Effectiveness and Safety of Electroacupuncture in Patients with Treatment-Resistant Insomnia: A Randomized, Assessor-Blinded, Waitlist-Controlled Pilot Trial

Jung-Hwa Lim,1,2,* So-Hyeon Park,1,2,* Kyeong-Ok Kim,3,4 Chang-Wan Kang,5 Eun Cho,6 Bo-Kyung Kim1,2 1Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, Yangsan-si, Gyeongsangnam-do, Republic of Korea; 2Pusan National University Korean Medicine Hospital, Yangsan-si, Gyeongsangnam-do, Republic of Korea; 3Department of Neuropsychiatry, School of Korean Medicine, Dongshin University, Naju-si, Jeollanam-do, Republic of Korea; 4Dongshin University Gwangju Korean Medicine Hospital, Gwangju, Republic of Korea; 5Department of Industrial Management & Big Data Engineering, Dong-Eui University, Busan, Republic of Korea; 6College of Pharmacy, Sookmyung Women’s University, Seoul, Republic of Korea*These authors contributed equally to this workCorrespondence: Bo-Kyung Kim, Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, 49, Busandaehak-ro, Yangsan-si, 50612, Republic of Korea, Email [email protected]: This study evaluated the effectiveness and safety of electroacupuncture in patients with treatment-resistant insomnia (TRI) who experienced persistent sleep disturbances despite using medication for more than 3 months.Patients and Methods: Fifty patients with TRI were randomly assigned to the experimental or waitlist control group. The experimental group received treatment twice a week for 6 weeks. Sleep parameters including the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary, and actigraphy, sleep-related symptoms, quality of life, and costs were evaluated.Results: ISI scores significantly decreased in the experimental group from 2 weeks after treatment initiation, with improvements persisting through the post-treatment and the 4-week follow-up (p < 0.02). After 4 weeks, more patients achieved the minimal clinically important difference for the ISI (p = 0.02). PSQI scores differed significantly between groups at follow-up (p = 0.01). Sleep diary analysis revealed improved morning refreshment from 2 weeks after treatment initiation through follow-up (p < 0.02), with a decrease in sleep onset latency of 12– 14 min. In contrast, actigraphy-based sleep parameters showed no significant differences between the groups. After two treatment sessions, ISI scores and moderate-to-severe accompanying symptoms improved. EuroQoL visual analogue scale and SF-36 scores also improved significantly (p = 0.002 and p = 0.007, respectively). Adverse events were similar between groups.Conclusion: Electroacupuncture was associated with improvements in subjective sleep parameters but not in objective actigraphy-based sleep measures in patients with TRI, suggesting that electroacupuncture may be a potential complementary treatment option for patients with insomnia unresponsive to conventional pharmacotherapy.Keywords: insomnia disorder, treatment-resistant insomnia, electroacupuncture, randomized controlled trial