Trial Outcomes & Findings for Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition (NCT NCT01849172)
NCT ID: NCT01849172
Last Updated: 2019-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
at baseline and week 8
Results posted on
2019-04-02
Participant Flow
Participant milestones
| Measure |
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).
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
180
|
|
Overall Study
COMPLETED
|
173
|
174
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition
Baseline characteristics by cohort
| Measure |
Acupuncture
n=180 Participants
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).
|
Sham Acupuncture
n=180 Participants
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
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=93 Participants
|
180 Participants
n=4 Participants
|
360 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 4.0 • n=93 Participants
|
48.1 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
48.4 years
STANDARD_DEVIATION 3.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=93 Participants
|
180 Participants
n=4 Participants
|
360 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
180 participants
n=93 Participants
|
180 participants
n=4 Participants
|
360 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at baseline and week 8The 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.
Outcome measures
| Measure |
Electroacupuncture
n=180 Participants
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.
|
Sham Electroacupuncture
n=180 Participants
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.
|
|---|---|---|
|
Change From Baseline in Menopause Rating Scale Total Score
|
6.3 units on a scale
Interval 5.0 to 7.7
|
4.5 units on a scale
Interval 3.2 to 5.8
|
SECONDARY outcome
Timeframe: at baseline，and weeks 4, 20 and 32Population: 6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in Menopause Rating Scale Total Score
Change at week 4
|
3.6 units on a scale
Interval 2.6 to 4.6
|
3.2 units on a scale
Interval 2.2 to 4.2
|
|
Change From Baseline in Menopause Rating Scale Total Score
Change at week 20
|
7.0 units on a scale
Interval 5.5 to 8.4
|
4.5 units on a scale
Interval 3.1 to 5.9
|
|
Change From Baseline in Menopause Rating Scale Total Score
Change at week 32
|
6.8 units on a scale
Interval 5.2 to 8.5
|
4.1 units on a scale
Interval 2.5 to 5.8
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
Change at week 4
|
1.5 units on a scale
Interval 1.1 to 2.0
|
1.4 units on a scale
Interval 1.0 to 1.8
|
|
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
Change at week 8
|
2.6 units on a scale
Interval 2.0 to 3.2
|
1.9 units on a scale
Interval 1.4 to 2.5
|
|
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
Change at week 20
|
3.0 units on a scale
Interval 2.4 to 3.5
|
2.0 units on a scale
Interval 1.5 to 2.5
|
|
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
Change at week 32
|
2.8 units on a scale
Interval 2.2 to 3.4
|
1.7 units on a scale
Interval 1.2 to 2.3
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in Psychological Domain of Menopause Rating Scale
Change at week 4
|
1.6 units on a scale
Interval 1.1 to 2.1
|
1.5 units on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Psychological Domain of Menopause Rating Scale
change at week 8
|
2.7 units on a scale
Interval 2.1 to 3.3
|
2.0 units on a scale
Interval 1.4 to 2.6
|
|
Change From Baseline in Psychological Domain of Menopause Rating Scale
change at week 20
|
2.9 units on a scale
Interval 2.2 to 3.6
|
2.0 units on a scale
Interval 1.3 to 2.7
|
|
Change From Baseline in Psychological Domain of Menopause Rating Scale
Change at week 32
|
3.0 units on a scale
Interval 2.2 to 3.7
|
2.0 units on a scale
Interval 1.3 to 2.8
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in Urogenital Domain of Menopause Rating Scale
Change at week 4
|
0.5 units on a scale
Interval 0.2 to 0.7
|
0.3 units on a scale
Interval 0.1 to 0.6
|
|
Change From Baseline in Urogenital Domain of Menopause Rating Scale
Change at week 8
|
1.0 units on a scale
Interval 0.7 to 1.4
|
0.5 units on a scale
Interval 0.2 to 0.8
|
|
Change From Baseline in Urogenital Domain of Menopause Rating Scale
Change at week 20
|
1.1 units on a scale
Interval 0.7 to 1.5
|
0.5 units on a scale
Interval 0.1 to 0.9
|
|
Change From Baseline in Urogenital Domain of Menopause Rating Scale
Change at week 32
|
1.0 units on a scale
Interval 0.6 to 1.5
|
0.4 units on a scale
Interval -0.1 to 0.9
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in Mean 24-h Hot Flash Score
Change at week 4
|
1.9 units on a scale
Interval 1.0 to 2.8
|
1.9 units on a scale
Interval 0.9 to 2.8
|
|
Change From Baseline in Mean 24-h Hot Flash Score
Change at week 8
|
3.6 units on a scale
Interval 2.6 to 4.7
|
2.5 units on a scale
Interval 1.4 to 3.5
|
|
Change From Baseline in Mean 24-h Hot Flash Score
Change at week 20
|
3.9 units on a scale
Interval 2.9 to 4.8
|
2.7 units on a scale
Interval 1.7 to 3.7
|
|
Change From Baseline in Mean 24-h Hot Flash Score
Change at week 32
|
4.1 units on a scale
Interval 2.7 to 5.5
|
1.9 units on a scale
Interval 0.5 to 3.2
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
Change at week 4
|
12.8 units on a scale
Interval 8.6 to 17.0
|
12.6 units on a scale
Interval 8.4 to 16.8
|
|
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
Change at week 32
|
26 units on a scale
Interval 19.4 to 32.7
|
17.6 units on a scale
Interval 11.0 to 24.3
|
|
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
Change at week 8
|
22.8 units on a scale
Interval 16.9 to 28.7
|
17.1 units on a scale
Interval 11.2 to 23.0
|
|
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
Change at week 20
|
25.3 units on a scale
Interval 18.9 to 31.7
|
18.2 units on a scale
Interval 11.9 to 24.6
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 4
|
1.9 units on a scale
Interval 1.1 to 2.8
|
1.7 units on a scale
Interval 0.9 to 2.6
|
|
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 20
|
3.7 units on a scale
Interval 2.7 to 4.7
|
2.7 units on a scale
Interval 1.6 to 3.7
|
|
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 8
|
3.4 units on a scale
Interval 2.4 to 4.4
|
2.5 units on a scale
Interval 1.5 to 3.5
|
|
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 32
|
3.8 units on a scale
Interval 2.8 to 4.8
|
2.4 units on a scale
Interval 1.4 to 3.4
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 20
|
6.1 units on a scale
Interval 4.4 to 7.9
|
4.2 units on a scale
Interval 2.5 to 6.0
|
|
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 32
|
6.4 units on a scale
Interval 4.5 to 8.3
|
4.3 units on a scale
Interval 2.4 to 6.2
|
|
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 4
|
2.8 units on a scale
Interval 1.7 to 4.0
|
2.8 units on a scale
Interval 1.7 to 4.0
|
|
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 8
|
5.5 units on a scale
Interval 4.0 to 7.0
|
3.8 units on a scale
Interval 2.4 to 5.3
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 4
|
7.4 units on a scale
Interval 4.7 to 9.6
|
7.3 units on a scale
Interval 4.9 to 9.7
|
|
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 8
|
12.4 units on a scale
Interval 9.1 to 15.8
|
9.5 units on a scale
Interval 6.2 to 12.9
|
|
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 20
|
14.1 units on a scale
Interval 10.6 to 17.6
|
10.1 units on a scale
Interval 6.6 to 13.7
|
|
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 32
|
14.3 units on a scale
Interval 10.7 to 18.0
|
10.0 units on a scale
Interval 6.4 to 13.6
|
SECONDARY outcome
Timeframe: at baseline, and weeks 4, 8, 20 and 32Population: 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
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.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 4
|
0.9 units on a scale
Interval 0.5 to 1.3
|
0.8 units on a scale
Interval 0.4 to 1.2
|
|
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 8
|
1.5 units on a scale
Interval 1.0 to 1.9
|
1.2 units on a scale
Interval 0.7 to 1.6
|
|
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 20
|
1.4 units on a scale
Interval 0.8 to 1.9
|
1.2 units on a scale
Interval 0.6 to 1.7
|
|
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
Change at week 32
|
1.5 units on a scale
Interval 0.7 to 2.2
|
1.0 units on a scale
Interval 0.2 to 1.8
|
SECONDARY outcome
Timeframe: at baseline, and weeks 8 and 20Population: 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.
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.
Outcome measures
| Measure |
Electroacupuncture
n=171 Participants
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.
|
Sham Electroacupuncture
n=172 Participants
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.
|
|---|---|---|
|
Change From Baseline in Serum FSH Level
Change at week 8
|
4.1 mIU/ml
Interval 0.4 to 7.9
|
2.0 mIU/ml
Interval -1.8 to 5.9
|
|
Change From Baseline in Serum FSH Level
Change at week 20
|
0.6 mIU/ml
Interval -0.4 to 5.3
|
0.4 mIU/ml
Interval -3.7 to 4.6
|
SECONDARY outcome
Timeframe: at baseline, and weeks 8 and 20Population: 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.
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.
Outcome measures
| Measure |
Electroacupuncture
n=143 Participants
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.
|
Sham Electroacupuncture
n=142 Participants
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.
|
|---|---|---|
|
Change From Baseline in Serum E2 Level
Change at week 8
|
-12.3 pmol/ml
Interval -59.5 to 35.0
|
19.5 pmol/ml
Interval -38.5 to 77.6
|
|
Change From Baseline in Serum E2 Level
Change at week 20
|
-2.3 pmol/ml
Interval -58.7 to 54.1
|
-11.3 pmol/ml
Interval -83.1 to 60.5
|
SECONDARY outcome
Timeframe: at baseline, and weeks 8 and 20Population: 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.
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.
Outcome measures
| Measure |
Electroacupuncture
n=171 Participants
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.
|
Sham Electroacupuncture
n=172 Participants
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.
|
|---|---|---|
|
Change From Baseline in Serum LH Level
Change at week 8
|
0.9 mIU/ml
Interval -1.3 to 3.2
|
1.7 mIU/ml
Interval -0.9 to 4.2
|
|
Change From Baseline in Serum LH Level
Change at week 20
|
-1.3 mIU/ml
Interval -4.2 to 1.6
|
0.1 mIU/ml
Interval -2.6 to 2.8
|
SECONDARY outcome
Timeframe: at baseline, weeks 8 and 20Population: 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.
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.
Outcome measures
| Measure |
Electroacupuncture
n=171 Participants
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.
|
Sham Electroacupuncture
n=172 Participants
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.
|
|---|---|---|
|
Change From Baseline in Serum FSH/LH Level
Change at week 8
|
0.2 ratio
Interval 0.1 to 0.3
|
-0.1 ratio
Interval -0.3 to 0.0
|
|
Change From Baseline in Serum FSH/LH Level
Change at week 20
|
0.2 ratio
Interval 0.0 to 0.3
|
0.0 ratio
Interval -0.1 to 0.1
|
SECONDARY outcome
Timeframe: weeks 1-8; weeks 9-32Population: 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
The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.
Outcome measures
| Measure |
Electroacupuncture
n=174 Participants
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.
|
Sham Electroacupuncture
n=175 Participants
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.
|
|---|---|---|
|
Number of Participants Who Used Other Treatment During Study
weeks 1- 8
|
8 Participants
|
8 Participants
|
|
Number of Participants Who Used Other Treatment During Study
weeks 20-32
|
7 Participants
|
9 Participants
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture
n=180 participants at risk
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).
|
Sham Acupuncture
n=180 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.56%
1/180 • Number of events 1 • 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.
|
0.00%
0/180 • 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.
|
|
Skin and subcutaneous tissue disorders
Severe needling pain
|
2.2%
4/180 • Number of events 5 • 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.
|
0.00%
0/180 • 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.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hematoma
|
1.1%
2/180 • Number of events 2 • 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.
|
0.00%
0/180 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
0.56%
1/180 • Number of events 1 • 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.
|
1.1%
2/180 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Abdominal discomforts
|
0.56%
1/180 • Number of events 2 • 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.
|
0.00%
0/180 • 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.
|
Additional Information
Dr.Zhishun Liu
Guang'an Men Hospital, China Academy of Chinese Medical Sciences
Phone: +86 01088002331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place