Efficacy and safety of auricular acupuncture in depression during the COVID-19 pandemic: a randomized multicenter clinical trial

• Grant number: 18/17469-5
• Support Opportunities: Regular Research Grants
• Start date: November 01, 2021
• End date: April 30, 2025
• Field of knowledge: Health Sciences - Collective Health - Preventive Medicine
• Principal Investigator: Alexandre Faisal Cury
• Grantee: Alexandre Faisal Cury
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• City of the host institution: São Paulo
• Associated researchers: Mariana Cabral Schveitzer ; Paulo Rossi Menezes

Abstract

Depression, often under-diagnosed and under-treated, is the leading cause of disability worldwide and contributes significantly to the global burden of diseases.The Covid-19 epidemic there was a considerable increase in cases.There is a growing demand for non-medicated forms of treatment for depression. In this sense, auricular acupuncture is considered a simple, low cost technique, well tolerated by patients. The Unified Health System (Sistema Único de Saúde -SUS) had this practice incorporated in 2006, but it lacks studies to verify its efficacy and safety. The main objective of this study is to evaluate the efficacy of auricular acupuncture to reduce depressive symptoms by comparing it to usual care and non-specific auricular acupuncture. It is a randomized clinical multicenter trial, blinded to the evaluator, participant and statistician. The study sample will be composed of 280 participants, divided equally into two groups: Experimental group - GE (auricular acupuncture) and Control group - GC (non-specific auricular acupuncture). The GE and GC participants will undergo 12 sessions of auricular acupuncture, 2 times a week. The primary outcome of the study will be the proportion of participants who present improvement of 50% or more in their symptoms, evaluated by PHQ-9, three months after inclusion. The secondary outcomes will be: improvement of 50% or more in their symptoms, after six months; quality of life (SF-36), sleep quality (PSQI), anxiety (STAI), change in the use of antidepressant medication, events and adverse effects, levels of Brain-derived neurotrophic factor (BDNF), Interleukin 1², Interleukin-6 and TNF-± in blood plasma. The data will be analyzed, aiming at treating according to the principles of CONSORT. A semi-structured interview will be applied to a sub-sample. These qualitative data will be analyzed using the Content Analysis method. The study will begin after approval by CEP-FMUSP. (AU)