Title: Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: A multicentre, blinded, randomized controlled clinical tria

Abstract

Background: Some adverse events following immunization (AEFI) were observed in potential association with injection of COVID-19 vaccines but without preventive intervention for it. We aimed to investigate efficacy of auricular acupressure (AA) therapy in preventing and (or) relieving AEFI after first dosage of the vaccine. Methods: We performed a multicentre randomized controlled trial with three arms, including AA group, SAA group, and WL group, carried out in four medical institutions in Chengdu, China, from March 17th to April 23rd, 2021. We involved the recipients with inclusion criteria, who were randomized into AA (AEFI-specific auricular points applied, n=52), sham AA (n=51) or wait-list (WL) (n=44) group. Primary outcomes were percentages of any AEFI and local pain, and secondary outcomes were percentages who reported other AEFI. They were followed at 1, 3, 5, 7, and 14 days with severity evaluated. Results: 147 participants (73.47% females) were included with an average age of 34.08. One day after the injection, participants in AA group showed significant reduction on percentages of any AEFI [intention-to-treat, difference of percentage (DP) = -20.13, 95%CI: -0.39, -0.02, p = 0.01; per-protocol, DP = -22.21, 95%CI: -0.40, -0.03, P = 0.02] and local pain (intention-to-treat, 95%CI: -0.36, -0.01, DP = 12.24, p = 0.03). The effects were slight at other follow-up days and for other outcomes, but with good safety. Conclusions: We firstly manifested superiority of AA for preventing and relieving AEFI related to COVID-19 vaccine injection, which is beneficial for the vaccine recipients, but evidence is limited.