| ObjectiveThis study observed the clinical symptoms, blood glucose control of Modified Zhizhu Decoction in the treatment of diabetic gastroparesis (DGP, with a disease name of Chinese medicine, Xiaoke Weipi), and evaluates its effectiveness and safety. Meanwhile we preliminarily studied its mechanism and the advantage comparing to the western medicine domperidone, for clinical diagnosising and using of pure Chinese herbal compound in the treatment of DGP(Xiaoke Weipi) in objective basis.MethodsThe study included 42 cases of DGP(Xiaoke Weipi) patients and randomly divided to control group and treatmentl group. Each group had 21 cases. During the course of treatment,1 cases of control group were shed. Based on the foundation treatment of Diabetes, the control group was given oral domperidone 10mg,3 times a day and the treatmentl group was given oral modified Zhizhu Decoction 200ml,2 times a day. The total course of treatment need 14 days. Before and after treatment, the clinical symptom score, blood glucose level and adverse reaction of DGP were observed. According to the symptom scores, the curative effect evaluation indexes were analyzed and compared between the two groups.ResultsSymptom scores:after 14 days of treatment, the treatment group can not only improve in patients with postprandial epigastric fullness, early satiety, belching, nausea, vomiting, epigastric pain, constipaion and other DGP symptoms, but also significantly improved systemic symptoms in patients with fatigue, dry mouth. Compared with the control group, the total score of clinical symptoms was significantly decreased (P＜0.01). Symptom effectiveness comparison:The total effective rate of the treatment group was 95.2%, the total effective rate of the control group was 65%, there were significant differences between the two groups(P＜0.05). Blood glucose:before and after treatment, the fasting and postprandial blood glucose, glycosylated hemoglobin of two groups were both decreased. There was statistical difference within the groups (P＜0.05), while there was no statistical difference between the two groups (P＞0.05). The results showed that modified Zhizhu Decoction in DGP patients was significantly better than the control group which had the domperidone in improving clinical symptoms. This may be related to modified Zhizhu Decoction had the effect of the promotion of gastric motility, antioxidation, anti inflammation and improving the microcirculation of gastric mucosa etc. In the control of blood glucose, there was no significant difference between the two groups, indicating that the treatment group and the control group in the treatment of blood sugar can effectively control, may related with the treatment of other antidiabetic drugs or diet, sports, but not related to the treatment of drug. Safety analysis:all included in the study before and after treatment safety index results were not found abnormal. No patients who because had severe vomiting to terminate the clinical trials. The treatment process did not appear severe liver and kidney dysfunction, arrhythmia and other adverse reactions, which had good safety.ConclusionModified Zhizhu Decoction can obviously improve the patients with postprandial epigastric fullness, early satiety, belching, nausea, vomiting and other clinical symptoms, without obvious adverse reaction. Traditional Chinese Medicine (TCM) believes that, Modified Zhizhu Decoction has the effect of Supplementing qi and nourishing yin, fortify the spleen and Xiaopi, which can obviously improve diabetes Weipi various gastrointestinal symptoms. It has good security, and those patients with high medication compliance. It is worth further clinical research and applications. |
