Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Proportion of responders
研究概览
简要总结
The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.
详细描述
Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural lesion. FD is claimed to affect 25% of the population in South Korea. Although conventional approaches based on current evidence such as proton pump inhibitor and prokinetic agents have been used, many FD patients turn to traditional Korean Medicine treatment largely due to the lack of satisfactory effect of these treatments.
Acupuncture treatment, one of the most sought therapeutic modalities in traditional Korean Medicine, has been commonly used for gastrointestinal disorders in Korea. However, the effect of acupuncture on FD has not been rigorously evaluated. In the present study, we will investigate whether 8 sessions of acupuncture treatment over 4 weeks, in comparison with no acupuncture treatment, i.e. waitlist-control, improve symptoms of FD. Outcome measures include proportion of responder, Korean version of Nepean Dyspepsia Index, EuroQol-5 Dimension, Functional Dyspepsia-Related Quality of Life, Beck's Depression Inventory, State-Trait Anxiety Inventory and ghrelin hormone. Genome-wide association study (GWAS) will be also conducted to elucidate any possible difference in genotype between responders and non-responders to acupuncture treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 ~ 75, with a elementary-school diploma or higher, should be able to read and write Korean
- •One who meet Rome III FD criteria* and has been suffering from FD for the last 3 months with symptom onset at least 6 months prior to diagnosis
- •One or more of the following:
- •Bothersome postprandial fullness
- •Early satiation
- •Epigastric pain
- •Epigastric burning
- •One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic symptoms
- •One who has normal esophagogastroduodenoscopy results within a year and been diagnosed with FD by a specialist consultation
- •One who receives no other treatments during the study
- •One who voluntarily agrees with study protocol and signs an written informed consent
排除标准
- •One who has peptic ulcer or gastroesophageal reflux disease (GERD)
- •One who has obvious signs of irritable bowel syndrome (IBS)
- •One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
- •One who has serious structural disease (disease of heart, lung, liver or kidney) or mental illness
- •One who has had surgery related with the gastrointestinal tract (Appendectomy more than 6 months ago is acceptable)
- •One who is pregnant or breastfeeding
- •One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2 weeks before participating in the trial)
- •One who is HIV-positive
- •One who has a problem of malabsorption or maldigestion
- •One who has difficulties in attending the trial or receiving treatments (e.g Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder in vision or hearing, impossibility of visit, illiterate, etc.)
- •One who does not want to sign the informed consents
- •One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is taking anticoagulant therapy
研究组 & 干预措施
Acupuncture
Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.
干预措施: Acupuncture (Device)
No treatment
The participants in this group are supposed to wait without any intervention for first 4 weeks. Then they receive the identical acupuncture treatments as in the treatment group for the following 4 weeks.
结局指标
主要结局
Proportion of responders
时间窗: Once in treatment period (4 wks)
The proportion of patients who answer "Yes" to more than half of adequate relief questions in the treatment period. Patients are expected to report their response to the acupuncture treatment by answering the following question at each visit: "After the last visit, have you had adequate relief of your stomach pain or discomfort?" Questions will be asked at each visit during treatment period (Twice a week for 4 wks, total 8 times - 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 wks). Responders are defined as patients reporting adequate relief for at least 50% of the study period (more than 4 times of "Yes" to adequate relief question out of total 8 questions). The proportion of responder will be compared statistically between experimental group and no intervention group.
次要结局
- Nepean Dyspepsia Index - Korean version (NDI-K)(After treatment (4 wks))
- Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire(After treatment (4 wks))
- Genotype analysis by Axiom® exome genotyping arrays(First visit (0 wk))
- EuroQol-5 Dimension (EQ-5D)(After treatment (4 wks))
- The State-Trait Anxiety Inventory (STAI)(After treatment (4 wks))
- Ghrelin hormone measurement (1. Total ghrelin, 2. Deacylated ghrelin)(After treatment (4 wks))
- Beck's Depression Inventory (BDI)(After treatment (4 wks))
研究者
Jae-Woo Park
Associate Professor, Department of Korean Internal Medicine
Kyunghee University Medical Center