Perimenopause
Conditions
Keywords
perimenopause, hot flash, palpitation
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
Interventions
OTHERAcupuncture
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.
Climen Tablets are commonly used for menopausal symptoms
Sponsors
Chengdu First People's Hospital
Chengdu PLA General Hospital
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 | — |
Countries
China
Outcome results
None listed