ConstipationNCT02047045

Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial

A study testing acupuncture and Prucalopride in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Constipation
What is being tested?: acupuncture and Prucalopride
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 560 participants
Where: No sites listed yet
Study dates: Apr 2014to May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 9Show fewer

women in gestation or lactation period;
blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
cardiac pacemaker carrier.

About this study

Official title: Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Multi-center Noninferiority Randomized Controlled Trial

Read the 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.

Conditions: Constipation
Being tested: acupuncture, Prucalopride
Keywords: severe chronic constipation, randomized controlled, electro-acupuncture, prucalopride
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acupunctureProcedure or surgery
Also called eletro-acupuncture
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.
PrucaloprideDrug
Also called serotonin 5-HT(4) receptor agonist
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.

Study groups in NCT02047045
Study group	Role	What they receive
Electro-acupuncture	Experimental	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. Receives: Procedure: acupuncture
Prucalopride	Active comparator	Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast Receives: Drug: Prucalopride

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: over weeks 3-8 (the latter 6-week treatment)

Secondary outcomes (8)

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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
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.
Measured: 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
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).
Measured: week 4 and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014May 2017

First posted28 Jan 2014 (estimated)
Study startApr 2014
Primary completionAug 2016
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047045
Sponsor's protocol ID: 2012BAI24B01SCC
Status last verified: Feb 2021
First submitted: 23 Jan 2014
Last updated: 22 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 25055821
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.
PubMed 33273258
Gao S, Zhu L, Yao H, Fang J, Liu Z. Effect of electroacupuncture versus prucalopride for ultra-severe chronic constipation: Secondary analysis of a randomized controlled trial. Integr Med Res. 2026 Mar;15(1):101253. doi: 10.1016/j.imr.2025.101253. Epub 2025 Sep 12.
PubMed 41080507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Functional Constipation (FC)
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All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Multi-center Noninferiority Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02047045
Acronym / sponsor ID: 2012BAI24B01SCC
Conditions: Constipation
Keywords: severe chronic constipation, randomized controlled, electro-acupuncture, prucalopride
Study type: Interventional
Recruitment status: Completed
Enrolment: 560 participants (actual)
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
Collaborators: Ministry of Science and Technology of the People´s Republic of China
Study start: Apr 2014
Primary completion: Aug 2016 (actual)
Study completion: May 2017 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Posted 30 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Data management: this trial will use the Remote Dara Capture (RDC) system for data entering and Data Verification Plan (DVP) for data examining.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Electro-acupuncture	Experimental	Procedure: acupunctureElectro-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	Active comparator	Drug: PrucalopridePrucalopride Succinate taken orally, 2mg/day in the morning before breakfast

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acupunctureAlso: eletro-acupunctureElectro-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.	Procedure or surgery	Electro-acupuncture
PrucaloprideAlso: serotonin 5-HT(4) receptor agonistPrucalopride 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.	Drug	Prucalopride

Primary outcome

the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
Time frame: 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).

8 secondary outcomes

the Proportion of Participants With ≥3 Mean Weekly CSBMs Over 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time to the First CSBMs
Time frame: 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
Time frame: week 4 and week 8

Results and safety

Results posted to the registry on 30 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Electro-acupuncture	280	277
Prucalopride	280	278

Primary outcome: the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8

Time frame: over weeks 3-8 (the latter 6-week treatment). Number. Unit: percentage of participants

Measure	Electro-acupuncture n = 277	Prucalopride n = 278
Value	36.2	37.8

Population analysed: We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the baseline analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: the whole study period (34 weeks, from week -2 to week 32). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Electro-acupuncture	1 of 277 (0.4%)	49 of 277 (17.7%)	Not reported
Prucalopride	0 of 278 (0%)	123 of 278 (44.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25055821Liu 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 publication: PubMed 33273258Liu 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.
Derived from this study: PubMed 41080507Gao S, Zhu L, Yao H, Fang J, Liu Z. Effect of electroacupuncture versus prucalopride for ultra-severe chronic constipation: Secondary analysis of a randomized controlled trial. Integr Med Res. 2026 Mar;15(1):101253. doi: 10.1016/j.imr.2025.101253. Epub 2025 Sep 12.
Individual participant dataSharing planned: Yes. 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.

Related trials for Constipation

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhishun Liu, Ph.D study chair

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture and Prucalopride in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 (time frame: over weeks 3-8 (the latter 6-week treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02047045, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.