Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia: a Protocol for a Randomized, Assessor-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 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 on functional dyspepsia compared with sham control. The study aims to clarify the mechanism of acupuncture by assessing functional magnetic resonance imaging and metabolomics.
详细描述
Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural lesion. Due to the lack of satisfactory effect of conventional treatments, many FD patients turn to alternative treatments such as acupuncture. Acupuncture, one of the most sought therapeutic modalities in traditional Korean Medicine, has been commonly used for treating gastrointestinal disorders.
However, the effect and mechanism of acupuncture on FD has not been rigorously evaluated. In the present study, we will investigate whether 10 sessions of acupuncture over 4 weeks, in comparison with sham acupuncture, improve symptoms of FD and activate regions of brain area. We will also perform metabolomics study to find the mechanism of acupuncture to FD. Outcome measures include proportion of responder, Korean version of Nepean Dyspepsia Index, Functional Dyspepsia-Related Quality of Life, Ways of Coping Question, Coping Strategy Questionnaire, Perception of bodily sensation, The State-Trait Anxiety Inventory, Center for Epidemiologic Studies Depression Scale, functional magnetic resonance imaging and metabolomic study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants should meet following conditions:
- •Aged of 30 - 49
- •Individuals who meet FD and postprandial distress syndrome (PDS) criteria in Rome III
- •Individuals who complain the degree of dyspepsia for more than 40 points of visual analogue scale (VAS; 0, no symptom at all; 100, the most severe symptom one ever had)
- •At least 3 questions show more than 2 points in Gastrointestinal impact scale
- •Individuals who have normal esophagogastroduodenoscopy results within a year and no organic diseases which can explain current symptoms such as peptic ulcer, dysplasia, mucosa-associated, lymphoid tissue lymphoma, esophageal cancer, gastric cancer
- •Individuals who are not supposed to take any other treatments associated with FD during the study
- •Individuals who voluntarily agree with a study protocol and sign a written informed consent
排除标准
- •Participants who report the followings will be excluded:
- •Individuals who have organic diseases such as gastroesophageal reflux disease
- •Individuals who have obvious signs of irritable bowel syndrome
- •Individuals who have alarm symptoms (weight loss, black or tar stool or dysphagia)
- •Individuals who have serious structural disease (disease of heart, lung, liver or kidney) or mental illness
- •Individuals who have had surgery related with the gastrointestinal tract , except for appendectomy more than six months ago
- •Individuals who are pregnant or breastfeeding
- •Individuals who are taking drugs which might affect gastrointestinal tract; minimum wash-out period of 2 weeks is required before participating in the trial
- •Individuals who are HIV-positive
- •Individuals who have a problem of mal-absorption
- •Individuals who have difficulties in attending the trial (eg. paralysis, serious mental illness, dementia, drug addiction, time constraint, severe disorder in vision or hearing, illiteracy, etc.)
- •Individuals who do not want to sign the informed consent
- •Individuals who have other diseases that could interfere acupuncture treatment, e.g. clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy
- •Individuals who have metal implants or fragments which might influence fMRI examination
研究组 & 干预措施
Acupuncture
Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.
干预措施: Acupuncture (Device)
Sham acupuncture
Participants in this group are given 10 times of sham acupuncture treatment for 4 weeks.
干预措施: Sham acupuncture (Device)
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 10 times - 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 wks). Responders are defined as patients reporting adequate relief for at least 50% of the study period (more than 5 times of "Yes" to adequate relief question out of total 10 questions). The proportion of responder will be compared statistically between intervention groups.
次要结局
- Nepean Dyspepsia Index - Korean version (NDI-K)(treatment (0 wks), After treatment (4 wks))
- Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire(Before treatment (0 wks), After treatment (4 wks))
- Ways of Coping Question (WCQ)(treatment (0 wks), After treatment (4 wks))
- Coping Strategy Questionnaire (CSQ)(Before treatment (0 wks), After treatment (4 wks))
- Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips)(Before treatment (0 wks), After treatment (4 wks))
- Metabolic profiling of plasma and urine(Time Frame: Before treatment (0 wks), After treatment (4 wks))
- The Center for Epidemiologic Studies Depression Scale (CES-D)(Before treatment (0 wks), After treatment (4 wks))
- The State-Trait Anxiety Inventory (STAI)(Before treatment (0 wks), After treatment (4 wks))
- Perception of bodily sensation (PDS)(Before treatment (0 wks))
研究者
Seok-Jae Ko
PhD, Professor, Department of Korean Internal Medicine
Kyunghee University Medical Center