摘要Background:Auriculotherapy is a simple,convenient,nonpharmacological option that has shown posi-tive effects for insomnia patients,but its efficacy and safety remain unknown.Objective:The aim of this study is to evaluate the efficacy and safety of auricular therapy for insomnia.Design,setting,participants and intervention:An 18-week(2-week screening,4-week treatment,and 12-week follow-up),recruiter-and assessor-blinded,randomized,sham-controlled trial was performed.Patients were recruited from outpatient settings at three clinical centers in China from 2 February 2023 to 26 January 2024.Participants had insomnia for more than 3 months and met the criteria classi-fied in the Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition).Patients were randomly assigned in a 1:1 ratio to receive auricular therapy(AT)or sham AT(SAT)for 4 consecutive weeks,twice a week,and once every 3 days.Main outcome measures:Primary outcome was the response rate at week 4 after treatment,defined as the percentage of patients with at least a 50％reduction in Pittsburgh Sleep Quality Index(PSQI)from base-line.Secondary outcomes consisted of response rates at other time points,PSQI and 4 related scales,actigraphy-recorded sleep efficiency,sleep arousal frequency,and total sleep time.Results:A total of 234 participants were screened,and 156 patients(122 female[78.2％];mean[standard deviation]age,37.2[13.5]years)were included in the intention-to-treat analysis,with 78 participants randomized to each group.A total of 117 participants(75％)were followed up for 3 months.The AT group had a higher response rate at week 4 than the SAT group(39.73％[29/73]vs 23.29％[17/73],P=0.03),and the response rates for the AT and SAT groups at week 2 were 28.38％(21/74)and 13.33％(10/75),respec-tively(P=0.02).The differences between the two groups in the PSQI at each time point(P<0.05)and the Insomnia Severity Index at weeks 4 and 12(both P=0.03)were also statistically significant.The other partial outcomes also showed statistically significant differences.Adverse events occurred in 2 cases in the AT group(2.60％).Conclusion:Four-week AT treatment was an effective and safe alternative therapy for insomnia,although the difference with the SAT treatment did not reach the minimal clinically important difference.Adverse events were mild or transient.