Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial
Abstract Background Depression is a prevalent non-motor symptom of Parkinson’s disease (PD) that significantly impacts patients’ quality of life. The Wuling capsule, a traditional Chinese medicine, is often utilized for treating depression, and this herbal medicine has been used to treat those PD pa...
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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/s12906-025-04991-y |
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| author | Yuwen Zhao Lin Li Dongya Huang Wentao Li Qiuyan Zhao Huiqin Liu Ran Xiong Meijuan Liu Jing Gan Na Wu Zhihua Liu Xinxin Chen Shizheng Zhang Huina Feng Jinfeng Lu Xiaodan Chen Yu Zhang Xiaohui Zhao Zhenguo Liu |
| author_facet | Yuwen Zhao Lin Li Dongya Huang Wentao Li Qiuyan Zhao Huiqin Liu Ran Xiong Meijuan Liu Jing Gan Na Wu Zhihua Liu Xinxin Chen Shizheng Zhang Huina Feng Jinfeng Lu Xiaodan Chen Yu Zhang Xiaohui Zhao Zhenguo Liu |
| author_sort | Yuwen Zhao |
| collection | DOAJ |
| description | Abstract Background Depression is a prevalent non-motor symptom of Parkinson’s disease (PD) that significantly impacts patients’ quality of life. The Wuling capsule, a traditional Chinese medicine, is often utilized for treating depression, and this herbal medicine has been used to treat those PD patients with depression. This study aims to assess the efficacy and safety of Wuling capsule in treating mild depression in patients with early PD. Methods This multicenter, double-blind, placebo-controlled randomized clinical trial included 160 patients with early PD who presented with a Hamilton Rating Scale for Depression (HAMD) score between 8 and 17 at the time of admission. The trial was conducted across five hospitals in China from December 2021 to March 2024. Eligible patients were randomly assigned to receive either Wuling capsule (0.99 g orally three times daily) or a placebo (0.99 g orally three times daily) for a duration of 12 weeks. Additional treatment according to established clinical guidelines.The primary outcome measure was the change in HAMD score. All statistical analyses were conducted on an intention-to-treat population. Results After 12 weeks of treatment, among the 160 patients with early PD and depression, 80 were assigned to the Wuling capsule group and 80 to the placebo group, with the median age of 70.5 (IQR,67.00–75.00) years and 77 (48.13%) were male. Patients in the Wuling capsule group demonstrated significantly greater reductions in depression severity compared to the placebo group at multiple time points: week 4 (difference, − 1.21 [95% CI, -2.38 to -0.04; P = 0.042]), week 8 (difference, − 1.41 [95% CI, -2.81 to -0.02; P = 0.047]), and week 12 (difference, − 1.46 [95% CI, -2.89 to -0.04; P = 0.044]). Adverse events were reported in 3 of 80 patients (3.75%) in the Wuling capsule group and 3 of 80 patients (3.75%) in the control group (P = 1), indicating no significant difference. Conclusion This randomized clinical trial demonstrated that treatment with Wuling capsule over a 12-week period effectively reduced HAMD score in patients with mild depression associated with PD and the treatment was well tolerated. Trial registration Chinese Clinical Trial Registry; registration number: ChiCTR2100046195; prospectively registered on May 9th, 2021. |
| format | Article |
| id | doaj-art-5a42fa4e6cc14cb5aaf02473026dc76f |
| institution | DOAJ |
| issn | 2662-7671 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-5a42fa4e6cc14cb5aaf02473026dc76f2025-08-20T03:04:18ZengBMCBMC Complementary Medicine and Therapies2662-76712025-07-0125111010.1186/s12906-025-04991-yEfficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trialYuwen Zhao0Lin Li1Dongya Huang2Wentao Li3Qiuyan Zhao4Huiqin Liu5Ran Xiong6Meijuan Liu7Jing Gan8Na Wu9Zhihua Liu10Xinxin Chen11Shizheng Zhang12Huina Feng13Jinfeng Lu14Xiaodan Chen15Yu Zhang16Xiaohui Zhao17Zhenguo Liu18Department of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Neurology, East Hospital, Tongji University School of MedicineDepartment of neurology, Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineDepartment of Neurology, The Fourth Division Hospital of Xinjiang Production and Construction CorpsDepartment of Neurology, Shanghai Pudong New Area People’s HospitalDepartment of Neurology, East Hospital, Tongji University School of MedicineDepartment of neurology, Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Neurology, Wenzhou Central HospitalDepartment of Neurology, Wenzhou Central HospitalDepartment of Neurology, Hangzhou Linping Hospital of Traditional Chinese MedicineDepartment of Neurology, Hangzhou Linping Hospital of Traditional Chinese MedicineTraditional Chinese Medical Hospital of ZhujiDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Neurology, Shanghai Pudong New Area People’s HospitalDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineAbstract Background Depression is a prevalent non-motor symptom of Parkinson’s disease (PD) that significantly impacts patients’ quality of life. The Wuling capsule, a traditional Chinese medicine, is often utilized for treating depression, and this herbal medicine has been used to treat those PD patients with depression. This study aims to assess the efficacy and safety of Wuling capsule in treating mild depression in patients with early PD. Methods This multicenter, double-blind, placebo-controlled randomized clinical trial included 160 patients with early PD who presented with a Hamilton Rating Scale for Depression (HAMD) score between 8 and 17 at the time of admission. The trial was conducted across five hospitals in China from December 2021 to March 2024. Eligible patients were randomly assigned to receive either Wuling capsule (0.99 g orally three times daily) or a placebo (0.99 g orally three times daily) for a duration of 12 weeks. Additional treatment according to established clinical guidelines.The primary outcome measure was the change in HAMD score. All statistical analyses were conducted on an intention-to-treat population. Results After 12 weeks of treatment, among the 160 patients with early PD and depression, 80 were assigned to the Wuling capsule group and 80 to the placebo group, with the median age of 70.5 (IQR,67.00–75.00) years and 77 (48.13%) were male. Patients in the Wuling capsule group demonstrated significantly greater reductions in depression severity compared to the placebo group at multiple time points: week 4 (difference, − 1.21 [95% CI, -2.38 to -0.04; P = 0.042]), week 8 (difference, − 1.41 [95% CI, -2.81 to -0.02; P = 0.047]), and week 12 (difference, − 1.46 [95% CI, -2.89 to -0.04; P = 0.044]). Adverse events were reported in 3 of 80 patients (3.75%) in the Wuling capsule group and 3 of 80 patients (3.75%) in the control group (P = 1), indicating no significant difference. Conclusion This randomized clinical trial demonstrated that treatment with Wuling capsule over a 12-week period effectively reduced HAMD score in patients with mild depression associated with PD and the treatment was well tolerated. Trial registration Chinese Clinical Trial Registry; registration number: ChiCTR2100046195; prospectively registered on May 9th, 2021.https://doi.org/10.1186/s12906-025-04991-yParkinson’s diseaseWuling capsuleDepression |
| spellingShingle | Yuwen Zhao Lin Li Dongya Huang Wentao Li Qiuyan Zhao Huiqin Liu Ran Xiong Meijuan Liu Jing Gan Na Wu Zhihua Liu Xinxin Chen Shizheng Zhang Huina Feng Jinfeng Lu Xiaodan Chen Yu Zhang Xiaohui Zhao Zhenguo Liu Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial BMC Complementary Medicine and Therapies Parkinson’s disease Wuling capsule Depression |
| title | Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial |
| title_full | Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial |
| title_fullStr | Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial |
| title_full_unstemmed | Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial |
| title_short | Efficacy and safety of Wuling capsule for the treatment of mild depression in patients with early Parkinson’s disease in China: a randomized clinical trial |
| title_sort | efficacy and safety of wuling capsule for the treatment of mild depression in patients with early parkinson s disease in china a randomized clinical trial |
| topic | Parkinson’s disease Wuling capsule Depression |
| url | https://doi.org/10.1186/s12906-025-04991-y |
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