Efficacy and Safety of Acupuncture for Functional Constipation

Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial

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. .

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Other: acupuncture; Drug: mosapride citrate

Detailed Description

functional constipation,acupuncture,effects and safety,pragmatic RCT

• Study Type: Interventional
• Enrollment (Actual): 684
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • No.5 Beixiange Street, Xuanwu District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: mosapride citrate,made in China

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Bristol Stool Scale at the 4th Week	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.	baseline and at 4 weeks
Change From Baseline in Difficulty Degree of Defecation at the 4th Week	This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty; Defecation straining; Severe defecation straining; 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]	baseline and at 4 weeks
Changes of the SBMs From Baseline at Week 8	[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]	baseline and at 8 weeks
Change From Baseline in the Bristol Stool Scale at the 8th Week	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.	baseline and at 8 weeks
Change From Baseline in Difficulty Degree of Defecation at the 8th Week	This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty; Defecation straining; Severe defecation straining; 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]	baseline and at 8 weeks

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: 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

Publications and helpful links

General Publications

• Li Y, Zheng H, Zeng F, Zhou SY, Zhong F, Zheng HB, Chen M, Jing XH, Cai YY, Jia BH, Zhu B, Liu ZS. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial. Trials. 2012 Jul 3;13:104. doi: 10.1186/1745-6215-13-104.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: November 8, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Acupuncture; Functional constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Mosapride; Citric Acid; Sodium Citrate
• Other Study ID Numbers: 2011CB505202