Evidence map›Paper›PMID 32664145›Full record

Trial reportMedicine2020

A randomized double-blind placebo-controlled multicenter trial of Bushen Yisui and Ziyin Jiangzhuo formula for constipation in Parkinson disease.

Zhaohui Jin, Zhengtang Liu, Lei Kang, Aoran Yang, Hongbo Zhao, XiaoYan Yan, Tianqing Zhang, Lei Gao, Aixian Liu, Boyan Fang

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 32% 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

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

  1. Pooled it
  2. Review
  3. 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

10 authors at 5 institutions in 2 countries.

Zhaohui JinParkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.ORCID 0000-0003-2079-8059
Zhengtang LiuGeriatrics Department, China Academy of Chinese Medical Sciences Xiyuan Hospital.
Lei KangMedical Insurance Office, Dongzhimen Hospital of Beijing University of Chinese Medicine.
Aoran YangTraditional Chinese Medicine Rehabilitation Center, Beijing Rehabilitation Hospital, Capital Medical University.
Hongbo ZhaoTraditional Chinese Medicine Rehabilitation Center, Beijing Rehabilitation Hospital, Capital Medical University.
XiaoYan YanPeking University Clinical Research Institute, Peking University First Hospital.
Tianqing ZhangNeurology Department, Beijing Longfu Hospital, Beijing, China.
Lei GaoParkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.
Aixian LiuParkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.
Boyan FangParkinson Medical Center, Beijing Rehabilitation Hospital, Capital Medical University.
Capital Medical University · CNBeijing United Family Hospital · CNDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine · CNPeking University · CNXiyuan Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionConstipation is a common nonmotor symptom of Parkinson disease (PD). Constipation can also impact patient's quality of life. Chinese herbal medicines have been used for the treatment of constipation in PD. This trial will evaluate the efficacy and safety of a Chinese herbal formula Bushen Yisui and Ziyin Jiangzhuo (BYZJ) for the treatment of constipation in PD. METHODS AND ANALYSIS: This randomized, double-blind, placebo-controlled, multicenter clinical trial will involve 4 hospitals in Beijing, China. The study will aim to recruit 90 PD patients with constipation between 30 and 80 years-of age with a score of 1 - 4 on the Hoehn and Yahr scale. Once recruited, Patients will be randomized into a BYZJ group or a placebo group in a 2:1 ratio. The trial will include a 1-week run-in period, a 4-week double-blind treatment period, a 4-week and a 12-week follow-up period. All patients will be educated about PD-related constipation during the run-in period. BYZJ granules and simulated granules will be administered twice daily for 4 weeks to the BYZJ group and the placebo group respectively. Assessments will be performed during run-in period, before the start of treatment (baseline, week 0), and at 4, 8, and 16 weeks. The primary outcome will be measured with the Constipation Severity Instrument, and secondary outcomes will be evaluated with the Patient Assessment of Constipation Quality of Life questionnaire, Bristol Stool Form Scale, Movement Disorders-Unified Parkinson Disease Rating Scale, Nonmotor Symptoms Scale, PD Sleep Scale, Parkinson Fatigue Scale-16. Laxative use (dose and frequency) will also be recorded. Intention-to-treat and per-protocol set analyses will be used to compare symptom improvement between the 2 groups. Any adverse events will be recorded. DISCUSSION: If found effective and safe, BYZJ formula will be one of Chinese herb to treat constipation and even other nonmotor or motor symptoms in PD patients. The results will sustain the broader use of BYZJ formula in PD.

Indexed as

AdultAgedAged, 80 and overConstipationDefecationDouble-Blind MethodDrugs, Chinese HerbalFemaleFollow-Up StudiesHumansMaleMiddle AgedParkinson DiseaseQuality of LifeTreatment Outcomebushen yisuiDrugs, Chinese Herbaljiangzhuo huoxue yishen

Identifiers

PMID32664145
PMCPMC7360320
OpenAlexW3041248212

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.