Phase 3
N=675
Efficacy and Safety of Acupuncture for Functional Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01411501 ↗Enrolled (actual)
675
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Change of the SBMs From Baseline at Week 4 — 2.7; 2.7; 2.2; 2.4 times per week — p=0.352
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- acupuncture (Other); mosapride citrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of the SBMs From Baseline at Week 4 |
2.7; 2.7; 2.2; 2.4 | 0.352 |
| SECONDARY Change From Baseline in the Bristol Stool Scale at the 4th Week |
3.9; 3.9; 3.9; 3.9 | 0.968 |
| SECONDARY Change From Baseline in Difficulty Degree of Defecation at the 4th Week |
40; 41; 33; 36; 69; 78 | 0.841 |
| SECONDARY Changes of the SBMs From Baseline at Week 8 |
2.3; 2.4; 2.1; 1.4 | 0.005 sig |
| SECONDARY Change From Baseline in the Bristol Stool Scale at the 8th Week |
3.4; 3.6; 3.4; 3.1 | 0.198 |
| SECONDARY Change From Baseline in Difficulty Degree of Defecation at the 8th Week |
45; 46; 40; 36; 75; 88 | 0.035 sig |
Summary
A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .
Eligibility Criteria
Inclusion Criteria
- Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
- Patients who are aged 18-75 years old
- Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
- Sign the informed consent out of one's own will
Exclusion Criteria
- Secondary constipation
- Patients with consciousness impairment, psychotic patients or patients unable to express clearly
- Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
- Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
- Women in pregnancy and lactation period
Data sourced from ClinicalTrials.gov (NCT01411501). 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.