Comparison Study for Perimenopausal Syndrome With Chinese Herbal Medicine
Condition: Menopausal Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Background: Perimenopausal syndrome (PMS) refers to a series of symptoms caused by the
      dynamic fluctuations of sex hormones during menopause. Menopausal symptoms including hot
      flushes, vaginal dryness and mood swings are experienced by about 80% of Chinese women aged
      45 to 60. In the past year, 235 patients visited CMCTR(ND), a TCM center set up by HA and
      operated by HKFTU Workers' Medical Clinics since 2008, suffered from PMS.

      According to literature review, high proportion of clinical trials regarding perimenopausal
      women used fixed formula treatment. However, different constitutional types were found in
      perimenopausal women and different fixed formulae were used in different research. Apart from
      kidney yin deficiency, perimenopausal women were also found in liver-kidney yin deficiency,
      kidney yang deficiency, kidney yin and yang deficiency, disharmony between heart and kidney,
      liver qi stagnation, etc. It is difficult to draw a conclusion that any single fixed formula
      could have the best efficacy on PMS. Therefore, it is worth studying to see whether syndrome
      differentiation would be a better choice for PMS treatment.

      Objective: The study aims to evaluate whether syndrome differentiated treatment is better
      than fixed formula (Er-Xian decoction) treatment for perimenopausal women.

      Design: This is a pilot single-blinded, randomized controlled trial.

      Participants: Chinese women aged 45-55 year with menstruation abnormalities (menstrual
      irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or
      amenorrhea of 2 to 12 months); also suffering any following perimenopausal symptoms:
      vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine,
      irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)

      Interventions: A randomized controlled trial will be conducted to assess the efficacy of
      syndrome differentiated treatment versus a fixed formula (Er-Xian decoction) in treating PMS.
      100 participants will be randomly divided into 2 groups. Intervention group of participants
      will be given medication by syndrome differentiating from qualified TCM Practitioners while
      the control group of participants will be given a fixed formula.

      Outcome measures: Primary assessments outcome measure is the Kupperman Index, and the
      secondary outcome measure is MENQOL questionnaire.
    

Detailed description: 
      Perimenopausal syndrome is also known as menopausal syndrome. Menopause Syndrome refers to
      women due to ovarian dysfunction or loss of estrogen causing a variety of systemic
      dysfunctions in the body, including the autonomic nervous system, dysfunction and metabolic
      disorders-based symptoms such as hot flushes and sweating, sleep disorders, depression,
      multiple joint pains, headache, dizziness, fatigue, etc. These symptoms seriously affect
      menopausal women . Modern medical treatment of perimenopausal syndrome mainly focus on
      Hormonal Therapy (HT). Studies have shown that the clinical effect of hormonal therapy would
      quickly relieve the symptoms of perimenopausal syndrome, including urogenital atrophy and
      prevention of osteoporosis .

      However there were some scholars believed that although short-term use of hormone supplement
      therapy could relieve the symptoms of perimenopausal women, the role of estrogen treatment in
      postmenopausal women still needed to be further explored . The reason was that hormonal
      replacement therapy can cause more adverse reactions and potential risks such as increased
      cardiovascular disease, cerebral infarction, breast-related diseases, risk of embolism in
      veins and lungs and other diseases .

      In the previous study, the investigators found that the Chinese herbal formula Er-Xian
      decoction was superior to placebo in reducing the frequency and severity of hot flushes and
      in relieving menopausal symptoms in Hong Kong perimenopausal women. It was well tolerated,
      with no serious adverse events noted during the study period. The study proved the
      effectiveness of traditional Chinese medicine in the treatment of menopausal symptoms. The
      investigators designed this experiment in order to further understand the effectiveness
      between syndrome differentiation treatment and fixed prescription.

      Syndrome differentiation and treatment is the process of recognizing and resolving diseases,
      the embodiment of the combination of theory and practice, the specific clinical application
      of principles and methods, and the basic principles guiding the clinical work of traditional
      Chinese medicine. Dialectics is the process of authentication. Syndrome is a summary of the
      pathological reflections of the body through four diagnostic methods (inspection, listening
      and smelling, inquiries, and palpation ). It would help to establish disease stages,
      including the location of disease, cause, nature, and relationship between healthy qi and
      pathogenic qi. Therefore, the syndrome would reveal the essence of the disease, and therefore
      enhance the disease management. Corresponding treatment method is determined based on the
      result of syndrome differentiation. Syndrome differentiation and treatment are two
      inseparable parts in the process of diagnosis and treatment of diseases.

      There is no record of the term of the perimenopausal syndrome in the ancient Chinese medicine
      books. The investigators can find some similar symptoms recorded in "Lily Disease" ,
      "Hysteria", and "Insomnia"or "Depression" and other diseases in ancient books. Modern Chinese
      medicine gynecology calls it "Premenopausal". Traditional Chinese medicine believes that in
      perimenopausal women, the kidney qi is gradually declining. Dysfunction of qi and blood is
      mainly caused by kidney deficiency. Among them, the syndrome of kidney yin deficiency is the
      most common. According to the literature, the syndrome types are divided as follows:

        1. Liver and Kidney Yin Deficiency Syndrome: Before and after menstruation, the essence and
           blood are weak, or the body is in yin deficiency, yin does not guard the yang, yang is
           disturbed. Clinical symptoms include sweating, hot flushes, insomnia, forgetfulness,
           backache and weak legs, dry genitals, menstrual disorders, red tongue with less coating,
           pulse is rapid and thready. Suggested Formula: Gan Mai Bai He Di Hung Tang

        2. Non Interaction Between Heart and Kidney:The woman's yin and yang are imbalanced, the
           yin essence is deficient, and the kidney yin deficiency and water does not nourish the
           wood, causing the liver fire to become prosperous. Common clinical symptoms include hot
           flush, sweating, palpitation, irritability, bitter mouth, dry mouth, red tongue with
           thin yellow coating, pulse is thready and rapid. Suggested formula: Tian Wang Bu Xin Dan

        3. Liver stagnation and qi stagnation syndrome: Chest tightness, hypotension, chest pain,
           mental depression, nervousness, abdominal pain, flushing, nervousness, petechial, chord
           pulse. Suggested formula: Shugan Granules (Danzhi Xiaoyao San without Ginger add
           Xiangfu)

        4. Kidney Yin Deficiency Syndrome: Fever, sweating, upset, Insomnia, dry mouth, ant feeling
           on the skin, early menstruation. Suggested formula: Liu Wei Di Huang Pill and Er Zhi
           Pill

        5. Spleen and Kidney Yang Deficiency Syndrome:Fatigue, delayed menstruation, swelling, fear
           of cold, frequent urination, pale tongue, white fur, deep and thread pulse. Suggested
           formula: You Gui pill and Li Zhong pill addition and subtraction
    

Intervention name(s): Intervention Group; Control Group
Intervention type(s): Drug; Drug
Intervention description(s): Gan Mai Bai He Di Hung Tang, Tian Wang Bu Xin Dan,Shugan Granules,Liu Wei Di Huang Pill and Er Zhi Pill , You Gui pill and Li Zhong pill addition and subtraction; Er-Xian decoction
Other intervention name(s): Chinese herbal medicine; Chinese herbal medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment