Study On The Clinical Efficacy Of Formula Granules And Traditional Decoction Pieces In The Treatment Of Metabolic Syndrome Of Spleen Deficiency And Dampness

Purpose:The purpose of this study is to study the clinical efficacy of formula granules and traditional decoction pieces in the treatment of metabolic syndrome of spleen deficiency and dampness excess type,to evaluate the efficacy and safety of Linggui Zhugan Decoction in the treatment of metabolic syndrome,and to evaluate the equivalence of formula granules and traditional decoction pieces in the treatment of diseases.Material and method:From March 2017 to June 2018,patients diagnosed as spleen deficiency and dampness-rich metabolic syndrome with fasting blood glucose(FPG)>6.1mmol/L or blood glucose(>7.8mmol/L)2 hours after sugar loading and/or diagnosed as diabetes mellitus and taking medicine,Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine and Affiliated Hospital of Shandong University of Traditional Chinese Medicine.A randomized,controlled,multi-center clinical trial design was used.A total of 56 cases were divided into granule test group(28 cases)and decoction control group(28 cases).The changes of fasting blood glucose(FPG)and improvement rate of TCM symptoms between and within the main observation groups were observed Results:1.45 cases met the inclusion criteria,24 cases in formula granule group and 21 cases in traditional Chinese medicine decoction group.Age ranges from 18 to 65.There was no statistical difference in general data between the two groups(P>0.05).2.Compared with before treatment,waist circumference and body weight of granule group and decoction group decreased significantly(P<0.01);body weight of granule group decreased compared with before treatment(P<0.05);there was no significant difference between the two groups before and after treatment(P>0.05).3.The diastolic blood pressure in granule group was significantly lower than that before treatment,and the difference was statistically significant(P<0.01).There was no significant difference between the two groups in systolic blood pressure and the diastolic blood pressure before and after treatment(P>0.05),and there was no significant difference between the twogroups before and after treatment(P>0.05).4.There were no significant differences in fasting blood glucose(FPG),glycated hemoglobin(HbA1c),total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),fasting insulin(FINS),insulin resistance index(HOMA-IR)between the two groups before and after treatment(P>0.05).The significance of accounting(P>0.05).5.The symptoms of mental fatigue and physical distress in the two groups were significantly improved compared with those before treatment(P<0.01),and there was no significant difference between the two groups before and after treatment(P>0.05).6.The symptoms of dizziness and dizziness in granule group were alleviated compared with those before treatment,the difference was statistically significant(P<0.05);the symptoms of dizziness and dizziness in Decoction group were significantly alleviated compared with those before treatment,the difference was statistically significant(P<0.01);after treatment,the decoction group had a slight advantage compared with granule group,the difference was statistically significant(P<0.05).7.There was no significant difference in TCM symptoms of chest tightness and distension between the two groups before and after treatment(P>0.05);there was no significant difference between the two groups after treatment(P>0.05).Conclusion:1.Linggui Zhugan Decoction can reduce waist circumference,weight and regulate blood pressure in patients with spleen deficiency and dampness-rich metabolic syndrome.2.Linggui Zhugan Decoction can effectively improve the symptoms of mental fatigue,physical distress and dizziness in patients with spleen deficiency and dampness-rich metabolic syndrome.3.The effect of the prescription granules in this study is similar to that of traditional decoction pieces in the treatment of metabolic syndrome of spleen deficiency and dampness excess.Because the prescription granules are convenient to carry and take,they are conducive to clinical application.