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CompletedNCT02471755Updated Nov 23, 2015Results posted

Electro-acupuncture for Menopausal Transition Symptoms

An interventional study of Eelectro-acupuncture and Sham Eelectro-acupuncture in Menopause, 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 2015-11-23.

Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
Female
01

Study summary

This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.

Read the detailed description

This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90 patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome. With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants. Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit. For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test. P\<0.05 was regarded as statistically significance.

02

Conditions studied

  • Menopause

Keywords

  • electro-acupuncture
  • menopause
  • menopausal transition symptoms
  • efficacy
  • RCT
  • placebo control
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Participants meeting the following criteria were included in study:

    1. Had a diagnosis of MT (cycle length irregularity: 7 days earlier or later than usual, the last menstruation was no longer than 11 month earliar over the previous year; Specific symptoms of MT: hot flashes, night sweating, insomnia, sexual problems, anxiety, depression etc.);
    2. Aged from 40 to 55 years old;
    3. Pregnancy test was negative;
    4. Participants were informed about the study and signed a consent form voluntarily.

Exclusion criteria

Exclusion Criteria:

  • Participants with any of the following criteria were omitted from the study:

    1. 3 month regular cycle length before enrollment;
    2. Took drugs for treatment in past month like estrogen, soybeans isoflavone, SSRIs, progestin, black sesame or vitamin E;
    3. Ovarian and uterine disease: ovarian cyst, uterine myoma more than 4cm in diameter, history of ovariectomy or hysterectomy;
    4. Willing or plan to become pregnant or to breast-feed;
    5. Regular took sedatives or anxiolytics;
    6. Habitual smoker or heavy alcoholic;
    7. Severe disease: history of radio-chemotherapy, coagulation disorders, severe dysfunction of liver or kidney, application of cardiac pacemaker or artificial joints, insufficiency controlled hypertension, diabetes, thyroid diseases, malignant tumor and psychiatric problems).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Electro-acupuncture Group

    Device: Eelectro-acupuncture

  • Placebo comparator
    Sham Electro-acupuncture Group

    Device: Sham Eelectro-acupuncture

Interventions

  • DeviceEelectro-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.

  • DeviceSham 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.

06

What researchers measure

Primary outcomes

  1. Change of Average 24 h Hot Flash Score From Baseline

    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.

    Time frame: week8;wee4,20,32

Secondary outcomes

  1. Change of MRS (Menopause Rating Scale) From Baseline

    MRS(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.

    Time frame: week8;wee4,20,32

  2. Change of FSH From Baseline

    Serum 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.

    Time frame: week8,week20

  3. Change of LH From Baseline

    Serum 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.

    Time frame: week8,week20

  4. Change of FSH/LH From Baseline

    Serum 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.

    Time frame: week8,week20

  5. Change of E2 From Baseline

    Serum 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.

    Time frame: week8,week20

07

Results

Posted Nov 23, 2015

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.

Participant flow — Overall Study
MilestoneElectro-acupuncture GroupSham Electro-acupuncture Group
Started4545
Completed4444
Not completed11
Withdrew: Withdrawal by subject10
Withdrew: Lost to follow-up01

Outcome measures

PrimaryChange of Average 24 h Hot Flash Score From Baseline

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.

Time frame:
week8;wee4,20,32
Reported as:
Median · Scores on a scale
Change of Average 24 h Hot Flash Score From Baseline
Scores on a scaleElectro-acupuncture GroupSham Electro-acupuncture Group
week8-2.29 (-4.79 to -0.47)-0.71 (-3.28 to 0.09)
week4-0.78 (-2.54 to 0.00)-0.71 (-2.72 to 0.34)
week20-2.43 (-4.90 to -0.86)-1.14 (-4.00 to 0.50)
week32-3.79 (-6.00 to -1.14)-0.87 (-4.57 to 0.14)
SecondaryChange of MRS (Menopause Rating Scale) From Baseline

MRS(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.

Time frame:
week8;wee4,20,32
Reported as:
Median · Scores on a scale
Change of MRS (Menopause Rating Scale) From Baseline
Scores on a scaleElectro-acupuncture GroupSham Electro-acupuncture Group
week8-4.00 (-9.00 to -1.25)-6.00 (-9.00 to 0.00)
week4-1.50 (-5.75 to 0.75)-4.00 (-6.50 to 0.00)
week20-6.00 (-11.00 to -1.00)-5.00 (-8.50 to -1.00)
week32-7.00 (-12.75 to -2.00)-5.00 (-10.00 to -0.50)
SecondaryChange of FSH From Baseline

Serum 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.

Time frame:
week8,week20
Reported as:
Median · mIU/ml
Change of FSH From Baseline
mIU/mlElectro-acupuncture GroupSham Electro-acupuncture Group
week8-1.90 (-9.98 to 10.03)0.70 (-1.87 to 11.04)
week20-1.69 (-11.11 to 24.22)1.93 (-0.58 to 18.67)
SecondaryChange of LH From Baseline

Serum 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.

Time frame:
week8,week20
Reported as:
Median · mIU/ml
Change of LH From Baseline
mIU/mlElectro-acupuncture GroupSham Electro-acupuncture Group
week8-2.58 (-7.99 to 3.61)0.99 (-3.01 to 4.78)
week20-0.66 (-8.56 to 11.11)0.79 (-0.13 to 9.74)
SecondaryChange of FSH/LH From Baseline

Serum 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.

Time frame:
week8,week20
Reported as:
Median · ratio
Change of FSH/LH From Baseline
ratioElectro-acupuncture GroupSham Electro-acupuncture Group
week80.10 (-0.10 to 0.33)-0.01 (-0.15 to 0.24)
week200.06 (-0.20 to 0.33)-0.01 (-0.10 to 0.18)
SecondaryChange of E2 From Baseline

Serum 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.

Time frame:
week8,week20
Reported as:
Median · pmol/l
Change of E2 From Baseline
pmol/lElectro-acupuncture GroupSham Electro-acupuncture Group
week82.92 (0.00 to 28.37)0.40 (-1.88 to 12.16)
week2013.75 (-1.22 to 62.76)2.43 (-14.56 to 31.38)

Adverse events

Collected over 32 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Electro-acupuncture Group—0/44 (0%)3/44 (6.8%)
Sham Electro-acupuncture Group—0/45 (0%)2/45 (4.4%)
Most frequent other events
Most frequent other events
EventElectro-acupuncture GroupSham Electro-acupuncture Group
HeadacheNervous system disorders1/441/45
sore throatGeneral disorders1/440/45
arthralgiaMusculoskeletal and connective tissue disorders1/440/45
fatigueGeneral disorders0/441/45

Baseline characteristics

Age, Continuous
Age, Continuous(years)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Mean51.05 ± 4.4150.69 ± 3.7950.84 ± 4.10
Sex: Female, Male
Sex: Female, Male(Participants)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Female444589
Male000
Educational Level
Educational Level(participants)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Preliminary education011
Secondary education332558
Tertiary education111930
Weight
Weight(Kg)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Mean58.02 ± 5.6657.66 ± 7.9557.84 ± 6.87
Height
Height(cm)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Mean159.39 ± 3.87159.49 ± 3.88159.44 ± 3.85
Menopausal Course
Menopausal Course(month)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Median16.00 (12.00 to 18.00)16.00 (12.50 to 24.00)16.00 (12.00 to 21.00)
Menopausal Stage
Menopausal Stage(participants)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Early stage172441
Late stage272148
Ever Received Drug Therapy
Ever Received Drug Therapy(participants)Electro-acupuncture GroupSham Electro-acupuncture GroupTotal
Yes516
No394483

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Beijing, Beijing 100053, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02471755
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible party
xiaoxuliu (doctor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Principal investigator
First posted
Jun 15, 2015
Start date
Apr 2013
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Nov 23, 2015
Last update
Nov 23, 2015

Study contacts

Zhishun Liu, Doctor
principal investigator · Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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