Abstract
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.
Highlights
Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson’s disease (PD)
Generalized estimating equation analyses revealed that the PCG group had significantly better improvement in Unified Parkinson’s disease Rating Scale (UPDRS)-III score at T1, T2, and T3 [time-by-group interaction, T1: β, −0.92; T2: β, −2.08; T3: β, −4.54)]
The PCG group showed a greater decrease in the total UPDRS score between T0 and T2 [−2.23 points per week vs. −0.21 points per week in the placebo group, p < 0.001]
Summary
Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson’s disease (PD). It is increasingly recognized that Parkinson’s disease (PD) is a common neurodegenerative disease with heterogeneous symptomatology, characterized by the inexorable progression of motor symptoms and a wide range of non-motor symptoms including sleep disturbances, autonomic dysfunction, neuropsychiatric disorders, and cognitive impairment (Armstrong and Okun, 2020). The combination of these motor and non-motor symptoms can cause severe disability in patients and impose heavy burdens for their caregivers (Schapira et al, 2017). There is little evidence showing that these patients would benefit substantially from one particular class of antiparkinsonian medications in terms of both motor and prevailing non-motor symptoms simultaneously (Chaudhuri et al, 2010)
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