Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Menopause Rating Scale
Study Overview
Brief Summary
The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Acupuncture
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.
Intervention: Acupuncture (Other)
Climen 21 Tablets
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.
Intervention: Climen 21 Tablets (Drug)
Outcomes
Primary Outcomes
Menopause Rating Scale
Time Frame: 12 weeks after randomization
The scale was developed and validated over the years from a research network of many institutions such as Organon Germany, Infratest Munich, Universities of Muenster and Berlin,the Berlin Center for Epidemiology and Health Research, etc. It is a scale consisted of 11 items, ranging from no symptoms to very severe symptoms.
Secondary Outcomes
- Level of follicle stimulating hormone in serum(0, 12, 24 weeks after randomization)
- Average hot flash score during 24 hours(0, 12, 24, 36 weeks after randomization)
- Level of Estradiol in serum(0, 12, 24 weeks after randomization)
- Menopausal Specific Quality of Life Questionnaire(asessed 0, 6, 12, 24, 36 weeks after randomization)
- Level of luteinizing hormone in serum(0, 12, 24 weeks after randomization)