Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Multi-center Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 560
- 主要终点
- the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
研究概览
简要总结
This trial is primarily aimed to compare the effect and safety of electro-acupuncture and prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6 months? Then, assess the patients' acceptance of electro-acupuncture.
详细描述
Study design: this trial is a multi-central randomized controlled trial which contains 14 centers. Random sequences will be generated by the clinical evaluating center of China Academy of Chinese Medical Sciences. Subjects are patients who have severe chronic constipation.
Sample size evaluation: Sample size will be based on the proportion of patients having mean complete spontaneous bowel movements (CSBMs) no less than 3 times per week. The proportion is 31.67% in our phase I clinical trial by using electro-acupuncture, and 30.9% in another trial by using prucalopride.The total sample size is 560.
Periods and primary outcome: participants will be assessed at baseline for 2 weeks, treated for 8 weeks, and followed up for 24 weeks. Primary outcome is the proportion of patients having mean CSBMs/week no less than 3 times over the latter 6-week treatment.
Quality control: the study is a randomized controlled trial; participants were included strictly; evaluators and statisticians are blinded; quality control officers of 3 different levels will supervise this trial.
Data management: this trial will use the Remote Dara Capture (RDC) system for data entering and Data Verification Plan (DVP) for data examining.
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
- Single (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 Rome Ⅲ criteria for diagnosing functional constipation;
- •severe chronic constipation (two or fewer CSBMs per week for more than 3 months）;
- •the weekly mean CSBMs are no more than 2 times during the 2-week baseline
- •aged from 18 to 75 years old
- •no use of drugs for constipation (emergency treatments should be excepted) during at least 2 weeks before enrollment; no acupuncture treatment for constipation in the previous 1 month; never joined any other trial in progress;
- •volunteered to join this research and signed the informed consent
排除标准
- •irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
- •mushy stool or watery stool are showed more than once during baseline when defecating spontaneously without any laxative (Bristol stool type 6 or 7);
- •history of pelvic floor dysfunction;
- •taking medicine in progress which can induce constipation;
- •severe hemorrhoid or anal fissure;
- •constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, abdominal aortic aneurysm or hepatosplenomegaly, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
- •women in gestation or lactation period;
- •blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
- •cardiac pacemaker carrier.
研究组 & 干预措施
Electro-acupuncture
Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks.
干预措施: acupuncture (Procedure)
Prucalopride
Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast
干预措施: Prucalopride (Drug)
结局指标
主要结局
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
时间窗: over weeks 3-8 (the latter 6-week treatment)
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 3-8. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: the latter 6 weeks of treatment (weeks 3-8).
次要结局
- the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.(over weeks 1-2, 11-12, 15-16, 19-20, 31-32.)
- the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.(over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.)
- Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.(over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.)
- Time to the First CSBMs(from the time of their first treatment to the time they having their first CSBMs)
- Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life(week 4 and week 8)
- Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.(over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.)
- the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8.(over weeks 1-2, 3-8.)
- the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.(over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.)
研究者
Liu Zhishun
Dean of Acupuncture Department of Guang'anmen Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences