Meta AnalysisID 6048
灯盏生脉胶囊治疗缺血性脑卒中：随机对照试验的系统评价和Meta分析
CRD42016042914
Is Chinese patent medicine Dengzhan Shengmai capsule effective and safe for treatment of ischemic stroke?
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Record Fields
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- Meta Analysis Id
- 6048
- Evidence Id
- 14606
- Core Evidence Id
- 14606
- Source Meta Analysis Id
- 6031
- Herb2 Meta Analysis Id
- HBMA006031
- Crd Id
- CRD42016042914
- Title
- Dengzhan shengmai capsule for ischemic stroke: a systematic review and meta-analysis of randomized controlled trials
- Review Question
- Is Chinese patent medicine Dengzhan Shengmai capsule effective and safe for treatment of ischemic stroke?
- Study Type Included
- We included randomized controlled trials (RCTs) studying Dengzhan Shengmai capsule for ischemic stroke.We also included RCTs without describing a randomization procedure.Both published and unpublished trials were included. We applied no restrictions regarding the language of publication and combined multiple publications reporting the same trial into one study.
- Condition Being Studied
- Stroke is a neurological impairment due to an acute focal injury of the central nervous system by a vascular cause. It is now the second most common cause of death and a leading cause of disability across the world according to the report of WHO.Most strokes (87%) are ischemic.The ischemic stroke mortality rate and recurrence rate is 21.8% and 30% respectively.There are no clinically effective neuroprotective agents until now. All available therapies for ischemic stroke convalescence or sequelae stage only are antiplatelet therapy, anticoagulant therapy, controlling blood pressure and blood lipids, but only have a moderate effect.
- Participant
- Participants should have been diagnosed by brain CT or MRI to confirm infarction and exclude hemorrhage regardless of their sex, age , race or disease stage were eligible .
- Animal
- Human Disease Modelled
- Intervention
- Chinese patent medicine Dengzhan Shengmai capsule (major ingredients include erigeron breviscapus, radix ginseng, radix ophiopogonis and fructus schisandrae) was regarded as the intervention, regardless of its dosage, duration.
- Comparator Control
- Placebo, an effective Western medicine or Chinese patent medicine intervention which was supported by reasonable clinical evidence. We also allowed a co-intervention if applied in all arms.
- Main Outcome
- Acute stage: (1) Death. (2) Disability or dependence defined as Barthel Index (BI) scores (People who are severely disabled and have to depend on help from other people for their activities of daily living). (3) Serious adverse events: fatal, life threatening, requiring change of treatment regimen. Convalescence(and sequelae stage): (1) Disability or dependence defined as Barthel Index (BI) scores. (2) quality of life. (3)recurrent rate. (4)Serious adverse events. Unclear stage: Don't distinguish between primary and secondary outcomes. Measures of effect at the end of the scheduled treatment or follow up period.
- Outcome Measure
- Additional Outcome
- Acute stage: (1) Changes of neurological deficit after treatment. The measures can focus on specific impairment (e.g., motor deficit or cognitive impairment) or global neurological deficit (e.g., the National Institutes of Health Stroke Scale (NIHSS);the Neurological Function Deficit Score (NFDS), a nationwide accepted scoringsystem recommended at the Fourth National Cerebrovascular Diseases Conference in China. (2) Quality of life if assessed in the included trials by validated scale without limitations on the specific scales used. (3) Treatment failure, defined as reduction of NFDS less than 18% or death according to the nationally approved criteria in China. (4) Non-serious adverse event. Convalescence (and sequelae stage): (1) Changes of neurological deficit after treatment. (2) Death. (3) Treatment failure. (4) Non-serious adverse event. Unclear stage:Don't distinguish between primary and secondary outcomes. Measures of effect At the end of the scheduled treatment or follow up period.
- Study Method
- Intervention, Systematic review
- Keyword
- Brain Ischemia; Capsules; Drugs, Chinese Herbal; Humans; Randomized Controlled Trials as Topic; Stroke
- Contact
- Ms Xiao-ying [email protected]
- Organisational Affiliation
- Beijing university of Chinese medicine http://www.bucm.edu.cn/
- Funding Source
- This work is supported by a research capacity establishment grant from the State Administration of Chinese Medicine (201207007)
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2016-07-22
- Anticipated Start Date
- 2016-02-20
- Anticipated Completion Date
- 2016-08-31
- Title Cn
- 灯盏生脉胶囊治疗缺血性脑卒中：随机对照试验的系统评价和Meta分析
- Title En
- Dengzhan shengmai capsule for ischemic stroke: a systematic review and meta-analysis of randomized controlled trials
- Bilingual Status
- complete