Trial · NCT02047045
Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
NCT02047045, Not applicable, Completed, Guang'anmen Hospital of China Academy of Chinese Medical Sciences; results first posted 2020-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial. Trials, record NCT02047045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02047045
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
- NCT number
- NCT02047045
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 560 participants, actual
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Conditions
- Constipation
- Interventions
- acupuncture, Prucalopride
- First posted
- 2014-01-28
- Last updated
- 2021-03-22
- Results first posted
- 2020-01-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | over weeks 3-8 (the latter 6-week treatment) | 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). |
| Secondary | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 11-12, 15-16, 19-20, 31-32. | 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. |
| Secondary | 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. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | 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. |
| Secondary | Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | |
| Secondary | Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | |
| Secondary | the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. | over weeks 1-2, 3-8. | 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. |
| Secondary | 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. | over weeks 1-2, 3-8, 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. |
| Secondary | Time to the First CSBMs | from the time of their first treatment to the time they having their first CSBMs | 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. |
| Secondary | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | week 4 and 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). |
| Other | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | over weeks 3-8 (the latter 6-week treatment) | 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. | percentage of participants | NUMBER |
| SECONDARY | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 11-12, 15-16, 19-20, 31-32. | 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. | percentage of participants | NUMBER |
| SECONDARY | 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. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | 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. | percentage of participants | NUMBER |
| SECONDARY | Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | 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. | bowel movements | MEAN |
| SECONDARY | Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | 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. | bowel movements | MEAN |
| SECONDARY | the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. | over weeks 1-2, 3-8. | The number of participants providing data of stool consistency was 270 in EA group and 266 in prucalopride group. | score | MEDIAN |
| SECONDARY | 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. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | 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. | score | MEDIAN |
| SECONDARY | Time to the First CSBMs | from the time of their first treatment to the time they having their first CSBMs | The number of participants providing data of time to the first CSBMs was 272 in EA group and 266 in prucalopride group. | days | MEDIAN |
| SECONDARY | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | week 4 and week 8 | 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. | score | MEAN |
| OTHER_PRE_SPECIFIED | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | Electro-acupuncture | 36.2 | percentage of participants | ||
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | Prucalopride | 37.8 | percentage of participants | ||
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Electro-acupuncture | weeks 1-2 | 27.1 | percentage of participants | |
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Prucalopride | weeks 1-2 | 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. | Electro-acupuncture | weeks 11-12 | 38.3 | percentage of participants | |
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Prucalopride | weeks 11-12 | 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. | Electro-acupuncture | weeks 15-16 | 38.0 | percentage of participants | |
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Prucalopride | weeks 15-16 | 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. | Electro-acupuncture | weeks 19-20 | 35.7 | percentage of participants | |
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Prucalopride | weeks 19-20 | 42.1 | percentage of participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline | STARTED | Electro-acupuncture | 280 | |
| Baseline | STARTED | Prucalopride | 280 | |
| Baseline | COMPLETED | Electro-acupuncture | 277 | |
| Baseline | COMPLETED | Prucalopride | 278 | |
| Baseline | NOT COMPLETED | Electro-acupuncture | 3 | |
| Baseline | NOT COMPLETED | Prucalopride | 2 | |
| Treatment Period (8 Weeks ) | STARTED | Electro-acupuncture | 277 | |
| Treatment Period (8 Weeks ) | STARTED | Prucalopride | 278 | |
| Treatment Period (8 Weeks ) | COMPLETED | Electro-acupuncture | 266 | |
| Treatment Period (8 Weeks ) | COMPLETED | Prucalopride | 263 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Electro-acupuncture | 1 | 277 | |
| other | Nausea | Gastrointestinal disorders | Prucalopride | 22 | 278 | |
| other | Abdominal Pain | Gastrointestinal disorders | Electro-acupuncture | 4 | 277 | |
| other | Abdominal Pain | Gastrointestinal disorders | Prucalopride | 38 | 278 | |
| other | Fever | General disorders | Electro-acupuncture | 2 | 277 | |
| other | Fever | General disorders | Prucalopride | 4 | 278 | |
| other | Faint | General disorders | Electro-acupuncture | 1 | 277 | |
| other | Faint | General disorders | Prucalopride | 5 | 278 | |
| other | Diarrhea | Gastrointestinal disorders | Electro-acupuncture | 4 | 277 | |
| other | Diarrhea | Gastrointestinal disorders | Prucalopride | 36 | 278 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Electro-acupuncture | ||
| Total, all-cause mortality | Prucalopride | ||
| Total, other adverse events | Electro-acupuncture | 49 | 277 |
| Total, other adverse events | Prucalopride | 123 | 278 |
| Total, serious adverse events | Electro-acupuncture | 1 | 277 |
| Total, serious adverse events | Prucalopride | 0 | 278 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Electro-acupuncture vs Prucalopride: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02047045
GET https://conductscience.org/api/trials/v1/NCT02047045/results?page=2