Si-Chun Gu1, Jie Zhou1, Qing Ye2, Can-Xing Yuan3. 1. Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. 2. Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. Electronic address: yeqing1982889@163.com. 3. Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. Electronic address: cxyuan1964@163.com.
Abstract
BACKGROUND:Depression in Parkinson's disease (dPD) is closely related to quality of life. Current studies have suggested that Pingchan Granule (PCG) might be effective for treating dPD. OBJECTIVE: This study determines the efficacy of PCG for depressive symptoms in Parkinson's disease (PD). DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This was a randomized, double-blind, placebo-controlled trial, conducted in Longhua Hospital, Shanghai, China. Patients diagnosed with idiopathic PD and clinically significant depressive symptoms (defined by a 24-item Hamilton Rating Scale for Depression [HAM-D] score ≥ 8) were included in this study, randomly assigned to PCG or placebo group in a 1:1 ratio and followed for 24 weeks. MAIN OUTCOME MEASURES: The primary outcome was the change from baseline to week 24 in HAM-D score among the set of patients who completed the study following the treatment protocol (per-protocol set). Secondary outcomes included changes in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part 2 (UPDRS-II), UPDRS part 3 (UPDRS-III), Parkinson's Disease Sleep Scale (PDSS) and Hamilton Rating Scale for Anxiety (HAM-A), between baseline and week 24. RESULTS:Eighty-six patients were enrolled, and 85 patients were included in the per-protocol set. HAM-D scores decreased by an adjusted mean of 11.77 (standard error [SE] 0.25) in the PCG group and 3.86 (SE 0.25) in the placebo group (between-group difference = 7.91, 95% confidence interval [7.22, 8.80], P < 0.001), in the multivariable linear regression. Improvements in scores on the UPDRS-II, UPDRS-III, PDSS, and HAM-A scales were also observed. CONCLUSION: Treatment with PCG was well tolerated and improved depressive symptoms and motor and other non-motor symptoms in PD. TRIAL REGISTRATION: Chinese Clinical Trial Register: ChiCTR-INR-17011949.
RCT Entities:
BACKGROUND:Depression in Parkinson's disease (dPD) is closely related to quality of life. Current studies have suggested that Pingchan Granule (PCG) might be effective for treating dPD. OBJECTIVE: This study determines the efficacy of PCG for depressive symptoms in Parkinson's disease (PD). DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This was a randomized, double-blind, placebo-controlled trial, conducted in Longhua Hospital, Shanghai, China. Patients diagnosed with idiopathic PD and clinically significant depressive symptoms (defined by a 24-item Hamilton Rating Scale for Depression [HAM-D] score ≥ 8) were included in this study, randomly assigned to PCG or placebo group in a 1:1 ratio and followed for 24 weeks. MAIN OUTCOME MEASURES: The primary outcome was the change from baseline to week 24 in HAM-D score among the set of patients who completed the study following the treatment protocol (per-protocol set). Secondary outcomes included changes in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part 2 (UPDRS-II), UPDRS part 3 (UPDRS-III), Parkinson's Disease Sleep Scale (PDSS) and Hamilton Rating Scale for Anxiety (HAM-A), between baseline and week 24. RESULTS: Eighty-six patients were enrolled, and 85 patients were included in the per-protocol set. HAM-D scores decreased by an adjusted mean of 11.77 (standard error [SE] 0.25) in the PCG group and 3.86 (SE 0.25) in the placebo group (between-group difference = 7.91, 95% confidence interval [7.22, 8.80], P < 0.001), in the multivariable linear regression. Improvements in scores on the UPDRS-II, UPDRS-III, PDSS, and HAM-A scales were also observed. CONCLUSION: Treatment with PCG was well tolerated and improved depressive symptoms and motor and other non-motor symptoms in PD. TRIAL REGISTRATION: Chinese Clinical Trial Register: ChiCTR-INR-17011949.