Safety
inflammation, depression, ideation, pain
ADVERSE EVENTS, INFLAMMATION, EVENTS, ADVERSE EFFECTS
Most participants reported mild pain at the needle application site (33 patients [94%] in the SA group vs 32 patients [91%] in the NSA group). One participant had mild local inflammation in 1 of the auricular points and received appropriate treatment. Regarding adverse events, an increase in depression scores was observed during data collection in 3 participants, and 7 individuals responded positively to question 9 of the PHQ-9, which addresses suicidal ideation. These cases were carefully monitored, and the independent data monitoring and safety committee did not consider these events related to the intervention. No statistically significant difference was found between the groups in the proportion of participants with adverse effects (ie, those arising from AA) and adverse events (ie, worsening of depression symptoms or suicidal ideation). Five participants withdrew from the study as a result of adverse effects. No severe adverse events were reported (