Evidence map›Paper›PMID 33881715›Full record

Trial reportChinese journal of integrative medicine2021

Efficacy of Yangyin Yiqi Huoxue Granule () in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial.

Yu Wang, Jie-Hong Yang, Hai-Tong Wan, Yu He, Bin Xu, Chang-Shan Ai, Hui-Fen Zhou, Li Yu, Hao-Fang Wan, Xiao-Dong Bie

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Chinese journal of integrative medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 17% 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, 14 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

10 authors at 2 institutions in 1 country.

Yu WangInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
Jie-Hong YangInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
Hai-Tong WanInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China. whtong@126.com.
Yu HeInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
Bin XuNeurology Department, Xinhua Hospital of Zhejiang Province, Hangzhou, 310005, China.
Chang-Shan AiNeurology Department, Integrated Medicine Hospital of Jilin Province, Yanbian, Jilin Province, 133001, China.
Hui-Fen ZhouInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
Li YuInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
Hao-Fang WanInstitute of Cardio-Cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, 310053, China.
Xiao-Dong BieChinese Medicine Department, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China.
Zhejiang Chinese Medical University · CNSecond Affiliated Hospital of Zhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (, YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage.

methodsThe total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG, ), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation, and secondary outcomes were the National Institute of Health Stroke Scale (NIHSS) score, Barthel activities of daily living (ADL) index score, the quality of life index (QLI) score, and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed.

resultsThe total of 288 participants were recruited between June 1, 2008 and September 30, 2009, and 287 patients received intervention; the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose, low-dose, positive and placebo control groups were 63.38%, 31.94%, 36.11% and 6.14%, respectively; there was a statistical difference between the two groups (P<0.01), while the high-dose YYHG treatment group was significantly higher than the other 3 groups (P<0.01). The improvement of NIHSS, ADL, QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group (P<0.05). In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale, the YYHG high-dose group was significantly better than the other three groups (P<0.05), and the YYHG low-dose group was better than the placebo control group (P<0.01). At the same time, except for the QLI score, the high-dose group was better than the low-dose group (P<0.05). In terms of safety, adverse reactions after YYHG treatment were generally mild (3.78%), and no serious adverse reactions have been reported.

conclusionYYHG is safe and effective in the treatment of IS patients with QYDBSS.

Indexed as

Brain IschemiaIschemic StrokeStrokeActivities of Daily LivingHumansQiQuality of LifeYin DeficiencyChinese medicineqi-yin deficiency and blood stasis syndromerandomized controlled trialstroke

Identifiers

PMID33881715
OpenAlexW3154988080

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.