Constipation
Conditions
Keywords
chronic functional constipation, electro-acupuncture, multi-center randomized controlled trial, efficacy, safety
Brief summary
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.
Detailed description
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.
Interventions
DEVICEelectro-acupuncture
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.
DEVICEsham electro-acupuncture
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.
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
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* meeting the diagnosis of Rome III criteria for chronic functional constipation; * severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months; * 18-75 years old; * no use of medicine for constipation during the two weeks before enrollment (except rescue medication); * no acupuncture treatment for constipation in recent 3 months; * never joined any other trial in process in 3 months; * volunteered to join this research and signed the informed consent.
Exclusion criteria
* Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs; * constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment; * pregnant women or women in lactation period * constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera; * bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera; * cardiac pacemaker carrier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment | Baseline and weeks 1-8 | the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mean Weekly CSBMs During Weeks 9-20 | Baseline and weeks 9-20 | The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline. |
| Mean Weekly SBMs During Weeks 1-8 | Baseline and weeks 1-8 | The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline. |
| Mean Scores for Stool Consistency and Straining During Weeks 1-8 | Baseline and 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. |
| Change of Average Weekly Degree of Difficulty in Defecation From Baseline | Baseline and weeks 1-8 | The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale. 0 = not at all 1. = more straining than not 2. = a great deal 3. = an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline |
| the Percentage of Participants With Three or More Weekly CSBMs | 1-20 weeks | the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20 |
| Number of Participants With Adverse Events Related to Acupuncture | 1-8 weeks | — |
| Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | 1-20 weeks | 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. |
| The Number of Participants Using Rescue Medicine for Constipation | 1-20 weeks | — |
| Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | 1-20 weeks | 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. |
| Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) | baseline and the end of 8th week | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 536 |
| 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. | 539 |
| Total | 1,075 |
Baseline characteristics
| Characteristic | Electro-acupuncture | Sham Electro-acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 89 Participants | 82 Participants | 171 Participants |
| Age, Categorical Between 18 and 65 years | 447 Participants | 457 Participants | 904 Participants |
| average number of times other measures were used Others | 0.08 number of times per week STANDARD_DEVIATION 0.58 | 0.06 number of times per week STANDARD_DEVIATION 0.43 | 0.07 number of times per week STANDARD_DEVIATION 0.51 |
| average number of times other measures were used Rescue medicine | 0.66 number of times per week STANDARD_DEVIATION 1.47 | 0.62 number of times per week STANDARD_DEVIATION 1.91 | 0.64 number of times per week STANDARD_DEVIATION 1.71 |
| Body-mass index | 22.32 kg/m^2 STANDARD_DEVIATION 3.04 | 22.75 kg/m^2 STANDARD_DEVIATION 3 | 22.54 kg/m^2 STANDARD_DEVIATION 3.03 |
| Coexisting illness Diabetes | 11 participants | 10 participants | 21 participants |
| Coexisting illness Digestive system disease | 11 participants | 16 participants | 27 participants |
| Coexisting illness Hypertension | 41 participants | 39 participants | 80 participants |
| Coexisting illness None | 395 participants | 403 participants | 798 participants |
| Coexisting illness Others | 78 participants | 71 participants | 149 participants |
| Complete Spontaneous Bowel Movements (CSBMs) Per Week | 0.39 number of times STANDARD_DEVIATION 0.62 | 0.42 number of times STANDARD_DEVIATION 0.62 | 0.41 number of times STANDARD_DEVIATION 0.62 |
| Constipation duration (mon) | 130.81 month STANDARD_DEVIATION 122.61 | 132.71 month STANDARD_DEVIATION 127 | 131.76 month STANDARD_DEVIATION 124.78 |
| Race/Ethnicity, Customized Han | 519 participants | 526 participants | 1045 participants |
| Race/Ethnicity, Customized Hui | 8 participants | 9 participants | 17 participants |
| Race/Ethnicity, Customized Man | 5 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized Miao | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized other | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Wei | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Zhuang | 1 participants | 2 participants | 3 participants |
| Score of Patient Assessment of Constipation Quality of Life(PAC-QOL) | 77.06 scores on a scale STANDARD_DEVIATION 19.27 | 75.06 scores on a scale STANDARD_DEVIATION 19.26 | 76.06 scores on a scale STANDARD_DEVIATION 19.28 |
| Sex: Female, Male Female | 415 Participants | 407 Participants | 822 Participants |
| Sex: Female, Male Male | 121 Participants | 132 Participants | 253 Participants |
| Spontaneous Bowel Movements (CSBMs) Per Week | 1.90 number of times STANDARD_DEVIATION 1.34 | 2.02 number of times STANDARD_DEVIATION 1.45 | 1.96 number of times STANDARD_DEVIATION 1.4 |
| Use of Other Measures by Participants None | 349 participants | 373 participants | 722 participants |
| Use of Other Measures by Participants Others | 17 participants | 19 participants | 36 participants |
| Use of Other Measures by Participants Rescue medicine | 170 participants | 147 participants | 317 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 534 | 24 / 538 |
| serious Total, serious adverse events | 0 / 534 | 0 / 538 |
Outcome results
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.
Time frame: Baseline and weeks 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment | 1.72 number of times | Standard Error 0.12 |
| Sham Electro-acupuncture | the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment | 0.82 number of times | Standard Error 0.13 |
Comparison: During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P\<0.001) times more than that in the SA group.p-value: <0.001Mixed Models Analysis
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 1. = more straining than not 2. = a great deal 3. = an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline
Time frame: Baseline and weeks 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Change of Average Weekly Degree of Difficulty in Defecation From Baseline | -0.74 scores on a scale | Standard Error 0.03 |
| Sham Electro-acupuncture | Change of Average Weekly Degree of Difficulty in Defecation From Baseline | -0.52 scores on a scale | Standard Error 0.03 |
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.
Time frame: Baseline and weeks 9-20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Changes in Mean Weekly CSBMs During Weeks 9-20 | 1.93 number of times | Standard Error 0.14 |
| Sham Electro-acupuncture | Changes in Mean Weekly CSBMs During Weeks 9-20 | 0.82 number of times | Standard Error 0.14 |
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.
Time frame: 1-20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：Rescue medicine | 0.34 number of times per week | Standard Error 0.04 |
| Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：others | 0.02 number of times per week | Standard Error 0.01 |
| Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week9-20：Rescue medicine | 0.25 number of times per week | Standard Error 0.04 |
| Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 9-20：others | 0.02 number of times per week | Standard Error 0.01 |
| Sham Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 9-20：others | 0.06 number of times per week | Standard Error 0.02 |
| Sham Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：Rescue medicine | 0.52 number of times per week | Standard Error 0.06 |
| Sham Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week9-20：Rescue medicine | 0.37 number of times per week | Standard Error 0.05 |
| Sham Electro-acupuncture | Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：others | 0.02 number of times per week | Standard Error 0.01 |
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.
Time frame: Baseline and weeks 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Mean Scores for Stool Consistency and Straining During Weeks 1-8 | 0.87 score on a scale | Standard Error 0.05 |
| Sham Electro-acupuncture | Mean Scores for Stool Consistency and Straining During Weeks 1-8 | 0.62 score on a scale | Standard Error 0.04 |
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.
Time frame: Baseline and weeks 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Mean Weekly SBMs During Weeks 1-8 | 2.30 number of times | Standard Error 0.1 |
| Sham Electro-acupuncture | Mean Weekly SBMs During Weeks 1-8 | 1.28 number of times | Standard Error 0.1 |
Secondary
Number of Participants With Adverse Events Related to Acupuncture
Time frame: 1-8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electro-acupuncture | Number of Participants With Adverse Events Related to Acupuncture | 31 participants |
| Sham Electro-acupuncture | Number of Participants With Adverse Events Related to Acupuncture | 24 participants |
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.
Time frame: 1-20 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：Rescue medicine | 28.92 percentage of participants |
| Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：others | 2.8 percentage of participants |
| Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week9-20：Rescue medicine | 19.40 percentage of participants |
| Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 9-20：others | 2.24 percentage of participants |
| Sham Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 9-20：others | 3.15 percentage of participants |
| Sham Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：Rescue medicine | 33.95 percentage of participants |
| Sham Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week9-20：Rescue medicine | 23.01 percentage of participants |
| Sham Electro-acupuncture | Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Week 1-8：others | 3.15 percentage of participants |
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.
Time frame: baseline and the end of 8th week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) | -25.65 score on a scale | Standard Error 2.39 |
| Sham Electro-acupuncture | Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) | -18.21 score on a scale | Standard Error 2.39 |
Secondary
The Number of Participants Using Rescue Medicine for Constipation
Time frame: 1-20 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week 1-8：Rescue medicine | 155 participants |
| Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week 1-8：others | 15 participants |
| Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week9-20：Rescue medicine | 104 participants |
| Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week 9-20：others | 12 participants |
| Sham Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week 9-20：others | 17 participants |
| Sham Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week 1-8：Rescue medicine | 183 participants |
| Sham Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week9-20：Rescue medicine | 124 participants |
| Sham Electro-acupuncture | The Number of Participants Using Rescue Medicine for Constipation | Week 1-8：others | 17 participants |
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
Time frame: 1-20 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electro-acupuncture | the Percentage of Participants With Three or More Weekly CSBMs | Week 1-8 | 31.34 percentage of participants |
| Electro-acupuncture | the Percentage of Participants With Three or More Weekly CSBMs | Week 9-20 | 37.69 percentage of participants |
| Sham Electro-acupuncture | the Percentage of Participants With Three or More Weekly CSBMs | Week 1-8 | 12.06 percentage of participants |
| Sham Electro-acupuncture | the Percentage of Participants With Three or More Weekly CSBMs | Week 9-20 | 14.10 percentage of participants |