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.

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.

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.