Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition

Not Applicable

Completed

Conditions: Menopausal Syndrome

Interventions: Other: sham electroacupuncture
Other: electroacupuncture

Registration Number: NCT01849172

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

Brief Summary: The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .

Detailed Description: Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect.

Our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 360

Inclusion Criteria

Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
40 to 55 years old.
Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -

Exclusion Criteria

Regular cycles during the past 3 months before enrollment.
use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
Patients with radiochemotherapy history or undergoing radiochemotherapy.
Cryptogenic vaginal bleeding
Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.
Existing skin diseases like eczema or psoriasis.
Severe hepatic/renal insufficiency.
Insufficiently controlled hypertension, diabetes or thyroid diseases.
Existing diabetic neuropathy, malignant tumor and psychiatric disorders.
Wish to become pregnant or is pregnant or breast-feeding.
Regular use of sedative or anxiolytic.
Smoking or alcohol intake.
Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).
With cardiac pacemaker or artificial joint.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham electroacupuncture	sham electroacupuncture	Sham electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).Specially constructed EA apparatus were used with no skin penetration, electricity output, or de qi requirement for needle manipulation One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.
electroacupuncture	electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Menopause Rating Scale Total Score	at baseline and week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean 24-h Hot Flash Score	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in Psychological Domain of Menopause Rating Scale	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in Menopause Rating Scale Total Score	at baseline，and weeks 4, 20 and 32	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.
Change From Baseline in Urogenital Domain of Menopause Rating Scale	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in Serum FSH Level	at baseline, and weeks 8 and 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.
Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire	at baseline, and weeks 4, 8, 20 and 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.
Change From Baseline in Serum LH Level	at baseline, and weeks 8 and 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.
Change From Baseline in Serum FSH/LH Level	at baseline, weeks 8 and 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.
Number of Participants Who Used Other Treatment During Study	weeks 1-8; weeks 9-32	The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.
Change From Baseline in Serum E2 Level	at baseline, and weeks 8 and 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.