Trial Outcomes & Findings for Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial (NCT NCT02047045)
NCT ID: NCT02047045
Last Updated: 2021-03-22
Results Overview
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 3-8. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: the latter 6 weeks of treatment (weeks 3-8).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
560 participants
Primary outcome timeframe
over weeks 3-8 (the latter 6-week treatment)
Results posted on
2021-03-22
Participant Flow
Participant milestones
| Measure |
Electro-acupuncture
Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks.
acupuncture: Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
|
Prucalopride
Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast
Prucalopride: Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 8 weeks.
|
|---|---|---|
|
Baseline
STARTED
|
280
|
280
|
|
Baseline
COMPLETED
|
277
|
278
|
|
Baseline
NOT COMPLETED
|
3
|
2
|
|
Treatment Period (8 Weeks )
STARTED
|
277
|
278
|
|
Treatment Period (8 Weeks )
COMPLETED
|
266
|
263
|
|
Treatment Period (8 Weeks )
NOT COMPLETED
|
11
|
15
|
|
Follow-up Period (24 Weeks)
STARTED
|
266
|
263
|
|
Follow-up Period (24 Weeks)
COMPLETED
|
265
|
262
|
|
Follow-up Period (24 Weeks)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Electro-acupuncture
Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks.
acupuncture: Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
|
Prucalopride
Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast
Prucalopride: Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 8 weeks.
|
|---|---|---|
|
Baseline
Withdrawal by Subject
|
3
|
2
|
|
Treatment Period (8 Weeks )
Adverse Event
|
3
|
1
|
|
Treatment Period (8 Weeks )
Lost to Follow-up
|
1
|
3
|
|
Treatment Period (8 Weeks )
Withdrawal by Subject
|
3
|
5
|
|
Treatment Period (8 Weeks )
moved far away out of work
|
3
|
0
|
|
Treatment Period (8 Weeks )
no reason was given
|
1
|
0
|
|
Treatment Period (8 Weeks )
refused to take drugs
|
0
|
5
|
|
Treatment Period (8 Weeks )
for safety considerations
|
0
|
1
|
|
Follow-up Period (24 Weeks)
Adverse Event
|
1
|
1
|
Baseline Characteristics
Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
Total
n=555 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.06 years
STANDARD_DEVIATION 16.12 • n=5 Participants
|
45.79 years
STANDARD_DEVIATION 16.00 • n=7 Participants
|
45.93 years
STANDARD_DEVIATION 16.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
446 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han
|
270 participants
n=5 Participants
|
275 participants
n=7 Participants
|
545 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
China
|
277 participants
n=5 Participants
|
278 participants
n=7 Participants
|
555 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over weeks 3-8 (the latter 6-week treatment)Population: We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the baseline analysis.
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 3-8. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: the latter 6 weeks of treatment (weeks 3-8).
Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
|
36.2 percentage of participants
|
37.8 percentage of participants
|
SECONDARY outcome
Timeframe: over weeks 1-2, 11-12, 15-16, 19-20, 31-32.Population: We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 1-2, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: weeks 1-2, 11-12, 15-16, 19-20, 31-32.
Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
27.1 percentage of participants
|
33.8 percentage of participants
|
|
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
38.3 percentage of participants
|
43.2 percentage of participants
|
|
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
38.0 percentage of participants
|
41.0 percentage of participants
|
|
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
35.7 percentage of participants
|
42.1 percentage of participants
|
|
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
37.6 percentage of participants
|
38.5 percentage of participants
|
SECONDARY outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Population: We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the increase in mean weekly CSBMs of each patient from baseline were calculated over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with ≥1 increase in the mean weekly CSMBs from baseline. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
49.5 percentage of participants
|
61.5 percentage of participants
|
|
the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 3-8
|
66.4 percentage of participants
|
63.3 percentage of participants
|
|
the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
63.5 percentage of participants
|
63.7 percentage of participants
|
|
the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
65.7 percentage of participants
|
66.2 percentage of participants
|
|
the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
61.4 percentage of participants
|
64.0 percentage of participants
|
|
the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
61.0 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Population: We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
1.27 bowel movements
Interval 1.17 to 1.38
|
1.78 bowel movements
Interval 1.66 to 1.89
|
|
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 3-8
|
1.96 bowel movements
Interval 1.86 to 2.06
|
1.97 bowel movements
Interval 1.87 to 2.08
|
|
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
2.00 bowel movements
Interval 1.9 to 2.1
|
2.01 bowel movements
Interval 1.9 to 2.12
|
|
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
1.93 bowel movements
Interval 1.82 to 2.03
|
2.07 bowel movements
Interval 1.95 to 2.18
|
|
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
1.90 bowel movements
Interval 1.8 to 2.0
|
2.00 bowel movements
Interval 1.89 to 2.11
|
|
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
1.94 bowel movements
Interval 1.83 to 2.05
|
1.99 bowel movements
Interval 1.89 to 2.1
|
SECONDARY outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Population: We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
1.85 bowel movements
Interval 1.72 to 1.98
|
2.91 bowel movements
Interval 2.78 to 3.03
|
|
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 3-8
|
2.13 bowel movements
Interval 2.03 to 2.24
|
2.60 bowel movements
Interval 2.49 to 2.7
|
|
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
1.87 bowel movements
Interval 1.76 to 1.97
|
2.43 bowel movements
Interval 2.33 to 2.54
|
|
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
1.65 bowel movements
Interval 1.53 to 1.76
|
2.38 bowel movements
Interval 2.28 to 2.49
|
|
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
1.59 bowel movements
Interval 1.48 to 1.7
|
2.33 bowel movements
Interval 2.22 to 2.44
|
|
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
1.50 bowel movements
Interval 1.38 to 1.62
|
2.24 bowel movements
Interval 2.13 to 2.36
|
SECONDARY outcome
Timeframe: over weeks 1-2, 3-8.Population: The number of participants providing data of stool consistency was 270 in EA group and 266 in prucalopride group.
The change from baseline in the mean score of stool consistency of each SBM over weeks 1-2 and weeks 3-8. Assessing time: baseline, weeks 1-2 and weeks 3-8. Patients will self-report their stool consistency of each SBM according to the 7-type Bristol Stool Form Scale (scored by 1 to 7 respectively). Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3 and 4 were deemed as a normal stool.
Outcome measures
| Measure |
Electro-acupuncture
n=270 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=266 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8.
weeks 1-2
|
0.48 score
Interval -0.08 to 1.13
|
0.67 score
Interval 0.06 to 1.38
|
|
the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8.
weeks 3-8
|
0.78 score
Interval 0.12 to 1.4
|
0.74 score
Interval 0.17 to 1.42
|
SECONDARY outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Population: The number of participants providing data of straining was 271 in EA group and 266 in prucalopride group over weeks 1-2/3-8; The number of participants providing data of straining was 264 in EA group and 261 in prucalopride group over weeks 11-12/15-16/19-20/31-32.
The change from baseline in the mean score of straining of each SBM over weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Assessing time: baseline, weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Patients will self-report their straining degree of each SBM in the defecation diaries according to the following scale. 0 = not difficult; 1 = a little difficult, need some straining to defecate; 2 = difficult, need straining to defecate; 3 = very difficult, need hard straining to defecate. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Electro-acupuncture
n=271 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=266 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
-0.33 score
Interval -0.83 to 0.0
|
-0.52 score
Interval -1.0 to 0.0
|
|
the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
week 3-8
|
-0.54 score
Interval -0.98 to -0.15
|
-0.63 score
Interval -1.0 to -0.13
|
|
the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
-0.60 score
Interval -1.13 to -0.14
|
-0.58 score
Interval -1.14 to 0.0
|
|
the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
-0.59 score
Interval -1.16 to -0.13
|
-0.57 score
Interval -1.13 to 0.0
|
|
the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
-0.67 score
Interval -1.2 to -0.17
|
-0.67 score
Interval -1.18 to 0.0
|
|
the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
-0.67 score
Interval -1.29 to -0.13
|
-0.67 score
Interval -1.24 to 0.0
|
SECONDARY outcome
Timeframe: from the time of their first treatment to the time they having their first CSBMsPopulation: The number of participants providing data of time to the first CSBMs was 272 in EA group and 266 in prucalopride group.
Abbreviation: CSBMs, complete spontaneous bowel movements. Time to the first CSBMs was counted by days. Rescue medicine or other measurements for constipation is not allowed to be used 48 hours before and after the first treatment for evaluating the time to the first complete spontaneous bowel movement. Participants were assessed after the first treatment until they having their first CSBMs.
Outcome measures
| Measure |
Electro-acupuncture
n=272 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=266 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Time to the First CSBMs
|
4 days
Interval 0.0 to 7.0
|
5 days
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: week 4 and week 8Population: The number of participants providing data of PAC-QOL was 261 in EA group and 260 in prucalopride group at week 4; The number of participants providing data of PAC-QOL was 261 in EA group and 257 in prucalopride group at week 8.
The change from baseline of the score of Patient Assessment of Constipation Quality of Life (PAC-QOL) at week 4 and week 8. PAC-QOL is a self-report questionnaire to evaluate the quality of life in patients with constipation, which was distributed by Mapi Research Trust in France. This questionnaire contains 28 items including 4 basic parts of physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. We use the Chinese version in our trial. Assessing point: baseline, week 4 and week 8. The score of PAC-QOL ranged from 1 to 5 (1 indicates no discomfort or feeling very satisfied, 5 indicates extreme severity and always appears or feeling very dissatisfied).
Outcome measures
| Measure |
Electro-acupuncture
n=261 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=260 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life
week 4
|
-0.71 score
Standard Deviation 0.64
|
-0.72 score
Standard Deviation 0.69
|
|
Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life
week 8
|
-1.09 score
Standard Deviation 0.79
|
-1.00 score
Standard Deviation 0.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
13.72 percentage of participants
|
7.91 percentage of participants
|
|
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 3-8
|
19.49 percentage of participants
|
17.99 percentage of participants
|
|
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
9.75 percentage of participants
|
6.83 percentage of participants
|
|
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
10.47 percentage of participants
|
7.19 percentage of participants
|
|
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
10.83 percentage of participants
|
5.76 percentage of participants
|
|
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
10.11 percentage of participants
|
6.47 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
0.75 tablet
Interval 0.5 to 1.0
|
0.50 tablet
Interval 0.5 to 2.5
|
|
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 3-8
|
0.17 tablet
Interval 0.17 to 0.33
|
0.67 tablet
Interval 0.33 to 1.5
|
|
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
0.50 tablet
Interval 0.5 to 1.0
|
0.75 tablet
Interval 0.5 to 2.0
|
|
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
0.50 tablet
Interval 0.5 to 1.0
|
0.50 tablet
Interval 0.5 to 1.5
|
|
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
0.50 tablet
Interval 0.5 to 1.0
|
1.00 tablet
Interval 0.5 to 1.25
|
|
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
0.50 tablet
Interval 0.5 to 1.0
|
1.00 tablet
Interval 0.5 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 1-2
|
40.00 ml
Interval 20.0 to 55.0
|
55.00 ml
Interval 40.0 to 60.0
|
|
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 3-8
|
18.33 ml
Interval 11.67 to 30.0
|
18.33 ml
Interval 10.0 to 35.0
|
|
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 11-12
|
30.00 ml
Interval 20.0 to 67.5
|
20.00 ml
Interval 10.0 to 52.5
|
|
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 15-16
|
55.00 ml
Interval 30.0 to 80.0
|
22.50 ml
Interval 20.0 to 50.0
|
|
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 19-20
|
52.50 ml
Interval 30.0 to 80.0
|
45.00 ml
Interval 25.0 to 52.5
|
|
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
weeks 31-32
|
55.00 ml
Interval 30.0 to 55.0
|
37.50 ml
Interval 20.0 to 55.0
|
POST_HOC outcome
Timeframe: over weeks 1-8A weekly CSBM responder was defined as a patient who had ≥3 CSBMs for a given week and an increase from baseline of ≥1 CSBM for that same week. An overall CSBM responder was a patient who was a weekly CSBM responder for at least 6 of the 8 treatment weeks (75%).
Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Proportion of Overall CSBM Responders Over Weeks 1-8
|
24.91 percentage of participants
|
25.54 percentage of participants
|
POST_HOC outcome
Timeframe: over weeks 1-8Outcome measures
| Measure |
Electro-acupuncture
n=277 Participants
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 Participants
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
the Proportion of Sustained CSBM Responder Over Weeks 1-8
|
24.91 percentage of participants
|
24.46 percentage of participants
|
Adverse Events
Electro-acupuncture
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Prucalopride
Serious events: 0 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Electro-acupuncture
n=277 participants at risk
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 participants at risk
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Cardiac disorders
Cardiac surgery due to myocardial infarction
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
Other adverse events
| Measure |
Electro-acupuncture
n=277 participants at risk
Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any.
EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
After the EA treatment is stopped, the participants will be followed up for 24 weeks.
|
Prucalopride
n=278 participants at risk
Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks.
Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
7.9%
22/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
4/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
13.7%
38/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Fever
|
0.72%
2/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.4%
4/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Faint
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.8%
5/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
4/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
12.9%
36/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Bloating
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.1%
3/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Cold
|
3.6%
10/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
9.0%
25/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Headache
|
1.4%
4/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
12.2%
34/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Dizziness
|
0.72%
2/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
7.2%
20/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Cardiac disorders
Palpitation
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
4.3%
12/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Blood-stained stools due to diarrhea
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Renal and urinary disorders
High uric acid
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Sense of hunger
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Scapulohumeral periarthritis
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Foot sprain
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck and shoulder pain
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Cervical spondylosis
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Local hematoma
|
0.72%
2/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.72%
2/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
2.5%
7/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Psychiatric disorders
Fear or nervous
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Nervous system disorders
Dry mouth
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.72%
2/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Reproductive system and breast disorders
Hyperplasia of mammary glands
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Nervous system disorders
Upper limb numbness
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Psychiatric disorders
Insomnia
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.1%
3/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Empyrosis
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Immune system disorders
Arthrolithisis
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.72%
2/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Distention in head
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Leg Hurt
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Stomachache
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.4%
4/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Knee Arthritis
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Knee joint pain
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.1%
3/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chest distress and short of breath
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Elevated blood pressure
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
General disorders
Toothache
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngalgia
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Soreness of waist
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
1.4%
4/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc herniation
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Psychiatric disorders
Depression
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Wrist sprain
|
0.00%
0/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.36%
1/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Reproductive system and breast disorders
Premature menstruation
|
0.72%
2/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Hepatobiliary disorders
Fatty liver
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.36%
1/277 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
0.00%
0/278 • the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
|
Additional Information
Zhishun Liu
Guang'anmen Hospital, China Academy Chinese Medical Sciences
Phone: +86 010 88002331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place