The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia
The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia
-  (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.
At Severance Hospital, patients with cholelithiasis with symptoms of indigestion are divided
 into the Motilitone® and Gasmotin® groups. Provide sufficient oral and written explanation of
 the clinical trial and obtain consent from the patient who has revealed his willingness to
 participate. Randomization uses random numbers, and patient assignment by random numbers is
 managed by a third party who does not have direct contact with the patient or clinical
 history, and after obtaining consent, the group according to the random number is given and
 medication is given. It is provided to. Each drug is prescribed for 6 months. The symptom
 score check should be completed at the first outpatient visit(3 months after administration).
 We will Check the following items through abdominal ultrasound examination 6 months after
 administration.

 : Gallbladder wall thickening presence and extent, number of gallstones, maximum diameter of
 gallstones, presence or absence of sludge. The general blood test (CBD) and general chemical
 test (SMA) are conducted three times at the first outpatient visit(3 months after
 administration), and the research expenses for 3 months and 6 months are supported by the
 research fund. In the final analysis, we compare the symptom scores between the two groups
 through the Student T-test, and compare the blood test and ultrasound using the Chi-square
 test. We want to confirm the following three things through this study. ① In patients with
 cholelithiasis with symptoms of dyspepsia, prospective data on the degree of symptom
 improvement following motilitone administration can be obtained. ② It is possible to evaluate
 the degree of relief or exacerbation of gallstones through ultrasound examination. ③ It is
 expected that it will be effective in improving symptoms and alleviating cholelithiasis in
 patients with dyspeptic cholelithiasis due to increased gallbladder contractility of
 motilitone.
Inclusion Criteria:

 1. 19 years old to under 75

 2. Patients with dyspepsia in patients with cholelithiasis

 3. Patients who consented to this study and conducted questionnaires and tests during
 follow up

 Exclusion Criteria:

 1. asymptomatic cholelithiasis

 2. Gallstones over 3cm

 3. Acute cholecystitis requires surgery

 4. pregnant women

 5. porcelain gallbladder

 6. Chronic cholecystitis with severe thickening of the gallbladder wall

 7. Patients with anomalous pancreato-biliary duct union,

 8. When other physicians believe that surgery is necessary

 9. Patients with a history of hypersensitivity to "motilitone" or its components

 ; Since this drug contains lactose, galactose intolerance, Patients with genetic
 problems such as Lapp lactase deficiency or glucose-galactose malabsorption.

 10. Hepatitis patients (Hepatitis carriers, cirrhosis patients) or suspected liver failure
 (AST, ALT levels are 1.5 times or more of normal values)