Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial

The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.

Study Overview

• Status: Completed
• Conditions: Menopausal Syndrome
• Intervention / Treatment: Other: TCM intervention; Other: Western intervention

Detailed Description

Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Longhua Hospital of Shanghai University of Traditional Chinese Medicine
  • Tianjin, China, 300170
    • Baokang Hospital of Tianjin University of Traditional Chinese Medicine
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Foshan Hospital of Traditional Chinese Medicine
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou University of Traditional Chinese Medicine
    • Guangzhou, Guangdong, China, 510360
      • Liwan Hospital of Traditional Chinese Medicine
  • Hubei
    • Wuhan, Hubei, China, 430061
      • Affiliated Hospital of Hubei College of Traditional Chinese Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Affiliated Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Aged 41-60;
• Amenorrhea for at least 6 months;
• Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
• Hot flushes and night sweats symptoms;
• Vaginal secretion decreased with or without dyspareunia;
• Kupperman Index (KI) score ≥ 15;
• Self-rating Anxiety Scale or Self-rating Depression Scale standard score >50,but <72(standard score= scale score ×1.25);
• FSH ≥ 20 IU/L;
• Thickness of endometrium ≤0.5cm if Amenorrhea for at least 12 months;or ≤1.5cm if Amenorrhea for 6 months to 12 months;
• Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency.

Exclusion Criteria:

• With malignant tumor in reproductive system;
• With benign tumor in reproductive system and need surgery;
• Malignant tumor in mammary gland;
• Irregular vaginal bleeding for unknown reasons;
• Thickness of endometrium ≥1.5cm by ultrasound examination;
• Have used Sex hormone medicine or joined other clinical trials 3 months before;
• Allergy;
• Severe diseases (eg., of the cardiovascular, liver, kidney) or uncontrolled endocrine diseases (eg., diabetes mellitus, hyperthyreosis )
• Severe psychiatric disease diagnosed by psychiatric physician;
• Refuse informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCM intervention; Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone	Other: TCM intervention; Drug: Particle of compound Chinese herbs(produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. One tablet placebo of Tibolone (provided by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months. Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months.
Active Comparator: Western intervention; Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs	Other: Western intervention; Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Kupperman index	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
blood serum estradiol	2 months

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Xiaoyun Wang, Bachelor, Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): June 18, 2012
• Last Update Submitted That Met QC Criteria: June 15, 2012
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: TCM intervention; menopausal syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 2007BAI20B014 (Other Identifier: State Administration of TCM of China)