Phase 2
Completed N=1,075
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Source: ClinicalTrials.gov NCT01726504 ↗Enrolled (actual)
1,075
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment — 1.72; 0.82 number of times — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment |
1.72; 0.82 | <0.001 sig |
| SECONDARY the Percentage of Participants With Three or More Weekly CSBMs |
31.34; 12.06; 37.69; 14.10 | — |
| SECONDARY Changes in Mean Weekly CSBMs During Weeks 9-20 |
1.93; 0.82 | — |
| SECONDARY Mean Weekly SBMs During Weeks 1-8 |
2.30; 1.28 | — |
| SECONDARY Mean Scores for Stool Consistency and Straining During Weeks 1-8 |
0.87; 0.62 | — |
| SECONDARY Change of Average Weekly Degree of Difficulty in Defecation From Baseline |
-0.74; -0.52 | — |
| SECONDARY Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) |
-25.65; -18.21 | — |
| SECONDARY Number of Participants With Adverse Events Related to Acupuncture |
31; 24 | — |
| SECONDARY Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used |
0.34; 0.52; 0.02; 0.02; 0.25; 0.37 | — |
| SECONDARY The Number of Participants Using Rescue Medicine for Constipation |
155; 183; 15; 17; 104; 124 | — |
| SECONDARY Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used |
28.92; 33.95; 2.8; 3.15; 19.40; 23.01 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01726504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.