N/A
N=360
Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition
Menopausal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01849172 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change From Baseline in Menopause Rating Scale Total Score — 6.3; 4.5 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- electroacupuncture (Other); sham electroacupuncture (Other)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Menopause Rating Scale Total Score |
3.6; 3.2; 7.0; 4.5; 6.8; 4.1 | — |
| SECONDARY Change From Baseline in Menopause Rating Scale Total Score |
3.6; 3.2; 7.0; 4.5; 6.8; 4.1 | — |
| SECONDARY Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale |
1.5; 1.4; 2.6; 1.9; 3.0; 2.0 | — |
| SECONDARY Change From Baseline in Psychological Domain of Menopause Rating Scale |
1.6; 1.5; 2.7; 2.0; 2.9; 2.0 | — |
| SECONDARY Change From Baseline in Urogenital Domain of Menopause Rating Scale |
0.5; 0.3; 1.0; 0.5; 1.1; 0.5 | — |
| SECONDARY Change From Baseline in Mean 24-h Hot Flash Score |
1.9; 1.9; 3.6; 2.5; 3.9; 2.7 | — |
| SECONDARY Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score |
12.8; 12.6; 22.8; 17.1; 25.3; 18.2 | — |
| SECONDARY Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire |
1.9; 1.7; 3.4; 2.5; 3.7; 2.7 | — |
| SECONDARY Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire |
2.8; 2.8; 5.5; 3.8; 6.1; 4.2 | — |
| SECONDARY Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire |
7.4; 7.3; 12.4; 9.5; 14.1; 10.1 | — |
| SECONDARY Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire |
0.9; 0.8; 1.5; 1.2; 1.4; 1.2 | — |
| SECONDARY Change From Baseline in Serum FSH Level |
4.1; 2.0; 0.6; 0.4 | — |
| SECONDARY Change From Baseline in Serum E2 Level |
-12.3; 19.5; -2.3; -11.3 | — |
| SECONDARY Change From Baseline in Serum LH Level |
0.9; 1.7; -1.3; 0.1 | — |
| SECONDARY Change From Baseline in Serum FSH/LH Level |
0.2; -0.1; 0.2; 0.0 | — |
| SECONDARY Number of Participants Who Used Other Treatment During Study |
8; 8; 7; 9 | — |
Summary
The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01849172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.