電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效研究
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Clinically significant response defined as 50% reduction in GAD-7 scores at 10 weeks
研究概览
简要总结
電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Randomized
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Rome III criteria for irritable bowel syndrome- diarrheal subtype:
- •(1) Current (weekly) symptoms of type and severity:
- •i. Abdominal pain intensity: weekly average of worst daily (in the past 24 hours) abdominal pain score of at least 1 on 0-4 5-point Likert scale, AND
- •ii. Stool consistency: at least one stool with a consistency of Type 6 or Type 7 Bristol Stool Score in at least 25% of the time.
- •(2) Normal colonic evaluation (colonoscopy or barium enema) within the past 5 years.
- •DSM-5 Criteria for Generalized Anxiety Disorder with GAD7 score 10 or above;
- •Provision of written consent.
排除标准
- •Functional dyspepsia (Rome III definition) and/or Gastro-esophageal reflux disease (Montreal definition) as dominant syndrome;
- •Previous gastrointestinal surgery (except appendicectomy and cholecystectomy);
- •History of organic disease of the gastrointestinal tract, such as colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, previous gastrointestinal surgery or systemic diseases that may cause diarrhea;
- •Pregnancy, lactation or not under proper contraception;
- •Concomitant use of anti-diarrheal drugs;
- •History of drug abuse or regular alcohol use in recent 6 months;
- •Active suicidal thoughts or history of violence or suicide attempts;
- •Currently suffering from depression of at least moderate severity (PHQ-9 15 or above);
- •History of severe mental illness, such as psychosis, bipolar disorder, or organic brain syndrome that may limit the response of anxiety and somatic symptoms to electroacupuncture.
- •History of psychotropic drug use or treatment in recent month xi) Currently receiving psychological treatment.
研究组 & 干预措施
Two groups
Traditional Chinese Medicine,Electroacupuncture versus Shame control+routine care
(to be continued)
Electroacupuncture + routine care: Patients randomized to electroacupuncture (EA) group will receive 10 sessions of EA over 10 weeks (1 session / week), each patient will receive EA on acupoints pairs (bilateral PC6 and HT7; bilateral ST36 and ST37; bilateral SP6 and LR3; left GV20 and Yintang).
(Electroacupuncture + routine care: to be continued)
A Chinese medicine practitioner (CMP) delivering the EA will insert sterile, single-use filiform EA needles, with a length of 25-40 mm and a diameter of 0.20 mm, with the aid of a guide tube at each of the points, after first disinfecting the skin.
(Shame control+routine care)
For patients randomized to the control group, ten sessions of sham EA on top of routine care same as the treatment group described above will be given on the same acupoints. The non-penetrating sham acupuncture will be used in this study.
(Shame control+routine care: to be continued)
Blunted telescopic placebo needles hidden inside foam cubes will be placed on the same acupoints as the EA group, touching the skin but without penetration deep into the acupoints. The needles are connected with electrical wire but no electrical stimulation will be applied during the sessions.
结局指标
主要结局
Clinically significant response defined as 50% reduction in GAD-7 scores at 10 weeks
次要结局
- (1)Clinically significant response in anxiety symptoms at 16 weeks
- (2)Bowel symptom at 10 and 16 weeks
- (3)Depressive (PHQ9) and Somatic symptoms (PHQ-15) scores at 10 and 16 weeks
- (4)EQ-5D health utility score as economic benefit at 10 and 16 weeks
- (5)Direct medical costs and indirect medical costs:time period: from week 0 to week 10 and from week 10 to week 16