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.