The effect of rikkunshito on gastrointestinal symptoms and gastric motor function: The first study in a Belgian functional dyspepsia population

Abstract

Background: Rikkunshito, a traditional Kampo medicine, has shown efficacy to treat functional dyspepsia (FD) in controlled trials in Japan. Its putative benefit for European patients and mechanism of action has not been established.Methods: This study examined the effect of rikkunshito on gastric motility and GI symptom perception in FD-PDS patients in a randomized, placebo-controlled, crossover study. After a 2-week run-in period, patients received rikkunshito or matching placebo (2.5 g t.i.d.) for 4 weeks, separated by a 4-week washout period. Symptoms were assessed by the Leuven Postprandial Distress Scale (LPDS) diary throughout the study. At baseline and after both treatment arms, intragastric pressure (IGP) was measured to evaluate gastric accommodation and gastric motility. Simultaneously, GI symptoms were scored on a 100 mm visual analogue scale. Validated symptom questionnaires (PAGI-SYM, VSI, DSS, and PHQ) were completed each study visit.Key Results: Twenty-three patients completed the study (33 ± 14 years, 22.7 ± 3.22 kg/m 2 ). Intragastric pressure was numerically, but not significantly, lower after rikkunshito compared with baseline and placebo (P = .14). No differences were found in gastric accommodation, nutrient volume tolerance, and symptoms assessed during IGP measurements. Early satiation and postprandial fullness (daily diary) decreased after rikkunshito compared with baseline (P < .041 for both). Placebo also improved most other symptoms assessed. No significant changes in VSI scores occurred. No adverse reactions occurred. Conclusions:Rikkunshito did not alter gastric motility. Treatment with rikkunshito improved upper GI symptoms in FD patients but similarly high placebo effects were observed using the LPDS diary, PAGI-SYM, SF-NDI, and DSS scores. Rikkunshito was safe and well-tolerated. K E Y W O R D Sfunctional dyspepsia, gastrointestinal symptoms, intragastric pressure, rikkunshito 2 of 11 | MASUY et Al. | INTRODUC TI ONFunctional dyspepsia (FD) is, with its prevalence of 5%-20% worldwide, one of the most common functional gastrointestinal disorders for which patients seek medical care. 1 FD is defined as the presence of recurrent or chronic symptoms thought to originate from the gastroduodenal region, in the absence of any structural abnormalities found during routine diagnostic procedures. According to the Rome III criteria, FD can be subdivided into two subgroups based on the most prominent symptoms. One subgroup is referred to as postprandial distress syndrome (PDS), characterized by meal-related symptoms. Cardinal PDS symptoms are postprandial fullness and early satiation. The second subgroup is the epigastric pain syndrome (EPS) subgroup, defined by meal-unrelated symptoms, including epigastric pain and epigastric burning. 2,3 The recently renewed Rome IV criteria decreased the overlap between both subgroups by considering epigastric pain manifesting after meal intake as belonging to PDS. 2,4Although the underlying pathophysiology of FD remains unclear, different pathophysiological...

Impact of joint hypermobility syndrome on gastric accommodation and nutrient tolerance in functional dyspepsia

“…Afterward, a second nasogastric feeding tube (Entral™, Maxtercatheters, Marseille, France) was inserted and positioned in the proximal stomach just below the LOS (not more than 5 cm below the LOS). [25][26][27][28][29][30][31][32][33][34] The position of both probes was confirmed by fluoroscopy. To ease intubation, Xylocaine ® 10% local anesthetic spray (NV AstraZeneca SA, Brussels, Belgium) and Endogel (TELIC, SA, Bigues, Spain) were applied.…”

“…For accurate data acquisition, the HRM probe was positioned in the fundus, corpus, and antrum following the larger curvature of the stomach. [25][26][27][28][29][30][31][32][33][34] The advancement of the tip of the probe into the duodenum is preferred but not essential for the assessment of fundus motility. Moreover, at least one sensor was placed at the level of the esophagus and at least once sensor at the level of the site of the lower esophageal sphincter (LOS).…”

Rikkunshito as a Therapeautic Agent for Functional Dyspepsia and its Prokinetic and Non-Prokinetic Effects

“…Shiratori et al used a barostat for measuring the volume of the stomach before and after the administration of rikkunshito in nine healthy volunteers and reported that the volume of the stomach increased significantly after the administration, with improvement in perceived stress ( Shiratori et al, 2011 ). Mausy et al examined the effect of rikkunshito on intra-gastric pressure with high-resolution manometry before and after treatment with rikkunshito; however, rikkunshito did not alter gastric motility ( Masuy et al, 2020 ). These differences might be caused by the characteristics of each modality.…”

“…Rikkunshito did not alter gastric motility. Treatment with rikkunshito improved upper gastrointestinal symptoms in FD patients, but similarly, high placebo effects were observed ( Masuy et al, 2020 ). A meta-analysis has reported that the combination of Western medication and rikkunshito was more helpful than the use of Western medication alone ( Ko et al, 2020 ).…”

Herbal medicines in functional dyspepsia—Untapped opportunities not without risks

“…No adverse reaction for RKT was recorded in both studies. In recent years, there are six RKT RCTs for FD with close to 1000 FD patients involved 54–59 . One Japanese study reported that RKT significantly improved epigastric pain ( p = 0.04), especially in H. pylori ‐infected patients (RKT 40.0% vs. placebo: 20.5%, p = 0.07), and seemed less effective among H. pylori ‐uninfected participants 55 (RKT: 29.3% vs. placebo: 25.6%, p = 0.72), while another Japanese RCT showed non‐consumption of alcohol was associated with the efficacy of RKT especially among H. pylori ‐infected participants 56 .…”