Trial Outcomes & Findings for Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer (NCT NCT03797586)

NCT ID: NCT03797586

Last Updated: 2025-07-15

Results Overview

A responder（Participant With Response） is defined as a patient that has at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM a week from the baseline for at least 6 of the 8 weeks of the treatment period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: weeks 1-8
• Results posted on: 2025-07-15

Participant Flow

Participant milestones

Measure	Electroacupuncture Group Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Overall Study STARTED	50	50
Overall Study COMPLETED	46	41
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal

Measure	Electroacupuncture Group Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Overall Study Lost to Follow-up	3	6
Overall Study Death	1	1
Overall Study Adverse Event	0	2

Baseline Characteristics

Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer

Baseline characteristics by cohort

Measure	Electroacupuncture Group n=50 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. The location of the acupoints will be based on Nomenclature and location of acupuncture points34 drafted in 2006 by the National Standard of the People's Republic of China (GB/T 12346-2006). The local skin will be routinely sterilized while the patient is in a supine position. For ST25 and SP14, 0.30×50 mm or 0.30×75 mm needles will be gently vertically inserted to the muscle layer of the abdominal wall, where patients will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Paired alligator clips of the EA apparatus will then be attached to the needle holders of the bilateral ST25, SP14, and ST37. The stimulation will be retained for 30 minutes, with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA. All needles will be removed after 30 minutes and pressure will be applied using a dry sterilized cotton ball to avoid bleeding. Patients will receive 24 treatment sessions over an 8-week period (3 sessions each week, ideally every other day). Patients will be followed up for another 8 weeks after the treatment stopped.	Sham Electroacupuncture Group n=50 Participants The patients in the sham electroacupuncture group will receive minimal needling at non-acupoints as bilateral sham ST25, SP14, and ST37. The sham ST25 and SP14 are located 2 cm horizontally outward of the points stimulaed in the EA group. The sham ST37 point is located outward of ST37 in the middle of the stomach and gallbladder channel. After sterilization of the skin, 0.30×40 mm needles will be directly inserted about 2-3 mm until they can stand up when attached by the alligator clips. No manipulation will be used and no deqi sensation will be elicited at any of the sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on. Patients will receive 24 treatment sessions over an 8-week period (3 sessions each week, ideally every other day). Patients will be followed up for another 8 weeks after the treatment stopped.	Total n=100 Participants Total of all reporting groups
Age, Continuous	63.60 years STANDARD_DEVIATION 10.40 • n=5 Participants	65.12 years STANDARD_DEVIATION 10.64 • n=7 Participants	64.36 years STANDARD_DEVIATION 10.50 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Han	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Race/Ethnicity, Customized Others	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment China	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
ECOG performance status 0	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
ECOG performance status 1	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
ECOG performance status 2	36 Participants n=5 Participants	22 Participants n=7 Participants	58 Participants n=5 Participants
ECOG performance status 3	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Type of primary cancer Lung	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Type of primary cancer Breast	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Type of primary cancer Colorectal	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Type of primary cancer Stomach	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Type of primary cancer Others	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Patients with cancer metastasis upon enrollment	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Type of treatment received at baseline Radiotherapy	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Type of treatment received at baseline Chemotherapy	33 Participants n=5 Participants	19 Participants n=7 Participants	52 Participants n=5 Participants
Type of treatment received at baseline Chemotherapy + radiotherapy	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Type of treatment received at baseline Targeted therapy	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Type of treatment received at baseline Other	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Type of opioid administered Oxycodone	25 Participants n=5 Participants	39 Participants n=7 Participants	64 Participants n=5 Participants
Type of opioid administered Morphine	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Type of opioid administered Others	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
No. of patients stratified by opioid dose 30-100 mg	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
No. of patients stratified by opioid dose >100 mg	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
History of chronic functional constipation	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: weeks 1-8

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8.

A responder（Participant With Response） is defined as a patient that has at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM a week from the baseline for at least 6 of the 8 weeks of the treatment period.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With Response	19 participants	4 participants

SECONDARY outcome

Timeframe: weeks 1-8, and weeks 13-16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 and weeks 13-16 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
A Change in the Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16. weeks 1-8	1.17 spontaneous bowel movements/week Interval 1.0 to 1.34	0.61 spontaneous bowel movements/week Interval 0.43 to 0.78
A Change in the Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16. weeks 13-16	0.59 spontaneous bowel movements/week Interval 0.42 to 0.78	0.23 spontaneous bowel movements/week Interval 0.04 to 0.43

SECONDARY outcome

Timeframe: weeks 1-8

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (SBMs) During Weeks 1-8	19 Participants	6 Participants

SECONDARY outcome

Timeframe: weeks 13-16

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM.The mean weekly spontaneous bowel movements (SBMs) during weeks 13-16 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.

Outcome measures

Measure	Electroacupuncture Group n=46 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=41 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (SBMs) During Weeks 13-16	4 Participants	1 Participants

SECONDARY outcome

Timeframe: weeks 1-8

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8	30 Participants	14 Participants

SECONDARY outcome

Timeframe: weeks 13-16

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 13-16 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.

Outcome measures

Measure	Electroacupuncture Group n=46 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=41 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 13-16	12 Participants	4 Participants

SECONDARY outcome

Timeframe: weeks 1-8, and weeks 13-16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation. The mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1-8 and weeks 13-16 is calculated by dividing the total frequency of CSBMs by the number of weeks recorded.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
A Change in the Mean Weekly Complete Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8 and Weeks 13-16. Week 1-8	0.84 CSBMs/week Interval 0.65 to 1.02	0.35 CSBMs/week Interval 0.16 to 0.54
A Change in the Mean Weekly Complete Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8 and Weeks 13-16. Week 13-16	0.32 CSBMs/week Interval 0.14 to 0.51	0.14 CSBMs/week Interval -0.06 to 0.33

SECONDARY outcome

Timeframe: weeks 1-8

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (CSBMs) During Weeks 1-8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: weeks 13-16

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.

Outcome measures

Measure	Electroacupuncture Group n=46 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=41 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (CSBMs) During Weeks 13-16	1 Participants	0 Participants

SECONDARY outcome

Timeframe: weeks 1-8

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8	21 Participants	9 Participants

SECONDARY outcome

Timeframe: weeks 13-16

An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.

Outcome measures

Measure	Electroacupuncture Group n=46 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=41 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 13-16	10 Participants	4 Participants

SECONDARY outcome

Timeframe: weeks 1-8, and weeks 13-16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

For stool consistency, each patient was asked to record their stool consistency according to the Bristol Stool Form Scale, on the following seven points scale (scored from 1 to 7 for stool types 1 to 7, respectively) .Higher scores indicate indicating a softer stool.The mean Bristol Stool Form Scale score for stool consistency of spontaneous bowel movements (SBMs) during weeks 1-8 and weeks 13-16 is calculated by dividing the total Bristol Stool Form Scale score of SBMs by the total number of SBMs recorded.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
A Change in the Mean Bristol Stool Form Scale Score for Stool Consistency of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16 Week 1-8	0.51 score on a scale Interval 0.29 to 0.73	0.28 score on a scale Interval 0.05 to 0.5
A Change in the Mean Bristol Stool Form Scale Score for Stool Consistency of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16 Week 13-16	0.25 score on a scale Interval 0.01 to 0.49	-0.07 score on a scale Interval -0.32 to 0.18

SECONDARY outcome

Timeframe: weeks 1-8, and weeks 13-16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

For assessment of straining of spontaneous bowel movement (SBM), each patient was asked to rate his/her score for straining using the following five-point scale: not at all difficulty (0), a little bit difficulty (1), moderately difficulty (2), quite a bit difficulty (3), extremely difficulty (4). Higher scores indicate a worse outcome.The mean score for the straining of SBMs during weeks 1-8 and weeks 13-16 is calculated by dividing the total score for the straining of SBMs by the total number of SBMs recorded.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
A Change in the Mean Score for the Straining of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16 Weeks 1-8	-0.58 score on a scale Interval -0.78 to -0.39	-0.12 score on a scale Interval -0.32 to 0.08
A Change in the Mean Score for the Straining of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16 Weeks 13-16	-0.30 score on a scale Interval -0.52 to -0.08	0.04 score on a scale Interval -0.19 to 0.27

SECONDARY outcome

Timeframe: week 8 and week 16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The Patient Assessment of Constipation-Symptom (PAC-SYM) is a 12-item evaluative questionnaire for the chronic constipation, which consists of 4-item abdominal, 3-item rectal, and 5-item stool subscales. Each item score ranges from 0 to 4 in the 2 weeks (14 days) prior to assessment，where 0 = symptom absent, 1 = mild,2 = moderate,3 = severe and 4 = very severe. Each subscale score will be calculated as the mean of the completed items for that subscale，which will range from 0 to 4. The total score will be calculated as the mean of all subscales. The total score of PAC-SYM range from 0 to 4.Lower scores indicate a better outcome. The specific evaluation of total scores of the PAC-SYM occurs at both week 8 and week 16.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
A Change in the Total Score of the Patient Assessment of Constipation-Symptom (PAC-SYM) Questionnaire From Baseline at Weeks 8 and 16 Week 8	-0.87 score on a scale Interval -1.01 to -0.73	-0.51 score on a scale Interval -0.65 to -0.37
A Change in the Total Score of the Patient Assessment of Constipation-Symptom (PAC-SYM) Questionnaire From Baseline at Weeks 8 and 16 Week 16	-0.47 score on a scale Interval -0.61 to -0.33	-0.11 score on a scale Interval -0.27 to 0.04

SECONDARY outcome

Timeframe: week 8 and week 16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The Patient Assessment of Constipation-Quality of Life (PAC-QOL) is a 28-item self-reported instrument for assessing the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. It is divided into four subscales: physical discomfort (items 1-4), psychosocial discomfort (items 5-12), worries/concerns (items 13-23), and satisfaction (items 24 to 28). Each of the item scores ranges from 0 (not at all) to 4 (extremely). Each of the item scores ranges from 0 (not at all) to 4 (extremely), with lower scores indicating a better quality of life. The each subscale score ranges from 0 to 4. The total score will be calculated as the mean of all subscales, ranging from 0 to 4. Lower scores indicate a better outcome. The specific evaluation of the PAC-QOL questionnaires' total scores occurs at both week 8 and week 16.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
A Change in the Total Scores of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaires From the Baseline at Weeks 8 and 16 Week 8	-0.62 units on a scale Interval -0.76 to -0.48	-0.36 units on a scale Interval -0.51 to -0.22
A Change in the Total Scores of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaires From the Baseline at Weeks 8 and 16 Week 16	-0.36 units on a scale Interval -0.53 to -0.2	-0.11 units on a scale Interval -0.27 to 0.06

SECONDARY outcome

Timeframe: week 8 and week 16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group in week 8. Four participants in the electroacupuncture group and 9 participants in the sham electroacupuncture group in week 16.

Each patient was asked to rate his/her efficacy of treatment using the following 7-point self-reporting scale: markedly worse (1), moderately worse (2),slightly worse (3), no change (4), slightly improved (5), moderately improved (6), markedly improved (7). Higher scores mean a better outcome.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Patients'Global Assessment of Treatment Efficacy Week 16 · Moderately improved	6 Participants	1 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · Slightly worse	0 Participants	0 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · Moderately worse	1 Participants	0 Participants
Patients'Global Assessment of Treatment Efficacy Week 16 · Markedly improved	8 Participants	0 Participants
Patients'Global Assessment of Treatment Efficacy Week 16 · Slightly improved	13 Participants	10 Participants
Patients'Global Assessment of Treatment Efficacy Week 16 · No change	3 Participants	19 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · Markedly improved	13 Participants	3 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · Moderately improved	21 Participants	4 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · Slightly improved	10 Participants	30 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · No change	2 Participants	8 Participants
Patients'Global Assessment of Treatment Efficacy Week 8 · Markedly worse	0 Participants	0 Participants
Patients'Global Assessment of Treatment Efficacy Week 16 · Slightly worse	6 Participants	1 Participants
Patients'Global Assessment of Treatment Efficacy Week 16 · Moderately worse	6 Participants	5 Participants
Patients'Global Assessment of Treatment Efficacy Week 16 · Markedly worse	4 Participants	5 Participants

SECONDARY outcome

Timeframe: weeks 1-8, and weeks 9-16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The percentage of patients using rescue medicine will be compared between groups during weeks 1-8, and weeks 9-16. The mean frequency of using rescue medicine per week during weeks 1-8 equals the total of rescue medicine consumption divided by 8. The mean frequency of using rescue medicine per week during weeks 9-16 equals the total of rescue medicine consumption divided by 8.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants Using Rescue Medicine During Weeks 1-8 and Weeks 9-16 Weeks 1-8 : Rescue medicine	24 participants	30 participants
Number of Participants Using Rescue Medicine During Weeks 1-8 and Weeks 9-16 Weeks 1-8 : Others	5 participants	4 participants
Number of Participants Using Rescue Medicine During Weeks 1-8 and Weeks 9-16 Weeks 9-16 : Rescue medicine	28 participants	29 participants
Number of Participants Using Rescue Medicine During Weeks 1-8 and Weeks 9-16 Weeks 9-16 : Others	5 participants	2 participants

SECONDARY outcome

Timeframe: weeks 1-8, and weeks 9-16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The mean frequency of using rescue medicine per week during weeks 1-8 equals the total of rescue medicine consumption divided by 8. The mean frequency of using rescue medicine per week during weeks 9-16 equals the total of rescue medicine consumption divided by 8.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
The Mean Frequency of Rescue Medicine Use Per Week During Weeks 1-8 and Weeks 9-16 Weeks 1-8 : Others	0.70 number of rescue medicine use per week Interval 0.15 to 1.25	0.94 number of rescue medicine use per week Interval 0.34 to 1.54
The Mean Frequency of Rescue Medicine Use Per Week During Weeks 1-8 and Weeks 9-16 Weeks 9-16 : Rescue medicine	0.62 number of rescue medicine use per week Interval 0.42 to 0.82	0.85 number of rescue medicine use per week Interval 0.66 to 1.05
The Mean Frequency of Rescue Medicine Use Per Week During Weeks 1-8 and Weeks 9-16 Weeks 1-8 : Rescue medicine	0.39 number of rescue medicine use per week Interval 0.2 to 0.59	0.65 number of rescue medicine use per week Interval 0.48 to 0.82
The Mean Frequency of Rescue Medicine Use Per Week During Weeks 1-8 and Weeks 9-16 Weeks 9-16 : Others	0.46 number of rescue medicine use per week Interval -0.05 to 0.97	0.47 number of rescue medicine use per week Interval -0.38 to 1.31

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline

Participants will be asked to answer the following questions before the intervention: "Do you think acupuncture will be effective in treating the disease in general?" "Do you think acupuncture will be effective in improving the OIC?" and "which acupuncture modalities do you prefer, EA or SA?" For each question, patients will choose one of the following answers: "unclear/whatever", "EA", or "SA"

Outcome measures

Measure	Electroacupuncture Group n=50 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=50 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Patients'Expectation of the Acupuncture Efficacy Do you think acupuncture will be effective for opioid-induced constipation? · Unclear	19 Participants	21 Participants
Patients'Expectation of the Acupuncture Efficacy Do you think acupuncture will be effective in treating diseases in general? · Yes	38 Participants	35 Participants
Patients'Expectation of the Acupuncture Efficacy Do you think acupuncture will be effective in treating diseases in general? · No	0 Participants	0 Participants
Patients'Expectation of the Acupuncture Efficacy Do you think acupuncture will be effective in treating diseases in general? · Unclear	12 Participants	15 Participants
Patients'Expectation of the Acupuncture Efficacy Do you think acupuncture will be effective for opioid-induced constipation? · Yes	31 Participants	29 Participants
Patients'Expectation of the Acupuncture Efficacy Do you think acupuncture will be effective for opioid-induced constipation? · No	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at week 8

Population: Answers from 3 participant in the electroacupuncture group and 5 participants in the sham electroacupuncture group were not recorded due to staff negligence.

Before treatment, we told participants that they had a 50% chance of receiving conventional electroacupuncture with a deeper insertion or minimal electroacupuncture with a superficial penetration. Conventional electroacupuncture and minimal electroacupuncture have probable similar efficacy. Both treatmentsused a relatively small electric intensity, and they may or may not feel the stimulation during treatment because of the relatively weak electrical stimulation and the tolerance of the human body. To assess the success of blinding, within 5 minutes after any treatment session at week 8, participants were asked to guess whether they had received conventional electroacupuncture in the previous weeks (yes or no)

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
The Patient Blinding Assessment Guess Conventional electroacupuncture	46 Participants	22 Participants
The Patient Blinding Assessment Guess Minimal electroacupuncture	1 Participants	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline, at weeks 8 and 16.

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The mean cancerous pain intensity and worst cancerous pain intensity during the preceding week will be evaluated by 11 grades (from "0=no pain" to "10=worst pain (the strongest pain ever experienced)" at baseline, as well as weeks 2, 4, 6, 8 and 16. Higher scores mean a worse outcome. The values at weeks 2, 4, 6, and 8 are summed and divided by 4. Value at week 16 is a single value.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Change in Numeric Rating Scales Score for Mean Cancer Pain Intensity Within the Preceding Week From Baseline Week 8	-0.17 score on a scale Interval -0.36 to 0.01	-0.003 score on a scale Interval -0.19 to 0.19
Change in Numeric Rating Scales Score for Mean Cancer Pain Intensity Within the Preceding Week From Baseline Week 16	-0.09 score on a scale Interval -0.37 to 0.2	0.14 score on a scale Interval -0.15 to 0.44

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline, at weeks 8 and 16.

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The mean cancerous pain intensity and worst cancerous pain intensity during the preceding week will be evaluated by 11 grades (from "0=no pain" to "10=worst pain (the strongest pain ever experienced)" at baseline, as well as weeks 2, 4, 6, 8 and 16. Higher scores mean a worse outcome.The values at weeks 2, 4, 6, and 8 are summed and divided by 4. Value at week 16 is a single value.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Change in Numeric Rating Scales Score for Worst Cancer Pain Intensity Within the Preceding Week From Baseline Week 16	0.03 score on a scale Interval -0.35 to 0.42	0.23 score on a scale Interval -0.17 to 0.63
Change in Numeric Rating Scales Score for Worst Cancer Pain Intensity Within the Preceding Week From Baseline Week 8	-0.19 score on a scale Interval -0.44 to 0.05	-0.07 score on a scale Interval -0.32 to 0.18

OTHER_PRE_SPECIFIED outcome

Timeframe: at week 8

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The percentage of patients discontinuing the opioid, and those with increase/decrease from baseline of ≥30% opioid usage per week was compared between groups during weeks 1-8

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 1-8 Remained unchanged	40 participants	34 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 1-8 Participants with the opioid consumption decrease ≥30%	0 participants	0 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 1-8 Participants with the opioid consumption increase ≥30%	6 participants	7 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 1-8 Participants with the opioid consumption increase <30%	1 participants	4 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 1-8 Participants with the opioid consumption decrease <30%	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at week 16

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8. One participant in the electroacupuncture group and 4 participants in sham electroacupuncture group dropped out over weeks 9-16.

The percentage of patients discontinuing the opioid, and those with increase/decrease from baseline of ≥30% opioid usage per week was compared between groups during weeks 9-16

Outcome measures

Measure	Electroacupuncture Group n=46 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=41 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 9-16 Remained unchanged	33 participants	29 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 9-16 Participants with the opioid consumption increase ≥30%	10 participants	9 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 9-16 Participants with the opioid consumption increase <30%	3 participants	3 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 9-16 Participants with the opioid consumption decrease ≥30%	0 participants	0 participants
Number of Participants With Change From Baseline in the Dose of Opioid Consumption From Baseline During Weeks 9-16 Participants with the opioid consumption decrease <30%	0 participants	0 participants

POST_HOC outcome

Timeframe: over weeks 1-8

Population: Three participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group did not complete 8-week treatment over weeks 1-8.

Responders are defined as those having at least three SBMs per week and an increase from baseline of at least one SBM per week for at least 6 weeks out of the 8-week treatment period. The percentage of sustained SBM(spontaneous bowel movements) responders is defined as patients who fulfilled these criteria for at least 3 of the last 4 weeks'treatment.

Outcome measures

Measure	Electroacupuncture Group n=47 Participants Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=45 Participants Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Number of Participants With Sustained SBM(Spontaneous Bowel Movements) Response	19 Participants	4 Participants

Adverse Events

Electroacupuncture Group

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Sham Electroacupuncture Group

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Electroacupuncture Group n=50 participants at risk Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=50 participants at risk Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Respiratory, thoracic and mediastinal disorders Death	2.0% 1/50 • Number of events 1 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.	0.00% 0/50 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.
Immune system disorders Death	0.00% 0/50 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.	2.0% 1/50 • Number of events 1 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.
Immune system disorders Cancer progression	0.00% 0/50 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.	2.0% 1/50 • Number of events 1 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.
Reproductive system and breast disorders Cancer progression	0.00% 0/50 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.	2.0% 1/50 • Number of events 1 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.

Other adverse events

Measure	Electroacupuncture Group n=50 participants at risk Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.	Sham Electroacupuncture Group n=50 participants at risk Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
Skin and subcutaneous tissue disorders Local hematoma	4.0% 2/50 • Number of events 2 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.	6.0% 3/50 • Number of events 3 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.
Skin and subcutaneous tissue disorders Inconsequential bleeding	2.0% 1/50 • Number of events 1 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.	4.0% 2/50 • Number of events 2 • All adverse events (AEs) will be recorded throughout the whole trial(17 weeks) in Adverse Event Form (AEF) by patients themselves and outcome assessors.

Additional Information

Dr.Zhishun Liu

Guang'anmen Hospital, China Academy Chinese Medical Sciences

Phone: +86 010 88002331

Email: liuzhishun@aliyun.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place