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Efficacy and Safety of Acupuncture for Functional Constipation

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01411501
First received: July 28, 2011
Last updated: November 8, 2015
Last verified: November 2015
Results First Received: September 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Constipation
Interventions: Other: acupuncture
Drug: mosapride citrate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Nine enrolled participants refused to join in the trial after signing the informed consent. So they were excluded from the trial.

Reporting Groups
  Description
Acupuncture at ST25 and BL25

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.

Acupuncture at LI11 and ST37

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.

Acupuncture at ST25, BL25, LI11 and ST37

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.

Medicine

oral use of mosapride citrate

mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal


Participant Flow:   Overall Study
    Acupuncture at ST25 and BL25   Acupuncture at LI11 and ST37   Acupuncture at ST25, BL25, LI11 and ST37   Medicine
STARTED   168   172   165   170 
COMPLETED   158   166   159   163 
NOT COMPLETED   10   6   6   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acupuncture at ST25 and BL25

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.

Acupuncture at LI11 and ST37

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.

Acupuncture at ST25, BL25, LI11 and ST37

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.

Medicine

oral use of mosapride citrate

mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal

Total Total of all reporting groups

Baseline Measures
   Acupuncture at ST25 and BL25   Acupuncture at LI11 and ST37   Acupuncture at ST25, BL25, LI11 and ST37   Medicine   Total 
Overall Participants Analyzed 
[Units: Participants]
 168   172   165   170   675 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.9  (17.4)   39.9  (16.8)   40.7  (16.8)   40.6  (16.7)   40.1  (16.9) 
Gender 
[Units: Participants]
         
Female   128   140   138   142   548 
Male   40   32   27   28   127 
Region of Enrollment 
[Units: Participants]
         
China   168   172   165   170   675 
Duration of functional constipation 
[Units: Months]
Mean (Standard Deviation)
 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 
[Units: 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] 
[Units: Times per week]
Mean (Standard Deviation)
 2.7  (1.9)   2.5  (1.7)   2.9  (2.0)   2.9  (2.8)   2.8  (2.1) 
[1] SBMs, spontaneous bowel movements.
Bristol scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.8  (1.3)   2.9  (1.4)   3.0  (1.5)   2.7  (1.4)   2.9  (1.8) 
[1] 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] 
[Units: Participants]
         
 5   8   9   5   27 
 63   60   68   59   250 
 68   69   58   72   267 
 30   35   28   31   124 
no defecation   2   0   2   3   7 
[1] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change of the SBMs From Baseline at Week 4   [ Time Frame: baseline and at 4 weeks ]

2.  Secondary:   Change From Baseline in the Bristol Stool Scale at the 4th Week   [ Time Frame: baseline and at 4 weeks ]

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

4.  Secondary:   Changes of the SBMs From Baseline at Week 8   [ Time Frame: baseline and at 8 weeks ]

5.  Secondary:   Change From Baseline in the Bristol Stool Scale at the 8th Week   [ Time Frame: baseline and at 8 weeks ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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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
e-mail: liuzhishun@aliyun.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
Study First Received: July 28, 2011
Results First Received: September 25, 2015
Last Updated: November 8, 2015
Health Authority: China: Food and Drug Administration