Houpu Paiqi mixture in treatment of functional dyspepsia: a multicenter randomized controlled study

Objective To evaluate the efficacy and safety of Houpu Paiqi mixture in treatment of functional dyspepsia (FD) with abdominal distension symptom. Methods From July 2014 to June 2015, in nine centers, a total of 162 FD patients with abdominal distension symptom and met Rome Ⅲ postprandial distress syndrome (PDS) diagnostic criteria were enrolled. All patients were randomly divided into trial group and control group, 81 patients in either group. The patients of trial group and control group took Houpu Paiqi mixture or placebo, respectively, 25 mL per time, twice daily, and both the courses of treatment were two weeks. Before and after the treatment, the improvement of main symptoms, total clinical efficacy rate and efficacy of traditional medicine between two groups were compared. Chi square test, Fisher exact probability method and Wilcoxon test were performed for statistical analysis. Results According to the results of per-protocol (PP) analysis, the total efficacy rate of trial group and control group was 69.4% (50/72) and 59.2% (42/71), respectively, and there was no statistically significant difference in total efficacy rate between the two groups (χ2=1.650, P=0.199). And there was no statistically significant difference in the improvement of PDS main symptoms (postprandial fullnessand early satiety) between the two groups (56.3%±27.9% vs 54.4%±32.1%, t=0.606, P=0.727). For those with baseline symptom score over 14, median early satiety score of trial group after the treatment was 0, which was lower than that of control group, and the difference was statistically significant (Z=-2.370, P=0.018). The total efficacy rate of traditional medicine of trial group was 80.8% (59/73) and that of control group was 72.0% (54/75), and the difference was not statistically significant (χ2= 0.676, P=0.411). Conclusion Houpu Paiqi mixture has certain efficacy in FD with abdominal distension, and could be used for the treatment of PDS-predominant FD. Key words: Houpu Paiqi mixture; Functional dyspepsia; Placebos; Control; Clinical trial