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.

Olfactory dysfunction (OD) is a common symptom of Corona Virus Disease 2019 (COVID-19). It is defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and represents one of the early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey has shown that some post-COVID-19 patients had no improvement 1 month after discharge from the hospital.

To explore the efficacy of acupuncture for OD in COVID-19 infected patients and to determine whether acupuncture could have benefits over sham acupuncture for OD in post-COVID-19 patients.

This is a single-blind, randomized controlled, cross-over trial. We plan to recruit 40 post-COVID-19 patients with smell loss or smell distortions lasting for more than 1 month. Qualified patients will be randomly allocated to the intervention group (real acupuncture) or the control group (sham acupuncture) at a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 weeks (Cycle 1) and a 2-week follow-up. After the follow-up, the control group will be subjected to real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will undergo the 4-week sham acupuncture. The primary outcomes will be the score changes on the questionnaire of olfactory functioning and olfaction-related quality of life at week 6, 8, 12, and 14 from the baseline. The secondary outcomes will be the changes in the olfactory test score at week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC).

The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 patients. This may provide a new treatment option for patients.