| Background: The current trend for TCM academic development tends to become slow, which is shown in two aspects: on the one hand, the practice of TCM international exchange turns to be difficult;on the other hand, the internal development of TCM industry is hindered by the conventional framework characterized by "individual-oriented" or "group-oriented". Consequently, the results from the relevant research and clinical practice are hardly integrated. This situation attributes to many reasons. First, when comparing the development patterns of TCM and contemporary natural science, the author thinks one of the reasons is the insufficient interpretation of TCM with contemporary scientific language as well as the lack of commonly acceptable technical terms, nomenclature and criterion. The theory of the discipline and clinical practice has not yet formed a united system which is able to self-develop. TCM stresses on clinical efficacy and deems it as the essence of its theories and value. Therefore, does it have a clear view on its diagnostic theories (including disease differentiation, syndrome differentiation and symptom differentiation)? Is there a unanimous standard for TCM disease differentiation, syndrome differentiation and symptom differentiation? What is the content in detail? After a primary research, the author found all the above issues are under exploration and controversy among experts who have given multiple explanations about the meaning and relation of disease differentiation, syndrome differentiation etc, and many individual theories and hypothesis have been established by the experts. Although TCM diagnosis has been studied at the theoretical level, research focused on the practice level has been seldom touched. The experience of clinical practice has shown the TCM therapy for ulcerative colitis has advantage over the current western medicine. However, it also corresponding reflects that the scarcity of standardization and consistence still prevail in the TCM diagnosis. Besides, there are many valuable clinical theories and experiences accumulated since ages waiting for further data mining and analysis. Concerning the aspect of TCM syndrome classification, discrepancy between its theory and clinicalapplication also exists to certain extent. Based on the TCM diagnosis for ulcerative colitis, this study aims to explore the relationship of TCM disease differentiation, syndrome differentiation and symptom differentiation and their functional identity in clinical practice in order to reconstruct the theoretical model for TCM diagnosis and intervention (not only for syndrome differentiation). It hopes to gain experience in setting up new explanation for TCM theories in the view of modern natural science and provide reference for the standardization of the whole discipline.Objective: the main purpose is to reconstruct and initially testify the theoretical model for the TCM diagnosis for ulcerative colitis. The secondary purpose is to establish a series of application tools for content analysis and methods for data analysis based on TCM knowledge.Design: There are two stages in the study. At stage one, the theoretical model is studied on the basis of content analysis of literature research;at stage two, the model is tested by a survey study.Stage one:Research method and procedure: (1) Object for literature research: the TCM literature about ulcerative colitis is extensively collected, including the medical records by ancient TCM doctors, modern professional publication, diagnostic criteria set up by academic organizations, books by eminent TCM doctors, medical journals and clinical case records. (2) Literature sampling: the collected literature is categorized, labeled and sampled. (3) The analytic unit is identified. (4) The tools for content analysis are framed. The scale for nuclear category about knowledge on disease differentiation, syndrome differentiation is set up and its consistency is evaluated. (5) Content analysis for TCM diagnosis and intervention, including qualitative and quantitive analysis. (6) Relevant explanation and comparison, establishment of the theoretical model.The main results: (1) General condition: Totally 299 pieces of TCM literature are evolved in the study, in which 149 are about theoretical study, the other 150 are about clinical practice;9 (3.0%) are modern comprehensive records, 13 (4. 3%) are works by eminent doctors, 182 (60. 9%) are journal papers, 57 (19. 1%) are ancient literature, 38 (12.7%) are clinical case records. (2) Diagnostic rules for ancient literature: the 57 pieces of ancient literature are all theoretical, in which hemafecia is the main symptom. The TCM intervention strategy is comprehensive therapy. 13 (22. 8%) are about diseases differentiation treatment, 34 (59.6%) are about syndrome differentiation treatment, 9 (15.8%) are about integration of disease differentiation and / syndrome differentiation. There are two conditions for disease /differentiation: the first one focuses on "bleeding" as the central etiologic and pathologic factor (14 pieces) which mainly attributes to the heat pathogen (including blood-heat, dampness-heat and wind-heat) and yang deficiency in the middle Jiao, the second one focuses on the general feature of the disease development which characterized by wind-heat and wind toxin or blood disturbance by wind-heat at the initial stage, by qi and blood disharmony at the middle stage, and by vitality deficiency (mainly qi and blood deficiency) at the chronic stage which mainly treated by gastric medicine. Concerning the mode of syndrome differentiation, single methods featured by the eight principles, Zang-fu and etiology are common. In short, it is characterized by heat and wind at the initial stage (the infected stage or bleeding stage), by the disharmony of qi and blood at the middle stage which is classified with heat, cold, dampness and vitality deficiency, and by vitality deficiency at the chronic stage which is mainly the deficiency of qi and blood. (3) The diagnostic rules for modern literature: there are 242 pieces of modern literature evolved in the study. The main clinical manifestation includes diarrhea, rectal bleeding, hemafecia and abdominal pain which lacks aggregative tendency. The methods of clinical intervention can be classified by local treatment, comprehensive treatment and integration of the two. In local treatment (144 pieces), the main treatment method is enema (122 pieces, 84. 7%) and the diagnostic basis is local ulcer. The intervention strategies include cleaning heat, detoxification and cleaning dampness, hemostasis and curing the ulcer, in which 13 pieces (6.9%) are about local syndrome differentiation. In comprehensive diagnosis (206 pieces), 89 are about disease differentiation, in which the common etiologic and pathogenic factors are "deficiency of spleen and dampness-heat" , "disturbance of coldness and heat" , "liver depression and spleen deficiency with dampness-heat and blood stasis" and "deficiency of spleen as basic reason" etc. The homogeneity of disease differentiation (22 pieces) is characterized by evil pathogen at the onset stage, insufficient vitality at the relief stage, or insufficient vitality plus evil stasis between the above two stage. There are 122 pieces of syndrome differentiation treatment in comprehensive therapy, which are mainly about diagnosis for Zang-fu, qi and blood and etiology integration. The most frequent syndromes are: aggregation of dampness and heat, yang deficiency of spleen and kidney, liver depression and spleen deficiency, spleen-qi deficiency, qi obstruction and blood stasis, spleen deficiency and dampness-heat, spleen deficiency and dampness obstruction, blood stasis, and disturbance of coldness and heat etc. (4) The comparison of ancient and modern diagnosis: The ancient therapy mainly stressed on comprehensive treatment, which the modern therapy stressed on local treatment. The ancient diagnosisand treatment are centered by the symptom "hemafecia" whose strategies mainly include "hemostasis, blood mediation and blood cultivation" , but this trait has been weakened in modern diagnosis. Concerning syndrome differentiation, the ancient literature is dominated by blood heat (14%) but only three (0.8%) are found in modern literature which is featured by dampness-heat (21.7%). Among the vitality deficiency syndromes, the ancient literature is mainly about the yang deficiency of spleen and stomach, but the modern literature is mainly about the yang deficiency of spleen and kidney. The ancient literature emphasizes external wind, but the modern literature only stresses on the application of wind medicine. There are few records about blood stasis and liver depression and spleen deficiency in ancient literature (2%, 1%), but more have been found in modern literature (9.1%, 13.7%). The ancient literature also stresses on the integration of disease differentiation and syndrome differentiation which is based on disease classification of stages and phrases to make further diagnosis (8/10);and the modern literature has more content in the integration of disease and syndrome differentiation, which includes the records about TCM syndrome differentiation and western medicine integration as well as pharmacology and the modification by syndromes based on disease differentiation therapy occupying a large portion in the study.Stage two:Research method and procedure: (1) cross-sectional study on ulcerative colitis patients: the study objects are patients diagnosed with ulcerative colitis in three hospitals including Guangdong Provincial Hospital of TCM. There are ten researchers in the study. The research instrument is the clinical case report form(CRF) developed by a strict process. The study period is from November 2005 to March 2006. (2) case-control retrospective study: the clinical records for ulcerative colitis patients are searched manually and from the hospital information management system, including those hospitalized in the gastroenterology department and rectal surgery department. There are 38 cases are accessed and the data are collected by the clinical case report form. (3) Data analysis: the study objective and content are determined by professional requirement, the methods includes descriptive analysis, uni-factor analysis, cluster analysis, and data mining methods such as rough set analysis, association rules and cluster analysis etc. The main results: (1) general materials: 81 valid CRFs are collected, in which one is excluded due to the diagnosis, therefore, there are 80 valid cases in the study, including 59 cases (73.8%) at the active stage, 21 cases (26.3%) at the relief stage. (2) Major TCM symptoms and diseases: ?Desermptive/ \statistics: among the patients at the active stage, the symptoms include hemafecia (46 cases), loose stool and diarrhea (45 cases), stool with mucus, purulence and blood (44 cases) whose frequencies are approximately equal, and they usually appears simultaneously. Among the patients at the relief stage, the commonly seen symptoms includes mucus stool (10 cases), abdominal pain (10 cases) and diarrhea (9 cases). The diseases which the researcher have diagnosed according to the nation diagnostic standard include "sever diarrhea or Da Jia Xie" (48 cases, most frequent), hemafecia (17 cases), and diarrhea (16 cases) etc. The modern local therapy as well as disease and syndrome differentiation can receive evident support from rectal endoscopy and relevant analysis. ?Rough set analysis on main symptoms at different stages: the filtered attributes which have great contribution to the diagnosis includes 14 items, i.e. acute onset, hemafecia, increased bowel frequency, normal bowel frequency, stool with mucus and blood, mucus stool etc. 19 rules for diagnostic classification at active stage are created, and 11 are created for relief stage. The result shows that three symptoms are important for stage classifications, i. e. appearance of hemafecia which is dominant , increased bowel frequency and acute onset which are of help for diagnosis. (3) The analysis of syndrome differentiation factors and key etiologic mechanism: CD Cluster analysis in multiple statistics: combined with professional knowledge, the result of cluster analysis for all selected symptoms indicates the existence of the following syndromes including: "sthenic syndrome" , "heat originated hemafecia at the active stage" , "deficiency of qi and blood" , and "abdominal pain due to deficiency syndrome " , "yang deficiency" , "qi and yang deficiency" and "liver depression and spleen deficiency" etc. The cluster analysis for tongue and pulse symptoms implies syndromes such as "heat or dampness-heat" , "qi unbalance or qi stasis" , "qi deficiency" , "yang deficiency or qi and blood deficiency" etc. The cluster results about clinical historical features imply "chronic onset" and "initial onset" as two categories. The loose stool symptom does not form as a aggregative tendency. The cluster results of hemafecia related symptoms indicate the existence of "heat" and "blood stasis" . And those of abdominal pain indicate the existence of "abdominal pain due to deficiency syndrome" , "pain location on the left lower abdomen" and "abdominal pain caused by sthenic syndromes" . ?Cluster analysis in data mining: the result from data mining is similar to that from multiple statistics. ?Association rules: the analysis based on the algorithm of association rules mainly focused on the tongue and pulse symptom indexes, which indicates the existence of the syndromes such as "qi deficiency" , "yang deficiency or blood deficiency" , "qi unbalance" , "dampness-heat" , "damp coldness" and "dampness" . It can be found thatone index owns different associations with other various indexes. (4) Rules for clinical classification: the cluster analysis for the 80 cases indicates classifications including: "the combination of dampness and heat, obstruction of qi mechanism" , "liver depression and spleen deficiency with dampness-heat" , "dominance of dampness-heat and toxin with the impairment of qi and yinw , "dampness-heat staying in the lower position with liver depression" , "primary spleen deficiency with liver depression and dampness-heat" , "primary spleen deficiency with dampness-heat" etc. And the differences in clinical stage, general condition of the patient and accompanied symptoms such as diarrhea and bowel hyperkinesias are also important factors to the classification. In general, there is no apparent tendency of aggregation in cluster analysis (especially with the inter-group linking method), and the results are only for reference.Conclusion: (1) TCM diagnosis is not only made by disease differentiation, but also on many models and methods. And hence the systematic evaluation based on content analysis is able to realize the initial reconstruction of the theoretical model for TCM diagnosis and intervention of ulcerative colitis. That is, to clarify the diagnostic approach respectively focusing on disease differentiation, syndrome differentiation and symptom differentiation in which the merits of TCM thinking can be effectively applied to analyze the relationship of relevant factors such as cause and effect, major and minor syndromes, and early or later so as to systematically and thoroughly master the main problems of the disease and set up the strategy for interventions. (2) The survey and data analysis of the study helps to identify some significant factors for establishing an initial theoretical model for the TCM diagnosis and intervention of ulcerative colitis, as well as some methods for data analysis under the theoretical framework of TCM. (3) Introduction and application of the analytic methods: The analytic methods such as content analysis and multiple analysis should be applied based on TCM knowledge so that fine and valid outcome can be expected.
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