Electro-acupuncture for Menopausal Transition Symptoms

Not Applicable

Completed

Conditions: Menopause

Interventions: Device: Eelectro-acupuncture
Device: Sham Eelectro-acupuncture

Registration Number: NCT02471755

Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 90

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

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electro-acupuncture Group	Eelectro-acupuncture	-
Sham Electro-acupuncture Group	Sham Eelectro-acupuncture	-

Primary Outcome Measures

Name	Time	Method
Change of Average 24 h Hot Flash Score From Baseline	week8;wee4,20,32	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.

Secondary Outcome Measures

Name	Time	Method
Change of FSH/LH From Baseline	week8,week20	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.
Change of E2 From Baseline	week8,week20	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.
Change of MRS (Menopause Rating Scale) From Baseline	week8;wee4,20,32	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.
Change of LH From Baseline	week8,week20	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.
Change of FSH From Baseline	week8,week20	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.