KMCRIC

Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled Study.

Gu SC, Ye Q, Wang CD, Zhao SR, Zhou J, Gao C, Zhang Y, Liu ZG, Yuan CX.

Front Pharmacol.

2022

13

739194.

10.3389/fphar.2022.739194.

35281890

http://www.ncbi.nlm.nih.gov/pubmed/35281890

Parkinson’s disease; motor function; non-motor function; pingchan granule; traditional Chinese medicine

파킨슨병; 운동 기능; 비운동 기능; 평전과립; 중의학

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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.

Copyright © 2022 Gu, Ye, Wang, Zhao, Zhou, Gao, Zhang, Liu and Yuan.

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