Evidence map›Paper›PMID 35698234›Full record

ArticleChinese medicine2022

Traditional Chinese medicine syndrome differentiation and treatment by stages of Parkinson's disease: study protocol for a multicentre, randomized, double-blind, placebo-controlled clinical trial.

Yuqing Hu, Sichun Gu, Xiaolei Yuan, Hui Li, Canxing Yuan, Qing Ye

Open access · goldAbstract read
In one paragraph

Article in Chinese medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Yuqing Hu *Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.
Sichun Gu *Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.
Xiaolei YuanEncephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.
Hui LiEncephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.
Canxing YuanEncephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.
Qing YeEncephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China. qingye@shutcm.edu.cn.
Shanghai University of Traditional Chinese Medicine · CNLonghua Hospital Shanghai University of Traditional Chinese Medicine · CN

Funding

Scientific and Innovative Action Plan of Shanghai 21Y31920300
6 · The paper itself

Abstract

backgroundParkinson'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.

methodsThis 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). EXPECTED OUTCOMES: 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.

trial registrationThis trial is registered at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ). REGISTRATION NUMBER: ChiCTR2200056373, Date: 2022-02-04, version 1.

Indexed as

Parkinson’s diseaseSyndrome differentiationTraditional Chinese medicine

Identifiers

PMID35698234
PMCPMC9190110
OpenAlexW4282823892

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.