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

NCT02047045 | Completed Results

• 1 other identifier: 2012BAI24B01SCC
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation

Keywords

severe chronic constipation; randomized controlled; electro-acupuncture; prucalopride

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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.

• 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.

Other Outcomes (3)

• Proportion of Patients Using Rescue Medicine 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.

• Average Dosage of Bisacodyl Used Weekly 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.

• Average Dosage of Glycerine Enema Used Weekly 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.

Study Arms (2)

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.

Procedure: acupuncture

Prucalopride

ACTIVE COMPARATOR

Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast

Drug: Prucalopride

Interventions

acupuncture PROCEDURE

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.

Also known as: eletro-acupuncture

Electro-acupuncture

Prucalopride DRUG

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.

Also known as: serotonin 5-HT(4) receptor agonist

Prucalopride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Related Publications (3)

• 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.

  PMID: 25055821 BACKGROUND

• 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.

  PMID: 33273258 RESULT

• 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.

  PMID: 41080507 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Acupuncture Therapy; prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Zhishun Liu
• Organization: Guang'anmen Hospital, China Academy Chinese Medical Sciences

liuzhishun@aliyun.com

+86 010 88002331

Study Officials

• Zhishun Liu, Ph.D

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Acupuncture Department of Guang'anmen Hospital

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 28, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: May 1, 2017
• Last Updated: March 22, 2021
• Results First Posted: January 30, 2020

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within six months after the publication of the clinical report
• 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.