The Clinical Efficacy Observation Of Huoxiang Zhengqi Capsules To Functional Dyspepsia

Objective:Evaluating the efficacy and safety of huoxiang zhengqi capsules in patients with functional dyspepsia (syndrome of accumulation of dampness in Middle-Jiao) and further exploring the traditional treatment of the functional dyspepsia.Methods:This test used randomized, double-blind, parallel controlled trial method. According to randomization number table,130 cases were divided into two groups, the experimental group and control group,65 cases in each group. Experimental group received huoxiang zhengqi capsules(0.45g) and placebo, control group received domperidone(10mg) and placebo for 4 weeks, three times a day. Before and after the treatment, the patients were tested in symptom scores, radiopaque markers, and 13C-octanoic acid breath test respectively. In addition, the security checks on patients were made before and after the treatment to learn the drug adverse reactions.Results:After four weeks of treatment, two cases fell off in experimental group and three cases fell off in control group. The reason of falling cases was that the patients were too busy to take medicine timely and cause a return visit, not the drug efficacy and adverse events. The effective number of cases in experimental group was 63 and in control group was 62.1. Comparison of symptom efficacy After treatment, the total efficiency of experimental group was 95.24%, and markedly effective rate was 49.21%; the total efficiency of control group was 83.87%, and markedly effective rate was 29.03%. The experimental group was significantly higher than the control group in symptom efficacy. (χ2=4.333, P=0.037)2. Comparison of symptom scores After four weeks treatment, the total symptom score improvement of the experimental group was better than the control group (P=0.003). The main symptom scores of bloating, early satiety, loss of appetite of the experimental group were significantly lower than the control group(P<0.05). But for sticky mouth/bad breath, no significant difference was between in the two groups (P=0.364).3. Radiopaque markers for gastric emptying Before treatment, two groups were no significant difference in gastric emptying (P>0.05). After treatment, in the experimental group,14 cases improved gastric emptying, accounting for 22.22% of the patients; in the control group,10 cases improved gastric emptying, accounting for 16.13% of the patients. In the improvement of five hours gastric emptying, the experimental group was significantly higher than the control group (P<0.05).4. 13C-octanoic acid breath test Before treatment, two groups were no significant difference in gastric emptying (P> 0.05). After treatment, the experimental group was significantly higher than the control group in the improvement of gastric emptying (P=0.043).Conclusions:Huoxiang zhengqi capsules could effectively relieve functional dyspepsia (syndrome of accumulation of dampness in Middle-Jiao) symptoms, increase gastrointestinal motility, and promote gastric emptying. It was safe and worthy for clinical application.