Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia Postprandial Distress Syndrome: Study Protocol For a Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Clinical Trial

Background: Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Based on the various symptoms present in patients with functional dyspepsia-postprandial distress syndrome (FD-PDS), routine agents such as acid suppressants, prokinetic drugs, and centrally acting drugs, offer limited treatment choice with potential side effects. As preliminary clinical trial showed that the marketed product Zhizhu Kuanzhong Capsule (ZZKZ) can improve symptoms in FD-PDS patients, our study aims to provide further evidence on the clinical efficacy and safety of ZZKZ in the treatment of patients with FD-PDS. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial, we recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial enrolls patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients are randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint is measured by self-rated Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early satiation, recorded once a day and 7 days a week. The primary analysis aims to compare the response rate for FD-PDS VAS score between the groups before and after 8 weeks of treatment with an alpha level of 0.05 (2-sided).Discussion: This trial aims to strengthen the evidence for the efficacy and safety of ZZKZ, a marketed product, in treating FD-PDS. Compared to previous clinical trial targeted FD-PDS, this trial has 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group.Trial registration: This study is registered with ClinicalTrials.gov on 28 January 2019, number NCT03825692.

Effect of a Persian metabolic diet on the functional dyspepsia symptoms in patients with postprandial distress syndrome: a randomized, double-blind clinical trial

Objectives Postprandial distress syndrome (PDS) is associated with food indigestion. Efficacy of drugs used against PDS is limited whereas dietary modifications were shown to have important beneficial effects. Traditional Persian Medicine (TPM) sages suggested a dietary regimen known as Persian metabolic diet (PMD) for the management of PDS patients. In this study, the efficacy of PMD in alleviating the symptoms of PDS was explored. Methods This single-center, parallel-group, randomized clinical trial included 56 patients whom were randomly allocated to PMD group (29 participants) and Optional diet (OD) group (27 participants). They were instructed to follow the protocol for two weeks. Using a standard validated questionnaire, all outcomes were evaluated at baseline, end of the intervention period, and end of follow-up time. Results At the end of the intervention period, comparing the changes of severity scores between the groups showed a statistically significant difference in week 2 (p-value<0.001) and week 8 (p-value<0.001) follow-up comparing to the baseline. Similarly, at the end of the follow-up period, epigastric fullness, epigastric discomfort, and bloating were significantly improved in the PMD group (p<0.001). Conclusions This diet prepared based on Persian medicine seems to be effective in relieving the symptoms of patients with PDS.

Modern aspects of the pathogenesis and treatment of dyspepsia

A review of current data suggests that the attention to the problem of dyspepsia is huge. The definition of functional dyspepsia was given in the Rome IV criteria, according to which two of its main options are distinguished – epigastric pain syndrome and postprandial distress syndrome. The term “uninvestigated dyspepsia” is important, which means the presence of dyspepsia symptoms in patients who have not performed diagnostic procedures to identify the organic causes of the pathology. The prevalence of uninvestigated dyspepsia in the world is about 21%. The prevalence of functional dyspepsia is significantly lower than the prevalence of uninvestigated dyspepsia and fluctuates around 10%. The risk factors for dyspepsia are usually tobacco smoking, non-steroidal anti-inflammatory drugs and/or aspirin, and Helicobacter pylori infection. The concept of the pathogenesis of functional dyspepsia undergoes significant changes. By analogy with the pathophysiology of irritable bowel syndrome, lesions of the relationship between the modulation of the cerebral cortex and the signal system of the gastroduodenal zone, the association of sluggish immune inflammation in the duodenum with motility and sensory activity of the stomach are most actively studied. The treatment of functional dyspepsia is a complex problem and changes after new ideas about its pathogenesis. Modern meta-analyzes have made it possible to expand the indications for the proton pump inhibitors administration, which can be actively used not only for the treatment of epigastric pain syndrome, but also for postprandial distress syndrome. Along with the required Helicobacter pylori eradication, there are reasons for the use of probiotics and antibiotics for the dyspepsia treatment.

Features of manifestations of functional dyspepsia in medical students of different years of study

Objective of the study: to clarify the influence of external factors on the symptoms of functional dyspepsia in medical students.Materials and methods: A survey of 105 students aged 20.2 ± 0.18 years was conducted. The survey was conducted on a special gastroenterological questionnaire GSRS. Also in the questionnaire we added questions that characterize postprandial distress syndrome. An additional questionnaire was conducted on issues that allow us to assess the influence of external factors on the functional dyspepsia of students (nutrition, bad habits, constitutional features).Results: During the study revealed: the intensity of manifestations of functional dyspepsia from 1 to 6 courses is reduced. Bad habits like smoking, eating at bedtime, using chewing gum, eating with alcohol have a negative effect on the digestive system, which can be a risk factor for developing functional dyspepsia. A correlation was also found between clinical syndromes: epigastric pain syndrome and reflux syndrome (r = 0.4), diarrhea syndrome (0.37), dyspeptic syndrome (0.5), constipation syndrome (0.37); postprandial distress syndrome and reflux syndrome (0.42), diarrhea syndrome (0.39), dyspeptic syndrome (0.83), constipation syndrome (0.39).Conclusions: The intensity of most manifestations of functional dyspepsia during the transition to older courses decreases, however, 4-year students are more susceptible to postprandial distress syndrome, which can be associated with adverse factors such as smoking, eating food at bedtime, using chewing gum, eating with alcohol.