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

Gu, Si-Chun; Zhou, Jie; Ye, Qing; Yuan, Can-Xing

doi:10.1016/j.joim.2020.12.006

Cited by 8 publications

(19 citation statements)

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“…We adopted the methods of our previous trial of PCG (Gu et al, 2021). Participants were initially evaluated during a screening visit at which demographic information and eligibility criteria were verified and informed consent was also obtained.…”

Section: Recruitment and Randomizationmentioning

confidence: 99%

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

Wang

et al. 2022

Front. Pharmacol.

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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.

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Section: Recruitment and Randomizationmentioning

confidence: 99%

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

Wang

et al. 2022

Front. Pharmacol.

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“…Zishen Pingchan granule (ZPG) is a traditional Chinese herbal recipe, widely used to treat PD for over 30 years [9]. ZPG protects nerve cells by inhibiting the hyperactivation of extracellular signal-regulated kinase and c-Jun N-terminal kinase pathways to reduce the inflammatory reaction [10].…”

Section: Introductionmentioning

confidence: 99%

“…ZPG protects nerve cells by inhibiting the hyperactivation of extracellular signal-regulated kinase and c-Jun N-terminal kinase pathways to reduce the inflammatory reaction [10]. A recent randomized, double-blind, placebo-controlled trial showed that the treatment with ZPG significantly improves the depressive symptoms of PD, with quite noticeable improvements in dyskinesia and delay in the progression of the disease [9].…”

Section: Introductionmentioning

confidence: 99%

Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study

et al. 2022

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Background and objective Zishen Pingchan granule (ZPG), a traditional Chinese herbal recipe for treating Parkinson’s disease (PD), is usually used as an add-on drug with some antiparkinsonian drugs in China. The objectives of this study were to evaluate the efficacy, safety, and tolerability of ZPG combined with pramipexole in the treatment of depression in PD (dPD). Methods A 12-week, multicenter, randomized, double-blind, and placebo-controlled study on ZPG was performed on a total of 200 patients who were treated with pramipexole but still had mild to moderate depressive symptoms. Patients were randomly divided into ZPG (n = 100) or placebo (n = 100). The primary effective result was the mean change from the baseline on the Hamilton Depression Scale 17 items (HAM-D-17) over 12 weeks and the clinical efficacy rate. Secondary endpoints were the mean change from the baseline in the Geriatric Depression Scale (GDS-15), Unified Parkinson's disease rating scale Part III (UPDRS III), Parkinson's quality of life scale (PDQ-8), and Parkinson's disease sleep scale (PDSS-2) over 12 weeks. Results After 12 weeks of treatment, ZPG significantly reduced the mean [95% confidence interval] HAMD score vs. placebo (− 1.43 scores [− 2.50, − 0.36]; p = 0.009). The clinical remission rate and responders of the ZPG group were higher than those of the placebo (46.1% vs. 31.0%; p = 0.041; 34.8% vs. 18.4%; p = 0.014). A significant improvement in the PDSS-2 score was also observed in the ZPG group compared with that in the placebo group (− 3.56 scores [− 5.77, − 1.35]; p = 0.002). A total of 7 patients (7.1%) in the ZPG group had mild adverse events (AEs) vs 9 patients (9%) in the placebo group. No severe AEs were observed in either group. The randomization and controlled clinical study revealed that ZPG was effective, safe, and well-tolerated. Conclusion ZPG combined with pramipexole further reduced the depressive symptoms and improved the sleeping quality of PD patients. Trial registration The protocol was retrospectively registered at the Chinese Clinical Trial Registry, Unique identifier: ChiCTR1800019942, date of registration: December 9, 2018; http://www.chictr.org.cn/showproj.aspx?proj=30432

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“…We rated 6 studies [8,12,13,15,16,19] to be at low risk of bias as they provided adequate blinding methods. We rated 2 studies to be at high risk of performance bias as participants and personnel were not blinded to group allocation [17,18] ; 1 study [14] to be at unclear risk of performance bias as blinding of participants and personnel was not reported.…”

Section: Resultsmentioning

confidence: 99%

Traditional Chinese Medicine for non-motor symptoms in Parkinson disease: A systematic review and meta-analysis of RCTs

2023

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Background: Parkinson disease (PD) is the second most common neurodegenerative disease, which has impacts on the patient’s quality of life due to non-motor symptoms such as sleep disorders, anxiety, and depression. Traditional Chinese medicine (TCM) has gained increasing attention in the diagnosis and treatment of PD with the concept of “overall concepts and dialectical treatment.” Therefore, exploring the characteristics of TCM in the treatment of PD can improve the level of diagnosis and treatment of PD. Methods: A comprehensive literature search was conducted using the following electronic databases: PubMed, Web of Science, Embase, Scopus, Cochrane Library, and China National Knowledge Infrastructure. The inclusion criteria were randomized controlled trials (RCTs) that compared TCM intervention with conventional treatments or placebo for non-motor symptoms in PD. The quality of the included RCTs was assessed using the Cochrane risk of bias tool. Results: A total of 9 RCTs involving 1714 participants with PD were included in this systematic review and meta-analysis. The meta-analysis showed that TCM was effective in improving non-motor symptoms, including depression (Hamilton depression rating scale [HAMD], weighted mean difference [WMD] = 4.24, 95% CI = 2.84–5.65, P < .0001), anxiety (HAMA, WMD = 4.03, 95% CI = 2.64–5.41, P < .0001), autonomic dysfunction (Scales for Outcomes in Parkinson’s disease–Autonomic, WMD = 4.57, 95% CI = 1.69–7.45, P = .002), non-motor symptoms (Movement Disorder Society-Unified Parkinson’s Disease Rating Scale-part 1, WMD = 0.66, 95% CI = 0.20–1011, P = .004), and quality of life (PDQ-39, WMD = 6.72, 95% CI = 0.87–12.58, P < .05), compared with baseline. Zishen Pingchan granules was particularly effective for depression (HAMD, WMD = −1.94, 95% CI = −3.07 to −0.81, P < .001, compared to placebo; HAMD, WMD = 3.40, 95% CI = 0.52–6.28, P < .05, after treatment). Pingchan granules was particularly effective for quality of life after treatment (PDQ-39, WMD = 10.20, 95% CI = 1.87−18.53, P < .05). Conclusions: TCM is effective and safety for improvement of depression, anxiety, autonomic dysfunctions, and quality of life in PD. Zishen Pingchan granules was particularly effective for depression; and Pingchan granules was particularly effective for quality of life.

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

Cited by 8 publications

References 40 publications

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

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

Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study

Traditional Chinese Medicine for non-motor symptoms in Parkinson disease: A systematic review and meta-analysis of RCTs

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