ABSTRACT
<p><b>Background</b>Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.</p><p><b>Methods</b>The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.</p><p><b>Results</b>(1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.</p><p><b>Conclusion</b>Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.</p><p><b>Trial Registration</b>https://clinicaltrials.gov/, NCT02460601.</p>
ABSTRACT
This article was aimed to study the synergy effect of effective substances group and mechanisms of Qi-Zhi Wei-Tong (QZWT) Granules in promoting gastrointestinal dynamic effect in order to explore its mechanism. Rats were divided into 16 groups. Different component compatibility was given to promote the gastrointestinal dynamic ef-fect. The traditional semi-solid paste carbon propelling analysis method was used to observe gastrointestinal motility changes of rats after medication. After intragastric administration, changes of NO, cGMP and Ca2+content in gastroin-testinal tissues were observed. The results showed that fructus aurantii flavonoids and Cyperi flavonoids had the most prominent effect in promoting gastrointestinal motility in QZWT Granules (P< 0.01), which were followed by Cyperus oil and limonene (P< 0.05). Two-way interactions indicated that the combination of fructus aurantii flavonoids and limonene had prominently promoting action in gastrointestinal motility, which was followed by the combination of fructus aurantii flavonoids and Cyperus oil, Cyperi flavonoids and Cyperus oil, limonene and Cyperus oil. Each effec-tive component can reduce the NO and cGMP content in gastrointestinal tissues, and increase the Ca2+ content. It was concluded that the study defined the correlation and synergy between effective components and promoting effect of gastrointestinal motility. Mechanism of the effective component to promote gastrointestinal dynamic might be relat-ed to the reducing of NO and cGMP content in gastrointestinal tissues and increasing of Ca2+ content. This study also provided a theoretical basis for further research on quality control, compatibility and spectrum-effect correlation of gastrointestinal motility promotion medications.