SAAM acupuncture for functional dyspepsia: a pilot trial

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Those who may be diagnosed with functional dyspepsia pursuant to ROME III diagnostic standard; in other words, those who have one or more symptoms among 1) to 4) without organic disease basis that can explain symptoms including esophagitis, Barrett’s esophagus, cancer, erosions or ulcers in endoscopy.
1) bothersome postprandial fullness; uncomfortably full after regular sized meal, more than 1 day/week, 2) early satiation; unable to finish regular sized meal, more than 1 day/week, 3) epigastric pain; pain or burning in middle of abdomen, at least 1 day/week, 4) epigastric burning; this criterion is incorporated in the same question as epigastric pain
2. Males and females aged 20 to 65.
3. Those who have undergone the above symptoms for a minimum of three months from at least six months ago to the present time.
4. Those whose numerical rating scale was at least moderately severe for the past week during their screening visit (0-100).
5. Those who consented to participation in this trial and signed an informed consent statement after listening to clear explanation of this clinical trial's purpose and characteristics.

Exclusion Criteria

1. Those who don't consent to an informed consent statement.
2. Those whose gastrointestinal motility stimulus such as gastrointestinal bleeding, mechanical ileus, enterobrosia is risky.
3. Pregnant, expecting pregnant or breast-feeding women.
4. Those who have warning symptoms like severe weight loss, melena, dysphagia, repeated vomiting, anemia, jaundice, abdominal mass, ascites.
5. Patients who have used oriental medical treatment during last 4 weeks.
6. Those who have participated in other clinical trials during the past 3 months.
7. Those who have undergone a gastrointestinal surgery except for appendectomy in the past or those who have a disease like cholangitis, pancreatitis.
8. Those who are not appropriate for participating in this clinical trial due to severe cardiovascular disease(MI, unstable angina, congestive heart failure etc.), severe neurological diseases(ICH, cbr-inf. etc.), acute,chronic liver disease(liver cancer, liver cirrhosis), malignant tumor, chronic lung disease and respiratory disease, poorly controlled hypertension, diabetes, drug addiction, alcoholism, chronic renal failure, active tuberculosis, other infectious disease, mental disease, and diet disorder that occurred for the recent one year.
9. Those who have taken a medication like PPIs(proton pump inhibitors), H2RAs(H2-receptor antagonist), corticosteroids, NSAIDs(non-steroidal anti-inflammatory drugs) that may affect evaluation of this research result.
10. Hemorrhagic disease or those who are taking anticoagulant drugs(except for aspirin).
11. Those who have experienced hypersensitivity reaction after acupuncture treatment.
12. Those who are inmates at group facilities such as social welfare institutions.
13. Others who clinical trial conductors consider inappropriate for participating in this trial.