Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01849172
• Collaborator: Ministry of Science and Technology of the People´s Republic of China (Other)
• Enrollment: 360
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .

Condition or Disease	Intervention/Treatment	Phase
Menopausal Syndrome	Other: electroacupuncture; Other: sham electroacupuncture	N/A

Detailed Description

Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect.

Our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition -a Multicenter Randomized Controlled Trial
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: electroacupuncture Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.	Other: electroacupuncture; Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).
Sham Comparator: sham electroacupuncture Sham electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).Specially constructed EA apparatus were used with no skin penetration, electricity output, or de qi requirement for needle manipulation One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.	Other: sham electroacupuncture; Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6). Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Menopause Rating Scale Total Score [at baseline and week 8]

   The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.

Secondary Outcome Measures

1. Change From Baseline in Menopause Rating Scale Total Score [at baseline，and weeks 4, 20 and 32]

   The change in Menopause Rating Scale (MRS）total score compared with baseline at weeks 4, 20 and 32 equals MRS total score at weeks 4, 20 and 32 minus MRS total score at baseline,respectively. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.

2. Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in somatic-vegetative domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the somatic-vegetative domain of MRS at weeks 4, 8, 20 and 32 minus the somatic-vegetative domain of MRS at baseline, respectively. The somatic-vegetative domain contains 4 items (items 1-3 and 11). Each of the item scores ranges from 0 to 4. The somatic-vegetative domain score will be calculated as the all somatic-vegetative items ranging from 0 to 16, with higher scores indicating worse symptoms.

3. Change From Baseline in Psychological Domain of Menopause Rating Scale [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in psychological domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the psychological domain of MRS at weeks 4, 8, 20 and 32 minus the psychological domain of MRS at baseline, respectively. The psychological domain contains 4 items (items 4-7). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all psychological items ranging from 0 to 16, with higher scores indicating worse symptoms.

4. Change From Baseline in Urogenital Domain of Menopause Rating Scale [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in urogenital domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the urogenital domain of MRS at weeks 4, 8, 20 and 32 minus the urogenital domain of MRS at baseline, respectively. The urogenital domain contains 3 items (items 8-10). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all urogenital items ranging from 0 to 12, with higher scores indicating worse symptoms.

5. Change From Baseline in Mean 24-h Hot Flash Score [at baseline, and weeks 4, 8, 20 and 32]

   The 24-h hot flash score was daily hot flash episodes multiplied by the corresponding severities. The change from baseline in mean 24-h HF score at weeks 4, 8, 20 and 32 equals the mean 24-h HF score at weeks 4 , 8, 20 and 32 minus the mean 24-h HF score at baseline, respectively. Hot flashes score consisted the number and the degree of hot flashes. The hot flashes score is the sum of the scores of all the hot flashes occurring in a whole day, with a higher score indicating worse symptoms. A 3-point rating scale allows the women to describe the perceived severity of hot flash. 1 point = mild hot flash, 2 point = moderate hot flash, 3 point = severe hot flash.

6. Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) total score at weeks 4, 8, 20 and 32 equals the MENQOL total score at weeks 4, 8, 20 and 32 minus the MENQOL score at baseline, respectively. It composed of 29 items and was divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Each of the item scores ranges from 0 to 6. The total score will be calculated as the all items ranging from 0 to 174, with lower scores indicating a better quality of life.

7. Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in the vasomotor domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the vasomotor domain of MENQOL at weeks 4, 8, 20 and 32 minus the vasomotor domain of MENQOL at baseline, respectively. The vasomotor domain contains 3 items (items 1-3). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all vasomotor items ranging from 0 to 18, with lower scores indicating a better quality of life.

8. Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in the psychosocial domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the psychosocial domain of MENQOL at weeks 4, 8, 20 and 32 minus the psychosocial domain of MENQOL at baseline, respectively. The psychosocial domain contains 7 items (items 4-10). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all psychosocial items ranging from 0 to 42, with lower scores indicating a better quality of life.

9. Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire [at baseline, and weeks 4, 8, 20 and 32]

   The change from baseline in the physical domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the physical domain of MENQOL at weeks 4, 8, 20 and 32 minus the physical domain of MENQOL at baseline, respectively. The physical domain contains 16 items (items 11-26). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all physical items ranging from 0 to 96, with lower scores indicating a better quality of life.

10. Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire [at baseline, and weeks 4, 8, 20 and 32]

    The change from baseline in the sexual functioning domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the sexual functioning domain of MENQOL at weeks 4, 8, 20 and 32 minus the sexual functioning domain of MENQOL at baseline, respectively. The sexual functioning domain contains 3 items (items 27-29). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all sexual functioning items ranging from 0 to 18, with lower scores indicating a better quality of life.

11. Change From Baseline in Serum FSH Level [at baseline, and weeks 8 and 20]

    The change from baseline in serum FSH level at weeks 8 and 20 equals FSH at weeks 8 and 20 minus FSH at baseline, respectively.

12. Change From Baseline in Serum E2 Level [at baseline, and weeks 8 and 20]

    The change from baseline in serum E2 level at weeks 8 and 20 equals E2 at weeks 8 and 20 minus E2 at baseline, respectively.

13. Change From Baseline in Serum LH Level [at baseline, and weeks 8 and 20]

    The change from baseline in serum LH level at weeks 8 and 20 equals LH at weeks 8 and 20 minus LH at baseline, respectively.

14. Change From Baseline in Serum FSH/LH Level [at baseline, weeks 8 and 20]

    The change from baseline in serum FSH/LH at weeks 8 and 20 equals FSH/LH at weeks 8 and 20 minus FSH/LH at baseline, respectively.

15. Number of Participants Who Used Other Treatment During Study [weeks 1-8; weeks 9-32]

    The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).

2. Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.

3. 40 to 55 years old.

4. Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -

Exclusion Criteria:

1. Regular cycles during the past 3 months before enrollment.

2. use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.

3. Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.

4. Patients with radiochemotherapy history or undergoing radiochemotherapy.

5. Cryptogenic vaginal bleeding

6. Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.

7. Existing skin diseases like eczema or psoriasis.

8. Severe hepatic/renal insufficiency.

9. Insufficiently controlled hypertension, diabetes or thyroid diseases.

10. Existing diabetic neuropathy, malignant tumor and psychiatric disorders.

11. Wish to become pregnant or is pregnant or breast-feeding.

12. Regular use of sedative or anxiolytic.

13. Smoking or alcohol intake.

14. Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).

15. With cardiac pacemaker or artificial joint.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangan'men Hospital	Beijing		China	100053

Sponsors and Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Ministry of Science and Technology of the People´s Republic of China

Investigators

• Study Chair: Zhishun Liu, Ph.D, Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• ClinicalTrials.gov Identifier: NCT01849172
• Other Study ID Numbers: BAI24B01
• First Posted: May 8, 2013
• Last Update Posted: Apr 2, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Acupuncture	Sham Acupuncture
Arm/Group Description	Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. acupuncture: Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).	Electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. sham acupuncture: Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6). Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actu
Period Title: Overall Study
STARTED	180	180
COMPLETED	173	174
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	Acupuncture	Sham Acupuncture	Total
Arm/Group Description	Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. acupuncture: Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).	Electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. sham acupuncture: Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actual	Total of all reporting groups
Overall Participants	180	180	360
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	180 100%	180 100%	360 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	48.7 (4.0)	48.1 (3.8)	48.4 (3.9)
Sex: Female, Male (Count of Participants)
Female	180 100%	180 100%	360 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	180 100%	180 100%	360 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Menopause Rating Scale Total Score
Description	The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.
Time Frame	at baseline and week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	180	180
Mean (95% Confidence Interval) [units on a scale]	6.3	4.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Electroacupuncture, Sham Electroacupuncture
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Change From Baseline in Menopause Rating Scale Total Score
Description	The change in Menopause Rating Scale (MRS）total score compared with baseline at weeks 4, 20 and 32 equals MRS total score at weeks 4, 20 and 32 minus MRS total score at baseline,respectively. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.
Time Frame	at baseline，and weeks 4, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8.

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	3.6	3.2
Change at week 20	7.0	4.5
Change at week 32	6.8	4.1

3. Secondary Outcome

Title	Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
Description	The change from baseline in somatic-vegetative domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the somatic-vegetative domain of MRS at weeks 4, 8, 20 and 32 minus the somatic-vegetative domain of MRS at baseline, respectively. The somatic-vegetative domain contains 4 items (items 1-3 and 11). Each of the item scores ranges from 0 to 4. The somatic-vegetative domain score will be calculated as the all somatic-vegetative items ranging from 0 to 16, with higher scores indicating worse symptoms.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	1.5	1.4
Change at week 8	2.6	1.9
Change at week 20	3.0	2.0
Change at week 32	2.8	1.7

4. Secondary Outcome

Title	Change From Baseline in Psychological Domain of Menopause Rating Scale
Description	The change from baseline in psychological domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the psychological domain of MRS at weeks 4, 8, 20 and 32 minus the psychological domain of MRS at baseline, respectively. The psychological domain contains 4 items (items 4-7). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all psychological items ranging from 0 to 16, with higher scores indicating worse symptoms.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	1.6	1.5
change at week 8	2.7	2.0
change at week 20	2.9	2.0
Change at week 32	3.0	2.0

5. Secondary Outcome

Title	Change From Baseline in Urogenital Domain of Menopause Rating Scale
Description	The change from baseline in urogenital domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the urogenital domain of MRS at weeks 4, 8, 20 and 32 minus the urogenital domain of MRS at baseline, respectively. The urogenital domain contains 3 items (items 8-10). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all urogenital items ranging from 0 to 12, with higher scores indicating worse symptoms.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	0.5	0.3
Change at week 8	1.0	0.5
Change at week 20	1.1	0.5
Change at week 32	1.0	0.4

6. Secondary Outcome

Title	Change From Baseline in Mean 24-h Hot Flash Score
Description	The 24-h hot flash score was daily hot flash episodes multiplied by the corresponding severities. The change from baseline in mean 24-h HF score at weeks 4, 8, 20 and 32 equals the mean 24-h HF score at weeks 4 , 8, 20 and 32 minus the mean 24-h HF score at baseline, respectively. Hot flashes score consisted the number and the degree of hot flashes. The hot flashes score is the sum of the scores of all the hot flashes occurring in a whole day, with a higher score indicating worse symptoms. A 3-point rating scale allows the women to describe the perceived severity of hot flash. 1 point = mild hot flash, 2 point = moderate hot flash, 3 point = severe hot flash.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	1.9	1.9
Change at week 8	3.6	2.5
Change at week 20	3.9	2.7
Change at week 32	4.1	1.9

7. Secondary Outcome

Title	Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
Description	The change from baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) total score at weeks 4, 8, 20 and 32 equals the MENQOL total score at weeks 4, 8, 20 and 32 minus the MENQOL score at baseline, respectively. It composed of 29 items and was divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Each of the item scores ranges from 0 to 6. The total score will be calculated as the all items ranging from 0 to 174, with lower scores indicating a better quality of life.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	12.8	12.6
Change at week 8	22.8	17.1
Change at week 20	25.3	18.2
Change at week 32	26	17.6

8. Secondary Outcome

Title	Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
Description	The change from baseline in the vasomotor domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the vasomotor domain of MENQOL at weeks 4, 8, 20 and 32 minus the vasomotor domain of MENQOL at baseline, respectively. The vasomotor domain contains 3 items (items 1-3). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all vasomotor items ranging from 0 to 18, with lower scores indicating a better quality of life.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	1.9	1.7
Change at week 8	3.4	2.5
Change at week 20	3.7	2.7
Change at week 32	3.8	2.4

9. Secondary Outcome

Title	Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
Description	The change from baseline in the psychosocial domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the psychosocial domain of MENQOL at weeks 4, 8, 20 and 32 minus the psychosocial domain of MENQOL at baseline, respectively. The psychosocial domain contains 7 items (items 4-10). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all psychosocial items ranging from 0 to 42, with lower scores indicating a better quality of life.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	2.8	2.8
Change at week 8	5.5	3.8
Change at week 20	6.1	4.2
Change at week 32	6.4	4.3

10. Secondary Outcome

Title	Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
Description	The change from baseline in the physical domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the physical domain of MENQOL at weeks 4, 8, 20 and 32 minus the physical domain of MENQOL at baseline, respectively. The physical domain contains 16 items (items 11-26). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all physical items ranging from 0 to 96, with lower scores indicating a better quality of life.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	7.4	7.3
Change at week 8	12.4	9.5
Change at week 20	14.1	10.1
Change at week 32	14.3	10.0

11. Secondary Outcome

Title	Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
Description	The change from baseline in the sexual functioning domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the sexual functioning domain of MENQOL at weeks 4, 8, 20 and 32 minus the sexual functioning domain of MENQOL at baseline, respectively. The sexual functioning domain contains 3 items (items 27-29). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all sexual functioning items ranging from 0 to 18, with lower scores indicating a better quality of life.
Time Frame	at baseline, and weeks 4, 8, 20 and 32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
Change at week 4	0.9	0.8
Change at week 8	1.5	1.2
Change at week 20	1.4	1.2
Change at week 32	1.5	1.0

12. Secondary Outcome

Title	Change From Baseline in Serum FSH Level
Description	The change from baseline in serum FSH level at weeks 8 and 20 equals FSH at weeks 8 and 20 minus FSH at baseline, respectively.
Time Frame	at baseline, and weeks 8 and 20

Outcome Measure Data

Analysis Population Description

FSH, LH, and FSH/LH values were missing in 9 participants in the electroacupuncture group and 8 participants in the sham electroacupuncture group at week 8, and in 16 participants in the electroacupuncture group and 14 participants in the sham electroacupuncture group at week 20.

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	171	172
Change at week 8	4.1	2.0
Change at week 20	0.6	0.4

13. Secondary Outcome

Title	Change From Baseline in Serum E2 Level
Description	The change from baseline in serum E2 level at weeks 8 and 20 equals E2 at weeks 8 and 20 minus E2 at baseline, respectively.
Time Frame	at baseline, and weeks 8 and 20

Outcome Measure Data

Analysis Population Description

Estradiol values were missing in 37 participants in the electroacupuncture group and 39 participants in the sham electroacupuncture group at week 8, and in 44 patients in the electroacupuncture group and 38 participants in the sham electroacupuncture group at week 20.

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	143	142
Change at week 8	-12.3	19.5
Change at week 20	-2.3	-11.3

14. Secondary Outcome

Title	Change From Baseline in Serum LH Level
Description	The change from baseline in serum LH level at weeks 8 and 20 equals LH at weeks 8 and 20 minus LH at baseline, respectively.
Time Frame	at baseline, and weeks 8 and 20

Outcome Measure Data

Analysis Population Description

FSH, LH, and FSH/LH values were missing in 9 participants in the electroacupuncture group and 8 participants in the sham electroacupuncture group at week 8, and in 16 participants in the electroacupuncture group and 14 participants in the sham electroacupuncture group at week 20.

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	171	172
Change at week 8	0.9	1.7
Change at week 20	-1.3	0.1

15. Secondary Outcome

Title	Change From Baseline in Serum FSH/LH Level
Description	The change from baseline in serum FSH/LH at weeks 8 and 20 equals FSH/LH at weeks 8 and 20 minus FSH/LH at baseline, respectively.
Time Frame	at baseline, weeks 8 and 20

Outcome Measure Data

Analysis Population Description

FSH, LH, and FSH/LH values were missing in 9 participants in the electroacupuncture group and 8 participants in the sham electroacupuncture group at week 8, and in 16 participants in the electroacupuncture group and 14 participants in the sham electroacupuncture group at week 20.

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	171	172
Change at week 8	0.2	-0.1
Change at week 20	0.2	0.0

16. Secondary Outcome

Title	Number of Participants Who Used Other Treatment During Study
Description	The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.
Time Frame	weeks 1-8; weeks 9-32

Outcome Measure Data

Analysis Population Description

6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32

Arm/Group Title	Electroacupuncture	Sham Electroacupuncture
Arm/Group Description	Acupoints of RN4, Bilateral EX-CA1, ST25 and SP 6 were used.For acupoints in the abdomen, the needles will be inserted vertically and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall. The needle will be inserted vertically at SP6 to a depth of 1 cun. Paired alligator clips of the EA apparatus will be attached transversely to the needle holders of the bilateral EX-CA1 and ST25. EA stimulation will last for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1mA. The current intensity will be increased until the skin around the acupoints shivers. The manipulation on RN4 and SP6 mentioned above should be performed every 10 minutes, three times in 30 minutes.Patients will be treated with EA 3 sessions a week on alternate days for 8 successive weeks, 24 sessions for each patient in total.	Non-points proximate to RN4 , EX-CA1，ST25 and SP6 were used. After sterilizing the skin, placebo needles of size 0.30×25 mm will be needled into adhesive pads without skin penetration or needle manipulation. The needle will be manipulated slightly with an even lifting, thrusting, and twisting method repeated three times for each point but no deqi. Paired alligator clips of the specially made EA apparatus (power output lines, which connect the alligator clips and the EA apparatus, will be cut inside with an appearance as usual) will be attached transversely to the needle holders of the bilateral sham-ST25 and sham-EX-CA1. The EA apparatus will be turned on with a working power indicator and the same sound as the EA group. The parameters of sham EA apparatus and the treatment course will be the same as in the EA group.
Measure Participants	174	175
weeks 1- 8	8 4.4%	8 4.4%
weeks 20-32	7 3.9%	9 5%

Adverse Events

Time Frame	32 weeks during the whole trial
Adverse Event Reporting Description	SAEs will be defined as events requiring hospitalization, causing disability or impaired ability to work, threatening life or resulting in death. AEs will be categorized as treatment related or non-treatment related based on its potential association with acupuncture needling procedure by acupuncturists and related specialists within 24 hours.
Arm/Group Title	Acupuncture		Sham Acupuncture
Arm/Group Description	Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes. acupuncture: Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).		Electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.sham acupuncture: Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6). Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually.
All Cause Mortality
	Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/180 (0%)		0/180 (0%)
Serious Adverse Events
	Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/180 (0%)		0/180 (0%)
Other (Not Including Serious) Adverse Events
	Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/180 (5%)		2/180 (1.1%)
Gastrointestinal disorders
Abdominal discomforts	1/180 (0.6%)	2	0/180 (0%)	0
Musculoskeletal and connective tissue disorders
Fatigue	1/180 (0.6%)	1	2/180 (1.1%)	2
Nervous system disorders
Dizziness	1/180 (0.6%)	1	0/180 (0%)	0
Skin and subcutaneous tissue disorders
Severe needling pain	4/180 (2.2%)	5	0/180 (0%)	0
Subcutaneous hematoma	2/180 (1.1%)	2	0/180 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.