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Efficacy and Safety of Acupuncture for Functional Constipation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411501
First Posted: August 8, 2011
Last Update Posted: December 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  Purpose
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. .

Condition Intervention Phase
Constipation Other: acupuncture Drug: mosapride citrate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Change of the SBMs From Baseline at Week 4 [ Time Frame: baseline and at 4 weeks ]
    [average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]


Secondary Outcome Measures:
  • Change From Baseline in the Bristol Stool Scale at the 4th Week [ Time Frame: baseline and at 4 weeks ]
    Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.

  • Change From Baseline in Difficulty Degree of Defecation at the 4th Week [ Time Frame: baseline and at 4 weeks ]

    This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.

    0—Without difficulty

    1. Defecation straining
    2. Severe defecation straining
    3. Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.

    [the average score of one week at the 4th week]-[the average score of one week at baseline]


  • Changes of the SBMs From Baseline at Week 8 [ Time Frame: baseline and at 8 weeks ]
    [average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]

  • Change From Baseline in the Bristol Stool Scale at the 8th Week [ Time Frame: baseline and at 8 weeks ]
    Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.

  • Change From Baseline in Difficulty Degree of Defecation at the 8th Week [ Time Frame: baseline and at 8 weeks ]

    This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.

    0—Without difficulty

    1. Defecation straining
    2. Severe defecation straining
    3. Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.

    [the average score of one week at the 8th week]-[the average score of one week at baseline]



Enrollment: 684
Study Start Date: September 2011
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture at ST25 and BL25
the points formula of back-shu point combination with front-mu point.
Other: acupuncture

Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).

Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.

Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.

Other Name: acupuncture and moxibustion
Experimental: Acupuncture at LI11 and ST37
the points formula of He-points
Other: acupuncture

Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).

Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.

Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.

Other Name: acupuncture and moxibustion
Experimental: Acupuncture at ST25, BL25, LI11 and ST37
the formula of He-point,back-shu point and front-mu point
Other: acupuncture

Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).

Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.

Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.

Other Name: acupuncture and moxibustion
Active Comparator: medicine
oral use of mosapride citrate
Drug: mosapride citrate
4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Other Name: mosapride citrate,made in China

Detailed Description:
functional constipation,acupuncture,effects and safety,pragmatic RCT
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411501


Locations
China
No.5 Beixiange Street, Xuanwu District
Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Chair: LIU Zhishun, phD Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01411501     History of Changes
Other Study ID Numbers: 2011CB505202
First Submitted: July 28, 2011
First Posted: August 8, 2011
Results First Submitted: September 25, 2015
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015
Last Verified: November 2015

Keywords provided by Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Acupuncture
Functional constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Citric Acid
Mosapride
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs