Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Menopausal Syndrome

Treatments: Other: sham electroacupuncture; Other: electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01849172

BAI24B01

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

electroacupuncture

Experimental group

Description:

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.

Treatment:

Other: electroacupuncture

sham electroacupuncture

Sham Comparator group

Description:

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.

Treatment:

Other: sham electroacupuncture