Abstract

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.

Highlights

  • The Rome II categorization lacked reliability, which was attributable to overlapping symptoms of various functional gastrointestinal disorder (FGID) such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), postprandial distress syndrome (PDS), and epigastric pain syndrome (EPS)

  • The Rome III committee subdivided functional dyspepsia (FD) into two distinct syndromes: PDS characterized by postprandial fullness and early satiety, and EPS accompanied by epigastric pain or burning [9,10]

  • We provide updated information related to the multi-acting pharmacological effects, safety, and clinical data of DA-9701 and propose further research on it

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Summary

Functional Dyspepsia

Functional gastrointestinal disorders (FGIDs) are the most common functional gastroenterologic abnormalities associated with physiological and morphological disturbances, and are often accompanied by conditions including motility dysfunction, visceral hypersensitivity, altered mucosal and immune functions, altered gut microbiota, and altered central nervous system processing [1,2,3]. The Rome II categorization lacked reliability, which was attributable to overlapping symptoms of various FGIDs such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), postprandial distress syndrome (PDS), and epigastric pain syndrome (EPS). The Rome IV consensus published in 2016 emphasized that FD should not be considered a single disorder It retained the subclassification of FD into PDS and EPS but strengthened the notion that these symptoms are separate entities that could overlap; it emphasized that the symptoms should be severe enough to be bothersome (i.e., a discomfort score of at least 2 on a scale of 1 to 5 in daily life) and occur more frequently than that in the normal population. Helicobacter pylori-associated dyspepsia is classified separately from true FD in the Rome IV criteria; affected patients are defined as a subset of those with FD-like symptoms and H. pylori infection, with symptom resolution 1 year after successful eradication of H. pylori [11,15]

Pathophysiology of FD and Current Treatments
Herbal Composition
Results
Effects of DA-9701 on GI Motility
Effects of DA-9701 on Fundic Relaxation
Effects of DA-9701 on Visceral Hypersensitivity
Safety of DA-9701
Clinical Studies of DA-9701
Conclusion and Future Prospects
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