The Preliminary Clinical Study Of Self- Prescribed Sangaiduteng Decoction In The Foot Bath Treatment Of Diabetic Peripheral Neurophathy(DPN)

Objectives To observe the effects of self-prescribed Sangaiduteng decoction in improving the symptoms of Chinese medicine, signs and symptoms, motion and sensory nerve conduction velocity of Diabetic peripheral neuropathy(DPN) patients, and evaluate the efficacy and safety.Methods From December 2014 to March 2016 in Endocrine department of Tangshan Chinese Medicine Hospital, 108 patients were randomly seleceted who meeting the diagnostic criteria for DPN and inclusion criteria, and were randomly divided into Control Group 1, Control Group 2 and Treatment Group. Patients in the Control Group 1 took the Mecobalamin Tablets(Eisai Pharmacentical Co.,Ltd), 0.5mg/time, 3 times a day.The Control Group 2 based on the therapy in the Control Group 1 was given 40 ? water footbath,40 mins/time, 1 time a day.The Treatment Group based on the therapy in the Control Group 1 was given footbath of self-prescribed Sangaiduteng decoction( the temperature and quanlity of water, soaking time and method were as same as the Control Group 2). Every 30 days for a course of treatment for patients, the following aspects were monitored involving the TCM syndrome score, Toronto score, MNCV1, MNCV2 and SNCV1 before and after treatment to judge its efficacy.Results The study involved in 108 cases, 8 cases didn't finish 1/2 course of the treatment. At the end of the trial, there were 32 cases of the Control Group 1, 35 cases of the Control Group 2 and 33 cases of the Treatment Group who had completed the trial. 1 Comparison of clinical efficacy in the three groups:The total efficiency rate of the Treatment Group, Control Group 2, Control Group 1 were 87.9%, 48.6% and 25.0%. The efficacy of Treatment Group was better than the Control Group 1 and Control Group 2(P<0.05). 2 Comparison of TCM syndrome score: Before treatment, the 3 groups had no significant difference in TCM syndrome score(P>0.05). After treatment, the TCM syndrome score of 3 groups were all improved(P<0.05), with the best effect in the Treatment Group(P<0.05). 3 Comparison of Toronto score: Before treatment, the 3 groups had no significant difference in Toronto score(P>0.05). After treatment, the Toronto score of 3 groups were all reduced(P<0.05), with the best effect in the Treatment Group(P<0.05).4 Comparison of nerve conduction velocity : Before treatment, the 3 groups had no significant difference in nerve conduction velocity(P>0.05). After treatment,the MNCV1, MNCV2 and SNCV1 of 3 groups were all increased(P<0.05), with the best effect in the Treatment Group(P<0.05).Conclusions Self-prescribed Sangaiduteng decoction could improve the DPN patients' symptoms and signs, increased their nerve conduction velocity, improve their symptoms of Chinese medicine. During the treatment, there was no adverse reaction. This treatment is safet, effective and worth of clinical application.