Clinical trial NCT02047045: Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
Official title: Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Multi-center Noninferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: severe chronic constipation
randomized controlled
electro-acupuncture
prucalopride
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2014-01-28
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Statistical analysis: Intention-To-Treat (ITT) analysis will be used in this study. One-sided test (non-inferiority) will be used for testing the primary outcomes; meanwhile, two-sided test will be used for evaluating other outcomes. A P value equal to or less than 0.05 is considered to indicate statistical significance.

Eligibility criteria: Inclusion Criteria:

1. meeting Rome Ⅲ criteria for diagnosing functional constipation;
2. severe chronic constipation (two or fewer CSBMs per week for more than 3 months）;
3. the weekly mean CSBMs are no more than 2 times during the 2-week baseline
4. aged from 18 to 75 years old
5. 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;
6. volunteered to join this research and signed the informed consent

Exclusion Criteria:

1. irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
2. mushy stool or watery stool are showed more than once during baseline when defecating spontaneously without any laxative (Bristol stool type 6 or 7);
3. history of pelvic floor dysfunction;
4. taking medicine in progress which can induce constipation;
5. severe hemorrhoid or anal fissure;
6. 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;
7. women in gestation or lactation period;
8. blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
9. cardiac pacemaker carrier.

Primary outcomes:
measure: the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
timeFrame: over weeks 3-8 (the latter 6-week treatment)
Secondary outcomes:
measure: the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
timeFrame: over weeks 1-2, 11-12, 15-16, 19-20, 31-32.
measure: 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.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
measure: Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
measure: Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
measure: the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8.
timeFrame: over weeks 1-2, 3-8.
measure: 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.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
measure: Time to the First CSBMs
timeFrame: from the time of their first treatment to the time they having their first CSBMs
measure: Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life
timeFrame: week 4 and week 8
Other outcomes:
measure: Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
measure: Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
measure: Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
timeFrame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, Ph.D
role: STUDY_CHAIR
References:
citation: Liu B, Wang Y, Wu J, Mo Q, Wang W, He L, Yan S, Liu Z. Effect of electroacupuncture versus prucalopride for severe chronic constipation: protocol of a multi-centre, non-inferiority, randomised controlled trial. BMC Complement Altern Med. 2014 Jul 23;14:260. doi: 10.1186/1472-6882-14-260.
citation: Liu B, Wu J, Yan S, Zhou K, He L, Fang J, Fu W, Li N, Su T, Sun J, Zhang W, Yue Z, Zhang H, Zhao J, Zhou Z, Song H, Wang J, Liu L, Wang L, Lv X, Yang X, Liu Y, Sun Y, Wang Y, Qin Z, Zhou J, Liu Z. Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Am J Gastroenterol. 2021 May 1;116(5):1024-1035. doi: 10.14309/ajg.0000000000001050.