| Objectives By observing the improvement of TCM syndrome and other indicators by Jiaogua Decoction in treating patients with Functional Dyspepsia(FD)due to Spleen deficiency and Qi stagnation type,we evaluate the clinical efficacy,provide practical basis for clinical application,and provide new ideas and methods for the treatment of this disease.Methods By using the design approach of random parallel controlled,72 FD(PDS)samples which were recruited from Department of Traditional Chinese Medicine of Hebei General Hospital(HBGH)with Spleen deficiency and Qi stagnation syndrome diagnostic criteria were selected.These patients saw a doctor from March to December of 2017,and they were divided into treatment and control group randomly.36 patients in the treatment group and 36 patients in the control group.The treatment group(36 cases)were treated with Jiaogua Decoction half an hour after the meal twice a day,and 150 ml each time.The control group was given a kind of Chinese traditional medicine named Zhizhu Kuanzhong Jiaonang.The patients need to take 3 tablets each time and 3 times everyday in half an hour after the meal.Two weeks for a patient was one course,and 2 courses of the clinical effect were observed.During the courses of treatment,changes on the clinical symptoms,water load test,and TCM syndrome of two groups before and after the treatment were evaluated.Furthermore,side effects and safety of medicine were compared and evaluated through the alterations of CBS,urinalysis and the function of liver and kidney.Using the statistical software of SPSS17.0 to make statistical analysis of all data,and the counting data were testified by X2 test;The measurement data were expressed as the average addition and subtraction standard deviation.The T test was used for the data of normal distribution,and non-parameter test was used for the data of non-conforming;Ranked data were testified by rank-sum test.Results After 4 weeks of treatment,4 cases fell off in each group(the treatment group and the control group),and 32 cases were completed in both groups.1 Clinical effect: In treatment group,the overall response rate of 93.75% was observed in 32 treated patients,including 30 effective patients and 2 invalid patients.In control group,the overall response rate was 81.25%,including 26 cases were effective and 6 cases were invalid.The statistical analysis showed that rank-sum test was P<0.05,which implied that the difference had statistical significance.It is showed that the clinical effect of TCM in the treatment group was better than that group.2 The comparison of each syndrome of TCM: After the treatment of 2 weeks,the syndromes of TCM were lower than before treatment in two groups.Due to P>0.05,there was no significant difference within two groups after 2 weeks of treatment by T test,which showed that the improvement of individual TCM syndromes in the two groups was not obvious.After the treatment of 4 weeks,the syndromes of TCM were also lower than before the treatment within two groups.Except for “mental fatigue” and “loose stool”,P<0.05 was statistically analyzed by T test,which showed that there was statistical significance.It means that two treatments had not significant effects on the improvement of “mental fatigue” and “loose stool”.3 The comparison of total syndromes of TCM: Compared with before treatment,the total syndromes of TCM decreased significantly after treatment by T test,P<0.05.This outcome can demonstrate that both treatment methods can improve the medical syndrome of FD patients.The difference of P<0.05 between the comparison of intragroup was statistically significant after 2 weeks by T test.However,there was no significant difference between the comparison of inter-group after two-week treatment by T test,P>0.05,which showed that there was no significant difference in the two groups after treatment of 2 weeks.The difference of P<0.05 between the comparison of inter-group was statistically significant after 4 weeks compared with 2 weeks by T test.It can be demonstrated that two therapies had the similar effects of treatment and no obvious differences in the short term.However,the outcomes of therapy in treatment group had more advantages in the long term.The mechanisms of Jiaogua Decoction was reasonable and effective.4 After treatment,both the threshold and full drinking volume in two groups were increased.However,there were no significant differences in the two groups,which showed that two treatments had the same effect on promoting gastrointestinal digestion.5 The safety parameters of two groups were in the normal range,and no adverse reactions were recorded in both groups.Conclusions Firstly,Jiaogua Decoction can effectively improve the TCM syndrome and clinical effect of Spleen deficiency and Qi stagnation type in patients with FD(PDS),which is better than Zhizhu Kuanzhong Jiaonang in the perspectives of greasy tongue,abdominal distention,early satiety,anorexia.The long-term effect of treatment was also satisfactory.Secondly,Jiaogua Decoction and Zhizhu Kuanzhong Jiaonang can promote stomach movement effectively.Finally,the adverse effects or renal and liver damage were also not observed evidently during the treating courses. |