| ObjectiveTo study the effects on glycated hemoglobin, blood glucose, cholesterol, weight, waist and hip circumference, BMI, insulin resistance and traditional Chinese medicine symptoms in patients with type2diabetes by use of Chinese herbal medicine formula Jiangtangtiaozhi for12weeks, and to analyze the efficacy of Jiangtangtiaozhi on reduction of lipid, glucose and weight in patients with type2diabetes.MethodsThis study adopted randomized, controlled, parallel research methods. Newly diagnosed obese patients with type2diabetes and dyslipidemia (syndrome of gastrointestinal full heat) were recruited from Guang An Men Hospital. There were149patients were included in this trial, and they were divided into Jiangtangtiaozhi formula group which contains76cases and metformin group which contains73cases through the central randomized method. The treatment group was given Jiangtangtiaozhi formula (boil-free granule of Traditional Chinese Medicine)1potion a day, bid. Patients in the control group were treated with metformin (tablet)0.25g, tid, the period of treatment in the two group was12weeks.Results①Baseline comparison:general information before treatment, key indicators, TCM symptom score and individual symptom total score between the two groups were not statistically different (P>0.05).②Hypoglycemic:HbA1c, FPG,2hPG decreased significantly in two groups when compared to levels before treatment. In group Jiangtangtiaozhi formula,the decrease of FPG was (1.85±2.06) mmol/L, as well, in group metformin was (1.51±1.44) mmol/L; In group Jiangtangtiaozhi formula, the decrease of2hPG, was (3.20±3.62) mmol/L, in group metformin was (1.99±3.84) mmol/L, there was statistically significant difference between the discrepancy of the two groups (P<0.05); In group Jiangtangtiaozhi formula, the decrease of HbA1c was(0.74±0.74)%, in group metformin was (0.73±0.85)%. In both groups, the level of FPG,2hPG, HbAlc decreased significantly compared with that of before-treatment (P<0.05). There was no statistically significant difference in decreased level of FPG,2hPG, HbAlc. between the two groups (P>0.05); Stratification analysis was made according to the initial value of HbA1c, it was showed that the decrease of HbA1c was significant with the increase of the initial value of HbAlc in both groups, at the level of8%≤HbAlc <9%, the decrease of level of HbAlc in group Jiangtangtiaozhi formula was superior to group metformin siginificantly.③Lipid decrease:Compared with before-treatment,the level of CHO, TG, LDL was significantly decreased in two groups (P<0.05); the increase of HDL level was not significant (P>0.05). The decrease of TG level in group Jiangtangtiaozhi formula was (0.47±1.26) mmol/L (P<0.05), that in group metformin was (0.31±2.18) mmol/L (P>0.05),there was no statistically significant difference between the two groups (P>0.05); The decrease of CHO level in group Jiangtangtiaozhi formula was (0.96±0.74) mmol/L, that in group metformin was (0.88±0.83) mmol/L; The decrease of LDL level in group Jiangtangtiaozhi formula was (0.71±0.64) mmol/L, that in group metformin was (0.69±0.57) mmol/L; In both groups, levels of CHO, LDL decreased significantly compared with before-treatment (P<0.05), there was no statistically significant difference between the two groups (P>0.05).④Losing weight:The decrease of weight, waist circumference, hip circumference, BMI in two groups was significant (P<0.05). The decrease of weight level in group Jiangtangtiaozhi formula was (2.04±1.96) Kg, that in group metformin was (1.85±2.31) Kg; The decrease of BMI value in group Jiangtangtiaozhi formula was (0.79±0.74) Kg/m2, that in group metformin was (0.67±0.87) Kg/m2; The decrease of waistline level in group Jiangtangtiaozhi formula was (1.53±4.93) cm, that in group metformin was (2.0±4.40) cm; The decrease of hip circumference level in group Jiangtangtiaozhi formula was (3.83±4.12) cm, that in group metformin was (3.38± 3.77) cm. In both groups, the decrease of Weight, BMI, waist circumference, hip circumference within was statistically significant compared with before-treatment (P <0.05), there was no significant difference between the two groups (P>0.05).⑤Effects on blood pressure:In both groups, The decrease of diastolic blood pressure was significant (P<0.05), and the decrease of systolic blood pressure was not significant (P>0.05).⑥Effects on insulin resistance:islet (3-cell function improved in both two groups, the trend of improve in Insulin resistance and insulin sensitivity was revealed in group Jiangtangtiaozhi formula. In improvement of HOMA-%B, the increase in group Jiangtangtiaozhi formula was (16.84±27.79), that in group metformin was (18.34±22.14), compared with before-treatment, the increase was significant (P<0.05), there was no significant difference between the two groups (P>0.05); In improvement of HOMA-IR, the increase in group Jiangtangtiaozhi formula was (0.41±0.20)(P <0.05), that in group metformin was (0.12±0.15)(P>0.05), there was no significant difference between the two groups (P>0.05).⑦Effects on TCM symptoms:The group Jiangtangtiaozhi formula were superior to group metformin in improving the clinical symptoms total score, efficiency and single symptom such as obstruction of flow of QI, constipation, bad breath, thirst and like cold drink, rapid and powerful pulse (P<0.05).ConclusionThis study preliminarily has showed that Jiangtangtiaozhi formula can significantly decrease glycosylated hemoglobin, blood glucose, blood lipids. waist and hip circumference, weight in patients which are components of metabolic syndrome and cardiovascular risk factors for patients with type2diabetes, and can improve function of islet β-cell and insulin resistance which is similar to the role of metformin, at the same time, Jiangtangtiaozhi formula was superior to metformin in improving TCM syndrome. In conclusion, efficacy of Jiangtangtiaozhi on reduction of lipid, glucose and weight in patients with type2diabetes has been demonstrated through all aspects above. |
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