Preliminary Development And Evaluation Of Type2Diabetes Mellitus TCM Syndrome Diagnostic Scale

Preliminary Development and Evaluation of Type2Diabetes Mellitus TCM Syndrome Diagnostic ScaleObjectiveThrough the research methods on clinical epidemiology transverse section and on literature review, the paper discussed the distribution, composition and related factors of Type2Diabetes TCM syndrome (Traditional Chinese Medicine syndrome), extracted the law of core TCM syndrome and sign of Type2Diabetes with multivariate statistics, and built the syndrome diagnostic scale, which aimed at providing a theoretical basis on the unification of the Chinese medicine awareness on Type2Diabetes and on the standardization of its clinical diagnosis and prevention and treatment.Research methods1. Literature review:to collect and collate the literatures on both TCM and combined TCM and Western medicine with clinics on Type2Diabetes in the recent30years, and summarized the distribution and composition of Type2Diabetes TCM syndrome.2. The study on clinical epidemiology transverse section:to design the four diagnostic information collection table for Type2Diabetes based on literature review and consultation from experts, after offerring training to the members involved in the study, and collected136qualified cases of demographic data, clinical history, the TCM four diagnostic information, laboratory test results and diagnosis of Chinese and western medicine comprehensively. By combing the several diagnosis criteria, the study divided and combined the patients’TCM four diagnostic information of and discriminate the syndrome attribute.3. Scale development:to extract, filter, and assign values to the symptoms and signs which could best represent the resulted syndrome attribute with statistic methods, based on the clinical survey and suggestions of experts; to use regression analysis and ROC curve for screening and assignment.4. Scale verification:to examine the feasibility, reliability and validity of the resulted scale with statistic methods.Results(I)Conclusion on literature review1.203Syndrome appearred in277qualified literatures, with deficiency of Yin as the most common one.2. There were9disease location syndrome elements occurred, namely spleen, kidney, choroid, stomach, lung, liver, heart, intestine and gall bladder;15disease nature syndrome elements occurred, namely heat, yin deficiency, wetness, blood stasis, phlegm, qi deficiency, dryness, yang deficiency, qi stagnation, jin deficiency, blood deficiency, qi constraint, fire, coldness, and wind.3. The most common combinations were liver+kidney for disease location, and qi deficiency+yin deficiency, yang deficiency+high heat, and yin deficiency+yang deficiency for disease nature.(II)Epidemiological results of the cross sectional study1. Basic Material:Male accounted up to60.29%of all the136type2diabetes with an age range of54.72±8.52(Max:70, Min:36). It was noticeable that patients between51to70made up68.38%of all the cases. In terms of the complications of type2diabetes, diabetic peripheral neuropathy disease was in the first list, followed by diabetic retinopathy, diabetic peripheral vascular disease and diabetic nephropathy. However, when taking into the consideration of the concomitant disease of type2diabetes, hypertension constitutes the largest proportion, followed by hyperlipemia, coronary disease and hepatic steatosis. The initial diagnosis age was concentrated in40-60years old, which hold72.79%of the sample.41patients were contaminated with genetic background of type2diabetes by the direct relatives like parents after historical review. When all the cases were assigned into the age group with their corresponding standard body mass index and waist-to-hip ratio, obesity was observed in12cases and abdominal obesity in102cases.2. In this study,9different TCM syndromes could be summarized with the most frequency-dampness syndrome. Other syndromes were ranked as qi deficiency, yin deficiency, dryness-heat, jin deficiency, phlegm, yang deficiency, blood stasis and qi stasis by their respective frequency in the sample.3. Different permutation and combination of the TCM syndrome could also be summarized in the study. These including11cases of none of the aforementioned syndrome (8.09%),21cases of the single syndrome (15.44%) which were mainly made up by dampness and phlegm,38cases of pair of the aforementioned syndrome (27.94%) which were made up by dampness and qi deficiency,27cases of triple of the aforementioned syndrome (19.85%) which were made up by yin deficiency, qi deficiency with dampness,23cases of quadruple of the aforementioned syndrome (16.91%) which were made up by yin deficiency, dryness-heat, qi deficiency with dampness,14cases of quintuple of the aforementioned syndrome (10.29%) which were made up by dampness, dryness-heat, qi-yin-jin-deficiency, one case of six fold and seven fold of the aforementioned syndrome respectively.4. The group of Jin deficiency syndrome was negatively correlated with the age range between35-50(p<0.05), no statistical differences were observed in the other two groups; no statistical differences were observed in all the groups concerning gender. Diabetic nephropathy was negatively correlated with the yang deficiency syndrome and Phlegm syndrome (p<0.05), diabetic peripheral neuropathy disease was negatively correlated with the dryness-heat syndrome and yang deficiency syndrome (p<0.05), nevertheless, positively correlated with the qi deficiency syndrome (p<0.05). However, hypertension was positively correlated with qi deficiency syndrome (p<0.05), hyperglycemia was positively correlated with correlated with dryness-heat syndrome (p<0.05), coronary disease was positively correlated with qi deficiency syndrome, blood-stasis and qi stasis Syndrome, nevertheless, negatively correlated with dryness-heat syndrome. Obesity was positively correlated with phlegm-dampness syndrome.5. Some of the syndromes were closely related, they were:yin deficiency syndrome with dryness-heat, jin deficiency, qi deficiency syndrome with blood stasis, dampness, blood stasis syndrome with qi deficiency, qi stasis, dryness-heat syndrome with yin deficiency, yang deficiency and jin deficiency, yang deficiency syndrome with dryness-heat, blood-stasis and qi stasis, dampness syndrome with qi deficiency, jin deficiency, yin deficiency with Over heat, qi stasis with blood stasis.(III)Scale Research ResultsType2diabetes disease and syndrome diagnostic scale was including basic information and syndrome diagnosis. Basic information includes9parts, such as general information, history of present illness, past history, personal history, allergy history, obstetrical history, family history, treatment history and physical examination. There were40entries in the basic information; syndrome diagnosis includes9syndromes and50entries.With experts’advice, and after screening by the logistic regression analysis, Backward, Conditional methods, the symptoms and signs most closely related to dampness were joint and muscle pain, obesity, somnolence, mouth sticky and greasy tongue coating, the overall accuracy rate was97.8%, and we assigned with6,4,4,4.1points respectively. The area under the ROC curve was0.992, compared with0.5(the reference value), the difference was significant (p<0.01). The diagnostic threshold was10points, and it showed that the method for diagnosis within the wetland permit being a high level.The symptoms and signs of Qi deficiency screened by equation were spontaneous sweating, shortness of breath, mental fatigue and palpitations. Meanwhile, the total correct rate was80.9%, and we assigned with them3,6,7,4points respectively. The area under the ROC curve was0.920. The diagnostic threshold was12points. The diagnosis level was high.The symptoms and signs of Yin deficiency screened by equation were night sweats, five upset dryness-heat, constipation, blurred vision, zeugmatic red, red tongue and urine sugar positive. The total correct rate was88.2%, respectively assignment2,4,3,3,3,2,3points; the area under the ROC curve for the0.938.The diagnostic threshold value was8points. And the diagnostic level was high.The symptoms and signs of dryness-heat screened by equation were thirsty, thirsting for cold, sweating, constipation, consumer Valley, good muscle, red face, red and dry skin. The total correct rate was99.3%. Respectively, the assignment were2,2,4,1,4,2,2,2point. The area under the ROC curve was0.991.The diagnostic threshold value was7points, and it was high.The symptoms and signs of body fluid loss were dry skin, thirst, sweating, constipation, dry tongue (old tongue), dry tongue coat (dry moss). The total correct rate was97.1%. Respectively, the assignment was4,3,4,2,4,2points. The area under the ROC curve was0.987. The diagnostic threshold value was9points, and it was high.The signs and symptoms of phlegm syndrome filtered out by equation were obesity, greasy tongue coating, slippery pulse, total cholesterol and triglycerides. The total correct rate was98.5%. Respectively, the assignment were1,6,4,3,6points. The area under the ROC curve was0.985. The diagnostic threshold value was12points, and it was high.The signs and symptoms of Yang deficiency filtered out by equation were chills, cold extremities, diarrhea, nocturnal, tongue body fat, and the tongue side of teeth marks. The total accuracy rate was97.8%, respectively, the assignment were5,5,4,4,2,2points. The area under the ROC curve was0.993.The diagnostic threshold value was10points, and it was high.The signs and symptoms of blood stasis filtered out by equation were chest pain, sharp pain, fingers and nails being violaceous color, dull purple tongue, and sublingual venae varicose veins astringent and stagnant pulse. The total accuracy rate was98.5%, respectively, the assignment were4,3,4,2,3,4points. The area under the ROC curve was0.997.The diagnostic threshold value was7points, and it was high.The signs and symptoms of qi stagnation filtered out by equation were the inflation threat, hypochondriac pain and stringy pulse. The total accuracy rate was96.3%, respectively, the assignment were7,7,6points. The area under the ROC curve was0.969.The diagnostic threshold value was7points, and it was high.(IV)Scale validation ResultsWe inspected this scale with20in-hospitalized patients of type2diabetes met the inclusion and exclusion criteria, the results were as follows:1. Reliability:the internal consistency test, the Cronbach a coefficient of this scale was0.766,9syndromes coefficient were:0.728,0.809,0.731,0.724,0.728,0.758,0.727,0.765and0.724, the result was acceptable; half reliability of the correlation coefficient. The scale reliability coefficient was0.771. and the results were ideal.2. Validity:the entries of the scale was screened and assessed by professionals, repeatedly verification and programmable. It has good content validity. By the individual and the sum of the validity analysis, the total score and wet, qi deficiency, dryness-heat, yang deficiency, qi stagnation and significant correlation. It can be judged in several parts of the design of the items above. And, it can be measured can represent the theme. Through experiments,4common factors were extracted, and by the maximum variance of the "Kaiser normalization rotation method, the characteristic roots of each factor was above1, and the cumulative contribution was more than70%. 3. Feasibility:The recovery rate of scales was100%; the rate of respondents to complete the scale100%in the survey; the average completion time was11.89±5.61minutes; it can be well accepted by patients.Conclusions1. Wet, qi deficiency, Yin deficiency, dryness-heat flashes, body fluid loss and sputum were common basic syndromes of this disease. The syndrome combinations were deficiency of qi or yin superimposed on wet or dryness-heat. Pathological aspects of the obese patients, the "full" leads to qi activity being stasis, then qi deficiency, qi stagnation, and organs muggy, liquid water gathering, refining liquid to be sputum, yin deficiency and body fluid deficiency were the main pathological link of this disease, being of the same with the pathogenesis described in "Huang Di Nei Jing", slightly different between the results of clinical studies and literature, wet, qi deficiency, yin deficiency were the core syndromes of the disease, being the key factor affecting other syndromes, meanwhile being the pathological results change from other syndromes.2. The disease and syndrome diagnostic scale of type2diabetes disease has good reliability, validity and feasibility, and it can be used as assessment tools of type2diabetes TCM syndrome clinical judgment.