4.6 Article

Pingchan granule for depressive symptoms in parkinson's disease: A randomized, double-blind, placebo-controlled trial

Journal

JOURNAL OF INTEGRATIVE MEDICINE-JIM
Volume 19, Issue 2, Pages 120-128

Publisher

ELSEVIER
DOI: 10.1016/j.joim.2020.12.006

Keywords

Pingchan granule; Depression; Parkinson's disease; Randomized controlled trial

Funding

  1. Key Technologies Research and Development Program [2017YFC1310301]
  2. New Frontier Technology Project by Shanghai Shen Kang Hospital Development Center [SHDC12018131]
  3. Shanghai Science and Technology Committee [17401934600, 15401970101]

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The study demonstrated that treatment with Pingchan Granule significantly improved depressive symptoms in Parkinson's disease patients, as well as motor and other non-motor symptoms.
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. (C) 2021 Shanghai Changhai Hospital. Published by ELSEVIER B.V. All rights reserved.

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