The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,075
- 试验地点
- 1
- 主要终点
- the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
研究概览
简要总结
The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.
详细描述
Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.
This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.
This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •meeting the diagnosis of Rome III criteria for chronic functional constipation;
- •severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
- •18-75 years old;
- •no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
- •no acupuncture treatment for constipation in recent 3 months;
- •never joined any other trial in process in 3 months;
- •volunteered to join this research and signed the informed consent.
排除标准
- •Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
- •constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
- •pregnant women or women in lactation period
- •constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
- •bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
- •cardiac pacemaker carrier.
研究组 & 干预措施
electro-acupuncture
- The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard).
- Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose.
Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.
干预措施: electro-acupuncture (Device)
sham electro-acupuncture
- The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin).
- Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin).
Length of Treatment and the treatment sessions are the same as treatment group.
干预措施: sham electro-acupuncture (Device)
结局指标
主要结局
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
时间窗: Baseline and weeks 1-8
the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
次要结局
- the Percentage of Participants With Three or More Weekly CSBMs(1-20 weeks)
- Changes in Mean Weekly CSBMs During Weeks 9-20(Baseline and weeks 9-20)
- Mean Weekly SBMs During Weeks 1-8(Baseline and weeks 1-8)
- Mean Scores for Stool Consistency and Straining During Weeks 1-8(Baseline and weeks 1-8)
- Change of Average Weekly Degree of Difficulty in Defecation From Baseline(Baseline and weeks 1-8)
- Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)(baseline and the end of 8th week)
- Number of Participants With Adverse Events Related to Acupuncture(1-8 weeks)
- Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used(1-20 weeks)
- The Number of Participants Using Rescue Medicine for Constipation(1-20 weeks)
- Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used(1-20 weeks)
研究者
Liu Baoyan
Vice President of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences