The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia

Summary

* (Cause of cholelithiasis) Recently, the average age has increased, and the occurrence of gallstones has increased as the dietary life has been westernized due to the improvement of socio-economic level. When cholesterol increases, the occurrence of gallstones increases. Factors include high-calorie high-fat diet, increasing age, women, pregnant women, obesity, and oral contraceptives. There are cases. As another cause, gallstones occur well even when bile stasis occurs due to a decrease in motility of the gallbladder. These are conditions that lower mobility. And cholelithiasis has a genetic tendency in about 30%. In addition, since the eating habits of the family are similar, the genetic factors and the eating habits overlap, which often leads to the occurrence of cholelithiasis in the family.
* (symptoms of cholelithiasis) In most cases, complaints of non-specific digestive system symptoms, such as abdominal bloating, nausea, and especially indigestion after fatty diet, are often observed. According to domestic reports, the nonspecific symptoms complained by patients with cholelithiasis were indigestion, flatulence, frequent belching, nausea, loss of appetite, diarrhea, and vomiting. In general, many healthy people without gallstones complain of non-specific digestive system symptoms in 50% of cases, and there is a possibility that functional gastrointestinal diseases such as dyspepsia, peptic ulcer, and gastritis may be accompanied by these digestive system symptoms. It is difficult to know whether it is unrelated to gallstones. Symptoms caused by typical cholelithiasis usually have a characteristic that they often improve on their own after a few hours, and the start and end of the symptoms are relatively clear and repeatedly occur. In addition, various symptoms are displayed depending on the presence or absence of inflammation and progression.
* (Principle of treatment of cholelithiasis)

1. Medical treatment: Medical treatment of gallstones is a method of dissolving using drugs to treat cholesterol gallstones in gallbladder stones. In 1973, Nakano et al. \[1\] published the first example of dissolving cholesterol gallstones using ursodeoxycholic acid (UDCA). Currently, UDCA is the only drug administered to patients with asymptomatic or mild symptoms of cholelithiasis in actual clinical practice, and there is no specific prescription drug.
2. Surgical treatment: In the case of indications of cholecystectomy, acute cholecystitis, severe symptoms, chronic cholecystitis with severe thickening of the gallbladder wall, repeated and severe symptoms, porcelain gallbladder, Patients with gallstones of 3 cm or more in size, patients with anomalous pancreato-biliary duct unions, or gallbladder polyps.
* (Study on increasing gallbladder contractility) So far, there have been studies that some drugs increase or decrease gallbladder contractility. Catnach SM et al. \[2\] reported that erythromycin increased gallbladder contractility in patients with autonomic neuropathy due to diabetes. Sengupta S et al. \[3\] reported that indoramin (α-adrenergic antagonist), a prokinetic agent, increased gallbladder contractility in patients with cholelithiasis, resulting in a significant decrease in gallbladder volume.

Motilitone® developed in Korea is a gastrointestinal motility stimulator that stimulates 5-HT4 receptors to increase acetylcholine secretion and has a mechanism of contracting smooth muscles, improving symptoms in patients with functional dyspepsia in cholelithiasis It is expected to be able to give, and it is thought to have the effect of preventing the crystallization of bile acids due to an increase in the gallbladder contractility, thereby preventing the formation of gallstones and preventing newly generated gallstones.

To date, there are no special drugs for dyspepsia or pain improvement in patients with cholelithiasis. It is hypothesized that administration of motilitone® will increase the contractile capacity of the gallbladder, thereby improving digestion and preventing further formation of gallstones. As a control group, Gasmotin® was administered to improve functional dyspepsia, and the degree of symptom improvement was measured and compared by completing the Symptom Score Questionnaire for Indigestion between the two groups.

Conditions

• Gallstone

Interventions

DRUG

Motilitone

1. Ingredients and content: corydalis tuber, pharbitis seed 50% EtOH extracts 30mg 2. Dosage method: Usually, adults take 1 tablet 3 times a day orally before meals. 3. Pharmacological action: * It stimulates 5-HT4 receptor as a gastrointestinal motility accelerator to increase acetylcholine secretion and contract smooth muscle. * Stimulates stomach smooth muscle contraction by suppressing the effect of dopamine on acetylcholine secretion by inhibiting D2 receptor ③ It shows a pharmacological action that stimulates gastrointestinal movement by acting in combination with 5-HT1A / B receptor.

DRUG

Gasmotin

1. Ingredient and content: mosapride citrate dihydrate 5.29mg (5mg as active ingredient) 2. Dosage method: Usually, an adult is orally administered 1 tablet 3 times a day before meals. 3. Pharmacological action: mosapride is a selective serotonin-4 (5-HT4) receptor agonist with gastrointestinal stimulating activity, contracting smooth muscle

Sponsors & Collaborators

• Yonsei University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

19 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-25

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• South Korea

Study Locations