Clinical Study Of Xueqi Decoction In The Treatment Of Diabetic Peripheral Neuropathy With Qi Deficiency And Blood Stasis Syndrome

Objective:To observe the clinical efficacy and safety of Chinese herbal compound Xuebi Formula(XBF)in the treatment of type 2 diabetic peripheral neuropathy,qi deficiency and blood stasis syndrome.Method:A randomized,double-blind,placebo-controlled,parallel design study was used to select Patients who met the criteria for the inclusion of type 2 diabetic peripheral neuropathy and were classified as qi deficiency and blood stasis by TCM syndrome differentiation.The included patients were randomly divided into a treatment group(blood stasis group)and a control group(placebo group),the study period was 6 months.The changes of TCM symptom scores,MNSI scores,HbAlc,and blood glucose before and after treatment were observed in patients with tyPe 2 diabetic peripheral neuropathy,qi deficiency and blood stasis syndrome.SPSS20:0 statistical software was used to perform statistical analysis on the research data to comprehensively evaluate the clinical efficacy and safety of Chinese herbal compound XBF in the treatment of type 2 diabetic peripheral neuropathy,qi deficiency and blood stasis syndrome.Results:1.Effects on TCM symptom scores:In terms of improving TCM symptom scores,the TCM symptom scores in the treatment group were significantly lower than those in the control group(P<0.01).In the improvement of individual TCM symptoms,after 6 months of treatment,the patients in the treatment group showed significant improvements in limb numbness,limb pain,lack of energy,lack of qi and no desire to speak,fatigue,soreness and weakness of waist and knees,and spontaneous perspiration symptoms,and the differences were statistically significant(P<0.01),which shows that XBF has significant effects in improving blood stasis symptoms such as limb pain,as well as qi deficiency symptoms such as numbness,lack of qi and no desire to speak,fatigue,and fatigue.However,in the control group,only the symptoms of soreness and weakness of waist and knees improved after treatment(P<0.05);other symptoms of qi deficiency and blood stasis included limb numbness,lamb pain,lack of qi and no desire to speak,fatigue,fatigue,spontaneous perspiration,and pale complexion did not change significantly(P>0.05).At the same time,the study found that the treatment group was significantly better than the control group in improving limb numbness,limb pain,lack of qi and no desire to speak,and fatigue(P<0.01 or P<0.05).It shows that the treatment group has obvious advantages in improving the clinical symptoms of qi deficiency and blood stasis syndrome of DPN compared with the control group.In short,XBF can improve the main clinical symptoms and TCM symptom scores of qi deficiency and blood stasis syndrome of DPN.2.Effects on glycated hemoglobin(HbAlc),fast blood glucose(FBG)and two hours postprandial blood glucose(2hPG):After 6 months of treatment,HbAlc,FBG,and 2hPG in the treatment group and the control group did not change significantly(P>0.05),indicating that XBF is not good at lowering blood glucose,so the efficacy of XBF is independent of lowering blood glucose and merely improving its neuropathy complications.3.Effects on the Michigan Neural Screening Scale(MNSI):After 6 months of treatment,the MNSI scores in the treatment group were significantly lower than before,and the difference was statistically significant(P<0.01);the control group has no significant change in MNSI scores before treatment(P>0.05).Between groups,the reduction in MNSI scores in the treatment group was significantly better than in the control group(P<0.01).Therefore,it is demonstrated that XBF can significantly improve the MNSI scores of DPN patients with qi deficiency and blood stasis syndrome.4.Effects on nerve conduction velocity(NCV):After 6 months of treatment,the MCV of the bilateral sacral nerve and the SCV of the bilateral superficial stenosis decreased in the treatment group after treatment.The difference was statistically significant(P<0.05).Between groups,the conduction velocity of the bilateral phrenic nerve and superficial temporal nerve in the treatment group was significantly better than that in the control group.Therefore,it was demonstrated that blood stasis can improve NCV in patients with qi deficiency and blood stasis type DPN.5.Effect on the curative effect:After 6 months of treatment,the total effective rate of the treatment group was 70.37%,and the total effective rate of the control group was 22.73%.The curative effect of the treatment group was significantly better than the control group,and the difference was statistically significant(P<0.01).Therefore,it is demonstrated that XBF treatment is effective for the treatment of qi deficiency and blood stasis syndrome of DPN.Conclusions:After 6 months of the study,it shows that XBF has certain effect on qi deficiency and blood stasis syndrome of DPN,and can imProve various clinical symPtoms and TCM symPtom scores of qi deficiency and blood stasis syndrome of DPN,and also can significantly reduce the MNSI score.At the same time,it can improve the MCV of the bilateral phrenic nerve and the SCV of the superficial nerve.However,in terms of reducing glycosylated hemoglobin and blood glucose,XBF has no significant effect.The analysis of the composition of XBF also found that it does not contain hypoglycemic herbs,indicating that XBF is independent of lowering blood glucose and merely improving its neuropathy complications.The formula is of safety and it is worth further study and promotion.