| Objective:To study the effects on traditional Chinese medicine symptoms,nerve conductive velocity,the sympathetic skin response measurement,glycated hemoglobin,blood glucose,and hemorheology examination parameters in patients with diabetic peripheral neuropathy by use of Chinese herbal medicine formula Xuebi for 12 weeks,and to analyze its efficacy Methods:This study adopted double-blind,randomized,controlled,parallel research methods.Newly diagnosed patients with diabetic peripheral neuropathy(syndrome of qi deficiency and blood stasis)were recruited from Guang An Men Hospital.40 patients were included in this trial and they were divided into Xuebi formula group which contains 20 cases and placebo group which contains 20 cases.The treatment group was given Xuebi formula(boil-free granule of Traditional Chinese Medicine)1 potion a day,bid.Patients in the control group were treated with placebo(boil-free granule of Traditional Chinese Medicine)1 potion a day,bid,the period of treatment in the two group was 12 weeks.Results:(1)Baseline 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).(2)Effects on TCM symptoms:the group Xuebi formula were superior to group placebo in improving the clinical symptoms total score,efficiency and single symptom.The effective rate of group Xuebi formula is 88.9%,while the effective rate of group placebo is 15.8%.The comparison between groups was statistically different.The effective rate on numbness of limb,limb pain,weak breathing and lazy talking,lack of strength,lumbar weakness and spontaneous sweating are 61.1%,44.4%,61.1%,77.8%,61.1%,66.7%,respectively.The comparison between groups on the effect of lack of strength was statistically difference(P<0.05)and the group Xuebi formula were superior to group placebo.(3)Effects on nerve conductive velocity:Xuebi formula could delay the deterioration of diabetic peripheral neuropathy.The motor nerve conduction velocity of nervus tibialis on the left both increase after treatment and group Xuebi formula increase more than in group placebo.The motor nerve conduction velocity of nervus tibialis on the right both decrease after treatment and group Xuebi formula increase less than in group placebo,while there was no statistically significant difference in and between two groups(P>0.05).The motor nerve conduction velocity of nervus peroneus communis on the right decrease significantly compared with that of before-treatment(P<0.05),while increase in group Xuebi formula and there was no statistically significant difference between two groups(P>0.05).The sensory nerve conduction velocity of superficial peroneal nerve and sural nerve on the right both decrease after treatment and group Xuebi formula decrease less than in group placebo.The sensory nerve conduction velocity of sural nerve on the left decrease significantly compared with that of before-treatment(P<0.05)and there was no statistically significant difference in group Xuebi formula(P>0.05).The sensory nerve conduction velocity of sural nerve on the left in group Xuebi formula is increasing.Showing that Xuebi formula could delay the deterioration of diabetic peripheral neuropathy.(4)Effects on the sympathetic skin response measurement:The sensation of warmth and thermal pain feeling on the right are both decreasing,group Xuebi formula decrease more than group placebo,while there was no statistically significant difference in and between two groups(P>0.05).The cold pain feeling and sensation of cold on the left are both increasing,while there was no statistically significant difference in and between two groups(P>0.05).The sensation of warmth and thermal pain feeling are both decreasing,group Xuebi formula decrease more than group placebo,the thermal pain feeling decrease significantly compared with that of before-treatment(P<0.05).Showing that Xuebi formula could improve temperature sensation and heat pain sensation in patients with diabetic peripheral neuropathy,making the patients more sensitive to temperature and thermal pain feeling.(5)Effects on hemorheology examination parameters:whole blood viscosity 5(1/S),whole blood viscosity 50(1/S),whole blood viscosity 100(1/S),fibrinogen,whole blood low shear relative index,whole blood low shear relative viscosity and red cell assembling index are increasing in both two groups.In group placebo,whole blood viscosity 5(1/S),whole blood viscosity 50(1/S),whole blood viscosity 100(1/S),whole blood low shear relative index and whole blood low shear relative viscosity increased significantly compared with that of before-treatment(P<0.05).Xuebi formula could decrease the level of whole blood viscosity 1(1/S),whole blood viscosity 5(1/S),whole blood viscosity 200(1/S),plasma viscosity,whole blood high shear relative index,whole blood high shear relative viscosity,erythrocyte deformation index,erythrocyte index of rigidity and assigned viscosity.Whole blood viscosity 1(1/S)and whole blood viscosity 5(1/S)decrease significantly compared with that of before-treatment(P<0.05).Placebo could increase the level of whole blood viscosity 1(1/S),whole blood viscosity 200(1/S),plasma viscosity,whole blood high shear relative index,whole blood high shear relative viscosity,erythrocyte deformation index,erythrocyte index of rigidity and assigned viscosity.In group placebo,whole blood viscosity 1(1/S)and whole blood viscosity 200(1/S)increased significantly compared with that of before-treatment(P<0.05).Showing that Xuebi formula could improve the microcirculation and blood rheology indexes in patients with diabetic peripheral neuropathy.(6)Effects on blood glucose level and blood electrolytes:the Xuebi formula group could influence blood glucose level and blood electrolytes to some extentConclusion:This study preliminarily has showed that Xuebi formula can significantly improve traditional Chinese medicine symptoms,delay the development of decreased on nerve conductive velocity,make the patients more sensitive to temperature and thermal pain feeling and improve hemorheology examination parameters,influence blood electrolytes to some extent.In conclusion,the efficacy of Xuebi on diabetic peripheral neuropathy have been verified. |
PDF Full Text Request