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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.
Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.
This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.
This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electro-acupuncture | Experimental |
Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. |
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| sham electro-acupuncture | Sham Comparator |
Length of Treatment and the treatment sessions are the same as treatment group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electro-acupuncture | Device | Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. |
| Measure | Description | Time Frame |
|---|---|---|
| the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment | the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline. | Baseline and weeks 1-8 |
| Measure | Description | Time Frame |
|---|---|---|
| the Percentage of Participants With Three or More Weekly CSBMs | the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20 | 1-20 weeks |
| Changes in Mean Weekly CSBMs During Weeks 9-20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baoyan Liu, Master | Vice President of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31636713 | Derived | Wang Y, Liu Y, Zhou K, Bauer BA, Liu B, Su T, Mo Q, Liu Z. The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial. Ther Adv Gastroenterol. 2019 Oct 9;12:1756284819881859. doi: 10.1177/1756284819881859. eCollection 2019. | |
| 27618593 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electro-acupuncture | The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose. The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose. Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. |
| FG001 | Sham Electro-acupuncture | The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Electro-acupuncture | The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose. The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose. Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment | the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline. | Posted | Mean | Standard Error | number of times | Baseline and weeks 1-8 |
|
All through the study
All Adverse events（AE）were recorded and measured by both participants themselves and acupuncturists.3 cases(2 in electro-acupuncture(EA)group and 1 in sham EA group)dropped out of this research before getting any intervention for effect,only having baseline data.Multipl imputation was adopted for these 3 in outcome measure part,but not for AE part.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electro-acupuncture | Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left needle | Injury, poisoning and procedural complications | Non-systematic Assessment |
The 8-week treatment and 12-week follow-up may not be long enough for EA to show its specific therapeutic effect. Efficacy of electro-acupuncture in relieving severe constipation was evaluated without classifying the types of constipation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liu Zhishun | Guang An Men Hosptial of China Academy of Chinese Medical Sciences | 86 13651016313 | liuzhishun@hotmail.com |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| sham electro-acupuncture | Device | Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group. |
|
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The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.
| Baseline and weeks 9-20 |
| Mean Weekly SBMs During Weeks 1-8 | The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline. | Baseline and weeks 1-8 |
| Mean Scores for Stool Consistency and Straining During Weeks 1-8 | average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, 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, 4 are normal. | Baseline and weeks 1-8 |
| Change of Average Weekly Degree of Difficulty in Defecation From Baseline | The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale. 0 = not at all
| Baseline and weeks 1-8 |
| Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) | Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline. | baseline and the end of 8th week |
| Number of Participants With Adverse Events Related to Acupuncture | 1-8 weeks |
| Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements. | 1-20 weeks |
| The Number of Participants Using Rescue Medicine for Constipation | 1-20 weeks |
| Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements. | 1-20 weeks |
| Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13. |
| 23768191 | Derived | Liu Z, Liu J, Zhao Y, Cai Y, He L, Xu H, Zhou X, Yan S, Lao L, Liu B. The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial. Trials. 2013 Jun 15;14:176. doi: 10.1186/1745-6215-14-176. |
| BG001 | Sham Electro-acupuncture | The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Body-mass index | Body-mass index was measured by research assistants.Data were tested using Student's t test. | Mean | Standard Deviation | kg/m^2 |
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| Constipation duration (mon) | Constipation duration was self-reported by participants.Data were tested using Student's t test. | Mean | Standard Deviation | month |
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| Coexisting illness | Coexisting illnesses was self-reported by participants.Data were tested using chi-square test. | Number | participants |
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| Use of Other Measures by Participants | Use of Other Measures by Participants:Data were tested using chi-square test. | Number | participants |
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| average number of times other measures were used | Average number of times other measures were used self-reported by participants.Data were tested using Student's t test. | Mean | Standard Deviation | number of times per week |
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| Complete Spontaneous Bowel Movements (CSBMs) Per Week | Number of CSBMs/week during the 2-week screening period was calculated from participants' diaries by summing weekly CSBMs or SBMs then dividing by two.Data were tested using Student's t test. | Mean | Standard Deviation | number of times |
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| Spontaneous Bowel Movements (CSBMs) Per Week | SBMs/week during the 2-week screening period was calculated from participants' diaries by summing weekly CSBMs or SBMs then dividing by two. | Mean | Standard Deviation | number of times |
|
| Score of Patient Assessment of Constipation Quality of Life(PAC-QOL) | The PAC-QOL was administered by research assistants at the baseline visit and was reported by participants.Data were tested using Student's t test.PAC-QOL scale ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Sham Electro-acupuncture | Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation. |
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| Secondary | the Percentage of Participants With Three or More Weekly CSBMs | the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20 | Posted | Number | percentage of participants | 1-20 weeks |
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| Secondary | Changes in Mean Weekly CSBMs During Weeks 9-20 | The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline. | Posted | Mean | Standard Error | number of times | Baseline and weeks 9-20 |
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| Secondary | Mean Weekly SBMs During Weeks 1-8 | The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline. | Posted | Mean | Standard Error | number of times | Baseline and weeks 1-8 |
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|
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| Secondary | Mean Scores for Stool Consistency and Straining During Weeks 1-8 | average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, 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, 4 are normal. | Posted | Mean | Standard Error | score on a scale | Baseline and weeks 1-8 |
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| Secondary | Change of Average Weekly Degree of Difficulty in Defecation From Baseline | The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale. 0 = not at all
| Posted | Mean | Standard Error | scores on a scale | Baseline and weeks 1-8 |
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| Secondary | Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) | Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline. | Posted | Mean | Standard Error | score on a scale | baseline and the end of 8th week |
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| Secondary | Number of Participants With Adverse Events Related to Acupuncture | Posted | Number | participants | 1-8 weeks |
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| Secondary | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements. | Posted | Mean | Standard Error | number of times per week | 1-20 weeks |
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| Secondary | The Number of Participants Using Rescue Medicine for Constipation | Posted | Number | participants | 1-20 weeks |
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| Secondary | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements. | Posted | Number | percentage of participants | 1-20 weeks |
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| 0 |
| 534 |
| 31 |
| 534 |
| EG001 | Sham Electro-acupuncture | Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation. | 0 | 538 | 24 | 538 |
| Nausea during acupuncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Faint during acupuncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Unbearable pricking (VAS≥8) | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pricking lasted more than 0.5 hour | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hematoma around the site of needling | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Bleeding/numbness/infection around the site of needling | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Sleeplessness after acupuncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Dizziness after acupuncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Other discomforts after acupuncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Week9-20：Rescue medicine |
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| Week 9-20：others |
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| Week9-20：Rescue medicine |
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| Week 9-20：others |
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| Week9-20：Rescue medicine |
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| Week 9-20：others |
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