Efficacy and Safety of Acupuncture for Functional Constipation

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01411501
• Collaborator: Ministry of Science and Technology of the People´s Republic of China (Other)
• Enrollment: 684
• Location: 1
• Arms: 4
• Duration (Months): 39
• Patients Per Site Per Month: 17.5

Study Details

Study Description

Brief 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. .

Condition or Disease	Intervention/Treatment	Phase
Constipation	Other: acupuncture; Drug: mosapride citrate	Phase 3

Detailed Description

functional constipation,acupuncture,effects and safety,pragmatic RCT

Study Design

• Study Type: Interventional
• Actual Enrollment: 684 participants
• 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
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of the SBMs From Baseline at Week 4 [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

1. Change From Baseline in the Bristol Stool Scale at the 4th Week [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.

2. Change From Baseline in Difficulty Degree of Defecation at the 4th Week [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 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]

3. Changes of the SBMs From Baseline at Week 8 [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]

4. Change From Baseline in the Bristol Stool Scale at the 8th Week [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.

5. Change From Baseline in Difficulty Degree of Defecation at the 8th Week [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 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: 2011CB505202
• First Posted: Aug 8, 2011
• Last Update Posted: Dec 11, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences: Acupuncture; Functional constipation
• Additional relevant MeSH terms: Constipation; Mosapride; Citric Acid; Sodium Citrate

Study Results

Participant Flow

Recruitment Details	The participants were recruited through the inpatients and outpatients settings in the 8 hospitals.We also recruited the participants through television and newspapers advertisements.
Pre-assignment Detail	Nine enrolled participants refused to join in the trial after signing the informed consent. So they were excluded from the trial.

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Period Title: Overall Study
STARTED	168	172	165	170
COMPLETED	158	166	159	163
NOT COMPLETED	10	6	6	7

Baseline Characteristics

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine	Total
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal	Total of all reporting groups
Overall Participants	168	172	165	170	675
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.9 (17.4)	39.9 (16.8)	40.7 (16.8)	40.6 (16.7)	40.1 (16.9)
Sex: Female, Male (Count of Participants)
Female	128 76.2%	140 81.4%	138 83.6%	142 83.5%	548 81.2%
Male	40 23.8%	32 18.6%	27 16.4%	28 16.5%	127 18.8%
Region of Enrollment (participants) [Number]
China	168 100%	172 100%	165 100%	170 100%	675 100%
Duration of functional constipation (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	7.0 (6.8)	6.3 (6.5)	5.6 (4.3)	5.8 (4.6)	6.2 (5.56)
Received Traditional Chinese Medicine therapies (participants) [Number]
Acupuncture	7 4.2%	9 5.2%	7 4.2%	3 1.8%	26 3.9%
Herbs	38 22.6%	48 27.9%	43 26.1%	44 25.9%	173 25.6%
Both	7 4.2%	5 2.9%	8 4.8%	5 2.9%	25 3.7%
Neither	116 69%	110 64%	107 64.8%	118 69.4%	451 66.8%
SBMs (times per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [times per week]	2.7 (1.9)	2.5 (1.7)	2.9 (2.0)	2.9 (2.8)	2.8 (2.1)
Bristol scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.8 (1.3)	2.9 (1.4)	3.0 (1.5)	2.7 (1.4)	2.9 (1.8)
Degree of straining during defecation (participants) [Number]
0	5 3%	8 4.7%	9 5.5%	5 2.9%	27 4%
1	63 37.5%	60 34.9%	68 41.2%	59 34.7%	250 37%
2	68 40.5%	69 40.1%	58 35.2%	72 42.4%	267 39.6%
3	30 17.9%	35 20.3%	28 17%	31 18.2%	124 18.4%
no defecation	2 1.2%	0 0%	2 1.2%	3 1.8%	7 1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Measure Participants	168	172	165	170
Mean (95% Confidence Interval) [times per week]	2.7	2.7	2.2	2.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture at ST25 and BL25, Acupuncture at LI11 and ST37, Acupuncture at ST25, BL25, LI11 and ST37, Medicine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.352
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Change From Baseline in the Bristol Stool Scale at the 4th Week
Description	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.
Time Frame	baseline and at 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Measure Participants	168	172	165	170
Mean (95% Confidence Interval) [units on a scale]	3.9	3.9	3.9	3.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture at ST25 and BL25, Acupuncture at LI11 and ST37, Acupuncture at ST25, BL25, LI11 and ST37, Medicine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.968
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Change From Baseline in Difficulty Degree of Defecation at the 4th Week
Description	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]
Time Frame	baseline and at 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Measure Participants	158	167	161	164
0	40 23.8%	41 23.8%	33 20%	36 21.2%
1	69 41.1%	78 45.3%	76 46.1%	76 44.7%
2	33 19.6%	36 20.9%	38 23%	43 25.3%
3	16 9.5%	12 7%	14 8.5%	9 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture at ST25 and BL25, Acupuncture at LI11 and ST37, Acupuncture at ST25, BL25, LI11 and ST37, Medicine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.841
	Comments
	Method	Kruskal-Wallis
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Measure Participants	168	172	165	170
Mean (95% Confidence Interval) [times per week]	2.3	2.4	2.1	1.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture at ST25 and BL25, Acupuncture at LI11 and ST37, Acupuncture at ST25, BL25, LI11 and ST37, Medicine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Change From Baseline in the Bristol Stool Scale at the 8th Week
Description	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.
Time Frame	baseline and at 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Measure Participants	168	172	165	170
Mean (Full Range) [units on a scale]	3.4	3.6	3.4	3.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture at ST25 and BL25, Acupuncture at LI11 and ST37, Acupuncture at ST25, BL25, LI11 and ST37, Medicine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.198
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Change From Baseline in Difficulty Degree of Defecation at the 8th Week
Description	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]
Time Frame	baseline and at 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture at ST25 and BL25	Acupuncture at LI11 and ST37	Acupuncture at ST25, BL25, LI11 and ST37	Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.	the points formula of He-points 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.	the formula of He-point,back-shu point and front-mu point 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.	oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Measure Participants	158	166	159	163
0	45 26.8%	46 26.7%	40 24.2%	36 21.2%
1	75 44.6%	88 51.2%	83 50.3%	67 39.4%
2	29 17.3%	25 14.5%	28 17%	44 25.9%
3	9 5.4%	7 4.1%	8 4.8%	16 9.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture at ST25 and BL25, Acupuncture at LI11 and ST37, Acupuncture at ST25, BL25, LI11 and ST37, Medicine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Acupuncture at ST25 and BL25		Acupuncture at LI11 and ST37		Acupuncture at ST25, BL25, LI11 and ST37		Medicine
Arm/Group Description	the points formula of back-shu point combination with front-mu point. 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.		the points formula of He-points 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.		the formula of He-point,back-shu point and front-mu point 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.		oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
All Cause Mortality
	Acupuncture at ST25 and BL25		Acupuncture at LI11 and ST37		Acupuncture at ST25, BL25, LI11 and ST37		Medicine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Acupuncture at ST25 and BL25		Acupuncture at LI11 and ST37		Acupuncture at ST25, BL25, LI11 and ST37		Medicine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/168 (0%)		0/172 (0%)		0/165 (0%)		0/170 (0%)
Other (Not Including Serious) Adverse Events
	Acupuncture at ST25 and BL25		Acupuncture at LI11 and ST37		Acupuncture at ST25, BL25, LI11 and ST37		Medicine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/168 (1.8%)		3/172 (1.7%)		6/165 (3.6%)		6/170 (3.5%)
Eye disorders
Eye discomfort	0/168 (0%)		1/172 (0.6%)		0/165 (0%)		0/170 (0%)
Fundus hemorrhage	0/168 (0%)		0/172 (0%)		0/165 (0%)		1/170 (0.6%)
Gastrointestinal disorders
Diarrhea	0/168 (0%)		0/172 (0%)		0/165 (0%)		1/170 (0.6%)
Musculoskeletal and connective tissue disorders
Joint pains	2/168 (1.2%)		0/172 (0%)		4/165 (2.4%)		0/170 (0%)
Back pain	0/168 (0%)		0/172 (0%)		0/165 (0%)		1/170 (0.6%)
Reproductive system and breast disorders
Irregular menstruation	0/168 (0%)		1/172 (0.6%)		0/165 (0%)		0/170 (0%)
Respiratory, thoracic and mediastinal disorders
Common cold	1/168 (0.6%)		1/172 (0.6%)		2/165 (1.2%)		3/170 (1.8%)

Limitations/Caveats

Unblinding of participants in the acupuncture and mosapride groups;an insufficient duration to assess the long term effect or risks;a missing assessment of electrocardiograms for possible cardiovascular harm of mosapride

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.