To evaluate the clinical efficacy of the real-world Liuwei Dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug.
Age: 45-55 years old
Patients with menopausal syndrome using Liuwei Dihuang Pills
Kidney Yin Deficiency Syndrome
Individuals allergic to any components of the drug or excipients;
Individuals with other endocrine diseases;
Individuals with organic lesions of the reproductive system;
Individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction;
Menopausal syndrome refers to a series of physical and psychosomatic symptoms caused by the gradual decline of ovarian function and fluctuating or decreasing levels of sex hormones before and after menopause in women.
Cohort
Prospective
Liuwei Dihuang pills
DrugConventional treatment （Hormones, selective 5-hydroxytryptamine reuptake inhibitors, etc.）+ Liu Wei Di Huang Pills
Change of Menopausal Symptoms
The Kupperman Rating Scale is a global tool for assessing menopausal symptoms. It has 13 items covering common perimenopausal symptoms like hot flashes, sweating, paresthesia, insomnia, irritability, depression, dizziness, fatigue, arthralgia, headache, palpitations, formication, urinary infections, and sexual status. Each item is weighted and summed for a total score of 0-63. A lower score means more severe perimenopausal symptoms.The modified Kupperman Rating Scale will be used to assess menopausal symptoms. Participants will complete the questionnaire before, after treatment, and during follow-up. Researchers will calculate the total score.
Change of Hormone Levels
Sex hormone levels are key for evaluating the endocrine status of menopausal women. In patients with menopausal syndrome, sex hormone levels show elevated Follicle-Stimulating Hormone and Luteinizing Hormone, and reduced Estradiol. High Follicle-Stimulating Hormone points to ovarian dysfunction. Changes in the Luteinizing Hormone/Follicle-Stimulating Hormone ratio may be linked to polycystic ovary syndrome, and decreased Estradiol is associated with ovarian failure.
Change of Quality in life
The Menopause-Specific Quality of Life Questionnaire assesses menopausal women's quality of life, covering four dimensions: vasomotor symptoms, psychosocial state, physical state, and sexual life, with 29 items in total. Each item is scored from 0 to 6, where 0 means no distress and 6 means extreme distress. The average score of items in each dimension is calculated. A higher score indicates lower quality of life in that dimension.
Change of TCM Syndrome Scores
The TCM syndrome score sheet, designed as per TCM theory, assesses menopausal patients' TCM syndromes, covering symptoms and signs inTCM, etc.Changes in TCM syndrome scores for menopausal syndrome reflect improvement or worsening. The scale uses a semi - quantitative grading method, assigning scores of 0, 1, 2, or 3 to represent the severity of symptoms in menopausal syndrome patients. The scores are added up to form the total syndrome score, with a minimum of 0 and a maximum of 42. A higher score means a more serious condition.
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China Academy of Chinese Medical Sciences
Lead sponsor
Lanxi Hospital of Traditional Chinese Medicine
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
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