The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Constipation
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 1075
- Locations
- 1
- Primary Endpoint
- the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Liu Baoyan
Vice President of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.
Outcomes
Primary Outcomes
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
Time Frame: Baseline and weeks 1-8
the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
Secondary Outcomes
- the Percentage of Participants With Three or More Weekly CSBMs(1-20 weeks)
- Changes in Mean Weekly CSBMs During Weeks 9-20(Baseline and weeks 9-20)
- Mean Weekly SBMs During Weeks 1-8(Baseline and weeks 1-8)
- Mean Scores for Stool Consistency and Straining During Weeks 1-8(Baseline and weeks 1-8)
- Change of Average Weekly Degree of Difficulty in Defecation From Baseline(Baseline and weeks 1-8)
- Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)(baseline and the end of 8th week)
- Number of Participants With Adverse Events Related to Acupuncture(1-8 weeks)
- Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used(1-20 weeks)
- The Number of Participants Using Rescue Medicine for Constipation(1-20 weeks)
- Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used(1-20 weeks)