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Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study
Background: Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson’s disease (PD). Objective: This study aimed at evaluating the efficacy and safety of PCG for motor and non-motor symptoms of PD. Methods: In this multicenter, randomized, double-blind, placebo-controlled tria...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8914044/ https://www.ncbi.nlm.nih.gov/pubmed/35281890 http://dx.doi.org/10.3389/fphar.2022.739194 |
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author | Gu, Si-Chun Ye, Qing Wang, Chang-De Zhao, Shao-Rong Zhou, Jie Gao, Chen Zhang, Yu Liu, Zhen-Guo Yuan, Can-Xing |
author_facet | Gu, Si-Chun Ye, Qing Wang, Chang-De Zhao, Shao-Rong Zhou, Jie Gao, Chen Zhang, Yu Liu, Zhen-Guo Yuan, Can-Xing |
author_sort | Gu, Si-Chun |
collection | PubMed |
description | Background: Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson’s disease (PD). Objective: This study aimed at evaluating the efficacy and safety of PCG for motor and non-motor symptoms of PD. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 292 participants with mild-to-moderate PD were included and followed for 36 weeks (24 week treatment, 12-week follow-up after intervention), randomly assigned at a 1:1 ratio to receive PCG or placebo. The primary outcomes included the severity of motor symptoms assessed by the Unified Parkinson’s disease Rating Scale (UPDRS) part 3 (UPDRS-III) score and the rate of disease progression assessed by the total UPDRS score. Secondary outcomes included non-motor symptoms assessed using the Scale for Outcomes in Parkinson’s Disease-Autonomic (SCOPA-AUT), Parkinson’s disease Sleep Scale (PDSS), 24-item Hamilton Rating Scale for Depression (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), UPDRS part 2 (UPDRS-II), and 39-item Parkinson’s Disease Questionnaire (PDQ-39) scores. Assessments were done at baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). Results: Generalized estimating equation analyses revealed that the PCG group had significantly better improvement in UPDRS-III score at T1, T2, and T3 [time-by-group interaction, T1: β, −0.92 (95% CI, −1.59–−0.25; p = 0.01); T2: β, −2.08 (95% CI, −2.90–−1.27; p < 0.001); T3: β, −4.54 (95% CI, −5.37–−3.71; p < 0.001))]. The PCG group showed a greater decrease (rate of disease change) in the total UPDRS score between T0 and T2 [−2.23 (95% CI, −2.72–−1.73; p < 0.001) points per week vs. −0.21 (95% CI, −0.80–0.39; p = 0.50) points per week in the placebo group, p < 0.001]. Ameliorations of SCOPA-AUT, PDSS, HAM-D, HAM-A, UPDRS-II, and PDQ-39 scores were also observed. Conclusion: PCG had a long-lasting and extensive symptomatic efficacy for both motor and non-motor symptoms of PD with good tolerance. Trial registration: Chinese Clinical Trial Register, ChiCTR-INR-17011949. |
format | Online Article Text |
id | pubmed-8914044 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-89140442022-03-12 Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study Gu, Si-Chun Ye, Qing Wang, Chang-De Zhao, Shao-Rong Zhou, Jie Gao, Chen Zhang, Yu Liu, Zhen-Guo Yuan, Can-Xing Front Pharmacol Pharmacology Background: Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson’s disease (PD). Objective: This study aimed at evaluating the efficacy and safety of PCG for motor and non-motor symptoms of PD. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 292 participants with mild-to-moderate PD were included and followed for 36 weeks (24 week treatment, 12-week follow-up after intervention), randomly assigned at a 1:1 ratio to receive PCG or placebo. The primary outcomes included the severity of motor symptoms assessed by the Unified Parkinson’s disease Rating Scale (UPDRS) part 3 (UPDRS-III) score and the rate of disease progression assessed by the total UPDRS score. Secondary outcomes included non-motor symptoms assessed using the Scale for Outcomes in Parkinson’s Disease-Autonomic (SCOPA-AUT), Parkinson’s disease Sleep Scale (PDSS), 24-item Hamilton Rating Scale for Depression (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), UPDRS part 2 (UPDRS-II), and 39-item Parkinson’s Disease Questionnaire (PDQ-39) scores. Assessments were done at baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). Results: Generalized estimating equation analyses revealed that the PCG group had significantly better improvement in UPDRS-III score at T1, T2, and T3 [time-by-group interaction, T1: β, −0.92 (95% CI, −1.59–−0.25; p = 0.01); T2: β, −2.08 (95% CI, −2.90–−1.27; p < 0.001); T3: β, −4.54 (95% CI, −5.37–−3.71; p < 0.001))]. The PCG group showed a greater decrease (rate of disease change) in the total UPDRS score between T0 and T2 [−2.23 (95% CI, −2.72–−1.73; p < 0.001) points per week vs. −0.21 (95% CI, −0.80–0.39; p = 0.50) points per week in the placebo group, p < 0.001]. Ameliorations of SCOPA-AUT, PDSS, HAM-D, HAM-A, UPDRS-II, and PDQ-39 scores were also observed. Conclusion: PCG had a long-lasting and extensive symptomatic efficacy for both motor and non-motor symptoms of PD with good tolerance. Trial registration: Chinese Clinical Trial Register, ChiCTR-INR-17011949. Frontiers Media S.A. 2022-02-25 /pmc/articles/PMC8914044/ /pubmed/35281890 http://dx.doi.org/10.3389/fphar.2022.739194 Text en Copyright © 2022 Gu, Ye, Wang, Zhao, Zhou, Gao, Zhang, Liu and Yuan. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Gu, Si-Chun Ye, Qing Wang, Chang-De Zhao, Shao-Rong Zhou, Jie Gao, Chen Zhang, Yu Liu, Zhen-Guo Yuan, Can-Xing Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study |
title | Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study |
title_full | Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study |
title_fullStr | Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study |
title_full_unstemmed | Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study |
title_short | Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study |
title_sort | pingchan granule for motor symptoms and non-motor symptoms of parkinson’s disease: a randomized, double-blind, placebo-controlled study |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8914044/ https://www.ncbi.nlm.nih.gov/pubmed/35281890 http://dx.doi.org/10.3389/fphar.2022.739194 |
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