Evidence map›Paper›PMID 36251140›Full record

Trial reportChinese journal of integrative medicine2022

Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial.

Xiao-Fei Yu, Xu-Ying Zhu, Can-Xing Yuan, Dan-Hong Wu, Yu-Wu Zhao, Jia-Jun Yang, Chang-de Wang, Wei-Wen Wu, Xue-Yuan Liu, Zhen-Guo Liu and 13 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Chinese journal of integrative medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02334969 (A Multi-center, Randomized, Double-blind and Placebo-controlled Clinical Research of 2200 Cases in Improving Curative Effect of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02334969 phase4completednot on this map

A Multi-center, Randomized, Double-blind and Placebo-controlled Clinical Research of 2200 Cases in Improving Curative Effect of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

TypeinterventionalSponsorXiaofei YuRan2016 to 2018Enrolled2,200ConditionsIschemic StrokeArmsNaoxintong Capsule, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

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

23 authors.

Xiao-Fei YuDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Xu-Ying ZhuDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Can-Xing YuanDepartment of Neurology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.
Dan-Hong WuDepartment of Neurology, Shanghai Third People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, 201900, China.
Yu-Wu ZhaoDepartment of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China.
Jia-Jun YangDepartment of Neurology, Shanghai Sixth People's Hospital East Branch, Shanghai, 201306, China.
Chang-de WangDepartment of Neurology, Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200083, China.
Wei-Wen WuDepartment of Neurology, Zhongshan Hospital Qingpu Branch Affiliated to Fudan University, Shanghai, 201799, China.
Xue-Yuan LiuDepartment of Neurology, Shanghai Tenth People's Hospital Affiliated to Tongji University, Shanghai, 200072, China.
Zhen-Guo LiuDepartment of Neurology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
Zhi-Yu NieDepartment of Neurology, Shanghai Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China.
Ben-Qiang DengDepartment of Neurology, Changhai Hospital, Shanghai, 200433, China.
Huan BaoDepartment of Neurology, Orient Hospital Affiliated to Tongji University, Shanghai, 200120, China.
Long-Xuan LiDepartment of Neurology, Shanghai Pudong New Area Gongli Hospital, Shanghai, 200135, China.
Chun-Yan WangDepartment of Neurology, Shanghai Yangpu Hospital of Traditional Chinese Medicine, Shanghai, 200090, China.
Hong-Zhi ZhangDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Jing-Si ZhangDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Ji-Han HuangCenter for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Fan GongDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Ming-Zhe WangDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Yong-Mei GuoDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Yan SunDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Ding-Fang CaiDepartment of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. dingfangcai@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding.

methodsA total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle.

resultsA total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05).

conclusionThe combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969).

Indexed as

Ischemic StrokeStrokeAdultCerebral HemorrhageDouble-Blind MethodDrugs, Chinese HerbalHumansPlatelet Aggregation InhibitorsSecondary PreventionDrugs, Chinese HerbalnaoxintongPlatelet Aggregation InhibitorsChinese medicineischemic strokeNaoxintong Capsulerandomized controlled trialsecondary prevention

Identifiers

PMID36251140

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Registered trials

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.