Abstract

Nonmotor symptoms (NMS) of Parkinson's disease (PD) have devastating impacts on both patients and their caregivers. Jiawei-Liujunzi Tang (JLT) has been used to treat some NMS of PD based on the Chinese medicine theory since Qing dynasty. Here we report a double-blind, randomized, placebo-controlled, add-on clinical trial aiming at evaluating the efficacy and safety of the JLT in treating NMS in PD patients. We randomly assigned 111 patients with idiopathic PD to receive either JLT or placebo for 32 weeks. Outcome measures were baseline to week 32 changes in Movement Disorder Society-Sponsored Revision of Unified PD Rating Scale (MDS-UPDRS) Parts I–IV and in NMS assessment scale for PD (NMSS). We observed improvements in the NMSS total score (p = 0.019), mood/cognition (p = 0.005), and reduction in hallucinations (p = 0.024). In addition, post hoc analysis showed a significant reduction in constipation (p < 0.001). However, there was no evidence of improvement in MDS-UPDRS Part I total score (p = 0.216) at week 32. Adverse events (AEs) were mild and comparable between the two groups. In conclusion, long-term administration of JLT is well tolerated and shows significant benefits in improving NMS including mood, cognition, and constipation.

Highlights

  • Parkinson’s disease (PD) is the second most common neurodegenerative disease in the world, with a prevalence rate of 1% in the population over age of 60 [1]

  • We observed a trend of improvement; a decreased score was obtained at week 32 in JiaweiLiujunzi Tang (JLT) group which suggested an improvement in nonmotor symptoms (NMS) in the MDSUPDRS Part I total score in the JLT group relative to the placebo group, though the difference was not statistically significant

  • The data indicate a significant difference in NMS assessment scale for PD (NMSS) for Parkinson’s disease total score between JLT group and placebo group after 32 weeks of treatment

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Summary

Introduction

Parkinson’s disease (PD) is the second most common neurodegenerative disease in the world, with a prevalence rate of 1% in the population over age of 60 [1]. Increasing attention has been paid to nonmotor aspects which might precede motor symptoms [2]. Common nonmotor symptoms (NMS) of PD include fatigue, mood disorders, hallucinations, constipation, and sleep disorders [3]. Though not fatal, they reduce quality of life for both patients and their caregivers [4]. The most common treatment for PD is levodopa. Levodopa primarily treats motor symptoms and it typically generates adverse events after long-term use [5]. As a result of both the failure of levodopa improving NMS and its side effects, patients often seek alternative treatments [6]

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