Efficacy and Safety of Electroacupuncture on Insomnia in Parkinson's Disease: A Multicentre, Randomized, Controlled Trial.

Background: Sleep disturbances, particularly insomnia, are prevalent and debilitating non-motor symptoms of Parkinson's disease (PD), significantly impacting quality of life. Current treatment options are limited by side effects and accessibility. Electroacupuncture (EA), a non-pharmacological approach, has shown promise in insomnia, while its specific impact on insomnia in PD remains unexplored.

Objectives: To determine the efficacy and safety of EA vs sham electroacupuncture (SA) on insomnia associated with PD.

Methods: We conducted a multicenter, participant-and assessor-blinded, randomized, sham-controlled clinical trial from March 1, 2024, to October 28, 2024, across eight sites in China. A total of 136 PD patients with insomnia were assigned to receive EA or SA (68 per arm) over an 8-week treatment period followed by a 12-week follow-up period. The primary outcome was the change in Parkinson's Disease Sleep Scale (PDSS) scores at week 8. A range of subjective sleep-related metrics and objective sleep assessments derived from polysomnography were utilized as secondary outcomes.

Results: Both groups showed significant improvements in PDSS scores, with the EA group demonstrating a greater effect (between-group difference, 13.50 [95%CI, 12.68 to 14.32]). Secondary outcomes, including Insomnia Severity Index, Epworth Sleepiness Scale, and polysomnography-derived parameters, also showed greater improvements in EA group. The effects were maintained during the 12-week follow-up with no severe adverse events. The blinding assessment confirmed successful blinding.

Conclusions: EA was effective in improving insomnia and related sleep disturbances in PD. This study provided Class I evidence supporting the integration of EA into the treatment regimen for insomnia in PD.