Evidence map›Paper›PMID 31076468›Full record

Trial reportBMJ open2019

Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial.

Liling Zeng, Guanghai Tang, Jing Wang, Jianbin Zhong, Zhangyong Xia, Jiexia Li, Guangsheng Chen, Yongbo Zhang, Saihua Luo, Gan Huang and 16 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01918722 (Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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.

NCT01918722 phase4unknown statusnot on this map

Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety

TypeinterventionalSponsorGuangzhou University of Traditional Chinese MedicineRan2013 to 2016Enrolled360ConditionsIntracerebral HemorrhageArmsICH-1(herbal medicine with Hirudo, Tabanus), placebo, ICH-2(herbal medicine without Hirudo, Tabanus)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. 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

26 authors.

Liling ZengThe Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Guanghai TangNeurology, Shenyang No. 2 hospital of traditional Chinese Medicine, Shenyang, China.
Jing WangNeurology, Shenzhen Longhua New District Center Hospital, Shenzhen, China.
Jianbin ZhongNeurology, Boji-affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Zhangyong XiaNeurology, Liaocheng People's Hospital, Liaocheng Clinical School of Taishan Medical University, Liaocheng, China.
Jiexia LiNeurology, Guangzhou Conghua district Hospital of Traditional Chinese Medicine, Guangzhou, China.
Guangsheng ChenNeurology, Boluo County People's Hospital, Huizhou, China.
Yongbo ZhangNeurology, Shouguang City People's Hospital, Shouguang, China.
Saihua LuoNeurology, Lianjiang People's Hospital, Lianjiang, China.
Gan HuangNeurology, Yangjiang Hospital of Traditional Chinese Medicine, Yangjiang, China.
Qianshan ZhaoNeurology, Jiangmen Wuyi Hospital of Chinese Medicine, Jiangmen, China.
Yue WanNeurology, Zhongshan Hospital of Hubei Province, Wuhan, China.
Chaojun ChenNeurology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou, China.
Kaiyun ZhuNeurology, Panyu district Hospital of Chinese Medicine, Guangzhou, China.
Hanzi QiaoNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Jian WangNeurology, First Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.
Tao HuangNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Xian LiuNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Qixin ZhangNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Rongming LinNeurology, Guangdong Second Hospital of Traditional Chinese Medicine, Guangzhou, China.
Haijun LiNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Baoying GongNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Xiuyan ChenNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Yuexiang ZhouNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Zehuai WenKey Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Jianwen GuoNeurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and efficacy of removing blood stasis (RBS) herbal medicine for the treatment of acute intracerebral haemorrhage (AICH) within a 6-hour time window. STUDY

designA randomised, multicentre, double-blind, placebo-controlled study performed in 14 hospitals in China. PARTICIPANTS AND

interventionsPatients with AICH were randomly assigned to receive a placebo, the ICH-1 (Intracerebral Haemorrhage) formula (eight herbs, including the RBS herbs OUTCOMES: The primary safety outcome was the incidence of haematoma enlargement at 24 hours and at 10 days after treatment. The secondary outcome was the incidence of poor prognosis (mortality or modified Rankin Scale score ≥5) assessed at 90 days after symptom onset.

resultsA total of 324 subjects were randomised between October 2013 and May 2016: 105 patients received placebo; 108 patients received the ICH-1 formula; and 111 patients received the ICH-2 formula. The incidence of haematoma enlargement at 24 hours was 7.8% in the placebo group, 12.3% in the ICH-1 group and 7.5% in the ICH-2 group; the incidence of haematoma enlargement on day 10 was 1.1% in the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 group, with no significant differences among the groups (P>0.05). The mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, and 0.9% in the ICH-2 group; the incidences of poor prognosis were 7.1% in the placebo group, 6.0% in the ICH-1 group and 4.8% in the ICH-2 group at 3 months, with no significant differences among the groups (p>0.05). However, the overall frequency of treatment-emergent adverse events in the ICH-1 group (12.1%) was higher among the three groups (5.8% and 2.8%, respectively, p

conclusionsUltra-early administration of ICH-1 formula for AICH patients did not exert significant beneficial effects on clinical outcomes but increased the risk of bleeding, which probably resulted from the inclusion of RBS herbal medicines in ICH-1. TRIALREGISTRATION NUMBER: NCT01918722.

Indexed as

Cerebral HemorrhageDrugs, Chinese HerbalHematomaHemorrhagePhytotherapyBlood CoagulationChinaDouble-Blind MethodDrug MonitoringFemaleHumansIncidenceMaleMiddle AgedMortalityTime-to-TreatmentDrugs, Chinese Herbalcrrichhematoma enlargementherbal medicineintracerebral hemorrhagerandomized controlled trials

Identifiers

PMID31076468
PMCPMC6528012

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.