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

Guangzhou University of Traditional Chinese Medicine

Status and phase: Completed; Phase 3

Conditions: Menopausal Syndrome

Treatments: Other: TCM intervention; Other: Western intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00933725

2007BAI20B014 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 patients

Sex: Female

Ages: 41 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 2 patient groups

TCM intervention

Experimental group

Description:

Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone

Treatment:

Other: TCM intervention

Western intervention

Active Comparator group

Description:

Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs

Treatment:

Other: Western intervention