Phase 2
N=475
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00508482 ↗Enrolled (actual)
475
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Change of Mean Weekly Spontaneous Bowel Movements — 2; 2; 2; 2 stools/week — p=0.238
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- deep needling (Other); Lactulose (Drug); shallow needling (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Mean Weekly Spontaneous Bowel Movements |
2; 2; 2; 2; 2; 1 | 0.238 |
| SECONDARY Change of Mean Value of Straining During Defecating |
0.835; 0.789; 0.868 | 0.573 |
| SECONDARY Change of Mean Value of Incomplete Evacuation |
0.75; 0.75; 0.75 | 0.271 |
| SECONDARY Change of Mean Value of Stool Consistency |
0.414; 0.438; 0.701 | <0.001 sig |
| SECONDARY Change of Mean Value of Abdominal Distention |
0.762; 0.693; 0.661 | 0.167 |
| SECONDARY Change of Mean Value of Cleveland Clinic Score |
4.5; 4.38; 4 | 0.066 |
| SECONDARY Time to the First Spontaneous Bowel Movement After the First Treatment |
27.08; 36.68; 16.52 | <0.001 sig |
| SECONDARY Percentage of the Usage of Emergency Drugs |
17.11; 14.29; 29.57 | 0.006 sig |
| SECONDARY Percentage of the Usage of Emergency Drugs |
17.11; 14.29; 29.57 | 0.006 sig |
| SECONDARY Percentage of the Usage of Emergency Drugs |
17.11; 14.29; 29.57 | 0.006 sig |
Summary
The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.
Eligibility Criteria
Inclusion Criteria
- meeting the diagnosis of Rome III criteria;
- aged from 18 to 75 years old;
- no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months;
- volunteered to join this trial and signed the informed consent form
Exclusion Criteria
- irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
- constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
- women in gestation or lactation period;
- abdominal aortic aneurysm or hepatosplenomegaly, etc.;
- blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
- cardiac pacemaker carrier.
Data sourced from ClinicalTrials.gov (NCT00508482). 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.