Clinical trial NCT01933204: Acupuncture for Relieving Perimenopausal Symptoms
Official title: Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Perimenopause
Keywords: perimenopause
hot flash
palpitation
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Chengdu First People's Hospital
name: Chengdu PLA General Hospital
First posted: 2013-09-02
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Menopause Rating Scale
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Menopausal Specific Quality of Life Questionnaire
timeFrame: asessed 0, 6, 12, 24, 36 weeks after randomization
measure: Average hot flash score during 24 hours
timeFrame: 0, 12, 24, 36 weeks after randomization
measure: Level of Estradiol in serum
timeFrame: 0, 12, 24 weeks after randomization
measure: Level of follicle stimulating hormone in serum
timeFrame: 0, 12, 24 weeks after randomization
measure: Level of luteinizing hormone in serum
timeFrame: 0, 12, 24 weeks after randomization
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: First affiliated hospital of Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Ying Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Zheng H, Zheng Q, Zhao L, Qin E, Wang Y, Zeng Q, Zheng H, Zhao Y, Sun W, Zhang X, Liu Z, Liu B. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial. Trials. 2014 May 30;15:198. doi: 10.1186/1745-6215-15-198.