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

Purpose: 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.