Trial Outcomes & Findings for A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation (NCT NCT00508482)
NCT ID: NCT00508482
Last Updated: 2014-06-04
Results Overview
Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
475 participants
Primary outcome timeframe
over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up
Results posted on
2014-06-04
Participant Flow
Recruitment ot this trial started in April 2008 and finished in Dec. 2010. Patients were recruited from clinics in each center by posters and advertisements in newspapers.
Participant milestones
| Measure |
Deep Needling Group
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Over 4 Weeks of Treatment
STARTED
|
237
|
119
|
119
|
|
Over 4 Weeks of Treatment
COMPLETED
|
216
|
102
|
99
|
|
Over 4 Weeks of Treatment
NOT COMPLETED
|
21
|
17
|
20
|
|
at the 4th Week of Follow-up
STARTED
|
216
|
102
|
99
|
|
at the 4th Week of Follow-up
COMPLETED
|
196
|
96
|
98
|
|
at the 4th Week of Follow-up
NOT COMPLETED
|
20
|
6
|
1
|
|
at the 12th Week of Follow-up
STARTED
|
196
|
96
|
98
|
|
at the 12th Week of Follow-up
COMPLETED
|
196
|
96
|
98
|
|
at the 12th Week of Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Deep Needling Group
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Over 4 Weeks of Treatment
Changed mind, didn't want to participate
|
9
|
7
|
4
|
|
Over 4 Weeks of Treatment
Lost to Follow-up
|
12
|
10
|
16
|
|
at the 4th Week of Follow-up
Lost to Follow-up
|
20
|
6
|
1
|
Baseline Characteristics
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
Baseline characteristics by cohort
| Measure |
Deep Needling Group
n=237 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=119 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=119 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
401 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Age, Continuous
|
45.18 years
STANDARD_DEVIATION 17.28 • n=5 Participants
|
45.21 years
STANDARD_DEVIATION 17.40 • n=7 Participants
|
43.71 years
STANDARD_DEVIATION 17.23 • n=5 Participants
|
44.87 years
STANDARD_DEVIATION 17.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
372 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Han
|
229 participants
n=5 Participants
|
115 participants
n=7 Participants
|
114 participants
n=5 Participants
|
458 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Minority
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
China
|
237 participants
n=5 Participants
|
119 participants
n=7 Participants
|
119 participants
n=5 Participants
|
475 participants
n=4 Participants
|
|
mean spontaneous bowel movements
|
2 stools/week
n=5 Participants
|
2 stools/week
n=7 Participants
|
2 stools/week
n=5 Participants
|
2 stools/week
n=4 Participants
|
|
straining during defecation
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=4 Participants
|
|
Incomplete evacuation
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=4 Participants
|
|
Stool consistency
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=4 Participants
|
|
abdominal distention
|
1 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
1 units on a scale
n=5 Participants
|
1 units on a scale
n=4 Participants
|
|
Cleveland Clinic Score
|
13 units on a scale
n=5 Participants
|
13 units on a scale
n=7 Participants
|
13 units on a scale
n=5 Participants
|
13 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-upPopulation: Intention-To-Treat(ITT) analysis was used.
Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Change of Mean Weekly Spontaneous Bowel Movements
over 4 weeks of treatment
|
2 stools/week
Interval 1.25 to 3.0
|
2 stools/week
Interval 1.0 to 2.75
|
2 stools/week
Interval 1.0 to 3.0
|
|
Change of Mean Weekly Spontaneous Bowel Movements
at the 12th week of follow-up
|
2 stools/week
Interval 0.5 to 3.0
|
1.5 stools/week
Interval 0.5 to 3.0
|
1 stools/week
Interval 0.0 to 2.0
|
|
Change of Mean Weekly Spontaneous Bowel Movements
at the 4th week of follow-up
|
2 stools/week
Interval 1.0 to 3.0
|
2 stools/week
Interval 0.0 to 3.0
|
1 stools/week
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: over 4 weeks of treatmentPopulation: ITT analysis was used
Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Change of Mean Value of Straining During Defecating
|
0.835 units on a scale
Standard Deviation 0.037 • Interval 0.25 to 1.5
|
0.789 units on a scale
Standard Deviation 0.053 • Interval 0.06 to 1.5
|
0.868 units on a scale
Standard Deviation 0.053 • Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: over 4 weeks of treatmentPopulation: ITT analysis was used.
Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Change of Mean Value of Incomplete Evacuation
|
0.75 units on a scale
Interval 0.0 to 1.5
|
0.75 units on a scale
Interval 0.0 to 1.5
|
0.75 units on a scale
Interval -0.25 to 1.25
|
SECONDARY outcome
Timeframe: over 4 weeks of treatmentPopulation: ITT analysis was used.
Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Change of Mean Value of Stool Consistency
|
0.414 units on a scale
Standard Deviation 0.025 • Interval 0.0 to 1.0
|
0.438 units on a scale
Standard Deviation 0.035 • Interval 0.0 to 1.0
|
0.701 units on a scale
Standard Deviation 0.035 • Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: over 4 weeks of treatmentPopulation: ITT analysis was used.
Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Change of Mean Value of Abdominal Distention
|
0.762 units on a scale
Standard Deviation 0.033 • Interval 5.0 to 9.0
|
0.693 units on a scale
Standard Deviation 0.041 • Interval 6.0 to 9.0
|
0.661 units on a scale
Standard Deviation 0.047 • Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: over 4 weeks of treatmentPopulation: ITT analysis was used
Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Change of Mean Value of Cleveland Clinic Score
|
4.5 units on a scale
Interval 2.25 to 7.25
|
4.38 units on a scale
Interval 1.06 to 6.44
|
4 units on a scale
Interval 1.25 to 6.25
|
SECONDARY outcome
Timeframe: counting by hoursPopulation: ITT analysis was used
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Time to the First Spontaneous Bowel Movement After the First Treatment
|
27.08 hours
Standard Deviation 27.53 • Interval 2.0 to 3.0
|
36.68 hours
Standard Deviation 32.75 • Interval 2.0 to 3.0
|
16.52 hours
Standard Deviation 18.84 • Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: over 4 weeks of treatmentPopulation: ITT analysis was used.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Percentage of the Usage of Emergency Drugs
|
9.65 percentage of participants
|
8.04 percentage of participants
|
33.91 percentage of participants
|
SECONDARY outcome
Timeframe: at the 4th week of follow-upPopulation: ITT analysis was used
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Percentage of the Usage of Emergency Drugs
|
10.53 percentage of participants
|
12.50 percentage of participants
|
30.43 percentage of participants
|
SECONDARY outcome
Timeframe: at the 12th week of follow-upPopulation: ITT analysis was used.
Outcome measures
| Measure |
Deep Needling Group
n=228 Participants
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 Participants
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 Participants
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Percentage of the Usage of Emergency Drugs
|
17.11 percentage of participants
|
14.29 percentage of participants
|
29.57 percentage of participants
|
Adverse Events
Deep Needling Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Shallow Needling Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lactulose Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Deep Needling Group
n=228 participants at risk
Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.
After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30\~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.
Patients were treated once a day, five times a week for continuous 4 weeks.
|
Shallow Needling Group
n=112 participants at risk
Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
|
Lactulose Group
n=115 participants at risk
Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
moderate or above pricking
|
0.88%
2/228 • Number of events 2 • The adverse event data were collected in about more than two years.
|
0.89%
1/112 • Number of events 1 • The adverse event data were collected in about more than two years.
|
0.00%
0/115 • The adverse event data were collected in about more than two years.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hemorrhage
|
1.3%
3/228 • Number of events 3 • The adverse event data were collected in about more than two years.
|
2.7%
3/112 • Number of events 3 • The adverse event data were collected in about more than two years.
|
0.00%
0/115 • The adverse event data were collected in about more than two years.
|
|
General disorders
mild fatigue
|
0.44%
1/228 • Number of events 1 • The adverse event data were collected in about more than two years.
|
0.89%
1/112 • Number of events 1 • The adverse event data were collected in about more than two years.
|
0.00%
0/115 • The adverse event data were collected in about more than two years.
|
|
Gastrointestinal disorders
diarrhea and abdominal discomfort
|
0.00%
0/228 • The adverse event data were collected in about more than two years.
|
0.00%
0/112 • The adverse event data were collected in about more than two years.
|
8.7%
10/115 • Number of events 10 • The adverse event data were collected in about more than two years.
|
Additional Information
Dr. Zhishun Liu
Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences
Phone: 0086-010-88001124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place