Acupuncture for olfactory dysfunction in infected COVID-19 patients:Study protocol for a randomized,sham-controlled clinical trial

Background: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.Objective: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.Methods: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).Discussion: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.