Trial Outcomes & Findings for Electro-acupuncture for Menopausal Transition Symptoms (NCT NCT02471755)
NCT ID: NCT02471755
Last Updated: 2015-11-23
Results Overview
Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
week8;wee4,20,32
Results posted on
2015-11-23
Participant Flow
This prospective RCT was conducted at Guang'anmen Hospital, China Academy of Chinese Medical Sciences (Beijing, China), from April 2013 to December 2014. Participants with MT were recruited via hospital posters.
A total of 192 participants were assessed for eligibility; 102 participants were excluded from the trial(53 didn't meet inclusion criteria, 26 declined to participate the trial, 23 for other reasons). 90 participants were randomly allocated to the EA group or the sham EA group.
Participant milestones
| Measure |
Electro-acupuncture Group
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Electro-acupuncture Group
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Electro-acupuncture for Menopausal Transition Symptoms
Baseline characteristics by cohort
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.05 years
STANDARD_DEVIATION 4.41 • n=5 Participants
|
50.69 years
STANDARD_DEVIATION 3.79 • n=7 Participants
|
50.84 years
STANDARD_DEVIATION 4.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Educational Level
Preliminary education
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Educational Level
Secondary education
|
33 participants
n=5 Participants
|
25 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Educational Level
Tertiary education
|
11 participants
n=5 Participants
|
19 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Weight
|
58.02 Kg
STANDARD_DEVIATION 5.66 • n=5 Participants
|
57.66 Kg
STANDARD_DEVIATION 7.95 • n=7 Participants
|
57.84 Kg
STANDARD_DEVIATION 6.87 • n=5 Participants
|
|
Height
|
159.39 cm
STANDARD_DEVIATION 3.87 • n=5 Participants
|
159.49 cm
STANDARD_DEVIATION 3.88 • n=7 Participants
|
159.44 cm
STANDARD_DEVIATION 3.85 • n=5 Participants
|
|
Menopausal Course
|
16.00 month
n=5 Participants
|
16.00 month
n=7 Participants
|
16.00 month
n=5 Participants
|
|
Menopausal Stage
Early stage
|
17 participants
n=5 Participants
|
24 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Menopausal Stage
Late stage
|
27 participants
n=5 Participants
|
21 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Ever Received Drug Therapy
Yes
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Ever Received Drug Therapy
No
|
39 participants
n=5 Participants
|
44 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
24 h Hot Flash Score
|
8.07 Scores on a scale
n=5 Participants
|
7.26 Scores on a scale
n=7 Participants
|
7.71 Scores on a scale
n=5 Participants
|
|
Menopause Rating Scale
|
17.50 Scores on a scale
n=5 Participants
|
15.00 Scores on a scale
n=7 Participants
|
16.00 Scores on a scale
n=5 Participants
|
|
FSH
|
42.85 mIU/ml
n=5 Participants
|
44.47 mIU/ml
n=7 Participants
|
44.12 mIU/ml
n=5 Participants
|
|
LH
|
33.08 mIU/ml
n=5 Participants
|
32.89 mIU/ml
n=7 Participants
|
32.89 mIU/ml
n=5 Participants
|
|
FSH/LH
|
1.38 ratio
n=5 Participants
|
1.44 ratio
n=7 Participants
|
1.42 ratio
n=5 Participants
|
|
E2
|
73.73 pmol/l
n=5 Participants
|
51.38 pmol/l
n=7 Participants
|
65.77 pmol/l
n=5 Participants
|
PRIMARY outcome
Timeframe: week8;wee4,20,32Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.
Outcome measures
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Change of Average 24 h Hot Flash Score From Baseline
week8
|
-2.29 Scores on a scale
Interval -4.79 to -0.47
|
-0.71 Scores on a scale
Interval -3.28 to 0.09
|
|
Change of Average 24 h Hot Flash Score From Baseline
week4
|
-0.78 Scores on a scale
Interval -2.54 to 0.0
|
-0.71 Scores on a scale
Interval -2.72 to 0.34
|
|
Change of Average 24 h Hot Flash Score From Baseline
week20
|
-2.43 Scores on a scale
Interval -4.9 to -0.86
|
-1.14 Scores on a scale
Interval -4.0 to 0.5
|
|
Change of Average 24 h Hot Flash Score From Baseline
week32
|
-3.79 Scores on a scale
Interval -6.0 to -1.14
|
-0.87 Scores on a scale
Interval -4.57 to 0.14
|
SECONDARY outcome
Timeframe: week8;wee4,20,32MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way. In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient. Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Change of MRS (Menopause Rating Scale) From Baseline
week8
|
-4.00 Scores on a scale
Interval -9.0 to -1.25
|
-6.00 Scores on a scale
Interval -9.0 to 0.0
|
|
Change of MRS (Menopause Rating Scale) From Baseline
week4
|
-1.50 Scores on a scale
Interval -5.75 to 0.75
|
-4.00 Scores on a scale
Interval -6.5 to 0.0
|
|
Change of MRS (Menopause Rating Scale) From Baseline
week20
|
-6.00 Scores on a scale
Interval -11.0 to -1.0
|
-5.00 Scores on a scale
Interval -8.5 to -1.0
|
|
Change of MRS (Menopause Rating Scale) From Baseline
week32
|
-7.00 Scores on a scale
Interval -12.75 to -2.0
|
-5.00 Scores on a scale
Interval -10.0 to -0.5
|
SECONDARY outcome
Timeframe: week8,week20Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Outcome measures
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Change of FSH From Baseline
week8
|
-1.90 mIU/ml
Interval -9.98 to 10.03
|
0.70 mIU/ml
Interval -1.87 to 11.04
|
|
Change of FSH From Baseline
week20
|
-1.69 mIU/ml
Interval -11.11 to 24.22
|
1.93 mIU/ml
Interval -0.58 to 18.67
|
SECONDARY outcome
Timeframe: week8,week20Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Outcome measures
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Change of LH From Baseline
week8
|
-2.58 mIU/ml
Interval -7.99 to 3.61
|
0.99 mIU/ml
Interval -3.01 to 4.78
|
|
Change of LH From Baseline
week20
|
-0.66 mIU/ml
Interval -8.56 to 11.11
|
0.79 mIU/ml
Interval -0.13 to 9.74
|
SECONDARY outcome
Timeframe: week8,week20Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Outcome measures
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Change of FSH/LH From Baseline
week8
|
0.10 ratio
Interval -0.1 to 0.33
|
-0.01 ratio
Interval -0.15 to 0.24
|
|
Change of FSH/LH From Baseline
week20
|
0.06 ratio
Interval -0.2 to 0.33
|
-0.01 ratio
Interval -0.1 to 0.18
|
SECONDARY outcome
Timeframe: week8,week20Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Outcome measures
| Measure |
Electro-acupuncture Group
n=44 Participants
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 Participants
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Change of E2 From Baseline
week8
|
2.92 pmol/l
Interval 0.0 to 28.37
|
0.40 pmol/l
Interval -1.88 to 12.16
|
|
Change of E2 From Baseline
week20
|
13.75 pmol/l
Interval -1.22 to 62.76
|
2.43 pmol/l
Interval -14.56 to 31.38
|
Adverse Events
Electro-acupuncture Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham Electro-acupuncture Group
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 |
Electro-acupuncture Group
n=44 participants at risk
Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
|
Sham Electro-acupuncture Group
n=45 participants at risk
Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.3%
1/44 • 32 weeks
|
2.2%
1/45 • 32 weeks
|
|
General disorders
sore throat
|
2.3%
1/44 • 32 weeks
|
0.00%
0/45 • 32 weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.3%
1/44 • 32 weeks
|
0.00%
0/45 • 32 weeks
|
|
General disorders
fatigue
|
0.00%
0/44 • 32 weeks
|
2.2%
1/45 • 32 weeks
|
Additional Information
Dr.Xiaoxu Liu
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phone: +86 10 8800 1124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place