Clinical Observation Of Modified Danggui Liuhuang Decoction In Treating Type2 Diabetic Peripheral Neuropathy Patients Of Qi- Yin Deficiency Complicated Static Blood Syndrome

Objective To observe the clinical effect and the safety of the Modified Danggui Liuhuang decoction in treating type 2 diabetic peripheral neuropathy(DNP)patients of qi-yin deficiency complicated static blood syndrome, and to primarily discuss its mechanism, to provide a reliable theoretical basis for its application.Methods All patients in this clinical study were recruited from November 2013 to December 2014 in the Central Hospital of Wuhan Traditional Chinese Medicine and endocrinology inpatient, a total of 70 cases, all patients were satisfied the diagnosis of DNP and qi-yin deficiency complicated static blood, excluding patients with other neurological diseases,aged from 35 to 75 years, obtained informed consent, and they were divided into treatment group and control group according to the order of treatments.Put 70 enrolled patients with DPN,all belong to qi-yin deficiency and blood stasis into treated group and contrast group according to the order of their hospital stay,each of them has 35 cases,all of them has regular exercise、diet、insulin、strict control of blood pressure and blood fats,35 patients were treated with oral mecobalamin 0.5mg three times a day in control group, which is provided by Eisai(national drug approval number H20030812),35 patients were treated with Modified Danggui Liuhuang decoction, which is made up of Chinese angelica 15 g,Radix Rehmanniae 15 g,Prepared Rehmanniae root 15 g,baical skullcap root 10 g,golden thread 6g,Cortex Phellodendri 10 g,milkvetch root 30 g,Rhizoma Ligustici Chuanxiong 15 g,stiff silkworm 10 g and suberect spatholobus stem 30 g,provided by the Central Hospital of Wuhan TCM Pharmacy in treated group twice a day(herbs are from Hubei Tianji Chinese Herbal Sliced Medicine Corporation),both of them were on the basis of glucose-lowering treatment, a course of treatment lasted for 3 months.Observations include the general demographic information, course of disease, safety indicators checks,TCM syndrome score sheet, effect of therapy table, TCSS questionnaire, nerve conduction velocity chart before and after this treatment.The research result is calculated by using the SPSS19.0 statistical analysis software for further analysis, with bilateral differences test, setting the P value greater than 0.05 is not statistically significant.Result ①Both mecobalamin tablets and Modified Danggui Liuhuang decoction can improve the symptoms of DPN patients,and Modified Danggui Liuhuang decoction’s effectiveness is awesome towards mecobalamin tablets; ② Their blood glucose and Hemoglobin A1 C remained stable before and after the treatment(P > 0.05); ③ Mecobalamin tablets and Modified Danggui Liuhuang decoction are helpful to relieve DPN patients’ symptoms, while the treatment group in the TCM syndrome score improved better than control group(P<0.05);④Two groups can improve patients’ TCSS score, and the treatment group did better than control group(P>0.05);⑤Two groups had no difference before the treatment in the nerve conduction velocity of median nerve and common peroneal nerve(P>0.05),these data are comparable, after the treatment, both groups were improved, while the treatment group is much more excellent than the control group in the nerve conduction velocity of median nerve and common peroneal nerve(P<0.05);⑥The treatment group’s feeling numb, ache improvement rate(84.6%,87.5%) obviously were higher than the comparison group’s(46.7%,50%)(P<0.05).The treatment group’s feeling decrease and lower limb tendon reflex improvement rate(57.1%、71.4%)were similar to the control group’s(85.7%、80%),in the treatment group and the control group, the overall efficacy rates were 77.1%(27/35) and 60%(21/35) respectively(P<0.05),the treatment did better than the control group in symptom standards;⑦Both groups’ hs-CRP were lower than the previous treatment, the SOD had gone up than before, both groups can improve the hemorheology,and the treatment group was better than the control group(P<0.05).Conclusion ①Both mecobalamin tablets and the Modified Danggui Liuhuang decoction have effect on diabetic peripheral neuropathy patients, the clinical symptoms and neurologic;②The Modified Danggui Liuhuang decoction has remarkable result in TCM syndrome score, Symptom effect rate,SOD,hs-CRP, hemorheology in comparison with the mecobalamin tablets; ③ The Modified Danggui Liuhuang decoction has multi-targets effects, no wound and safety, so which will be worth widespreadly applying, with the regular treatment. This study is an effective method in treating DPN; it can delay the target organ damage of diabetes and enrich the method of Chinese medicine treatment of DPN by syndrome differentiation.