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

Abstract

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

Polyvinylpyrrolidone-Capped Copper Oxide Nanoparticles-Anchored Pramipexole Attenuates the Rotenone-Induced Phenotypes in a Drosophila Parkinson’s Disease Model

“…RT plus PVP–CuO NPs did not show any significant increase in climbing activity compared to RT-induced PD flies (Figure ; F (7, 56) = 20.37; P < 0.05), and those exposed to RT plus PPX–PVP–CuO NC showed a significant increase of 1.04-fold in climbing activity, compared to RT plus PPX-exposed flies (Figure ; F (7, 56) = 20.37; P < 0.05). The control groups PPX, PPX–PVP–CuO NC, and PVP–CuO NPs did not show any significant decrease in the climbing activity compared to the control group (Figure ; F (7, 56) = 20.37; P < 0.05), as it was reported earlier that PPX effectively improves motor functions and depressive symptoms in PD-induced animal and flies. , These findings lead to the present observations about the better affinity of PPX–PVP–CuO NC compared to RT-induced PD flies. The RT-induced PD flies lost jumping and flying activity compared to the control group.…”

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

“…We considered 5 trials [8,12,13,15,19] to be at low risk of attrition bias, as no participants withdraw, or had low rates of missing data, or an intention-to-treat analysis were performed in the statistical analysis. Two trials [16,18] were to be at high risk of attrition bias, as the missing data was not performed with intention-to-treat analysis.…”

“…We rated 7 trials [8,[13][14][15][16][17]19] to be at low risk of selection bias as they performed appropriate allocation concealment. Two trials were rated to be at high risk of selection bias as they did not report the methods of allocation concealment.…”

Clinical evidence and mechanisms of traditional Chinese medicine in major diseases

“…After 200 PD patients complicated with depression who were taking pramipexole (an antihistamine used to treat PD and its syndromes) were administered Zishen Pingzhan granules or a placebo for 12 weeks, patients in the TCM treatment group showed significant improvement in depression scale scores and PD sleep scale scores compared with those in the placebo group, and they also demonstrated better tolerability and safety. [61] 3.1.2. Mechanisms…”