Abstract：Objective：To observe the clinical effect of Zhishi Xiaopi pills combined with trimebutine maleate for functional dyspepsia(FD) and its effect on gastrointestinal hormones in serum. Methods： A total of 88 cases of FD patients were randomly divided into the control group and the treatment group，44 cases in each group. The control group was treated with trimebutine maleate，and the treatment group was additionally treated with Zhishi Xiaopi pills based on the treatment of the control group. Before and after treatment， the positive rates of helicobacter pylori(Hp) and the changes in gastrointestinal hormones including 5- hydroxytryptamine(5- HT)， somatostatin(SS) and nitric oxide(NO) in serum in the two groups were observed and compared. The clinical effect in the two groups was counted. Results：The total effective rate was 90.9% in the treatment group and 65.9% in the control group，the difference being significant(P＜0.05). After treatment，the positive rates of Hp in the two groups were significantly decreased when compared with those before treatment(P＜0.05)，and the one in the treatment group was significantly lower than that in the control group(P＜0.05). After treatment，the 5-HT levels in serum in the two groups were increased when compared with those before treatment(P＜0.05)， and the levels of SS and NO in serum were decreased(P＜0.05)；the improvement of the above indexes in the treatment group was better than that in the control group(P＜0.05). Conclusion：The therapy of Zhishi Xiaopi pills combined with medicines that regulate gastric motility for FD has definite curative effect， and can significantly reduce positive rates of Hp and effectively improve levels of gastrointestinal hormones.