Evidence map›Paper›PMID 32456617›Full record

Trial reportBMC neurology2020

DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis: a single-center, randomized, double-blind, placebo-controlled study.

Dawei Chen, Yanwei Yin, Jin Shi, Fen Yang, Kehua Wang, Faguo Zhao, Wenping Li, Bin Li

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): A randomized, controlled, multicenter trial.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2023
    Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. 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

8 authors at 1 institution in 1 country.

Dawei ChenDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Yanwei YinDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Jin ShiDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China. shijin_dr9@126.com.ORCID http://orcid.org/0000-0003-4217-3869
Fen YangDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Kehua WangDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Faguo ZhaoDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Wenping LiDepartment of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Bin LiPET Center, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.
Air Force General Hospital PLA · CN

Funding

Dl-3-butylphthalide phase IV clinical study 2014ZX09104002-002
6 · The paper itself

Abstract

backgroundDL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis.

methodsIn this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200 mg or 20 mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively.

results48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5% ± 11.4% vs. 85.8% ± 12.5%, p = 0.000), whereas no change was found in placebo group (86.9% ± 11.6% vs. 87.8% ± 11.7%, p = 0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2 = 5.247, OR = 3.31, p = 0.022).

conclusionsNBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis.

trial registrationChinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered (http://www.chictr.org.cn/index.aspx).

Indexed as

BenzofuransDouble-Blind MethodHumansIntracranial ArteriosclerosisNeuroprotective Agents3-n-butylphthalideBenzofuransNeuroprotective AgentsCerebral atherosclerotic stenosisCerebral blood flowCerebral hypoperfusionDL-3-n-butylphthalideSingle-photon emission computed tomography

Identifiers

PMID32456617
PMCPMC7251861
OpenAlexW3032278475

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.