A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Change of Mean Weekly Spontaneous Bowel Movements
研究概览
简要总结
The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.
详细描述
Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, one of the most frequently used treatment is catharsis, which deals with the symptom. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment.
Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture therapy is safe and effective and the therapeutic effects are still present several months after the treatment has been completed.
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
- 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;
- •aged from 18 to 75 years old;
- •no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months;
- •volunteered to join this trial and signed the informed consent form
排除标准
- •irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
- •constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
- •women in gestation or lactation period;
- •abdominal aortic aneurysm or hepatosplenomegaly, etc.;
- •blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
- •cardiac pacemaker carrier.
研究组 & 干预措施
deep needling group
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location, were used. After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 20~60mm until piercing into the muscle layer. Paired alligator clips of the electric acupuncture (EA) apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose. Patients were treated once a day, five times a week for continuous 4 weeks.
干预措施: deep needling (Other)
lactulose group
Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
干预措施: Lactulose (Drug)
shallow needling group
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
干预措施: shallow needling (Other)
结局指标
主要结局
Change of Mean Weekly Spontaneous Bowel Movements
时间窗: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up
Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.
次要结局
- Change of Mean Value of Straining During Defecating(over 4 weeks of treatment)
- Change of Mean Value of Incomplete Evacuation(over 4 weeks of treatment)
- Change of Mean Value of Stool Consistency(over 4 weeks of treatment)
- Change of Mean Value of Abdominal Distention(over 4 weeks of treatment)
- Change of Mean Value of Cleveland Clinic Score(over 4 weeks of treatment)
- Time to the First Spontaneous Bowel Movement After the First Treatment(counting by hours)
- Percentage of the Usage of Emergency Drugs(at the 12th week of follow-up)
研究者
Liu Zhishun
Chief of the Acupuncture Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences