An interventional study of electroacupuncture and sham electroacupuncture in Menopausal Syndrome, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to female participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-04-02.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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 Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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).
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.
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.
Time frame: at baseline and week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: weeks 1-8; weeks 9-32
| Milestone | Acupuncture | Sham Acupuncture |
|---|---|---|
| Started | 180 | 180 |
| Completed | 173 | 174 |
| Not completed | 7 | 6 |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change From Baseline in Menopause Rating Scale Total Score | 6.3 (5.0 to 7.7) | 4.5 (3.2 to 5.8) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 3.6 (2.6 to 4.6) | 3.2 (2.2 to 4.2) |
| Change at week 20 | 7.0 (5.5 to 8.4) | 4.5 (3.1 to 5.9) |
| Change at week 32 | 6.8 (5.2 to 8.5) | 4.1 (2.5 to 5.8) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 1.5 (1.1 to 2.0) | 1.4 (1.0 to 1.8) |
| Change at week 8 | 2.6 (2.0 to 3.2) | 1.9 (1.4 to 2.5) |
| Change at week 20 | 3.0 (2.4 to 3.5) | 2.0 (1.5 to 2.5) |
| Change at week 32 | 2.8 (2.2 to 3.4) | 1.7 (1.2 to 2.3) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 1.6 (1.1 to 2.1) | 1.5 (1.0 to 2.0) |
| change at week 8 | 2.7 (2.1 to 3.3) | 2.0 (1.4 to 2.6) |
| change at week 20 | 2.9 (2.2 to 3.6) | 2.0 (1.3 to 2.7) |
| Change at week 32 | 3.0 (2.2 to 3.7) | 2.0 (1.3 to 2.8) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 0.5 (0.2 to 0.7) | 0.3 (0.1 to 0.6) |
| Change at week 8 | 1.0 (0.7 to 1.4) | 0.5 (0.2 to 0.8) |
| Change at week 20 | 1.1 (0.7 to 1.5) | 0.5 (0.1 to 0.9) |
| Change at week 32 | 1.0 (0.6 to 1.5) | 0.4 (-0.1 to 0.9) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 1.9 (1.0 to 2.8) | 1.9 (0.9 to 2.8) |
| Change at week 8 | 3.6 (2.6 to 4.7) | 2.5 (1.4 to 3.5) |
| Change at week 20 | 3.9 (2.9 to 4.8) | 2.7 (1.7 to 3.7) |
| Change at week 32 | 4.1 (2.7 to 5.5) | 1.9 (0.5 to 3.2) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 12.8 (8.6 to 17.0) | 12.6 (8.4 to 16.8) |
| Change at week 8 | 22.8 (16.9 to 28.7) | 17.1 (11.2 to 23) |
| Change at week 20 | 25.3 (18.9 to 31.7) | 18.2 (11.9 to 24.6) |
| Change at week 32 | 26 (19.4 to 32.7) | 17.6 (11.0 to 24.3) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 1.9 (1.1 to 2.8) | 1.7 (0.9 to 2.6) |
| Change at week 8 | 3.4 (2.4 to 4.4) | 2.5 (1.5 to 3.5) |
| Change at week 20 | 3.7 (2.7 to 4.7) | 2.7 (1.6 to 3.7) |
| Change at week 32 | 3.8 (2.8 to 4.8) | 2.4 (1.4 to 3.4) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 2.8 (1.7 to 4.0) | 2.8 (1.7 to 4.0) |
| Change at week 8 | 5.5 (4.0 to 7.0) | 3.8 (2.4 to 5.3) |
| Change at week 20 | 6.1 (4.4 to 7.9) | 4.2 (2.5 to 6.0) |
| Change at week 32 | 6.4 (4.5 to 8.3) | 4.3 (2.4 to 6.2) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 7.4 (4.7 to 9.6) | 7.3 (4.9 to 9.7) |
| Change at week 8 | 12.4 (9.1 to 15.8) | 9.5 (6.2 to 12.9) |
| Change at week 20 | 14.1 (10.6 to 17.6) | 10.1 (6.6 to 13.7) |
| Change at week 32 | 14.3 (10.7 to 18.0) | 10.0 (6.4 to 13.6) |
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.
| units on a scale | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 4 | 0.9 (0.5 to 1.3) | 0.8 (0.4 to 1.2) |
| Change at week 8 | 1.5 (1.0 to 1.9) | 1.2 (0.7 to 1.6) |
| Change at week 20 | 1.4 (0.8 to 1.9) | 1.2 (0.6 to 1.7) |
| Change at week 32 | 1.5 (0.7 to 2.2) | 1.0 (0.2 to 1.8) |
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.
| mIU/ml | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 8 | 4.1 (0.4 to 7.9) | 2.0 (-1.8 to 5.9) |
| Change at week 20 | 0.6 (-0.4 to 5.3) | 0.4 (-3.7 to 4.6) |
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.
| pmol/ml | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 8 | -12.3 (-59.5 to 35.0) | 19.5 (-38.5 to 77.6) |
| Change at week 20 | -2.3 (-58.7 to 54.1) | -11.3 (-83.1 to 60.5) |
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.
| mIU/ml | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 8 | 0.9 (-1.3 to 3.2) | 1.7 (-0.9 to 4.2) |
| Change at week 20 | -1.3 (-4.2 to 1.6) | 0.1 (-2.6 to 2.8) |
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.
| ratio | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| Change at week 8 | 0.2 (0.1 to 0.3) | -0.1 (-0.3 to 0.0) |
| Change at week 20 | 0.2 (0.0 to 0.3) | 0.0 (-0.1 to 0.1) |
The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.
| Participants | Electroacupuncture | Sham Electroacupuncture |
|---|---|---|
| weeks 1- 8 | 8 | 8 |
| weeks 20-32 | 7 | 9 |
Collected over 32 weeks during the whole trial. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acupuncture | 0/180 (0%) | 0/180 (0%) | 9/180 (5%) |
| Sham Acupuncture | 0/180 (0%) | 0/180 (0%) | 2/180 (1.1%) |
| Event | Acupuncture | Sham Acupuncture |
|---|---|---|
| Severe needling painSkin and subcutaneous tissue disorders | 4/180 | 0/180 |
| Subcutaneous hematomaSkin and subcutaneous tissue disorders | 2/180 | 0/180 |
| FatigueMusculoskeletal and connective tissue disorders | 1/180 | 2/180 |
| DizzinessNervous system disorders | 1/180 | 0/180 |
| Abdominal discomfortsGastrointestinal disorders | 1/180 | 0/180 |
| Age, Categorical(Participants) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 180 | 180 | 360 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Median | 48.7 ± 4.0 | 48.1 ± 3.8 | 48.4 ± 3.9 |
| Sex: Female, Male(Participants) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Female | 180 | 180 | 360 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| China | 180 | 180 | 360 |
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences