The Study Of Construction And Clinical Effects Of "Variable-stable And Sequential Eight Methods" Type 2 Diabetes Health Programs

Objective:This study aimed to construct "Variable-stable and sequential eight methods" Type 2 Diabetes(T2DM) Health Programs through methods of data mining, then assess its clinical effects in new cases with T2DM through prospective randomized controlled clinical study, thus provide proof for prevention and treatment of T2DM.Methods:1. Base on Chinese herb program which has already formed, formulate search strategies and search daily regimen of T2DM about therapies like tonifying kidney, removing pathogenic heat from blood, tonifying qi and yin, promoting blood circulation for removing blood stasis, clearing away the lung-heat and promote the secretion of saliva or body fluid, clearing away heat and promoting dieresis, smoothing liver, and nursing mind, establish data base and analysize with statistical methods. Then form "Variable-stable and sequential eight methods" Type 2 Diabetes(T2DM) Health Programs.2.128 new cases of T2DM were randomly divided into Glucophage group(n=64) and Glucophage+health program group(n=64), both groups received regular exercise and diet guidance. Glucophage group received oral drug treatment. Despite oral drug treatment, Glucophage+health program group also received intervention of "Variable-stable and sequential eight methods" T2DM Health Programs. Both groups were treated for 12 weeks. Weight and waistline were recorded, FPG,2hPPG, FIMS, HbAlc, blood fat were measured, BMI, HOMA-IR and HOMA-IS were calculated, integral TCM syndrome score and diabetes specific quality of life score (DSQL) were evaluated before and after treatment.Results:1.Baseline data:general information (age, age segmented structure, gender, education level) and outcome measures were compared before treatment, there were no significant differences between two groups, baseline information were balanced and comparable.2. Index of physical examination:After treatment, weight, waistline and BMI in both groups were lower than before treatment (P<0.05). After treatment, significant differences were observed between groups, effects of Glucophage +health program group were better than Glucophage group (P＜0.05)3. Glycemic index:After treatment, FPG,2hPPG, and HbAlc were lower than before treatment (P<0.05). There were significant differences between groups, effects of Glucophage+health program group were better than Glucophage group (P＜0.05).4. Blood fat index:After treatment, TC, TG and LDL were lower and HDL were higher than before treatment in both groups (P<0.05). There were significant differences between groups, effects of Glucophage+health program group were better than Glucophage group (P＜0.05)5. Insulin sensitivity index:After treatment, HOMA-IR of both groups were lower and HOMA-IS of both groups were higher than before treatment(P<0.05). There were significant differences between groups, effects of Glucophage+ health program group were better than Glucophage group (P＜0.05)6. DSQL index:After treatment, DSQL of both groups were lower than before treatment(P<0.05). After treatment, significant differences were observed between groups, effects of Glucophage+health program group were better than Glucophage group (P＜0.05)7. Integral TCM syndrome score index:There was no significant change of Integral TCM syndrome score during the whole course in Glucophage group (P>0.05). While in Glucophage+health program group, the score after treatment was lower than before treatment (P＜0.05). Significant differences were observed between groups (P＜0.05)8. Curative effects:the effective rate of Western Medicine in Glucophage group was 53.1%, while 78.1% in Glucophage+health program group, there was significant differences between groups (P＜0.05). The effective rate of TCM in Glucophage group was 14.1%, while 73.4% in Glucophage+health program group, there was significant differences between groups (P＜0.05)9. Changes of TCM syndromes:patients’symptoms were usually characterized as combination of two-four Chinese medical syndrome, and showed dynamic changes. At the early stage of treatment, syndromes with high frequency of occurrence were damp-heat blocking in the body, depression of liver-QI, and lung-heat impairing bodyf luid. At the middle stage of treatment, syndromes with high frequency of occurrence were depression of liver-QI, damp-heat blocking in the body, and deficiency of both vital energy and yin. At the end stage of treatment, syndromes with high frequency of occurrence in Glucophage group were depression of liver-QI, damp-heat blocking in the body, and deficiency of both vital energy and yin, while in Glucophage+ health program group were deficiency of the kidney, deficiency of both vital energy and yin, and blood stasis. At following-up period, syndromes with high frequency of occurrence in Glucophage group were depression of liver-QI, damp-heat blocking in the body, and blood stasis, while in Glucophage+health program group were deficiency of the kidney, deficiency of both vital energy and yin, and blood stasis.10. safety:both groups had no adverse events and had good safety.Conclusion:1. "Variable-stable and sequential eight methods" Type 2 Diabetes(T2DM) Health Programs may help to control weight, waistline, and body mass index, improve glucose and lipid metabolism, reduce insulin resistance. What’smore, it may also help to eliminate clinical symptoms and promote life quality.2. The pathogenesis of diabetes are complicated with the presence of multiple and dynamic changing syndroms, so we shall strictly abide by the principles of treatment according to syndrome differentiation, not rigidly adhere to one syndrome one prescription. Dynamic differentiation and sequential therapy may help to achieve good clinical curative effect.