Acupuncture for Relieving Perimenopausal Symptoms

Chengdu University of Traditional Chinese Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Perimenopause

Treatments: Other: Acupuncture; Drug: Climen 21 Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01933204

2012BAI24B01

Details and patient eligibility

About

The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.

Full description

• A randomised controlled trial with superiority design
• A total of 220 participants will be included in 3 centers
• 2 arms: acupuncture group and Climen® group

Enrollment: 220 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days.
• Reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
• Age 40-50 years.
• Not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis.
• Willing to participate and signing the inform consent.

Exclusion criteria

• Had a regular menopausal cycle 3 months before this trial.
• Taking estrogen, selective serotonin reuptake inhibitor(SSRI), soy isoflavone, progesterone, Vitamin E or black cohosh in the 4 weeks before inclusion.
• receiving chemoradiotherapy.
• Agnogenic vaginal bleeding.
• Coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc.
• Dermal diseases, e.g., eczema, psoriasis.
• Liver or kidney failure.
• Uncontrollable hypertension, diabetes, or thyroid diseases.
• With diabetic neuropathy, malignant cancer and mental diseases (including depression).
• Intend to gestation, in gestation period or lactation period.
• Using sedative or antianxiety drugs.
• With smoking or intemperance problems.
• Using cardiac pacemaker, or joint prosthesis.
• Low compliance.
• Benign tumor in breast.
• Family history of breast cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Using basic points combined with additional points. Basic points are fixed, while additional points will be selected from a list of points categorized by syndrome differentiation.

Treatment:

Other: Acupuncture

Climen 21 Tablets

Active Comparator group

Description:

COMPOSITION 11 white tablets each containing estradiol-17-valerate 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate 1 mg.

Treatment:

Drug: Climen 21 Tablets