Abstract: Objective To investigate the effects of Chinese herb formula Tangtongfang by bathing the affected feet of patients with diabetic peripheral neuropathy (DPN) in the pattern of Qi deficiency and blood stasis. Methods A parallel, randomized, controlled clinical research was performed. 70 diabetics in the inpatient and outpatient divisions of the Department of Endocrinology, Guanganmen Hospital, from January 2005 to October 2007 were investigated. They were divided randomly into two groups, treatment group and control group, 35 cases in each group. Before study, there were no statistic differences between the two groups, including gender, age, course of diabetes mellitus(DM), course of DPN, blood glucose (including fasting blood glucose and postprandial blood glucose), traditional Chinese medicine(TCM) symptom scores and nerve conduction velocity (NCV). The treatment group were treated with Tangtongfang bathing and the control group were treated with warm water bathing. Each group was also administered Vitamin B₁ 20 mg, t.i.d and Vitamin B₆ 20 mg, t.i.d respectively. All patients were keeping their routine treatment and diabetic care to control their blood glucose, such as diets, practices and drugs. Clinical symptoms and electrophysiological tests in diabetic peripheral neuropathy syndrome were investigated. The period of treatment was 8 weeks.Results After study, 9 cases retreated from this clinical trial totally, 4 cases in the treatment group whereas 5 in the control group. Among 4 common single symptoms, coolness feeling of the feet of diabetic patients was significantly improved (P<0.05) after bathed with Tangtongfang. The change of TCM symptom scores and tibialis NCV was significantly improved (P＜0.001, P<0.05) in the treatment group. The improvement ratio was 45.2% and 61.3% in the treatment group, while was 10% and 3.3% in the control group. In each group there was no statistical difference between pre-and post-study with blood test, urine test, blood ALT, blood BUN and Cr, ECG examination (P>0.05). No adverse event was observed in each group.Conclusion Tangtongfang bathing improved several symptoms of patients suffering from DPN, especially the symptom of coolness feeling of the patients' feet. No adverse event was observed. This result showed that Tangtongfang bathing was worthy of using as a safe agent in treatment of DPN.

Key words: Chinese herb formula Tangtongfang, diabetic peripheral neuropathy, clinical study