline situation; 6 articles just simply described as "two groups have comparable," None of article illustrates the calculation method of sample size, distributional conceal and intentional treatment analysis; 11 articles have statistical methods, not explicating detailedly have 9 articles; 2 articles have records about adverse reactions; All documents are not based on blind method, exit and lost to follow-up.3,Clinical articles that chinese medicine periodic therapy for irregular menstruation have published bias, and are comparatively small sample size.4,The effect size (the scale between experimental group and curative effect)of TCM cycle therapy (efficient) that OR is 3.29, 95% confidence interals is [2.44,4.43]. Conclusion1,The number of the literature research is small and the quality is not high, so its reasoning strength weaker, it requires more high quality research to increase argument intensity.2,In clinical research design many problems should be to improved, such as correct and strict implementations of Random and double-blind,choices of therapeutic indexes,observations of Follow-up and adverse reaction.3,Preliminary think, TCM periodic therapy for irregular menstruation have better effect than the treatment used in control group.4,The clinical study design of TCM periodic therapy is a challenging task stern in front of doctors.