针刺与假针刺治疗帕金森病患者失眠的随机对照临床试验
Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson's disease: a randomized controlled clinical trial.
作者信息
Liu Shuting, Li Haining, Zhang Jiamei, Ma Xiaona, Chen Junda, Yang Tingting, Chen Bing, Yang Ningai, Zhan Xiuping, Li Jianxia, Wang Guowei, Huang Yinlan, Wang Zhenhai
机构信息
School of Traditional Chinese Medicine, Ningxia Medical University, Yinchuan, 750004, People's Republic of China.
Department of Neurology, General Hospital of Ningxia Medical University, Yinchuan, 750004, People's Republic of China.
出版信息
BMC Complement Med Ther. 2025 Jul 19;25(1):278. doi: 10.1186/s12906-025-05009-3.
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.
背景
帕金森病相关失眠（PD - I）对患者的整体健康有深远影响。先前研究结果表明，针灸可能会改善帕金森病患者的睡眠质量。然而，评估针灸治疗PD - I有效性的临床证据仍未公开。
方法
在这项随机对照试验中，我们于2023年11月24日至2024年6月18日招募了60名符合条件的参与者。最终随访时间为2024年9月20日。患有PD - I的参与者被随机（1:1）分配到真针灸（TA）组或假针灸（SA）组。主要结局是从基线到第16周帕金森病睡眠量表（PDSS）评分的变化。次要结局包括失眠评估、运动障碍、药物撤药率，同时也记录了不良反应。
结果
与SA组相比，TA组的睡眠质量率在第4周时有所提高，其特征是91 - 120分范围内的评分比例显著上升，0 - 60分范围内的评分大幅下降。此外，TA组的PDSS评分变化显著高于SA组，差值为21.4分（95%CI，15.6至27.2），并且这种差异在整个随访期直至第16周都保持一致。从基线到第4周，TA组的匹兹堡睡眠质量指数（PSQI）降至8.9分（95%CI，3.6至14.2），SA组降至10.8分（95%CI，4.3至17.3）。从基线到第4周和第8周，TA组的入睡时间减少，实际睡眠时间和睡眠效率均增加。
结论
本研究结果表明，针灸可能会改善PD - I患者的治疗效果，从而为针灸的安全性和有效性评估提供临床证据。
试验注册
本试验已在中国临床试验注册中心注册（ChiCTR2300077729）。于2023年7月18日提交，2023年11月17日注册。
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