Trial Outcomes & Findings for Efficacy and Safety of Acupuncture for Functional Constipation (NCT NCT01411501)
NCT ID: NCT01411501
Last Updated: 2015-12-11
Results Overview
\[average number of spontaneous bowel movements in a week at week 4\]-\[average number of spontaneous bowel movements in a week at baseline\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
684 participants
Primary outcome timeframe
baseline and at 4 weeks
Results posted on
2015-12-11
Participant Flow
The participants were recruited through the inpatients and outpatients settings in the 8 hospitals.We also recruited the participants through television and newspapers advertisements.
Nine enrolled participants refused to join in the trial after signing the informed consent. So they were excluded from the trial.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
168
|
172
|
165
|
170
|
|
Overall Study
COMPLETED
|
158
|
166
|
159
|
163
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Acupuncture for Functional Constipation
Baseline characteristics by cohort
| Measure |
Acupuncture at ST25 and BL25
n=168 Participants
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
n=172 Participants
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
n=165 Participants
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
n=170 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
Total
n=675 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 16.7 • n=4 Participants
|
40.1 years
STANDARD_DEVIATION 16.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
548 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
168 participants
n=5 Participants
|
172 participants
n=7 Participants
|
165 participants
n=5 Participants
|
170 participants
n=4 Participants
|
675 participants
n=21 Participants
|
|
Duration of functional constipation
|
7.0 months
STANDARD_DEVIATION 6.8 • n=5 Participants
|
6.3 months
STANDARD_DEVIATION 6.5 • n=7 Participants
|
5.6 months
STANDARD_DEVIATION 4.3 • n=5 Participants
|
5.8 months
STANDARD_DEVIATION 4.6 • n=4 Participants
|
6.2 months
STANDARD_DEVIATION 5.56 • n=21 Participants
|
|
Received Traditional Chinese Medicine therapies
Acupuncture
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Received Traditional Chinese Medicine therapies
Herbs
|
38 participants
n=5 Participants
|
48 participants
n=7 Participants
|
43 participants
n=5 Participants
|
44 participants
n=4 Participants
|
173 participants
n=21 Participants
|
|
Received Traditional Chinese Medicine therapies
Both
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Received Traditional Chinese Medicine therapies
Neither
|
116 participants
n=5 Participants
|
110 participants
n=7 Participants
|
107 participants
n=5 Participants
|
118 participants
n=4 Participants
|
451 participants
n=21 Participants
|
|
SBMs
|
2.7 times per week
STANDARD_DEVIATION 1.9 • n=5 Participants
|
2.5 times per week
STANDARD_DEVIATION 1.7 • n=7 Participants
|
2.9 times per week
STANDARD_DEVIATION 2.0 • n=5 Participants
|
2.9 times per week
STANDARD_DEVIATION 2.8 • n=4 Participants
|
2.8 times per week
STANDARD_DEVIATION 2.1 • n=21 Participants
|
|
Bristol scale
|
2.8 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Degree of straining during defecation
0
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
5 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Degree of straining during defecation
1
|
63 participants
n=5 Participants
|
60 participants
n=7 Participants
|
68 participants
n=5 Participants
|
59 participants
n=4 Participants
|
250 participants
n=21 Participants
|
|
Degree of straining during defecation
2
|
68 participants
n=5 Participants
|
69 participants
n=7 Participants
|
58 participants
n=5 Participants
|
72 participants
n=4 Participants
|
267 participants
n=21 Participants
|
|
Degree of straining during defecation
3
|
30 participants
n=5 Participants
|
35 participants
n=7 Participants
|
28 participants
n=5 Participants
|
31 participants
n=4 Participants
|
124 participants
n=21 Participants
|
|
Degree of straining during defecation
no defecation
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and at 4 weeks\[average number of spontaneous bowel movements in a week at week 4\]-\[average number of spontaneous bowel movements in a week at baseline\]
Outcome measures
| Measure |
Acupuncture at ST25 and BL25
n=168 Participants
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
n=172 Participants
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
n=165 Participants
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
n=170 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Change of the SBMs From Baseline at Week 4
|
2.7 times per week
Interval 2.3 to 3.0
|
2.7 times per week
Interval 2.3 to 3.1
|
2.2 times per week
Interval 1.9 to 2.5
|
2.4 times per week
Interval 2.0 to 2.9
|
SECONDARY outcome
Timeframe: baseline and at 4 weeksBristol 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.
Outcome measures
| Measure |
Acupuncture at ST25 and BL25
n=168 Participants
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
n=172 Participants
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
n=165 Participants
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
n=170 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Change From Baseline in the Bristol Stool Scale at the 4th Week
|
3.9 units on a scale
Interval 3.7 to 4.1
|
3.9 units on a scale
Interval 3.8 to 4.1
|
3.9 units on a scale
Interval 3.7 to 4.1
|
3.9 units on a scale
Interval 3.7 to 4.1
|
SECONDARY outcome
Timeframe: baseline and at 4 weeksThis 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. \[the average score of one week at the 4th week\]-\[the average score of one week at baseline\]
Outcome measures
| Measure |
Acupuncture at ST25 and BL25
n=158 Participants
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
n=167 Participants
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
n=161 Participants
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
n=164 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
0
|
40 participants
|
41 participants
|
33 participants
|
36 participants
|
|
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
3
|
16 participants
|
12 participants
|
14 participants
|
9 participants
|
|
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
1
|
69 participants
|
78 participants
|
76 participants
|
76 participants
|
|
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
2
|
33 participants
|
36 participants
|
38 participants
|
43 participants
|
SECONDARY outcome
Timeframe: baseline and at 8 weeks\[average number of spontaneous bowel movements in a week at week 8\]-\[average number of spontaneous bowel movements in a week at baseline\]
Outcome measures
| Measure |
Acupuncture at ST25 and BL25
n=168 Participants
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
n=172 Participants
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
n=165 Participants
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
n=170 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Changes of the SBMs From Baseline at Week 8
|
2.3 times per week
Interval 1.9 to 2.7
|
2.4 times per week
Interval 2.1 to 2.7
|
2.1 times per week
Interval 1.7 to 2.5
|
1.4 times per week
Interval 1.0 to 1.8
|
SECONDARY outcome
Timeframe: baseline and at 8 weeksBristol 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.
Outcome measures
| Measure |
Acupuncture at ST25 and BL25
n=168 Participants
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
n=172 Participants
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
n=165 Participants
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
n=170 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Change From Baseline in the Bristol Stool Scale at the 8th Week
|
3.4 units on a scale
Interval 3.2 to 3.6
|
3.6 units on a scale
Interval 3.5 to 3.8
|
3.4 units on a scale
Interval 3.2 to 3.6
|
3.1 units on a scale
Interval 2.9 to 3.3
|
SECONDARY outcome
Timeframe: baseline and at 8 weeksThis 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. \[the average score of one week at the 8th week\]-\[the average score of one week at baseline\]
Outcome measures
| Measure |
Acupuncture at ST25 and BL25
n=158 Participants
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
n=166 Participants
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
n=159 Participants
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
n=163 Participants
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
2
|
29 participants
|
25 participants
|
28 participants
|
44 participants
|
|
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
3
|
9 participants
|
7 participants
|
8 participants
|
16 participants
|
|
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
0
|
45 participants
|
46 participants
|
40 participants
|
36 participants
|
|
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
1
|
75 participants
|
88 participants
|
83 participants
|
67 participants
|
Adverse Events
Acupuncture at ST25 and BL25
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Acupuncture at LI11 and ST37
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Acupuncture at ST25, BL25, LI11 and ST37
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Medicine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture at ST25 and BL25
n=168 participants at risk
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
n=172 participants at risk
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
n=165 participants at risk
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
n=170 participants at risk
oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
|
|---|---|---|---|---|
|
Eye disorders
Eye discomfort
|
0.00%
0/168 • 8 weeks
|
0.58%
1/172 • 8 weeks
|
0.00%
0/165 • 8 weeks
|
0.00%
0/170 • 8 weeks
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/168 • 8 weeks
|
0.58%
1/172 • 8 weeks
|
0.00%
0/165 • 8 weeks
|
0.00%
0/170 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
0.60%
1/168 • 8 weeks
|
0.58%
1/172 • 8 weeks
|
1.2%
2/165 • 8 weeks
|
1.8%
3/170 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pains
|
1.2%
2/168 • 8 weeks
|
0.00%
0/172 • 8 weeks
|
2.4%
4/165 • 8 weeks
|
0.00%
0/170 • 8 weeks
|
|
Eye disorders
Fundus hemorrhage
|
0.00%
0/168 • 8 weeks
|
0.00%
0/172 • 8 weeks
|
0.00%
0/165 • 8 weeks
|
0.59%
1/170 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/168 • 8 weeks
|
0.00%
0/172 • 8 weeks
|
0.00%
0/165 • 8 weeks
|
0.59%
1/170 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/168 • 8 weeks
|
0.00%
0/172 • 8 weeks
|
0.00%
0/165 • 8 weeks
|
0.59%
1/170 • 8 weeks
|
Additional Information
Liu Zhishun
Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Phone: 8610-010-88001124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place