Comparison Study for Perimenopausal Syndrome With Chinese Herbal Medicine

• Status: Not yet recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Baptist University
• Collaborator: HKFTU Workers' Medical Clinics - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre (North District)

Criteria

Inclusion Criteria:

1. Chinese women aged 45-55 years

2. 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)

3. Suffering any of the following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)

4. Did not use hormonal therapy at least 3 months before entry into the study

5. Willing to give a written informed consent form to participate in the clinical study

Exclusion Criteria:

1. Bilateral ovarian resection or pelvic radiotherapy for ovarian cysts and uterine fibroids with a diameter greater than 4 cm

2. Unexplained irregular vaginal bleeding

3. Suffer from diabetic neuropathy or malignant tumor

4. Have used sex hormones in the past 3 months, such as estrogen, progesterone, soy isoflavones etc.

5. Patients who have participated in or are participating in other clinical trials in the past 3 months

6. Serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system

7. Take sedatives or anti-anxiety drugs regularly

8. Smoking or alcohol habits

9. Patients with mental illness

10. Cannot cooperate with the treatment