346 Semi-Individualized Acupuncture for Insomnia Disorder: A Randomized Sham-Controlled Trial

Abstract Introduction Acupuncture is an alternative treatment for improving sleep quality and the effectiveness is thought to be optimized with an individualized approach resembling real practice. However, existing evidence is limited by methodological shortcomings due to blinding issues, standardized measures, and diagnostic procedures. It was of the present study’s interest to examine the efficacy and safety of semi-individualized acupuncture treatment on insomnia. Methods Adults with DSM-5 insomnia disorder (n = 140) were randomized with 1:1 allocation to a 4-week intervention traditional acupuncture (TA) or validated non-invasive sham acupuncture (SA). The selection of acupoints was semi-individualized by the acupuncturist. As the primary outcome, the sleep efficiency (SE) by sleep diary was assessed at baseline, 1-week posttreatment, and 5-week posttreatment. Other sleep parameters derived from sleep diary, the wrist-actigraphy-derived sleep parameters, insomnia symptom severity, anxiety, and depressive symptoms, as well as the health-related quality of life, were also evaluated. Results Although linear mixed-effect model revealed both groups did not attain significant difference in sleep-diary-derived SE and other outcome measures (all P > 0.05), TA promising effect on improving insomnia symptom (within-group effect size, d = 1.13 & 1.30 at 1-week & 5-week posttreatment respectively) and also a higher proportion of subjects achieved SE ≥ 85% compared with SA (55.6% versus 36.4% at week 9, P = 0.03). Besides, subjects in TA group reported significantly greater improvement in both the total sleep time (TST) derived from sleep diary and actigraph than those in the SA group at 1-week posttreatment (difference in mean changes from baseline: sleep diary = 22.0 min, p = 0.01; actigraphy =18.8 min, P = 0.02) but not 5-week posttreatment. Conclusion This study is the first to evaluate the effect of the TCM-theory-based individualized acupuncture on sleep using a sham-control design. A 4-week semi-individualized acupuncture is able to significantly increase total sleep time with few adverse events. Support (if any) Research Grants Council of Hong Kong, Early Career Scheme (Project no.: 25101017)