Clinical trial NCT01726504: The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Official title: The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: chronic functional constipation
electro-acupuncture
multi-center randomized controlled trial
efficacy
safety
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: 2012-11-15
Enrollment: 1075
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: The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.

Detailed description: Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.

This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.

This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.

Eligibility criteria: Inclusion Criteria:

* meeting the diagnosis of Rome III criteria for chronic functional constipation;
* severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
* 18-75 years old;
* no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
* no acupuncture treatment for constipation in recent 3 months;
* never joined any other trial in process in 3 months;
* volunteered to join this research and signed the informed consent.

Exclusion Criteria:

* Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
* constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
* pregnant women or women in lactation period
* constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
* bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
* cardiac pacemaker carrier.

Primary outcomes:
measure: the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
timeFrame: Baseline and weeks 1-8
Secondary outcomes:
measure: the Percentage of Participants With Three or More Weekly CSBMs
timeFrame: 1-20 weeks
measure: Changes in Mean Weekly CSBMs During Weeks 9-20
timeFrame: Baseline and weeks 9-20
measure: Mean Weekly SBMs During Weeks 1-8
timeFrame: Baseline and weeks 1-8
measure: Mean Scores for Stool Consistency and Straining During Weeks 1-8
timeFrame: Baseline and weeks 1-8
measure: Change of Average Weekly Degree of Difficulty in Defecation From Baseline
timeFrame: Baseline and weeks 1-8
measure: Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)
timeFrame: baseline and the end of 8th week
measure: Number of Participants With Adverse Events Related to Acupuncture
timeFrame: 1-8 weeks
measure: Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
timeFrame: 1-20 weeks
measure: The Number of Participants Using Rescue Medicine for Constipation
timeFrame: 1-20 weeks
measure: Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
timeFrame: 1-20 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Vice President of China Academy of Chinese Medical Sciences
name: Baoyan Liu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Liu Y, Zhou K, Bauer BA, Liu B, Su T, Mo Q, Liu Z. The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial. Therap Adv Gastroenterol. 2019 Oct 9;12:1756284819881859. doi: 10.1177/1756284819881859. eCollection 2019.
citation: Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
citation: Liu Z, Liu J, Zhao Y, Cai Y, He L, Xu H, Zhou X, Yan S, Lao L, Liu B. The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial. Trials. 2013 Jun 15;14:176. doi: 10.1186/1745-6215-14-176.