DA‐9701 improves colonic transit time and symptoms in patients with functional constipation: A prospective study

Kim, Su Young; Woo, Hyun Sun; Kim, Kyoung Oh; Choi, Sung Han; Kwon, Kwang An; Chung, Jun‐Won; Kim, Yoon Jae; Kim, Jung Ho; Park, Dong Kyun

doi:10.1111/jgh.13807

Cited by 11 publications

(10 citation statements)

References 51 publications

(153 reference statements)

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“…Fourth, the outcome measures were patients’ and clinicians’ scales; thus, there was a lack of objective measure of GI motility in this trial. However, previous studies demonstrated a significant gastrokinetic effect of DA‐9701 with dynamic magnetic resonance imaging, 22,24 thereby supporting the results of the present study. One previous study reported that DA‐9701 enhances colonic transit time in patients with functional constipation 23 .…”

Section: Discussionsupporting

confidence: 91%

“…However, in animal studies with 50 to 100 times higher doses of DA‐9701 than a therapeutic oral dose (which is a similarly high dose for humans), the maximum concentrations of the 2 constituents in the brain were much lower than the half‐maximal inhibitory concentration values for D 2 ‐receptor antagonism by both of them 56 . This means that DA‐9701 with a therapeutic dose hardly has central antidopaminergic activity and it does not significantly induce hyperprolactinemia in humans as consistently reported by several independent studies 5,21,24 . This trial was focused on GI symptoms and GI health‐related QoL in patients with PD, and most participants had stable parkinsonian motor features without fluctuation.…”

Section: Discussionmentioning

confidence: 94%

“…A dynamic magnetic resonance imaging study revealed that DA‐9701 enhances gastric emptying in healthy elderly populations 23 . In people with chronic constipation, DA‐9701 improved colonic motility revealed by colon transit time 24 . A recent small‐scale, head‐to‐head trial has shown noninferior efficacy of DA‐9701 over domperidone on gastric dysmotility symptoms in patients with PD 25 .…”

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confidence: 99%

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Double‐Blind, Randomized, Placebo‐Controlled Trial of DA‐9701 in Parkinson's Disease: PASS‐GI Study

et al. 2020

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A BS TRACT: Objectives: This study aimed to assess the efficacy of DA-9701 on gastrointestinal symptomrelated quality of life in patients with Parkinson's disease on stable dopaminergic medications. Methods: This multicenter, double-blind, placebo-controlled, phase 4 trial included a total of 144 patients with Parkinson's disease with gastrointestinal dysfunctions based on predefined criteria. Participants were randomized to take either DA-9701 or placebo for 4 weeks, and then both groups were administered DA-9701 for an additional 8 weeks while antiparkinsonian medications were unchanged. The primary outcome measure was gastrointestinal symptoms and related quality-of-life changes assessed on the Korean Nepean dyspepsia index after 4 and 12 weeks of therapy. We also evaluated the impact of DA-9701 therapy on parkinsonian motor symptoms at each time point. Results: The gastrointestinal symptom-related quality-oflife score significantly improved in the DA-9701-treated group compared with the placebo-treated group after 4weeks (adjusted P = 0.012 by linear mixed effect model analysis). The overall gastrointestinal symptom and dyspepsia sum scores improved at 12 weeks after intervention in the DA-9701-first treated group (adjusted P = 0.002 and 0.014, respectively) and also in the placebo-first treated group (adjusted P = 0.019 and 0.039) compared with the baseline. Parkinsonian motor severity was not significantly affected by DA-9701 treatment in both groups at 4 and 12 weeks after intervention. There were no drugrelated serious adverse events throughout the trial. Conclusions: DA-9701 therapy improved gastrointestinal symptom-related quality of life, and 12 weeks of daily administration can relieve the overall severity of gastrointestinal symptoms in patients with Parkinson's disease without affecting motor symptoms.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 94%

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confidence: 99%

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Double‐Blind, Randomized, Placebo‐Controlled Trial of DA‐9701 in Parkinson's Disease: PASS‐GI Study

et al. 2020

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“…for 24 days was associated with a significantly reduced colonic transit time (CTT) ( p = 0.001) and decreased segmental CTT ( p < 0.001). In addition, all constipation-related subjective symptoms, including spontaneous bowel movement frequency, significantly improved compared to those before treatment, without any serious adverse effects [99].…”

Section: Clinical Studies Of Da-9701mentioning

confidence: 99%

DA-9701 (Motilitone): A Multi-Targeting Botanical Drug for the Treatment of Functional Dyspepsia

Jin

Son

2018

IJMS

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Functional dyspepsia (FD) is the most common functional gastrointestinal disorder (FGID). FD is characterized by bothersome symptoms such as postprandial fullness, early satiety, and epigastric pain or burning sensations in the upper abdomen. The complexity and heterogeneity of FD pathophysiology, which involves multiple mechanisms, make both treatment and new drug development for FD difficult. Current medicines for FD targeting a single pathway have failed to show satisfactory efficacy and safety. On the other hand, multicomponent herbal medicines that act on multiple targets may be a promising alternative treatment for FD. DA-9701 (Motilitone), a botanical drug consisting of Corydalis Tuber and Pharbitidis Semen, has been prescribed for FD since it was launched in Korea in 2011. It has multiple mechanisms of action such as prokinetic effects, fundus relaxation, and visceral analgesia, which are mediated by dopamine D2 and several serotonin receptors involved in gastrointestinal (GI) functions. In clinical studies, DA-9701 has been found to be beneficial for improvement of FD symptoms and GI functions in FD patients, while showing better safety compared to that associated with conventional medicines. In this review, we provide updated information on the pharmacological effects, safety, and clinical results of DA-9701 for the treatment of FGIDs.

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“…DA-9701 has an affinity for the 5-HT 4 receptor, and some animal studies have showed it increases colonic motility (122,129). A prospective and single-center study investigated the efficacy of DA-9701 in 27 patients with functional constipation by Rome III criteria (135). After administration of 30 mg DA-9701 three times a day for 24 days, spontaneous bowel movement, stool form, and constipation-related subjective symptoms were improved.…”

Section: Constipationmentioning

confidence: 99%

Herbal Therapies in Functional Gastrointestinal Disorders: A Narrative Review and Clinical Implication

Kim

Na-yeon

et al. 2020

Front. Psychiatry

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The pathophysiology of functional gastrointestinal disorders (FGIDs) is still unclear and various complex mechanisms have been suggested to be involved. In many cases, improvement of symptoms and quality of life (QoL) in patients with FGIDs is difficult to achieve with the single-targeted treatments alone and clinical application of these treatments can be challenging owing to the side effects. Herbal preparations as complementary and alternative medicine can control multiple treatment targets of FGIDs simultaneously and relatively safely. To date, many herbal ingredients and combination preparations have been proposed across different countries and together with a variety of traditional medicine. Among the herbal therapies that are comparatively considered to have an evidence base are iberogast (STW-5) and peppermint oil, which have been mainly studied and used in Europe, and rikkunshito and motilitone (DA-9701), which are extracted from natural substances in traditional medicine, are the focus of this review. These herbal medications have multi-target pharmacology similar to the etiology of FGIDs, such as altered intestinal sensory and motor function, inflammation, neurohormonal abnormality, and have displayed comparable efficacy and safety in controlled trials. To achieve the treatment goal of refractory FGIDs, extensive and high quality studies on the pharmacological mechanisms and clinical effects of these herbal medications as well as efforts to develop new promising herbal compounds are required.

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DA‐9701 improves colonic transit time and symptoms in patients with functional constipation: A prospective study

Abstract: DA-9701 accelerates colonic transit and safely improves symptoms in patients with functional constipation. Therefore, we suggest that this novel agent could help to treat patients with this condition.

Cited by 11 publications

References 51 publications

Double‐Blind, Randomized, Placebo‐Controlled Trial of DA‐9701 in Parkinson's Disease: PASS‐GI Study

Double‐Blind, Randomized, Placebo‐Controlled Trial of DA‐9701 in Parkinson's Disease: PASS‐GI Study

DA-9701 (Motilitone): A Multi-Targeting Botanical Drug for the Treatment of Functional Dyspepsia

Herbal Therapies in Functional Gastrointestinal Disorders: A Narrative Review and Clinical Implication

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