Acupuncture for Relieving Perimenopausal Symptoms
- Conditions
- Perimenopause
- Interventions
- Other: AcupunctureDrug: Climen 21 Tablets
- Registration Number
- NCT01933204
- Lead Sponsor
- Chengdu University of Traditional Chinese Medicine
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture 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. Climen 21 Tablets 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.
- Primary Outcome Measures
Name Time Method Menopause Rating Scale 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 Outcome Measures
Name Time Method 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 The Menopausal Specific Quality of Life Questionnaire (MENQOL) is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
Level of luteinizing hormone in serum 0, 12, 24 weeks after randomization
Trial Locations
- Locations (2)
First affiliated hospital of Chengdu University of TCM
🇨🇳Chengdu, Sichuan, China
Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China