Hu Yuqing, Gu Sichun, Yuan Xiaolei, Li Hui, Yuan Canxing, Ye Qing
Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.
Chin Med. 2022 Jun 13;17(1):68. doi: 10.1186/s13020-022-00625-4.
Parkinson's disease (PD) is a progressive neurodegenerative disease common in aged populations. Classified by Hoehn & Yahr stages, patients are often divided into mild/early stage, moderate/middle stage, and advanced/late stage. With disease progression, PD shows high heterogeneity in each stage. Based on traditional Chinese medicine (TCM) syndrome differentiation theory and our previous works, we found that during the early stage, the main syndrome is Yin deficiency of the liver and kidney; during the moderate stage, the main syndromes are phlegm heat and wind stirring and blood stasis and wind stirring; and during the late stage, the dominant syndromes are deficiency of Yin and Yang and deficiency of Qi and blood. Hence, we proposed a new model of TCM treatment by the stage of PD. Based on Shudi Pingchan formula, an experimental formula of our team, we developed Ziyin Pingchan formula, Jiedu Pingchan formula, and Fuzheng Pingchan formula to treat each stage. This study is designed to evaluate the therapeutic effect of treating Parkinson's disease by stages using traditional Chinese medicine and to provide an evidence base for forming a standardized scheme of diagnosis and treatment.
This study is designed as a multicentre, randomized, double-blind, placebo-controlled clinical trial. Patients will be stratified into 3 subgroups according to Hoehn & Yahr stage; 172, 168, and 72 participants will be required to be in the mild PD, moderate PD, and advanced PD subgroups, respectively, and will be randomized into the treatment or control group at a 1:1 ratio. The mild PD subgroup will receive a 48-week intervention, and the other 2 groups will receive a 24-week intervention. All groups will have a follow-up visit 12 weeks after starting the intervention. The intervention group will receive the Ziyin Pingchan formula, Jiedu Pingchan formula, or Fuzheng Pingchan formula, and the control group will receive the corresponding placebo. The primary outcomes will be the first addition of levodopa for the mild PD subgroup, the duration of the "OFF" period for the moderate PD subgroup, and the Parkinson's Disease Questionnaire (PDQ-39) for the advanced PD subgroup. The secondary outcomes will also be verified by subgroups, including the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), and the nonmotor symptom scale (NMSS).
To our knowledge, this is the first trial to combine TCM syndrome differentiation with PD clinical stages and put it into clinical practice. The results of this trial will provide clinical evidence for the therapeutic effect of TCM formulas on PD patients of all stages and help build a new TCM treatment by stage model of PD.
This trial is registered at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ).
ChiCTR2200056373, Date: 2022-02-04, version 1.
帕金森病（PD）是一种在老年人群中常见的进行性神经退行性疾病。根据Hoehn & Yahr分期，患者通常分为轻度/早期、中度/中期和重度/晚期。随着疾病进展，帕金森病在每个阶段都表现出高度异质性。基于中医综合征分化理论和我们之前的研究，我们发现早期主要证型为肝肾阴虚；中期主要证型为痰热动风、血瘀动风；晚期主要证型为阴阳两虚、气血两虚。因此，我们提出了一种基于帕金森病阶段的中医治疗新模式。基于我们团队的实验方熟地平颤方，我们开发了滋阴平颤方、解毒平颤方和扶正平颤方来治疗各个阶段。本研究旨在评估中医分期治疗帕金森病的疗效，并为形成标准化诊疗方案提供循证依据。
本研究设计为一项多中心、随机、双盲、安慰剂对照的临床试验。患者将根据Hoehn & Yahr分期分为3个亚组；轻度帕金森病、中度帕金森病和重度帕金森病亚组分别需要172、168和72名参与者，并将以1:1的比例随机分为治疗组或对照组。轻度帕金森病亚组将接受48周的干预，其他2组将接受24周的干预。所有组在开始干预12周后进行随访。干预组将接受滋阴平颤方、解毒平颤方或扶正平颤方，对照组将接受相应的安慰剂。主要结局指标将是轻度帕金森病亚组首次加用左旋多巴的时间、中度帕金森病亚组“关”期的持续时间以及重度帕金森病亚组的帕金森病问卷（PDQ-39）。次要结局指标也将按亚组进行验证，包括统一帕金森病评定量表（UPDRS）、帕金森病睡眠量表-2（PDSS-2）、帕金森病自主神经功能结局量表（SCOPA-AUT）和非运动症状量表（NMSS）。
据我们所知这是首次将中医综合征分化与帕金森病临床分期相结合并应用于临床实践的试验。本试验结果将为中药方剂对各阶段帕金森病患者的治疗效果提供临床证据，并有助于建立一种新的帕金森病中医分期治疗模式。
本试验在中国临床试验注册中心（http://www.chictr.org.cn/）注册。
ChiCTR2200056373，日期：2022年2月4日，版本1 。
