Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial
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 effe...
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BMC
2025-07-01
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| Series: | BMC Complementary Medicine and Therapies |
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| Online Access: | https://doi.org/10.1186/s12906-025-05009-3 |
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| author | Shuting Liu Haining Li Jiamei Zhang Xiaona Ma Junda Chen Tingting Yang Bing Chen Ningai Yang Xiuping Zhan Jianxia Li Guowei Wang Yinlan Huang Zhenhai Wang |
| author_facet | Shuting Liu Haining Li Jiamei Zhang Xiaona Ma Junda Chen Tingting Yang Bing Chen Ningai Yang Xiuping Zhan Jianxia Li Guowei Wang Yinlan Huang Zhenhai Wang |
| author_sort | Shuting Liu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-6a796d97ecf04cd4a88cbf58edce9713 |
| institution | Kabale University |
| issn | 2662-7671 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-6a796d97ecf04cd4a88cbf58edce97132025-08-20T04:01:43ZengBMCBMC Complementary Medicine and Therapies2662-76712025-07-0125111210.1186/s12906-025-05009-3Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trialShuting Liu0Haining Li1Jiamei Zhang2Xiaona Ma3Junda Chen4Tingting Yang5Bing Chen6Ningai Yang7Xiuping Zhan8Jianxia Li9Guowei Wang10Yinlan Huang11Zhenhai Wang12School of Traditional Chinese Medicine, Ningxia Medical UniversityDepartment of Neurology, General Hospital of Ningxia Medical UniversityInstitute of Medical Sciences, General Hospital of Ningxia Medical UniversityInstitute of Medical Sciences, General Hospital of Ningxia Medical UniversitySchool of Traditional Chinese Medicine, Ningxia Medical UniversityInstitute of Medical Sciences, General Hospital of Ningxia Medical UniversityTraditional Chinese Medicine Hospital of TongnanInstitute of Medical Sciences, General Hospital of Ningxia Medical UniversityThe First Clinical Medical School, Ningxia Medical UniversityThe First Clinical Medical School, Ningxia Medical UniversityDepartment of Neurology, NHC Key Laboratory of Diagnosis and Treatment On Brain Functional Diseases, The First Affiliated Hospital of Chongqing Medical UniversitySchool of Traditional Chinese Medicine, Ningxia Medical UniversityDepartment of Neurology, General Hospital of Ningxia Medical UniversityAbstract 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.https://doi.org/10.1186/s12906-025-05009-3AcupunctureSham acupunctureParkinson’s diseaseInsomniaParkinson Disease Sleep ScaleRandomized controlled trial |
| spellingShingle | Shuting Liu Haining Li Jiamei Zhang Xiaona Ma Junda Chen Tingting Yang Bing Chen Ningai Yang Xiuping Zhan Jianxia Li Guowei Wang Yinlan Huang Zhenhai Wang Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial BMC Complementary Medicine and Therapies Acupuncture Sham acupuncture Parkinson’s disease Insomnia Parkinson Disease Sleep Scale Randomized controlled trial |
| title | Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial |
| title_full | Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial |
| title_fullStr | Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial |
| title_full_unstemmed | Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial |
| title_short | Acupuncture versus sham acupuncture in the treatment of insomnia for patients with Parkinson’s disease: a randomized controlled clinical trial |
| title_sort | acupuncture versus sham acupuncture in the treatment of insomnia for patients with parkinson s disease a randomized controlled clinical trial |
| topic | Acupuncture Sham acupuncture Parkinson’s disease Insomnia Parkinson Disease Sleep Scale Randomized controlled trial |
| url | https://doi.org/10.1186/s12906-025-05009-3 |
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