Rikkunshito simultaneously improves dyspepsia correlated with anxiety in patients with functional dyspepsia: A randomized clinical trial (the <scp>DREAM</scp> study)

Tominaga, Kazunari; Sakata, Yasuhisa; Kusunoki, Hiroaki; Odaka, Takeo; Sakurai, Katsunobu; Kawamura, Osamu; Nagahara, Akihito; Takeuchi, Toshihisa; Fujikawa, Yoshiko; Oshima, Tadayuki; Kato, Mototsugu; Furuta, Takahisa; Murakami, Kazunari; Chiba, Tetsuhiro; Miwa, Hiroto; Kinoshita, Yoshikazu; Higuchi, Kazuhide; Kusano, Motoyasu; Iwakiri, Ryuichi; Fujimoto, Kazuma; Tack, Jan; Arakawa, Tetsuo

doi:10.1111/nmo.13319

Cited by 68 publications

(76 citation statements)

References 36 publications

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“…These results are in line with a previous study by Tominaga et al, 25 showing beneficial effects of rikkunshito on PDS symptoms. These results are in line with a previous study by Tominaga et al, 25 showing beneficial effects of rikkunshito on PDS symptoms.…”

Section: Discussionsupporting

confidence: 93%

“…Interestingly, these symptoms, scored on the LPDS diary, were only improved after rikkunshito treatment compared with the run-in phase of the study. These results are in line with a previous study by Tominaga et al, 25 showing beneficial effects of rikkunshito on PDS symptoms. However, for several symptoms assessed with other questionnaires in the current study, significant improvements from run-in were found for both rikkunshito and placebo, or for placebo alone.…”

Section: Discussionsupporting

confidence: 93%

“…However, for several symptoms assessed with other questionnaires in the current study, significant improvements from run-in were found for both rikkunshito and placebo, or for placebo alone. 24,25 These results imply that a 4-week treatment period with rikkunshito may be suboptimal for obtaining significant symptom improvement. These results reflect the small sample size of the current study and also confirm the presence of an important placebo effect in this study population.…”

Section: Discussionmentioning

confidence: 97%

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

Masuy

Carbone²,

Holvoet³

et al. 2019

Neurogastroenterology Motil

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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...

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 97%

See 1 more Smart Citation

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

Masuy

Carbone²,

Holvoet³

et al. 2019

Neurogastroenterology Motil

Self Cite

View full text Add to dashboard Cite

show abstract

“…The studies published between 1991 and 2019 were included. Patients had FD, [15][16][17][18][19][20][21][22]13,14,[23][24][25][26][27][28][29][30][31][32] and constipation [56][57][58][59][60][61][62] in 19, 23 and 7 trials respectively. More than 33 different kinds of herbal formulae were tested in the included trials.…”

Section: Resultsmentioning

confidence: 99%

Herbal medicine in the treatment of functional gastrointestinal disorders: A systematic review with meta‐analysis

Tan

Gwee

Tack

et al. 2019

J of Gastro and Hepatol

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Background and Aims The efficacy of herbal medicines (HMs) for functional gastrointestinal disorders (FGIDs) including irritable bowel syndrome (IBS), functional dyspepsia (FD) and functional constipation (FC) is controversial. A systematic review with meta‐analysis was conducted to determine their effectiveness for FGIDs. Methods We searched the following electronic databases till July 2019 with English language restriction: The Cochrane Library, EMBASE and PUBMED. Randomized double‐blind controlled trials of HMs compared with placebo or conventional pharmacological drugs for adult FGIDs patients were included. Results In total, 49 trials involving 7396 participants with FGIDs were included. The risk of bias was low in 9, unclear in 36, and high in 4 trials. More than 33 different herbal formulae were tested. HMs demonstrated statistically significant benefits for symptom improvement compared with placebo in 46 trials (RR = 1.67, 95% CI 1.48–1.88). When compared with conventional pharmacological therapy in 5 trials, HMs were found to be non‐inferior (RR = 1.10, 95% CI 1.03–1.18). The number of trials with regards to FD, IBS and FC were 19, 23 and 7 respectively. Subgroup analysis found that HMs were better than placebo in alleviating symptoms for FD (RR = 1.50, 95% CI 1.32–1.69), IBS (RR = 1.62, 95% CI 1.32–1.97) and FC (RR = 3.83, 95% CI 2.26–6.50). HMs tended to have more patients with adverse events than placebo, but similar to conventional pharmacological drugs. Conclusions Our findings provide a positive signal for HMs as a potentially well‐tolerated and effective treatment for FGIDs, deserving further examination in high‐quality trials.

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“…26,50 On the other hand, there are limited reports on the use of the modified FSSG in placebo-controlled double-blind controlled trials in patients with FD, 51 and further verification is necessary. In addition, many doctors use the revised FSSG to diagnose FD and evaluate the effects of FD treatment in daily medical care.…”

Section: Modified Fssg Scores After Treatment Amentioning

confidence: 99%

Effects of acotiamide on functional dyspepsia patients with heartburn who failed proton pump inhibitor treatment in Japanese patients: A randomized, double‐blind, placebo‐controlled crossover study

Funaki

Ogasawara

Kawamura

et al. 2019

Neurogastroenterology Motil

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Background: Functional dyspepsia (FD) and non-erosive reflux disease (NERD) are gastrointestinal disorders that often overlap. In this randomized, double-blind, placebo-controlled crossover study, the effects of adding acotiamide to treatment with proton pump inhibitors (PPI) were investigated in FD patients with heartburn who failed PPI treatment, corresponding to PPI-resistant NERD. Methods:The subjects included 16 FD patients with heartburn who failed PPI treatment, and they were administered acotiamide or a placebo for 28 days. After suspending medication for 28 days, the trial drug and placebo were crossed over and administered for 28 days. Before the study began and after each administration period, high-resolution impedance manometry (HRiM) was performed, and the modified frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) questionnaire was administered.Key Results: Postprandial fullness in the FD assessment and all modified FSSG items were significantly lower in the acotiamide group than in the placebo group.Esophagogastric junction pressure was significantly higher in the acotiamide group.The distal contractile integral (DCI) pressure and the highest DCI pressure both increased significantly in the acotiamide group. Moreover, in the acotiamide group, the frequency of abnormal primary peristalsis decreased to normal levels; complete bolus transit (CBT), an indicator of esophageal clearance, increased; and CBT time decreased. Conclusions & Inferences:Acotiamide was considered to improve upper gastrointestinal functions not only in the stomach but also in the esophagus. Adding acotiamide to PPI therapy appears to improve upper abdominal symptoms in FD patients with heartburn who failed PPI treatment.

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Rikkunshito simultaneously improves dyspepsia correlated with anxiety in patients with functional dyspepsia: A randomized clinical trial (the DREAM study)

Abstract: Rikkunshito may be beneficial for FD patients to simultaneously treat gastrointestinal and psychological symptoms.

Cited by 68 publications

References 36 publications

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

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

Herbal medicine in the treatment of functional gastrointestinal disorders: A systematic review with meta‐analysis

Effects of acotiamide on functional dyspepsia patients with heartburn who failed proton pump inhibitor treatment in Japanese patients: A randomized, double‐blind, placebo‐controlled crossover study

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