Abstract
Background:Functional dyspepsia (FD) is a highly prevalent functional gastrointestinal disorder which brings a significant impact on patients’ quality of life. Although there are many available treatments to alleviate dyspepsia symptoms, most of them are far from satisfactory. Traditional Chinese medicine (TCM) has shown good potential in the treatment of FD, especially in terms of improving symptoms and adverse effects of Western medicine. Qizhi Weitong granule (QZWTG), a TCM preparation, has been utilized in treating FD for a long time and has achieved good clinical results. However, the existing evidence of its efficacy and mechanism of action is insufficient. Hence, the purpose of this study is to evaluate the efficacy and safety of QZWTG in the treatment of FD.Methods:This study is a multicenter, randomized, double-blinded, double-placebo, positive drug parallel controlled clinical study. The experiment will be carried out in 8 hospitals at the same time, and a total of 384 cases of participants will be randomly assigned to the experimental group and the control group (n = 192). The experimental group will be given QZWTG and Mosapride citrate tablet placebo, and the control group will be given QZWTG placebo and Mosapride citrate tablet. After 4 weeks of intervention and 2 weeks of follow-up, the efficacy and safety of QZWTG in patients with FD will be observed. The primary outcomes are the change in the main symptom score. The secondary outcomes include TCM syndrome evaluation, the change of the Hamilton anxiety scale and the Hamilton depression scale, and advanced events. This study will explore the biological mechanism of QZWTG in the treatment of FD through the results of blood and urine metabolomics.Discussion:This trial will provide first-hand evidence on whether QZWTG is noninferior to Mosapride citrate tablet. There will be a new option for the treatment of FD if noninferiority is set up. In addition, the efficacy and safety of QZWTG in the treatment of FD will be evaluated, and the mechanism of QZWTG in the treatment of FD will be explored through the metabolomics of blood and urine. On the other hand, as far as we know, this study may be the largest trial of efficacy and safety of QZWTG in the treatment of FD, which has important application value.
Highlights
Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders,[1] which is characterized by a series of dyspepsia symptoms such as postprandial fullness, early satiation, epigastric pain, in the absence of structural explanation.[2]
In Rome IV, according to the difference of main symptoms, FD can be divided into 2 subgroups: postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), the 2 subgroups can overlap.[2]
Gastric motility disorder and sensorimotor abnormality are recognized as one of the main factors leading to FD, and prokinetics are recommended for the treatment of FD.[2,9]
Summary
Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders,[1] which is characterized by a series of dyspepsia symptoms such as postprandial fullness, early satiation, epigastric pain, in the absence of structural explanation.[2]. FD is considered to be caused by multiple factors, which may be related to abnormalities of gastric motility, gastric hypersensitivity, brain-gut interaction,[6] duodenal acid,[7] duodenal bile, duodenal barrier defect, and immune activation.[8] Gastric motility disorder and sensorimotor abnormality are recognized as one of the main factors leading to FD, and prokinetics are recommended for the treatment of FD.[2,9] a number of randomized controlled clinical studies have shown that the efficacy of prokinetic agents,[10,11,12] such as Cisapride, in patients with FD is significantly higher than that of placebo, which can significantly alleviate the symptoms of dyspepsia,[13] such as upper abdominal fullness,[14] but the clinical application of it is limited due to the side effects of heart.[15] In addition, existed treatment options may be effective for FD, but their therapeutic effect is far from satisfactory.
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