Back to resultsEffect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Prucalopride
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring severe chronic constipation, randomized controlled, electro-acupuncture, prucalopride
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electro-acupuncture
Prucalopride
Arm Description
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.
Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast
Outcomes
Primary Outcome Measures
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
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).
Secondary Outcome Measures
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 1-2, 11-12, 15-16, 19-20, 31-32. 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: 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.
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the increase in mean weekly CSBMs of each patient from baseline were calculated over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with ≥1 increase in the mean weekly CSMBs from baseline. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%.
Assessing time frame: 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.
Mean Weekly SBMs and Its Change From Baseline 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.
The change from baseline in the mean score of stool consistency of each SBM over weeks 1-2 and weeks 3-8. Assessing time: baseline, weeks 1-2 and weeks 3-8. Patients will self-report their stool consistency of each SBM according to the 7-type Bristol Stool Form Scale (scored by 1 to 7 respectively). Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid.
Type 3 and 4 were deemed as a normal stool.
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.
The change from baseline in the mean score of straining of each SBM over weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Assessing time: baseline, weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Patients will self-report their straining degree of each SBM in the defecation diaries according to the following scale. 0 = not difficult; 1 = a little difficult, need some straining to defecate; 2 = difficult, need straining to defecate; 3 = very difficult, need hard straining to defecate. Higher scores mean a worse outcome.
Time to the First CSBMs
Abbreviation: CSBMs, complete spontaneous bowel movements. Time to the first CSBMs was counted by days. Rescue medicine or other measurements for constipation is not allowed to be used 48 hours before and after the first treatment for evaluating the time to the first complete spontaneous bowel movement. Participants were assessed after the first treatment until they having their first CSBMs.
Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life
The change from baseline of the score of Patient Assessment of Constipation Quality of Life (PAC-QOL) at week 4 and week 8. PAC-QOL is a self-report questionnaire to evaluate the quality of life in patients with constipation, which was distributed by Mapi Research Trust in France. This questionnaire contains 28 items including 4 basic parts of physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. We use the Chinese version in our trial. Assessing point: baseline, week 4 and week 8. The score of PAC-QOL ranged from 1 to 5 (1 indicates no discomfort or feeling very satisfied, 5 indicates extreme severity and always appears or feeling very dissatisfied).
Full Information
NCT ID
NCT02047045
First Posted
January 23, 2014
Last Updated
February 24, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China
1. Study Identification
Unique Protocol Identification Number
NCT02047045
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
severe chronic constipation, randomized controlled, electro-acupuncture, prucalopride
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electro-acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Prucalopride
Arm Type
Active Comparator
Arm Description
Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
eletro-acupuncture
Intervention Description
Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Prucalopride
Other Intervention Name(s)
serotonin 5-HT(4) receptor agonist
Intervention Description
Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 32 weeks.
Primary Outcome Measure Information:
Title
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
Description
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).
Time Frame
over weeks 3-8 (the latter 6-week treatment)
Secondary Outcome Measure Information:
Title
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
Description
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 1-2, 11-12, 15-16, 19-20, 31-32. 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: weeks 1-2, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 11-12, 15-16, 19-20, 31-32.
Title
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.
Description
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the increase in mean weekly CSBMs of each patient from baseline were calculated over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with ≥1 increase in the mean weekly CSMBs from baseline. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%.
Assessing time frame: weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Title
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Title
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Title
the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8.
Description
The change from baseline in the mean score of stool consistency of each SBM over weeks 1-2 and weeks 3-8. Assessing time: baseline, weeks 1-2 and weeks 3-8. Patients will self-report their stool consistency of each SBM according to the 7-type Bristol Stool Form Scale (scored by 1 to 7 respectively). Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid.
Type 3 and 4 were deemed as a normal stool.
Time Frame
over weeks 1-2, 3-8.
Title
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.
Description
The change from baseline in the mean score of straining of each SBM over weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Assessing time: baseline, weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Patients will self-report their straining degree of each SBM in the defecation diaries according to the following scale. 0 = not difficult; 1 = a little difficult, need some straining to defecate; 2 = difficult, need straining to defecate; 3 = very difficult, need hard straining to defecate. Higher scores mean a worse outcome.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Title
Time to the First CSBMs
Description
Abbreviation: CSBMs, complete spontaneous bowel movements. Time to the first CSBMs was counted by days. Rescue medicine or other measurements for constipation is not allowed to be used 48 hours before and after the first treatment for evaluating the time to the first complete spontaneous bowel movement. Participants were assessed after the first treatment until they having their first CSBMs.
Time Frame
from the time of their first treatment to the time they having their first CSBMs
Title
Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life
Description
The change from baseline of the score of Patient Assessment of Constipation Quality of Life (PAC-QOL) at week 4 and week 8. PAC-QOL is a self-report questionnaire to evaluate the quality of life in patients with constipation, which was distributed by Mapi Research Trust in France. This questionnaire contains 28 items including 4 basic parts of physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. We use the Chinese version in our trial. Assessing point: baseline, week 4 and week 8. The score of PAC-QOL ranged from 1 to 5 (1 indicates no discomfort or feeling very satisfied, 5 indicates extreme severity and always appears or feeling very dissatisfied).
Time Frame
week 4 and week 8
Other Pre-specified Outcome Measures:
Title
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Title
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Title
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time Frame
over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, Ph.D
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing study protocol, informed consent form, and statistical analysis plan are in the supplementary digital files with the clinical report. For statistical code and data sets, proposals should be directed to yanshiyan0927@sina.com, and requestors need to sign a data access agreement, if approved.
IPD Sharing Time Frame
Within six months after the publication of the clinical report
IPD Sharing Access Criteria
For statistical code and data sets, proposals should be directed to yanshiyan0927@sina.com, and requestors need to sign a data access agreement, if approved.
Citations:
PubMed Identifier
25055821
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.
Results Reference
background
PubMed Identifier
33273258
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.
Results Reference
result
Learn more about this trial
Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
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