Comparing the effectiveness of pattern differentiation treatment and fixed formula treatment for perimenopausal syndrome with Chinese herbal medicine: A study protocol

To further understand and compare the effectiveness of pattern differentiation treatment and fixed prescription treatment in perimenopausal syndrome. The study will be conducted in the Hong Kong Federation of Trade Unions Workers’ Medical Clinics, Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre (Hong Kong, China). One hundred Chinese women, aged 45–55 years, will be recruited. The participants will be randomized into 2 groups. The intervention group will be administered medication, based on pattern differentiation, by qualified traditional Chinese medicine (TCM) practitioners. After each evaluation, TCM practitioners will evaluate and revise the prescription, based on the participants' patterns. The control group will be given the standard formula, i.e., the Erxian decoction, which contains 6 herbs. The treatment period and the follow-up period will be 8 weeks each. The primary assessment outcome measure will be the Kupperman Index, and the secondary outcome measure will be the Menopause-specific Quality of Life Questionnaire score. Pattern-differentiated treatment is the basic principle of TCM to understand and treat diseases. The study will show the pattern-differentiated treatment is effectiveness than the fixed prescription.