Acupuncture for Relieving Perimenopausal Symptoms

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

Detailed Description
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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

Official Title
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Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial

Conditions
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Perimenopause

Intervention / Treatment
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* Other: Acupuncture
* Drug: Climen 21 Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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. | Other: Acupuncture<br>* Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.<br>|
| Active Comparator: Climen 21 Tablets<br>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. | Drug: Climen 21 Tablets<br>* Climen Tablets are commonly used for menopausal symptoms<br>* Other names: Climen Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopause Rating Scale | 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. | 12 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal Specific Quality of Life Questionnaire | 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). | asessed 0, 6, 12, 24, 36 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 | 
| Level of follicle stimulating hormone in serum |  | 0, 12, 24 weeks after randomization | 
| Level of luteinizing hormone in serum |  | 0, 12, 24 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perimenopause, hot flash, palpitation