Evidence map›Paper›PMID 32361934›Full record

Trial reportChinese journal of integrative medicine2020

Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase II, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial.

Ming-Zhe Hu, Zi-Yi Zhou, Zhong-Yu Zhou, Hui Lu, Min Gao, Long-Min Liu, Hai-Qing Song, An-Ji Lin, Qing-Ming Wu, Hong-Fei Zhou and 3 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Chinese journal of integrative medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

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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

13 authors at 10 institutions in 1 country.

Ming-Zhe HuThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
Zi-Yi ZhouDepartment of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Zhong-Yu ZhouDepartment of Acupuncture and Moxibustion, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China.
Hui LuDepartment of Neurology, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning, 530011, China.
Min GaoDepartment of Neurology, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, 510095, China.
Long-Min LiuDepartment of Traditional Chinese Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200062, China.
Hai-Qing SongDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.
An-Ji LinDepartment of Traditional Chinese Medicine, Xiamen Hospital of Traditional Chinese Medicine, Xiamen, 361001, China.
Qing-Ming WuDepartment of Acupuncture and Moxibustion, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, 410005, China.
Hong-Fei ZhouDepartment of Neurology, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110032, China.
Lei LiSchool of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Xia WangYoucare Pharmaceutical Group Dingcheng Branch, Beijing, 100176, China.
Ye-Feng CaiDepartment of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China. caiyefeng@126.com.
Guangzhou University of Chinese Medicine · CNHubei Provincial Hospital of Traditional Chinese Medicine · CNCapital Medical University · CNGuangdong Provincial Hospital of Traditional Chinese Medicine · CNGuangxi University · CNHuazhong University of Science and Technology · CNHunan University of Traditional Chinese Medicine · CNLiaoning University of Traditional Chinese Medicine · CNShanghai University of Traditional Chinese Medicine · CNUnion Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effect and safety of Hydroxysafflor Yellow A for Injection (HSYAI) in treating patients with acute ischemic stroke (AIS) and blood stasis syndrome (BSS).

methodsA multicenter, randomized, double-blind, multiple-dose, active-controlled phase II trial was conducted at 9 centers in China from July 2013 to September 2015. Patients with moderate or severe AIS and BSS were randomly assigned to low-, medium-, high-dose HSYAI groups (25, 50 and 70 mg/d HSYAI by intravenous infusion, respectively), and a control group (Dengzhan Xixin Injection (, DZXXI) 30 mL/d by intravenous infusion), for 14 consecutive days. The primary outcome was the Modified Rankin Scale (mRS) score ⩽1 at days 90 after treatment. The secondary outcomes included the National Institute of Health Stroke Scale (NIHSS) score ⩽1, Barthel Index (BI) score ⩾95, and BSS score reduced ⩾30% from baseline at days 14, 30, 60, and 90 after treatment. The safety outcomes included any adverse events during 90 days after treatment.

resultsOf the 266 patients included in the effectiveness analysis, 66, 67, 65 and 68 cases were in the low-, medium-, and high-dose HSYAI and control groups, respectively. The proportions of patients in the medium- and high-dose HSYAI groups with mRS score ⩽1 at days 90 after treatment were significantly larger than the control group (P<0.05). The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium- and high-dose HSYAI groups were all significantly higher than the control group (P<0.05). No significant difference was reported among the 4 groups in any specific adverse events (P>0.05).

conclusionsHSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS. The medium (50 mg/d) or high dose (75 mg/d) might be the optimal dose for a phase III trial. (Registration No. ChiCTR-2000029608).

Indexed as

AgedBrain IschemiaCerebrovascular CirculationChalconeDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInjectionsMaleMiddle AgedQuinonesStrokeSurveys and QuestionnairesChalconehydroxysafflor yellow AQuinonesacute ischemic strokeblood stasis syndromeChinese medicinehydroxysafflor yellow Arandomized controlled trial

Identifiers

PMID32361934
OpenAlexW3022853084

What OpenQuestion holds

Textmetadata
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.