Background: This study aimed to evaluate the effects of add-on Yang-Xue-Qing-Nao granules (YXQN) on sleep dysfunction in patients with Parkinson's disease (PD).
Methods: PD participants fitted with an actigraph took either YXQN or placebo granules in a randomized manner for 12 weeks while maintaining other anti-parkinsonism medications (e.g., dopaminergic agent, dopamine agonist) unchanged. Additional participants without sleep disturbance or PD served as controls. The changes in detrended fluctuation analysis (DFA) of physical activity with respect to diurnal activity (DA), evening activity (EA), nocturnal activity (NA), Parkinson's disease sleep scale (PDSS) score and unified Parkinson's disease rating scale (UPDRS) score were evaluated every 4 weeks during the 12-week YXQN intervention period and again at week 16.
Results: A total of 61 (placebo group, n = 30; YXQN group, n = 31) idiopathic PD participants with sleep dysfunction (mean age ± standard deviation, 63.4 ± 8.6 years; mean duration of illness, 5.8 ± 6.6 years) completed the study. Significant improvements in EA (p = 0.033, 0.037 and 0.029), DA (p = 0.041, 0.038 and 0.027) and PDSS score (p = 0.034, 0.028 and 0.029) were observed in the YXQN group at weeks 8 and 12, and maintained until week 16, respectively.
Conclusion: YXQN improved the DFA parameters, and PDSS and UPDRS scores in PD participants.