title: Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial.
abstract: OBJECTIVE
  To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation (TRABC) in treatment of hypertensive intracerebral hemorrhage (HICH).
  
  
  METHODS
  This was a multi-center prospective randomized open-label blinded-endpoint (PROBE) trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale (mRS). Secondary outcomes were the absorption of hematoma and edema, National Institutes of Health Stroke Scale (NIHSS) scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded.
  
  
  RESULTS
  After 3 months of treatment, the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%, respectively, and in the control group 48.1% and 63.9%, respectively, with a significant difference between groups (P<0.01). Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group (P=0.038). Average Barthel scores in the treatment group after treatment was 89.11±19.93, and in the control group 82.18±24.02 (P=0.003). NIHSS scores of the two groups after treatment decreased significantly compared with before treatment (P=0.001). Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment (P<0.05). There were 4 deaths, 2 in each group, and 11 adverse events, 6 in the treatment group and 5 in the control group.
  
  
  CONCLUSIONS
  The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment, without increasing intracerebral hematoma expansion and re-bleeding.
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Jing-Ya
authors.initials: JY
authors.lastname: Li
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Li-Xin
authors.initials: LX
authors.lastname: Yuan
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. 13522973039@163.com.
authors.forename: Gen-Ming
authors.initials: GM
authors.lastname: Zhang
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhou
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Gao
authors.affiliation: Tongzhou Traditional Chinese Medicine Hospital of Beijing, Beijing, 101100, China.
authors.forename: Qing-Bin
authors.initials: QB
authors.lastname: Li
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Che
authors.initials: C
authors.lastname: Chen
mesh_terms: D001775:Blood Circulation; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use; D023381:Endpoint Determination; D005260:Female; D006406:Hematoma / Q000097:blood / Q000150:complications / Q000188:drug therapy; D006801:Humans; D020299:Intracranial Hemorrhage, Hypertensive / Q000097:blood* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020521:Stroke / Q000097:blood / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Chinese herbs; activating blood circulation to remove stasis; hypertensive intracerebral hemorrhage; prospective randomized open-label blinded-endpoint trial