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Efficacy and Safety of Acupuncture for Functional Constipation

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ClinicalTrials.gov Identifier: NCT01411501
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Constipation
Interventions Other: acupuncture
Drug: mosapride citrate
Enrollment 684
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 Details 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
Hide 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
Arm/Group Title Acupuncture at ST25 and BL25 Acupuncture at LI11 and ST37 Acupuncture at ST25, BL25, LI11 and ST37 Medicine Total
Hide 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 Number of Baseline Participants 168 172 165 170 675
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
38.9  (17.4) 39.9  (16.8) 40.7  (16.8) 40.6  (16.7) 40.1  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 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  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
168 172 165 170 675
Duration of functional constipation  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
Acupuncture 7 9 7 3 26
Herbs 38 48 43 44 173
Both 7 5 8 5 25
Neither 116 110 107 118 451
SBMs   [1] 
Mean (Standard Deviation)
Unit of measure:  Times per week
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
2.7  (1.9) 2.5  (1.7) 2.9  (2.0) 2.9  (2.8) 2.8  (2.1)
[1]
Measure Description: SBMs, spontaneous bowel movements.
Bristol scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
2.8  (1.3) 2.9  (1.4) 3.0  (1.5) 2.7  (1.4) 2.9  (1.8)
[1]
Measure 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.
Degree of straining during defecation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 172 participants 165 participants 170 participants 675 participants
0 5 8 9 5 27
1 63 60 68 59 250
2 68 69 58 72 267
3 30 35 28 31 124
no defecation 2 0 2 3 7
[1]
Measure Description: This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. Zero means defecating with no effort and 3 means defecating with great effort. A 0 score is considered a better than 3 for outcome. Patients score for themselves according to their own feelings.
1.Primary Outcome
Title Change of the SBMs From Baseline at Week 4
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 168 172 165 170
Mean (95% Confidence Interval)
Unit of Measure: times per week
2.7
(2.3 to 3.0)
2.7
(2.3 to 3.1)
2.2
(1.9 to 2.5)
2.4
(2.0 to 2.9)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.352
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Bristol Stool Scale at the 4th Week
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 168 172 165 170
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.9
(3.7 to 4.1)
3.9
(3.8 to 4.1)
3.9
(3.7 to 4.1)
3.9
(3.7 to 4.1)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Difficulty Degree of Defecation at the 4th Week
Hide Description

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]

Time Frame baseline and at 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 158 167 161 164
Measure Type: Number
Unit of Measure: participants
0 40 41 33 36
1 69 78 76 76
2 33 36 38 43
3 16 12 14 9
Show Statistical Analysis 1 Hide 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 [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Changes of the SBMs From Baseline at Week 8
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 168 172 165 170
Mean (95% Confidence Interval)
Unit of Measure: times per week
2.3
(1.9 to 2.7)
2.4
(2.1 to 2.7)
2.1
(1.7 to 2.5)
1.4
(1.0 to 1.8)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Bristol Stool Scale at the 8th Week
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 168 172 165 170
Mean (Full Range)
Unit of Measure: units on a scale
3.4
(3.2 to 3.6)
3.6
(3.5 to 3.8)
3.4
(3.2 to 3.6)
3.1
(2.9 to 3.3)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Difficulty Degree of Defecation at the 8th Week
Hide Description

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]

Time Frame baseline and at 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
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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

Overall Number of Participants Analyzed 158 166 159 163
Measure Type: Number
Unit of Measure: participants
0 45 46 40 36
1 75 88 83 67
2 29 25 28 44
3 9 7 8 16
Show Statistical Analysis 1 Hide 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 [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acupuncture at ST25 and BL25 Acupuncture at LI11 and ST37 Acupuncture at ST25, BL25, LI11 and ST37 Medicine
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acupuncture at ST25 and BL25 Acupuncture at LI11 and ST37 Acupuncture at ST25, BL25, LI11 and ST37 Medicine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/168 (0.00%)   0/172 (0.00%)   0/165 (0.00%)   0/170 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acupuncture at ST25 and BL25 Acupuncture at LI11 and ST37 Acupuncture at ST25, BL25, LI11 and ST37 Medicine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/168 (1.79%)   3/172 (1.74%)   6/165 (3.64%)   6/170 (3.53%) 
Eye disorders         
Eye discomfort *  0/168 (0.00%)  1/172 (0.58%)  0/165 (0.00%)  0/170 (0.00%) 
Fundus hemorrhage *  0/168 (0.00%)  0/172 (0.00%)  0/165 (0.00%)  1/170 (0.59%) 
Gastrointestinal disorders         
Diarrhea *  0/168 (0.00%)  0/172 (0.00%)  0/165 (0.00%)  1/170 (0.59%) 
Musculoskeletal and connective tissue disorders         
Joint pains *  2/168 (1.19%)  0/172 (0.00%)  4/165 (2.42%)  0/170 (0.00%) 
Back pain *  0/168 (0.00%)  0/172 (0.00%)  0/165 (0.00%)  1/170 (0.59%) 
Reproductive system and breast disorders         
Irregular menstruation *  0/168 (0.00%)  1/172 (0.58%)  0/165 (0.00%)  0/170 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Common cold *  1/168 (0.60%)  1/172 (0.58%)  2/165 (1.21%)  3/170 (1.76%) 
*
Indicates events were collected by non-systematic assessment
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
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.
Results Point of Contact
Name/Title: Liu Zhishun
Organization: Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Phone: 8610-010-88001124
Responsible Party: Liu Zhishun, 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