Evidence map›Paper›PMID 35962349›Full record

Trial reportJournal of translational medicine2022

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.

Houxu Ning, Hao Zhou, Jingru Ren, Gaiyan Zhou, Ning Yang, Zhenfu Wang, Canxing Yuan, Zuojun Tian, Juping Chen, Lihua Shen and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. 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

15 authors at 9 institutions in 1 country.

Houxu Ning *Department of Chinese Medicine, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Hao Zhou *Department of Neurology, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Jingru RenDepartment of Neurology, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Gaiyan ZhouDepartment of Neurology, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Ning YangDepartment of Chinese Medicine, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Zhenfu WangDepartment of Neurology, Chinese PLA General Hospital, Beijing, 100036, China.
Canxing YuanDepartment of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Zuojun TianDepartment of Neurology, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, 510000, China.
Juping ChenDepartment of Neurology, Changshu Hospital of Traditional Chinese Medicine, Changshu, 215500, China.
Lihua ShenDepartment of Neurology, Affiliated Hospital of Nantong University, Nantong University, Nantong, 226000, China.
Huifen ZhengDepartment of Neurology, Geriatric Hospital of Nanjing Medical University, Nanjing Medical University, Nanjing, 210000, China.
Yang ZhaoDepartment of Neurology, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210022, China.
Haidong WangDepartment of Chinese Medicine, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Weiguo LiuDepartment of Neurology, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China. wgliunbh@sina.com.ORCID 0000-0001-5916-9837
Zhenguo LiuDepartment of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China. zhenguoliu2011@aliyun.com.
Nanjing Brain Hospital · CNNanjing University of Chinese Medicine · CNChangshu No.1 People's Hospital · CNChinese PLA General Hospital · CNFirst Affiliated Hospital of Guangzhou Medical University · CNNanjing Medical University · CNNantong University · CNShanghai Jiao Tong University · CNShanghai University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveZishen 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).

methodsA 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.

resultsAfter 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.

conclusionZPG 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.

Indexed as

Parkinson DiseaseAgedBenzothiazolesDepressionDouble-Blind MethodHumansPramipexoleProspective StudiesQuality of LifeSeverity of Illness IndexTreatment OutcomeBenzothiazolesPramipexoleDepression in the Parkinson's diseasePramipexoleRandomized controlled trialZishen Pingchan granules

Identifiers

PMID35962349
PMCPMC9373440
OpenAlexW4291123483

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Registered trials

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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.