Clinical trial NCT01849172: Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition
Official title: Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition -a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal Syndrome
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2013-05-08
Enrollment: 360
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
3. 40 to 55 years old.
4. 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:

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

Primary outcomes:
measure: Change From Baseline in Menopause Rating Scale Total Score
timeFrame: at baseline and week 8
Secondary outcomes:
measure: Change From Baseline in Menopause Rating Scale Total Score
timeFrame: at baseline，and weeks 4, 20 and 32
measure: Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in Psychological Domain of Menopause Rating Scale
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in Urogenital Domain of Menopause Rating Scale
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in Mean 24-h Hot Flash Score
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire
timeFrame: at baseline, and weeks 4, 8, 20 and 32
measure: Change From Baseline in Serum FSH Level
timeFrame: at baseline, and weeks 8 and 20
measure: Change From Baseline in Serum E2 Level
timeFrame: at baseline, and weeks 8 and 20
measure: Change From Baseline in Serum LH Level
timeFrame: at baseline, and weeks 8 and 20
measure: Change From Baseline in Serum FSH/LH Level
timeFrame: at baseline, weeks 8 and 20
measure: Number of Participants Who Used Other Treatment During Study
timeFrame: weeks 1-8; weeks 9-32
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guangan'men Hospital
Study officials:
affiliation: Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
name: Zhishun Liu, Ph.D
role: STUDY_CHAIR
References:
citation: Liu Z, Wang Y, Xu H, Wu J, He L, Jiang JY, Yan S, Du R, Liu B. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:242. doi: 10.1186/1745-6215-15-242.