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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .
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 â…¡ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electroacupuncture | Experimental | 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. |
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| sham electroacupuncture | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Menopause Rating Scale Total Score | 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. | at baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Menopause Rating Scale Total Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu, Ph.D | Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangan'men Hospital | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24950841 | Derived | Liu Z, Wang Y, Xu H, Wu J, He L, Jiang JY, Yan S, Du R, Liu B. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:242. doi: 10.1186/1745-6215-15-242. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | 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). |
| FG001 | Sham Acupuncture | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Menopause Rating Scale Total Score | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline and week 8 |
|
32 weeks during the whole trial
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Zhishun Liu | Guang'an Men Hospital, China Academy of Chinese Medical Sciences | +86 01088002331 | liuzhishun@aliyun.com |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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| sham electroacupuncture | Other | 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. |
|
| at baseline，and weeks 4, 20 and 32 |
| Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in Psychological Domain of Menopause Rating Scale | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in Urogenital Domain of Menopause Rating Scale | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in Mean 24-h Hot Flash Score | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire | 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. | at baseline, and weeks 4, 8, 20 and 32 |
| Change From Baseline in Serum FSH Level | 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. | at baseline, and weeks 8 and 20 |
| Change From Baseline in Serum E2 Level | 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. | at baseline, and weeks 8 and 20 |
| Change From Baseline in Serum LH Level | 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. | at baseline, and weeks 8 and 20 |
| Change From Baseline in Serum FSH/LH Level | 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. | at baseline, weeks 8 and 20 |
| Number of Participants Who Used Other Treatment During Study | The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32. | weeks 1-8; weeks 9-32 |
| BG001 | Sham Acupuncture | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Sham Electroacupuncture | 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. |
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| Secondary | Change From Baseline in Menopause Rating Scale Total Score | 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. | 6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline，and weeks 4, 20 and 32 |
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| Secondary | Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in Psychological Domain of Menopause Rating Scale | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in Urogenital Domain of Menopause Rating Scale | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in Mean 24-h Hot Flash Score | 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 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire | 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. | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline, and weeks 4, 8, 20 and 32 |
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| Secondary | Change From Baseline in Serum FSH Level | 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. | 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. | Posted | Mean | 95% Confidence Interval | mIU/ml | at baseline, and weeks 8 and 20 |
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| Secondary | Change From Baseline in Serum E2 Level | 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. | 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. | Posted | Mean | 95% Confidence Interval | pmol/ml | at baseline, and weeks 8 and 20 |
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| Secondary | Change From Baseline in Serum LH Level | 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. | 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. | Posted | Mean | 95% Confidence Interval | mIU/ml | at baseline, and weeks 8 and 20 |
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| Secondary | Change From Baseline in Serum FSH/LH Level | 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. | 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. | Posted | Mean | 95% Confidence Interval | ratio | at baseline, weeks 8 and 20 |
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| Secondary | Number of Participants Who Used Other Treatment During Study | The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32. | 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 | Posted | Count of Participants | Participants | weeks 1-8; weeks 9-32 |
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| 0 |
| 180 |
| 0 |
| 180 |
| 9 |
| 180 |
| EG001 | Sham Acupuncture | 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. | 0 | 180 | 0 | 180 | 2 | 180 |
| Severe needling pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Subcutaneous hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Fatigue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Abdominal discomforts | Gastrointestinal disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| Change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 20 |
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| Change at week 32 |
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| change at week 8 |
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| change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 20 |
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| Change at week 32 |
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| Change at week 8 |
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| Change at week 32 |
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| Change at week 20 |
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| Change at week 20 |
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| Change at week 20 |
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| Change at week 20 |
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| weeks 20-32 |
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