Constipation
Conditions
Keywords
severe chronic constipation, randomized controlled, electro-acupuncture, prucalopride
Brief summary
This trial is primarily aimed to compare the effect and safety of electro-acupuncture and prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3\ 6 months? Then, assess the patients' acceptance of electro-acupuncture.
Detailed description
Study design: this trial is a multi-central randomized controlled trial which contains 14 centers. Random sequences will be generated by the clinical evaluating center of China Academy of Chinese Medical Sciences. Subjects are patients who have severe chronic constipation. Sample size evaluation: Sample size will be based on the proportion of patients having mean complete spontaneous bowel movements (CSBMs) no less than 3 times per week. The proportion is 31.67% in our phase I clinical trial by using electro-acupuncture, and 30.9% in another trial by using prucalopride.The total sample size is 560. Periods and primary outcome: participants will be assessed at baseline for 2 weeks, treated for 8 weeks, and followed up for 24 weeks. Primary outcome is the proportion of patients having mean CSBMs/week no less than 3 times over the latter 6-week treatment. Quality control: the study is a randomized controlled trial; participants were included strictly; evaluators and statisticians are blinded; quality control officers of 3 different levels will supervise this trial. Data management: this trial will use the Remote Dara Capture (RDC) system for data entering and Data Verification Plan (DVP) for data examining. Statistical analysis: Intention-To-Treat (ITT) analysis will be used in this study. One-sided test (non-inferiority) will be used for testing the primary outcomes; meanwhile, two-sided test will be used for evaluating other outcomes. A P value equal to or less than 0.05 is considered to indicate statistical significance.
Interventions
PROCEDUREacupuncture
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.
DRUGPrucalopride
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 32 weeks.
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. meeting Rome Ⅲ criteria for diagnosing functional constipation; 2. severe chronic constipation (two or fewer CSBMs per week for more than 3 months）; 3. the weekly mean CSBMs are no more than 2 times during the 2-week baseline 4. aged from 18 to 75 years old 5. no use of drugs for constipation (emergency treatments should be excepted) during at least 2 weeks before enrollment; no acupuncture treatment for constipation in the previous 1 month; never joined any other trial in progress; 6. volunteered to join this research and signed the informed consent
Exclusion criteria
1. irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs; 2. mushy stool or watery stool are showed more than once during baseline when defecating spontaneously without any laxative (Bristol stool type 6 or 7); 3. history of pelvic floor dysfunction; 4. taking medicine in progress which can induce constipation; 5. severe hemorrhoid or anal fissure; 6. constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, abdominal aortic aneurysm or hepatosplenomegaly, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment; 7. women in gestation or lactation period; 8. blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin; 9. cardiac pacemaker carrier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. | — |
| 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. |
Other
| Measure | Time frame |
|---|---|
| Average Dosage of Glycerine Enema Used Weekly 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. |
| Average Dosage of Bisacodyl Used Weekly 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electro-acupuncture 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. | 277 |
| Prucalopride 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. | 278 |
| Total | 555 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | Withdrawal by Subject | 3 | 2 |
| Follow-up Period (24 Weeks) | Adverse Event | 1 | 1 |
| Treatment Period (8 Weeks ) | Adverse Event | 3 | 1 |
| Treatment Period (8 Weeks ) | for safety considerations | 0 | 1 |
| Treatment Period (8 Weeks ) | Lost to Follow-up | 1 | 3 |
| 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 ) | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Electro-acupuncture | Prucalopride | Total |
|---|---|---|---|
| Age, Continuous | 46.06 years STANDARD_DEVIATION 16.12 | 45.79 years STANDARD_DEVIATION 16 | 45.93 years STANDARD_DEVIATION 16.06 |
| Race/Ethnicity, Customized Han | 270 participants | 275 participants | 545 participants |
| Race/Ethnicity, Customized Others | 7 participants | 3 participants | 10 participants |
| Region of Enrollment China | 277 participants | 278 participants | 555 participants |
| Sex: Female, Male Female | 222 Participants | 224 Participants | 446 Participants |
| Sex: Female, Male Male | 55 Participants | 54 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 277 | 123 / 278 |
| serious Total, serious adverse events | 1 / 277 | 0 / 278 |
Outcome results
Primary
the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electro-acupuncture | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | 36.2 percentage of participants |
| Prucalopride | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | 37.8 percentage of participants |
Secondary
Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life
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).
Time frame: week 4 and week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electro-acupuncture | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | week 4 | -0.71 score | Standard Deviation 0.64 |
| Electro-acupuncture | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | week 8 | -1.09 score | Standard Deviation 0.79 |
| Prucalopride | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | week 4 | -0.72 score | Standard Deviation 0.69 |
| Prucalopride | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | week 8 | -1.00 score | Standard Deviation 0.78 |
Secondary
Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | 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 | 2.00 bowel movements |
| Prucalopride | 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 | 1.78 bowel movements |
| Prucalopride | 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 | 2.07 bowel movements |
| Prucalopride | 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 | 1.97 bowel movements |
| Prucalopride | 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 | 1.99 bowel movements |
| Prucalopride | 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 | 2.01 bowel movements |
Secondary
Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | 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 | 2.33 bowel movements |
| Prucalopride | 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 | 2.91 bowel movements |
| Prucalopride | 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 | 2.38 bowel movements |
| Prucalopride | 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 | 2.60 bowel movements |
| Prucalopride | 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 | 2.24 bowel movements |
| Prucalopride | 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 | 2.43 bowel movements |
Secondary
the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. | weeks 1-2 | 0.67 score |
| Prucalopride | the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. | weeks 3-8 | 0.74 score |
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | 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 |
| Prucalopride | 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 | -0.52 score |
| Prucalopride | 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 | -0.57 score |
| Prucalopride | 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 | -0.63 score |
| Prucalopride | 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 |
| Prucalopride | 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 | -0.58 score |
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | 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 | 64.0 percentage of participants |
| Prucalopride | 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 | 61.5 percentage of participants |
| Prucalopride | 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 | 66.2 percentage of participants |
| Prucalopride | 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 | 63.3 percentage of participants |
| Prucalopride | 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 | 61.5 percentage of participants |
| Prucalopride | 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 | 63.7 percentage of participants |
Secondary
the Proportion of Participants With ≥3 Mean Weekly CSBMs 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | weeks 19-20 | 42.1 percentage of participants |
| Prucalopride | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | weeks 1-2 | 33.8 percentage of participants |
| Prucalopride | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | weeks 11-12 | 43.2 percentage of participants |
| Prucalopride | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | weeks 15-16 | 41.0 percentage of participants |
| Prucalopride | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | weeks 31-32 | 38.5 percentage of participants |
Secondary
Time to the 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.
Time frame: from the time of their first treatment to the time they having their first CSBMs
Population: The number of participants providing data of time to the first CSBMs was 272 in EA group and 266 in prucalopride group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electro-acupuncture | Time to the First CSBMs | 4 days |
| Prucalopride | Time to the First CSBMs | 5 days |
Other Pre-specified
Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time frame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 19-20 | 1.00 tablet |
| Prucalopride | Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 1-2 | 0.50 tablet |
| Prucalopride | 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 |
| Prucalopride | Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 3-8 | 0.67 tablet |
| Prucalopride | Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 31-32 | 1.00 tablet |
| Prucalopride | Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 11-12 | 0.75 tablet |
Other Pre-specified
Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time frame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 19-20 | 45.00 ml |
| Prucalopride | Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 1-2 | 55.00 ml |
| Prucalopride | Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 15-16 | 22.50 ml |
| Prucalopride | 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 |
| Prucalopride | Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 31-32 | 37.50 ml |
| Prucalopride | Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 11-12 | 20.00 ml |
Other Pre-specified
Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
Time frame: over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Electro-acupuncture | 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 |
| Prucalopride | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 31-32 | 6.47 percentage of participants |
| Prucalopride | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 1-2 | 7.91 percentage of participants |
| Prucalopride | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 3-8 | 17.99 percentage of participants |
| Prucalopride | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 11-12 | 6.83 percentage of participants |
| Prucalopride | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 19-20 | 5.76 percentage of participants |
| Prucalopride | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | weeks 15-16 | 7.19 percentage of participants |
Post Hoc
the Proportion of Overall CSBM Responders Over Weeks 1-8
A 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%).
Time frame: over weeks 1-8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electro-acupuncture | the Proportion of Overall CSBM Responders Over Weeks 1-8 | 24.91 percentage of participants |
| Prucalopride | the Proportion of Overall CSBM Responders Over Weeks 1-8 | 25.54 percentage of participants |
Post Hoc
the Proportion of Sustained CSBM Responder Over Weeks 1-8
Time frame: over weeks 1-8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electro-acupuncture | the Proportion of Sustained CSBM Responder Over Weeks 1-8 | 24.91 percentage of participants |
| Prucalopride | the Proportion of Sustained CSBM Responder Over Weeks 1-8 | 24.46 percentage of participants |