Abstract
BACKGROUND: Parkinson's disease-related insomnia (PD-I) has a profound impact on the overall well-being of patients. The findings of previous studies suggested that acupuncture may potentially improve the quality of sleep-in patients with PD. However, the clinical evidence to assess the effectiveness of acupuncture in managing PD-I remains undisclosed. METHODS: In this randomized controlled trial, we enrolled 60 eligible participants between November 24, 2023 and June 18, 2024. Final follow-up was September 20, 2024. Participants with PD-I were allocated randomly (1:1) to the true acupuncture (TA) group or sham acupuncture (SA) group. The primary outcome was the change in the Parkinson Disease Sleep Scale (PDSS) score from baseline to week 16. The secondary outcomes included the assessment of insomnia, movement disorders, drug withdrawal rate and adverse effect were also recorded. RESULTS: The sleep quality rate of the TA group showed an increase at the 4th week, characterized by a notable rise in the proportion of scores within the range of 91-120 and a substantial decrease in scores ranging from 0-60, as compared to the SA group. Moreover, there was a significantly higher change observed in PDSS score for the TA group compared to the SA group, with a difference of 21.4 points (95% CI, 15.6 to 27.2), and this disparity remained consistent throughout the follow-up period until week 16. From baseline to week 4, the Pittsburgh Sleep Quality Index (PSQI) decreased to 8.9 points (95% CI, 3.6 to 14.2) in the TA group and 10.8 points (95% CI, 4.3 to 17.3) in the SA group. The TA group presented a reduction in time to sleep and an increase in both actual sleep duration and sleep efficiency from baseline to week 4 and week 8. CONCLUSION: The findings of this study suggest that acupuncture may enhance the management of patients with PD-I, thereby providing clinical evidence for the safety and efficacy evaluation of acupuncture. TRIAL REGISTRATION: This trial has been registered at Chinese Clinical Trial Registry (ChiCTR2300077729). Submitted 18 July 2023, Registered 17 November 2023.