Acupuncture for Relieving Perimenopausal Symptoms

Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Perimenopause
• Intervention / Treatment: Other: Acupuncture; Drug: Climen 21 Tablets

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Chengdu University of Traditional Chinese Medicine
    • Chengdu, Sichuan, China, 610075
      • First affiliated hospital of Chengdu university of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Acupuncture; 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.
Active Comparator: 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.	Drug: Climen 21 Tablets; Climen Tablets are commonly used for menopausal symptoms; Other Names: Climen Tablets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Collaborators: Chengdu PLA General Hospital; Chengdu First people's hospital
• Investigators: Principal Investigator: Ying Li, MD, PhD, Chengdu University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: perimenopause; hot flash; palpitation
• Other Study ID Numbers: 2012BAI24B01 (Other Grant/Funding Number: the Ministry of Science and Technology of PRC)