| Objective: To observe the clinical effect of Xiaopi Daozhi pill in treating functional dyspepsia(FD)with syndrome of Qi stagnancy and dampness-stagnation,and to Provide new theoretical and clinical basis for further treatment of FD by Traditional Chinese Medicine.Methods: 100 patients with FD were randomized into treatment group(50 cases)and control group(50 cases),patients in the treatment group were treated with Xiaopi Daozhi pill,in the control group were treated with Mosapride Citrate Tablets.The clinical symptoms,Gastric Electrical Activities,Motilin's level,quality of life and condition of tongue were compared before and after 2 weeks,4 weeks of treatment by using SPSS21.0 statistical software,meanwhile,the safety of application and conditions of prognosis were evaluated during treatment process.Results: 5 cases were felled of during treatment process,47 cases in the treatment group and 48 cases in the control group were accepted final assessment.(1)Comparison of score on clinical symptoms: Except the symptoms of diarrhoea and fatigue in the control group,the remaining symptoms of both groups were better than those before treatment(P<0.05).The symptoms of abdominal distension,stomachache,early satiation,poor appetite and depressed emotion were not significantly different between the two groups after 2 weeks of treatment(P>0.05),while the symptoms mentioned above of the treatment group was better than those in the control group when finished 4 weeks of observation(P<0.05).The symptoms of belching and hiccups was not significantly different between the two groups during treatment Process(P>0.05).(2)Comparison of efficiency on clinical symptoms: After 2 weeks of treatment,the total efficiency rate of the treatment group was 68.09 %,which was not significant differences compared with 70.83 % in the control group(P>0.05).The total efficacy rate of the treatment group(91.49%)was higher than the control group(75%)after 4 weeks of treatment(P<0.05).(3)Comparison of Gastric Electrical Activities: The percentage about slow waves of gastric electricity including before and after meals,the ratio about primary power of after meals and before meals were better than those before treatment(P<0.05).The percentage about slow waves of gastric electricity before meals had no significant differences between the two groups during treatment process(P>0.05).The percentage about slow waves of gastric electricity after meals and the ratio about primary power of after meals and before meals were not significantly different between the two groups after 2 weeks of treatment(P>0.05),while the parameters mentioned above of treatment group was higher than those in the control group after finishing 4 weeks of observation(P< 0.05).(4)Comparison of Motilin's level: After treatment,the level of Motilin was increased in both groups(P<0.05).There was no significant difference between the two groups after 2 weeks or 4 weeks of treatment with the level of Motilin(P>0.05).(5)Comparison about patient's quality of life: After treatment,the patient's quality of life was higher than that before treatment(P<0.05),there was no significant difference about quality of life between the two groups after 2 weeks of treatment(P>0.05),and the treatment group was significantly higher after 4 weeks treatment(P<0.05).(6)Comparison of tongue condition: The condition of tongue in patients among the treatment group was improved more than that of the control group whether after 2 weeks or 4 weeks of treatment(P< 0.05).(7)Comparison of the safety about application and conditions of prognosis: There were no adverse reaction in both groups during treatment process.The recurrence rate was 11.9 % in the treatment group,which was significantly lower than 38.89 % in the control group(P< 0.05).Conclusion:(1)Xiaopi Daozhi pill has significant effect on FD with syndrome of Qi stagnancy and dampness-stagnation,not only can alleviate the clinical symptoms,correct the disturbance of gastric rhythm,enhance the level of Motilin,but also can increase the quality of life and improve the physical condition,besides,few adverse reaction and it can prevent disease recurrence effectively.(2)The mechanism on the treatment of FD with Xiaopi Daozhi pill may be related to correcting the disturbance of gastric rhythm,increasing the level of Motilin so that gastric activities were enhanced and brain-gut axis was regulated. |
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